Document ID: FDA-2014-N-0189-82904
Agency: fda
Document Type: Rule
Title: Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and
Cosmetic Act, as Amended by the Family Smoking Prevention and
Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco
Products and Required Warning Statements for Tobacco Products
Posted Date: 2016-05-10T04:00Z

[Federal Register Volume 81, Number 90 (Tuesday, May 10, 2016)]
[Rules and Regulations]
[Pages 28973-29106]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-10685]

[[Page 28973]]

Vol. 81

Tuesday,

No. 90

May 10, 2016

Part III

Department of Health and Human Services

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Food and Drug Administration

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21 CFR Parts 1100, 1140, and 1143

Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and 
Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco 
Control Act; Restrictions on the Sale and Distribution of Tobacco 
Products and Required Warning Statements for Tobacco Products; Final 
Rule

  Federal Register / Vol. 81 , No. 90 / Tuesday, May 10, 2016 / Rules 
and Regulations  

[[Page 28974]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1100, 1140, and 1143

[Docket No. FDA-2014-N-0189]
RIN 0910-AG38

Deeming Tobacco Products To Be Subject to the Federal Food, Drug, 
and Cosmetic Act, as Amended by the Family Smoking Prevention and 
Tobacco Control Act; Restrictions on the Sale and Distribution of 
Tobacco Products and Required Warning Statements for Tobacco Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is issuing this final 
rule to deem products meeting the statutory definition of ``tobacco 
product,'' except accessories of the newly deemed tobacco products, to 
be subject to the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 
as amended by the Family Smoking Prevention and Tobacco Control Act 
(Tobacco Control Act). The Tobacco Control Act provides FDA authority 
to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, 
smokeless tobacco, and any other tobacco products that the Agency by 
regulation deems to be subject to the law. With this final rule, FDA is 
extending the Agency's ``tobacco product'' authorities in the FD&C Act 
to all other categories of products that meet the statutory definition 
of ``tobacco product'' in the FD&C Act, except accessories of such 
newly deemed tobacco products. This final rule also prohibits the sale 
of ``covered tobacco products'' to individuals under the age of 18 and 
requires the display of health warnings on cigarette tobacco, roll-your 
own tobacco, and covered tobacco product packages and in 
advertisements. FDA is taking this action to reduce the death and 
disease from tobacco products. In accordance with the Tobacco Control 
Act, we consider and intend the extension of our authorities over 
tobacco products and the various requirements and prohibitions 
established by this rule to be severable.

DATES: This rule is effective August 8, 2016. See section IV of this 
document regarding compliance dates for certain provisions.

FOR FURTHER INFORMATION CONTACT: Gerie Voss or Katherine Collins, 
Office of Regulations, Center for Tobacco Products, Food and Drug 
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 877-
287-1373, AskCTP@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

Table of Contents

Executive Summary
I. Background
II. Legal Authority
    A. Summary of Legal Authority
    B. Responses to Comments Regarding Legal Authority
III. Use of Premarket Pathways for Newly Deemed Products
    A. Background: The Three Pathways To Market a New Tobacco 
Product
    B. Interpretation of Substantial Equivalence
    C. Comments on the Grandfather Date
    D. Impact of Premarket Requirements
    E. Clinical Studies and PMTAs
    F. Premarket Pathways and Continuum of Risk
    G. Other Comments
IV. Implementation
    A. Effective Date for Rule
    B. Compliance Periods for Certain Provisions
    C. Policy for Certain Regulatory Requirements for All 
Manufacturers of Newly Deemed Products
    D. Compliance Policy Regarding Certain Provisions and Small-
Scale Tobacco Product Manufacturers
V. Premarket Review Requirements and Compliance Policy
    A. Compliance Policy for Premarket Review Requirements
    B. Responses to Comments Regarding Compliance Periods for 
Premarket Review Requirements
VI. Components, Parts, and Accessories
    A. Definitions
    B. Discussion of Requirements Associated With Components and 
Parts
VII. Regulation of Cigars and Selection of Option 1
    A. Health Risks of Premium Cigars
    B. Youth and Young Adults Use Premium Cigars
    C. Patterns of Use Do Not Preclude Users From Experiencing 
Negative Health Effects
    D. Responses to Other Cigar Comments
VIII. Regulation of Electronic Nicotine Delivery Systems (Including 
E-Cigarettes) and the Continuum of Nicotine-Delivering Products
    A. Terminology
    B. Prevalence
    C. Toxicity and Nicotine in E-Liquid and Aerosol
    D. Quality Control
    E. Misperceptions
    F. Use as a Cessation Product
    G. Modified Risk Claims
    H. Dual and Polytobacco Use
    I. Applicability of Section 901
    J. Definitions
    K. Sottera Decision
IX. Effect of Deeming Rule on Vape Shop Manufacturers
    A. Premarket Requirements (Sections 910 and 905)
    B. Ingredient Listing and HPHC Requirements (Sections 904 and 
915)
    C. Registration and Product Listing (Section 905)
    D. Tobacco Health Document Submissions (Section 904)
    E. Office of Small Business Assistance
X. Regulation of Other Categories of Products
    A. Nicotine in Newly Deemed Products
    B. Dissolvables
    C. Gels
    D. Pipe Tobacco
    E. Waterpipe Tobacco
    F. Additional Novel and Future Tobacco Products
XI. Additional Automatic Provisions Applicable to Newly Deemed 
Products
    A. Sections 902 and 903--Adulteration and Misbranding
    B. Sections 904 and 915--Ingredient Listing and Reporting of 
HPHCs
    C. Section 905--Registration and Listing
    D. Section 911--Elimination of Low, Light, and Mild, and Other 
Unauthorized Modified Risk Claims
    E. Section 919--User Fees
    F. Tobacco Control Act section 102--Prohibition Against Free 
Samples
XII. Requests for Additional Regulations Applicable to Newly Deemed 
Products
    A. Ban on Flavored Tobacco Products
    B. Additional Access Restrictions
    C. Nicotine Exposure Warnings
XIII. Severability
XIV. Description of the Final Rule--Part 1100
    A. Section 1100.1--Scope
    B. Section 1100.2--Requirements
    C. Section 1100.3--Definitions
XV. Description of the Final Rule--Part 1140
    A. Section 1140.1--Scope
    B. Section 1140.2--Purpose
    C. Section 1140.3--Definitions
    D. Section 1140.10--General Responsibilities of Manufacturers, 
Distributors, and Retailers
    E. Section 1140.14--Additional Responsibilities of Retailers
    F. Comments and Responses Regarding Minimum Age and 
Identification Requirements
    G. Comments and Responses Regarding Vending Machines
XVI. Description of the Final Rule--Part 1143
    A. Section 1143.1--Definitions
    B. Section 1143.3--Required Warning Statement Regarding 
Addictiveness of Nicotine
    C. Section 1143.5--Required Warning Statements for Cigars
    D. Section 1143.7--Language Requirements for Required Warning 
Statements
    E. Section 1143.9--Irremovable or Permanent Required Warning 
Statements
    F. Section 1143.11--Does Not Apply to Foreign Distribution
    G. Section 1143.13--Effective Date
    H. Comments and Responses Regarding Required Warning Statements
XVII. National Environmental Policy Act
XVIII. Analysis of Impacts
XIX. Paperwork Reduction Act of 1995
    A. Responses to Comments Regarding Proposed Collection of 
Information
    B. Existing Burdens Associated With Tobacco Products Currently 
Subject to the FD&C Act (i.e., Cigarettes, Cigarette

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Tobacco, Roll-Your-Own Tobacco, and Smokeless Tobacco) With Approved 
OMB Control Numbers
    C. Burdens Associated With Tobacco Products Currently Subject to 
the FD&C Act But Not Yet Approved by OMB
    D. New Collections of Information That Apply Only to Deemed 
Products
XX. Executive Order 13132; Federalism
XXI. Executive Order 13175; Tribal Consultation
XXII. References

Executive Summary

Purpose of the Rule

    Cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless 
tobacco were immediately covered by FDA's tobacco product authorities 
in chapter IX of the FD&C Act (21 U.S.C. 387 through 387u) when the 
Tobacco Control Act went into effect. For other kinds of tobacco 
products, the statute authorizes FDA to issue regulations ``deeming'' 
them to be subject to such authorities. Consistent with the statute, 
once a tobacco product is deemed, FDA may put in place ``restrictions 
on the sale and distribution of a tobacco product,'' including age-
related access restrictions and advertising and promotion restrictions, 
if FDA determines the restrictions are appropriate for the protection 
of the public health. This final rule has two purposes: (1) To deem all 
products that meet the definition of ``tobacco product'' under the law, 
except accessories of a newly deemed tobacco product, and subject them 
to the tobacco control authorities in chapter IX of the FD&C Act and 
FDA's implementing regulations; and (2) to establish specific 
restrictions that are appropriate for the protection of the public 
health for the newly deemed tobacco products. In accordance with 
section 5 of the Tobacco Control Act, we consider and intend the 
extension of our authorities over tobacco products and the various 
requirements and prohibitions established by this rule to be severable.
    FDA is taking this action to reduce the death and disease from 
tobacco products. Deeming all ``tobacco products'' (including 
components and parts but excluding accessories of the newly deemed 
products) to be subject to the FD&C Act will result in significant 
benefits for the public health. The final rule defines ``component or 
part'' and ``accessory'' to provide additional clarity as to which 
products are subject to FDA's tobacco product authority. With respect 
to these definitions, FDA notes that ``component'' and ``part'' are 
separate and distinct terms within chapter IX of the FD&C Act. However, 
for purposes of this final rule, FDA is using the terms ``component'' 
and ``part'' interchangeably and without emphasizing the distinction 
between the terms. FDA may clarify the distinctions between `component' 
and `part' in the future. Specifically, ``Component or Part'' means 
``any software or assembly of materials intended or reasonably 
expected: (1) To alter or affect the tobacco product's performance, 
composition, constituents or characteristics; or (2) to be used with or 
for the human consumption of a tobacco product. The term excludes 
anything that is an accessory of a tobacco product.'' Components and 
parts of the newly deemed tobacco products, but not their related 
accessories, are included in the scope of this final rule. The 
following is a nonexhaustive list of examples of components and parts 
used with electronic nicotine delivery systems (ENDS) (including e-
cigarettes): E-liquids; atomizers; batteries (with or without variable 
voltage); cartomizers (atomizer plus replaceable fluid-filled 
cartridge); digital display/lights to adjust settings; clearomisers, 
tank systems, flavors, vials that contain e-liquids, and programmable 
software. Similarly, the following is a nonexhaustive list of examples 
of components and parts used with waterpipe tobacco: Flavor enhancers 
and the vials in which they are contained; hose cooling attachments; 
water filtration base additives (including those which are flavored); 
flavored waterpipe tobacco charcoals and the wrappers or boxes that 
contain the charcoals; and bowls, valves, hoses, and heads.
    FDA is defining ``accessory'' to mean ``any product that is 
intended or reasonably expected to be used with or for the human 
consumption of a tobacco product; does not contain tobacco and is not 
made or derived from tobacco; and meets either of the following: (1) Is 
not intended or reasonably expected to affect or alter the performance, 
composition, constituents, or characteristics of a tobacco product or 
(2) is intended or reasonably expected to affect or maintain the 
performance, composition, constituents, or characteristics of a tobacco 
product but (i) solely controls moisture and/or temperature of a stored 
product or (ii) solely provides an external heat source to initiate but 
not maintain combustion of a tobacco product.'' Examples of accessories 
are ashtrays, spittoons, hookah tongs, cigar clips and stands and pipe 
pouches, because they do not contain tobacco, are not derived from 
tobacco, and do not affect or alter the performance, composition, 
constituents, or characteristics of a tobacco product. Examples of 
accessories also include humidors or refrigerators that solely control 
the moisture and/or temperature of a stored product and conventional 
matches and lighters that solely provide an external heat source to 
initiate but not maintain combustion of a tobacco product. An electric 
heater or charcoal used for prolonged heating of waterpipe tobacco is 
not an accessory because it is maintaining the combustion of the 
tobacco. Accessories of newly deemed tobacco products are not included 
within the scope of this final rule, although accessories of 
cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless 
tobacco remain subject to FDA's tobacco product authorities. FDA is not 
regulating accessories of newly deemed tobacco products because 
accessories, unlike components or parts, are expected to have little 
direct impact on the public health.
    This final deeming rule affords FDA additional tools to reduce the 
number of illnesses and premature deaths associated with tobacco 
product use. For example, FDA will be able to obtain critical 
information regarding the health risks of newly deemed tobacco 
products, including information derived from ingredient listing 
submissions and reporting of harmful and potentially harmful 
constituents (HPHCs) required under the FD&C Act. As of the effective 
date, persons who own or operate a domestic establishment engaged in 
the manufacture, preparation, compounding, or processing of tobacco 
products (hereinafter, ``manufacturing establishments'') will be 
subject to the registration requirements. FDA will thus receive 
information on the location and number of manufacturing establishments, 
which will allow the Agency to establish effective compliance programs. 
In addition, this rule authorizes FDA to take enforcement action 
against manufacturers who sell and distribute products with 
unsubstantiated modified risk tobacco product (MRTP) claims, or false 
or misleading claims on their labeling or advertising, thus allowing 
for better-informed consumers and helping to prevent the use of 
misleading campaigns targeted to youth populations. It will also 
prevent from entering the market new tobacco products that are not 
appropriate for the protection of public health, are not substantially 
equivalent to a valid predicate product, or are not exempt from 
substantial equivalence (SE). Finally, the newly deemed tobacco 
products may be subject to future regulations that FDA determines are

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appropriate for the protection of public health.

Summary of the Major Provisions of the Regulatory Action

    The final rule has two main sections: (1) Deeming provisions and 
(2) additional provisions to protect public health.
    Deeming Provisions--After thorough review of the comments and the 
scientific evidence, FDA has concluded that Option 1 (including all 
cigars, rather than a subset) more effectively protects the public 
health and, therefore, has made that the scope of the final rule. 
Accordingly, this final rule deems all products meeting the statutory 
definition of ``tobacco product,'' except accessories of the newly 
deemed tobacco products, to be subject to FDA's tobacco product 
authorities under chapter IX of the FD&C Act. Section 201(rr) of the 
FD&C Act (21 U.S.C. 321(rr)), as amended by the Tobacco Control Act, 
defines the term ``tobacco product,'' to mean ``any product made or 
derived from tobacco that is intended for human consumption, including 
any component, part, or accessory of a tobacco product (except for raw 
materials other than tobacco used in manufacturing a component, part, 
or accessory of a tobacco product)'' and does not mean ``an article 
that is a drug under subsection (g)(1), a device under subsection (b), 
or a combination product described in section 353(g) of this title.'' 
\1\ Products that meet the statutory definition of ``tobacco products'' 
include currently marketed products such as dissolvables not already 
regulated by FDA, gels, waterpipe tobacco, ENDS (including e-
cigarettes, e-hookah, e-cigars, vape pens, advanced refillable personal 
vaporizers, and electronic pipes), cigars, and pipe tobacco.
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    \1\ FDA notes that some products falling within the FD&C Act's 
definition of ``tobacco product'' may not be considered tobacco 
products for Federal excise tax purposes (see 26 U.S.C. 5702(c)). 
Taxation of tobacco products, as defined by the Internal Revenue 
Code, falls under the jurisdiction of the U.S. Department of the 
Treasury/Alcohol and Tobacco Tax and Trade Bureau (TTB). Neither 
FDA's act of ``deeming'' nor any other FDA regulations directly 
affect the taxation of any tobacco product.
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    In addition, this final rule deems any additional current and 
future tobacco products that meet the statutory definition of ``tobacco 
product,'' except accessories of such newly deemed products, to be 
subject to FDA's authorities under chapter IX of the FD&C Act. For 
example, FDA envisions that there could be tobacco products developed 
in the future that provide nicotine delivery through means (e.g., via 
dermal absorption or intranasal spray) similar to currently marketed 
medicinal nicotine products, but which are not drugs or devices. These 
products would be ``tobacco products'' and subject to FDA's chapter IX 
authorities in accordance with this final deeming rule.
    Upon the effective date of this final rule (i.e., 90 days from the 
date of publication), the newly deemed products will be subject to the 
same FD&C Act provisions and relevant regulatory requirements to which 
cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless 
tobacco are subject, with respect to the following:
    (1) Enforcement action against products determined to be 
adulterated or misbranded (other than enforcement actions based on lack 
of a marketing authorization during an applicable compliance period);
    (2) Required submission of ingredient listing and reporting of 
HPHCs;
    (3) Required registration of tobacco product manufacturing 
establishments and product listing;
    (4) Prohibition against sale and distribution of products with 
modified risk descriptors (e.g., ``light,'' ``low,'' and ``mild'' 
descriptors) and claims unless FDA issues an order authorizing their 
marketing;
    (5) Prohibition on the distribution of free samples (same as 
cigarettes); and
    (6) Premarket review requirements.
    These actions will improve the public health by affording FDA 
critical information regarding the health risks of such products; 
preventing new products from entering the market unless such marketing 
is appropriate for the protection of public health, the products are 
found substantially equivalent to a valid predicate product, or the 
products are found exempt from the SE requirements; and preventing the 
use of unsubstantiated modified risk claims, which may mislead 
consumers and lead them to initiate tobacco product use or to continue 
using tobacco when they would otherwise quit.
    Additional Provisions--In addition to the provisions in the FD&C 
Act and implementing regulations that apply automatically to the newly 
deemed products, FDA has the authority to invoke its other authorities 
under the Tobacco Control Act in regulating these products. At this 
time, under section 906(d) of the FD&C Act (21 U.S.C. 387f(d)), FDA is 
establishing three restrictions for covered tobacco products: (1) 
Requirement for a minimum age of purchase; (2) requirement for health 
warnings for product packages and advertisements (which FDA is also 
applying to cigarette tobacco and roll-your-own tobacco); and (3) 
prohibition of vending machine sales of such products, unless the 
vending machine is located in a facility where the retailer ensures 
that individuals under 18 years of age are prohibited from entering at 
any time. The term ``covered tobacco products'' is defined as those 
products deemed to be subject to the FD&C Act under section 1100.2 of 
title 21 of the Code of Federal Regulations (CFR), other than a 
component or part that is not made or derived from tobacco. We have 
slightly modified the definition of ``covered tobacco products'' from 
the notice of proposed rulemaking (NPRM) to clarify that components or 
parts that are ``covered tobacco products'' include not only those that 
contain tobacco or nicotine, but also those that contain any tobacco 
derivative (i.e., we have changed the NPRM definition, which excluded 
``any component or part of a tobacco product that does not contain 
nicotine or tobacco,'' to exclude ``any component or part of a tobacco 
product that is not made or derived from tobacco'' as stated in this 
final rule).
    Effective Dates--The deeming provisions (i.e., those provisions 
that automatically apply to newly deemed products) and minimum age and 
identification and vending machine restrictions are effective 90 days 
from the date of publication of the final rule. The health warning 
requirements are effective 24 months from the date of publication of 
the final rule, with an additional 30-day period in which a 
manufacturer may continue to introduce into interstate commerce 
existing inventory manufactured before the effective date that does not 
contain the required warning statements on packaging.
    This means that:
     After the effective date, no manufacturer, packager, 
importer, distributor, or retailer of cigarette tobacco, roll-your-own 
tobacco, cigars, or other covered tobacco products may advertise any 
such product if the advertisement does not comply with this rule;
     After the effective date, no person may manufacture for 
sale or distribution within the United States any such product the 
package of which does not comply with this rule;
     Beginning 30 days after the effective date, a manufacturer 
may not introduce into domestic commerce, any such product, 
irrespective of the date of manufacture, if its package does not comply 
with this rule (i.e., non-compliant products manufactured prior to the 
effective date may not be

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distributed for retail sale after 30 days following the effective 
date);
     After the effective date, a distributor or retailer may 
not sell, offer to sell, distribute, or import for sale or distribution 
within the United States any such product the package of which does not 
comply with this regulation, unless the covered tobacco product was 
manufactured prior to the effective date; and
     After the effective date, however, a retailer may sell 
covered tobacco products in packages that do not have a required 
warning if the retailer demonstrates it falls outside the scope of this 
rule as described in 21 CFR 1143.3(a)(3) and 1143.5(a)(4).
    Compliance Policy for Premarket Review--Manufacturers of newly 
deemed products that are ``new tobacco products'' as defined in section 
910(a)(1) of the FD&C Act will be required to obtain premarket 
authorization of their products through one of three pathways--SE., 
exemption from SE., or premarket tobacco product applications (sections 
905 and 910 of the FD&C Act). As stated in the NPRM, we understand 
that, for some newly deemed tobacco products, particularly novel 
products, there may not be appropriate predicate products that were on 
the market on February 15, 2007, to support a SE claim. Accordingly, in 
the NPRM, FDA contemplated a compliance period of 24 months after the 
effective date of the final rule for the submission of applications for 
all newly deemed, new tobacco products under all three marketing 
pathways--premarket tobacco applications (PMTAs), SE reports, and SE 
exemption requests.\2\
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    \2\ Although the NPRM did not explicitly include SE exemption 
requests as one of the marketing pathways that applicants could 
utilize within a compliance period, FDA did intend for its 
contemplated 24-month compliance period to be available for all 
marketing pathways.
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    FDA carefully considered numerous comments regarding the 
contemplated compliance period. Many comments expressed concern that 
newly deemed, new tobacco products would remain available and could 
continue to be marketed indefinitely without scientific review. Other 
comments expressed concern, and some submitted data, regarding the 
effect that flavors have on youth and young adult use of tobacco 
products. FDA also received comments and data regarding the potential 
for some net public health benefits that could accrue if flavored ENDS 
remain available. After carefully considering all of these comments, 
FDA here announces a revised compliance policy as well as the final 
rule. (Agency compliance/enforcement policies are not subject to the 
requirements that govern notice-and-comment rulemaking. Prof'ls & 
Patients for Customized Care v. Shalala, 56 F.3d 592 (5th Cir. 1995) (a 
compliance policy guide is not a substantive rule and not subject to 
the Administrative Procedure Act's (APA) notice-and-comment 
rulemaking); Takhar v. Kessler, 76 F.3d 995, 1002 (9th Cir. 1996) (FDA 
compliance policy guides were not required to go through notice-and-
comment procedures). But because the relevant time periods are of 
obvious interest, FDA laid out its anticipated compliance policy in the 
NPRM, and for similar reasons, is announcing its revised compliance 
policy here, rather than in a separate guidance document.) As a result 
of FDA's compliance policy, we expect that many manufacturers will keep 
their products on the market beyond the effective date of this final 
rule. However, if a manufacturer of a product is unable to support an 
SE claim for its product (e.g., is unable to identify a valid 
predicate, or does not submit an SE report with a valid predicate 
within the compliance period, or does not receive authorization within 
a continued compliance period) and does not obtain authorization under 
one of the other available marketing pathways before the end of an 
applicable compliance period, such products remaining on the market 
will be subject to enforcement (e.g., seizure, injunction) for failure 
to have a marketing authorization under sections 905 and 910 of the 
FD&C Act.
    FDA's NPRM included detailed requests for comments on different 
possible compliance policy approaches. 79 FR at 23175-77. FDA received 
many comments on these compliance-policy issues. For example, comments 
jointly submitted by 24 health and medical organizations stated that 
the contemplated 24-month compliance period and indefinite period of 
continued marketing during FDA review included in the NPRM would 
prolong the public's exposure to products that contain nicotine, a 
highly addictive substance, and that do not meet the statutory standard 
for the grant of a marketing order (Comment No. FDA-2014-N-0189-
79772.). They stated that this approach would allow manufacturers to 
market the newly deemed products in ways that appeal to youth and to 
manipulate the content of these products in uncontrolled ways for an 
indefinite period (id.). Ranking minority members of the Energy and 
Commerce Committee, Health Subcommittee, and Oversight and 
Investigations Subcommittee, U.S. House of Representatives also called 
for a more protective compliance period than the one contemplated in 
the NPRM, arguing that the proposed compliance period ``puts the 
nation's youth at risk'' (Comment No. FDA-2014-N-0189-80119). Further, 
a network of tobacco control policy and legal specialists expressed 
concern regarding the effect of continued marketing of tobacco products 
that have not been reviewed under the applicable public health 
standards of the Tobacco Control Act (Comment No. FDA-2014-N-0189-
81044). FDA also received comments suggesting that the agency should 
stagger the compliance periods for different product classes based on 
the continuum of risk, with ENDS having a longer compliance period than 
other product classes (e.g., Comment No. FDA-2014-N-0189-81859; Comment 
No. FDA-2014-N-0189-10852). FDA also received comments and new data 
regarding the effect of flavored tobacco products on youth and young 
adult use.
    FDA understands that the appeal of flavors and use of flavored 
tobacco products have an important role in the initiation and continued 
use of tobacco products, and in the health risks associated with use of 
these products. Based on all of these comments, we have determined that 
exercising enforcement discretion indefinitely could put youth and 
young adults at risk for tobacco-related death and disease. However, we 
recognize that the availability of alternatives to traditional tobacco 
flavors in some products (e.g., ENDS) may potentially help some adult 
users who are attempting to transition away from combusted products. 
Furthermore, at least some flavored combusted products are likely to be 
``grandfathered'' and therefore would remain on the market regardless 
of the compliance period provided in the preamble. Taking into 
consideration all of the comments on the compliance period and flavors, 
we are establishing staggered compliance periods. This approach will 
enable FDA to balance concerns regarding the extended availability of 
all newly deemed, new tobacco products without scientific review, 
concerns regarding flavored tobacco products' appeal to youth, and 
emerging evidence that some adults may potentially use certain flavored 
tobacco products to transition away from combusted tobacco use. FDA is 
establishing staggered initial compliance periods based on the expected 
complexity of the applications to be submitted, followed by continued

[[Page 28978]]

compliance periods for FDA review such that our exercise of enforcement 
discretion will end twelve months after each initial compliance period. 
In other words, manufacturers of all newly deemed, new tobacco products 
will have a 12-, 18- or 24-month initial compliance period in which to 
prepare applications for marketing authorization, as well as a 12-month 
continued compliance period after those dates in which to obtain 
authorization from FDA (resulting in total compliance periods of 24, 
30, or 36 months). After the close of the continued compliance period, 
products will be subject to enforcement unless they are grandfathered 
or are the subject of a marketing authorization order. FDA's revised 
compliance policy for premarket review--resulting in products remaining 
on the market while manufacturers seek review but also contemplating an 
end to the continued compliance policy--will balance the public health 
concerns raised in the comments, allow the Agency to more efficiently 
manage the flow of incoming applications, and encourage high-quality 
premarket submissions from applicants.
    According to this revised compliance policy, for newly deemed 
products that are on the market on the effective date of this final 
rule and were not on the market on February 15, 2007, FDA is providing 
a 12-month initial compliance period for manufacturers to submit (and 
FDA to receive) an SE exemption request, an 18-month initial compliance 
period for manufacturers to submit (and FDA to receive) SE 
applications, and a 24-month initial compliance period for 
manufacturers to submit (and FDA to receive) a PMTA.
    If manufacturers submit (and FDA receives) the applications during 
their respective compliance periods, FDA, for a certain period of time 
as discussed in the following paragraph, intends to continue the 
compliance policy and does not intend to initiate enforcement action 
for these products remaining on the market without FDA authorization.
    For newly deemed tobacco products using the SE Exemption pathway, 
this continued compliance period (i.e., the time during which FDA does 
not intend to enforce the premarket review requirements) will close 24 
months after the effective date of part 1100 of this final deeming rule 
(i.e.,12 months after the 12-month initial compliance period closes for 
submission and receipt of SE exemption requests). The earlier 
submission period for the SE exemption pathway is intended to allow the 
manufacturer time to consider other pathways if the exemption request 
is denied or if FDA refuses to accept the request if, for example, the 
application is incomplete. For newly deemed tobacco products using the 
SE pathway, this continued compliance period will close 30 months after 
the effective date of part 1100 of this final deeming rule (i.e., 12 
months after the 18-month initial compliance period closes for 
submission and receipt of SE Reports). For newly deemed tobacco 
products using the PMTA pathway, this continued compliance period will 
close 36 months after the effective date (i.e., 12 months after the 24-
month compliance period closes for submission and receipt of PMTAs). 
Any such newly deemed tobacco product for which an application under 
one of the three marketing pathways has not been submitted within 24 
months from the effective date of part 1100 of this final deeming rule 
will not benefit from this continued compliance policy and will be 
subject to enforcement as of that date. In addition, once the 
respective continued compliance period ends for products with 
applications submitted according to this policy, products remaining on 
the market without premarket authorizations in effect, even if the 
product has a pending application that was originally submitted by its 
respective initial compliance deadline set forth previously in this 
document, will be subject to enforcement. However, if at the time of 
the conclusion of the continued compliance period, the applicant has 
provided the needed information and review of a pending marketing 
application has made substantial progress toward completion, FDA may 
consider, on a case-by-case basis, whether to defer enforcement of the 
premarket authorization requirements for a reasonable time period.
    Regarding concerns as to the inability to use the SE pathway for 
certain products, FDA notes that an applicant may use as a predicate 
any tobacco product commercially marketed in the United States as of 
February 15, 2007, or previously found substantially equivalent (note 
that we interpret the phrase ``as of'' February 15, 2007, as meaning 
that the tobacco product was commercially marketed (other than 
exclusively in test markets) in the United States on February 15, 2007. 
If your tobacco product had been commercially marketed in the United 
States before February 15, 2007, but was not commercially marketed on 
that date, it is not a grandfathered product and may not be 
commercially marketed unless you obtain a marketing authorization under 
section 910 of the FD&C Act).\3\ This may possibly include a predicate 
that is in a different category or subcategory than the new product 
that is the subject of the SE report. While FDA currently does not have 
a policy that limits comparisons to the same category, we do see cross-
category comparisons as more challenging for an applicant and we may 
express limitations on such comparisons in the future, if they become 
warranted as we gain experience regulating newly deemed products. FDA 
also is continuing to research e-cigarettes, other ENDS, and heated 
cigarette products that likely were on the market ``as of'' (i.e., on) 
February 15, 2007. Additionally, FDA has determined that some e-
cigarettes and other ENDS were manufactured in 2006 and commercially 
marketed in the United States in early 2007. In particular, we have 
identified an ENDS product that may have been on the market on February 
15, 2007. This product may possibly be able to serve as a valid 
predicate for purposes of the SE pathway. The burden of demonstrating 
that a valid predicate exists rests with the manufacturer submitting a 
SE report. To facilitate the determination that a product is eligible 
to serve as a valid predicate, any individual who has evidence that an 
e-cigarette or other ENDS was commercially marketed in the United 
States on February 15, 2007, may submit a stand-alone grandfather 
submission to FDA (See final guidance, ``Establishing That a Tobacco 
Product Was Commercially Marketed in the United States as of February 
15, 2007'' (79 FR 58358, September 29, 2014)). (Based on FDA's 
experiences to date, and since stand-alone grandfather submissions are 
purely voluntary, FDA does not anticipate that many manufacturers will 
make such submissions, but this option is available.) Regardless of the 
predicate selected for comparison, manufacturers are responsible for 
providing scientific data adequate to demonstrate that, in the case of 
an SE report, the characteristics of the new product are the same as 
the predicate or, if the characteristics are different, that these 
differences do not cause the new product to raise different questions 
of public health. We encourage interested parties to review the 
applications FDA

[[Page 28979]]

posts on http://www.fda.gov for examples of products that do not raise 
different questions of public health when compared with the specified 
predicate product.
---------------------------------------------------------------------------

    \3\ FDA Guidance states that ``[i]f you cannot provide 
documentation specifically dated on February 15, 2007, FDA suggests 
you provide documentation of commercial marketing for a reasonable 
period of time before and after February 15, 2007.'' Guidance for 
Industry entitled ``Establishing That a Tobacco Product Was 
Commercially Marketed in the United States as of February 15, 2007 
(79 FR 58358, Sept. 29, 2014), The guidance also provides examples 
of sources of evidence, e.g., bills of lading.
---------------------------------------------------------------------------

    Vape Establishments Acting as Manufacturers--Several comments asked 
FDA to clarify whether e-cigarette retail stores and vape 
establishments are considered ``tobacco product manufacturers'' under 
the FD&C Act. In response, FDA has explained that establishments that 
mix or prepare e-liquids or create or modify aerosolizing apparatus for 
direct sale to consumers are tobacco product manufacturers under the 
definition set forth in the FD&C Act and, accordingly, are subject to 
the same legal requirements that apply to other tobacco product 
manufacturers.
    Revisions to Health Warning Requirements--FDA is finalizing this 
deeming rule with a few changes to the proposed health warning 
requirements for newly deemed products. For example, FDA has slightly 
revised the nicotine warning statement to read: ``WARNING: This product 
contains nicotine. Nicotine is an addictive chemical.'' The alternative 
warning statement for products that do not contain nicotine (i.e., no 
nicotine at detectable levels) is revised to read: ``This product is 
made from tobacco.'' We have also provided additional language 
explaining the process for self-certifying that the product does not 
contain nicotine, which must be submitted to FDA, and the recordkeeping 
recommendations for this self-certification. E-liquids that do not 
contain tobacco or nicotine or are not derived from tobacco or nicotine 
do not meet the definition of ``covered tobacco product,'' as described 
throughout this final rule, and will not be required to carry an 
addiction warning or to submit a self-certification. In addition, we 
have added language to clarify that the warning statements on packages 
must be printed in at least 12-point font size to be conspicuous and 
legible.
    Further, we have added a provision to indicate that a product 
package too small or otherwise unable to accommodate a label with 
sufficient space to bear such information will be exempt from the 
requirements to place the warning statement directly on packages (as 
required in Sec.  1143.3(a)(1)), as long as the warning requirements 
enumerated in Sec.  1143.3(a)(2) and (d) are met. For instance, for 
small packages, the warning statement must appear on the two principal 
display panels on the outer carton or other outer container or wrapper 
or on a tag otherwise permanently affixed to the tobacco product 
package. This required warning must be printed using the same 
specifications in Sec.  1143.3(a)(1) and (2) (which provide the 
specifications for the addiction warning). In such cases, the carton, 
outer container, wrapper, or tag would serve as one of the principal 
display panels.
    Reproductive Health Warning for Cigars--In the proposed deeming 
rule, FDA proposed to require four of the five warnings already 
included on most cigar packages and in most cigar advertisements as a 
result of settlement agreements between the Federal Trade Commission 
(FTC) and the seven largest U.S. cigar manufacturers (hereinafter, 
``FTC consent decrees''). (See, e.g., In re Swisher International, 
Inc., Docket No. C-3964.) FDA did not propose to require the fifth 
warning (SURGEON GENERAL WARNING: Tobacco Use Increases the Risk of 
Infertility, Stillbirth and Low Birth Weight), but asked for comments 
regarding this decision. Upon further consideration, FDA has decided to 
require a fifth warning regarding reproductive health effects and cigar 
use specifically, which reads ``WARNING: Cigar use while pregnant can 
harm you and your baby.'' This requirement is supported by existing 
scientific evidence and is appropriate for the protection of the public 
health. However, because the general statement ``Tobacco smoke 
increases the risk of infertility, stillbirth and low birth weight'' is 
also a true statement, and because scientific evidence demonstrates 
that cigar smoke is similar in content and effects to cigarette smoke, 
FDA is allowing the use of the reproductive health warning required by 
the FTC consent decrees as an optional alternative to the fifth FDA 
warning. FDA expects that providing the optional alternative will 
benefit entities bound by the FTC consent decrees.
    Nicotine Exposure Warning and Child-Resistant Packaging--After 
reviewing the comments, FDA recognizes the importance of alerting 
consumers to, and protecting children from, the hazards from ingestion 
of, and eye and skin exposure to, e-liquids containing nicotine. Toward 
that end, FDA issued an advance NPRM (ANPRM) prior to this deeming rule 
(80 FR 51146 (2015)), seeking comments, data, research, or other 
information that may inform regulatory actions FDA may take with 
respect to a nicotine exposure warning and child-resistant packaging. 
In addition, elsewhere in this issue of the Federal Register, FDA has 
made available draft guidance, which when final will describe FDA's 
current thinking regarding some appropriate means of addressing the 
premarket authorization requirements for newly deemed ENDS products, 
including recommendations for exposure warnings and child-resistant 
packaging that would help to support a showing that the marketing of a 
product is appropriate for the protection of public health.
    Requests for Additional Regulations Applicable to Newly Deemed 
Products--In the NPRM, FDA noted that, once the products were deemed, 
the Agency could issue additional regulations applicable to newly 
deemed products, including product standards under section 907 of the 
FD&C Act (21 U.S.C. 387g). FDA received many suggestions for additional 
regulations that should apply to the newly deemed products. FDA is 
taking these comments under advisement and considering whether to issue 
NPRMs for such provisions.
    Compliance Policy Regarding Certain Provisions and Small-Scale 
Tobacco Product Manufacturers--In the NPRM, FDA requested comment on 
the ability of small manufacturers of newly deemed tobacco products to 
fully comply with the requirements of the FD&C Act and how FDA might be 
able to address those concerns. Considering the comments and FDA's 
finite enforcement resources, the Agency's view is that those resources 
may not be best used in immediately enforcing certain provisions of 
this rule against certain manufacturers that are small-scale tobacco 
product manufacturers and that may need additional time to comply with 
certain requirements of the FD&C Act. Generally, for purposes of this 
new compliance policy in which FDA is specifying additional periods of 
time for such manufacturers to comply with certain provisions (i.e., 
additional time to respond to SE deficiency letters, an additional six-
month compliance period for the tobacco health document submission 
requirements, and additional time to submit ingredient listings, as 
discussed in Section IV.D). As with manufacturers generally, these 
small-scale tobacco manufacturers will also benefit from additional 
assistance with their marketing applications, including: a Regulatory 
Health Project Manager so that they have a single point of contact in 
FDA's Center for Tobacco Products (CTP's) Office of Science (OS) for 
questions about their marketing applications; an appeals process for 
denial of marketing applications (of which one small business has 
already taken advantage); and staff from CTP's Office of Compliance and 
Enforcement (OCE), who assist such businesses in helping them to 
identify documents that may be used to establish that their

[[Page 28980]]

predicate products were on the market on February 15, 2007. Further, 
CTP's OCE will continue to assist small-scale tobacco product 
manufacturers in their submission of rotational warning plans for FDA 
approval and to provide a system to assist such businesses in 
navigating the regulatory requirements of FDA. FDA considers a ``small-
scale tobacco product manufacturer'' to be a manufacturer of any 
regulated tobacco product that employs 150 or fewer full-time 
equivalent employees and has annual total revenues of $5,000,000 or 
less. In formulating our thinking on what a small-scale tobacco product 
manufacturer is for purposes of this policy, FDA has considered all 
available data on employment, revenues, production volume and other 
details of operation for current manufacturers of newly deemed 
products. FDA considers a manufacturer to include each entity that it 
controls, is controlled by, or is under common control with. To help 
make FDA's individual enforcement decisions more efficient, a 
manufacturer may voluntarily submit information regarding employment 
and revenues.\4\
---------------------------------------------------------------------------

    \4\ FDA notes that our current thinking regarding ``small-scale 
tobacco product manufacturer'' for purposes of this compliance 
policy differs from definitions of ``small manufacturer'' or ``small 
tobacco product manufacturer'' that pertain in several other 
contexts, including definitions established by the Small Business 
Administration or the Tobacco Control Act's definition of a ``small 
tobacco product manufacturer.'' FDA notes that its current thinking 
reflects an evaluation of all available data regarding manufacturers 
of newly deemed tobacco products, as well as careful review of the 
potentially unique interests of the smallest tobacco product 
manufacturers as considered in light of the Agency's statutory 
obligations regarding the protection of public health.
---------------------------------------------------------------------------

    Policy for Certain Regulatory Requirements for All Manufacturers of 
Newly Deemed Products--Although FDA maintains that all of the automatic 
provisions are important given that all tobacco products have inherent 
risks, FDA recognizes that compliance with many of the automatic 
provisions may be challenging at first for entities that are new to 
Federal public health regulation. In addition, FDA expects that it will 
obtain necessary information from its regulation of finished tobacco 
products. As a result, FDA has established a compliance policy for 
premarket submission and for obtaining authorization with respect to 
certain components and parts of newly deemed tobacco products. We note 
that FDA also intends to issue a guidance regarding HPHC reporting 
under section 904(a)(3), and later a testing and reporting regulation 
as required by section 915, with enough time for manufacturers to 
report given the 3-year compliance period for HPHC reporting. Section 
904(a)(3) requires the submission of a report listing all constituents, 
including smoke constituents identified as harmful or potentially 
harmful (HPHC) by the Secretary. Section 915 requires the testing and 
reporting of the constituents, ingredients, and additives the Secretary 
determines should be tested to protect the public health. The section 
915 testing and reporting requirements apply only after FDA issues a 
regulation implementing that section, which it has not yet done. Until 
these testing and reporting requirements have been established, newly 
deemed tobacco products (and currently regulated tobacco products) are 
not subject to the testing and reporting provisions found under section 
915. As noted elsewhere in this document, FDA does not intend to 
enforce the reporting requirements under section 904(a)(3) for newly 
deemed products before the close of the 3-year compliance period, even 
if the HPHC guidance and the section 915 regulation are issued well in 
advance of that time.
    Severability--In accordance with section 5 of the Tobacco Control 
Act, FDA considers and intends the extension of its authorities over 
all tobacco products and the various requirements and prohibitions 
established by this rule to be severable. It is FDA's interpretation 
and position that the invalidity of any provision of this rule shall 
not affect the validity of any other part of this rule. In the event 
any court or other lawful authority were to temporarily or permanently 
invalidate, restrain, enjoin, or suspend any provision of this final 
rule, FDA would conclude that the remaining parts continue to be valid. 
As stated in section 5 of the Tobacco Control Act, if certain 
applications of this rule to persons or circumstances (discussed in the 
preamble or otherwise) are held to be invalid, application of such 
provisions to any other person or circumstance will not be affected and 
will continue to be enforced. Each provision of the rule is 
independently supported by data and analysis as described or referenced 
in this preamble and, if issued separately, would remain a proper 
exercise of FDA authority.

Costs and Benefits

    This final rule deems all products meeting the statutory definition 
of ``tobacco product,'' except accessories of a newly deemed tobacco 
product, to be subject to chapter IX of the FD&C Act. This final rule 
also finalizes additional provisions that would apply to certain newly 
deemed products as well as to certain other tobacco products. Once 
deemed, tobacco products become subject to the FD&C Act and its 
implementing regulations. The FD&C Act requirements that will apply to 
newly deemed products include establishment registration and product 
listing, ingredient listing, HPHC testing and reporting, premarket 
submissions prior to the introduction of new products, and labeling 
requirements. Free samples of newly deemed tobacco products will also 
be prohibited. The additional provisions of this final rule include 
minimum age and identification requirements, vending machine 
restrictions, and required warning statements for packages and 
advertisements.

                                                   Table 1--Summary of Quantified Costs Over 20 Years
                                                                       [$ million]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                            Lower bound                     Upper bound     Lower bound                     Upper bound
                                                               (3%)        Primary  (3%)       (3%)            (7%)        Primary  (7%)       (7%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Present Value of Private Sector Costs...................           517.7           783.7         1,109.8           450.4           670.9           939.8
Present Value of Government Costs \1\...................           204.6           204.6           204.6           145.7           145.7           145.7
Present Value of Total Costs............................           722.3           988.2         1,314.4           596.1           816.5         1,085.4
Annualized Value of Private Sector Costs................            34.8            52.7            74.6            42.5            63.3            88.7
Annualized Value of Government Costs \1\................            13.8            13.8            13.8            13.8            13.8            13.8
Annualized Value of Total Costs.........................            48.5            66.4            88.3            56.3            77.1           102.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ FDA costs represent an opportunity cost, but this rule will not result in changes to overall FDA accounting costs, the size of the Federal budget,
  or the total amount of tobacco industry user fees.

[[Page 28981]]

    The direct benefits of making each of the newly deemed tobacco 
products subject to the requirements of chapter IX of the FD&C Act are 
difficult to quantify, and we cannot predict the size of these benefits 
at this time. Table 1 summarizes the quantified costs of this final 
rule over 20 years. For the reasons provided in the preamble and 
analysis of impacts, FDA has concluded that the benefits of the final 
rule justify the costs. Among other effects, new products will be 
subject to an evaluation to ensure they meet the appropriate public 
health standard for the pathway before they can be marketed, labeling 
cannot contain misleading statements, and FDA will be made aware of the 
ingredients in newly deemed tobacco products. If, without the final 
rule, new products would pose substantially greater health risks than 
those already on the market, the premarket requirements made effective 
by this final rule would keep such products from appearing on the 
market and worsening the health effects of tobacco product use. The 
warning statements required by this final rule will help consumers 
better understand and appreciate the risks and characteristics of 
tobacco products.

I. Background

    Cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless 
tobacco were immediately covered by FDA's tobacco product authorities 
in chapter IX of the FD&C when the Tobacco Control Act went into 
effect. For other tobacco products, the statute authorized FDA to issue 
regulations ``deeming'' them to be subject to such authorities. 
Consistent with the statute, once a tobacco product is deemed, FDA may 
put in place ``restrictions on the sale and distribution of a tobacco 
product,'' if FDA determines the restrictions are appropriate for the 
protection of the public health (21 U.S.C. 387f(d)(1)).
    The Surgeon General has long recognized that the addictive nature 
of tobacco products is due to the presence of highly addictive nicotine 
that can be absorbed into the bloodstream (see, e.g., Ref. 1 at 6-9). 
While the amount of nicotine delivered and the means through which it 
is delivered can either reduce or enhance nicotine's potential for 
abuse and physiological effects (Ref. 2 at 113), nicotine is addictive. 
In general, the quicker the delivery, rate of absorption, and 
attainment of peak concentrations of nicotine, the greater the 
potential for addiction (id.).
    The Surgeon General reported that ``most people begin to smoke in 
adolescence and develop characteristic patterns of nicotine dependence 
before adulthood'' (Ref. 3). These youth develop physical dependence 
and experience withdrawal symptoms when they try to quit smoking (id.). 
As a result, addiction to nicotine is often lifelong (Ref. 4), and 
youth and young adults generally ``underestimate the tenacity of 
nicotine addiction and overestimate their ability to stop smoking when 
they choose'' (Ref. 5). For example, in a study of over 1,200 sixth 
grade students who inhaled tobacco products, 58.5 percent had lost 
autonomy over their tobacco use (i.e., had difficulty trying to quit) 
(Ref. 6). One survey also revealed that ``nearly 60 percent of 
adolescents believed that they could smoke for a few years and then 
quit'' (Ref. 7). Research conducted in animal models has indicated that 
exposure to substances such as nicotine can disrupt prenatal brain 
development and may have long-term consequences on executive cognitive 
function and on the risk of developing a substance abuse disorder and 
various mental health problems as an adult (Ref. 8), and this exposure 
to nicotine can also have long-term results on decreasing attention 
performance and increasing impulsivity which could promote the 
maintenance of nicotine use behavior (id.).
    The Surgeon General also emphasizes that ``nicotine addiction 
develops as a neurobiologic adaptation to chronic nicotine exposure,'' 
suggesting that the pattern of tobacco product use (e.g., frequency of 
using the product) is a factor in the facilitation of nicotine 
addiction (Ref. 9 at 112). The Surgeon General also noted ``all forms 
of nicotine delivery do not pose an equal risk in establishing and 
maintaining addiction'' and this may be because the pharmacokinetics of 
various nicotine containing products differ (id.). The FDA-approved 
nicotine patch is an example of slow absorption and once-a-day dosing 
which results in minimal potential for addiction (Ref. 2 at 113). In 
1988, the Surgeon General recognized that the ultimate levels of 
nicotine absorbed into the blood from tobacco products on the market at 
that time can be similar in magnitude regardless of the product forms 
used to deliver nicotine (Ref. 1). For example, research has shown that 
oral use of smokeless tobacco products that do not emit smoke results 
in ``high venous concentrations of nicotine equal to those for use of 
cigarettes'' (Ref. 2 at 113).
    FDA believes that the inhalation of nicotine (i.e., nicotine 
without the products of combustion) is of less risk to the user than 
the inhalation of nicotine delivered by smoke from combusted tobacco 
products. However, limited data suggest that the pharmacokinetic 
properties of inhaled nicotine can be similar to nicotine delivered by 
combusted tobacco products. Thus, inhaled nicotine from a non-
combustible product may be as addictive as inhaled nicotine delivered 
by combusted tobacco products. Researchers recognize that the effects 
from nicotine exposure by inhalation without combustion are likely not 
responsible for the high prevalence of tobacco-related death and 
disease in this country (Refs. 10, 11). Although nicotine itself has 
not been shown to cause the chronic disease associated with tobacco 
use, the 2014 Surgeon General's report noted that there are still risks 
associated with nicotine (Ref. 9 at 111). For example, nicotine at high 
enough doses has acute toxicity (id.). Research in animal models have 
demonstrated that nicotine exposure during fetal development may have 
lasting adverse consequences for brain development (id.). Nicotine also 
adversely affects maternal and fetal health during pregnancy, 
contributing to multiple adverse outcomes such as preterm delivery and 
stillbirth (id.; citing Refs. 12, 13). Further, data from studies of 
mice also suggest that nicotine exposure during adolescence may have 
lasting adverse consequences for brain development (id.). Some studies 
in animal models also have found that nicotine can have detrimental 
effects on the cardiovascular system and potentially disrupt the 
central nervous system (Refs. 14, 15).
    ``Since the 1964 Surgeon General's report, comprehensive tobacco 
control programs and policies have been proven effective for 
controlling tobacco use'' (Ref. 9 at 36). Accordingly, FDA is issuing 
this final rule to serve two purposes: (1) To deem products that meet 
the definition of ``tobacco product'' under the law, except accessories 
of newly deemed tobacco products, and subject them to the tobacco 
control authorities in the FD&C Act; and (2) to establish specific 
restrictions that are appropriate for the protection of the public 
health for the newly deemed tobacco products. To satisfy these 
purposes, FDA proposed two options (Option 1 and Option 2), which 
provided two alternatives for the scope of the deeming provisions and, 
consequently, the application of the additional specific provisions. 
Under Option 1, all products meeting the definition of a ``tobacco 
product,'' except accessories of newly deemed tobacco products, would 
be deemed. Option 2 was the same as Option 1,

[[Page 28982]]

except a subset of cigars known as ``premium cigars'' would be 
excluded.
    Currently, tobacco products unregulated by FDA are widely available 
and come in many forms, including cigars, pipe tobacco, waterpipe 
tobacco, liquids (e-liquids) for ENDS (the most popular of which are 
electronic cigarettes, but also include e-hookah, e-cigars, vape pens, 
personal vaporizers, and electronic pipes), liquid nicotine that is 
made or derived from tobacco, nicotine gels, and certain dissolvable 
tobacco products (i.e., dissolvable products that do not currently meet 
the definition of ``smokeless tobacco'' in section 900(18) of the FD&C 
Act (21 U.S.C. 387(18)) because they do not contain cut, ground, 
powdered, or leaf tobacco and instead contain nicotine extracted from 
tobacco). Upon implementation of this final rule, currently unregulated 
tobacco products and future products meeting the definition of 
``tobacco product'' under section 201(rr) (except accessories of newly 
deemed tobacco products) will be subject to chapter IX of the FD&C Act.
    FDA issued a proposed deeming rule on April 25, 2014 (79 FR 23142). 
We received over 135,000 comments on the NPRM. Comments were received 
from tobacco product manufacturers, retailers, academia, medical 
professionals, local governments, advocacy groups, and consumers. To 
make it easier to identify comments and our responses, the word 
``Comment,'' in parentheses, will appear before each comment, and the 
word ``Response,'' in parentheses, will appear before each response. We 
have numbered the comments to make it easier to distinguish between 
comments; the numbers are for organizational purposes only and do not 
reflect the order in which we received the comments or any value 
associated with them. We have combined similar comments under one 
numbered comment. In addition to the comments specific to this 
rulemaking that we address in the following paragraphs, we received 
many general comments expressing support or opposition to the rule and 
separate provisions within the rule. These comments express broad 
policy views and do not address specific points related to this 
rulemaking. Therefore, these general comments do not require a 
response. Other comments outside the scope of this rulemaking also have 
not been addressed here. The remaining comments, as well as FDA's 
responses, are included in this document.

II. Legal Authority

A. Summary of Legal Authority

    As set forth in the preamble to the NPRM (79 FR 23142 at 23145), 
the Tobacco Control Act provided FDA with the authority to regulate 
tobacco products by, among other things, adding chapter IX to the FD&C 
Act. Section 901 of the FD&C Act (21 U.S.C. 387a) provides that this 
new chapter (Chapter IX--Tobacco Products) applies to all cigarettes, 
cigarette tobacco, roll-your-own tobacco, and smokeless tobacco and to 
any other tobacco products that the Secretary of Health and Human 
Services by regulation deems to be subject to this chapter. In 
accordance with section 901 of the FD&C Act, FDA issued a NPRM to 
extend FDA's ``tobacco product'' authorities to products that meet the 
statutory definition of ``tobacco product'' in section 201(rr) of the 
FD&C Act,\5\ except the accessories of these tobacco products, and 
provided two separate options as to the scope of cigar products that 
would be deemed subject to FDA's tobacco authorities. FDA is selecting 
Option 1 deeming all tobacco products, including premium cigars, except 
the accessories of the newly deemed products, with this final rule.
---------------------------------------------------------------------------

    \5\ Section 201(rr) of the FD&C Act defines ``tobacco product,'' 
in relevant part, as any product made or derived from tobacco that 
is intended for human consumption, including any component, part, or 
accessory of a tobacco product (except for raw materials other than 
tobacco used in manufacturing a component, part, or accessory of a 
tobacco product). 21 U.S.C. 321(rr).
---------------------------------------------------------------------------

    In addition, section 906(d)(1) of the FD&C Act authorizes FDA to 
require restrictions on the sale and distribution of a tobacco product, 
if the Agency determines that ``such regulation would be appropriate 
for the protection of the public health.'' FDA has determined that the 
additional restrictions included with this final rule (i.e., minimum 
age and identification requirements, vending machine restrictions, and 
health warning statements) are ``appropriate for the protection of the 
public health.''
    These authorities are supplemented by section 903 of the FD&C Act 
(21 U.S.C. 387c), which provides, among other things, that a tobacco 
product is misbranded unless the manufacturer, packer, or distributor 
thereof includes in all advertisements and other descriptive printed 
matter issued or caused to be issued by the manufacturer, packer, or 
distributor with respect to that tobacco product a brief statement of 
the uses of the tobacco product and relevant warnings, precautions, 
side effects, and contraindications (section 903(a)(8)(B)(i) of the 
FD&C Act). Section 903(a)(7)(B) of the FD&C Act also provides that a 
tobacco product is misbranded if it is sold or distributed in violation 
of a regulation prescribed under section 906(d) of the FD&C Act.
    In addition, section 701(a) of the FD&C Act (21 U.S.C. 371(a)) 
provides FDA with authority to issue regulations for the efficient 
enforcement of the FD&C Act.

B. Responses to Comments Regarding Legal Authority

    FDA received comments on a wide range of legal issues, including 
FDA's authority to deem tobacco products subject to the FD&C Act and 
constitutional issues that may be implicated by the NPRM. FDA carefully 
considered these comments and concludes that the Agency has authority 
to deem the tobacco products covered under this final rule. FDA is not 
aware of other legal concerns from comments that prevent the Agency 
from taking the actions included in this final rule. A summary of 
comments regarding legal authority, and FDA's responses, follows.
1. Section 901 Authority
    (Comment 1) Generally, the comments did not challenge FDA's 
authority under section 901 of the FD&C Act, but at least one comment 
argued that section 901 does not grant FDA the authority to deem, ``in 
a sweeping manner,'' all products (excluding accessories) that meet the 
statutory definition of ``tobacco product.'' The comment argued that 
Congress intended to grant FDA discretion to deem products only on a 
product-by-product basis, or at best, a category-by-category basis, and 
that FDA lacks authority to ``simply swallow all extant and future 
tobacco products up in its authority[.]''
    (Response) FDA disagrees. Section 901 grants FDA the authority to 
deem ``any . . . tobacco products that the Secretary by regulation 
deems to be subject to [chapter IX of the FD&C Act].'' There is no 
provision in the statute that restricts FDA's authority to deem all 
tobacco products that meet the statutory definition or requires FDA to 
deem products on an individual or product category basis.
    The comment did not provide a basis for the claim that Congress 
intended to restrict FDA's deeming authority to piecemeal deeming of 
specific categories of products and no such restrictions exist. FDA 
believes that deeming tobacco products on a product or category basis 
would create regulatory loopholes, substantial delay (at the risk to 
public health), and significantly impede FDA's ability to

[[Page 28983]]

create a comprehensive regulatory scheme.
    Even if there was ambiguity in the wording of section 901, which 
FDA does not believe there is, FDA would be entitled to deference on 
this interpretation of the statute (Chevron U.S.A., Inc. v. Natural 
Res. Def. Council, Inc., 467 U.S. 837, 842-45 (1984), quoting Morton v. 
Ruiz, 415 U.S. 199, 231 (1974) (``We have long recognized that 
considerable weight should be accorded to an executive department's 
construction of a statutory scheme it is entrusted to administer, and 
the principle of deference to administrative interpretations . . .'')).
    (Comment 2) At least one comment questioned whether section 901 of 
the FD&C Act provides authority to deem future tobacco products under 
the new rule. Specifically, the comment argued that a ``tobacco 
product'' must exist at the time the rule takes effect for it to be 
subject to ``deeming'' under the rule.
    (Response) FDA disagrees. The term ``tobacco product'' is defined 
in section 201(rr) of the FD&C Act, 21 U.S.C. 321(rr), to mean ``any 
product made or derived from tobacco that is intended for human 
consumption, including any component, part, or accessory of a tobacco 
product (except for raw materials other than tobacco used in 
manufacturing a component, part, or accessory of a tobacco product),'' 
and excluding drugs, devices, and combination products as defined under 
the FD&C Act. The definition has no temporal element, and nothing in 
the statute limits FDA's deeming authority to products or categories of 
products that are currently marketed. Contrary to Congress's intention 
in enacting the statute, the proposed interpretation would 
substantially impede FDA's ability to protect the public health. 
Indeed, FDA's ability to regulate new products would be further delayed 
by months or even years after the introduction of each new product, as 
the Agency would have to initiate a rulemaking to deem each new product 
before existing regulations would apply. Such an interpretation would 
frustrate the intent underlying the Tobacco Control Act and endanger 
the public health.
    Moreover, we note that the Agency is not simply creating a rule to 
apply to theoretical products with completely unknown risks that will 
be developed in the future. Instead, FDA is finalizing this rule to 
include all ``tobacco products'' within the scope of its regulatory 
authority based on the potential harm posed by existing products and 
the Agency's experience with the regulation of such products (which 
have all been made or derived from tobacco). This experience has shown 
us that it would be easier for manufacturers and more protective for 
public health for a company to know (prior to development and 
marketing) that its product must be reviewed and authorized by FDA in 
order to be offered for sale in the United States.
    (Comment 3) A number of comments contended that section 901(g) of 
the FD&C Act requires FDA to consult with other Federal Agencies before 
promulgating a new rule under chapter IX of the FD&C Act.
    (Response) FDA agrees that section 901(g) requires FDA to 
``endeavor to consult with other Federal Agencies, as appropriate.'' 
FDA consulted with other Federal Agencies during the Federal Agency 
review process required by Executive Order 12866, satisfying its 
requirement under section 901(g).
2. FDA's Exercise of Authority
    (Comment 4) Some comments, largely from the ENDS industry, argued 
that FDA is required to establish that deeming will benefit public 
health, and that insufficient evidence exists to do so. Specifically, 
they argued that FDA is unable to quantify the health risks of certain 
products (namely, e-cigarettes) \6\ without multiple long-term studies, 
and that currently such studies do not exist. A few comments cited the 
public health standard in section 906(d) of the FD&C Act as authority 
for these claims.
---------------------------------------------------------------------------

    \6\ FDA notes that most comments referred to ``e-cigarettes'' 
when discussing ENDS products. Therefore, FDA refers to ``e-
cigarette'' in the comment summaries. Because FDA's responses 
generally apply to all ENDS products (the most popular of which are 
electronic cigarettes, but also includes e-hookah, e-cigars, vape 
pens, personal vaporizers, and electronic pipes), FDA's responses to 
the comments generally use the term ``ENDS.''
---------------------------------------------------------------------------

    (Response) FDA disagrees. These comments attempted to impose a 
standard for the application of FDA's deeming authority that is not 
created by statute or otherwise. Under section 901(b), chapter IX of 
the FD&C Act shall apply to all cigarettes, cigarette tobacco, roll-
your-own tobacco, and smokeless tobacco and to any other tobacco 
products that the Secretary by regulation deems to be subject to this 
chapter (emphasis added). The only pertinent limitations on the scope 
of FDA's deeming authority are the definition of ``tobacco product'' 
set forth in section 201(rr) of the FD&C Act and a provision regarding 
tobacco growers and similar entities and tobacco leaf that is not in 
the possession of a manufacturer of tobacco products in section 
901(c)(2) of the FD&C Act.
    FDA disagrees with the comments that argued that the standard set 
forth in section 906(d) of the FD&C Act applies to the act of deeming 
tobacco products. Sections 901 and 906(d)(1) provide FDA with separate 
authorities. Section 901 gives FDA the authority to deem additional 
products to be subject to chapter IX. Once products are subject to 
chapter IX, FDA can use other authorities in chapter IX, such as 
section 906(d), to take regulatory action with respect to such 
products. By its own language, section 906(d) applies to regulations 
FDA issues requiring restrictions on the sale and distribution, 
including restrictions on the access to, and the advertising and 
promotion of, a tobacco product; therefore, the standard in section 
906(d)(1) applies only to the additional regulations issued by FDA 
under section 906(d) (such as the minimum age and identification 
requirements and vending machine restrictions this rule is promulgating 
in Sec.  1140.14, and the health warning requirements in Sec. Sec.  
1143.3 and 1143.5) and not to deeming itself or the provisions in the 
statute that apply automatically to newly deemed products.
    Although FDA is not required to meet a particular public health 
standard to deem tobacco products, regulation of the newly deemed 
products will be beneficial to public health. The Agency has concluded, 
based on scientific data, that the newly deemed products should be 
regulated due to their potential for public harm (e.g., 79 FR at 23154-
23158) and regulation is necessary to learn more about that potential. 
Greater regulatory certainty created by premarket authorizations should 
help companies to invest in creating novel products, with greater 
confidence that improved products will enter the market without having 
to compete against equally novel, but more dangerous products. For 
example, a company wishing to invest the additional resources needed to 
ensure that its e-cigarette is designed and manufactured with 
appropriate methods and controls will be more likely to do so if the 
product is not competing against products that are more cheaply and 
crudely made, yet appear to be identical to the consumer. Over time, 
since the ``appropriate for the protection of the public health'' 
standard involves comparison to the general tobacco product market, FDA 
believes the employment of the premarket authorities could create 
incentives for producers to develop products that are less dangerous 
when consumed, less likely to lead to initiation of tobacco use, and/or 
easier to quit.
    Further, FDA's premarket review of the newly deemed products will

[[Page 28984]]

increase product consistency. For example, FDA's oversight of the 
constituents of e-cigarettes cartridges will help to ensure quality 
control relative to the chemicals and their quantities being 
aerosolized and inhaled. At present, there is significant variability 
in the concentration of chemicals amongst products--including 
variability between labeled content and concentration and actual 
content and concentration (e.g., Refs. 16, 17, 18, 19, 20). Without a 
regulatory framework, users who expect consistency in these products 
may instead be subject to significant variability in nicotine content 
among products, raising potential public health and safety issues. 
Implementation of the premarket review requirements also will allow FDA 
to monitor product development and changes and to prevent more harmful 
or addictive products from reaching the market.
    In addition, as FDA discussed in the NPRM, deeming all tobacco 
products will provide FDA with critical information regarding the 
health risks of the products including information derived from 
ingredient listing submissions and reporting of HPHCs required under 
the FD&C Act (79 FR 23142 at 23148). Obtaining this information is 
particularly important given the addictiveness of nicotine and the 
toxicity associated with tobacco products. Given that ``[e]xposure to 
secondhand tobacco smoke has been causally linked to cancer, 
respiratory, and cardiovascular diseases, and to adverse effects on the 
health of infants and children,'' this information will be helpful in 
further assessing the toxicity of the newly deemed tobacco products 
(Ref. 9 at 7).\7\
---------------------------------------------------------------------------

    \7\ As stated in the 2014 Surgeon General's Report, ``the burden 
of death and disease from tobacco use in the United States is 
overwhelmingly caused by cigarettes and other combusted tobacco 
products'' (Ref. 9 at 7).
---------------------------------------------------------------------------

    Many of these comments also argued that FDA's acknowledgment that 
it does ``not currently have sufficient data . . . to determine what 
effects e-cigarettes have on the public health'' is an admission that 
FDA does not know, and cannot determine, whether regulation of these 
products will benefit public health. FDA disagrees. That language 
follows the statement, ``some have advanced views that certain new 
tobacco products that are noncombustible . . . may be less hazardous, 
at least in certain respects, than combustible products . . . ,'' and 
refers to the lack of evidence supporting such asserted benefits (79 FR 
23142 at 23144). Whether ENDS generally may eventually be shown to have 
a net benefit on or harm to public health at the population level--and 
there have not yet been long-term studies conducted to support either 
claim at this time--regulation of ENDS will still benefit public 
health. The 2014 Surgeon General's Report also notes that ``[f]urther 
research with attention to their individual and population-level 
consequences will be helpful to fully address these questions. However, 
the promotion of noncombustible products is much more likely to provide 
public health benefits only in an environment where the appeal, 
accessibility, promotion, and use of cigarettes and other combusted 
tobacco products are being rapidly reduced'' (Ref. 9 at 874).
    FDA noted in the NPRM that many public health benefits will flow 
from deeming tobacco products (including e-cigarettes and other ENDS). 
Even if a category of products were to prove generally beneficial, 
individual products within that category may raise concerns. For 
example, some products may be particularly attractive to youth or 
deliver unexpected high levels of toxicants. In addition, once all 
tobacco products are deemed, any manufacturer seeking to market its 
product as a modified risk tobacco product (MRTP) will be required to 
provide substantiation and obtain an order from FDA before making such 
claims, where it is currently not subject to such requirements under 
the FD&C Act. More generally, regulation and product review allows the 
Agency to help ensure the public health is protected. FDA's regulatory 
tools, including the adulteration and misbranding provisions in 
sections 902 (21 U.S.C. 387b) and 903 of the FD&C Act as applied to 
newly deemed products, will help to protect consumers by subjecting all 
tobacco products to certain basic requirements, such as that their 
labeling and advertising not be false or misleading. FDA will be able 
to take enforcement action against any tobacco products that do not 
meet these requirements. Further, implementation of the requirements 
regarding premarket applications, SE reports, and exemption requests 
(sections 905 and 910 of the FD&C Act (21 U.S.C. 387e and 387j, 
respectively)) will increase product consistency and help protect the 
public health from adverse impacts. For example, although there is 
currently variability in the concentrations of chemicals in e-liquids, 
FDA oversight of the constituents in e-liquids and ENDS will help to 
ensure quality control over the types and quantities of chemicals being 
aerosolized and inhaled (79 FR 23142 at 23149). Once deemed, the 
Tobacco Control Act authorizes FDA to impose certain types of 
restrictions that it has determined are appropriate to the protection 
of public health. Under this authority, FDA is imposing certain 
restrictions for ENDS and other products, such as minimum age 
requirements.
    The need for deeming is further confirmed by the continued dramatic 
rise in youth and young adult use of tobacco products such as e-
cigarettes and waterpipe tobacco, and continued youth and young adult 
use of cigars (mainly cigarillos). As discussed in the NPRM, e-
cigarettes are widely available in retail outlets such as kiosks in 
shopping malls and on the Internet and their online popularity has 
surpassed that of snus which has been on the market far longer than e-
cigarettes (Ref. 21).
    Recent studies show a dramatic rise in the use of ENDS products. 
The Centers for Disease Control and Prevention (CDC) and FDA analyzed 
data from the 2011-2014 National Youth Tobacco Surveys (NYTS) and found 
that current (past 30 day) e-cigarette use among high school students 
increased nearly 800 percent from 1.5 percent in 2011 to 13.4 percent 
in 2014 (Ref. 22). In 2014, a total of 24.6 percent of high school 
students reported current use of a tobacco product (id.). Among all 
high school students, e-cigarettes (13.4 percent) were the most common 
tobacco products used (id.). This increase was not limited to any one 
demographic group; e-cigarettes were the most commonly used product 
among high school non-Hispanic whites, Hispanics, and persons of non-
Hispanic other races (id.). E-cigarettes (3.9 percent) were also the 
tobacco product used most commonly by middle school students (id.). 
From 2011 to 2014, statistically significant nonlinear increases were 
observed among high school students for current e-cigarette use (1.5 
percent to 13.4 percent) (id.). Among middle school students, 
statistically significant increases were observed from 2011 to 2014 
(id.). In 2014, an estimated 4.6 million middle and high school 
students currently used any tobacco product (i.e., cigarettes, cigars, 
smokeless tobacco, e-cigarettes, hookahs, tobacco pipes, snus, 
dissolvable tobacco, and bidis), of which an estimated 2.2 million 
students currently used two or more tobacco products. Overall, in 2014, 
2.4 million middle and high school students reported current use of e-
cigarettes (id.). The data also demonstrated that when use of all 
tobacco products was considered in aggregate, there was no

[[Page 28985]]

change in overall current tobacco use among middle and high school 
students.
    Another recently published study found that ninth grade students 
who reported having ever used e-cigarettes at the baseline assessment 
were approximately 2.7 times more likely than non-e-cigarette users to 
have started smoking combusted tobacco products (cigarettes, cigars, 
waterpipe tobacco) and 1.7 times more likely to have started smoking 
conventional cigarettes 6 to 12 months later (Ref. 23). While this 
study indicates that e-cigarette users are more likely than non-e-
cigarette users to also use combusted tobacco products 12 months later, 
it cannot be determined by the research findings if such users would 
have used combusted tobacco products regardless of e-cigarette use. 
Researchers noted that some teens are more likely to use e-cigarettes 
prior to combustible tobacco products for several reasons including the 
availability of e-cigarettes in flavors attractive to youth (id.).
    In terms of young adult and adult use of e-cigarettes, evidence 
from the most recent studies on ENDS use among young adults and adults 
indicates that among adults who had never smoked cigarettes, prevalence 
of ever e-cigarette use was highest among young adults aged 18 to 24 
and decreased with increasing age (Ref. 24). However, current cigarette 
smokers and recent former smokers (i.e., those who quit smoking within 
the past year) were more likely to use e-cigarettes than long-term 
former smokers (i.e., those who quit smoking more than 1 year ago) and 
adults who had never smoked. Current cigarette smokers who had tried to 
quit in the past year were also more likely to use e-cigarettes than 
those who had not tried to quit (id.). It is noted that it cannot be 
determined by the research findings: (1) Whether former cigarette 
smokers who now exclusively use e-cigarettes would not have ceased 
smoking cigarettes regardless of e-cigarette use; and (2) whether the 
e-cigarette use preceded quitting or the quitting occurred first and 
then was followed by later e-cigarette use.
    The data from the 2011 through 2014 NYTS also show that high school 
students' use of waterpipe tobacco more than doubled during this time 
period. In fact, researchers observed substantial increases in 
waterpipe tobacco use among both middle and high school students from 
2011 through 2014 culminating in an estimated 1.6 million waterpipe 
tobacco youth users in 2014 (Ref. 22). From 2013 to 2014, prevalence 
almost doubled for high school students from 5.2 percent (770,000) to 
9.4 percent (1.3 million) and more than doubled for middle school 
students from 1.1 percent (120,000) to 2.5 percent (280,000) (id.). 
These findings are consistent with earlier research on older youths and 
young adults discussed in the comments stating that waterpipe tobacco 
use continues to increase in popularity, particularly among college 
students, with as many as 40 percent reporting ever using waterpipe 
tobacco and 20 percent reporting current use (i.e., use within the past 
30 days) on some college campuses (Refs. 25, 26).
    Likewise, youth continue to use cigars. Data from the 2014 NYTS 
indicate that 8.2 percent (1,200,000) of high school students and 1.9 
percent (220,000) of middle school students had smoked cigars 
(including cigars, cigarillos, or little cigars) in the past 30 days 
(Ref. 22). Nineteen percent of students in 8th, 10th, and 12th grades 
participating in the Monitoring the Future study in 2014 also reported 
smoking small or little cigars (which represents a decrease from 23.1 
percent in 2010, but it is unclear if subjects misidentified cigars as 
cigarettes during the study) (Ref. 27). In addition, the 2014 National 
Survey on Drug Use and Health (NSDUH) found that more than 2,500 youth 
under the age of 18 smoke their first cigar each day, nearly as many as 
those who smoke their first cigarette each day (more than 2,600) (Ref. 
28). Nevertheless, data on youth cigar use from the Youth Risk Behavior 
Surveillance System (YRBSS) shows that current cigar use among youth 
(i.e., use of a cigar, cigarillo, or little cigar on at least one day 
during the last 30 days) has declined between 1997 and 2013 (22 percent 
to 12.6 percent); however, no statistically significant change was 
observed between 2011 (13.1 percent) and 2013 (12.6 percent) (Ref. 29).
    (Comment 5) At least one comment argued that the rule violates the 
APA, 5 U.S.C. 706, saying that it requires FDA to provide ``the 
specific basis for [its] conclusion and the data on which each of [its] 
critical assumptions is based'' (quoting Ranchers Cattlemen Action 
Legal Fund United Stockgrowers of America, No. 04-cv-51, 2004 WL 
1047837 at *7 (D. Mont. Apr. 26, 2004), and FDA failed to do so.
    (Response) FDA disagrees. The unpublished district court case 
quoted in the comment was reversed by the Ninth Circuit on exactly this 
point (415 F.3d 1078 (9th Cir. 2005)). The Ninth Circuit stated the 
correct standard: ``All that is required is that the agency have 
`considered the relevant facts and articulated a rational connection 
between the facts found and the choices made' '' (id. at 1093). See 
Citizens to Preserve Overton Park, Inc. v. Volpe, 401 U.S. 402, 416 
(1971); Motor Vehicle Mfrs. Ass'n of U.S., Inc. v. State Farm Mut. 
Auto. Ins. Co., 463 U.S. 29, 42-43 (1983).
    In any event, the NPRM contains substantial explanation of FDA's 
reasoning in proposing this rule, including over 190 citations to 
scientific literature, and the NPRM and the final rule's supplementary 
information contain many pages explaining the data and comments 
considered, the conclusions drawn from the literature, and FDA's 
rationale for the final rule, fully satisfying the Administrative 
Procedure Act (APA).
    (Comment 6) A few comments objected that FDA did not discuss the 
possibility of illicit markets in the proposed deeming rule, stating 
that FDA is required to consider the consequences of illicit markets 
under section 907(b)(2) of the FD&C Act.
    (Response) FDA disagrees. Section 907(b)(2) does not apply to 
deeming, but rather applies only to the promulgation of regulations 
establishing tobacco product standards under section 907 of the FD&C 
Act. In any event, the Agency cannot refuse to act in furtherance of 
the public health because some individuals might violate the law. 
Nevertheless, FDA authority over the newly deemed tobacco products will 
give it means to determine which products are legally on the market and 
which are counterfeit or otherwise illegally marketed and to take 
enforcement action against manufacturers who sell and distribute 
illegal products. The Tobacco Control Act gives the Agency these and 
other authorities, such as section 920 of the FD&C Act (21 U.S.C. 
387t), to help address illicit tobacco products.
3. Constitutional Issues
    The Tobacco Control Act includes provisions restricting tobacco 
product marketing. As discussed in this document, some of these 
provisions apply to all products covered by the statute--including the 
newly deemed products--and others authorize FDA to impose additional 
restrictions. We received comments that argue that some of the 
restrictions this final rule imposes on newly deemed products violate 
the First Amendment.
a. Free Samples of Tobacco Products
    (Comment 7) A few comments questioned the constitutionality of the 
ban on the distribution of free samples of tobacco products. (See Sec.  
1140.16(d)(1)).) First, the comments argued that distributing free 
samples is a form of commercial speech that is protected by the First 
Amendment and that the ban is unconstitutional as

[[Page 28986]]

applied to the newly deemed products. Citing Central Hudson Gas and 
Electric Corp. v. Public Services Commission, 447 U.S. 557, 566 (1980), 
the comments argued that, accordingly, FDA must show that the ban is 
narrowly tailored to directly and materially advance a substantial 
State interest and that FDA failed to do so. The comments stated that 
while the court in Discount Tobacco City & Lottery v. United States, 
674 F.3d 509 (6th Cir. 2012), cert. denied sub nom. Am. Snuff Co., LLC 
v. United States, 133 S. Ct. 1996 (2013) (``Discount Tobacco''), upheld 
the Tobacco Control Act's sampling ban on cigarettes, the evidence the 
court used to uphold that ban does not support the same ban for the 
newly deemed tobacco products. They argued that FDA has presented no 
evidence that samples of these products lead to youth initiation and, 
therefore, the Agency would not be advancing a legitimate government 
interest with this ban. Additionally, they suggested that even if the 
ban did advance a legitimate government interest, FDA could achieve the 
same results through less restrictive means, such as by allowing 
samples in qualified adult-only facilities, as FDA does with smokeless 
tobacco.
    (Response) FDA disagrees that the ban on free samples is 
unconstitutional. First, although FDA acknowledges that in Discount 
Tobacco, 674 F.3d at 538-39, the Sixth Circuit treated the distribution 
of free samples as a form of commercial speech, FDA continues to 
believe that distribution of free samples is conduct not speech. 
Provisions that regulate conduct without a significant expressive 
element do not implicate the First Amendment. See Arcara v. Cloud 
Books, Inc., 478 U.S. 697, 706-07 (1986). Additionally, a free sample 
ban is akin to a price restriction (i.e., tobacco products cannot be 
free)--a ``form[ ] of regulation that would not involve any restriction 
on speech.'' 44 Liquormart, Inc. v. Rhode Island, 517 U.S. 484, 507 
(1996) (opinion of Stevens, J.). Therefore, the free sample provision 
regulates the distribution of a product, and there is no First 
Amendment right to distribute free samples of a tobacco product.
    Second, even if the distribution of free samples does implicate the 
First Amendment, as the Sixth Circuit concluded, the court went on to 
uphold the constitutionality of the restriction on free samples of 
tobacco products. Discount Tobacco, 674 F.3d at 541. In Discount 
Tobacco, as here, the manufacturers of tobacco products argued that the 
government failed to show that the ban would directly and materially 
advance the government interest of decreasing use of tobacco products 
by youth. The manufacturers further argued that even if the sampling 
ban were effective, there are less restrictive methods of preventing 
youth tobacco use (id. at 538, 541). The Sixth Circuit rejected both 
arguments, and held that the government ``presented extensive 
documentation that free samples of tobacco products are [an] `easily 
accessible source of these products to young people,' . . . and freely 
obtainable, even with the tobacco industry's `voluntary codes that 
supposedly restrict distribution of free samples to underage persons''' 
id. at 541 (quoting 61 FR 44396 at 44460, 45244-45 & nn. 1206-08 
(August 28, 1996)). The Court further held that free samples ``may 
serve as the best advertisement of all for a product that is 
physiologically addictive, and socially attractive to youth'' (id.).
    The comments do not attempt to distinguish Discount Tobacco. Here, 
where there is a substantial government interest in preventing youth 
access to all tobacco products, and the newly deemed products, like the 
products considered by the Sixth Circuit Court of Appeals, are also 
``physiologically addictive, and socially attractive to youth,'' 
Discount Tobacco is directly on point. As we stated in the NPRM, the 
prohibition against free samples will eliminate a pathway for youth to 
access tobacco products, which can help in reducing youth initiation 
and therefore short-term and long-term morbidity and mortality 
resulting from these products.
    Youth are uniquely susceptible to biological, social, and 
environmental influences to use and become addicted to tobacco 
products. See section X.A. As FDA recognized as early as 1995, ``[f]ree 
samples give young people a `risk-free and cost-free way to satisfy 
their curiosity' about tobacco products, and, when distributed at 
cultural or social events, may increase social pressure on young people 
to accept and to use the free samples'' (60 FR 41314 at 41326 (quoting 
Ref. 30). For these reasons, we believe it is critical to prohibit the 
distribution of free samples of newly deemed tobacco products, which 
are highly addictive and can lead to a lifetime of tobacco use, with 
attendant adverse health consequences.
    FDA received comments noting extensive sampling of some newly 
deemed products in venues that may attract youth, including:
     The major sellers of e-cigarettes distribute free samples 
in venues likely to attract large audiences.
     At least eight e-cigarette companies promote their 
products through sponsored or sampling events, many of which appear to 
be youth-oriented (Ref. 31).
     In 2012 and 2013 alone, 6 e-cigarette companies sponsored 
or provided free samples at 348 events, many of which were music 
festivals and motorsport events geared toward young people--including 
Grand Prix auto racing events (id.).
     Field research in Oregon found that e-cigarette retailers 
include the opportunity to sample the wide variety of flavored nicotine 
cartridges in their sales pitches with test stations for free sampling 
(Comments of Oregon Health Authority, FDA-2014-N-0189-76358).
    As described above and in the NPRM, the free sample provision will 
address distribution of newly deemed tobacco products at venues such as 
these. Contrary to the assertions in the comments, FDA does not believe 
that it could achieve the same results by allowing samples of newly 
deemed products in qualified adult-only facilities, as FDA does with 
smokeless tobacco. In section 102(a)(2)(G) of the Tobacco Control Act 
(21 U.S.C. 387a-1(a)(2)(G)), Congress required FDA to reissue the final 
1996 rule (published in the Federal Register of August 28, 1996, 61 FR 
44396), with several changes, including the addition of a narrow 
exception to the free sample ban to allow for distribution of smokeless 
tobacco products in qualified, adult-only facilities (QAOFs). This 
exception is very prescriptive and operates only in very limited 
instances (e.g., where the product is distributed in a specific type of 
temporary enclosed structure with age verification by a law enforcement 
officer or a security guard licensed by a governmental entity, and with 
the amount of smokeless tobacco per adult consumer subject to specific 
portion requirements). If FDA were to extend this exception, in whole 
or in part, to other tobacco products (when Congress explicitly 
extended the free sample ban to cigarettes and all ``other tobacco 
products,'' which would include all future deemed tobacco products and 
laid out the qualified adult-only facility exception only for 
smokeless), FDA would have to justify such an exception in light of the 
potential adverse public health impact of allowing free samples and 
determine the particular parameters of the exception as appropriate for 
newly deemed tobacco products. This would include, at a minimum, 
parameters relating to type of facility, means of access, type(s) of 
tobacco products distributed, and portion sizes for each type of 
tobacco product for which FDA is creating an exception. Newly deemed 
products have been largely unregulated and their markets,

[[Page 28987]]

particularly for novel noncombustible products such as ENDS, are 
dynamic. Comments did not provide evidence demonstrating that the 
distribution of free samples of newly deemed tobacco products would be 
consistent with protecting public health. While there is evidence 
suggesting that distribution of tobacco products is harmful (e.g., 
courts have expressed concern that free samples can provide young 
people with easy access to tobacco products), FDA has not yet obtained 
product-specific evidence and, therefore, cannot set limits for the 
quantities or portion sizes of products taken away from a QAOF that are 
commensurate with the current exception for smokeless tobacco products. 
Therefore, QAOFs could still allow for access to tobacco products in a 
manner that will have a negative public health impact.
    Prohibiting free samples is a minor restriction on distribution, 
and tobacco product manufacturers, distributors, and retailers remain 
free to inform consumers about their products. The free sample 
prohibition does not interfere with the ability of a manufacturer, 
distributor or retailer to communicate truthful and nonmisleading 
information to adult consumers. We further address this prohibition and 
respond to additional comments in section XI.F.
    (Comment 8) Some comments recommended that FDA exempt e-cigarettes 
from the prohibition on free samples. In the alternative, the comments 
recommended that FDA restrict the circumstances in which free samples 
may be given to adult consumers. For example, comments suggested that 
FDA require age verification for each recipient of a free sample and 
limit the amount of free products that recipients may take away from an 
event in which samples are distributed.
    (Response) We disagree for the reasons discussed in the response to 
the previous comment. As stated in the NPRM, prohibiting free samples 
eliminates a pathway to tobacco products for youth, which can help to 
reduce initiation and thus decrease morbidity caused by use of tobacco 
products (79 FR 23142 at 23149). In addition, the United States Court 
of Appeals for the Sixth Circuit previously recognized that FDA has 
provided ``extensive'' evidence that free tobacco samples constitute an 
``easily accessible source'' for youth (Discount Tobacco City & 
Lottery, Inc. v. United States, 674 F.3d 509, 541 (6th Cir. 2012) 
(citing 61 FR 44396 at 44460, August 28, 1996), cert. denied sub nom. 
Am. Snuff Co., LLC v. United States, 133 S. Ct. 1966 (2013)). With the 
growth in the use of ENDS, particularly by youth (see section VIII.B), 
a free sample prohibition is necessary to reduce youth access to ENDS 
and possibly a transition to combusted tobacco products (see Ref. 23).
b. Modified Risk Tobacco Products
    Section 911 of the FD&C Act (21 U.S.C. 387k) prohibits the 
introduction or delivery for introduction into interstate commerce of 
any MRTP without an FDA order in effect under section 911(g). An MRTP 
is a tobacco product that is sold or distributed for use to reduce harm 
or the risk of tobacco-related disease associated with commercially 
marketed tobacco products; this includes tobacco products, the product 
label, labeling, or advertising of which represents that it is less 
harmful or presents a lower risk of disease than other tobacco 
products.
    (Comment 9) A comment from one tobacco company argued that section 
911 is unconstitutional on its face. This comment argued, at length, 
that FDA's oversight of claims that a particular tobacco product is 
safer than others violates the First Amendment--even as applied to 
currently regulated products, such as cigarettes.
    (Response) Comments addressed to the facial constitutionality of a 
statute are generally outside the scope of an agency's rulemaking 
authority. Am. Meat Inst. v. U.S. Dep't of Agric., 760 F.3d 18, 25 
(D.C. Cir. 2014) (en banc) (``We do not think the constitutionality of 
a statute should bobble up and down at an administration's 
discretion.''). That said, FDA disagrees with the challenges against 
section 911's constitutionality. The Sixth Circuit considered and 
unanimously rejected the same argument in Discount Tobacco, 674 F.3d at 
531-37, and the Supreme Court denied the manufacturers' petition for a 
writ of certiorari (133 S. Ct. 1966 (2013)). As the Sixth Circuit 
explained, section 911 requires that a manufacturer establish health 
claims for particular tobacco products to FDA before marketing, rather 
than allow only post-market review of such claims (674 F.3d at 537 
(``it would be a virtual impossibility to unring the bell of 
misinformation after it has been rung'')). This provision does not 
``infringe significantly on noncommercial speech'' since it leaves 
``untouched'' manufacturers' ``ability to make `direct comments on 
public issues' '' (id. at 533 (citation omitted)). Instead, the court 
held, what section 911 restricts is commercial speech, since it applies 
to consumer-directed claims regarding a manufacturer's specific 
products (id.). That restriction on commercial speech, the court held, 
is constitutional under Central Hudson Gas & Electric Corp. v. Public 
Service Commission, 447 U.S. 557 (1980): It advances a substantial 
government interest in preventing inaccurate and harmful health claims 
about tobacco products of the sort that the industry has made for many 
decades, and it is sufficiently tailored because it concerns only 
consumer-targeted speech about tobacco products' health effects or 
contents and is no more extensive than warranted. Discount Tobacco, 674 
F.3d at 534-37. FDA observes that this comment did not address Discount 
Tobacco's holding or the Sixth Circuit's analysis.
    (Comment 10) A few comments argued that section 911 may violate the 
First Amendment if it is applied to ban descriptions of e-cigarettes 
and other noncombustible products as ``smokeless'' or ``smoke-free.''
    (Response) FDA has carefully considered the comments that argued 
that noncombusted products, including ENDS, should be permitted to use 
the terms ``smokeless'' and smoke-free'' to describe their products. We 
note that section 911 provides that ``No smokeless tobacco product 
shall be considered to be [an MRTP] solely because its label, labeling, 
or advertising uses the following phrases to describe such product and 
its use: `smokeless tobacco,' `smokeless tobacco product,' `not 
consumed by smoking,' `does not produce smoke,' `smokefree' [and four 
more similar terms].'' However, this provision only applies to 
``smokeless tobacco,'' which is explicitly defined in the FD&C Act as 
``any tobacco product that consists of cut, ground, powdered, or leaf 
tobacco and that is intended to be placed in the oral or nasal cavity'' 
(section 900(18) of the FD&C Act). ENDS do not fall within that 
definition. Moreover, in contrast to ENDS, consumption of ``smokeless 
tobacco products,'' as defined, does not require the use of heat, 
inhalation of the product into the lungs, or exhalation of constituents 
into the close environment. FDA is also aware that some e-cigarettes 
are heated to a high enough level to cause combustion of the e-liquid. 
For these reasons, and until FDA obtains product-specific evidence, the 
Agency will evaluate an ENDS manufacturer's use of ``smokeless'' or 
``smoke-free'' (and similar descriptive terms) on a case-by-case basis, 
and the Agency will continue to apply the MRTP provisions in a manner 
consistent with the statute and Constitution. This case-by-case 
approach to ``smokeless,'' ``smoke-free,'' and similar terms is 
appropriate as

[[Page 28988]]

applied to ENDS, which encompasses a broad, heterogeneous, and evolving 
category of products.
4. Required Warning Labels
    This final rule requires advertising and packaging warnings for 
newly deemed covered tobacco products and for cigarette tobacco and 
roll-your-own tobacco, as authorized by Section 906(d) of the FD&C Act, 
21 U.S.C. 387f (d). Packaging and advertising for all newly deemed 
products other than cigars must display an addictiveness warning that 
states: ``WARNING: This product contains nicotine. Nicotine is an 
addictive chemical.'' (Subject to certain requirements, the 
manufacturer of a product that does not contain nicotine may use an 
alternative warning that states: ``This product is made from 
tobacco.'') Packaging and advertising for cigars must display either 
the addictiveness warning, or one of five others specified in the rule.
    The final rule requires the warnings to appear on at least 30 
percent of the two principal display panels of the package, and at 
least 20 percent of the area of advertisements. These are the same 
warning sizes Congress established for smokeless tobacco in the Tobacco 
Control Act: At least 30 percent of smokeless-tobacco packaging's two 
principal panels, and at least 20 percent of the area of each 
advertisement. 15 U.S.C. 4402(a)(2)(A), (b)(2)(B). In the same Act, 
Congress prescribed an even larger size for cigarette warnings: 50 
percent of the front and rear panels of cigarette packaging (and the 
same 20 percent size for cigarette advertisements) (15 U.S.C. 
1333(a)(2), (b)(2)). (The larger warning sizes required for cigarettes 
have not yet been implemented, because FDA's initial regulations 
implementing a graphics component for cigarette warnings were vacated 
by the DC Circuit Court of Appeals in R.J. Reynolds Tobacco Co. v. FDA, 
696 F.3d 1205 (D.C. Cir. 2012), overruled on other grounds by Am. Meat 
Inst., 760 F.3d at 22-23.)
    A detailed discussion of the warning requirements appears in 
section XVI.
a. First Amendment Challenges
    The required warnings are a form of compelled disclosure, and are 
thus subject to First Amendment scrutiny. Milavetz, Gallop & Milavetz, 
P.A. v. United States, 559 U.S. 229, 249 (2010); Riley v. Nat'l Fed'n 
of the Blind of N.C., Inc., 487 U.S. 781, 797-98 (1988).
    (Comment 11) Although the comments generally did not dispute the 
need for warning labels, some commenters questioned the accuracy of the 
addictiveness warning as applied to cigars, contending that cigar users 
do not always inhale.
    (Response) Nicotine is ``one of the most addictive substances used 
by humans'' (Ref. 7). ``Because the extension of First Amendment 
protection to commercial speech is justified principally by the value 
to consumers of the information such speech provides,'' the 
manufacturers' ``constitutionally protected interest in not providing 
any particular factual information in his advertising is minimal.'' Am. 
Meat Inst., 760 F.3d at 26 (quoting Zauderer v. Office of Disciplinary 
Counsel, 471 U.S. 626, 651 (1985)).
    Cigar packaging and advertisements are required to display one of 
six warnings, one of which is the addictiveness warning. Research 
indicates that most cigar smokers do inhale some amount of smoke, even 
when they do not intend to inhale, and are not aware of doing so (Refs. 
32, 33). Even when cigar smokers do not breathe smoke into their lungs, 
they are still subject to the addictive effects of nicotine through 
nicotine absorption (Refs. 32, 34). This is because cigar smoke 
dissolves in saliva, allowing the smoker to absorb sufficient nicotine 
to create dependence, even if the smoke is not inhaled (Refs. 34, 35).
    (Comment 12) A few comments argued that the First Amendment 
prohibits a requirement for covered tobacco products to carry warning 
labels that cover 30 percent of the two principal display panels of the 
packaging. These comments argued that manufacturers have limited space 
on packaging to communicate information to consumers, including 
branding and marketing information, and that requiring manufacturers to 
dedicate 30 percent of that space for a warning is unduly burdensome, 
because it prevents manufacturers from using that space to convey their 
own messages. The comments argued that the warning label presents a 
simple message that could be relayed in a smaller space.
    (Response) FDA disagrees. In Discount Tobacco, the Sixth Circuit 
considered and rejected the same First Amendment arguments against the 
size required by the Tobacco Control Act for cigarette and smokeless 
tobacco warnings. Discount Tobacco, 674 F.3d at 567. The court found 
ample evidence supporting the size requirements, and held that the 
manufacturers failed to show ``that the remaining portions of their 
packaging [were] insufficient for them to market their products'' (id. 
at 564-66, 567). The comments argued that the requirement that the 
warning cover 30 percent of the two principal display panels is unduly 
burdensome and would prevent manufacturers of newly deemed products 
from communicating information about their products. As in Discount 
Tobacco, the comments failed to substantiate that claim with evidence. 
Nor did the comments provide evidence that the same size requirements 
for smokeless tobacco--which have been in force since 2010--have unduly 
burdened the speech of smokeless tobacco manufacturers.
    As the court explained in Discount Tobacco, Congress required 
larger warnings for smokeless tobacco and cigarettes in the wake of the 
Surgeon General's conclusion that existing warnings were ```given 
little attention or consideration by viewers''' and IOM's analysis 
showing that those warnings ```fail[ed] to convey relevant information 
in an effective way.''' Discount Tobacco, 674 F.3d at 562 (quoting 
Refs. 3, 7).
    The comments contending that the warning label size is burdensome 
or unjustified are misplaced for the same reasons identified by the 
Discount Tobacco court. After emphasizing that the relevant First 
Amendment standard looks only to whether mandatory warnings are 
reasonably related to the government's interest, Discount Tobacco, 674 
F.3d at 567 (citing Zauderer v. Office of Disciplinary Counsel, 471 
U.S. 626, 651 (1985)), the Sixth Circuit held that the required 
cigarette warning labels, which were to cover 50 percent of the two 
primary panels of cigarette packs (far more than the 30 percent 
required here), did not violate the First Amendment because ``[a]mple 
evidence supports the size requirement for the new warnings . . . and 
Plaintiffs have not shown that the remaining portions of their 
packaging are insufficient for them to market their products.'' (674 
F.3d at 567; see also id. at 530-31 (Clay, J., concurring in result) 
(finding that the government demonstrated that the Tobacco Control 
Act's size and placement requirements satisfied Zauderer scrutiny).)
    Article 11 of the Framework Convention on Tobacco Control (FCTC), 
evidence of a strong worldwide consensus regarding a regulatory 
strategy for addressing the serious negative impacts of tobacco 
products,\8\ recognized the importance of having warnings cover at 
least 30 percent of the area of the two principal display panels. The 
European Union (EU) requires that health warnings comprise 30 percent 
of the area on the front of the package and 40 percent on the back of 
the package

[[Page 28989]]

(2001/37/EC). Users are more likely to recall warnings that are in a 
larger size and that appear on the front/major surfaces of the tobacco 
product package. (Ref. 7). Before a warning label can help a consumer 
better understand and appreciate the risks against which it warns, the 
consumer must notice and pay attention to the warning. The likelihood 
that a consumer will do so depends upon warning's size and position. 
(Refs. 36, 37, 38, 39, 40).
---------------------------------------------------------------------------

    \8\ There are 180 parties to the WHO's FCTC as of November 2015. 
At this time, the United States is a signatory but has not ratified 
this treaty.
---------------------------------------------------------------------------

    Some comments sought to support their First Amendment arguments 
against the warning label sizes by citing the D.C. Circuit's decision 
in R.J. Reynolds v. FDA, 696 F.3d 1205 (D.C. Cir. 2012), which vacated 
specific cigarette warnings previously issued by FDA. However, the 
decision in Reynolds was based on the graphics components of the 
cigarette warnings, not their size. Moreover, the reasoning of the 
Reynolds panel decision was overtaken by the D.C. Circuit's more recent 
en banc decision in American Meat Institute, 760 F.3d at 22-23.
    FDA recognizes that the warning size requirement for covered 
tobacco products may present special difficulties for products in 
particularly small packages. To address this concern, FDA has added 
subsection (d) to Sec.  1143.4. Under Sec.  1143.4(d), a product that 
is too small or otherwise unable to accommodate a label with sufficient 
space to bear the required warning, printed in the required font size, 
may instead carry the warning on the carton or other outer container or 
wrapper. In cases where there is no carton or other outer container or 
wrapper that is large enough to carry the warning, the product may 
carry the warning on a tag firmly and permanently affixed to the 
package.
    FDA agrees that other warnings on tobacco product packages, such as 
a warning regarding the risk of nicotine poisoning (as suggested by one 
particular comment), may also provide consumers with important health 
risk information. Therefore, elsewhere in this issue of the Federal 
Register, FDA has made available draft guidance, which when final will 
describe FDA's current thinking regarding some appropriate means of 
addressing the premarket authorization requirements for newly deemed 
ENDS products, including recommendations for exposure warnings that 
would help to support a showing that a product is appropriate for the 
protection of public health. FDA also has issued an ANPRM seeking 
comments, data, research, or other information that may inform 
regulatory actions FDA might take with respect to nicotine exposure 
warnings and child-resistant packaging for certain tobacco products. If 
FDA determines that it is appropriate for the protection of the public 
health to require such a warning (in addition to the addiction 
warning), FDA will consider at that time whether it is necessary to 
change the formatting requirements for the addiction warning to ensure 
that all warnings are clear and conspicuous.
b. Preemption of State Law Warning Requirements
    (Comment 13) A number of comments sought an affirmative statement 
from FDA that the NPRM preempts State and local warning requirements. A 
few of the comments directly referenced California's reproductive 
health warning requirements for products containing nicotine (a notice 
mandated by Proposition 65). Many cited the explicit preemption 
provisions that apply to cigarettes and smokeless tobacco (see 15 
U.S.C. 1334(b) and 4406(b)). One manufacturer argued that it would be 
arbitrary and capricious to subject the newly deemed products to a 
patchwork of Federal, State, and municipal requirements, while 
cigarettes and smokeless tobacco warning requirements are uniform 
across States and potentially less stringent. The comment further 
argued that it would be particularly unreasonable to subject 
noncombusted products to State and local labeling requirements because 
(according to the comment) noncombusted products are ``safer than 
cigarettes.''
    Taking the other side of the issue were comments from public health 
groups and a joint comment from 29 State Attorneys General who 
advocated for an explicit statement that the NPRM does not preempt 
State and local warning requirements, including California's 
Proposition 65. At a minimum, they suggested that FDA change the 
heading of part 1143 from ``Required Warning Statement'' to ``Minimum 
Required Warning Statement'' to indicate that the deeming rule does not 
preclude other health warnings.
    (Response) Section 916(a)(1) of the FD&C Act (21 U.S.C. 387p) 
expressly preserves the authority of State and local governments to, 
among other things, enact and enforce laws regarding tobacco products 
that are in addition to, or more stringent than, requirements 
established under chapter IX of the FD&C Act. The preservation of State 
and local governmental authority over tobacco products is limited by 
section 916(a)(2) of the FD&C Act, which expressly preempts any State 
or local requirement that is different from, or in addition to, any 
requirement under chapter IX of the FD&C Act relating to tobacco 
product standards, premarket review, adulteration, misbranding, 
labeling, registration, good manufacturing practices, or MRTPs.\9\ 
However, section 916(a)(2)(B) of the FD&C Act states that the express 
preemption provision in section 916(a)(2)(A) does not apply to 
requirements relating to, among other things, the sale, distribution, 
possession, information reporting to the State, exposure to, access to, 
the advertising and promotion of, or use of, tobacco products by 
individuals of any age. A State or local statute is facially preempted 
only if no set of circumstances exists under which the statute would be 
valid. (See Comm. of Dental Amalgam Mfrs. & Distribs. v. Stratton, 92 
F.3d 807, 810 (9th Cir. 1996).) FDA notified State and local 
jurisdictions about the potential impact this rule could have on their 
requirements. No State or local laws in effect at the close of the 
public comment period were identified that FDA determined would be 
preempted by this final rule.
---------------------------------------------------------------------------

    \9\ We note that while section 906(e) of the FD&C Act refers to 
``good manufacturing practices,'' FDA refers to any regulations that 
could be issued under section 906(e) as tobacco product 
manufacturing practices.
---------------------------------------------------------------------------

    With respect to the argument that it would be arbitrary and 
capricious to allow States and localities to subject newly deemed 
products to different warning requirements than cigarettes and 
smokeless tobacco products, we note that the preemptive effect depends 
on the relevant statutes. The preemption provisions of the Federal 
Cigarette Labeling and Advertising Act of 1965 (FCLAA) (15 U.S.C. 1334) 
and the Comprehensive Smokeless Tobacco Health Education Act of 1986 
(CSTHEA) (15 U.S.C. 4406), which apply to cigarettes and smokeless 
products, respectively, are significantly different from section 916 of 
the FD&C Act. For example, the FCLAA and CSTHEA provisions expressly 
preempt State and local regulation of the content of cigarette and 
smokeless product advertisements, while section 916(a)(2)(B) of the 
FD&C Act exempts State and local advertising restrictions from 
preemption.
    Separate and apart from the issue of preemption, elsewhere in this 
issue of the Federal Register, FDA has made available draft guidance, 
which when final will describe FDA's current thinking regarding some 
appropriate means of addressing the premarket authorization 
requirements for newly deemed ENDS products, including

[[Page 28990]]

recommendations for exposure warnings that would help support a showing 
that a product is appropriate for the protection of public health. 
Additionally, FDA notes that some ENDS product manufacturers have 
voluntarily included exposure warnings on their products. Accordingly, 
FDA has changed the heading of part 1143 from ``Required Warning 
Statements'' to ``Minimum Required Warning Statements'' in order to 
clarify that part 1143 is not intended to prevent tobacco product 
manufacturers from including truthful, non-misleading warnings on their 
products' packaging or advertisements voluntarily or as a result of FDA 
guidance.

III. Use of Premarket Pathways for Newly Deemed Products

    As stated in the proposed deeming rule, manufacturers of newly 
deemed products that are ``new tobacco products'' as defined in section 
910(a)(1) of the FD&C Act will be required to obtain premarket 
authorization of their products through one of three pathways--SE., 
exemption from SE., or premarket tobacco product application (PMTAs) 
(sections 905 and 910 of the FD&C Act). The substantive requirements of 
these provisions are set by statute and, thus, have not changed from 
the NPRM. However, FDA has revised the compliance periods for 
submitting premarket applications, as discussed in section V.A.
    As an initial matter, with this final rule, we are also clarifying 
when FDA will consider a document to have been submitted for purposes 
of the compliance periods for submission of documents and data required 
by the automatic provisions of the statute. In the NPRM, we noted that 
the automatic provisions require companies to submit information to 
FDA, and we proposed various compliance periods to provide industry 
with time to make such submissions (e.g., ``the manufacturer submits a 
905(j) report for the product by [effective date of part 1100 plus 24 
months]''). As previously discussed publically (see http://www.fda.gov/tobaccoproducts/newsevents/ucm393894.htm), FDA generally relies on the 
date of receipt of a submission by FDA's Document Control Center (DCC) 
as the date that the document was submitted (not the date that the 
submitter sent it). The DCC has been and will continue to be fully 
equipped to receive tobacco product submissions (including the number 
of submissions expected at the close of compliance periods). Therefore, 
regulated entities should ensure that FDA's DCC receives any submission 
by the due date or end of compliance period. The time it takes to 
review a premarket application is dependent upon the type of 
application and the complexity of the product. FDA has taken many steps 
to reduce the previous backlog and prevent further backlogs of 
marketing applications pending FDA review. FDA intends to act as 
expeditiously as possible with respect to all new applications, while 
ensuring that statutory standards are met. If an applicant wishes to 
discuss a product application, the applicant may request a meeting as 
set forth in FDA's final guidance entitled ``Meetings with Industry and 
Investigators on the Research and Development of Tobacco Products'' 
(announced May 25, 2012, 77 FR 31368).
    In addition, we are clarifying that FDA distinguishes between a 
marketing application that has been ``filed,'' one that ``has been 
accepted,'' and one that has been ``submitted'' to FDA. A marketing 
application has been ``submitted'' when a complete application is 
delivered and received electronically, through the mail, or through a 
courier to CTP's Document Control Center (DCC). Once a complete PMTA 
application is submitted and received by CTP's DCC, FDA will have 180 
days to consider the application as described in section 910(c)(A) of 
the Tobacco Control Act. A marketing application ``has been accepted'' 
after the Agency completes a preliminary review and determined that the 
application on its face contains information required by the statutory 
and/or regulatory provisions applicable to that type of application. A 
marketing application has been ``filed'' after the Agency completes a 
threshold review and has determined that a complete, substantive review 
is warranted. This filing review occurs only for a PMTA or a modified 
risk application and results in either a filing letter or a refusal to 
file letter.

A. Background: The Three Pathways To Market a New Tobacco Product

    We received a large number of comments addressing the pathways to 
market a new tobacco product. Comments from industry argued that the 
review process for a new tobacco product is simply too difficult--that 
the standard is too high, and that the burden of submitting an 
application is too great. Many manufacturers of the newly deemed 
products argued that the two alternative pathways--SE and the SE 
exemption--are not available to them because there is no predicate to 
which they can claim SE. We address these comments in the following 
sections.
    Under section 910 of the FD&C Act, manufacturers must receive FDA's 
permission to market new, including newly modified, tobacco products in 
the United States. The provision applies to all tobacco products 
covered by the FD&C Act, however, those that were commercially marketed 
in the United States on February 15, 2007 (the grandfather date) do not 
constitute new tobacco products and therefore do not require such 
premarket authorization. See section 910(a) of the FD&C Act (defining 
``new tobacco product'' as any tobacco product (including those 
products in test markets) that was not commercially marketed in the 
United States as of February 15, 2007, or has been modified since that 
date).
    Products that were introduced or modified after the grandfather 
date may seek permission to market under one of three pathways. The 
manufacturer may submit a PMTA, which is an application that requires 
the manufacturer to provide information about the product, including 
ingredients, additives, properties, manufacture, processing, labeling, 
and health risks, among other things (section 910(b) of the FD&C Act). 
FDA will grant permission to market the new product if the PMTA shows 
that it would be appropriate for the protection of the public health, 
among other things (section 910(c)(2) of the FD&C Act; see also section 
910(c)(4) (requiring FDA to consider the risks and benefits to both 
users and nonusers, and explicitly requiring FDA to consider the effect 
of marketing the product on the likelihood that existing users of 
tobacco products will stop using them, and the likelihood that nonusers 
of tobacco products will start)). Whether the marketing of a product is 
appropriate for the protection of the public health will be evaluated 
on a case-by-case basis (in accordance with Section 910(c)(4) of the 
FD&C Act) and with consideration of the continuum of risk of nicotine-
delivering products. The statute instructs FDA to base its findings 
regarding whether marketing the tobacco product would be appropriate 
for the protection of public health on well-controlled investigations, 
which may include one or more clinical investigations, where 
appropriate. However, it also allows FDA to authorize that its findings 
be made on the basis of valid scientific evidence other than controlled 
studies if FDA finds such other evidence sufficient to evaluate the 
tobacco product (section 910(c)(5) of the FD&C Act). We received 
several comments addressing the burden the PMTA application places on 
manufacturers, including the expense and time that clinical studies 
require.

[[Page 28991]]

Elsewhere in this issue of the Federal Register, FDA is announcing the 
availability of a draft guidance, which when final will provide the 
Agency's current thinking regarding some appropriate means of 
addressing the premarket authorization requirements for newly deemed 
ENDS products, including specific recommendations concerning how to 
support a showing that the marketing of a new tobacco product is 
appropriate for the protection of the public health.
    The second pathway to market is the SE pathway, which allows for a 
manufacturer to apply for permission to market a tobacco product that 
it demonstrates is ``substantially equivalent'' to a tobacco product 
that was marketed on the grandfather date or to a product previously 
found substantially equivalent (the ``predicate'') (section 
910(a)(2)(A) and section 905(j) of the FD&C Act). To receive marketing 
authorization under the SE pathway, a manufacturer must submit an 
application that shows that the product to be marketed has the same 
characteristics as the predicate tobacco product or has different 
characteristics and the information submitted contains information, 
including clinical data if deemed necessary by the Secretary, that 
demonstrates that it is not appropriate to regulate the product under 
section 910 because the product does not raise different questions of 
public health (section 910(a)(3)(A) of the FD&C Act). The statute 
defines ``characteristics,'' for this purpose, as the materials, 
ingredients, design, composition, heating source, or other features of 
a tobacco product (section 910(a)(3)(B) of the FD&C Act).
    As new tobacco products continue to evolve from the cigarettes and 
smokeless tobacco that were on the market on the grandfather date, the 
SE pathway may not be available for some new products. The availability 
of the SE pathway for the newly deemed products was the subject of many 
comments, with some arguing that a different, later grandfather date 
should be adopted, and others arguing there should be no change in the 
grandfather date and that the newly deemed products should proceed 
through the PMTA pathway if no appropriate predicate is available.
    Under the third pathway, a product may be exempted from the SE 
requirements if the only change to the product is a minor change and 
that change only involves a change to an additive in a tobacco product 
that can be sold under the FD&C Act, for which an SE report is not 
necessary and where the exemption is otherwise appropriate, as 
discussed in section 905(j)(3) of the FD&C Act.

B. Interpretation of Substantial Equivalence

    (Comment 14) Some comments argued that FDA should interpret 
``substantial equivalence'' broadly so that newly deemed products could 
avoid what the comments characterize as the more burdensome new tobacco 
product application (PMTA) pathway with a showing that the product has 
some similar characteristics to the predicate products.
    (Response) FDA disagrees. SE is explicitly defined in section 
910(a)(3) of the FD&C Act, which provides, in relevant part, that the 
term ``substantially equivalent'' or ``substantial equivalence'' means 
that the Secretary by order has found that the tobacco product: (1) Has 
the same characteristics as the predicate tobacco product or (2) has 
different characteristics and the information submitted contains 
information, including clinical data if deemed necessary by the 
Secretary, that demonstrates that it is not appropriate to require a 
PMTA because the product does not raise different questions of public 
health. Section 910(a)(3)(B) provides that the term ``characteristics'' 
means the materials, ingredients, design, composition, heating source, 
or other features of a tobacco product. A product must have the same 
characteristics--all of the same characteristics--as the predicate 
product, to be found substantially equivalent under section 
910(a)(3)(A)(i) of the FD&C Act or if the new product has different 
characteristics FDA must find that the new product does not raise 
different questions of public health under section 910(a)(3)(A)(ii).
    FDA notes that for newly deemed products about which concerns have 
been raised with respect to the availability of an appropriate 
predicate--e.g., e-cigarettes--many of these products have entirely 
different characteristics from traditional tobacco products. As such, a 
manufacturer would need to satisfy section 910(a)(3)(A)(ii) (i.e., 
demonstrate that the new product does not raise different questions of 
public health as compared to the predicate). FDA is continuing to 
research e-cigarettes, other ENDS, and heated cigarette products that 
likely were on the market on February 15, 2007, and is working to 
determine the availability of such products for comparison. FDA 
determined that some e-cigarettes were manufactured in 2006 and 
introduced into the United States in early 2007. In particular, we have 
identified a non-flavored e-cigarette (also marketed as an ``e-cigar'') 
that may have been on the market on February 15, 2007. This product may 
possibly be able to serve as an appropriate predicate for purposes of 
the SE pathway. The burden of demonstrating that a valid predicate 
exists rests with the manufacturer submitting a SE report. To 
facilitate the determination that a product is eligible as a predicate 
for an SE application, any individual who has evidence that an e-
cigarette or other tobacco product was commercially marketed in the 
United States on February 15, 2007, is encouraged to contact the Agency 
at 1-877-CTP-1373. Regardless of the predicate selected for comparison, 
manufacturers are responsible for providing scientific data adequate to 
demonstrate that, in the case of an SE Report, the characteristics are 
the same or, if the characteristics are different, these differences do 
not cause the new product to raise different questions of public 
health. It should also be noted that, where the predicate and new 
products are in a different category or subcategory, the evidence 
needed to obtain marketing authorization through the PMTA pathway may 
be similar to gather and submit than that needed for the SE pathway. 
For example, as stated in the NPRM, it is possible that an applicant 
may not need to conduct any new nonclinical or clinical studies for 
PMTA, while in other cases, such as where there is limited 
understanding of a product's potential impact, nonclinical and clinical 
studies may be required for market authorization. In cases where no new 
nonclinical or clinical studies are needed, the effort associated with 
gathering and submitting a PMTA may not be materially greater than that 
for an SE Report.
    As stated earlier, the FD&C Act does not place limitations on which 
pathway manufacturers can use to seek market authorization for a new 
product. Thus, manufacturers may choose to submit applications under 
any of the three legal pathways. To obtain marketing authorization 
under the PMTA pathway, manufacturers are required to establish, among 
other things, that permitting their products to be marketed would be 
appropriate for the protection of public health. In establishing this, 
manufacturers should take into account, and FDA will consider, the ways 
in which the new product is likely to be used. For example, PMTAs for 
these products should contain information on whether the product is 
likely to be used alone or together with other legally

[[Page 28992]]

marketed tobacco products (such as available delivery systems), as well 
as the type and range of other products with which it is likely to be 
used.
    For example, where a manufacturer seeks authorization of a new e-
liquid to be used with ENDS, the manufacturer may need to provide 
evidence and analysis of the product's likely impact when used in the 
range of delivery systems available. Similarly, a manufacturer seeking 
authorization of a stand-alone apparatus component--such as a heating 
coil or cartridge--may need to provide evidence and analysis of the 
product's likely impact when used together with the range of other 
components and liquids available.
    In the case of e-liquids, FDA expects that it may be possible for 
manufacturers to satisfy the statute by demonstrating that marketing of 
the liquid is appropriate for the protection of public health as it may 
be used in any of the legally available delivery systems. While FDA 
recognizes that there may remain some degree of uncertainty in any such 
analysis, FDA expects that the range of delivery system specifications 
authorized by FDA will provide a sufficiently specific spectrum of 
possibilities, such that a meaningful public health impact analysis can 
be done.
    In the case of ENDS hardware/apparatus components, FDA expects that 
it may be difficult for manufacturers to make the showing necessary to 
meet the statutory standard, given the great extent of possible 
variations in combinations of hardware components, if all are 
considered and sold separately. Thus, with respect to apparatus, FDA 
expects that manufacturers will be most successful where authorization 
is sought for entire delivery systems, rather than individual 
components. In the case of these complete delivery systems--systems for 
which the application covers all potential parts, including 
customizable options as applicable, and where labeling, instructions 
for use and/or other measures are used to help ensure use as intended--
FDA expects that the range of possible outcomes may be narrow enough 
for the manufacturer to demonstrate, and for FDA to assess, public 
health impact.
    (Comment 15) Some comments asserted that under section 
910(a)(3)(A)(ii) of the FD&C Act, certain categories of products should 
easily meet the SE standard because the products, overall, are 
beneficial to public health when compared to traditional, combustible 
cigarettes.
    (Response) The issue of whether a product or certain categories of 
products may be beneficial to an individual is different than whether a 
category of products, overall, has a net positive benefit on population 
health. As explained in the NPRM, a category of products may benefit 
some individual tobacco users but may not have an overall net 
population health benefit if it leads to increased tobacco product 
initiation or dual use. In any event, this is a consideration relevant 
under the PMTA standard, not the SE standard.
    Under section 910(a)(3)(A)(ii), a product can be found 
substantially equivalent to a predicate product even if it does not 
share all of the same characteristics of the predicate, if the 
information submitted contains information, including clinical data if 
deemed necessary by the Secretary, that demonstrates that it is not 
appropriate to require a new product application because the product 
does not raise different questions of public health as compared to the 
predicate.
    FDA will authorize the marketing of products through the SE pathway 
that meet the applicable standards in the FD&C Act. However, the SE 
pathway is a comparison between a new tobacco product and a predicate 
identified by the submitter, not an evaluation of whether the product 
is appropriate for the protection of the public health more generally 
as would be conducted under an application under section 910(b) (i.e., 
a PMTA). Therefore, some differences between new and predicate products 
may not be appropriate for an SE Report, and the product instead is 
more suited to seeking authorization using a PMTA. Additionally, as the 
SE pathway is a specific comparison between a predicate and a new 
tobacco product, it does not necessarily provide a pathway to market 
for entire categories of products. Rather, under section 
910(a)(3)(A)(ii), an application for SE must show that any differences 
in characteristics between the product and the predicate ``do not raise 
different questions of public health.''
    (Comment 16) A small number of comments argued that newly deemed 
products should be permitted to be marketed under the SE pathway even 
if they do not share the same characteristics as the claimed predicate.
    (Response) The statute does allow for applicants to use the SE 
pathway for new tobacco products that have different characteristics 
than the predicate product. To receive a marketing authorization under 
the SE pathway, these applicants must show that the new product has 
different characteristics and the information submitted contains 
information, including clinical data if necessary, to show that the 
product does not raise different questions of public health (section 
910(a)(3)(A)(ii)).
    (Comment 17) A few comments argued that section 910(a)(3)(A)(ii) 
allows for cross-category comparisons (i.e., applicants may provide a 
comparison to predicate products from similar (but not identical) 
tobacco product categories).
    (Response) It is up to the manufacturer to select an appropriate 
predicate tobacco product and provide the scientific evidence 
demonstrating SE. If the manufacturer provides scientific evidence and 
a rationale that demonstrates to FDA that the new product does not 
raise different questions of public health than the predicate (even 
though there are differences from the predicate product), FDA could 
issue an SE order. However, manufacturers of cigars or ENDS would have 
great difficulty showing that a product is substantially equivalent to 
a combusted cigarette or a smokeless tobacco product. For example, if 
FDA received an SE Report for a new product that is an ENDS closed 
aerosol generating apparatus and a predicate product that is a filtered 
combusted cigarette, then the product characteristics between the new 
and predicate products would be different. Because of the differences 
in characteristics in this example, a significant amount of scientific 
evidence would be needed to demonstrate that the new product does not 
raise different questions of public health. Such evidence, as discussed 
in FDA's 2011 Guidance titled ``Section 905(j) Reports: Demonstrating 
Substantial Equivalence,'' could include but would not be limited to 
the following: (1) Smoke yield data from HPHCs, (2) actual use data 
demonstrating how smoke topography compares between the new and 
predicate products, (3) actual use data demonstrating how the amount of 
product use varies between the new and predicate products (e.g., number 
of puffs per day), and (4) marketing data indicating how consumer 
perception (product appeal) by youth differs between the new and 
predicate products. In these cases, it would be difficult to show that 
the differences between the product and the predicate product are such 
that the product ``does not raise a different question of public 
health.''
    In addition, the evidence required to make such a showing may be as 
substantial or even greater than the evidence required under the PMTA 
pathway (section 910(b)), and the PMTA pathway allows for different 
effects on public health--as long as the applicant

[[Page 28993]]

provides a demonstration that the product is appropriate for the 
protection of the public health. Nevertheless, there is nothing in the 
statute to prohibit the attempted use of cross-category comparisons in 
an SE submission, but it is the responsibility of the manufacturer to 
provide appropriate and sufficient evidence to support a finding of SE.
    (Comment 18) A few comments from industry argued that FDA should 
interpret ``substantial equivalence'' as the term is applied to medical 
devices under section 510(k) of the FD&C Act (21 U.S.C. 360(k)), which 
does not require premarket review for what the comments refer to as 
``even the slightest change to a predicate.''
    (Response) FDA's interpretation of SE with respect to medical 
devices is based on a different statutory section than is applicable to 
tobacco products. FDA has issued guidance interpreting SE within the 
meaning of section 910 of the FD&C Act.

C. Comments on the Grandfather Date

    We received numerous comments on the February 15, 2007, grandfather 
date and the challenges it may present to certain categories of the 
newly deemed products. We address those comments as follows.
    Lack of Authority To Change the Grandfather Date to a Later Date. 
As stated in the NPRM, FDA has determined that it lacks authority to 
change the grandfather date, which is set by statute (79 FR 23142 at 
23174). FDA specifically asked for comments on our legal 
interpretation. We received a large number of comments in response to 
this statement, but none provided a legal theory that would support 
changing the date.
    (Comment 19) A number of comments argued that adoption of a later 
grandfather date would be an acceptable exercise of FDA's discretion 
under section 701(a) of the FD&C Act, which provides FDA authority to 
issue regulations ``for the efficient enforcement'' of the statute. 
Others argued that an alternative date would be a permissible Agency 
interpretation of the statute, subject to deference under the Chevron 
doctrine. (See Chevron U.S.A., Inc. v. NRDC, 467 U.S. 837 (1984).)
    (Response) After careful consideration of these comments, FDA 
concludes that it lacks authority to change the grandfather date for 
the newly deemed products. The grandfather date is prescribed in the 
statute. Section 910(a)(1)(A) of the FD&C Act states, in pertinent 
part, that the term ``new tobacco product'' means any tobacco product 
(including those products in test markets) that was not commercially 
marketed in the United States on February 15, 2007. For purposes of the 
SE pathway, the statute also clearly states that a predicate product 
must be commercially marketed (other than for test marketing) in the 
United States on February 15, 2007, in both section 910(a)(2)(A) and 
section 910(j)(1). FDA's authority is not so broad as to allow FDA to 
issue a regulation that contradicts a clear statutory provision.
    Many comments cited examples of FDA's exercise of discretion to 
show that FDA can and should exercise discretion to change the 
grandfather date. For example, comments pointed to FDA's decision to 
extend compliance deadlines, as well as FDA's guidance informing 
industry that it does not intend to take enforcement action against 
manufacturers who make tobacco blending changes without a premarket 
submission for a new tobacco product when such tobacco blending changes 
are intended to address the natural variation of tobacco (e.g., tobacco 
blending changes due to variation in growing conditions). However, the 
exercise of discretion reflected in these examples did not require FDA 
to contradict the clear language of the Tobacco Control Act, as 
changing the grandfather date would.
    (Comment 20) A number of comments argued that the February 15, 
2007, date in section 910 of the FD&C Act is simply an anachronism, 
that the date was only intended to apply to the initially regulated 
products, and the fact that the statutory language does not provide a 
different date is simply a drafting error.
    (Response) FDA disagrees and is aware of no evidence supporting 
this view. Congress carefully distinguished those provisions of the 
statute that would apply to all tobacco products from those that would 
apply only to the initially regulated products or, in some cases, only 
to traditional cigarettes. (See, e.g., section 102(a)(1) of the Tobacco 
Control Act (requiring FDA to issue a rule establishing restrictions on 
the sale and distribution of cigarettes and smokeless tobacco, with 
certain different provisions for the two categories of products).) If 
Congress had intended that there be a later grandfather date for 
tobacco products deemed subject to the statute after its date of 
enactment, it would have provided one.
    (Comment 21) Some comments argued that application of the February 
15, 2007, date is unfair to the manufacturers of the newly deemed 
tobacco products (particularly e-cigarettes) because they were not on 
notice of pending regulation and they contended that ``all newly deemed 
products will be forced from the market.'' Thus, they argue, decisions 
were made to invest in an industry that was presumed to be unregulated, 
and now the industry must bear unanticipated costs.
    (Response) FDA disagrees with comments stating that all newly 
deemed products will be forced to be removed from the market as some 
newly deemed products will qualify as ``grandfathered'' products under 
the statute and any that are not grandfathered will be able to apply 
for premarket authorization. The Tobacco Control Act plainly provides 
for regulation of all tobacco products. FDA also clearly stated its 
intention to deem these products long before the NPRM was published 
(see Unified Agenda, Spring 2011, RIN 0910-AG38). Therefore, 
manufacturers of the newly deemed products have been on notice for more 
than 4 years that these products could and likely would be regulated.
    The ENDS industry has acknowledged that it was aware of both FDA's 
intention to regulate ENDS and the applicability of the Tobacco Control 
Act to e-cigarettes and other ENDS, as evidenced by the litigation in 
Smoking Everywhere, Inc. v. Food & Drug Administration, 680 F. Supp.2d 
62 (D.D.C. 2010), affirmed by Sottera, Inc. v. Food & Drug 
Administration, 627 F.3d 891 (D.C. Cir. 2010), which was pending during 
the passage of the Tobacco Control Act. When FDA attempted to regulate 
e-cigarettes as a drug-device combination, plaintiffs Sottera (doing 
business as NJOY) and Smoking Everywhere argued that Congress intended 
for tobacco products, including their own, to be subject to the Tobacco 
Control Act and not to the drug and device provisions of the FD&C Act. 
The district court described plaintiffs' position as follows: ``In FDA 
v. Brown and Williamson Tobacco Corp., the Supreme Court held that 
tobacco products, like traditional cigarettes, are not subject to FDA 
regulation as a drug or device. [529 U.S. 120 (2000).] Because 
electronic cigarettes, as marketed by plaintiffs, are the functional 
equivalent of traditional cigarettes, plaintiffs contend that FDA 
cannot regulate their products [as combination drug-device products]. 
They further contend that Congress's recent enactment of the [Tobacco 
Control Act] supports their argument. Under the [Act], FDA may now 
regulate tobacco products, which the Act defines as ``any product made 
or derived from tobacco that is intended for human consumption,'' . . . 
but it cannot regulate those products as it would a

[[Page 28994]]

drug or device under the FDCA[.] There being no dispute that the 
nicotine in plaintiffs' electronic cigarettes is naturally distilled 
from actual tobacco and is intended for human consumption, . . . 
plaintiffs assert that their electronic cigarettes qualify as a tobacco 
product and are therefore exempt from regulation as a drug-device 
combination.'' (Smoking Everywhere v. FDA, 680 F. Supp. 2d 62, 66-67 
(D.D.C. 2010).)
    The district court found that, ``it is apparent from Congress's 
broad definition of `tobacco product' that it intended the Tobacco 
Act's regulatory scheme to cover far more than the fixed array of 
traditional tobacco products[.]'' (Id. at 71.) ENDS manufacturers were 
made especially aware of FDA's authority to deem their products and 
subject them to the tobacco control authorities of the FD&C Act when 
the court noted that ``. . . now that FDA has regulatory power over 
electronic cigarettes through the Tobacco Act, any harm to the public 
interest or to third parties caused by an injunction that merely 
forbids FDA from regulating electronic cigarettes as a drug-device 
combination is greatly diminished.'' (Id. at 77-78.)
    On appeal, the D.C. Circuit affirmed, commenting that ``the Tobacco 
Act provides the FDA with regulatory authority over tobacco products 
without requiring therapeutic claims. . . . [T]he act broadly defines 
tobacco products as extending to `any product made or derived from 
tobacco.' '' Sottera, Inc. v. Food & Drug Administration, 627 F.3d 891, 
897 (D.C. Cir. 2010) (quoting 21 U.S.C. 321(rr)(1); emphases added by 
the court). The D.C. Circuit went on to state that ``the [lower] court 
rightly found that the FDA has authority under the Tobacco Act to 
regulate electronic cigarettes''--authority that, it added, was 
``unquestioned.'' Id. at 898.
    (Comment 22) Some comments argued that FDA previously exercised 
enforcement discretion to amend the grandfather date of the reissued 
1996 rule (published in the Federal Register of August 28, 1996, 61 FR 
44396) with respect to use of a trade or brand name of a nontobacco 
product for cigarettes or smokeless tobacco products and argued that 
FDA has the authority to take similar action with respect to the SE 
grandfather date.
    (Response) FDA disagrees. In section 102 of the Tobacco Control 
Act, Congress required FDA to reissue the 1996 final rule regarding 
cigarettes and smokeless tobacco identical to the original rule (61 FR 
44396 at 44615 through 44618), with certain enumerated exceptions. 
Congress did not list the grandfather date for the use of nontobacco 
brand-names as one of the exceptions. Nonetheless, the Agency issued a 
compliance policy stating that it did not intend to enforce the January 
1, 1995, grandfather date for the use of a nontobacco brand name while 
considering what changes to the regulation, if any, would be 
appropriate. Section 102(a)(4) also gave FDA authority to amend its own 
rule. On November 17, 2011, FDA issued the proposed brand name rule (76 
FR 71281) seeking to exercise its authority to amend the January 1, 
1995, date that was originally included in 21 CFR 897.16(a) to June 22, 
2009, in recognition of the fact that 14 years elapsed since the 
publication of the 1996 final rule. Using the January 1995 date would 
have significantly changed the provision, from one that was intended to 
apply prospectively to one that applies retroactively. The statute does 
not give FDA similar authority to change the provisions in section 910 
of the FD&C Act to amend the grandfather date.

D. Impact of Premarket Requirements

    (Comment 23) Numerous comments argued that if the SE pathway is not 
available for some newly deemed products, manufacturers will have to 
use the PMTA pathway, will not have sufficient resources to complete 
PMTAs, and will be forced to remove their products from the market. 
Members of the e-cigarette industry further argued that removal of 
their products would be detrimental to public health. However, other 
comments expressed concern regarding any delay in implementing and 
enforcing the premarket review requirements given the data showing the 
growing use of the newly deemed products, particularly among youth and 
young adults.
    (Response) As an initial matter, FDA notes that the primary 
premarket pathway for new tobacco products is the premarket tobacco 
product application pathway, and that the SE and SE exemption pathways 
are exceptions to that pathway, but manufacturers can choose to submit 
applications under any of the three pathways for which they think they 
can meet the criteria in the FD&C Act for marketing authorization for a 
new product. See section 910(a)(2)(A) of the FD&C Act stating that an 
order for a new tobacco product is required unless the Secretary has 
issued an order that the tobacco product is substantially equivalent to 
tobacco product commercially marketed. The SE pathway is not intended 
to be available to every product. Rather, by its terms, the SE pathway 
is limited to products that can be shown to be substantially equivalent 
to a product that was on the market on the grandfather date. If that 
showing cannot be made, the appropriate premarket pathway is the 
premarket tobacco product application pathway.
    To obtain marketing authorization under the PMTA pathway, 
manufacturers are required to establish, among other things, that 
permitting their products to be marketed would be appropriate for the 
protection of public health. In establishing this, manufacturers should 
take into account, and FDA will consider, the ways in which the new 
product is likely to be used. We also note that, elsewhere in this 
issue of the Federal Register, FDA has made available draft guidance, 
which when final will describe FDA's current thinking regarding some 
appropriate means of addressing the premarket authorization 
requirements for newly deemed ENDS products. Should firms have specific 
questions regarding application content and information necessary to 
satisfy the filing criteria under section 910(b) or ways to reduce 
burden by reference to another submission, they may contact CTP's OS at 
1-877-CTP-1373.
    For example, where a manufacturer seeks authorization of a new e-
liquid to be used with ENDS, the manufacturer may need to provide 
evidence and analysis of the product's likely impact when used in the 
range of delivery systems available. Similarly, a manufacturer seeking 
authorization of a stand-alone apparatus component--such as a heating 
coil or cartridge--may need to provide evidence and analysis of the 
product's likely impact when used together with the range of other 
components and liquids available.
    In the case of e-liquids, FDA expects that it may be possible for 
manufacturers to satisfy the statute by demonstrating that marketing of 
the liquid is appropriate for the protection of public health as it may 
be used in any of the legally available delivery systems. While FDA 
recognizes that there may remain some degree of uncertainty in any such 
analysis, FDA expects that the range of delivery system specifications 
authorized by FDA will provide a sufficiently specific spectrum of 
possibilities, such that a meaningful public health impact analysis can 
be done.
    In the case of ENDS hardware/apparatus components, FDA expects that 
it may be difficult for manufacturers to make the showing necessary to 
meet the statutory standard, given the great extent of possible 
variations in combinations of

[[Page 28995]]

hardware components, if all are considered and sold separately. Thus, 
with respect to apparatus, FDA expects that manufacturers will be most 
successful where authorization is sought for entire delivery systems, 
rather than individual components. In the case of these complete 
delivery systems--systems for which the application covers all 
potential parts, including customizable options as applicable, and 
where labeling, instructions for use and/or other measures are used to 
help ensure use as intended--FDA expects that the range of possible 
outcomes may be narrow enough for the manufacturer to demonstrate, and 
for FDA to assess, public health impact.
    FDA also notes that many comments from the ENDS industry emphasized 
the potential public health benefits of these products in their 
comments on the NPRM. For example, numerous industry comments argued 
that restrictions on access to the newly deemed products would be 
detrimental to public health, as the products may be less toxic than 
conventional cigarettes and may be successfully used as a cessation 
product. FDA's consideration of public health benefits of products will 
be included in FDA's review of PMTAs based on the evidence.
    (Comment 24) A few comments expressed concern that if manufacturers 
would be forced to submit PMTAs rather than SE applications, they would 
need to conduct more animal studies to meet PMTA requirements.
    (Response) FDA shares an interest in reducing the reliance on 
animal-based studies, and the Agency is committed to the three ``Rs'' 
of reduction, refinement, and replacement in animal testing. Although 
we are hopeful that in vitro assays and computer models can ultimately 
help to replace much of the need for animal testing, there are still 
many areas for which non-animal testing is not yet a scientifically 
valid and available option. FDA is committed to addressing concerns 
raised regarding use of animal testing methods, while still ensuring 
that the Agency satisfies its public health and patient safety 
responsibilities and acts in accordance with its governing statutes.
    (Comment 25) One comment stated that e-cigarettes have two 
variables--the ratio of the propylene glycol to vegetable glycerin and 
the level of nicotine in the product--which would result in many 
combinations and, therefore, require submission of numerous, very 
costly PMTAs for products that have very minor variations. In contrast, 
one comment noted that the lower number of ingredients in e-cigarettes 
means that less information will be required in PMTAs for e-cigarettes 
than for other products.
    (Response) The requirements and costs of a PMTA may vary based on 
the type and complexity of the product. Variations in the ratio of 
ingredients, such as propylene glycol and glycerin, would indicate that 
products have different levels of each of these ingredients. As stated 
in section 910(a)(1)(B) of the FD&C Act, any change in an ingredient 
level, as with additions or removal of ingredients, yields a new 
tobacco product.
    We also note that the statute requires FDA to review PMTAs based on 
well-controlled investigations, ``when appropriate,'' or other valid 
scientific evidence sufficient to evaluate the tobacco product. In 
addition, elsewhere in this issue of the Federal Register, FDA has made 
available draft guidance, which when final will describe FDA's current 
thinking regarding some appropriate means of addressing the premarket 
authorization requirements for newly deemed ENDS products. Should firms 
have specific questions regarding application content and information 
necessary to satisfy the filing criteria under section 910(b) or ways 
to reduce burden by reference to another submission, they may contact 
CTP's OS at 1-877-CTP-1373.
    (Comment 26) Many comments stated that a requirement to prepare 
PMTAs for all of the many parts and components that go into some of the 
newly deemed tobacco products would create an effective ban of these 
products.
    (Response) The definition of a tobacco product includes components 
and parts, and these products are subject to the automatic provisions 
of the FD&C Act, including premarket authorization requirements. 
However, at this time, FDA intends to limit enforcement of the 
premarket authorization provisions to finished tobacco products. In 
this context, a finished tobacco product refers to a tobacco product, 
including all components and parts, sealed in final packaging intended 
for consumer use (e.g., filters or filter tubes sold separately to 
consumers or as part of kits). For example, an e-liquid sealed in final 
packaging that is to be sold or distributed to a consumer for use in a 
finished tobacco product will be subject to enforcement if it is on the 
market without authorization. In contrast, an e-liquid that is sold or 
distributed for further manufacturing into a finished ENDS product is 
not itself a finished tobacco product. At this time, FDA does not 
intend to enforce the premarket authorization requirements against such 
e-liquids or other components and parts of newly deemed products that 
are sold or distributed solely for further manufacturing without a 
marketing order.
    (Comment 27) Many expressed concern that requiring cigars to comply 
with the PMTA requirements would either force cigars off the market or 
require them to mimic cigarettes in uniformity of size, shape, and 
taste, which would change the fundamental nature of the cigar industry. 
At least one comment stated that FDA should eliminate the premarket and 
SE application requirements for cigars and instead implement a system 
by which cigar manufacturers could introduce new products to the market 
after providing 90 days' notice to FDA of their intentions to do so.
    (Response) FDA disagrees. Sections 905 and 910 of the FD&C Act 
establish specific requirements that apply to new tobacco products 
before they may be marketed. Some cigars may be grandfathered and other 
products may have valid predicate products and may be able to avail 
themselves of the SE pathway to market. FDA generally expects that 
cigars with blending changes (other than blending changes to address 
the natural variation of tobacco, FDA's policy for which is discussed 
in the response to Comment 28) will be able to successfully use the SE 
pathway so long as the blending change does not significantly raise 
levels of HPHCs in the product (i.e., raising different questions of 
public health). If a product is unable to utilize the SE pathway and is 
not eligible for an SE exemption, the statute requires the product 
(including limited or seasonal blends) to obtain a marketing 
authorization through the PMTA pathway. As explained previously, the 
requirements of a particular PMTA may also vary based on the type and 
complexity of the product. If an applicant wishes to discuss a product 
application, the applicant may request a meeting as set forth in FDA's 
final guidance entitled ``Meetings with Industry and Investigators on 
the Research and Development of Tobacco Products'' (announced May 25, 
2012, 77 FR 31368).
    (Comment 28) A number of comments discussed the natural variability 
in the tobacco used for cigars and pipe tobacco, stating that because 
the characteristics of tobacco used for each of these products can vary 
from year to year, manufacturers must use different blends to create a 
consistent product. Some comments expressed concerns that each blending 
change could result in a new product for which manufacturers and 
importers would be

[[Page 28996]]

required to submit a PMTA. They also stated that this would be 
economically unfeasible for limited editions and special releases for 
cigars and pipe tobacco. Others expressed concerns that tobacco 
blending changes and natural variations of the tobacco used in the 
product, such as the number of ribs or perforations in a cigar wrapper, 
may produce different results for HPHC testing of the same product. 
These comments advocated that cigars and pipe tobacco should be either 
excluded from the ingredient listing, HPHC listing, and premarket 
review requirements or manufacturers should be allowed to make tobacco 
blending changes without being required to submit a marketing 
application or comply with HPHC testing and reporting requirements.
    (Response) FDA is aware that the tobacco used to produce some of 
the newly deemed products can naturally vary from year to year. As 
stated in section IV.C.1, FDA does not intend to enforce the premarket 
authorization requirements where manufacturers make tobacco blending 
changes without premarket authorization for tobacco blending changes to 
address the natural variation of tobacco (e.g., tobacco blending 
changes due to variation in growing conditions) in order to maintain a 
consistent product. However, FDA does intend to enforce the premarket 
authorization requirement for tobacco blending changes that are 
intended to alter the chemical or perception properties of the new 
product (e.g., nicotine level, pH, smoothness, harshness, etc.) 
compared to the predicate product, and such changes should be reported 
under 910 or 905(j). In addition, FDA intends to issue a guidance 
regarding HPHC reporting under section 904(a)(3), and later a testing 
and reporting regulation as required by section 915, with enough time 
for manufacturers to report given the 3-year compliance period for HPHC 
reporting. As noted elsewhere in this document, FDA does not intend to 
enforce the reporting requirements under section 904(a)(3) for newly 
deemed products before the close of the 3-year compliance period, even 
if the HPHC guidance is issued well in advance of that time. 
Additionally, changes made to the number of ribs or perforations in a 
cigar wrapper as well as any changes to ingredients or additives, would 
result in a new tobacco product (as stated in section 910(a)(1)(B)) and 
would require a marketing application and authorization under section 
910 or 905(j). FDA intends to enforce other applicable requirements 
(e.g., ingredient listing) against manufacturers making blending 
changes to address the natural variation of tobacco.
    (Comment 29) Some comments stated that small companies are at a 
competitive disadvantage compared to larger companies because they do 
not have the resources to complete PMTAs. They feared that FDA's 
premarket requirements would force many companies to remove their 
products from the market and that, as a result, cigarette use would 
increase. To address these concerns, comments suggested that FDA 
stagger requirements based on the size of the business to protect small 
businesses and spur innovation. They stated that staggered compliance 
periods could be based on the number of employees in the business, 
number of products the business has, and/or the product's placement on 
the continuum of risk. In addition, some comments stated that such 
staggered dates could be based on FDA's issuance of final PMTA guidance 
for each product category, which would allow for more meaningful and 
complete submissions. They also stated that, because such guidance 
likely would include issues of first impression, the Agency is required 
to first issue the guidance in draft form before issuing a final 
guidance. Some comments stated that staggered PMTA compliance periods 
may not be sufficient to address the competitive disadvantage of small 
companies because they still would not have the resources to complete a 
PMTA for each of their new tobacco products.
    Other comments believed that premarket requirements should apply 
equally to all manufacturers, regardless of size, for several reasons. 
First, they explained that the FD&C Act states that the purpose of a 
PMTA is to ensure that permitting marketing of a tobacco product would 
be ``appropriate for the protection of the public health'' (section 
910(c)(2)(A)) and that this public health purpose should outweigh 
concerns regarding small businesses. The comments noted that the public 
health purpose of the Tobacco Control Act does not differentiate 
between large and small businesses. Second, they stated that the public 
health concerns presented by products of small manufacturers are no 
less significant than the public health concerns presented by products 
of large manufacturers. They also noted that small manufacturers may 
lack the quality control processes that they believed large 
manufacturers already have in place. They also noted that many small 
businesses are e-cigarette retail establishments that mix their own e-
liquids, which can be accessible to children and potentially subject to 
tampering and, therefore, should not receive additional time to comply 
with critical automatic requirements. Third, they stated that Congress 
did not intend for small manufacturers to have additional time to 
comply with all of the automatic provisions under the law once they are 
deemed. Instead, Congress only intended that small manufacturers 
receive additional time to comply with good manufacturing practices 
under section 906(e)(1)(B) of the FD&C Act and testing requirements 
under section 915(d) (21 U.S.C. 387o). If Congress had intended for 
small manufacturers to receive additional time to comply with other 
provisions, it would have explicitly said so. Fourth, they stated that 
FDA already provides adequate assistance to small businesses with the 
small business center (included as part of CTP's OCE) and frequent 
Webinar programs, but other comments stated that the small business 
center was not properly organized and staffed.
    (Response) FDA is announcing multiple policies with this final rule 
including a policy for ``small-scale tobacco product manufacturers'' 
discussed in section IV.D. FDA is announcing this policy, because 
``small-scale tobacco product manufacturers'' do not have the same 
business capabilities of larger businesses. Moreover, FDA did not 
receive any comments from large manufacturers suggesting that they are 
in need of the relief that is being provided for small-scale tobacco 
product manufacturers. Congress also acknowledged the potential 
disparity by requiring FDA to establish the Office of Small Business 
Assistance (OSBA) within CTP to assist small tobacco product 
manufacturers and retailers in complying with the law. OSBA is 
available to assist manufacturers with any questions regarding 
statutory and regulatory requirements and will continue to provide 
support with respect to these newly finalized regulations. Small 
business owners may contact the OSBA by calling 1-877-CTP-1373 or 
sending a message to SmallBiz.Tobacco@fda.hhs.gov. FDA intends to 
expand the staffing for the OSBA to provide support for manufacturers 
who are newly regulated by FDA.
    As discussed in the earlier section of this final rule describing 
the purpose of this rule, FDA will be able to obtain critical 
information regarding the health risks of newly deemed tobacco 
products, including information derived from ingredient listing 
submissions and reporting of HPHCs. Because FDA did not previously have 
regulatory authority

[[Page 28997]]

over these products, it does not have access to commercial confidential 
information on materials, ingredients, design, composition, heating 
source and other features of these products. As FDA gains experience 
regulating these newly deemed tobacco products, the Agency expects 
there will be more information to aid manufacturers seeking premarket 
determination that a tobacco product is ``appropriate for the 
protection of public health.'' However, it would negatively impact 
public health if FDA were to significantly delay implementation of its 
premarket requirement authorities after issuance of this deeming rule. 
Such delay could result in more youth becoming addicted to nicotine. 
FDA recognized that ENDS are different than conventional tobacco 
products, and that more specific guidance would be useful to 
manufacturers in preparing premarket applications. Therefore, FDA has 
made available draft guidance, which when final, will describe FDA's 
current thinking regarding some appropriate means of addressing the 
premarket authorization requirements for newly deemed ENDS products, 
including recommendations that would help to support a showing that the 
marketing of a product is appropriate for the protection of public 
health. FDA intends to issue additional guidance in the future.

E. Clinical Studies and PMTAs

    (Comment 30) Comments expressed concern about the need for costly 
clinical studies to develop PMTAs that satisfy the requirements under 
section 910 of the FD&C Act. They indicated that FDA's previous 
statements, including language from draft guidance that recommends the 
collection of numerous types of data ranging from chemistry to in vivo 
toxicology and possible clinical trials, suggest the need for costly 
studies that are redundant and unnecessary. They also noted the 
Government Accountability Office's (GAO's) summary of this issue, which 
stated ``CTP's guidance document for the PMTA pathway states that PMTA 
submissions should include data from well-controlled studies 
demonstrating that the tobacco product is appropriate for the 
protection of the public health. [According to CTP,] '[d]ata from such 
studies must address, for example, the health risks associated with the 
product in comparison to the health risks of other products on the 
market and the product's effect on the likelihood that current tobacco 
users will stop using tobacco products''' (Ref. 41 at 18-19).
    (Response) In the NPRM, FDA included discussion intended to 
supplement and clarify its earlier statements regarding clinical 
studies needed for PMTAs (79 FR 23142 at 23176 and 23177). As we noted, 
FDA expects that, in some cases, it may be possible for an applicant to 
obtain a PMTA marketing authorization order without conducting any new 
nonclinical or clinical studies where there is an established body of 
evidence regarding the public health impact of the product. However, in 
cases where there have been few or no scientific studies of a product's 
potential impact on the public health, new nonclinical and clinical 
studies may be required for market authorization. In addition, 
elsewhere in this issue of the Federal Register, FDA is announcing the 
availability of a draft guidance, which when final will provide the 
Agency's current thinking regarding some appropriate means of 
addressing the premarket authorization requirements for newly deemed 
ENDS products, including the need for ``clinical studies'' for the 
purposes of preparing PMTAs for ENDS.
    (Comment 31) Several comments suggested that section 910(c)(5)(B) 
provides FDA with authority to develop a flexible framework for PMTAs 
that would not require well-controlled investigations. They suggested 
the following alternatives to the requirement of well-controlled 
investigations:
     Create a user registry for e-cigarette users to input 
baseline demographic, cessation and initiation, adverse experiences, 
and followup data for collection of real-world data;
     Identify clinical studies that will constitute ``valid 
scientific data'' and identify historical controls and published 
literature suitable for comparative purposes;
     Adopt a process similar to FDA's process for new medical 
devices, where the product can undergo de novo review to obtain a lower 
risk classification and be subject to general controls and specific 
controls (rather than the premarket requirements under sections 905 and 
910(d));
     Use a process similar to the accelerated approval process 
for new drugs for serious or life-threatening illnesses, which bases 
approval on the effect of the drug on a surrogate endpoint; and
     Adopt a method similar to the dietary supplement process, 
based on registration, ingredient disclosures, and good manufacturing 
practice (GMP) compliance checks.
    (Response) FDA is not implementing these changes. Most of the 
approaches in the comments are all implemented under different 
statutory authorities that do not apply to tobacco products. FDA's 
responses to these individual suggestions are discussed in the 
following paragraphs.
     Create a user registry for e-cigarette users to input 
baseline demographic, cessation and initiation, adverse experiences, 
and follow-up data for collection of real-world data--
    The data and information in a PMTA must be sufficient to show that 
the marketing of the specific new tobacco product is ``appropriate for 
the protection of the public health'' (section 910(c)(4) of the FD&C 
Act). This information from a user registry would not be sufficient on 
its own to support a marketing application, but it could provide 
additional real-time information (e.g., adverse experiences that may 
otherwise be gathered in more long-term studies). If an applicant 
wishes to use a registry or other alternatives, we encourage it to 
request a meeting with FDA to discuss these and other issues before it 
prepares and submits an application.
     Identify clinical studies that will constitute ``valid 
scientific data'' and identify historical controls and published 
literature deemed suitable for comparative purposes--
    FDA does not have enough information at this time to do this in a 
manner that would be generally applicable. It may be possible for an 
applicant to submit information (e.g., published literature, marketing 
information) with appropriate information or data that would be 
adequate scientific data for parts of the application. This will likely 
be limited to specific aspects of the PMTA requirements (e.g., 
nonclinical work, shelf life/stability, health risks based on consumer 
information). If an applicant wishes to use this or other alternatives, 
we encourage them to request a meeting with FDA to discuss these and 
other issues in the context of a particular product before they prepare 
and submit an application.
     Adopt a process similar to FDA's process for new medical 
devices, where the product can undergo de novo review to obtain a lower 
risk classification and be subject to general controls and specific 
controls (rather than the premarket requirements under sections 905 and 
910(d))--
    FDA is not authorized to deviate from the premarket requirements of 
chapter IX of the FD&C Act. The medical device requirements in chapter 
V of the FD&C Act apply to medical devices only, not tobacco products 
as defined in section 201(rr) of the FD&C Act.
     Use a process similar to the accelerated approval process 
for new

[[Page 28998]]

drugs for serious or life-threatening illnesses, which bases approval 
on the effect of the drug on a surrogate endpoint--
    The purpose of the accelerated drug approval process was to 
establish procedures designed to expedite the development, evaluation, 
and marketing of new therapies intended to treat persons with life-
threatening and severely debilitating illnesses, especially where no 
satisfactory alternative therapy exists. This is not the case with a 
tobacco product. Section 910(b) of the FD&C Act requires that specific 
contents be contained in a PMTA. In addition, as stated in section 
910(c)(4) of the FD&C Act, the data and information in a PMTA must be 
sufficient to show that the marketing of a new tobacco product is 
``appropriate for the protection of the public health.'' FDA believes 
that an accelerated premarket review process is neither feasible nor 
appropriate for these products at this time. However, if an applicant 
believes it can demonstrate that its new product is ``appropriate for 
the protection of public health'' in an accelerated fashion, we 
encourage it to request a meeting with FDA to discuss these and other 
issues before they prepare and submit an application.
     Adopt a method similar to the dietary supplement process, 
based on registration, ingredient disclosures, and GMP compliance 
checks--
    As stated in section 910(c)(4) of the FD&C Act, the data and 
information in a PMTA must be sufficient to show that the marketing of 
a new tobacco product is ``appropriate for the protection of the public 
health.'' The method suggested in this comment would differ from the 
process and standard outlined in sections 905 and 910 of the FD&C Act 
and, therefore, is inapplicable to tobacco products.
    The FD&C Act states that determining whether a new product is 
appropriate for the protection of the public health shall be determined 
``when appropriate . . . on the basis of well-controlled 
investigations.'' (section 910(c)(5)(A)). However, section 910(c)(5)(B) 
of the FD&C Act also allows the Agency to consider other ``valid 
scientific evidence'' if found sufficient to evaluate the tobacco 
product. Thus, if an application includes, for example, information 
(e.g., published literature, marketing information) with appropriate 
bridging studies, FDA will review that information to determine whether 
it is valid scientific evidence sufficient to demonstrate that the 
product is appropriate for the protection of the public health. If an 
applicant has questions or other alternatives to well-controlled 
investigations it would like to utilize, we recommend that it meet with 
FDA to discuss the approach prior to preparing and submitting an 
application (see FDA guidance entitled ``Meetings with Industry and 
Investigators on the Research and Development of Tobacco Products''). 
We also note that, elsewhere in the Federal Register, FDA is announcing 
the availability of a draft guidance, which when final will provide the 
Agency's current thinking regarding some appropriate means of 
addressing the premarket authorization requirements for newly deemed 
ENDS products.

F. Premarket Pathways and Continuum of Risk

    (Comment 32) We received many comments requesting that FDA provide 
an expedited or abbreviated pathway for those products that are on the 
less harmful end of the continuum of risk spectrum. Some comments 
stated that noncombusted and nicotine delivery products derived from, 
but not containing, tobacco should be treated differently than 
combusted products for the purposes of premarket review and that less 
harmful products need an accelerated pathway to ensure continued 
innovation. They also stated that the different risks and benefits 
associated with tobacco derived nicotine delivery products make the 
PMTA process and FDA's draft PMTA guidance inapplicable. Other comments 
claimed that e-cigarettes and other tobacco derived nicotine delivery 
products are not tobacco products at all and do not fit into the strict 
tobacco product regulatory framework. The comments also stated that an 
abbreviated pathway should be based on public participation to decide 
what information is sufficient to determine that the product is 
appropriate for the protection of the public health without impeding 
innovation.
    Some comments also suggested that FDA require a premarket 
notification or report, similar to EU's Tobacco Products Directive, 
where the notification certifies that the product has met specific 
product standards, and the Agency could approve the product based on 
the certification.
    At least one comment disagreed with the idea of providing an 
expedited or abbreviated pathway for some products, stating that FDA 
will not know if the products are less harmful until it reviews the 
applications.
    (Response) An ENDS is a tobacco product as long as it meets the 
definition of ``tobacco product'' under section 201(rr) of the FD&C 
Act. Regardless of the type of tobacco product (and its potential risks 
and benefits), all tobacco products going through the PMTA pathway must 
meet all the requirements for a premarket authorization in section 910 
of the FD&C Act before FDA can issue such an authorization. In 
addition, we note that, at this time, while there is general evidence 
of harm for all classes of newly deemed products, FDA has not yet 
obtained product-specific evidence regarding the various ENDS on the 
market. Since ENDS products contain nicotine, it is possible that such 
products may result in overall public health harm if individuals who 
would not have initiated tobacco use in the absence of ENDS ultimately 
graduate to combusted products (though scientific data regarding this 
hypothesis is unclear) or use them in conjunction with combusted 
products or if the users would never have initiated tobacco use absent 
the availability of ENDS. In addition, nicotine use in any form is of 
particular concern for youth and pregnant women. On the other hand, if 
ENDS promote transition from combustible tobacco use among current 
users, there could be a public health benefit. The 2014 Surgeon General 
Report notes that ``[f]urther research with attention to their 
individual and population-level consequences will be helpful to fully 
address these questions. However, the promotion of noncombustible 
products is much more likely to provide public health benefits only in 
an environment where the appeal, accessibility, promotion, and use of 
cigarettes and other combusted tobacco products are being rapidly 
reduced'' (Ref. 9 at 873). FDA believes that regulation of all tobacco 
products will help to address these questions and provide public health 
benefits.
    (Comment 33) Many comments expressed concern regarding the cost of 
PMTAs for newly deemed products and the effect that this requirement 
will have on cigarette smokers who are attempting to quit. They also 
disagreed with FDA's assertion that premarket review will enhance 
innovation (79 FR 23142 at 23149), stating that the cost of submitting 
PMTAs is more of a business concern than competition with lower quality 
products. They claimed that the PMTA process would have the largest 
negative impact on open system apparatus, which some comments believed 
are the most popular with people who have achieved complete 
substitution from conventional cigarettes to e-cigarettes. The comment 
suggests that the result would be that newer e-cigarettes would not 
make it onto the market, driving up prices, and

[[Page 28999]]

driving adult consumers back to conventional cigarettes.
    (Response) The Tobacco Control Act provides for three specific 
marketing pathways for new tobacco products--SE., SE exemption, and 
PMTA; it does not provide alternative pathways. Through the PMTA 
pathway, FDA will ensure that only products that are shown to be 
appropriate for the protection of public health are permitted to be 
marketed. Use of the PMTA pathway also will allow FDA to monitor 
product development and changes and to prevent more harmful or 
addictive products from reaching the market. The PMTA pathway will 
incentivize development of tobacco products that pose less risk to 
human health by limiting market access for more-risky competitor 
products. Furthermore, since the ``appropriate for the protection of 
the public health'' standard involves comparison to the general tobacco 
product market existing at the time of an application, FDA believes 
that, over time, the premarket authorities will move the market toward 
less-risky tobacco products.
    A recently published paper by Friedman (Ref. 42) looked at youth 
smoking rates in states that enacted early bans on sales of e-
cigarettes to minors. The author concluded, based on state-level 
combusted cigarette smoking data available through 2013, that the 
decline in adolescent smoking rates slowed in states that enacted 
restrictions on access to ENDS by minors before January 2013, relative 
to states that did not. Some have interpreted the results of the study 
as providing evidence that any policies that restrict access to e-
cigarettes or regulate e-cigarettes could increase consumption of 
combusted tobacco products. However, the research has several 
limitations that are acknowledged in the study. First, the survey data 
used in the study, from the NSDUH, track changes in the prevalence of 
cigarette smoking but lack information available on e-cigarette use. As 
such, the study does not establish that youth switched directly from 
using ENDS to smoking combusted cigarettes after restrictions on sales 
of e-cigarettes to minors were enacted, only that the decline in 
prevalence of cigarette smoking slowed in states where such 
restrictions were enacted relative to states that did not. Second, the 
fact that the study examines a period very early on in the development 
of the market for ENDS products may also limit the inferences that can 
be drawn for substitution and dual usage patterns that will emerge as 
the market matures. Third, the ``increase'' in the prevalence of youth 
smoking is relative to what would have been predicted from ongoing 
trends; in both states that did and states that did not enact 
restrictions, the prevalence of youth smoking continued to decline, 
just at a slower rate in the states that enacted bans. Finally, given 
these issues, FDA acknowledges this paper as a first attempt to study 
potential impacts of youth ENDS access restrictions, but more research 
will be necessary to explore the potential effects of this rule on 
product switching or dual usage.
    (Comment 34) Some comments suggested that FDA should establish a 
monograph-like system to allow e-cigarettes seeking to enter the market 
to be compared to a baseline or ``model'' e-cigarette. In addition, a 
few comments suggested that combustible product manufacturers should 
also be able to compare their products to a reference product to ease 
SE burdens.
    (Response) FDA disagrees as these suggested alternatives are not 
consistent with the Tobacco Control Act. Under the SE pathway, FDA must 
determine if the new tobacco product raises different questions of 
public health than an identified, and valid, predicate product. To be 
an eligible predicate product under section 910 of the FD&C Act, the 
product must have been commercially marketed in the United States on 
February 15, 2007, or been previously found substantially equivalent.
    Moreover, elsewhere in this issue of the Federal Register, FDA has 
made available a final guidance to provide information for 
manufacturers on how to establish and reference a Tobacco Product 
Master File (TPMF). We expect reliance on TPMFs to increase efficiency 
and reduce any burdens on manufacturers. As discussed in section IX, 
because of the nature of upstream supply of many components for ENDS 
products, especially e-liquids, FDA anticipates that commercial 
incentives will be sufficient to drive manufacturer reliance on the 
system of master files. We note that, at present, FDA understands that, 
based on the Agency's review of publically available data, the number 
of entities engaged in upstream production of liquid nicotine and 
flavors specifically developed for use with e-liquids is small. 
Specifically, based on internet searches and information provided on 
firm Web sites, FDA estimates that there are roughly five to ten major 
pure liquid nicotine suppliers, most of which claim to have a 
significant market share.\10\ Several of these companies already have 
master files with FDA for their nicotine products or report that they 
are ready to file submissions to meet U.S. and EU regulatory 
requirements. An online search of flavor manufacturers revealed many 
suppliers of flavorings that can be added to food or other consumer 
products; any of these products potentially could be used as e-liquid 
flavoring. However, FDA searches identified only two to three flavor 
houses that make flavoring specifically for e-liquids.\11\ Given these 
realities of the marketplace, FDA expects that the master file system 
will be widely appealing and widely utilized by the ENDS industry.
---------------------------------------------------------------------------

    \10\ See, e.g., Ref. 43. FDA Internet searches included review 
of Web sites identifying product suppliers, such as 
www.thomasnet.com and www.alibaba.com, as well as manufacturer Web 
sites and news reports on the market.
    \11\ FDA Internet searches included review of Web sites 
identifying product suppliers, such as www.thomasnet.com and 
www.alibaba.com, as well as manufacturer Web sites and news reports 
on the market.
---------------------------------------------------------------------------

    (Comment 35) Comments suggested that the ``appropriate for the 
protection of the public health'' standard for PMTAs was meant for 
those products with well-established risks to consumers and should not 
apply to e-cigarettes. They suggested that FDA establish a different 
standard for issuing PMTA orders for e-cigarettes (i.e., that the 
product is no more hazardous than currently marketed tobacco products).
    (Response) FDA disagrees with comments suggesting the use of a 
different standard for e-cigarettes and other ENDS. Section 910(c)(4) 
specifies the standard FDA is to apply in deciding whether to issue a 
PMTA marketing authorization order. That section states that the 
product must be ``appropriate for the protection of the public health'' 
which ``shall be determined with respect to the risks and benefits to 
the population as a whole, including users and nonusers of the tobacco 
product, and taking into account--(A) the increased or decreased 
likelihood that existing users of tobacco products will stop using such 
products; and (B) the increased or decreased likelihood that those who 
do not use tobacco products will start using such products.'' FDA is 
not authorized to deviate from this statutory standard.
    (Comment 36) Some comments recommended that FDA deem products 
currently on the market without subjecting those products to the 
statute's premarketing requirements. Similarly, some comments argued 
that the premarket requirements should not apply to specific categories 
of products (specifically, e-cigarettes and other novel tobacco 
products), including those that are introduced after the enactment of 
the rule. They stated that

[[Page 29000]]

this large burden does not have a clear benefit to public health.
    (Response) The statute automatically subjects deemed products to 
the statutory requirements for ``tobacco products'' in chapter IX of 
the FD&C Act. Once deemed, the products are subject to all statutory 
provisions that apply to all tobacco products covered by the FD&C Act. 
See section 901(b) of the FD&C Act (``This subchapter shall apply to 
all cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless 
tobacco and to any other tobacco products that the Secretary by 
regulation deems to be subject to this subchapter.''). Section 910, 
which establishes the procedures that must be followed before a new 
tobacco product can be authorized for marketing, is one of the 
statutory provisions that apply automatically to all tobacco products, 
including newly deemed products. FDA believes that the premarket review 
requirements will, in fact, benefit public health, as discussed in the 
NPRM (79 FR 23142 at 23148 and 23149).
    (Comment 37) Some comments stated that FDA must get a better 
scientific understanding of e-cigarettes before finalizing the 
compliance period for premarket review of these products. One comment 
also proposed a system in which FDA could create product standards 
under section 907 of the FD&C Act for the entire category of e-
cigarettes and then approve or reject PMTAs for individual e-cigarettes 
based upon whether they meet the standards.
    (Response) FDA disagrees with comments suggesting that the Agency 
needs additional time before determining an appropriate compliance 
period for the premarket review requirements for ENDS. As we have 
stated throughout the document, FDA has data regarding health harms 
generally associated with all of the categories of tobacco products 
regulated under this rule (including ENDS). FDA is regulating these 
products in accordance with this knowledge. FDA also disagrees with 
comments suggesting that FDA can change the statutory requirements and 
standards for issuing PMTA orders. FDA's revised compliance policy for 
submission of PMTAs and other premarket submissions is discussed in 
section V.A.
    (Comment 38) At least one comment suggested that applicants be able 
to utilize publications regarding scientific understanding of e-
cigarettes as harm reduction products to support their PMTAs.
    (Response) FDA agrees that applicants can include scientific 
literature as part of their PMTA submission pursuant to section 
910(b)(1). In addition, elsewhere in this issue of the Federal 
Register, FDA has made available draft guidance, which when final will 
describe FDA's current thinking regarding some appropriate means of 
addressing the premarket authorization requirements for newly deemed 
ENDS products, including the use of scientific literature.
    (Comment 39) Comments recommended that FDA issue PMTA orders based 
only on HPHC data and appeal to children, as well as a manufacturer's 
postmarketing commitments to conduct long-term studies regarding 
effects of e-cigarette use (similar to the supplemental application 
processes for new drug applications (NDA) and device premarket approval 
supplement regimes codified in 21 CFR 314.70 and 814.39, respectively). 
Comments also suggested that FDA create a supplemental PMTA for 
modifications and minor modifications to tobacco products so each 
product would not require a full PMTA.
    (Response) FDA disagrees. The statutory authorities for FDA's 
regulation of drugs, devices, and tobacco products are different. 
Section 506A of the FD&C Act (21 U.S.C. 356a) authorizes FDA to utilize 
a supplemental NDA process allowing manufacturers to make manufacturing 
changes to approved drugs and section 515 (21 U.S.C. 360e) allows 
device manufacturers to supplement their premarket approval 
applications for modifications to products. Although FDA does not have 
the same ability to allow an applicant to obtain an authorization and 
later supplement the application (given the different statutory scheme 
for tobacco products), FDA is actively considering other opportunities 
for efficiency and streamlining in the PMTA process, consistent with 
its mission to protect the public health.
    (Comment 40) One comment suggested that FDA publish guidance on how 
the Agency will determine whether an e-cigarette is substantially 
equivalent to a predicate product. According to this comment, the SE 
review should focus on the aerosol delivered to the consumer to 
determine whether a new e-cigarette raises different questions of 
public health.
    (Response) FDA may issue guidances for specific product categories 
at a later date. However, FDA finds that the available guidance for SE 
reports should be sufficient to assist manufacturers in preparing 
reports and to advise them of the factors FDA considers when assessing 
SE reports, as evidenced by the fact that the agency has issued many 
orders regarding SE to applicants that have utilized the available 
guidance (for the most recent SE actions, see http://www.fda.gov/TobaccoProducts/Labeling/MarketingandAdvertising/ucm435693.htm). 
Previously issued SE orders were for products whose applications may 
differ substantially from those for the newly deemed tobacco products. 
As required by section 910(a)(3)(A) of the FD&C Act and as stated in 
FDA's guidance documents, the Agency must consider product 
characteristics when evaluating SE reports. The constituents found in 
e-cigarette aerosol are just some of the characteristics that FDA will 
consider when reviewing SE reports for e-cigarettes. Other 
characteristics include the materials, other ingredients, design, 
composition, heating source, and other features of the e-cigarette (see 
section 910(a)(3)(B)). We also encourage prospective applicants to 
review the applications FDA posts on www.fda.gov for examples of 
products that have different characteristics but do not raise different 
questions of public health when compared with the specified predicate 
product.
    (Comment 41) Some comments provided several suggestions as to how 
FDA can craft the PMTA process to acknowledge the position of e-
cigarettes on the continuum of nicotine-delivering products. For 
example, they indicated that e-cigarettes should not need to undergo a 
rigorous, comprehensive premarket review process and, instead, should 
be given an abbreviated pathway that would allow FDA to achieve the 
same objectives. For example, some comments suggested that, in order to 
streamline the process, a PMTA for an e-cigarette should be required to 
contain only the following: (1) A sample of the product; (2) specimens 
of proposed labeling; (3) a description of the product's principles of 
operation; (4) ingredient listing for e-liquids; (5) a description of 
methods of manufacturing and processing; and (6) a description of 
quality control and product testing systems. They suggested that FDA 
could require e-cigarettes to comply with product standards once they 
are established.
    Other comments urged FDA to impose strict regulations on the sale 
of e-cigarettes, including extensive premarket review, to ensure that 
future generations are not burdened by nicotine addiction. While some 
of these comments noted that there may be potential benefits to some 
individuals, they believed the Agency cannot lower its scientific 
standards, weaken its requirements for rigorous science, or change its 
requirements for evaluating the public health impact of e-cigarettes. 
To determine eligibility for expedited

[[Page 29001]]

review or an abbreviated pathway, these comments stated that FDA must 
recognize that: (1) The use of any tobacco product, including a well-
regulated e-cigarette, poses a greater risk than using no tobacco 
product; and (2) the scientific evidence does not demonstrate 
substantial reduction in harm to an individual from e-cigarette use if 
the consumer dual uses with cigarettes, except when dual use is a 
short-term pathway to quitting smoking cigarettes.
    (Response) Section 910(b) of the FD&C Act lays out the specific 
elements to be submitted in a PMTA and 910(c)(2)(A) specifies that FDA 
cannot authorize the marketing of a product where there is a lack of 
showing that the marketing of a new tobacco product is ``appropriate 
for the protection of the public health.'' The FD&C Act states that 
this finding will be determined, when appropriate, on the basis of 
well-controlled investigations (section 910(c)(5)(A)). However, section 
910(c)(5)(B) of the FD&C Act also allows the Agency to consider other 
``valid scientific evidence'' if found sufficient to evaluate the 
tobacco product. Thus, if an application includes, for example, 
information (e.g., published literature, marketing information) with 
appropriate bridging studies, FDA will review that information to 
determine whether it is valid scientific evidence sufficient to 
demonstrate that a product is appropriate for the protection of the 
public health. If an applicant has questions or other alternatives to 
well-controlled investigations it would like to utilize, we recommend 
that the applicant meet with FDA to discuss the approach prior to 
preparing and submitting an application (see FDA guidance ``Meetings 
with Industry and Investigators on the Research and Development of 
Tobacco Products''). In addition, elsewhere in this issue of the 
Federal Register, FDA has made available ENDS PMTA draft guidance 
which, when final, will describe FDA's current thinking regarding some 
appropriate means of addressing the premarket authorization 
requirements for newly deemed ENDS products.
    (Comment 42) Given the differences among newly deemed product 
categories and the potential benefits from these products, some 
comments said that FDA should develop clear guidance regarding the 
scientific evidence the Agency will need to review the safety and 
health impact of these products and to accelerate the review of 
marketing applications where necessary.
    (Response) To help provide clarity regarding submission 
requirements for marketing applications, FDA has issued several 
guidance documents, and is finalizing other guidance documents, 
regarding the evidence needed for SE reports, including FDA draft 
guidance entitled ``Substantial Equivalence Reports: Manufacturer 
Requests for Extensions or to Change the Predicate Tobacco Product'' 
(79 FR 41292, July 15, 2014), and FDA guidance entitled ``Establishing 
That a Tobacco Product Was Commercially Marketed in the United States 
as of February 15, 2007,'' among others. FDA also has issued a draft 
guidance entitled ``Applications for Premarket Review of New Tobacco 
Products'' (76 FR 60055, September 28, 2011). In addition, elsewhere in 
this issue of the Federal Register, FDA has made available draft 
guidance, which when final will describe FDA's current thinking on some 
appropriate means of addressing the premarket authorization 
requirements for newly deemed ENDS products. If FDA determines that 
additional guidance is necessary to help manufacturers prepare 
marketing applications, FDA will issue additional guidance and publish 
a notice of availability in the Federal Register.
    (Comment 43) One comment stated that, because there is a lack of 
scientific evidence to show the health impact of vapor products, 
applying the premarket requirements to this category of products is 
premature. Therefore, the comment suggested that FDA exercise 
enforcement discretion to delay implementation of this requirement 
until more evidence is available.
    (Response) FDA has established a compliance policy regarding the 
premarket review requirements. This is described in section V.A. As 
discussed elsewhere in this document, we believe the compliance period 
is appropriate, and it takes into account the time for firms to 
generate and submit the information for a PMTA. The requirements and 
costs of a PMTA may vary based on the type and complexity of the 
product. For example, where there is limited understanding of a 
product's potential impact on public health, nonclinical and clinical 
studies may be required for market authorization. In such case, the 
requirements and cost of the PMTA likely would be higher (and the 
review time longer) than for a product in which there is already 
substantial scientific data on the potential public health impact. This 
information provided as part of premarket review (design, ingredients, 
levels of HPHCs) will provide critical information on these products.
    (Comment 44) One comment suggested that FDA regulate e-cigarettes 
as an adult consumer product without providing additional details.
    (Response) It is unclear what this comment envisioned by suggesting 
that FDA regulate e-cigarettes as an adult consumer product. 
Nevertheless, FDA must regulate tobacco products in accordance with the 
Tobacco Control Act, including section 910 of the FD&C Act, which 
states that in reviewing PMTAs for new tobacco products, FDA must 
consider whether the marketing of such product is appropriate for the 
protection of the public health, and that this finding is to be 
determined with respect to the risks and benefits to the population as 
a whole, including users and nonusers of the product, taking into 
account--the increased or decreased likelihood that existing users of 
tobacco products will stop using such products; and the increased or 
decreased likelihood that those who do not use tobacco products will 
start using such products (section 910(c)(4) of the FD&C Act). This 
public health standard requires the Agency to consider the impact of 
the products on the ``population as a whole,'' not simply the adult 
population that may be using such products.
    (Comment 45) Some comments stated that FDA regulations should 
support manufacturers' efforts to invest in alternative tobacco 
products with the potential to reduce harm.
    (Response) The Agency continues to support development of 
alternative tobacco products with the potential to reduce harm, and 
believes that the PMTA, MRTP, and other regulatory provisions will help 
foster the development of tobacco products that pose less risk to human 
health. In addition, as a practical effect of the Agency's compliance 
policy for premarket review of newly deemed tobacco products, FDA 
expects that many manufacturers, including those with alternative 
tobacco products, will continue to market their products during 
preparation of submissions and for the continued compliance period 
afterward. The time it takes to review premarket applications is 
dependent upon the type of application and the complexity of the 
product.

G. Other Comments

    (Comment 46) A few comments suggested that FDA review and authorize 
marketing of products at the ingredient level. For example, if a 
tobacco product contained only preauthorized ingredients, the product 
could be marketed, possibly through self-certification. If the product 
used unapproved ingredients, the manufacturer would be required to

[[Page 29002]]

submit a PMTA containing information on only those ingredients or meet 
established testing guidelines. The comments suggested that standards 
that could be used to assess the ingredients may include the U.S. 
Pharmacopeial Convention (USP), FDA's Generally Recognized as Safe 
(GRAS) standards, the New Drug Products Q3B(R2) guidance; and the Food 
Chemicals Codex or FDA Redbook of Foods.
    (Response) FDA disagrees. Section 910 of the FD&C Act requires FDA 
to evaluate the new tobacco product as a whole to determine whether the 
authorization of marketing of the product is appropriate for the 
protection of the public health. In addition, we note that GRAS status 
for a food additive does not mean that the substance is GRAS when 
inhaled, since GRAS status does not take inhalation toxicity into 
account and applies only to intended uses that may reasonably be 
expected to result, directly or indirectly, in its becoming a component 
or otherwise affecting the characteristics of any food (section 201(s) 
of the FD&C Act.).
    (Comment 47) A few comments expressed concern as to the 
contemplated compliance periods for HPHC testing (with a proposed 
compliance period of 3 years following the effective date of the final 
rule) and the contemplated 24-month compliance period for marketing 
applications, because applicants will need to submit HPHC data with 
their PMTAs. They requested that FDA delay its enforcement of PMTA and 
SE application requirements until it has established an HPHC list and 
validated methodology for individual products.
    (Response) While applicants should submit certain information about 
HPHCs as part of their applications, the requirement to submit HPHC 
listings under section 904 of the FD&C Act (21 U.S.C. 387d) is separate 
and distinct from the premarket review requirements under section 910. 
HPHC information submitted under section 904 will assist FDA in 
assessing potential health risks and determining if future regulations 
to address a product's health risks are warranted. For PMTAs, FDA 
expects that applicants will report the levels of HPHCs as appropriate 
for each product, so the reported HPHCs will differ among different 
product categories. Elsewhere in this issue of the Federal Register, 
FDA has made available draft guidance, which when final will describe 
FDA's current thinking regarding some appropriate means of addressing 
the premarket authorization requirements for newly deemed ENDS 
products, including information regarding HPHCs. The Agency recommends 
that manufacturers consult with CTP's OS about what is appropriate in 
the context of a specific application.
    FDA recognizes, however, that it could be difficult for certain 
manufacturers of the newly deemed products (e.g., small businesses) to 
comply with the section 904 HPHC requirements for all of their 
currently marketed products. For example, contract laboratories may not 
be prepared for the large volume of requests for the testing of 
quantities of the HPHCs for all brands and subbrands of tobacco 
products marketed prior to the effective date. Thus, we have 
established a compliance period of 3 years for submission of this data 
under section 904 for products on the market as of the effective date. 
In addition, in the context of all newly deemed products considered in 
total, many products may be grandfathered and will thus not be required 
to obtain premarket authorization through one of three pathways--SE, 
exemption from SE, or premarket tobacco product applications (sections 
905 and 910 of the FD&C Act). Given that the number of newly deemed 
products in total seeking PMTA orders likely will be much smaller than 
the total number of such tobacco products on the market as of the 
effective date (given that many products will be grandfathered and that 
some products may exit without submission of an application), FDA 
expects that the HPHC information submitted as part of these PMTA 
applications can be obtained within the 2-year submission period for 
newly deemed tobacco products. (FDA notes that the proportion of 
products that may qualify as grandfathered is likely to vary for 
different product categories. For example, the ENDS product category, 
for which the market has changed dramatically since 2007, is likely to 
have a smaller proportion of grandfathered products than some other 
product categories.)
    Moreover, elsewhere in this issue of the Federal Register, FDA has 
made available a final guidance to provide information on how to 
establish and reference a Tobacco Product Master File (TPMF). FDA notes 
that we expect reliance, to the extent applicable, on TPMFs to increase 
efficiency and reduce any burdens on manufacturers. As discussed in 
section IX, because of the nature of upstream supply of many components 
for ENDS products, especially e-liquids, FDA anticipates that 
commercial incentives will be sufficient to drive manufacturer reliance 
on the system of master files. We note that, at present, FDA 
understands, based on publically available information, that the number 
of entities engaged in upstream production of liquid nicotine and 
flavors specifically developed for use with e-liquids is in the range 
of seven to thirteen entities (see earlier discussion in response to 
comment 34). Given the nature of the marketplace, FDA expects that the 
master file system will be widely appealing and widely utilized by the 
ENDS industry.
    (Comment 48) Several comments noted that large numbers of tobacco 
product manufacturers waited until March 22, 2011 (the date that 
provisional SE reports were due for the original tobacco products 
subject to the FD&C Act) to submit their SE reports. They considered 
this an abuse of the process and expressed concern that manufacturers 
of newly deemed products would act similarly, particularly with a 24-
month compliance period. They suggested that FDA expressly require 
companies to meet all other requirements, including ingredient 
reporting and quality controls, to be able to avail themselves of this 
extended compliance period. Other comments stated that any compliance 
period should be contingent on FDA issuing orders on all pending SE 
reports already submitted to the Agency.
    (Response) FDA understands concerns about the Agency's timely 
review of applications given the influx of SE reports that FDA received 
at the close of the SE provisional period (March 22, 2011). However, 
FDA has taken several steps to address the resulting backlog and to 
provide helpful feedback to industry to encourage more complete, 
streamlined submissions and reviews, including: (1) Encouraging 
teleconferences between the assigned regulatory health project manager 
and the applicant; (2) streamlining the SE report review process by 
modifying the preliminary review so that it focuses only on 
administrative issues and allowing submission deficiencies to be 
communicated to the applicant more quickly; (3) providing information 
on FDA's Web site about the three pathways available to market products 
(including SE) and developing public Webinars to explain the Agency's 
processes; and (4) publishing guidance documents. On March 24, 2014, 
FDA announced that the Agency no longer has a backlog of regular SE 
reports awaiting review. The Agency is now reviewing regular SE reports 
as they are received. FDA expects that these steps will help reduce the 
time it will take FDA to review submissions for newly deemed products. 
In addition, FDA has specified end dates for the compliance

[[Page 29003]]

periods for such products, after which such products on the market 
without authorization (even if applications submitted during the 
relevant compliance periods are still under review) will be subject to 
enforcement. We note that these staggered compliance dates will help to 
manage the flow of applications into FDA. If an applicant wishes to 
discuss a product application, the applicant may request a meeting as 
set forth in FDA's final guidance entitled ``Meetings with Industry and 
Investigators on the Research and Development of Tobacco Products'' 
(announced May 25, 2012, 77 FR 31368).
    (Comment 49) At least one comment suggested that FDA should require 
manufacturers that have not received their marketing authorizations 
within 1 year after the effective date of the final deeming to include 
a statement on their packaging and labeling indicating that the product 
is pending FDA evaluation under the Tobacco Control Act.
    (Response) FDA declines to issue such a labeling requirement at 
this time. We do not have evidence that the statement will be 
appropriate for the protection of the public health, as determined with 
respect to the risks and benefits to the population as a whole (which 
is the standard for such a requirement under section 906(d) of the FD&C 
Act). FDA also is concerned about consumer confusion or misconceptions 
that could result from such a requirement.
    (Comment 50) At least one comment suggested that application of 
premarket review requirements to the newly deemed products (namely, e-
cigarettes) is unnecessary, because the benefits that would accrue as a 
result of deeming are independent of the premarket review provisions.
    (Response) FDA disagrees. The premarket provisions of the statute 
apply automatically to deemed products. While FDA outlined in the NPRM 
a number of public health benefits that would accrue as a result of 
deeming products subject to chapter IX as a whole (79 FR 23142 at 23148 
and 23149), as explained in this document, FDA believes that the public 
health benefits that will accrue from the premarket review provisions 
are substantial. Implementation of these provisions will allow FDA to 
monitor product development and to prevent potentially more harmful or 
addictive products from reaching the market. Premarket review is 
especially critical given the changing nature of the ENDS technology 
and industry and the increasing interest in these products from youth 
and young adults. FDA's premarket review also will increase product 
consistency. For example, FDA's oversight of the constituents of e-
cigarette and other ENDS cartridges will help to ensure quality control 
relative to the chemicals and their quantities being aerosolized and 
inhaled. At present, there is significant variability in the 
concentration of chemicals among some products--including variability 
between labeled content and concentration and actual content and 
concentration (see section VIII.D). Without a regulatory framework, 
users will be subject to significant variability among products, 
raising potential public health and safety issues.

IV. Implementation

    FDA's proposal stated that part 1100, deeming additional tobacco 
products to be subject to chapter IX of the FD&C Act, and the minimum 
age and identification and vending machine restrictions in part 1140 
would be effective 30 days after publication of the final rule and 
listed compliance periods for different requirements. FDA received many 
comments regarding the proposed effective date, compliance periods, and 
other enforcement issues. A summary of these comments and FDA's 
responses are included as follows.

A. Effective Date for Rule

    FDA proposed that part 1100, deeming products to be subject to the 
chapter IX automatic provisions, and the minimum age and identification 
and vending machine restrictions in part 1140 be effective 30 days from 
the publication date of the final rule. Based on our review of 
comments, FDA is finalizing this rule so that the automatic provisions, 
minimum age provisions, and vending machine restrictions will be 
effective 90 days from the date of the final rule's publication, as 
explained in this document. The compliance periods for other sections 
are discussed in this section.
    (Comment 51) A few comments expressed concern regarding the 
effective date of the deeming provisions in part 1100, which is also 
the effective date of the minimum age and identification regulations. 
They stated that a 30-day effective date for the minimum age and 
identification regulations provides too small a window of time for 
retailers to adjust employee training curricula, train and educate 
employees, raise awareness of the new requirements, and adjust in-store 
or point-of-sale job aids to ensure compliance. These comments 
requested a 6-month compliance period for both the youth access and 
vending machine provisions.
    (Response) FDA recognizes that certain retailers may need more than 
30 days to begin compliance with the youth access and vending machine 
restrictions included in this rule. For example, ENDS retail 
establishments or cigar retailers that have not previously been subject 
to similar restrictions for cigarettes and smokeless tobacco may need 
additional time to implement these regulations. To address these 
situations, FDA is establishing a 90-day effective date for this 
deeming provision and the accompanying automatic provisions in the FD&C 
Act, as well as the minimum age and identification requirements and 
vending machine restrictions. FDA does not believe that a 6-month 
compliance period is necessary to educate retailers on these 
requirements given that many retailers also sell products that are 
currently subject to Federal and/or State and local regulations 
regarding minimum age and identification.
    (Comment 52) Some comments suggested that FDA delay the effective 
dates of all deeming provisions until the Agency can issue product 
standards (under section 907) and good manufacturing practice 
regulations (under section 906(e)), as these are the most important 
requirements for the newly deemed products. They stated, however, that 
all rulemaking on e-cigarettes should be delayed until the science is 
firmly established to allow for more informed FDA decisionmaking.
    (Response) FDA disagrees. As we have stated throughout the 
document, FDA has data regarding health harms generally associated with 
all of the categories of tobacco products regulated under this rule 
(including ENDS). FDA is regulating these products in accordance with 
this knowledge. We will continue to build upon our product-specific 
knowledge through the information we receive as a result of the 
application of the FD&C Act's automatic provisions, such as ingredient 
reporting and the reporting of HPHCs, to newly deemed tobacco products. 
In addition, as discussed in the NPRM, FDA believes that many public 
health benefits will accrue as a result of deeming these products (79 
FR 23142 at 23148 and 23149). It would not protect the public health to 
forego implementation of these provisions until FDA can issue final 
product standards and tobacco product manufacturing practice 
regulations. It is also important to note that this final deeming rule 
is a foundational rule that enables FDA to issue future regulations if 
FDA determines that they would be appropriate for the protection of 
public health.
    (Comment 53) Comments stated the NPRM is a ``major rule'' according 
to the

[[Page 29004]]

Office of Information and Regulatory Affairs, 5 U.S.C. 804(2) (1996), 
and the Congressional Review Act mandates that the rule cannot take 
effect until 60 days after the final rule is published in the Federal 
Register (5 U.S.C. 801(a)(3) (1996)). Therefore, they requested that 
FDA change the effective date for this rule and the compliance periods 
for parts 1100 and 1140 to at least 60 days following publication of 
the final rule.
    (Response) FDA is providing a 90-day effective date for parts 1100 
and 1140 with this final rule.

B. Compliance Periods for Certain Provisions

    To avoid confusion about existing dates in the FD&C Act that are 
based on the date of enactment of the law and to provide time for firms 
to comply with provisions that require labeling changes or information 
submissions to the Agency, FDA proposed compliance timeframes for 
certain provisions. The final compliance dates are included in tables 2 
and 3.
    (Comment 54) Comments requested that FDA impose the same 
requirements on the newly deemed products that apply to currently 
regulated products, including the same compliance periods for all 
provisions and the same marketing and advertising restrictions. In 
addition, they stated that establishing exemptions would create a 
significant administrative burden for FDA, and that a single, 
comprehensive plan would be easier for industry to understand and for 
the Agency to implement.
    (Response) With this final rule, FDA is deeming additional tobacco 
products subject to its chapter IX tobacco authorities. This means that 
newly deemed products will be subject to all provisions in the FD&C Act 
applicable to ``tobacco products'' in the same way that currently 
regulated tobacco products are also subject to those provisions. Under 
section 901, FDA is authorized to deem products subject to ``chapter 
IX,'' not to particular provisions of chapter IX. Thus, there are no 
exemptions from particular requirements for any product category 
(although FDA is announcing enforcement policies for certain 
requirements and for small-scale tobacco product manufacturers as 
discussed throughout this document). FDA is subjecting covered tobacco 
products to the additional provisions (i.e., age and identification 
requirements, vending machine restrictions, and health warning 
requirements) discussed in this final rule. If FDA later determines 
that further marketing and advertising restrictions for newly deemed 
products are appropriate and meet the applicable standard in section 
906(d), FDA will follow the requirements of the APA to implement such 
restrictions.
    With respect to compliance periods, FDA is providing different 
compliance periods for certain automatic requirements of the FD&C Act 
that are generally similar to the timeframes provided in the statute 
for currently regulated products to meet certain requirements after the 
law's date of enactment.
1. HPHC Reporting Requirements (Section 904)
    As of the effective date of this rule, the ingredient listing and 
HPHC reporting requirements of section 904 will apply to the newly 
deemed products. To provide manufacturers sufficient time to comply 
with these requirements, FDA is providing compliance periods for these 
requirements as stated in table 3.
    (Comment 55) Most comments agreed with the compliance timeframes 
included in table 1B of the NPRM, aside from the HPHC requirements 
under section 904(a)(3) (79 FR 23142 at 23172 through 23174). They 
argued that the compliance period for testing and listing of HPHCs was 
not sufficient for several reasons, including: The costs associated 
with compliance; the lack of clear product-specific guidance; and the 
lack of available independent laboratories to complete the testing for 
the many small businesses that would be affected by the requirements.
    (Response) The compliance period for HPHC reporting under section 
904(a)(3) is the effective date of this rule plus 3 years. FDA intends 
to issue guidance regarding HPHC reporting, and later a testing and 
reporting regulation as required by section 915, with enough time for 
manufacturers to report given this compliance period. Section 904(a)(3) 
requires the submission of a report listing all constituents, including 
smoke constituents, identified as harmful or potentially harmful (HPHC) 
by the Secretary. Section 915 requires the testing and reporting of the 
constituents, ingredients, and additives the Secretary determines 
should be tested to protect the public health. The section 915 testing 
and reporting requirements apply only after FDA issues a regulation 
implementing that section, which it has not yet done. Until these 
testing and reporting requirements have been established, newly deemed 
tobacco products (and currently regulated tobacco products) are not 
subject to the testing and reporting provisions found under section 
915. As noted elsewhere in this document, FDA does not intend to 
enforce the reporting requirements under section 904(a)(3) for newly 
deemed products before the close of the 3-year compliance period, even 
if the HPHC guidance is issued well in advance of that time. In 
addition, at this time, FDA also does not intend to enforce this 
requirement in relation to manufacturers of components and parts used 
for incorporation into finished tobacco products. In this context, a 
finished tobacco product refers to a tobacco product, including all 
components and parts, sealed in final packaging intended for consumer 
use (e.g., filters or filter tubes sold separately to consumers or as 
part of kits). FDA considers an e-liquid to be a finished tobacco 
product if sold separately and not as part of an ENDS.
    The Agency is committed to helping industry better understand the 
tobacco product review process and the requirements of the law and will 
continue holding public Webinars and meetings with industry. FDA has 
also published guidance on meetings with industry; this has enabled FDA 
to have many productive meetings to address companies' specific 
questions on their development of tobacco products. In addition, FDA 
intends to issue guidance regarding HPHC reporting, and later a testing 
and reporting regulation as required by section 915, with enough time 
for manufacturers to report given the 3-year compliance period for HPHC 
reporting. As noted elsewhere in this document, FDA does not intend to 
enforce the reporting requirements under section 904(a)(3) for newly 
deemed products before the close of the 3-year compliance period, even 
if the HPHC guidance is issued well in advance of that time.
2. Registration and Listing (Section 905)
    As of the effective date of this rule, those persons who own or 
operate domestic manufacturing establishments engaged in manufacturing 
newly deemed tobacco products (including those that engage in the 
blending of pipe tobacco and the mixing of e-liquids as discussed in 
section IX.C) will be required to register with FDA and submit product 
listings under section 905. This deeming rule will not require foreign 
manufacturing establishments to register their establishments or to 
list their tobacco products in order to sell them in the United States. 
However, foreign manufacturing establishments will be required to 
comply with the registration and listing requirements of section 905 of 
the FD&C Act after a registration and listing rule is final and 
effective. Because the compliance period for registration and listing

[[Page 29005]]

depends on the date of publication of this final rule, FDA intends to 
revise the current guidance (``Registration and Product Listing for 
Owners and Operators of Domestic Tobacco Product Establishments''), 
which FDA expects to issue within six months following the effective 
date of the final deeming rule, to clarify the compliance periods for 
manufacturers of newly deemed tobacco products.
    (Comment 56) Most of those comments regarding the registration and 
listing requirements stated that the contemplated compliance period was 
sufficient, because these requirements are not costly or time-consuming 
for manufacturers, provided FDA's electronic submission system is 
working effectively. A minority of comments asked for a longer 
compliance period that would be based on FDA published guidance for 
individual product categories that includes examples of completed 
registration and listing forms.
    Most of the comments also stated that foreign and domestic 
companies should be required to comply with registration and listing 
requirements at the same time to ensure fair and equal treatment among 
each product category. They stated that this was especially important 
given that many of the novel products are manufactured outside the 
United States and that comprehensive registration requirements will 
promote equitable assessment and collection of user fees.
    (Response) FDA agrees with comments stating that the contemplated 
compliance period for registration and listing is sufficient. To 
provide additional assistance to newly deemed product manufacturers, 
FDA intends to provide examples of completed registration and listing 
forms for each major category of newly deemed products at least 6 
months before the end of the compliance period. In addition, in 2013, 
CTP adopted a new electronic system, FDA Unified Registration and 
Listing System (FURLS), with capacity to accept registration and 
listing submissions for all FDA-regulated products, which has and will 
continue to simplify the process of submitting registration and listing 
information, making it more efficient for industry and providing faster 
access to this information by both FDA and industry. Unlike the 
previous eSubmitter process, FURLS is an online application that allows 
users to access multiple databases simply by going to the FURLS Web 
site and viewing and updating their data at any time. Questions 
regarding registration and listing requirements can be directed to 
CTP's call center at 1-877-CTP-1373 and to CTP's Office of Small 
Business Assistance, which is part of OCE.
    Further, section 905 of the FD&C Act requires FDA to issue a rule 
through the notice and comment rulemaking process in order to apply the 
registration and product listing requirements to foreign 
manufacturers--the requirements for domestic manufacturers are 
immediately implemented and do not require a regulation. (Section 
905(h) of the FD&C Act.) FDA has announced its intent to issue a rule 
regarding registration and listing, including application of the 
requirements to foreign manufacturers, in the Unified Agenda (RIN No. 
0910-AG89).
3. Modified Risk (Section 911)
    As of the effective date of this rule, section 911 will 
automatically apply to the newly deemed products. Among other 
requirements, this section prohibits the introduction or delivery for 
introduction into interstate commerce of MRTPs, including those with 
certain specified descriptors (``light,'' ``low,'' ``mild,'' or similar 
descriptors) in the label, labeling, and advertising of such products, 
unless manufacturers submit a MRTP application and receive FDA 
authorization before marketing. The basic requirement for premarket 
review of MRTPs will apply immediately upon the effective date. To 
provide manufacturers sufficient time to comply with the prohibition on 
products with specified descriptors, FDA is providing a compliance 
period for this requirement, as stated in table 3.
    (Comment 57) The comments generally stated the 1-year compliance 
period for section 911(b)(2)(A)(ii) was sufficient, but some stated 
that it was unnecessary for FDA to provide any compliance period and 
that manufacturers should begin complying with these provisions upon 
the final rule's effective date.
    (Response) FDA believes that the 12-month period to comply with the 
restrictions set forth in section 911(b)(2)(A)(ii) (after which a 
manufacturer may not manufacture, without an order in the effect, any 
tobacco product which contains ``light,'' ``low,'' or ``mild,'' or 
similar descriptors on label, labeling, or advertising), and the 
additional 30-day period where manufacturers may continue to distribute 
products into domestic commerce, are consistent with the effective 
dates originally included in the Tobacco Control Act. Under section 
911(b)(3), the prohibition on the manufacture and distribution of 
tobacco products containing ``light,'' ``low,'' or ``mild,'' or similar 
descriptors appearing on labeling, labels, or advertising (unless an 
order was issued authorizing their marketing) took effect 12 months 
after the date of enactment of the Tobacco Control Act, and 
manufacturers also had an additional 30 days after the effective date 
to continue to introduce these products with these descriptors into 
domestic commerce. Additionally, this compliance policy balances the 
need to help consumers better understand and appreciate the health 
risks of these newly deemed tobacco products while providing 
manufacturers with sufficient time to revise the label, labeling, and 
advertising as appropriate.
    This compliance policy does not extend to other MRTPs as defined in 
the remaining sections of 911(b) (e.g., tobacco products of which the 
label, labeling, or advertising explicitly or implicitly represents 
that the product presents a lower risk of tobacco-related disease or is 
less harmful than one or more other commercially marketed tobacco 
products, the product or its smoke contains a reduced level/presents a 
reduced exposure to a substance, or the product or its smoke does not 
contain/is free of a substance; or action taken by a manufacturer 
directed to consumers through media or otherwise, other than through 
the product's label, labeling, or advertising that would be reasonably 
expected to result in consumers believing that the tobacco product or 
its smoke may present a lower risk of disease or is less harmful than 
one or more commercially marketed tobacco products, or presents a 
reduced level/exposure to substance(s), or does not contain/is free of 
a substance(s)). Just as these provisions took effect immediately upon 
the enactment of the Tobacco Control Act for currently regulated 
products, newly deemed products will be expected to comply with these 
provisions on the effective date of part 1100. The agency believes this 
is necessary in order to ensure that consumers better understand and 
appreciate the health risks of newly deemed products, particularly 
where a product's label, labeling, or advertising makes express or 
implied claims of reduced risk or less harm or that a product has 
reduced levels of or is free of a substance(s).
4. Required Warnings
    (Comment 58) A few comments suggested that manufacturers should be 
required to implement the proposed health warnings within 6 months 
following the effective date of this rule. One comment stated that the 
health warnings should take effect no later than 12 months from 
publication of the

[[Page 29006]]

final rule. They stated that the delay in implementing the health 
warnings has the potential to continue to foster the perception, 
particularly on the part of youth, that e-cigarettes are safe products 
and the misunderstanding that they have been found to be safe and 
effective cessation products. They also stated that the shorter 
compliance period is necessary to quickly make consumers aware of the 
possibility of becoming addicted to e-cigarettes.
    (Response) FDA has considered the comments and the time and 
resources it will take for manufacturers to comply with the health 
warnings requirements and the need to provide these messages to 
consumers and has determined that the proposed effective date of 24 
months after publication of this rule for the warning requirements in 
part 1143 is appropriate.
5. Compliance Period Tables
    The final compliance period table for various provisions is 
included in this document. (The compliance policy for submission of 
premarketing applications is discussed in section V.A.) To clarify, 
effective dates differ from compliance periods. While a requirement is 
effective on a certain date (here, the ``effective date''), for many 
provisions, FDA is providing a compliance period with additional time 
during which FDA does not intend to enforce compliance with the 
regulation. We note that the compliance periods and provisions for 
sections 904(a)(3) and 904(a)(4) have been consistent with FDA's 
approach for currently marketed tobacco products and FDA's final 
guidance entitled ``Tobacco Health Document Submission'' (75 FR 20606, 
April 20, 2010). In addition, FDA has revised the compliance period for 
section 903(a)(8) of the FD&C Act from ``effective date of part 1100 
PLUS 1 year'' to ``24 months after the publication of this final 
regulation'' so that it is consistent with the effective dates for the 
health warning requirements in part 1143 of this final rule.

          Table 2--Compliance With Various Automatic Provisions
------------------------------------------------------------------------
           FD&C Act citation                    Compliance period
------------------------------------------------------------------------
902(1)-(5), (8)........................  Effective date of part 1100.
903(a)(1)..............................  Effective date of part 1100.
903(a)(6)-(7)..........................  Effective date of part 1100.
904(c)(2), (3).........................  Effective date of part 1100.
905(i)(3)..............................  Effective date of part 1100.
911(a), 911(b) [with the exception of    Effective date of part 1100.
 products sold or distributed using the
 descriptors set forth in
 911(b)(2)(A)(ii)].
919(a).................................  See FDA's final rule revising
                                          the current user fee
                                          regulations published
                                          concurrently with this final
                                          deeming rule.
------------------------------------------------------------------------

                                Table 3--Compliance Periods for Other Provisions
----------------------------------------------------------------------------------------------------------------
                        FD&C Act citation                                        Compliance period
----------------------------------------------------------------------------------------------------------------
903(a)(2)........................................................  24 months after the publication of this final
                                                                    regulation.
                                                                   * This is designed to match the 24 month
                                                                    effective date of the health warnings.
903(a)(3)........................................................  Effective date of part 1100 PLUS 1 year.
                                                                   * This is designed to match the 1 year
                                                                    deadline in the FD&C Act for currently
                                                                    regulated products.
903(a)(4)........................................................  24 months after the publication of this final
                                                                    regulation.
                                                                   * This is designed to match the 24 month
                                                                    effective date of the health warnings.
903(a)(8)........................................................  24 months after the publication of this final
                                                                    regulation.
                                                                   * This is designed to match the 24 month
                                                                    effective date of the health warnings.
904(a)(1), 904(c)(1).............................................  Effective date of part 1100 PLUS 6 months
                                                                    (products on the market as of the effective
                                                                    date) or 90 days before delivery for
                                                                    introduction into interstate commerce
                                                                    (products entering the market after the
                                                                    effective date).
                                                                   * This matches the timeframes provided in
                                                                    this section.
904(a)(3)........................................................  Effective date of part 1100 PLUS 3 years or,
                                                                    for products delivered for introduction into
                                                                    interstate commerce later than 3 years after
                                                                    the effective date, 90 days before delivery
                                                                    for introduction into interstate commerce
                                                                    (products entering the market after the
                                                                    effective date).
                                                                   * This matches the timeframes provided in
                                                                    this section.
904(a)(4)........................................................  Effective date of part 1100 PLUS 6 months.
                                                                   * This matches the timeframes provided in
                                                                    this section.
905(b), (c), (d), (h)............................................  If the final rule publishes in the second
                                                                    half of the calendar year, FDA intends to
                                                                    issue a compliance policy with a compliance
                                                                    period for registration that is no later
                                                                    than 6 months into the subsequent calendar
                                                                    year.
                                                                   * This matches the timeframes provided in
                                                                    this section.
905(i)(1)........................................................  Same compliance period as that for initial
                                                                    registration; see date specified for 905(b).
907(a)(1)(B).....................................................  Effective date of part 1100 PLUS 2 years.
                                                                   * This matches the timeframe provided in this
                                                                    section.
911(a), (b)(1), (b)(2)(A)(ii), (b)(3)............................  Use of ``light,'' ``low,'' and ``mild''
                                                                    descriptors: Effective date of part 1100
                                                                    PLUS 1 year (stop manufacture);
                                                                   Effective date of part 1100 PLUS 13 months
                                                                    (stop distribution).
                                                                   * This matches the timeframes provided in
                                                                    this section.
920(a)(1)........................................................  24 months after the publication of this final
                                                                    regulation.
                                                                   * This is designed to match the 24 month
                                                                    effective date of the health warnings.
----------------------------------------------------------------------------------------------------------------

[[Page 29007]]

6. Other Enforcement Issues
    (Comment 59) A few comments expressed concern that this rule will 
result in the growth of an illicit market for certain newly deemed 
tobacco products, particularly e-cigarettes and e-liquids. They 
suggested that such an illicit market could make products more 
available and more attractive to youth and young adults. They also 
feared that this illicit market would worsen if FDA were to ban certain 
e-liquid flavorings, stating that the deeming rule (and/or a ban on 
certain flavorings) would result in consumers mixing their own e-
liquids, even though the comments stated that most consumers are not 
adept at handling or mixing chemicals. These ``do-it-yourself 
manufacturers,'' as the comments referred to them, would increase 
health risks, because more individuals possessing pure nicotine could 
lead to more accidental poisonings and the possibility of overdoses. 
Comments pointed to a survey from an e-cigarette forum which stated 
that ``[a]bout 79 percent of respondents said they would 'look to the 
black market' if products they use 'were banned tomorrow,' while 14 
percent said they would return to smoking analog cigarettes'' (e.g., 
Ref. 44).
    Comments also expressed concern that regulation will increase 
prices of the newly deemed tobacco products and consumers will turn to 
an illicit market to obtain products for lower prices. For example, 
they stated that some markets for cigarettes (e.g., New York) 
experience smuggling rates of beyond 50 percent, as consumers seek 
products for lower costs. These comments expected a similar result to 
occur after the deeming rule becomes effective (see Ref. 45).
    Further, they stated that this illicit market would cause 
additional problems like stifling innovation for regulated companies, 
because companies operating in the illicit market would not be 
complying with costly regulations and would be able to take advantage 
of innovations elsewhere in the world. They theorized that this illicit 
market would favor very small domestic producers over existing medium-
sized domestic manufacturers with better quality control and safety 
mechanisms.
    In addition to concerns about e-cigarettes, comments expressed 
concerns about the potential for illicit markets for other newly deemed 
products. For example, they stated that a final deeming regulation 
(without an exemption for premium cigars) would exacerbate the black 
market that already exists for premium Cuban cigars. The comments also 
noted that those involved in the waterpipe tobacco industry already 
operate more informally (e.g., without local regulation) and, 
therefore, the deeming regulation would cause more business to be 
transacted in illicit markets. They also expressed concern about the 
development of a flourishing illicit market if flavors were not 
permitted in the deemed products.
    (Response) FDA understands these concerns, but believes that this 
rule will not increase current illicit practices or create new illicit 
markets, because FDA is not banning any tobacco product with this 
deeming rule. Even if some illicit trade were to develop in an attempt 
to evade the requirements of this rule, FDA does not believe it would 
result in a volume sufficient to outweigh the public health benefits of 
the rule. FDA authority over the newly deemed tobacco products will 
give it means to determine which products are legally on the market and 
which are counterfeit or otherwise illegally marketed. The Tobacco 
Control Act gives the Agency these and other authorities, such as 
section 920 of the FD&C Act (21 U.S.C. 387t), to help address illicit 
tobacco products.
    In addition, FDA recently commissioned a report from the National 
Research Council and Institute of Medicine Panel to help us better 
understand and consider all aspects of illicit tobacco markets (Ref. 
46). This report focused mainly on combustible products, especially 
cigarettes, as they are the subject of most illicit tobacco trade. The 
relevance of those findings to an assessment of the potential for 
illicit trade in tobacco products more generally in the United States, 
such as ENDS products, is open to question. Overall, illicit trade in 
cigarettes is under 10 percent. It is not clear if illicit trade in any 
of the newly deemed products will be greater or less than that observed 
for cigarettes. Evidence from Canada shows the development of an 
illicit market in ENDS products in that particular context where the 
government currently regulates all nicotine-containing electronic 
smoking products as medical devices under the Food and Drugs Act, 
regardless of the products' health claims.\12\ Canada does, however, 
have a legal market for the sale of non-nicotine containing ENDS 
products. Despite the fact that Health Canada has not approved any 
nicotine-containing ENDS products for sale or importation in the 
country a 2015 e-cigarette usage study (Ref. 48) showed usage rates 
among Canadian populations that were similar to those among U.S. 
populations.
---------------------------------------------------------------------------

    \12\ ENDS and e-liquids that do not contain nicotine can be 
legally sold in Canada. Health Canada issued a Notice in 2009 
regarding electronic cigarette products that contain nicotine (Ref. 
47).
---------------------------------------------------------------------------

    Despite the potential for some illicit ENDS market activity to 
occur, FDA emphasizes that the presence of an illicit market does not 
affect its legal authority to regulate such products and that there is 
evidence that many ENDS manufacturers will likely submit premarket 
applications in the United States.
    Moreover, as stated previously, FDA expects that the public health 
benefits that likely will accrue as a result of this final rule will be 
greater than the negative effects that could result if there were an 
increase in illicit markets. This final deeming rule will afford FDA 
additional tools to reduce the number of illnesses and premature deaths 
associated with tobacco product use. For example, FDA will be able to 
obtain critical information regarding the health risks of newly deemed 
tobacco products, including information derived from ingredient listing 
submissions and reporting of HPHCs required under the FD&C Act. FDA 
will also receive information on the location and number of 
manufacturing establishments, which will allow the Agency to establish 
effective compliance programs. In addition, because of this rule, FDA 
will be able to take enforcement action against manufacturers of newly 
deemed products who make unsubstantiated MRTP claims or false or 
misleading claims about their products, thus allowing for better-
informed consumers and helping to prevent the use of misleading 
campaigns targeted to youth populations. It will also prevent from 
entering the market new products that are not appropriate for the 
protection of public health, are not substantially equivalent to a 
valid predicate product, or are not exempt from SE. Finally, the newly 
deemed tobacco products may be subject to future regulations that FDA 
determines are appropriate.
    FDA believes that this rule will not stifle innovation but could, 
instead, encourage it. The greater regulatory certainty created by the 
premarket review process may encourage companies to invest in creating 
potentially beneficial novel products, with greater confidence that 
improved products will not be competing against equally novel, but more 
dangerous, products. For example, a company may be more willing to 
invest the additional resources needed to ensure that its product is 
designed and manufactured with appropriate methods and controls.

[[Page 29008]]

The PMTA pathway will incentivize development of tobacco products that 
pose less risk to human health by limiting market access by riskier 
competitor products. Furthermore, since the ``appropriate for the 
protection of the public health'' standard involves comparison to the 
general tobacco product market, FDA believes that, over time, the 
premarket authorities will move the market toward less risky tobacco 
products.

C. Policy for Certain Regulatory Requirements for All Manufacturers of 
Newly Deemed Products

    FDA received many comments expressing concern regarding the 
regulatory and financial burdens associated with certain automatic 
provisions that will apply to newly deemed products once this rule 
becomes effective. In response to comments, FDA has considered 
instances in which the Agency has implemented compliance policies for 
currently regulated products. Accordingly, the Agency is announcing the 
following compliance policy with respect to newly deemed products. As 
with any such policy, the Agency will review and revise this policy as 
appropriate. If FDA were to change this policy, the Agency would 
provide notice to affected entities.
1. Substantial Equivalence
    As provided in guidance for currently regulated products 
(``Demonstrating the Substantial Equivalence of a New Tobacco Product: 
Responses to Frequently Asked Questions (Edition 2)'' (80 FR 53810, 
September 8, 2015)), FDA does not intend to enforce against 
manufacturers who make tobacco blending changes without a marketing 
authorization if the tobacco blending changes are intended to address 
the natural variation of tobacco (e.g., due to variation in growing 
conditions) in order to maintain a consistent product. However, FDA 
does intend to enforce the premarket authorization requirements for 
tobacco blending changes that are intended to alter the chemical or 
perception properties of the new product (e.g., nicotine level, pH, 
smoothness, harshness).
    FDA does not intend to take enforcement action for at least 30 
calendar days from the date the not substantially equivalent (NSE) 
order issues for those products that are in a retailer's current 
inventory at a specific retail location on the date FDA issues the NSE 
order. This policy extends only to tobacco products that are already in 
a retail store that offers the products for sale directly to adult 
consumers.
    FDA has provided guidance (``Demonstrating the Substantial 
Equivalence of a New Tobacco Product: Responses to Frequently Asked 
Questions (Edition 2)'') on currently regulated tobacco products 
stating that a change in supplier, where the new supplier is used for 
the same ingredient, additive, component, part, or material, with 
identical specifications, would not render a new tobacco product. This 
guidance also will apply to newly deemed products.
2. Reporting of HPHCs
    FDA intends to issue guidance regarding HPHC reporting, and later a 
testing and reporting regulation as required by section 915, with 
enough time for manufacturers to report given the 3-year compliance 
period for HPHC reporting. Section 904 (a)(3) requires the submission 
of a report listing all constituents, including smoke constituents, 
identified as harmful or potentially harmful (HPHC) by the Secretary. 
Section 915 requires the testing and reporting of the constituents, 
ingredients, and additives the Secretary determines should be tested to 
protect the public health. The section 915 testing and reporting 
requirements apply only after FDA issues a regulation implementing that 
section, which it has not yet done. Until these testing and reporting 
requirements have been established, newly deemed tobacco products (and 
currently regulated tobacco products) are not subject to the testing 
and reporting provisions found under section 915. As noted elsewhere in 
this document, FDA does not intend to enforce the reporting 
requirements under section 904(a)(3) for newly deemed products before 
the close of the 3-year compliance period, even if the guidance is 
issued well in advance of that time. At this time, FDA also does not 
intend to enforce this requirement in relation to manufacturers of 
components and parts used for incorporation into finished tobacco 
products. In the future, we intend to evaluate if there are additional 
constituents that are present in newly deemed products and should be 
included in the HPHC list for reporting. FDA also intends to issue 
guidance to further refine the list of reportable HPHCs based on 
product class.
3. Tobacco Health Document Submission
    Although section 904(a)(4) sets out an ongoing requirement to 
submit tobacco health documents developed after June 22, 2009 (the date 
of enactment of the Tobacco Control Act), FDA generally does not intend 
to enforce the requirement with respect to all such documents at this 
time, so long as a specified set of documents is submitted by the 
effective date plus 6 months. FDA intends to publish additional 
guidance that specifies the scope of such health documents within three 
to six months of the publication date of this final rule, with 
sufficient advance time for manufacturers and importers to prepare 
their submissions.
    FDA does intend to collect other tobacco health documents developed 
after June 22, 2009, but before doing so the Agency will publish 
additional guidance specifying the timing of subsequent submissions. 
Note that, despite this compliance policy with respect to timeliness of 
submissions, manufacturers and importers are still to preserve all 
tobacco health documents developed after June 22, 2009, for future 
submissions to FDA. Failure to submit tobacco health documents 
developed after June 22, 2009, because of a failure to preserve them 
after publication of this rule will constitute a violation of section 
904(a)(4).
4. Compliance Policy for Components and Parts
    As discussed in section VI.B, at this time FDA does not intend to 
enforce certain requirements for components and parts of newly deemed 
products that are sold or distributed for further manufacturing into 
finished tobacco products.

D. Compliance Policy Regarding Certain Provisions and Small-Scale 
Tobacco Product Manufacturers

    In the NPRM, FDA requested comment on the ability of smaller 
manufacturers of newly deemed tobacco products to fully comply with the 
requirements of the FD&C Act and how FDA might be able to address those 
concerns. Considering the comments and FDA's finite enforcement 
resources, the Agency's view is that those resources may not be best 
used in immediately enforcing the provisions of this rule against 
certain manufacturers that are small-scale tobacco product 
manufacturers and that fail to comply with certain requirements of the 
FD&C Act. Therefore, FDA generally intends to grant small-scale tobacco 
manufacturers additional time to respond to SE deficiency letters and 
to not bring enforcement action against those small-scale tobacco 
product manufacturers who submit ingredient listings within 12 months 
of the effective date of this rule, and is granting small-scale tobacco 
product manufacturers an additional six-month compliance period for the 
tobacco health document submission

[[Page 29009]]

requirements. As with any such policy, FDA will review and revise these 
policies as appropriate. If FDA were to change these policies, FDA 
would do so consistent with its Good Guidance Practices regulations.
    For purposes of this compliance policy, FDA generally considers a 
``small-scale tobacco product manufacturer'' to be a manufacturer of 
any regulated tobacco product that employs 150 or fewer full-time 
equivalent employees and has annual total revenues of $5,000,000 or 
less. FDA considers a manufacturer to include each entity that it 
controls, is controlled by, or is under common control with. To help 
make FDA's individual enforcement decisions more efficient, a 
manufacturer may voluntarily submit information regarding all relevant 
factors, including information regarding employment and revenues. 
Interested manufacturers may contact CTP's call center at 1-877-CTP-
1373 for questions regarding this compliance policy. We note that FDA's 
thinking regarding ``small-scale tobacco product manufacturer'' differs 
from the definition of ``small tobacco product manufacturer'' in 
section 900(16) of the FD&C Act.
    FDA notes that our thinking regarding what a ``small-scale tobacco 
product manufacturer'' is for purposes of this policy is designed to 
align with the nature of the specific relief provided. That is, the 
relief provided (as described throughout this document) relates 
generally to requirements for entities to compile or report 
information. These activities may require an investment of employee 
time and/or financial resources that is more challenging for the 
smallest entities to achieve. For these reasons, the threshold takes 
note of both employee resources (FTEs) and financial resources (annual 
revenues), ensuring that those entities with the most limited human and 
financial resources are uniquely considered in FDA's decisions about 
enforcement of these provisions, precisely because the provisions may 
require resources not as readily available to these entities. Further, 
as stated elsewhere in this document, in formulating its thinking, FDA 
has considered all available data on employment, revenues, production 
volume and other details of operation for current manufacturers of 
newly deemed products. In addition, FDA notes that its current approach 
reflects a careful review of the potentially unique interests of the 
smallest tobacco product manufacturers as considered in light of the 
Agency's statutory obligations regarding the protection of public 
health.
1. SE Extension Requests (Section 905(j))
    Although information adequate to make submissions should be 
available to all manufacturers, we expect small manufacturers to have 
more difficulty in putting this information together in an SE Report. 
FDA presently intends, for the first 30 months following the effective 
date of this rule, to grant extensions to small-scale tobacco product 
manufacturers for SE reports that need additional time to respond to SE 
deficiency letters. Extensions are not automatically granted. Requests 
will be considered on a case-by-case basis. Any extensions granted are 
likely to be limited in time--for example, where a manufacturer 
normally might have 90 days to respond to a deficiency letter, FDA 
will, for small-scale tobacco product manufacturers, grant an 
additional 30 days for such a response. FDA encourages all small-scale 
tobacco product manufacturers, especially those with limited or no 
experience with the SE pathway, to submit SE reports as early as 
possible. FDA is not instituting a similar policy for extension 
requests related to PMTAs (nor is it providing additional time for 
small-scale tobacco product manufacturers to prepare PMTAs) given the 
already-extended compliance period for PMTAs, which provides an 
additional 6 months to submit a PMTA, discussed in section V.A.
2. Tobacco Health Document Submissions (Section 904(a)(4))
    To address concerns of small-scale tobacco product manufacturers 
regarding the submission of certain health documents, and in 
recognition of FDA's current enforcement priorities, FDA, for an 
additional 6 months following the end of the generally applicable 
compliance period, intends not to bring enforcement action against 
those small-scale tobacco product manufacturers who submit the required 
information.
3. Ingredient Listing Submissions (Section 904(a)(1))
    FDA understands concerns that small-scale tobacco product 
manufacturers may need additional time to comply with section 
904(a)(1)'s requirement that manufacturers submit ingredient lists. FDA 
presently intends not to bring enforcement action against those small-
scale tobacco product manufacturers who submit section 904(a)(1)'s 
required information within 12 months of the effective date of this 
final rule.
4. Assistance With Marketing Applications
    As with manufacturers in general, these small-scale tobacco 
manufacturers will also benefit from additional assistance with their 
marketing applications, including the designation of a Regulatory 
Health Project Manager so that they have a single point of contact in 
CTP's OS for questions about their marketing applications. They will 
also have access to an appeals process in the event that FDA denies 
their marketing applications (of which one small business has already 
taken advantage). Staff from CTP's OCE also will assist small-scale 
tobacco product manufacturers with identifying the types of documents 
that may be used to establish that their predicate products were on the 
market on February 15, 2007. This may include several calls or 
correspondence with the manufacturer as it submits different documents 
to the Agency.
5. Assistance in Navigating Other Regulatory Requirements
    CTP's OCE will continue to assist small-scale tobacco product 
manufacturers in submitting rotational warning plans for FDA approval. 
These plans provide the firm's plan for how the required warnings will 
be displayed on the packaging and advertising for their product, as 
required by 21 CFR 1143.5. This may include several calls or 
correspondence with the small business as it seeks approval from the 
Agency.
    CTP also has a system to assist small businesses in navigating the 
regulatory requirements of FDA. For example, the Center has a Call 
Center that triages all calls received from regulated industry. The 
Center's Office of Small Business responds to hundreds of calls, emails 
and correspondences from small businesses every year to assist them in 
answering their specific questions on how to comply with the law.

V. Premarket Review Requirements and Compliance Policy

    Section 910 of the FD&C Act requires FDA authorization in order to 
market a new tobacco product. As described elsewhere, the FD&C Act 
contains three pathways for obtaining premarket authorization: SE 
exemptions, SE reports, and PMTAs.
    Tobacco products that were on the market on February 15, 2007, are 
grandfathered and do not require premarket authorization. However, as 
described throughout this preamble, these products are subject to the 
other requirements of the statute.

[[Page 29010]]

A. Compliance Policy for Premarket Review Requirements

    In the NPRM, FDA contemplated a compliance period of 24 months 
following the effective date for submitting a premarket application (SE 
exemption request, SE report, or PMTA), with a continued compliance 
period pending review of those applications (79 FR 23142 at 23144). In 
essence, the products would remain on the market during this indefinite 
compliance period until the agency rendered a decision on an 
application or the application was withdrawn.
    Agency compliance/enforcement policies are not subject to the 
requirements that govern notice-and-comment rulemaking. Prof'ls & 
Patients for Customized Care v. Shalala, 56 F.3d 592 (5th Cir. 1995) (a 
compliance policy guide is not a substantive rule and not subject to 
APA's notice-and-comment rulemaking); Takhar v. Kessler, 76 F.3d 995, 
1002 (9th Cir. 1996) (FDA compliance policy guides were not required to 
go through notice-and-comment procedures). But because the relevant 
time periods are of obvious interest, FDA laid out its anticipated 
compliance policy in the NPRM, and for similar reasons, is announcing 
its revised compliance policy here in the preamble to the final rule, 
rather than in a separate guidance document.
    FDA has considered the comments and data submitted in response to 
the compliance policy in the NPRM. Some comments expressed concern 
about the extended availability of newly deemed, new tobacco products 
without scientific review. Others provided additional data regarding 
youth and young adult use of flavored tobacco products. In addition, 
others comments discussed the potential public health benefits from the 
availability of certain flavored newly deemed products (as discussed in 
section VIII.F). Taking the diverse comments on these issues, as well 
as the uncertainty regarding the positive or negative impact on public 
health from products like ENDS, into account, FDA has decided to 
implement the compliance policy with staggered initial compliance 
periods based on the expected complexity of the applications, followed 
by continued compliance periods for FDA review, such that our 
enforcement discretion will end twelve months after each initial 
compliance period. Under the policy described here for the staggered 
compliance periods, and while FDA is conducting its review of marketing 
applications during the continued compliance period, the Agency does 
not intend to take enforcement action against products remaining on the 
market for failure to have a premarket authorization order.
    The compliance periods are staggered to improve efficiency for both 
FDA and regulated entities given that the time it takes to prepare 
premarket applications is dependent upon the type of application and 
complexity of the product. FDA intends to act as expeditiously as 
possible with respect to all new applications, while ensuring that 
statutory standards are met. Further, if at the time of the conclusion 
of the continued compliance period, the applicant has provided the 
needed information and review of a pending marketing application has 
made substantial progress toward completion, FDA may consider, on a 
case-by-case basis, whether to defer enforcement of the premarket 
authorization requirements for a reasonable time period.
    FDA's revised compliance policy for premarket review aims to 
balance the public health concerns raised in the comments, allow the 
Agency to more efficiently manage the flow of incoming applications, 
and encourage high-quality premarket submissions from applicants.
    In accordance with the Tobacco Control Act (sections 905 and 910 of 
the FD&C Act), a new tobacco product may be legally marketed only if 
FDA has authorized its marketing under one of the three premarket 
pathways described throughout this document. As a result of the 
compliance policy being announced, we expect that manufacturers of 
certain newly deemed, new tobacco products will continue to market 
their products without FDA authorization for certain time periods.
1. FDA's Revised Compliance Policy Is Informed by Comments Submitted in 
Response to the NPRM
    FDA received many comments responding to its detailed requests for 
comment on possible compliance approaches. 79 FR at 23175-77. Some 
comments expressed concern that the compliance policy for premarket 
review described in the NPRM would permit the continued marketing of 
tobacco products that have not been reviewed under the public health 
standards of the Tobacco Control Act. For example, comments jointly 
submitted by 24 health and medical organizations stated that the 
contemplated 24-month compliance period and indefinite period of 
continued marketing during FDA's review included in the NPRM would 
prolong the public's exposure to products that contain nicotine, a 
highly addictive substance, and that do not meet the statutory standard 
for the grant of a marketing order (Comment No. FDA-2014-N-0189-
79772.).
    They also stated that this approach would allow manufacturers to 
continue to market the newly deemed products in ways that appeal to 
youth and to manipulate the content of these products in uncontrolled 
ways for an indefinite period (id.). They urged FDA to forego its 
contemplated compliance policy unless proper precautions are taken to 
limit the time period these products are allowed to remain on the 
market pending FDA review and authorization. In addition, they 
expressed concern that manufacturers, knowing that submission of an 
application will permit them to market products for years, have 
incentive to submit numerous applications (regardless of how incomplete 
or deficient the applications).
    A network of tobacco control policy and legal specialists also 
expressed concern regarding the effect of continued marketing of new 
tobacco products that have not been reviewed under the applicable 
public health standards of the Tobacco Control Act (Comment No. FDA-
2014-N-0189-81044). This organization noted the thousands of 
provisional SE reports submitted in the last five days before the 
statutory deadline, where such applications pending FDA review are 
``being used as placeholders that will allow the tobacco industry to 
continue to introduce new products at will, rather than following the 
proper legal procedures established by the Tobacco Control Act.'' They 
proposed a staggered timeline to submit applications under the three 
marketing pathways and a definite time period in which FDA would no 
longer exercise enforcement discretion with respect to premarket review 
of these products, noting that such an approach would incentivize 
industry to generate high-quality, complete applications within the 
initial compliance period.
    In addition, two large organizations dedicated to the health of 
youth and young adults urged FDA not to implement a compliance period 
of any length for products sold in characterizing flavors other than 
tobacco or any covered tobacco products that use marketing practices 
known to appeal to children and youth (Comment No. FDA-2014-N-0189-
67268; Comment No. FDA-2014-N-0189-79413.). Ranking minority members of 
the Energy and Commerce Committee, Health Subcommittee, and Oversight 
and Investigations Subcommittee, U.S. House of Representatives also 
called for a more protective compliance period than the one 
contemplated in the

[[Page 29011]]

NPRM, arguing that the proposed compliance period ``puts the nation's 
youth at risk'' (Comment No. FDA-2014-N-0189-80119). These comments, 
among others, all stressed the attractiveness of these newly deemed 
tobacco products to youth and young adults and the need for a more 
restrictive compliance policy to ensure that FDA limits the continued 
marketing of new tobacco products that have not been reviewed under the 
public health standards of the Tobacco Control Act.
    Further, in response to FDA's requests for comments and data in the 
NPRM, numerous comments included data, research, and personal stories 
regarding the impact of candy and fruit flavors in tobacco products, 
including their appeal to youth and young adults, youth perceptions of 
flavored tobacco products, and their potential effect on transition 
from combusted tobacco product use (particularly, comments noted, in 
the case of adults using flavored ENDS to attempt to switch completely 
away from cigarette smoking). In addition, many comments urged FDA to 
take immediate action regarding flavored tobacco products as a result 
of increasing prevalence of flavored product use, and new data show 
continued growth in youth and young adult usage of flavored tobacco 
products.
    In deciding upon a compliance policy to announce with this final 
rule, FDA considered all these comments and sought to balance the 
Agency's concern about the continued marketing of new tobacco products 
that have not been reviewed by FDA, the potential harmful impact of 
flavored tobacco products on youth, and the possibility that some of 
those products are playing a role in helping some tobacco users 
transition away from what is likely the most harmful form of nicotine 
delivery for an individual user, combusted tobacco products. FDA 
considered adopting the compliance policy as described in the preamble 
to the NPRM or a compliance policy that would provide different 
compliance periods for flavored and non-flavored tobacco products. FDA 
also considered providing different compliance periods for different 
product categories. For example, certain industry comments urged FDA to 
stagger compliance dates for different product categories, to delay 
compliance until FDA publishes a final guidance for each product 
category and to provide ENDS manufacturers a lengthier compliance 
period based on where they purport to fit within the risk continuum for 
nicotine-delivering products (e.g., Comment No. FDA-2014-N-0189-81859; 
Comment No. FDA-2014-N-0189-10852).
    In response to these comments, we note that nicotine use in any 
form is of particular concern for youth and pregnant women. On the 
other hand, some evidence suggests that ENDS may potentially promote 
transition away from combusted tobacco use among some current users and 
it is possible that there could be a public health benefit. See also 
section III.F for additional discussion of premarket pathways and the 
continuum of nicotine-delivering products. Based on currently available 
scientific evidence, this revised compliance policy strikes an 
appropriate balance among various, often competing, considerations.
2. FDA Is Announcing a Revised Compliance Policy With Staggered 
Timeframes and Continued Compliance Periods
    In the interest of public health and taking into account the fact 
that there are products already on the market that will now be subject 
to premarket review, and in light of the considerations discussed in 
section 1 above, we have established the following compliance policy 
for newly deemed tobacco products. For those newly deemed products that 
were on the market on the effective date of this final rule, but that 
were not on the market on February 15, 2007, FDA is providing two 
compliance periods: One for submission and FDA receipt of applications 
and one for obtaining premarket authorization. Although such products 
are subject to the premarket review requirements of the FD&C Act, FDA 
does not intend to initiate enforcement action for failure to have 
premarket authorization during the respective compliance periods.
    The compliance period for submission and FDA receipt of 
applications for newly deemed tobacco products under the three 
premarket pathways is as follows:

    SE Exemption Requests--12 months from the effective date of this 
final rule
    SE Reports--18 months from the effective date of this final rule
    PMTAs--24 months from the effective date of this final rule

    FDA is adopting the staggered timelines in this policy to account 
for the possibility that applicants may need additional time to gather 
information for certain premarket submissions that may require 
additional data. For example, if a manufacturer plans to submit an SE 
Exemption Request, the firm may only need to identify the product, 
provide certification statements, and gather scientific information on 
the additive change itself and any supporting information demonstrating 
that the change to the product is minor and an SE Report is not 
necessary. This is less information than that likely required for a 
PMTA. We expect this policy will also create a more manageable flow of 
premarket applications for newly deemed products. FDA expects that this 
staggering of deadlines also will benefit regulated industry, since it 
will allow for greater efficiency of FDA review and incentivize higher 
quality applications, which will reduce review times for all products. 
New products for which no application has been submitted by 24 months 
from the effective date of this rule will no longer be subject to this 
compliance policy and will be subject to enforcement.
    Unless FDA has issued an order denying or refusing to accept the 
submission, products for which timely premarket submissions have been 
submitted will be subject to a continued compliance period for 12 
months after the initial compliance period described previously. For 
such products, FDA does not intend to initiate enforcement for failure 
to have premarket authorization during this continued compliance 
period, which is as follows:
    SE Exemption Requests--24 months from the effective date of this 
final rule (12 months after the compliance period for submission of 
such requests)
    SE Reports--30 months from the effective date of this final rule 
(12 months after the compliance period for submission of such reports)
    PMTAs--36 months from the effective date of this final rule (12 
months after the compliance period for submission of such 
requests).\13\
---------------------------------------------------------------------------

    \13\ In addition, we note that any new tobacco product that was 
not on the market on the effective date of the rule (i.e., 90 days 
after the publication date) is not covered by this compliance policy 
and will be subject to enforcement if marketed without authorization 
after the effective date.
---------------------------------------------------------------------------

    Once the continued compliance period ends, new tobacco products on 
the market without authorization will be subject to enforcement. FDA 
will act as expeditiously as possible with respect to all new 
applications, while ensuring that statutory standards are met. FDA 
expects that this revised compliance policy will encourage the 
submission of high quality applications. By providing a date in which 
the continued compliance period ends, manufacturers will have an 
incentive to submit a complete application and respond substantively 
and expeditiously to questions raised during the review process instead 
of an incomplete or deficient application just to stay on the market 
indefinitely. This staggered

[[Page 29012]]

compliance policy also will provide FDA with a more manageable flow of 
incoming applications to be reviewed, allowing the agency to more 
quickly make decisions on applications.
    FDA believes the staggered compliance periods will be sufficient 
for manufacturers to provide high quality applications. To help provide 
clarity regarding submission requirements for marketing applications, 
FDA has issued several guidance documents, and is finalizing other 
guidance documents, regarding the evidence needed for SE reports, 
including FDA draft guidance entitled ``Substantial Equivalence 
Reports: Manufacturer Requests for Extensions or to Change the 
Predicate Tobacco Product'' (79 FR 41292, July 15, 2014), and FDA 
guidance entitled ``Establishing That a Tobacco Product Was 
Commercially Marketed in the United States as of February 15, 2007,'' 
among others. FDA also has issued a draft guidance entitled 
``Applications for Premarket Review of New Tobacco Products'' (76 FR 
60055, September 28, 2011). In addition, elsewhere in this issue of the 
Federal Register, FDA has made available draft guidance, which when 
final will describe FDA's current thinking on some appropriate means of 
addressing the premarket authorization requirements for newly deemed 
ENDS products. If FDA determines that additional guidance is necessary 
to help manufacturers prepare marketing applications, FDA will issue 
additional guidance and publish a notice of availability in the Federal 
Register.
    Further, if at the time of the conclusion of the continued 
compliance period, the applicant has provided the needed information 
and review of a pending marketing application has made substantial 
progress toward completion, FDA may consider, on a case-by-case basis, 
whether to defer enforcement of the premarket authorization 
requirements for a reasonable time period.

B. Responses to Comments Regarding Compliance Periods for Premarket 
Review Requirements

    (Comment 60) FDA received many comments suggesting that we change 
the proposed compliance period for submitting marketing applications. 
Some comments suggested that the compliance period should be 24 months 
from the date FDA either announces its intent to no longer exercise 
enforcement discretion regarding premarket requirements or issues 
product-specific guidance on the preparation of PMTAs and the 
submission of HPHC testing results. They suggested that the issuance of 
the guidance documents be based upon the continuum of risk presented by 
nicotine-delivering products. Other comments suggested that we extend 
the PMTA compliance period to 5 years following the effective date of 
the final rule to give manufacturers sufficient time to complete the 
required testing.
    (Response) FDA has already published for public comment draft 
guidance for industry regarding the submission of PMTAs, which when 
final will represent FDA's current thinking on this topic. In addition, 
elsewhere in this issue of the Federal Register, FDA has made available 
draft guidance, which when final will describe FDA's current thinking 
regarding some appropriate means of addressing the premarket 
authorization requirements for newly deemed ENDS products. FDA is 
committed to helping industry better understand the tobacco product 
premarket review process and will continue to hold public Webinars and 
meetings with industry. FDA has also published guidance on meetings 
with industry, and FDA has had many productive meetings to address 
companies' specific questions on the development of tobacco products. 
As FDA reviews product applications for currently regulated and newly 
deemed categories of products, we intend to identify topics for which 
rulemaking or more product specific guidance is appropriate.
    Moreover, along with finalizing this rule, FDA is setting forth an 
initial 2-year compliance period for the submission of a PMTA for newly 
deemed, new tobacco products, followed by a continued compliance period 
of up to 12 months for FDA to review the application. FDA believes that 
this will give sufficient time for manufacturers of such products to 
prepare high quality applications, and for FDA to review new 
applications as expeditiously as possible, while ensuring that the 
statutory standards are met. FDA's compliance policy is further 
described in section V.A of.
    (Comment 61) Comments were split as to whether the NPRM's 
contemplated premarket review compliance timeframes (i.e., 24 months 
for manufacturers to submit and for FDA to receive a marketing 
application) should apply to manufacturers of newly deemed products. 
While many industry comments sought additional time to comply with 
these requirements, many other comments suggested that the reason 
Congress delayed application of certain requirements to the currently 
regulated products (e.g., cigarettes and smokeless tobacco) was to 
account for the creation, staffing, and training for a new FDA center. 
In addition, they stated that manufacturers of the newly deemed 
products cannot argue that they did not have adequate notice that they 
would need to comply with premarket requirements given that the Unified 
Agenda entry for the deeming proposal published on July 7, 2011, and 
was continually updated in subsequent Unified Agenda entries. They 
argued that establishing similar timeframes for the newly deemed 
products only benefits industry and is detrimental to the public 
health.
    (Response) FDA has considered these comments and concludes that the 
staggered compliance periods included with this final rule are 
sufficient to allow manufacturers of previously unregulated tobacco 
products to submit applications without unduly delaying compliance. As 
stated elsewhere in this document, FDA has taken several steps to 
provide helpful feedback to industry to encourage more complete, 
streamlined submissions and reviews, including: (1) Encouraging 
teleconferences between the assigned regulatory health project manager 
and the applicant; (2) streamlining the SE report review process by 
modifying the preliminary review so that it focuses only on 
administrative issues and allowing submission deficiencies to be 
communicated to the applicant more quickly; (3) providing information 
on FDA's Web site about the three pathways available to market products 
(including SE) and developing public Webinars to explain the Agency's 
processes; and (4) publishing guidance documents. FDA intends to act as 
expeditiously as possible with respect to all new applications, 
ensuring that statutory standards are met.
    (Comment 62) One comment suggested FDA allow for submission of a 
confidential e-cigarette product report in order to satisfy premarket 
review requirements. Similarly, another comment encouraged FDA to 
establish a ``Tobacco Product Master File'' (TPMF) system similar to 
the Agency's Drug Master File (DMF) and Food Additive Master File 
(FAMF) systems to allow for e-cigarette/personal vaporizer and e-liquid 
suppliers to submit confidential product information (including 
information on formulations, facilities, processes, and articles used 
in the manufacturing, processing, packaging, and storing of ingredients 
used).
    (Response) FDA does allow for the submission and use of information 
to be incorporated by reference similar to master file programs for 
other FDA-regulated products. In addition, elsewhere in this issue of 
the Federal Register, FDA has made available a final guidance to 
provide information on how

[[Page 29013]]

to establish and reference a TPMF. TPMFs are expected to help 
applicants of newly deemed products prepare premarket and other 
regulatory submissions because they can reference information in TPMFs 
rather than develop the information on their own.
    Such a system would be especially helpful in the area of newly 
deemed tobacco products. Because of the nature of upstream supply of 
many components for ENDS products, especially e-liquids, FDA 
anticipates that commercial incentives will be sufficient to drive 
manufacturer reliance on the system of master files. We note that, at 
present, FDA understands that, based on publically available 
information, the number of entities engaged in upstream production of 
liquid nicotine and flavors specifically developed for use with e-
liquids is small, in the range of seven to thirteen entities (see 
earlier discussion in response to comment 34). Given the nature of the 
marketplace, FDA expects that the master file system will be widely 
appealing and widely utilized by the ENDS industry.
    (Comment 63) At least one comment stated that FDA should prioritize 
review of applications for products currently on the market over those 
seeking to enter the market and that FDA should establish clear review 
deadlines. Another comment suggested that priority should be given to 
those products whose marketing is unlikely to be seen by youth or is 
limited to existing adult users of the product.
    (Response) During the initial implementation of the Tobacco Control 
Act, FDA received a large number of applications for currently marketed 
tobacco products. For these provisional products being reviewed through 
the SE pathway, in order to appropriately prioritize review, FDA 
performed a public health impact evaluation of the product's potential 
to raise different questions of public health. Currently marketed 
products with the highest potential to raise different questions of 
public health were placed in the tier to be reviewed first. If 
appropriate, FDA may consider using a prioritization method for newly 
deemed products.
    FDA understands the value of establishing timelines for review of 
applications. For products not on the market on the effective date, FDA 
intends to establish review performance goals in the future as it did 
with currently regulated products.
    (Comment 64) Some comments suggested that FDA continue to employ 
measures to ensure that completed SE reports and PMTAs are submitted as 
expeditiously as possible during the compliance period. They noted that 
FDA currently employs a ``refuse-to-accept'' policy for SE applications 
that allows FDA to make a threshold determination as to whether an SE 
application is sufficiently complete for the Agency to review. They 
stated that this policy will help to ensure that manufacturers of the 
newly deemed products do not try to unduly extend the time that 
products are marketed without FDA review of their applications.
    (Response) FDA agrees. FDA plans to take all reasonable measures to 
ensure that applications are reviewed in a timely manner. FDA intends 
to continue employing its ``refuse-to-accept'' policy for SE Reports 
and other marketing applications (including SE Exemption Requests and 
PMTAs).
    (Comment 65) Many comments suggested that FDA should develop a 
product category specific framework for submission of PMTAs in light of 
the large number of products for which PMTAs will be required, the size 
and cost of PMTAs, and FDA's available resources. The comments 
suggested that the compliance period should be based on the date FDA 
issues a category specific guidance document. The comments stated that, 
without category specific guidance, the PMTA process will effectively 
eliminate certain tobacco product categories, including the premium 
cigar industry. These comments asserted that it was Congress' intent to 
treat categories of tobacco products differently, as shown by the 
provisions banning flavored cigarettes, providing special 
considerations regarding menthol, establishing MRTP provisions, and 
creating baseline standards under sections 910 and 907.
    (Response) As stated previously, the statute specifies the 
premarket pathways for tobacco products. Congress subjected all new 
tobacco products to the same premarket review requirements in sections 
905 and 910. FDA has taken many steps to reduce and prevent backlogs of 
marketing applications pending FDA review and intends to act as 
expeditiously as possible with respect to all new applications, while 
ensuring that statutory standards are met. Elsewhere in this issue of 
the Federal Register, FDA has made available draft guidance, which when 
final will describe FDA's current thinking regarding some appropriate 
means of addressing the premarket authorization requirements for newly 
deemed ENDS products. FDA may issue additional category specific 
guidance as appropriate. FDA is committed to helping industry better 
understand the tobacco product premarket review process and will 
continue to hold public Webinars and meetings with industry. In the 
category of cigars, and for premium cigars in particular, we expect 
that some products will remain on the market due to their status as 
grandfathered products, and that others will be able to make use of the 
SE pathway.
    (Comment 66) While many comments stated that they needed additional 
time to comply with premarketing requirements, many other comments 
stated that the contemplated 2-year compliance period was too long. For 
example, comments jointly submitted by 24 health and medical 
organizations stating that the contemplated 24-month compliance period 
included in the NPRM would prolong the public's exposure to products 
that contain nicotine, a highly addictive substance, and that, in their 
view, do not meet the statutory standard for the grant of a marketing 
order (Comment No. FDA-2014-N-0189-79772.). They stated that it would 
allow manufacturers to continue to market the newly deemed products in 
ways that appeal to youth and to manipulate the content of these 
products in uncontrolled ways for an indefinite period (id.). These 
comments also argued that a 2-year compliance period will result in 
large numbers of adolescents experimenting with newly deemed products 
and becoming established e-cigarette users or users of other tobacco 
products. Some suggested that FDA reduce the compliance period to 6 
months or 12 months and others suggested different compliance periods 
for SE reports, SE exemption requests, and PMTAs. One comment stated 
that FDA's burden estimates show that the PMTA process should take 18 
months, so the compliance period should not extend beyond 18 months. 
Alternatively, other comments stated that there should not be any 
compliance period for products because the PMTA process was created to 
provide a higher scrutiny of review for new products with unknown 
health risks and a compliance period is contrary to this purpose. They 
also stated that a compliance period would allow the industry to flood 
the market place with products and manufacturers would not have an 
incentive to quickly develop high-quality applications. In addition, 
some comments suggested that FDA should not provide a compliance period 
for combusted products, such as pipe tobacco or cigars, because there 
is no parallel provision in the current statute for such products.
    Some comments also suggested that manufacturers that sell flavored 
tobacco products or that market tobacco

[[Page 29014]]

products to children should not be afforded any compliance period to 
satisfy the premarket review requirements of the FD&C Act (79 FR at 
23176). For example, two large organizations dedicated to the health of 
youth and young adults urged FDA not to grant a compliance period of 
any length for products sold in characterizing flavors other than 
tobacco or any covered tobacco products that use marketing practices 
known to appeal to children and youth (Comment No. FDA-2014-N-0189-
67268; Comment No. FDA-2014-N-0189-79413.).
    Many comments also stated that manufacturers should not be able to 
avail themselves of the compliance period unless they agree to restrict 
their marketing to adults. However, some comments expressed concern as 
to how such a restriction could be administered in accordance with the 
First Amendment. In addition, Ranking minority members of the Energy 
and Commerce Committee, Health Subcommittee, and Oversight and 
Investigations Subcommittee, U.S. House of Representatives called for a 
more protective compliance period than the one contemplated in the 
NPRM, arguing that a 24-month compliance period ``puts the nation's 
youth at risk'' (Comment No. FDA-2014-N-0189-80119).
    (Response) Once this rule takes effect, it will be illegal to sell 
these tobacco products to anyone under the age of 18. This final 
deeming rule is foundational, affording FDA with the authority to issue 
other regulations restricting sales and distribution, including 
advertising and promotion, under section 906(d).
    FDA struck a balance by revising the initial compliance period for 
SE exemption requests and SE reports to 12 and 18 months, respectively, 
and is setting forth a 2-year compliance period for manufacturers of 
newly deemed, new tobacco products to submit (and FDA to receive) a 
PMTA. FDA believes that these time periods are sufficient for 
manufacturers to prepare high quality applications addressing the 
requirements in the statute.
    FDA has given extensive consideration to having different 
compliance periods for flavored and non-flavored products. There is 
some evidence suggesting that flavored products pose a greater public-
health risk than non-flavored products. FDA understands that the appeal 
of flavors and use of flavored tobacco products have an important role 
in the initiation and continued use of tobacco products, and in the 
health risks associated with use of these products. Many comments and 
studies provided data and information regarding youth and young adult 
use of flavored tobacco products in recent years. (E.g., Refs. 49, 50, 
51, 52, 53, 54, 55, 56). And flavors appear to encourage greater use. 
(E.g., Ref. 57; Refs. 58, 59). The availability of appealing flavors is 
a commonly cited reason for use of non-combusted products among young 
tobacco users. (E.g., Refs. 60, 61)
    However, several considerations weigh against a shorter compliance 
period for flavored products. There are potential countervailing health 
concerns. At least some flavored combusted products (which are of 
particular concern because they are known to present similar risks to 
cigarettes and are youth appealing) are likely to be ``grandfathered'' 
and, therefore, would remain on the market regardless of the compliance 
period or enforcement policy for newly deemed, noncombusted flavored 
products. And, in any event, comments suggested that the availability 
of flavors in non-combusted tobacco products, such as ENDS, are 
appealing to current smokers of combusted products and may entice 
smokers to consider switching to e-cigarettes. (e.g., Comment No. FDA-
2014-N-0189-75088; Comment No. FDA-2014-N-0189-79096). And FDA is aware 
of emerging self-reports from current and former cigarette smokers 
supporting this claim. (See Refs. 62, 63.) Section VIII.F below 
discusses the preliminary evidence available to date regarding 
effectiveness of ENDS to help smokers transition from, or reduce their 
consumption of, combusted tobacco products. But at least some think 
that flavor variety is very important. (See, e.g., Ref. 63). More 
research, especially longitudinal research, is needed to understand how 
flavoring impacts tobacco use over time (Ref. 64).
    Finally, as with other tobacco products that will be regulated 
under this rule, FDA is cognizant of the transition that will be 
required for regulated entities. Several comments expressed concern 
that even the proposed 24-month compliance period was not sufficient to 
submit complete applications for all of their products. For example, 
one comment noted that most of the e-cigarette market ``are small and 
medium-sized businesses owned and operated by individuals and families 
[and] most, if not all of these smaller enterprises lack the resources 
to tackle such a high administrative burden'' associated with 
submitting multiple PMTAs within the time period (Comment No. FDA-2014-
N-0189-80496). Several comments also expressed concern that the 24-
month proposed compliance period would benefit larger companies with 
more resources to complete product applications at the expense of small 
and mid-size companies (e.g., Comment No. FDA-2014-N-0189-76162). FDA 
notes that a shorter period would have an even greater impact on these 
businesses.
    In light of these considerations, FDA believes that a two-year 
compliance period for flavored products, as with other tobacco 
products, represents the exercise of its enforcement discretion in a 
way that strikes an appropriate balance between providing industry time 
to transition and protecting the public health. Over time, FDA expects 
to see additional data on the role of certain flavored products in 
supporting reduction in or abstinence from the use of combusted 
products, as well as further data on the role of flavored products in 
youth initiation, use, and dual use. Such data will help inform FDA's 
regulation of, and product standards for, these and other tobacco 
products.
    In developing this compliance period, FDA balanced three important 
public health considerations: Concern about the extended availability 
of newly deemed, new tobacco products without scientific review; 
concern about flavored products' youth appeal; and preliminary data 
that some individuals may potentially use such products to transition 
away from combusted tobacco use. Taking these factors into account, and 
based on currently available scientific evidence, FDA determined that 
the compliance periods described in Section V.A. strikes an appropriate 
balance to protect public health. FDA is establishing staggered 
compliance periods based on the expected complexity of the applications 
and continued compliance periods for FDA review such that our exercise 
of enforcement discretion will end twelve months after each initial 
compliance period. In addition, FDA is announcing that it intends in 
the future to issue a proposed product standard that would, if 
finalized, eliminate characterizing flavors in all cigars including 
cigarillos and little cigars.
    Elsewhere in this issue of the Federal Register, FDA has made 
available draft guidance, which when final will describe FDA's current 
thinking regarding some appropriate means of addressing the premarket 
authorization requirements for newly deemed ENDS products. FDA 
recognizes that flavored e-liquids are especially attractive to youth 
and young adults. Attractiveness to youth and young adults is an 
important factor in evaluating whether the marketing of a product is

[[Page 29015]]

appropriate for the protection of the public health. Manufacturers 
should provide information on possible toxicity, addictiveness, and 
appeal of flavored tobacco products with their premarket review 
applications.

VI. Components, Parts, and Accessories

    In the preamble to the NPRM, we asked for comments, including 
supporting facts, research, and other evidence, regarding FDA's 
proposal to include components and parts of the newly deemed products 
(but not accessories) under the scope of this rule. We also asked for 
comments as to whether FDA should define components and parts of 
tobacco products and how those items might be distinguished from 
accessories (79 FR 23142 at 23152 and 23153). After reviewing the 
comments, FDA is finalizing this rule to include components and parts 
of the newly deemed products (but excluding accessories of such 
products) within the scope of this rule. FDA is also explaining its 
current compliance policy with respect to components and parts and 
certain requirements that will become effective with this deeming rule.

A. Definitions

    In response to comments, FDA is including definitions of 
``accessory'' and ``component or part'' in parts 1100, 1140, and 1143. 
As stated in this final rule, an ``accessory'' means any product that 
is intended or reasonably expected to be used with or for the human 
consumption of a tobacco product; does not contain tobacco and is not 
made or derived from tobacco; and meets either of the following:
    (1) Is not intended or reasonably expected to affect or alter the 
performance, composition, constituents, or characteristics of a tobacco 
product, or
    (2) Is intended or reasonably expected to affect or maintain the 
performance, composition, constituents, or characteristics of a tobacco 
product but (i) solely controls moisture and/or temperature of a stored 
product; or (ii) solely provides an external heat source to initiate 
but not maintain combustion of a tobacco product.
    FDA has structured paragraph (2)(ii) to ensure that coils and 
charcoal are not encompassed by the definition of ``accessory.''
    ``Composition,'' as used in this definition, means the manner in 
which the materials, including, for example, ingredients, additives, 
and biological organisms, are arranged and integrated. Examples of 
accessories are ashtrays, spittoons, hookah tongs, cigar clips and 
stands, and pipe pouches, because they do not contain tobacco and are 
not derived from tobacco and do not affect or alter the performance, 
composition, constituents, or characteristics of a tobacco product. 
Accessory examples also include humidors that solely control the 
moisture and/or temperature of a stored product and a burner that 
solely provides an external heat source to initiate but not maintain 
combustion of a tobacco product. As stated in the NPRM, accessories of 
newly deemed products are not deemed with this final rule.
    In addition, FDA is defining ``component or part'' to mean any 
software or assembly of materials intended or reasonably expected: (1) 
To alter or affect the tobacco product's performance, composition, 
constituents, or characteristics; or (2) to be used with or for the 
human consumption of a tobacco product. The definition excludes 
anything that is an accessory of a tobacco product.
    We note that the term ``material'' means an assembly of 
ingredients, including additives. Materials are assembled to form 
components and parts. For example, material could be considered the 
glue or paper pulp for a cigarette where the paper pulp includes 
multiple ingredients (e.g., multiple types of tobacco, water, and 
flavors) assembled into the paper (or pulp depending on the water 
content). A material could be considered the plastic in the mouthpiece 
of an ENDS containing multiple ingredients and additives assembled 
together to create a product.
    In determining whether software or an assembly of materials might 
be ``intended or reasonably expected'' to alter or affect the tobacco 
product's performance, composition, constituents, or characteristics or 
to be used with or for the human consumption of a tobacco product (and, 
therefore, whether it is a component or part), FDA is not bound by the 
manufacturer or distributor's subjective claims of intent. Rather, FDA 
can consider the totality of the circumstances, including direct and 
circumstantial objective evidence, which encompasses a variety of 
factors such as circumstances surrounding the distribution of the 
product or the context in which it is sold (see, e.g., 21 CFR 201.128 
(drugs), 21 CFR 801.4 (devices); see also U.S. v. Travia, 180 F.Supp.2d 
115, 119 (D.D.C. 2001)) and sales data.
    Some examples of materials intended or reasonably expected to be 
used with or for the human consumption of a tobacco product are:
     Atomizers and cartomizers used with ENDS;
     water filtration base additives (including those which are 
flavored) used with waterpipe tobacco; and
     pouches or flavorings used with any of the newly deemed 
products (whether or not the pouch or flavoring contains nicotine or 
tobacco).
    Some examples of materials intended or reasonably expected to alter 
or affect the tobacco product's performance, composition, constituents, 
or characteristics are:
     The cellophane wrapping or plastic tube for a single 
cigar;
     a plastic bag or tin holding loose pipe tobacco; and
     a glass or plastic vial container of e-liquid.

Although these examples are materials that are generally intended to 
prevent unintended changes to the characteristics of the tobacco 
product, they are also intended or reasonably expected to alter or 
affect the performance, composition, constituents, or characteristics 
of a tobacco product. For example, these materials often leach 
ingredients into the consumed product. As some comments noted, with 
ENDS, there is the potential for substances to leach from the 
containing vial into the e-liquid and these leachates may be inhaled 
when the e-liquids are used as intended, posing additional health risks 
for consumers. They often can also impact the moisture level or shelf 
life of a tobacco product (e.g., whether a cigar is in a hard pack or 
soft pack, and whether pipe tobacco is in a plastic or metal 
container). The moisture level of a tobacco product, and changes to 
that moisture level, can, for example, significantly impact consumers' 
exposure to nicotine and other constituents. In some cases, menthol or 
other ingredients may have been applied to these materials in order to 
have them become incorporated into the consumed product.
    FDA recognizes that in some circumstances some assemblies of 
materials can operate as both an aspect of the package and a component 
or part of the tobacco product. In such situations, the Agency is only 
examining a distinct subset of packaging materials that function as a 
component or part of a tobacco product by having the potential to alter 
or affect the tobacco product's performance, composition, constituents, 
or characteristics. Packaging materials that do not alter or affect, 
and are not reasonably expected to alter or affect, the tobacco 
product's performance, composition, constituents, or characteristics 
are not components or parts of a tobacco product. For example,

[[Page 29016]]

a glass vial containing an e-liquid is a component or part of the 
tobacco product, whereas a hard plastic blister pack in which the glass 
vial of e-liquid is distributed and sold to consumers is not.
    FDA intends to seek additional public comment and issue a rule or 
guidance to provide further clarification on assemblies of materials 
that are a ``component or part'' of a tobacco product because they are 
intended or reasonably expected to alter or affect the tobacco 
product's performance, composition, constituents, or characteristics or 
are intended or reasonably expected to be used with or for the human 
consumption of a tobacco product.
    Many comments specifically asked for clarification and examples of 
which objects used with waterpipe tobacco would be considered 
components, parts, and accessories. The following is a nonexhaustive 
list of examples of components and parts used with waterpipe tobacco: 
Flavor enhancers; hose cooling attachments; water filtration base 
additives (including those which are flavored); flavored hookah 
charcoals; and bowls, valves, hoses, and heads. The following is a 
nonexhaustive list of objects used with waterpipe tobacco that would 
likely be considered accessories: Hookah glow balls, foil pokers, 
shisha oyster forks, tongs, and bags.
    Many comments also sought clarification and examples as to which 
objects used with e-cigarettes would be considered components, parts, 
and accessories. The following is a nonexhaustive list of examples of 
components and parts of ENDS (including e-cigarettes): Atomizers, 
flavors used or intended to be used with ENDS (with or without 
nicotine), e-liquid solvents, tanks and tank systems, batteries (with 
or without variable voltage), coils, cartomizers, digital display/
lights to adjust settings, clearomisers, and programmable software. The 
following is a nonexhaustive list of examples of objects used with e-
cigarettes or other ENDS that would likely be considered accessories: 
Screwdrivers and lanyards.
    A summary of comments regarding these issues, and FDA's responses, 
is included as follows.
    (Comment 67) Many comments urged FDA to define components, parts, 
and accessories (particularly for e-cigarettes) to standardize 
enforcement nationally, prevent confusion in the marketplace (including 
among retailers), close any potential loopholes to circumvent 
compliance, increase transparency, and ensure inspectors are enforcing 
regulations, while also taking into account retailers who are making a 
good faith effort to comply with the law. Many comments provided 
suggested definitions for ``component or part'' and ``accessory.'' 
Other comments stated that FDA should not define these categories of 
products, because it is too difficult to properly define such large 
categories of products and any definitions quickly would become 
outdated.
    (Response) FDA agrees that definitions of component or part and 
accessory would be appropriate and has included definitions consistent 
with factors noted in the proposal and consideration of comments. 
Although we indicated in the NPRM that accessories are not expected to 
be used with or for consumption of a tobacco product, we also indicated 
our expectation that accessories will have little impact on the public 
health. While the definition of accessory is different than the 
description in the NPRM, based on consideration of the comments, it 
captures our original intent and the classes of products that the 
Agency views as accessories. The definitions of component, part, and 
accessory, which are discussed at the beginning of this section VI.A of 
the document, are included in Sec. Sec.  1100.3, 1140.3, and 1143.1.
    (Comment 68) Several comments expressed concern about FDA's 
statement in the NPRM that the Agency may consider rule revisions if 
FDA later decides to extend its regulatory authority to components and 
parts of newly deemed tobacco products that do not contain tobacco or 
nicotine. They stated that the Tobacco Control Act does not permit FDA 
to regulate such objects if they do not employ tobacco as a raw 
material.
    (Response) FDA disagrees. To clarify, FDA is finalizing its 
proposal to deem all tobacco products, including all components and 
parts, but excluding accessories of newly deemed tobacco products, to 
be subject to chapter IX of the FD&C Act. However, the additional 
restrictions (i.e., minimum age and identification, vending, and health 
warnings provisions) only apply to ``covered tobacco products.'' The 
health warning provisions apply to ``covered tobacco products,'' 
cigarette tobacco, and roll-your-own tobacco. The term ``covered 
tobacco products'' includes all newly deemed tobacco products except 
those components and parts that are not made or derived from tobacco.
    FDA also disagrees that the FD&C Act does not authorize FDA to 
regulate products that do not employ tobacco as a raw material. Section 
901 of the FD&C Act states that chapter IX of the FD&C Act applies to 
all cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless 
tobacco and to any other tobacco products that the Secretary of Health 
and Human Services by regulation deems to be subject to chapter IX. 
Section 201(rr) of the FD&C Act defines ``tobacco product,'' in 
relevant part, as any product made or derived from tobacco that is 
intended for human consumption, including any component, part, or 
accessory of a tobacco product (except for raw materials other than 
tobacco used in manufacturing a component, part, or accessory of a 
tobacco product). Therefore, the statute gives FDA authority to deem 
additional tobacco products, including all components, parts, and 
accessories, except for raw materials (other than tobacco) that go into 
manufacturing of components, parts, or accessories of a tobacco 
product. Examples of such raw materials would be unprocessed acacia gum 
(taken from a tree and not processed) and minted titanium dioxide (used 
for whitening cigarette and tipping paper). In this rule, FDA is not 
deeming accessories to be subject to chapter IX and, although it is 
deeming all components and parts to be subject to chapter IX, it is not 
applying the additional restrictions (i.e., minimum age and 
identification, vending, and health warnings provisions) to components 
and parts that are not made or derived from tobacco. Nevertheless, if 
FDA were to consider extending its authority to accessories or to apply 
additional restrictions to components or parts, FDA would do so through 
the rulemaking process.
    (Comment 69) A few comments expressed concern that the rule would 
create incentives for manufacturers to separate nicotine-containing 
components from nonnicotine-containing components to evade regulatory 
requirements. They stated that the rule would allow minors to purchase 
nicotine delivery systems, as long as they do not contain e-liquids, 
and obtain the e-liquids from other sources (e.g., friends, parents, 
online).
    (Response) FDA understands these concerns. However, this deeming 
rule covers tobacco product components and parts intended or reasonably 
expected to be used with or for the human consumption of a tobacco 
product. In addition, as stated in Sec.  1140.16, retailers of newly 
deemed tobacco products may not sell covered tobacco products (through 
any medium, including the Internet) to individuals under 18 years of 
age. FDA will continue to actively enforce the minimum age restriction 
for

[[Page 29017]]

mail order and Internet sales, which will help to reduce youth access 
to the nicotine and tobacco containing components, without which they 
cannot use the other components of ENDS.
    (Comment 70) Some comments stated that the objects used in or with 
an e-cigarette (including batteries, wire, screws, silica) should be 
beyond the scope of FDA's authority, because they do not become part of 
the tobacco product until they are constructed by the consumer. Others 
stated that FDA should regulate these objects given reports regarding 
the malfunctioning of certain e-cigarette components (e.g., dangers of 
exploding batteries (Ref. 65)) and the fact that the e-liquid cannot be 
consumed without each component working in conjunction to deliver 
nicotine to the consumer. These comments asked FDA to clarify whether 
the Agency will regulate only the nicotine-containing cartridges in a 
line of products that includes varying degrees of nicotine including 
cartridges advertised as nicotine free if they are intended to be used 
with or for the human consumption of a tobacco product.
    (Response) This final deeming rule deems all tobacco products as 
they are defined in section 201(rr) of the FD&C Act, except accessories 
of newly deemed products, but including components and parts as defined 
in this rule. The wires, screws, and silica meet the definition of 
component or part, as they are an assembly of materials intended or 
reasonably expected to be used with or for the human consumption of a 
tobacco product and are not accessories of a tobacco product. FDA also 
remains concerned about reports of exploding batteries. Batteries that 
are co-packaged with other components or parts of an ENDS (e.g., 
cartridges and tanks) or otherwise intended or reasonably expected to 
be used with or for the consumption of ENDS are components or parts and 
subject to FDA's tobacco product authorities. However, as noted 
elsewhere in this document, for ENDS hardware or delivery system 
components or parts, such as batteries, FDA expects that it may be 
difficult for manufacturers to obtain premarket authorization for such 
products, given the great extent of possible variations in combinations 
of hardware components, if all considered and sold separately. Thus, 
with respect to such apparatus, FDA expects that manufacturers will be 
most successful where authorization is sought for entire delivery 
systems, rather than individual components. Elsewhere in this issue of 
the Federal Register, FDA also has made available draft guidance, which 
when final will represent some appropriate means of addressing the 
premarket authorization requirements for newly deemed ENDS products and 
will include FDA's current thinking regarding compliance with existing 
voluntary standards for ENDS batteries.
    In addition, nicotine-containing cartridges that include varying 
degrees of nicotine are components or parts and subject to FDA's 
chapter IX authorities because they constitute an assembly of materials 
intended or reasonably expected to be used with or for the human 
consumption of a tobacco product and do not constitute a tobacco 
product accessory. Upon the effective date of this final rule, FDA 
intends to regulate the entire line of cartridges (including cartridges 
that include varying degrees of nicotine or those that do not contain 
nicotine, if they meet the definition of component or part).
    (Comment 71) Several comments urged FDA to include all e-liquids in 
the minimum age and identification requirements and vending machine 
restrictions in the revised part 1140, including e-liquids that do not 
contain nicotine, because they are easily accessible to minors online 
and can be mixed with nicotine. In addition, they suggested that FDA 
require the proposed addiction warning on all components or parts sold 
in conjunction with e-liquid.
    (Response) FDA disagrees. Under this deeming rule, e-cigarettes 
that contain nicotine cannot be sold to youth under the age of 18. In 
addition, an e-liquid with nicotine is a covered tobacco product and, 
therefore, will be required to have a health warning under part 1143. 
As previously discussed, an e-liquid without nicotine is a component 
(and subject to FDA's tobacco control authorities), if it is intended 
or reasonably expected to be used with or for the human consumption of 
a tobacco product (e.g., with liquid nicotine) and does not constitute 
a tobacco product accessory, but an e-liquid that does not contain 
nicotine or tobacco is not required to carry a warning, nor is it 
subject to the minimum age and identification requirements and vending 
machine restrictions under parts 1140 and 1143 because it is not a 
covered tobacco product as defined by this rule. Because components 
without nicotine or tobacco are intended to be used with a covered 
tobacco product, which contains nicotine or tobacco, FDA believes that 
it is appropriate to require only the covered tobacco product to be 
subject to the minimum age and vending machine provisions and to carry 
the warning. Moreover, if a warning is overused, there is the danger 
that it will grow stale.
    (Comment 72) One comment disagreed with what it characterized as 
FDA's assertions that tobacco product accessories do not pose a public 
health risk or environmental risk and stated that such objects are 
harmful to humans and the food chain.
    (Response) FDA wishes to clarify language included in the NPRM 
regarding accessories (79 FR 23142 at 23153). FDA did not propose, nor 
is it stating in this final rule, that tobacco product accessories do 
not pose any public health risk. Instead, we indicated that tobacco 
product accessories as defined in the rule likely have less (rather 
than ``no'') risk to the overall public health, which we reiterate in 
this final rule. FDA is regulating components and parts (and not 
accessories) of the newly deemed products, so the Agency can better 
focus its resources on those objects with a greater likely impact on 
public health. Similarly, FDA did not state that this rule would not 
impact the environment. Rather, the environmental analysis included in 
the NPRM stated that the impacts of this rule will not have a 
significant impact on the human environment according to the standard 
imposed by the National Environmental Policy Act, as stated in the 
proposed environmental assessment (EA). The final EA and Finding of No 
Significant Impact (FONSI) are included in the docket.
    (Comment 73) The comments suggested several different regulatory 
approaches for components, parts, and accessories. First, several 
comments stated that FDA should weigh the relative risks of these 
products and impose the least burdensome requirements necessary to 
effectively manage or mitigate those risks. They suggested that FDA 
treat these products the way the Agency does with its review of 
marketing applications. For example, they noted that FDA's draft and 
final guidance documents on PMTAs and SE reports explain that FDA does 
not intend to enforce the requirements of either section 910 or 905(j) 
of the FD&C Act for components of regulated tobacco products that are 
sold or distributed solely for further manufacturing into finished 
tobacco products because the Agency anticipates ``receiving relevant 
information regarding such new tobacco products in the PMTA submission 
for the finished regulated tobacco products'' (citing draft guidance, 
``Applications for Premarket Review of New Tobacco Products''). Second, 
some comments believed that manufacturers of e-cigarette components and 
parts

[[Page 29018]]

should be required to submit marketing applications given the aerosols 
and ``vapors'' that consumers generate when using certain components or 
parts. Third, some comments stated that instead of requiring 
manufacturers of components and parts to comply with the automatic 
requirements for the newly deemed products, FDA should require them to 
ensure that all of their components and parts that contain tobacco or 
tobacco derivatives are shipped and packaged with labeling that 
indicates that they are intended for further manufacture.
    (Response) At this time, FDA intends to limit enforcement of the 
premarket review requirements to finished tobacco products. For 
purposes of this compliance policy applicable to newly deemed products, 
a finished tobacco product refers to a tobacco product, including all 
components and parts, sealed in final packaging intended for consumer 
use (e.g., filters or filter tubes sold separately to consumers or as 
part of kits). FDA does not at this time intend to enforce these 
requirements for components and parts of newly deemed products that are 
sold or distributed solely for further manufacturing into finished 
tobacco products. In addition, FDA does not believe that it is 
warranted at this time to require components and parts that contain 
tobacco or tobacco derivatives to include labeling that indicates they 
are intended for further manufacture.
    (Comment 74) Some comments stated that FDA should regulate all 
components, parts, and accessories, as long as they have a foreseeable 
impact on the public health. They believed that omitting accessories 
from the scope of the deeming rule ignores the clear statutory language 
that explicitly defines ``tobacco product'' to include accessories.
    (Response) FDA disagrees. Although Congress included 
``accessories'' within the definition of ``tobacco product'' in section 
201(rr) of the FD&C Act, it did not explicitly require that FDA include 
all components, parts, and accessories within the scope of its rule to 
deem additional tobacco products under section 901. Accessories, as 
defined in this rule, likely have less risk to the overall public 
health, and the benefits to overall public health for deeming 
accessories subject to FDA's tobacco product authorities are also 
likely less. Therefore, FDA is excluding them from the scope of this 
deeming rule.
    (Comment 75) Some comments stated that items also used for purposes 
other than for tobacco use (i.e., a lighter or matches that can be used 
to light candles) should be classified as accessories and, therefore, 
not subject to FDA's chapter IX authorities. For example, batteries 
used in advanced personal vaporizers can be found in laptop battery 
packs or cordless drill packs. These comments also stated that items 
such as lighters and batteries may (or may not) be used in consumption 
of a tobacco product or are regulated by the Consumer Product Safety 
Act (as are child-resistant lighters) and, therefore, should not be 
subject to FDA's tobacco product authorities.
    (Response) FDA agrees that it is not necessary to regulate 
batteries that are not intended or reasonably expected to be used with 
a tobacco product under its tobacco product authorities. However, it is 
important that batteries that are co-packaged with other parts of an 
ENDS (e.g., cartridges and tanks) or otherwise intended or reasonably 
expected to be used with ENDS are components subject to FDA's tobacco 
product authorities. FDA remains concerned about reports of exploding 
e-cigarette batteries and finds that regulating them can help address 
these problems. Toward that end, elsewhere in this issue of the Federal 
Register, FDA has made available draft guidance, which when final will 
describe FDA's current thinking regarding some appropriate means of 
addressing the premarket authorization requirements for newly deemed 
ENDS products, including compliance with existing voluntary standards 
for ENDS batteries.
    (Comment 76) Some comments stated that walk-in humidors for cigars 
should not be subject to FDA regulation because they are important to 
retailers and allow consumers to browse a retailer's stock and make a 
selection.
    (Response) As discussed previously, any item that is intended or 
reasonably expected to be used with or for the human consumption of a 
newly deemed tobacco product; does not contain tobacco or a tobacco 
derivative; and is intended or reasonably expected to affect or 
maintain the characteristics of the newly deemed tobacco product but 
solely controls moisture and/or temperature of a stored newly deemed 
tobacco product, is an accessory and excluded from this deeming rule. 
Therefore, unless the humidor is designed to affect the tobacco product 
in a manner other than controlling moisture or temperature, such walk-
in cigar humidors are not subject to this rule.
    (Comment 77) A few comments expressed concern that e-cigarette 
tanks and cartridges would not be included within the proposed vending 
machine restrictions because they do not contain nicotine at the time 
of sale. They said that such objects are not standardized and that 
their quality, composition, and safety are not regulated and, 
therefore, they should be subject to FDA's chapter IX authorities.
    (Response) FDA does not believe it is necessary for tanks and 
cartridges that do not contain nicotine or tobacco to be subject to the 
vending machine restrictions because they can only be used to consume 
tobacco or nicotine derived from tobacco with other products that are 
subject to the additional restrictions. However, FDA is aware of the 
current lack of regulation or standardization of tanks and cartridges, 
which are components and parts that FDA is deeming to be subject to 
FDA's chapter IX authorities with this rule. After the effective date 
of this final rule, FDA will have authority to issue tobacco product 
manufacturing practice regulations under section 906(e) of the FD&C Act 
and product standards under section 907 of the FD&C Act to address the 
quality, composition, and safety of these components and parts. FDA 
also notes that these components and parts will usually be subject to 
premarket review, either by themselves, as components and parts 
intended for consumer use, or as components and parts of products that 
undergo further manufacturing for which the end product will be subject 
to premarket review.
    (Comment 78) A few comments expressed concern with FDA's 
characterization of objects used during a waterpipe tobacco session 
(i.e., the burners, holders, screens, and other objects used with 
waterpipe tobacco). They stated that all waterpipe burners and holders 
can affect waterpipe tobacco emissions, and noted that foil is heated 
to the same extent as charcoal during waterpipe use and, therefore, can 
present a burning danger (Ref. 66). In addition, the heating source, 
screen (or aluminum foil), and hose can have a significant impact on 
passive and active exposure and smoking/puffing behaviors and, 
therefore, should be components or parts subject to chapter IX of the 
FD&C Act.
    (Response) FDA has included definitions of ``component,'' ``part,'' 
and ``accessory'' with this final rule to provide additional clarity 
regarding the characterization of products used during a waterpipe 
session. According to these definitions, the screen (or aluminum foil) 
and hoses that are co-packaged with other parts of a hookah or 
marketed, advertised, or otherwise intended for use with a hookah are 
parts or components and subject to FDA's tobacco product authorities. 
However, for example, an external burner or

[[Page 29019]]

heating source that is not incorporated into the hookah would be an 
accessory, provided that it does not contain tobacco or a tobacco 
derivative and solely provides an external heat source to initiate but 
not maintain combustion of a tobacco product. The holder also is an 
accessory and not subject to chapter IX of the FD&C Act.
    (Comment 79) A few comments suggested that charcoal or wood cinder 
used with waterpipe tobacco should be considered a tobacco product and 
deemed under this regulation. They explained that combustion of these 
products produces toxicants and may emit carcinogens, carbon monoxide, 
polycyclic aromatic hydrocarbons, and other cancer causing agents.
    (Response) FDA finds that such products are components or parts; 
therefore, they are subject to FDA's chapter IX authorities. They are 
an assembly of materials intended or reasonably expected to be used 
with or for the human consumption of a tobacco product and are not 
accessories. As we have noted throughout this document, an accessory 
does not contain tobacco and is not made or derived from tobacco, and 
it meets one of the following: (1) Is not intended or reasonably 
expected to affect or alter the performance, composition, constituents, 
or characteristics of a tobacco product; or (2) is intended or 
reasonably expected to affect or maintain the performance, composition, 
constituents, or characteristics of a tobacco product but (i) solely 
controls moisture and/or temperature of a stored product; or (ii) 
solely provides an external heat source to initiate but not maintain 
combustion of a tobacco product. Therefore, the charcoal or wood cinder 
intended or reasonably expected to be used with or for the human 
consumption of waterpipe tobacco are components or parts. Further, 
charcoal and wood cinders are not considered accessories given that 
they: (1) Do not contain tobacco and are not made or derived from 
tobacco; and (2) are intended or reasonably expected to alter the 
characteristics of a tobacco product but do not solely control moisture 
and/or temperature of a stored product and do not solely provide an 
external heat source to initiate but not maintain combustion. Instead, 
both charcoal and wood cinder are used to maintain the combustion of 
waterpipe tobacco.
    (Comment 80) Many comments asked for clarification as to whether 
certain items associated with cigar use should be termed 
``accessories,'' including cigar tip cutters, permeable humidor 
buttons, removable tips, mouthpieces, removable filters, holders, 
lighters, ashtrays, and cases.
    (Response) FDA generally expects cigar tip cutters, permeable 
humidor buttons, holders, ashtrays, and cases would be accessories that 
are not subject to FDA regulation. In addition, as stated in this 
section (discussing the definitions of component or part and 
accessory), for the purposes of this regulation, any item that does not 
contain tobacco or a tobacco derivative and is not integrated in a 
tobacco product, but rather solely provides an external heat source, to 
initiate but not maintain combustion of a tobacco product (such as a 
lighter) is not subject to this deeming rule. However, removable tips, 
mouthpieces, and filters are all intended to be used by adult consumers 
in the human consumption of a tobacco and do not meet the definition of 
accessory, therefore, are included within the scope of this final rule.
    (Comment 81) A few comments expressed concern that vaporizers sold 
separately without nicotine can be modified or ``hacked,'' which 
researchers found could increase toxins and other dangerous components, 
including formaldehyde (Ref. 67). They stated that online videos show 
how to ``hack'' an e-cigarette, including how to change the apparatus 
to increase the temperature of the ``vapor.'' Because of these 
concerns, they argued that such items should be considered components 
and parts and under FDA's jurisdiction.
    (Response) FDA agrees that vaporizers are components or parts of a 
tobacco product. These objects are an assembly of materials intended or 
reasonably expected to be used with or for the consumption of a tobacco 
product and do not constitute tobacco product accessories. Therefore, 
they are tobacco product components or parts and subject to FDA's 
chapter IX authorities. FDA considers components or parts sold directly 
to consumers to be finished tobacco products. A finished tobacco 
product refers to a tobacco product, including all components and 
parts, sealed in final packaging intended for consumer use (e.g., 
filters or filter tubes sold separately to consumers or as part of 
kits). FDA remains concerned about adverse events associated with ENDS 
use and finds that regulating them can help address these problems. 
Toward that end, elsewhere in this issue of the Federal Register, FDA 
has made available draft guidance, which when final will describe FDA's 
current thinking regarding some appropriate means of addressing the 
premarket authorization requirements for newly deemed ENDS products.
    (Comment 82) One comment requested that flavored rolling papers be 
included as a newly deemed tobacco product. Another comment claimed 
that flavored papers should not be subject to FDA's tobacco control 
authorities, because they do not pose a danger to public health.
    (Response) Rolling papers intended for use with cigarette tobacco 
or roll-your-own tobacco are already subject to FDA's tobacco control 
authorities under section 901 of the FD&C Act because they are 
components of cigarettes and cigarette tobacco. Upon the effective date 
of this final rule, rolling papers (including flavored papers) intended 
for use with newly deemed tobacco products would be tobacco product 
components or parts and subject to FDA's chapter IX authorities.

B. Discussion of Requirements Associated With Components and Parts

    FDA received many inquiries about how the automatic provisions 
associated with deeming tobacco products would apply to components and 
parts. Components and parts of newly deemed tobacco products are 
subject to all of the automatic provisions included in the FD&C Act, as 
further discussed as follows.
1. Ingredient Listing (Sections 904(a)(1) and 904(c)); Health Document 
Submission (Section 904(a)(4)); and Registration and Product Listing 
(Section 905)
    At this time, FDA intends to limit enforcement to finished tobacco 
products. A finished tobacco product refers to a tobacco product, 
including all components and parts, sealed in final packaging intended 
for consumer use (e.g., filters, filter tubes, e-cigarettes, or e-
liquids sold separately to consumers or as part of kits). FDA does not 
at this time intend to enforce these requirements for components and 
parts of newly deemed products that are sold or distributed solely for 
further manufacturing into finished tobacco products.
2. SE Reports and PMTAs (Section 905(j) and 910)
    At this time, FDA intends to limit enforcement to finished tobacco 
products. FDA does not at this time intend to enforce these 
requirements for components and parts of newly deemed products that are 
sold or distributed solely for further manufacturing into finished 
tobacco products.
3. Reporting of HPHCs (Section 915)
    At this time, FDA intends to limit enforcement to finished tobacco

[[Page 29020]]

products. See section IX for further discussion of ENDS retail 
establishments and the responsibilities of upstream manufacturers for 
reporting of HPHCs. The Agency is working to determine an appropriate 
compliance policy to deal with HPHCs for newly deemed products 
(including e-liquids) and is intending to issue guidance with enough 
time for manufacturers to report given the 3-year compliance period.

VII. Regulation of Cigars and Selection of Option 1

    As discussed in the preamble to the NPRM (79 FR 23142 at 23150 
through 23152), it has been suggested that different kinds of cigars 
may have the potential for varying effects on public health. 
Accordingly, FDA proposed two options for the categories of cigars to 
be subject to this deeming rule. Option 1 proposed to deem all products 
meeting the statutory definition of ``tobacco product,'' except 
accessories of a proposed deemed tobacco product, to be subject to 
FDA's tobacco product authorities under chapter IX of the FD&C Act. 
Option 2 proposed to deem all products meeting the statutory definition 
of ``tobacco product,'' except accessories of a proposed deemed tobacco 
product and a subset of cigars referred to as ``premium cigars'' to be 
subject to FDA's tobacco product authorities under chapter IX of the 
FD&C Act. FDA notes that individual hand rollers of cigars would be 
considered manufacturers under chapter IX of the FD&C Act, and subject 
to the same requirements as other tobacco product manufacturers.
    (Comment 83) Some comments that supported Option 1 stated that FDA 
should regulate premium cigars, in part, because they meet the 
statutory definition of ``tobacco product.''
    (Response) FDA agrees. All cigars, including those referred to as 
premium cigars, meet the definition of a ``tobacco product'' under 
section 201(rr) of the FD&C Act.
    After thorough review of the comments and the scientific evidence, 
FDA has concluded that deeming all cigars, rather than a subset, more 
completely protects the public health and therefore has adopted Option 
1 in the final rule. FDA has concluded that: (1) All cigars pose 
serious negative health risks, (2) the available evidence does not 
provide a basis for FDA to conclude that the patterns of premium cigar 
use sufficiently reduce the health risks to warrant exclusion, and (3) 
premium cigars are used by youth and young adults. The fact that some 
premium cigar smokers might smoke such products infrequently or report 
that they do not inhale does not negate the adverse health effects of 
tobacco smoke or demonstrate that cigars do not cause secondhand smoke-
related disease in others. Therefore, we find there is no appropriate 
public health justification to exclude premium cigars from the scope of 
the final deeming rule and that it is appropriate to deem them.

A. Health Risks of Premium Cigars

    Researchers estimate that regular cigar smoking was responsible for 
approximately 9,000 premature deaths or almost 140,000 years of 
potential life lost among adults 35 years or older in 2010 (Ref. 68). 
Cigar smoke contains many of the same harmful constituents as cigarette 
smoke and may have higher levels of several harmful compounds (Ref. 68, 
citing Ref. 69 at 55-104). All cigar smokers have an increased risk of 
oral, esophageal, laryngeal, and lung cancer compared to non-tobacco 
users (Refs. 35, 69). Among those who report inhaling cigar smoke, 
there are significantly elevated levels of many types of cancer and 
other adverse health effects, such as increased risk of heart and 
pulmonary disease (Refs. 69, 70). Cigar smokers also are at a marked 
increase in risk for chronic obstructive pulmonary disease (COPD) and 
experience higher mortality risk from COPD than nonsmokers (Refs. 70, 
71). In addition, cigar smokers have a higher risk of fatal and 
nonfatal stroke than nonsmokers (Ref. 72). All cigars produce 
secondhand smoke, which causes negative health effects such as heart 
disease and lung cancer in bystanders (Refs. 35, 69).
    Nevertheless, we do note that the 2014 Surgeon General's Report 
states that when compared with persons who smoke cigarettes, those who 
use cigars exclusively have a lower risk for many smoking-related 
diseases (Ref. 9 at 428 citing Ref. 69). Although smoke from cigars 
contains the same toxic substances as cigarette smoke, cigar smokers 
generally smoke at a lower frequency and tend not to inhale the smoke, 
thus reducing (but not eliminating) their exposure to its toxic 
substances (id.). Former cigarette smokers are more likely to inhale 
cigar smoke than are primary cigar smokers who have never smoked 
cigarettes (id.).
    While most studies cited in this section do not explicitly pertain 
to premium cigars, the bulk of the established data on the health 
effects of cigar smoking is based on smokers of traditional, large 
cigars and, therefore, is applicable to the toxicity of premium cigars 
given that they share the same characteristics and are generally smoked 
in similar ways.
    While exposure to higher levels of cigar smoke for a longer period 
of time increases the adverse health risks due to cigar smoking (just 
as it does for cigarettes), the Surgeon General has stated that no 
amount of smoking is safe (Ref. 2). Further, there are no data 
indicating that premium cigar users are not susceptible to health 
risks, as discussed in section VII.C. FDA's responses to comments on 
the health risks of premium cigars are included in the following 
paragraphs.
    (Comment 84) Proponents of Option 1 stated there is no public 
health justification for exempting premium cigars and that deeming 
premium cigars will benefit the public health immediately through the 
automatic and additional provisions and the imposition of future 
product standards. They also stated that exempting premium cigars would 
have a negative impact on the public health.
    (Response) FDA agrees. As stated in the NPRM, there will be many 
public health benefits associated with deeming tobacco products 
(including products referred to as premium cigars). For example, the 
adulteration and misbranding provisions in sections 902 and 903 of the 
FD&C Act, as applied to the newly deemed products, will protect 
consumers because FDA will be able to take enforcement action against 
any non-compliant tobacco product, such as a product with false or 
misleading labeling or advertising. In addition, ingredient listings 
and reports of HPHCs under sections 904 and 915 of the FD&C Act will 
assist FDA in better understanding the contents of regulated products. 
That information would assist FDA in assessing potential health risks 
and determining if future regulations to address the health risks posed 
by particular products are warranted. With application of the section 
905 registration and listing requirements, FDA will be able to conduct 
biennial inspections of tobacco product manufacturers. Further, 
implementation of the premarket review provisions of sections 905, 910, 
and 911 of the FD&C Act will allow FDA to monitor product development 
and changes and to prevent more harmful or addictive products from 
reaching the market. Moreover, there were no data provided to support 
the premise that there are different patterns of use of premium cigars 
and that these patterns result in lower health risks.
    (Comment 85) Some comments argued that exempting premium cigars 
from deeming would set a dangerous precedent that it is appropriate for 
FDA not to regulate certain tobacco products by virtue of their 
potential for varying

[[Page 29021]]

effects on public health. An exemption could mislead consumers to 
believe that premium cigars are safe, which contradicts the available 
evidence that all cigars are harmful and potentially addictive. In 
addition, the current population of premium cigar users would be left 
unprotected, potentially decreasing the likelihood that they would 
quit, and leading more youth and young adults to initiate use of 
premium cigars or substitute products.
    (Response) FDA agrees with these comments. Accordingly, FDA has 
selected Option 1 deeming all cigars, rather than a subset, for the 
scope of this final rule.
    (Comment 86) Many comments that supported Option 2 argued that 
premium cigars do not present a public health threat significant enough 
to warrant regulation and that no evidence was presented that 
regulation of premium cigars would substantially improve the public 
health. These comments stated that premium cigars represent a small 
portion of the tobacco product and cigar markets (annual premium cigar 
estimate in the United States of 300 million units compared to nearly 
14 billion total cigar units and nearly 300 billion cigarettes) (Ref. 
73), and there is no evidence that premium cigars have the same health 
consequences or habitual use patterns as other tobacco products. They 
generally relied on two studies, Funck-Brentano et al. and Turner et 
al., to claim that premium cigars deliver little nicotine to users, by 
inhalation or oral absorption (Refs. 74, 75). They also claimed that 
cigars do not significantly elevate the risk of addiction or death 
(Refs. 76, 77) and stated that, in some studies, there were a very 
small number of cancer cases or deaths among cigar smokers (Refs. 78, 
79). They also noted the nonsignificant odds ratios for those consuming 
1 to 2 cigars per day (Refs. 69, 79) and for the risk of lung cancer 
and ``tobacco-related cancers'' among exclusive cigar smokers (Ref. 
80).
    (Response) FDA disagrees with these claims and finds that the cited 
studies or critiques are not persuasive. Regarding the claim that 
premium cigars deliver little nicotine to users, the Turner study (Ref. 
75) was a study of only 10 male hospital workers conducted more than 30 
years ago. The findings of the Turner study, based on carboxyhemoglobin 
and plasma nicotine levels, suggested that former cigarette smokers who 
occasionally smoked cigars or regularly smoked pipes had greater cigar 
smoke inhalation and absorption than primary cigar and pipe smokers 
(i.e., those who never smoked cigarettes). This study also reported 
that average plasma nicotine concentrations among primary cigar and 
pipe smokers were somewhat elevated 60 minutes into a cigar smoking 
session compared with levels measured after smoking abstinence (Ref. 
75). Notwithstanding the small sample size, the study results still 
demonstrate that cigars deliver nicotine to users.
    Similarly, the Funck-Brentano et al. study (Ref. 74) assessed 
biomarkers of tobacco exposure and toxicity in a small sample of cigar 
(corona-sized or larger cigar) or pipe smokers (n = 30), cigarette 
smokers (n = 28), and nontobacco users (n = 30), making this small 
biomarker study less persuasive. In fact, the study authors state: 
``These results should not be seen as a justification for the smoking 
of pipes and cigars, which are clearly associated with clinically 
significant health hazards. We emphasize that we cannot determine 
whether our results are explained by the type of tobacco smoked or by 
the different inhalation pattern in pipe/cigar smokers and cigarette 
smokers.''
    A recent analysis of biomarkers of tobacco exposure among cigar 
smokers used data from the 1999-2012 National Health and Nutrition 
Examination Survey, a nationally representative survey (Ref. 81). The 
sample included more than 220 primary cigar (i.e., current cigar/never 
cigarette) smokers and more than 180 secondary cigar (i.e., current 
cigar/former cigarette) smokers (id.). The researchers found that serum 
cotinine concentrations among primary (and secondary) cigar smokers 
were substantially higher than in nontobacco users in crude and 
adjusted analyses (id.). In addition, adjusted analyses showed that 
concentrations of NNAL (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol), 
blood cadmium, and lead were also higher among primary (and secondary) 
cigar smokers compared with nontobacco users (id.). Therefore, not only 
were the cited studies unpersuasive, but this robust and recent 
analysis contradicts those studies.
    In addition, FDA did not find persuasive studies cited in comments 
for the proposition that cigars do not significantly elevate the risk 
of addiction or death. To support this proposition, comments relied in 
part on a study (Ref. 76) in which a panel scored the worldwide 
harmfulness of 12 nicotine products using a multicriteria decision 
analysis approach. Although cigarettes ranked higher than either little 
cigars and other cigars on an aggregate harm score, the study found 
cigar smoking does result in morbidity, mortality, and dependence.
    The other study used to support the proposition that cigars are not 
a significant public health threat (Ref. 77) found a significant 
association between primary cigar or pipe smokers and lung cancer 
mortality risk, which refutes the claim that cigar use does not 
significantly elevate the risk of death. In addition, this study found 
an association between COPD mortality risk and secondary cigar or pipe 
smoking (but not for primary cigar and pipe smoking). Also, contrary to 
the assertions of commenters, a recent systematic review of cigar 
smoking and mortality summarized the results of 22 published studies 
from 16 different prospective cohorts and found that primary cigar 
smoking was associated with increased risk of mortality from all 
causes, several types of cancers, coronary heart disease, and aortic 
aneurysm (Ref. 82). Mortality risks were greater with increasing number 
of cigars smoked per day and self-reported level of inhalation, 
however, primary cigar smokers reporting no inhalation still had highly 
elevated mortality risks for oral, esophageal, and laryngeal cancers 
(id.). In addition, a recent study estimated that in 2010 more than 
9,000 premature deaths annually were attributable to regular cigar 
smoking (i.e., those who reported smoking cigars on at least 15 of the 
past 30 days) (Ref. 68).
    Moreover, FDA reviewed a study by Boffetta et al. (Ref. 78), which 
commenters relied upon to claim that a very small number of cancer 
cases existed among cigar smokers and, therefore, premium cigars should 
not be regulated. The Boffetta et al. study (id.) used a case-control 
design to assess the association between lung cancer risk and cigar 
smoking. The authors determined that the overall association between 
primary cigar or cigarillo smokers and lung cancer was significant and 
found significant associations in all but one area (id.). For all other 
estimates, the results were statistically significant. We also note 
that, despite the relatively small number of cancer cases in this 
study, it is only one part of a larger body of evidence that 
demonstrates the increased risk of serious adverse health effects 
associated with cigar smoking (Refs. 35, 69, 70, 71, 72, 77, 79, 83).
    (Comment 87) Some comments stated cigar smokers are not at risk of 
becoming addicted to tobacco products based on their use of cigars. 
Other comments stated that certain attributes of premium cigars 
increase the likelihood for nicotine dependence, including their size, 
the amount of tobacco (and, therefore, nicotine) in the cigar, and the 
longer amount of time that it takes to smoke the cigar.

[[Page 29022]]

Additionally, these comments suggested that because cigar tobacco is 
more alkaline than cigarette tobacco, nicotine may be absorbed into the 
blood stream more rapidly, even without inhaling (Refs. 84, 85).
    (Response) FDA agrees that all cigars are potentially addictive. As 
discussed in the preamble to the NPRM, a cigar can contain as much 
tobacco as a whole pack of cigarettes, and nicotine yields from smoking 
a cigar can be up to eight times higher than yields from smoking a 
cigarette (79 FR 23142 at 23154). Although the amount of nicotine taken 
in by a cigar user depends on various factors like how long the person 
smokes the cigar, the number of puffs taken, and the degree of 
inhalation, a leading review of the science of cigar smoking concluded 
that ``[c]igars are capable of providing high levels of nicotine at a 
sufficiently rapid rate to produce clear physiological and 
psychological effects that lead to dependence, even if the smoke is not 
inhaled'' (Ref. 35). In addition, regardless of whether premium cigar 
smokers inhale, buccal absorption of nicotine does occur, and cigar 
smokers may also absorb nicotine through the lips due to the alkalinity 
of cigar tobacco (Refs. 86, 87). This increased nicotine yield and 
absorption increases the risk of nicotine addiction from cigar smoking. 
Researchers analyzing data from the NYTS found that although the 
percentage of youth reporting various measures of dependence was lower 
for cigars than for cigarettes or smokeless tobacco, some youth did 
report some measures of cigar addiction (Ref. 88). This study found 
that 6.7 percent of middle and high school students who only smoked 
cigars also reported strong cravings for a tobacco product during the 
past 30 days, and 7.8 percent reported sometimes/often/always feeling 
irritable or restless when not using tobacco--which are measures of 
dependence (id.) We note that the Surgeon General has found that all 
forms of nicotine delivery do not pose an equal risk in establishing or 
maintaining nicotine addiction (Ref. 9).
    (Comment 88) Many comments remarked that premium cigars do not pose 
the same adverse health effects as cigarettes and other types of cigars 
because most studies of cigar health effects do not differentiate 
between types of cigars. They claimed this lack of evidence precludes 
conclusions about the health effects of premium cigars specifically.
    (Response) The science is clear that cigar use of all types can 
lead to negative health effects, as discussed throughout this section 
of the document. Thus, the contention that studies are inconclusive 
about the health effects of premium cigars because they do not 
differentiate between types of cigars is not persuasive.
    All cigar use is harmful and potentially addictive. Cigar smokers 
have an increased risk of oral, esophageal, laryngeal, and lung cancer 
compared to nonsmokers (Refs. 35, 69). Among those who report inhaling 
cigar smoke, there are significantly elevated levels of many types of 
cancer and other health effects, such as increased risk of heart and 
pulmonary disease (Refs. 69, 70). Cigar smokers also have a marked 
increase in risk for COPD and experience higher mortality risk from 
COPD than nonsmokers (Refs. 70, 71). In addition, cigar smokers have a 
higher risk of fatal and nonfatal stroke than nonsmokers (Ref. 72). All 
cigars produce secondhand smoke, which causes negative health effects 
such as heart disease and lung cancer in bystanders (Refs. 35, 69).
    We note that the Surgeon General reported in 2014 that, 
``[c]ompared with persons who smoke cigarettes, smokers who smoke pipes 
or cigars exclusively have a lower risk for many smoking-related 
diseases (internal citation omitted). Smoke from pipes and cigars 
contains the same toxic substances as cigarette smoke, but those who 
use a pipe or cigar usually smoke at a lower frequency; observation 
indicates that they tend not to inhale the smoke, thus reducing their 
exposure to its toxic substances (internal citations omitted). Evidence 
indicates that former cigarette smokers are more likely to inhale pipe 
or cigar smoke than are primary pipe and cigar smokers who have never 
smoked cigarettes (internal citations omitted)'' (Ref. 9 at 428-429). 
However, research indicates that most cigar smokers do inhale some 
amount of smoke, even when they do not intend to inhale, and are not 
aware of doing so (Refs. 32, 33).
    Finally, FDA specifically sought comment on how the potential 
different patterns of use for premium cigars might result in different 
or decreased health impacts, but no such evidence was submitted (see 
discussion in section VII.C of document).
    (Comment 89) Some comments indicated that many cigar users, 
including those who smoke premium cigar brands, are also current or 
former cigarette users, increasing their exposure to toxic constituents 
and the health risks of using combusted tobacco products (Refs. 89, 
90). Additionally, they stated that these users are more likely to 
inhale when they use cigars and may smoke more cigars per day, 
significantly increasing their health risks (Refs. 33, 91, 92, 93, 94).
    (Response) FDA agrees. Given the adverse health effects of all 
cigars, FDA has selected Option 1 deeming all cigars, rather than a 
subset, for the scope of this final deeming rule.
    (Comment 90) Some comments raised concerns about dual and polyuse 
of cigars and other tobacco products, which is common among both adults 
and youth (Refs. 90, 95). For example, in one study, 35.1 percent of 
adult premium cigar users, 58.3 percent of cigarillo and other mass 
market cigar users (i.e., those reporting their usual cigar did not 
have a filter and the usual brand was not premium), and 75.2 percent of 
little filtered cigar users also smoked cigarettes (Ref. 90). Some 
comments noted that multiple product use is concerning because 
polytobacco users are more likely to report symptoms of nicotine 
dependence (Ref. 88).
    (Response) As FDA stated in the NPRM, we are concerned about the 
use of multiple products, especially combusted tobacco products.

B. Youth and Young Adults Use Premium Cigars

    Proponents of Option 2 have stated that an exemption for premium 
cigars is warranted because youth prefer machine-made cigars (as 
opposed to hand-rolled) given their low price, flavoring, and easier 
availability. However, although youth and young adults have a higher 
use of cigarillos and other mass market cigars, studies indicate that 
they are also using premium cigars.
    (Comment 91) Many comments cited data showing that among those age 
12 and older, past month cigar use decreased slightly from 5.4 percent 
in 2002 to 5.2 percent in 2012 after peaking at 5.7 percent in 2004 
(Ref. 89 at Figure 4.1). Among youth only (ages 12 to 17), cigar 
smoking prevalence declined between 2004 (4.8 percent) and 2012 (2.6 
percent) (Ref. 89 at Figure 4.1). Trend data from the National Youth 
Risk Behavior Survey also indicate that cigar use among male high 
school students, female students, and white, black, and Hispanic 
students either declined or remained stable from 1997 to 2011 (Ref. 9). 
Additionally, from 1997 to 2013, ``a significant linear decrease 
occurred overall in the prevalence of current [youth] cigar use (22.0 
percent-12.6 percent)'' (Ref. 96), which was observed from data 
collected by the CDC 1997-2013 YRBS (Ref. 29). Accordingly, they 
questioned whether FDA should be regulating cigars.

[[Page 29023]]

    Other comments included data indicating that youth cigar use has 
not declined when compared to use of other tobacco products. They noted 
that many youth surveys show youth cigar smoking to be higher than, or 
about the same as, cigarette smoking. For example, in 2013, among U.S. 
high school males, the prevalence of current (past 30 day) cigar 
smoking (16.5 percent) was comparable to current (past 30 day) 
cigarette smoking (16.4 percent) (Ref. 96). Additionally, in 21 U.S. 
cities that conducted the 2013 YRBS, the prevalence of current cigar 
smoking (8.6 percent) was comparable to current cigarette smoking (7.7 
percent) among high school students (id.). In 2014, NYTS reported that 
among high school Non-Hispanic black students, 8.8 percent reported 
smoking cigars in the past 30 days, whereas 4.5 percent reported 
smoking cigarettes in the past 30 days (Ref. 22). In addition, among 
high school males overall, the prevalence of past 30 day cigar smoking 
(10.8 percent) was comparable to past 30 day cigarette smoking (10.6 
percent) (id.). Measures of youth use of cigars may underestimate 
prevalence due to incorrect self-identification as a non-cigar smoker 
and confusion between the various cigar products (Refs. 97, 98, 99). 
Accordingly, the comments supported FDA's regulation of all cigars.
    (Response) FDA remains concerned about the use of all tobacco 
products, particularly combusted tobacco products like cigars and 
cigarettes, and remains most concerned about use by youth and young 
adults given their unique susceptibility to the addictiveness of 
nicotine. Although supporters of Option 2 relied upon NSDUH data 
showing a decline in cigar smoking prevalence among individuals aged 12 
to 17 from 2004 to 2012, the NSDUH's questions about ever and past 30-
day use of cigars did not include examples of specific brands. We note 
that the Surgeon General's 2014 report states that ``data from the 
1997-2011 obtained from the National YRBS indicate that current cigar 
use among male high school students declined from 1997-2005 and then 
remained stable from 2005-2011. Among female students, current cigar 
use declined from 1997-2011.'' (Ref. 9 at 736, internal references 
omitted). The 2013 YRBS, a nationally representative survey of 13,000 
youths, indicated that cigar use prevalence trends have decreased from 
1997-2013 for youth in grades 9 through 12 (22 percent in 1997 to 12.6 
percent in 2013) (Ref. 29).
    Evidence suggests that some youth may recognize the brand of cigar 
they smoke, but not that it is a ``cigar'' in general terms and, 
therefore, may not report their cigar use (Refs. 98, 100). When 
examples of brand names were added to the 2012 NYTS, there was a 
pronounced increase from 2011 in reported cigar smoking among non-
Hispanic black females (Ref. 100). Among NYTS high school students 
overall from 2000 to 2011, there was no change in prevalence of cigar 
smoking (Ref. 101). This lack of decline in cigar smoking is a concern 
considering cigarette smoking among high school students did 
significantly decline over these periods (id.). Among NYTS high school 
students overall from 2011 to 2014, there was a decrease in prevalence 
of current use of cigars from 11.6 percent to 8.2 percent (Ref. 22).
    (Comment 92) The comments were divided as to whether youth use 
premium cigars. Some comments provided data demonstrating youth use of 
premium cigars. Others submitted mainly informal industry surveys and 
anecdotal evidence illustrating that the majority of premium cigar 
users are older adult males who smoke infrequently and often in a 
celebratory nature. A few other comments stated that patterns of use 
studies are inconclusive, because many studies do not differentiate 
between premium cigars and mass-market cigars.
    (Response) Although youth and young adults tend to smoke mass 
market cigar brands, they are also using premium cigars. In one study, 
researchers used data from the 2010-2011 NSDUH and Nielsen market 
scanner data to define a study sample consisting of 6,678 past 30-day 
cigar smokers who reported smoking a usual brand of cigars (Ref. 59). 
While many youth identified a mass market cigar as the brand they used 
most often, this analysis reveals that 3.8 percent of youth aged 12 to 
17 and 12.1 percent of young adults aged 18 to 25 also identified 
certain premium cigars to be the brand they smoked most often (id.). 
Individuals in both cohorts reported at least eight different premium 
cigar brands among the brands they used most often, providing evidence 
that youth and young adults are smoking premium cigars (id.).
    One study analyzing data from the 2012-2013 National Adult Tobacco 
Survey (NATS), with 60,192 participants 18 years and older found that 
of those smokers whose type of cigar could be identified based on the 
attributes of their usual product (e.g., premium cigar smoker, little 
cigar smoker, cigarillo smoker), 19.9 percent were premium cigar 
smokers (Ref. 90). More specifically, 15.1 percent of cigar smokers 
aged 18 to 29 years old, who identified themselves as smoking every 
day, some days, or rarely, indicated the cigar they usually smoked on 
those occasions was a premium cigar (id.), which clearly illustrates 
that young adults are using premium cigars. Although some comments 
questioned the applicability of the NATS data on premium cigar use by 
youth and young adults (in part, because the study did not use the 
proposed definition of ``premium cigar'' in the NPRM), FDA is not 
persuaded. FDA does not believe it is necessary for the definition of 
premium cigars in this study to match exactly the definition in the 
NPRM in order to draw inferences about the use of different types of 
cigar products. These data, along with the NSDUH and Nielsen market 
scanner data discussed previously, clearly indicate that youth and 
young adults are using premium cigars.
    Some comments stated the previously mentioned studies show only 
minimal premium cigar use by minors. By contrast, they relied on Soldz 
et al. (Ref. 102), which examined preferred cigar brands based on a 
survey of Massachusetts middle and high school students. Although the 
study did not include any particular premium cigars among the brands 
reported, 16.4 percent of youth cigars users were categorized as 
preferring a ``non-listed'' brand which the authors suggested ``may 
largely consist of premium cigars.'' The authors based this 
determination given the participants' positive association between the 
``non-listed'' brands and parental cigar use and the negative 
association between the listed cigar brands and parental cigar use. 
Consequently, FDA does not believe this study demonstrates that youth 
do not use premium cigars. These comments also did not provide 
persuasive peer-reviewed evidence indicating that youth and young 
adults do not use these products. In addition, comments stating that 
youth and adult cigar use studies are not conclusive with regard to 
premium cigars because they do not differentiate between cigar types 
are not persuasive. Such studies show that youth and young adults smoke 
cigars, and other studies that do differentiate between product types, 
such as those previously discussed, indicate that youth and young 
adults do, in fact, use premium cigars.
    In light of the health risks associated with the use of all types 
of cigars, FDA has selected Option 1 and is deeming all cigars, 
including premium cigars, in this rule.
    (Comment 93) A few comments disagreed with FDA's characterization 
of one study cited in the NPRM (Ref. 103) for the proposition that 
young

[[Page 29024]]

adults often mistakenly view non-cigarette tobacco products, such as 
cigars, as safe alternatives to cigarettes. They noted that most young 
adult participants in the study rated shisha, herbal cigarettes, and 
herbal smokeless as ``safer than cigarettes,'' but rated cigars and 
kreteks as more harmful.
    (Response) Many consumers believe that noncigarette tobacco 
products, including cigars, are less harmful than cigarettes. Although 
the overall study population did rate cigars as more harmful, there 
were subgroups (such as African Americans and non-Hispanic whites) that 
rated cigars from ``a little safer'' to ``much safer.'' Deeming all 
tobacco products, including premium cigars, to be subject to chapter IX 
of the FD&C Act will help to alleviate mistaken beliefs that certain 
tobacco products are safe alternatives to cigarettes by virtue of the 
fact that they are not subject to FDA regulation.
    (Comment 94) A few comments also stated that premium cigar use 
among young adults is irrelevant because Congress did not task FDA with 
protecting young adults who are lawfully permitted to purchase tobacco 
products.
    (Response) FDA is concerned with tobacco use by all age groups, 
including young adults and adults who may lawfully purchase these 
products. The Tobacco Control Act charges FDA with protecting the 
public health generally, not only the health of minors (section 3 of 
the Tobacco Control Act). Nevertheless, FDA is particularly concerned 
with tobacco use by youth and young adults, as they are uniquely more 
susceptible to becoming addicted to nicotine than adults or older 
smokers. As discussed in the NPRM, most tobacco users begin using prior 
to the age of 18 and believing they will be able to quit. However, most 
youth are unable to stop tobacco use once they become addicted. 
Accordingly, FDA is taking steps to reduce the potential harm to youth 
and young adults from tobacco products.
    (Comment 95) Many comments expressed concerns regarding flavored 
cigars, including flavored premium cigars, and their effect on youth 
initiation. Some comments concluded there is no evidence that minors 
consume flavored premium cigars, relying on one study in which the 
flavored premium cigar brands of youth use accounted for only a 
fraction (0.1 percent) of the less than 4 percent reported use of 
premium cigar brands (Ref. 59).
    (Response) FDA is announcing that it intends in the future to issue 
a proposed product standard that, if finalized, would eliminate 
characterizing flavors in all cigars including cigarillos and little 
cigars.
    (Comment 96) Some comments argued that premium cigars do not pose 
youth access issues because manufacturers and retailers do not market 
them to youth (i.e., they are not cheap, candy- and fruit-flavored, or 
easy to access) and age verification is already required at the point 
of sale limiting access to adults only. They relied, in part, on FDA's 
statements in the 1996 tobacco youth access rule in which FDA stated 
there was insufficient evidence of youth cigar use to warrant cigar 
regulation (61 FR 44396). The comments stated there is no evidence that 
the situation has changed since then and that exempting premium cigars 
from tobacco product regulation is also warranted because youth do not 
use premium cigars to any significant degree.
    (Response) FDA disagrees. The Agency's statement regarding the 
availability of evidence to support cigar regulation was made 18 years 
ago and based on the evidence available at that time. In fact, FDA 
explicitly stated that there was insufficient evidence to regulate 
cigars ``at this time'' (i.e., 1996) (61 FR 44396 at 44422). Moreover, 
the 1996 rule was issued under the authority of the FD&C Act prior to 
the passage of the Tobacco Control Act. Consequently, one of the 
reasons FDA did not assert jurisdiction over cigars in the 1996 rule 
was because it did not have sufficient evidence ``that these products 
satisfy the definitions of drug and device in the act'' (61 FR 44396 at 
44423). Cigars, including premium cigars, clearly do satisfy the 
definition of a ``tobacco product'' and evidence has become available 
since 1996 indicating that youth and young adults use cigars, including 
premium cigars (Refs. 59, 68, 90).

C. Patterns of Use Do Not Preclude Users From Experiencing Negative 
Health Effects

    Proponents of Option 2 claimed that patterns of use preclude 
premium cigar smokers from experiencing the negative health effects of 
tobacco smoke because they smoke infrequently and do not inhale. 
However, despite our explicit requests in the NPRM, the comments did 
not include data indicating that premium cigar smokers are not subject 
to disease risk and addiction. FDA's responses to comments regarding 
these issues are included as follows.
    (Comment 97) Many comments stated that a majority of cigar users 
are occasional smokers (two to six cigars per week) and do not inhale 
(citing Refs. 69, 75). They also indicated that premium cigar use does 
not lead to addiction. Finally, some comments noted that occasional 
cigar users have not been studied in epidemiological research, and data 
for the lowest level of cigar users (one to two cigars per day) do not 
reveal mortality rates that are significantly different from nonsmokers 
(Refs. 69, 79). However, other comments included evidence suggesting 
increased disease risk and nicotine dependence among infrequent cigar 
users and those reporting they do not inhale.
    (Response) FDA disagrees that patterns of use preclude premium 
cigar users from experiencing the negative health effects of these 
products. All cigars produce toxic cigar smoke (Refs. 35, 69). In 
addition, studies have shown that cigar smoking can cause several 
different types of cancer even without inhalation (Refs. 69, 104). For 
example, one study found an increased risk in head and neck cancers in 
people who were not cigarette smokers but had previously smoked only 
cigars (Ref. 104).
    While inhaling cigar smoke poses much higher morbidity and 
mortality rates than not inhaling, significant risk still exists for 
those who do not inhale. Researchers found that the risk of stomach 
cancer mortality was significantly higher among cigar users who 
reported they did not inhale when compared to those who did not use 
tobacco products (Ref. 105). Additionally, among primary cigar smokers 
reporting that they do not inhale, relative mortality risk was still 
highly elevated for oral, esophageal, and laryngeal cancers (Ref. 83). 
A recent systematic review of cigar smoking and mortality summarized 
the results of 22 published studies from 16 different prospective 
cohorts and found that primary cigar smoking was associated with 
increased risk of mortality from all causes, several types of cancers, 
coronary heart disease, and aortic aneurysm compared to nonsmokers 
(Ref. 82). Mortality risks were greater with increasing number of 
cigars smoked per day and self-reported level of inhalation; however, 
primary cigar smokers reporting no inhalation still had highly elevated 
mortality risks for oral, esophageal, and laryngeal cancers compared to 
nonsmokers (id.). In addition, even if they do not intend to inhale and 
are not aware that they are doing so, most cigar smokers do inhale some 
amount of smoke (Refs. 32, 34).
    Although studies indicate that some cigar smokers may absorb less 
tobacco smoke, they also show that all cigar smoking is harmful. 
Regardless of whether cigar smokers inhale, they are

[[Page 29025]]

still subject to the addictive and other adverse health effects of the 
product through absorption of nicotine and harmful constituents (Refs. 
32, 81).
    (Comment 98) Supporters of Option 2 claimed that premium cigar 
smokers use cigars less frequently than cigarette and smokeless tobacco 
users and, therefore, premium cigars should either not be regulated or 
should be subject to less regulation. They relied upon a study showing 
that the adult prevalence of everyday or occasional use of cigarettes 
was 18 percent and 2.6 percent for smokeless tobacco products, compared 
to 2 percent for cigars, cigarillos, and little filtered cigars (Ref. 
106).
    (Response) Although the prevalence of cigar smoking in the U.S. 
population is lower than cigarette smoking, use of cigars still 
presents health risks. Researchers estimate that regular cigar smoking 
was responsible for approximately 9,000 premature deaths or almost 
140,000 years of potential life lost among adults 35 years or older in 
2010 (Ref. 68). As stated in the previous response, all cigars produce 
toxic cigar smoke (Refs. 35, 69). Any cigar use exposes the mouth and 
throat to tobacco smoke and studies have shown that cigar smoking can 
cause several different types of cancer even without inhalation (Refs. 
69, 104). Health risks still exists for those who do not inhale. For 
example, researchers found that the risk of stomach cancer mortality 
was significantly higher among cigar users who reported they did not 
inhale when compared to those who did not use tobacco products (Ref. 
107). Additionally, among primary cigar smokers reporting that they do 
not inhale, relative mortality risk was still highly elevated for oral, 
esophageal, and laryngeal cancers (Ref. 83). Therefore, all cigars 
expose users to toxic and cancer-causing substances and increase the 
risk of harm. Basing an exemption for premium cigars on current use 
patterns would be inappropriate given that patterns may change over 
time and in response to regulation. Consequently, FDA has concluded 
that deeming all cigars, including premium cigars, is appropriate for 
the protection of the public health.

D. Responses to Other Cigar Comments

    (Comment 99) Some comments expressed concern that if FDA did not 
deem all tobacco products subject to regulation, the tobacco industry 
would adjust its products to fit the exemption for premium cigars in 
Option 2 and preferential economic treatment of certain manufacturers 
would result. These comments argued that just as manufacturers of roll-
your-own tobacco changed their roll-your-own product to classify it as 
pipe tobacco to take advantage of positive tax treatment, manufacturers 
would seek similar ways to circumvent regulations and continue 
marketing products that are detrimental to public health.
    (Response) Because FDA has selected Option 1 deeming all cigars, 
rather than a subset, for this final rule, these comments are moot.
    (Comment 100) Many comments stated that it is important for FDA to 
regulate all tobacco products, including cigars, pipe tobacco, and e-
cigarettes in the same way, and that the Agency should ensure that a 
consistent set of regulatory criteria is applied to all tobacco 
products and nicotine delivery systems. According to the comments, 
failure to regulate all tobacco products would provide incentives for 
manufacturers to market new tobacco-based or tobacco-derived products 
that are unregulated and may induce people to switch to the unregulated 
products.
    (Response) FDA agrees that it is appropriate for the protection of 
the public health to regulate all tobacco-derived products meeting the 
definition of ``tobacco product.'' There is inherent risk in all 
tobacco-derived products. Further, the Agency agrees that use patterns 
may change (and have changed) over time and in response to regulation.
    (Comment 101) At least one comment expressed concern that FDA 
relied upon an abstract presented at the Conference for the Society for 
Research on Nicotine and Tobacco (SRNT) as a basis for proposing Option 
1. The comment stated that because the abstract was not a full peer-
reviewed research article, stakeholders were unable to adequately 
respond to the claims made.
    (Response) FDA disagrees. Additional analysis of the data that was 
the subject of this SRNT abstract was conducted and a paper was 
published and submitted to the docket, allowing for stakeholders to 
comment on it (Ref. 90). The abstract presented at SRNT also was not 
the sole basis for proposing Option 1. FDA appropriately characterized 
this as preliminary data and included additional data and information 
to support this proposed option. In addition, FDA has supplemented the 
information and data supporting Option 1, as discussed in section VII, 
to provide additional evidence of premium cigar use by youth and young 
adults and to illustrate that the patterns of use for premium cigars do 
not preclude users from negative health effects.
    (Comment 102) Comments urged FDA to adopt a category-specific 
approach to regulation of cigars in order to more effectively address 
the variations in use patterns, manufacturing, and ingredients across 
the product category. Other comments, however, urged FDA to broadly 
regulate all cigars in the same way to reduce initiation and current 
use among youth. More specifically, comments advocated prohibiting 
flavors, including menthol, in all cigars, prohibiting self-service 
displays, and establishing minimum pack size requirements for all 
cigars.
    (Response) Although the statute does not require FDA to make any 
public health finding in order to deem tobacco products, the Agency has 
determined that cigar use presents health risks and that all cigars 
should be brought under its regulatory authority. However, FDA is 
providing a compliance policy that will provide additional time for 
manufacturers of newly deemed products to comply with certain 
requirements, and which will reduce the burdens on manufacturers as 
they become regulated by FDA for the first time. As explained elsewhere 
in this document, FDA is announcing that it intends in the future to 
issue a proposed product standard that would eliminate characterizing 
flavors in all cigars including cigarillos and little cigars.
    (Comment 103) Some comments supporting Option 2 argued that FDA is 
not obligated to deem all tobacco products that meet the statutory 
definition of ``tobacco product.'' They also stated that the intent of 
the Tobacco Control Act was to target tobacco products marketed to 
children and products that cause addiction, which is why ``cigarette'' 
and ``little cigar'' were specifically defined in the Tobacco Control 
Act and large and premium cigars were not similarly defined. Thus, they 
claim exempting premium cigars is consistent with Congress' intent that 
premium cigars not be regulated, which they state is further evidenced 
by introduction of such legislation in Congress.
    (Response) FDA agrees that the Agency is not obligated to deem all 
tobacco products but disagrees with comments purporting to explain 
Congress' intent to only regulate products marketed to children. The 
purpose of the Tobacco Control Act was to provide authority to FDA to 
regulate tobacco products and protect not only the health of minors, 
but also the health of the public overall (section 3 of the Tobacco 
Control Act). While use of tobacco products by youth was and continues 
to be a significant focus of the law, it is clear that Congress did not 
intend that the Tobacco Control Act reach only products marketed to 
children, as they included many

[[Page 29026]]

provisions applicable to tobacco products marketed to adults.
    (Comment 104) Many comments expressed concern that premium cigar 
regulation would impose considerable costs and place excessive burdens 
on small businesses without quantifiable benefits. In particular, many 
comments stated that premarket review would be cost-prohibitive for 
premium cigar manufacturers, effectively eliminating their ability to 
release special editions and seasonal blends. They also claimed that 
HPHC testing and reporting and other regulatory requirements like the 
prohibition on free samples would be equivalent to a de facto ban on 
premium cigars. They also expressed concern about the political and 
economic impact of premium cigar regulation on two foreign nations 
given the potential impact on production and exports of their premium 
cigars to the United States.
    Some comments also argued that an exemption for premium cigars is 
appropriate, because premium cigars are unique in the way that they are 
made, marketed, sold, purchased, and used. They stated that regulation 
would stifle innovation in the premium cigar market, devastate a long-
time social and cultural phenomenon, and limit the freedoms of 
businesses and consenting adults to sell and purchase a legal product.
    (Response) FDA understands these concerns. The Agency has 
determined that cigar use presents health risks and that all cigars 
should be brought under its regulatory authority.
    To assist newly regulated firms, FDA is announcing in this final 
rule a compliance policy to address some of the possible burdens 
suggested by comments (section IV.D). For example, FDA does not intend 
to enforce the premarket review requirements against cigar 
manufacturers that make tobacco blending changes to address the natural 
variation of tobacco (e.g., tobacco blending changes due to variation 
in growing conditions) in order to maintain a consistent product. 
However, FDA intends to enforce the premarket requirements for products 
that have tobacco blending changes (including those involved in 
seasonal and boutique blends) that are intended to alter chemical or 
perception properties of the new tobacco product (e.g., nicotine level, 
pH, smoothness, harshness). FDA also is working to determine an 
appropriate compliance policy to deal with HPHCs for newly deemed 
products and is intending to issue guidance regarding HPHC reporting, 
and later a testing and reporting regulation as required by section 
915, with enough time for manufacturers to report given the 3-year HPHC 
reporting compliance period. As noted elsewhere in this document, FDA 
does not intend to enforce the reporting requirements for newly deemed 
products before the close of the 3-year compliance period, even if the 
guidance is issued well in advance of that time. In addition, as 
discussed in section IV.D, FDA is announcing a compliance policy for 
small-scale tobacco product manufacturers (which likely would include 
premium cigar manufacturers), which states that FDA generally intends 
to grant small-scale tobacco manufacturers additional time to respond 
to SE deficiency letters and to not bring enforcement action against 
those small-scale tobacco product manufacturers who submit ingredient 
lists within 12 months of the effective date of the rule, and is 
granting these manufacturers an additional six-month compliance period 
for the requirements to submit tobacco health documents. FDA believes 
that this compliance policy will help to assist these manufacturers 
with regulatory compliance.
    FDA also understands concerns from cigar retailers about the effect 
that a ban on free samples could have on their ability to promote new 
products. FDA wishes to clarify that allowing prospective adult buyers 
to smell or handle a cigar is not considered the distribution of a 
``free sample'' for the purpose of 21 CFR 1140.16 as long as the 
product is not actually consumed in the retail facility and the 
prospective buyer does not leave the facility with a free tobacco 
product (whole or part). Affording adult consumers the opportunity to 
handle the product will give them the ability to feel the resistance of 
the cigar's structure, and allow them to clearly see the color of the 
product, which is an indication of the fermentation period for the 
tobacco. It also will allow users to capture the aroma of the cigar and 
the box (if the cigar is sold in a package). Therefore, it would not be 
considered a free sample if a prospective buyer smells the cigar while 
handling it. We believe that in most circumstances, other retail 
facilities, including ENDS retail establishments, can similarly allow 
customers to touch, hold, and smell their products without violating 
the free sample ban. However, if the prospective buyer lights and draws 
or puffs on the cigar to keep the cigar lit, or otherwise uses the free 
cigar or leaves the retail establishment with a free cigar, this would 
constitute a ``free sample'' in violation of Sec.  1140.16.
    (Comment 105) Many comments requested that the exemption for 
premium cigars be extended to hand-operated, vintage machine-made 
cigars. Comments stated such cigars are indistinguishable from handmade 
premium cigars, are sold on the same shelves as premium cigars, and do 
not resemble mass-market cigars. The comments further argued that 
consumers perceive them to be just like value-priced handmade cigars 
and treating them differently would create significant enforcement 
issues for FDA. They stated that, without an exemption, manufacturers 
of these products would be forced to close and eliminate jobs, 
negatively impacting the regional economy where such cigars are 
produced.
    (Response) As already stated, FDA has selected Option 1 deeming all 
cigars, rather than a subset, for this final deeming rule. Therefore, 
all cigars, including hand-operated, vintage machine-made cigars, are 
deemed and subject to the requirements of chapter IX of the FD&C Act 
and implementing regulations. Concerns noted by some comments about the 
burdens of regulation are addressed in sections IV.C and IV.D.
    (Comment 106) At least one comment expressed concern that retailers 
may not be able to determine whether a cigar meets all of the elements 
of the final definition of a ``covered cigar.'' Therefore, the comment 
stated that retailers should not be liable for a manufacturer's 
improperly labeled premium cigars (similar to the retailer ``safe 
harbor'' for required warning labels and advertising in the proposed 
cigarette graphic warning rule (75 FR 69524 at 69535, November 12, 
2010)).
    (Response) FDA has selected Option 1, which requires all cigars 
(rather than a subset) to include the textual health warnings. FDA also 
notes, however, that Sec.  1143.5(a)(4) does provide a retailer ``safe 
harbor'' for required warning labels for packaging that contains a 
health warning; is supplied to the retailer by a manufacturer, 
importer, or distributor who has the required state, local, or Alcohol 
and Tobacco Tax and Trade Bureau (TTB)-issued license or permit, if 
applicable; and is not altered by the retailer in a way that is 
material to the requirements of Sec.  1143.5. Retailers must have the 
required warnings on advertisements as stated in Sec.  1143.5(b)(1).
    (Comment 107) Some comments stated that FDA has the authority to 
assert jurisdiction over all cigars and differentially apply 
regulations to certain cigars if shown to be appropriate based on 
scientific evidence. Thus, according to the comments, if it were 
established that premium cigar risk is of a different nature and degree 
than the

[[Page 29027]]

risks of other types of cigars based on who uses them and how they are 
used, the Agency could apply its authority in a way that fits the risks 
posed by the product. These comments concluded that because of this, it 
is unnecessary and would be inappropriate to completely exempt premium 
cigars.
    Similarly, some comments applied the notion of a ``continuum of 
risk'' to cigars. They stated that premium cigars are at the lower end 
of the spectrum (Ref. 76) due to the common usage patterns (i.e., 
described as most frequently used by adults, on special occasions, and 
users do not inhale). Therefore, they urged that FDA regulate premium 
cigars in line with the notion of a continuum of risk.
    (Response) FDA agrees that a continuum of nicotine-delivering 
products does exist as demonstrated by the lower levels of toxicants in 
ENDS in comparison to cigarettes, and may warrant different 
requirements for products at different ends of this continuum. However, 
commenters have not substantiated their claims that the patterns of use 
for premium cigars preclude users from negative health effects. 
Instead, as discussed throughout this section, cigar use poses a 
greater risk than not smoking, and lack of inhalation do not prevent 
the onset of cigar-related morbidity and mortality. Therefore, FDA has 
concluded that it is appropriate for all cigars to be brought under its 
regulatory authority.
    (Comment 108) Several comments stated that it would be 
inappropriate and inaccurate for FDA to treat ``cigars'' as a single 
homogenous category or to simply overlay the existing regulatory 
framework for cigarettes onto the diverse suite of deemed products. 
They further stated that because of the significant differences among 
cigar products, it is critical that FDA distinguish between the 
specific cigar subtypes in determining whether any, some, or all cigars 
should be subject to regulation. If FDA were to do otherwise, they 
believe the Agency would risk establishing an arbitrary and capricious, 
overly broad regulatory scheme that fails to meet its burden to protect 
the public health without imposing undue burden on the industry.
    (Response) FDA disagrees. Upon review of comments and scientific 
evidence, FDA has determined that all cigars present a risk to public 
health and, consequently, should be deemed.
    (Comment 109) A few comments discussed different regulatory 
approaches for make-your-own cigar products (e.g., cigar wrappers and 
cigar tobacco). At least one comment suggested treating these products 
as cigars while others urged regulation of them in a manner similar to 
cigarette papers and roll-your-own tobacco.
    (Response) With this final rule, make-your-own cigar products, 
including cigar wrappers and cigar tobacco, are tobacco products and 
subject to FDA's tobacco control authorities under chapter IX of the 
FD&C Act. Cigar wrappers containing tobacco or tobacco-derived nicotine 
and cigar tobacco packaged and sold individually are also subject to 
the warning requirement for ``covered tobacco products'' found in Sec.  
1143.3.
    (Comment 110) At least one comment stated that FDA should not 
permit manufacturers to self-classify their products as cigarettes or 
cigars, and if premium cigars are exempted, should not permit self-
classification of cigars as premium or nonpremium.
    (Response) Regardless of how they may be classified by their 
manufacturers, cigars and cigarettes will be classified based on the 
definitions included in this final rule.
    (Comment 111) A few comments argued that bias existed for any study 
or analysis cited in the NPRM that was written or contributed to by FDA 
employees. These comments were concerned that FDA employees generating 
and analyzing data did so to support the proposed regulation of cigars.
    (Response) FDA disagrees. FDA notes that most of the studies cited 
in the NPRM that were authored by FDA employees have been published in 
peer-reviewed journals. Where the NPRM discussed research results 
presented at a professional conference, SRNT, but not yet included in a 
peer-reviewed journal, FDA clearly stated so and specifically requested 
comment (79 FR at 23151). That research has since been published (Ref. 
90).
    (Comment 112) Some comments criticized the methodologies used by 
researchers in studies FDA cited in the NPRM (e.g., Ref. 59). For 
example, they claimed that the Delnevo, et al. study regarding youth 
use of flavored cigars (id.) was flawed, because the study cites any 
use of the brand by youth as use of the flavored variety of that cigar 
brand (even though the respondent might use an unflavored variety of 
that cigar). The comments had additional concerns regarding the study, 
such as missing data on cigar brand from 13 percent of cigar smokers, 
as well as concerns about whether study participants provided accurate 
information regarding cigar brand used, and whether the study 
population was representative of the U.S. population. Other comments 
stated that studies in peer-review journals are politically biased and 
that studies that oppose tobacco product regulation are often 
prohibited from publication.
    (Response) The Delnevo, et al. publication found that youth and 
young adults are significantly more likely than older adults to prefer 
cigar brands that are more likely to be flavored (Ref. 59). Because no 
national data directly compared youth and adult flavored cigar use 
within the same study, Delnevo and colleagues conducted an ecological 
analysis combining data from the 2010-2011 NSDUH on cigar brand smoked 
most often, with Nielsen data indicating the percent of the cigar 
brands' market share that are labeled as flavored cigar products. These 
results, coupled with information on the prevalence of flavored cigar 
use from studies restricted to youth or to young adults, provide 
additional indirect evidence of the popularity of flavored cigars among 
younger cigar smokers as compared to older adult cigar smokers. 
Especially when coupled with research results on the prevalence of 
flavored cigar use in studies restricted to youth or young adults, this 
study provides additional supporting evidence of the widespread appeal 
of flavored varieties of these products among young Americans. The 
comments noted that, in the 2010-11 NSDUH, 13 percent of cigar smokers 
did not report a usual cigar brand and expressed concern about the 
ability of those who reported their usual cigar brands to do so 
accurately. Some cigar smokers may in fact not actually have a cigar 
brand they smoke most often and consequently did not provide a brand 
response, while other respondents may have chosen not to provide their 
usual brand information. Among the latter group, missing data is always 
a concern, although there is no evidence from the study to suggest that 
those who provided brand information were systematically different than 
those who did not. Additionally, the comments did not provide evidence 
to substantiate the concern that respondents were not reporting the 
brand names they actually used. Lastly, FDA does not agree with 
concerns about representativeness of the survey. The NSDUH is designed 
to be representative of the U.S. civilian, non-institutionalized 
population, ages 12 and older (http://www.samhsa.gov/data/population-data-nsduh). FDA does not rely on any single study to support decisions 
included in this final rule. FDA cited many peer reviewed studies in 
the NPRM and relies upon many peer-reviewed studies to support the 
decisions included in this final rule, including the Delnevo 
publication.

[[Page 29028]]

VIII. Regulation of Electronic Nicotine Delivery Systems (Including E-
Cigarettes) and the Continuum of Nicotine-Delivering Products

    In the preamble to the NPRM, FDA noted that there are distinctions 
in the health risks presented by various nicotine-delivering products. 
FDA requested comment as to how e-cigarettes should be regulated based 
on this continuum of risk. We explained that some studies have revealed 
the existence of toxicants in both the e-cigarette liquid and the 
exhaled aerosol of some e-cigarettes but that we do not have sufficient 
data to determine what effects e-cigarettes have on public health at 
the population level. We also noted that some individuals report using 
e-cigarettes to successfully quit smoking, but we expressed concerns 
about dual use of e-cigarettes and combusted tobacco products and the 
possibility that flavored e-liquids are leading children to initiate 
tobacco use with e-cigarettes.
    In this final rule, FDA clarifies that although there are many 
types of ENDS (including e-cigarettes, e-cigars, e-hookah, vape pens, 
personal vaporizers, and electronic pipes), all are subject to FDA's 
chapter IX authorities with this final deeming rule. Comments regarding 
e-cigarettes, including comments on how the products should be 
regulated in light of this continuum, and FDA's responses are discussed 
in the following sections.

A. Terminology

    (Comment 113) Some comments expressed confusion as to what is 
encompassed by the term ``e-cigarette.'' Other comments stated that the 
``electronic smoking devices'' covered under this deeming rule should 
include e-cigarettes, e-cigars, e-hookah, and vape pens.
    (Response) FDA agrees that electronic nicotine delivery systems or 
ENDS are sold under several different names including e-cigarettes, e-
cigars, e-hookah, vape pens, personal vaporizers, and electronic pipes. 
These products all meet the definition of ``tobacco product'' and, 
therefore, under this rule, all are subject to FDA's tobacco control 
authorities, regardless of a novel name or heating source. In addition, 
the definition of tobacco product includes components and parts (the 
objects intended or reasonably expected to be used with or for the 
human consumption of a tobacco product that are not accessories) (e.g., 
e-liquids, tanks, cartridges, pods, wicks, atomizers), which, under 
this rule, have also been deemed to be subject to FDA's authority under 
chapter IX of the FD&C Act.

B. Prevalence

    In the NPRM, FDA expressed concern about the increase in prevalence 
of the newly deemed products, particularly the alarming rise in e-
cigarette use by middle school and high school students. The comments 
included peer-review studies, focus group results, and data regarding 
the prevalence of ENDS use.
    (Comment 114) Some comments noted that it was difficult to fully 
ascertain prevalence of use of these products because they are sold 
under many different names. However, they generally agreed that the 
prevalence of e-cigarette use has increased in recent years, citing 
peer-reviewed studies and data from state or regional surveys (e.g., 
Ref. 108). For example, comments cited the 2013 North Carolina Youth 
Tobacco Survey (NCYTS) and expressed concern that, while the current 
cigarette smoking rates among North Carolina high school students 
decreased in recent years, the overall current use of tobacco products 
increased from 22.5 percent in 2011 to 24.5 percent in 2013. In 
particular, the rate of e-cigarette use increased from 1.7 percent in 
2011 to 7.7 percent in 2013, and 2.7 percent of high school students 
who had never tried a cigarette indicated that they were considering 
using e-cigarettes in the next year.
    However, some of these comments believed that the data showing an 
increase in e-cigarette use among youth and young adults only reflects 
their experimentation (and not long-term use) and that there are no 
data showing that this experimentation leads to long-term use or dual 
use with combusted tobacco products. Others stated that although e-
cigarette use may be increasing among youth and young adults, this 
increase is due to the fact that young adult smokers are switching to 
e-cigarettes, as are adult smokers.
    (Response) FDA agrees with comments stating that the prevalence of 
use of the newly deemed tobacco products has been increasing, which 
further substantiates the need for this final rule. FDA remains 
concerned about the rise in use of newly deemed products by youth and 
young adults, particularly the increase in use of ENDS. As we stated in 
the NPRM and throughout this document, long-term studies are not yet 
available to determine whether these youth and young adults are only 
experimenting with tobacco use, becoming established ENDS users or dual 
users, or transitioning to combusted products. In addition, there is 
not sufficient evidence to conclude that youth and young adults are 
using ENDS as a means to quit smoking.
    (Comment 115) Many comments contended that the great majority of e-
cigarette users consist of former smokers and those trying to quit 
smoking, rather than those who are initiating tobacco use with e-
cigarettes (e.g., Ref. 109). The comments included data from regional 
surveys indicating that even where there has been a significant 
increase in youth and young adult e-cigarette use, the increase is seen 
in experimenters and not daily users. For example, a few comments 
referred to a report commissioned by Public Health England which 
referred to a study that found that only 1 percent of 16 to 18-year-old 
never smokers have experimented with e-cigarettes and few, if any, 
progress to sustained use (Ref. 110).
    (Response) Data reported by the CDC's National Center for Health 
Statistics (NCHS), which provides the first estimates of e-cigarette 
use among U.S. adults from a nationally representative household 
interview study, indicate that current cigarette smokers and recent 
former smokers (i.e., those individuals who quit smoking within the 
past year) were more likely to use e-cigarettes than long-term former 
smokers (i.e., those individuals who quit smoking more than one year 
ago) and adults who had never smoked (Ref. 24). In addition, the CDC 
states that current cigarette smokers who had tried to quit smoking in 
the past year were more likely to use e-cigarettes than those who had 
not tried to quit (id.). It is noted that it cannot be determined by 
the research findings: (1) Whether former cigarette smokers who now 
exclusively use e-cigarettes would have ceased smoking cigarettes 
regardless of e-cigarette use; and (2) whether the e-cigarette use 
preceded or followed smoking cessation. Similar patterns have been 
observed in Europe, where researchers found that ``e-cigarette use was 
more likely among smokers who had made a past year quit attempt'' when 
compared to smokers who had not (Ref. 111). As discussed in further 
detail in response to Comment 144, a meta-analysis of 15 cohort 
studies, 3 cross-sectional studies, and two clinical trials (one RCT, 
one non-RCT) found that cigarette smokers who also used e-cigarettes 
had statistically significantly worse quit rates than those cigarette 
smokers who did not use e-cigarettes (Ref. 112).
    However, FDA also remains concerned about the dramatic rise in ENDS 
use among youth; between 2011 and 2014, past 30 day e-cigarette use 
among high school students increased nearly 800 percent from 1.5 
percent in 2011 to 13.4 percent in 2014 (Ref. 22),

[[Page 29029]]

and between 2011 and 2013, the number of never-smoking youth who had 
reported ever using an e-cigarette increased 3-fold, from 79,000 to 
more than 263,000 youth (Ref. 113). The Surgeon General has stated that 
adolescents appear to be particularly vulnerable to the adverse effects 
of nicotine on the central nervous system (Ref. 9), and ENDS may 
deliver as much nicotine as other tobacco products (Ref. 114).
    FDA is investing in long-term, population-level research, such as 
the PATH Study, to help assess the likelihood that previous nonusers of 
tobacco who experiment with ENDS will initiate regular tobacco use over 
time. Such longitudinal studies can further assess the factors 
associated with potential smoking cessation among e-cigarette users.
    (Comment 116) The comments generally agreed that youth are 
increasingly using e-cigarettes, but disagreed as to the product's 
impact on nicotine addiction. As FDA noted in the proposal and as 
discussed by many comments, the CDC found that ever use of e-cigarettes 
by middle and high school students in the United States increased from 
3.3 percent in 2011 to 6.8 percent in 2012 (Ref. 108). While the 
majority of comments recognized an increase in dual use, some suggested 
that this was not an issue because youth are using e-cigarettes to quit 
smoking, resulting in some dual use until they can completely abstain 
from conventional cigarettes (Ref. 115).
    (Response) FDA remains concerned about the rise in ENDS use among 
youth and young adults as well as the trends in dual use of ENDS and 
combusted products in both youth and adults (Ref. 116). In addition, as 
stated in the NPRM and throughout this final rule, all tobacco products 
are potentially addictive and some ENDS may deliver as much nicotine as 
other tobacco products (Ref. 20). The Surgeon General has stated that 
adolescents appear to be particularly vulnerable to the adverse effects 
of nicotine on the central nervous system (Ref. 9). FDA believes that 
this final deeming rule, along with the minimum age restrictions and 
health warning requirements, is an important step toward combatting 
this rise in tobacco product use among youth and young adults.
    A recently published paper by Friedman (Ref. 42) looked at youth 
smoking rates in states that enacted early bans on sales of e-
cigarettes to minors and concluded, based on state-level data available 
through 2013, that the decline in adolescent smoking rates slowed in 
states that enacted restrictions on access to ENDS by minors before 
January 2013, relative to states that did not. Given the various issues 
with this study (see previous discussion regarding this publication in 
response to comment 33), FDA acknowledges this paper as a first attempt 
to study potential impacts of youth ENDS access restrictions, but 
emphasizes that further research will be needed to explore the effects 
of this rule on product switching and dual usage.

C. Toxicity and Nicotine in E-Liquid and Aerosol

    Although FDA noted in the NPRM that we do not currently have 
sufficient data about e-cigarettes and similar products to fully 
determine what effects they have on the public health, we identified 
concerns regarding the toxicants in e-liquid and the exhaled aerosol 
and the nicotine delivery from e-cigarettes. Comments were divided on 
the safety and toxicity of e-liquids, e-cigarettes, and the exhaled 
aerosol.
    (Comment 117) The comments expressed concerns that e-cigarette 
users subject themselves to dangerous constituents, including 
formaldehyde and other toxicants. One comment stated that the release 
of formaldehyde occurs only when the voltage on e-cigarettes is set to 
4.8 volts or higher (Ref. 67). Some comments also submitted studies 
showing the existence of other e-liquid constituents, including 
prescription weight loss and erectile dysfunction drugs (Ref. 117).
    (Response) Studies show that e-liquid tobacco products contain 
nicotine, propylene glycol, glycerin, tobacco specific nitrosamines, 
tobacco alkaloids, carbonyls, ethylene glycol, diacetyl, and acetyl 
propionyl (Refs. 19, 118, 119). Chemicals such as nicotine, carbonyls, 
tobacco specific nitrosamines, heavy metals, and volatile organic 
compounds have been identified in e-cigarette aerosols (Refs. 19, 118, 
119, 120, 121, 122).
    In addition, several studies substantiated the data included with 
comments, finding that flavored e-liquids contain chemicals that could 
be dangerous to consumers when inhaled. For example, researchers in one 
study tested 159 e-liquids with sweet flavors, such as toffee, 
chocolate, and caramel, and found that almost three quarters of the 
samples (74 percent) contained diacetyl or acetyl propionyl (Ref. 123), 
both of which pose known inhalation risks (e.g., Ref. 124). Among those 
that tested positive, nearly half of the e-liquids in the study could 
expose users to levels that exceed recommended workplace limits for 
breathing these chemicals (Ref. 123). An additional recent study 
analyzed 51 types of flavored e-cigarettes for total mass of diacetyl, 
2,3-pentanedione, and acetoin (Ref. 125). Researchers detected diacetyl 
above the laboratory limit of detection 39 of the 51 flavors tested, 
ranging from limit of qualification (LOQ) to 239 [mu]g/e-cigarette. 
2,3-pentanedione and acetoin were also detected in 23 and 46 of the 51 
flavors tested at concentrations up to 64 and 529 [mu]g/e-cigarette 
(id.). It is noted that the study involved a convenience sample of 51 
types of flavored e-cigarettes and may not be representative of the 
types of e-liquids currently available to users. Absent a regulatory 
standard, FDA acknowledges that it may not be possible to account for 
the wide variability of concentrations of constituents in the flavors 
of current ENDS products. Another study analyzed 30 e-cigarette liquids 
and found that many flavors, including cotton candy and bubble gum, 
contained aldehydes, a class of chemicals that can cause respiratory 
irritation, airway constriction, and other effects (Ref. 126). 
Specifically, researchers noted that two flavors, a dark chocolate and 
a wild cherry, would expose e-cigarette users to more than twice the 
recommended workplace safety limit for the aldehydes vanillin and 
benzaldehyde (id.). Similarly, researchers found that several cinnamon-
flavored e-liquids contained a chemical, cinnamaldehyde, which 
researchers stated was highly toxic to human cells in laboratory tests 
(Ref. 127).
    Some studies have found that lower levels of toxicants are observed 
in e-cigarette aerosols than in combusted tobacco smoke (Ref. 122). FDA 
recognizes that specific product design parameters, such as voltage, 
can affect toxicant deliveries (Ref. 67). For example, some ENDS 
devices and some power levels of operating ENDS devices have been 
reported to deliver more formaldehyde than other ENDS products and 
conventional cigarettes (Refs. 67, 128, 129) and can affect the public 
health. In addition, a 2010 study conducted by the Virginia 
Commonwealth University determined that in a controlled evaluation of 
smokers na[iuml]ve to the use of e-cigarettes and using a particular 
model of e-cigarette, acute effects of using the product did not result 
in measurable levels of nicotine or carbon monoxide, although e-
cigarettes did suppress nicotine/tobacco abstinence symptom ratings 
(Ref. 130). Moreover, a recent evaluation of the relative health risks 
of ENDS products conducted by Public Health England has drawn attention 
to scientific reviews concluding that ENDS

[[Page 29030]]

are ``likely to be much less, if at all, harmful to users or 
bystanders'' and a prior paper that reported the findings from an 
international expert panel of academics. Employing an analysis model 
that quantifies the relative health harms of 12 tobacco products using 
a series of 14 harm criteria, the expert panel determined that while 
cigarettes scored 100 percent in their assessment of maximum relative 
harm, ENDS products were rated to have only 4 percent maximum relative 
harm, which contributed to Public Health England's assessment that ENDS 
are around 95 percent safer than smoking combusted cigarettes (Ref. 
131; see Refs. 76, 132).
    The recent evaluation's use of the prior paper has several 
limitations, and the prior paper itself observed that it was reporting 
outcomes based on the decision-conferencing process from a group of 
experts who were selected without any ``formal criterion,'' though 
``care was taken to have raters from many different disciplines'' and 
primarily based on geographic location ``to ensure a diversity of 
expertise and perspective'' (Ref. 76). In addition, the authors 
acknowledge that there is a ``lack of hard evidence for the harms of 
most products on most of the criteria'' (Refs. 76, 133, 134). The 
authors did not explain what scientific information was available to 
the experts upon which they should base their ratings. The authors did 
not explain the derivation of the quantitative assessment of each harm 
criterion. It is unclear if the authors carried out or referenced a 
quantitative risk analysis, a standard practice when assessing relative 
risk, nor did the authors indicate that they used mean levels of 
exposure to HPHCs in users or other quantitative evidence as an 
approximation of risk. In addition, population effects appear to be 
largely outside the scope of this analysis since the manuscript did not 
address the likelihood that the characteristics of the products would 
make them more or less likely to appeal to new users, be used in 
conjunction with other tobacco products or discourage quitting. They 
did not describe an assessment of population effects such as a 
quantitative assessment of youth use prevalence. FDA does not find the 
beliefs reported in the prior paper (Ref. 76) to be sufficiently 
conclusive on the relative risks of using different tobacco 
products.\14\ However, previous studies detected the presence of 
aldehydes, especially formaldehyde, in the vapor from some ENDS to 
exist at levels much lower than in cigarette smoke (Ref. 132). 
Moreover, across several Japanese brands evaluated by another 
researcher in a self-published Web site, under some use conditions, 
ENDS released 1/50th of the level of formaldehyde released by 
cigarettes (Ref. 135). The highest level detected was six times lower 
than the level in cigarette smoke (id.). A clinical investigation 
comparing the levels of toxicants and carcinogen metabolites in the 
urine of e-cigarette users and combusted cigarette users found that e-
cigarette users had significantly lower levels of all evaluated 
toxicants, which included acrolein and crotonaldehyde (Ref. 136). But 
other research, published as a letter to the editor of the New England 
Journal of Medicine, reported that ENDS devices operated at 5 volts 
delivered a mean of 390+/-90 [mu]g per 10 puff sample which is greater 
than 150 [mu]g, the estimated average delivery of formaldehyde than 
conventional cigarettes. No formaldehyde-releasing agents were detected 
when ENDS were operated at 3.3 volts (Ref. 128). A subsequent peer-
reviewed article on 5 variable-power ENDS devices found large 
variations in formaldehyde delivery across devices (Ref. 129). The 
first device yielded more formaldehyde than combustible cigarettes at 
every power level tested, and the second device delivered more 
formaldehyde at the highest power level tested; the remaining three 
devices delivered less formaldehyde than combustible cigarettes at all 
power levels tested (id.) The same research found that aldehyde 
delivery varied by 750-fold from one ENDS device to another (id.). The 
article referenced in one comment (Ref. 67) reported that increasing 
the voltage from 3.2 to 4.8 volts increased formaldehyde, acetaldehyde, 
and acetone levels from 4-fold to over 200-fold.
---------------------------------------------------------------------------

    \14\ In addition, at least one source has identified other flaws 
with the expert panel employed in the Nutt et al. report, including 
potential conflicts of interest and no prespecified expertise on 
tobacco control among the panel members (Ref. 133).
---------------------------------------------------------------------------

    (Comment 118) The comments in support of limited or no regulation 
for e-cigarettes cited studies showing that e-cigarette use resulted in 
improvements in many health indicators of former cigarette smokers. 
Most of these comments relied upon published literature concluding 
that, despite the lack of long-term health data, e-cigarettes are 
``likely to be much less, if at all, harmful to users and bystanders'' 
(Ref. 132). They also noted that clinical studies to date indicate that 
e-cigarettes generally are well-tolerated and do not produce serious 
adverse events following use for up to 24 months (Refs. 107, 137). Many 
relied upon an analysis of the 47 e-cigarette adverse event reports FDA 
received from 2007 to 2012, which found that only 8 of them were 
considered serious (e.g., pneumonia, congestive heart failure, 
disorientation, seizure, hypotension, facial burns, chest pain and 
rapid heartbeat, infant choking on an e-cigarette cartridge, loss of 
vision) (Ref. 138).
    Some comments also stated that e-cigarettes provide subjective 
health benefits to current smokers. For example, in one Internet survey 
of 1,347 current e-cigarette users, among those who were former 
smokers, 75 percent reported improved breathing, less coughing, and 
feeling healthier overall after switching to e-cigarettes (Ref. 139). 
They also claimed that e-cigarette use leads to improved sense of smell 
and taste and general physical status (Ref. 109). In addition, they 
stated that some of the harms caused by smoking can be reversed by 
switching to e-cigarettes (Ref. 140).
    (Response) FDA agrees that the majority of reported adverse events 
appear to have been not serious. The FDA adverse event reporting system 
has inherent limitations as a measure of the impact of e-cigarettes 
since ENDS are a newly deemed product and reporting adverse events 
associated with tobacco products (including e-cigarettes and other 
ENDS) is voluntary; therefore, the reports received may have 
underrepresented the true number and types of adverse events associated 
with ENDS. The data cannot be used to calculate incidence (occurrence) 
rates or to estimate risk. Moreover, FDA has concerns with relying upon 
the types of short-term studies provided in the comments. Short-term 
studies fail to analyze the exposure risk of tobacco use and inhalation 
that damage health over a lifetime of repeated, extended exposure. 
Given the relatively new entrance of ENDS on the market, consumers have 
not had the duration of use for researchers to fully assess the 
morbidity and mortality effects for ENDS on either the individual or 
the population.
    FDA recognizes that completely switching from combusted cigarettes 
to ENDS may reduce the risk of tobacco-related disease for individuals 
currently using combusted tobacco products, given the products' 
comparative placements on the continuum of nicotine-delivering 
products. A recent review from Public Health England (discussed in 
greater detail in response to Comment 117) suggests substantial 
reductions in the exposure to harmful constituents typically associated 
with smoking in ENDS products compared to cigarettes, and that most of 
the chemicals causing smoking-related

[[Page 29031]]

disease from combusted tobacco use are absent and the chemicals that 
are present pose limited danger (Ref. 131). A scientific review of 
published studies of the toxicity of certain e-liquids found that ``[e-
cigarette] aerosol can contain some of the toxicants present in tobacco 
smoke, but at levels which are much lower. Long-term health effects of 
[e-cigarette] use are unknown but compared with cigarettes, [e-
cigarettes] are likely to be much less, if at all, harmful to users or 
bystanders'' (Ref. 132). ENDS products have been found in some studies 
to release aldehydes at much lower levels than that in cigarette smoke, 
with one Web site posting stating that, across several Japanese brands, 
under some use conditions, that ENDS products release 1/50th the level 
of formaldehyde released in cigarettes (Ref. 133).
    However, study results have been inconsistent about the effects of 
these products. Some short-term studies suggest that ENDs may not 
affect heart rate, cardiac function, lung function, or complete blood 
count indices to the extent of conventional cigarettes (Refs. 130, 141, 
142). A literature search, however, concluded that the current 
scientific evidence on short-term effects are limited and there are no 
adequate data on long-term health effects (Ref. 143). Other studies 
have demonstrated increase in mean heart rate and inflammatory measures 
(such as white blood cells) and changes in lung function after use 
(Refs. 141, 142, 144, 145). Some research has found that there are some 
ENDS devices and some power levels of operating ENDS devices that 
deliver more formaldehyde than other ENDS products and conventional 
cigarettes (Refs. 67, 128, 129). Further, the review by Hajek et al. 
(Ref. 132) referred to in this comment as showing health benefits and 
finding a lack of negative health effects of e-cigarettes, may have 
limited generalizability due to the variability of e-cigarette 
products. The authors expressly recognized that there are many 
deficiencies in the available data.
    (Comment 119) Some comments believed that FDA should not be 
concerned about e-liquids because they are restricted to the same 
nicotine levels as other products (e.g., cigarettes, hookah, smokeless 
tobacco, NRTs).
    (Response) FDA disagrees with comments stating that the Agency 
should not be concerned with ENDS use. First, a direct comparison of 
the nicotine level in cigarettes (and other currently regulated tobacco 
products) with the nicotine level in e-liquids is not a particularly 
helpful or relevant comparison. More helpful and clinically meaningful 
is the comparison between the amount of nicotine delivered to the user 
after using a cigarette (or other conventional tobacco product) versus 
the amount of nicotine delivered after using an ENDS (Ref. 146). 
Therefore, even if an e-liquid has the same nicotine level, it may 
deliver a different level of nicotine than the comparator product. It 
is also possible that comparable nicotine delivery consistently 
produced by ENDS that meet the requirements of the Tobacco Control Act 
may increase the facilitation of product switching from cigarettes to 
ENDS--which could (with appropriate regulatory oversight) potentially 
reduce the overall health harm caused by combusted tobacco. Further 
research is necessary to determine the causal factors that influence 
product switching from cigarettes to ENDS (or vice versa) and the 
subsequent health impacts.
    Second, FDA disagrees with the notion that e-liquids are restricted 
to the same level of nicotine as other tobacco products. E-liquids are 
available in a wide range of nicotine concentrations, but delivery to 
the user is based on multiple factors, including the humectant in the 
e-liquid, the temperature to which the e-liquid is heated, the user 
experience, device designs, and design modifications (Ref. 147). Data 
suggest that experienced ENDS users are able to achieve clinically 
significant nicotine levels and levels similar to those generated by 
traditional cigarettes (Refs. 114, 148, 149, 150). Moreover, heating 
the e-liquids to higher temperatures and using the ENDS in ways other 
than intended (e.g., dripping the e-liquid directly onto the atomizer) 
may result in nicotine delivery that is actually higher than that of a 
conventional cigarette (Ref. 16).
    Third, FDA disagrees with the premise that the Agency should not be 
concerned with tobacco products that may have lower nicotine levels 
than cigarettes or other tobacco products, as may be the case with some 
ENDS. Even if ENDS products have lower levels of nicotine, they still 
have the potential to addict users, particularly youth and young 
adults, as discussed in section VIII.C. As the Surgeon General has 
stated, nicotine is the primary addictive substance in tobacco products 
(Ref. 9). Regardless of the nicotine content of the tobacco products, 
FDA believes that deeming tobacco products will result in significant 
public health benefits and that the additional restrictions imposed by 
this rule are appropriate for the protection of the public health.
    (Comment 120) One comment expressed concern about the lack of 
research regarding the environmental impacts of e-cigarette use and 
storage.
    (Response) FDA is funding studies regarding environmental impacts 
due to ENDS manufacturing, use, and disposal following use. In 
addition, FDA has been conducting a series of public workshops to 
obtain information on e-cigarettes and their impact on public health. 
Potential environmental impacts were discussed during the first 
workshop (79 FR 55815, September 17, 2014).
    (Comment 121) Some comments expressed concern about the health 
effects of propylene glycol exposure from e-cigarette use. They also 
stated that the use of glycerol and propylene glycol, both of which are 
humectants, may cause uninformed users to become inadvertently 
dehydrated.
    (Response) FDA recognizes that information about the health effects 
of the constituents in e-liquids and ENDS aerosols in both users and 
nonusers is limited and that this issue should be explored to better 
understand the impacts of these products on the population health.
    (Comment 122) As FDA noted in the NPRM, one study detected 
diethylene glycol in one e-cigarette cartridge (79 FR 23142 at 23157). 
A few comments took issue with FDA's reliance on the study, because the 
amount of diethylene glycol reported was so low that it was unlikely to 
cause harm to consumers and had not been replicated in other scientific 
studies to date.
    (Response) FDA appropriately characterized this study in the NPRM, 
stating that diethylene glycol ``was found in only 1 of 18 cartridges 
studied and it was not found at all in another 16 studies'' (79 FR 
23142 at 23157). FDA agrees that the amount found was low, but 
reiterates that diethylene glycol is a toxicant and, therefore, is a 
cause for concern.
    (Comment 123) We received many comments regarding the safety of the 
aerosol that is emitted from e-cigarettes. These comments expressed 
concern that individuals incorrectly believe that the aerosol emitted 
from e-cigarettes is harmless and stated that e-cigarette aerosol is 
not simply water ``vapor,'' as is sometimes advertised (Ref. 151). They 
provided studies indicating that the primary or mainstream and exhaled 
or secondhand e-cigarette aerosols have been found to contain at least 
10 chemicals known to cause cancer, birth defects, or other 
reproductive harm (Ref. 65). They also noted that potentially harmful 
constituents have been identified in some e-liquids and their aerosol, 
including tobacco-specific nitrosamines, heavy metals, and

[[Page 29032]]

carbonyls, albeit at significantly lower levels than in cigarette smoke 
(Refs. 65, 118, 152, 153, 154, 155, 156). Studies have shown that the 
primary aerosol contains measurable amounts of nicotine, which can have 
an impact on both users and nonusers (Ref. 144, 147).
    We also received comments stating that the aerosol is completely 
harmless or significantly less harmful than tobacco smoke from 
combusted tobacco products; the comments included data from peer-
reviewed publications (Refs. 144, 156, 157, 158), a presentation at a 
professional conference (Ref. 159), and individual company testing. 
These comments also submitted research that was not peer-reviewed, 
which stated that there were no key tobacco smoke toxicants in e-
cigarettes (Ref. 160).
    (Response) FDA recognizes that the aerosol that is exhaled by users 
of some e-cigarettes and similar electronic apparatus may not pose as 
much harm as smoke emitted from combusted tobacco products. However, 
given that studies do indicate that both nicotine and other toxicants 
are found in the exhaled aerosol, limiting exposures must be 
considered. (See section XII regarding the potential for product 
standards and tobacco product manufacturing practices on manufacturers 
of newly deemed products.) In the absence of short- and long-term 
studies on the potential impact of secondary exposure to aerosol, FDA 
cannot conclude that the aerosol is harmless. Moreover, as stated 
throughout this document, the Tobacco Control Act does not require that 
FDA make a finding that a product is harmful in order to deem it to be 
subject to chapter IX of the FD&C Act; FDA is authorized to deem any 
product that meets the definition of a ``tobacco product'' pursuant to 
section 901 of the FD&C Act.
    (Comment 124) A few comments stated that the aerosol must be safe 
because the primary constituents of the liquid that generate the e-
cigarette aerosol are propylene glycol and glycerin. They stated that 
inhalation of such constituents is harmless because they are designated 
as ``generally recognized as safe'' (GRAS) by FDA. They cited animal 
inhalation studies showing limited toxicological effects from either 
propylene glycol or glycerin (e.g., Ref. 161).
    (Response) FDA disagrees with comments claiming that the aerosol is 
safe due to certain components being recognized as GRAS. It is 
important to note that the definition of food additive in section 
201(s), and its exclusion of GRAS substances, relates to intended uses 
that may reasonably be expected to result, directly or indirectly, in 
its becoming a component or otherwise affecting the characteristics of 
any food (section 201(s) of the FD&C Act). E-liquid is not food or 
intended for ingestion; therefore, the fact that propylene glycol and 
glycerin have been designated GRAS for food does not necessarily mean 
that these components are safe for inhalation. (See additional 
responses in this section of the document regarding FDA's concerns with 
ENDS aerosol.)
    (Comment 125) Several comments that stated that e-cigarettes are 
harmless cited one study in which the author concluded that there ``is 
no serious concern about the contaminants such as volatile organic 
compounds'' in the e-cigarette ``vapor'' and that tobacco-specific 
nitrosamine (TSNA) levels in the ``vapor'' are just as hazardous as 
those TSNAs in NRT products (Ref. 162). Some of these comments 
specifically asked why FDA did not include this study in the proposed 
deeming rule.
    (Response) FDA has considered these findings and agrees that the 
exhaled aerosol from ENDS users is potentially less hazardous than 
secondhand smoke from combusted cigarettes. However, FDA disagrees with 
the author's conclusion that exposure to aerosol (``vapor'') ``pose[s] 
no apparent concern'' (Ref. 162). FDA recognizes that the aerosol that 
is exhaled by users of some e-cigarettes and similar electronic 
apparatus may not pose as much harm as smoke emitted from combusted 
tobacco products. However, given that studies do indicate that both 
nicotine and other toxicants are found in the exhaled aerosol, limiting 
exposures must be considered. FDA has repeatedly noted the potential 
benefits and need for additional information regarding ENDS and, 
therefore, the research included in the NPRM accurately summarized the 
state of the research on e-cigarettes (and the other newly deemed 
products) at the time it was drafted.
    (Comment 126) A few comments claimed that there are many e-liquids 
on the market that do not contain nicotine and, therefore, e-liquids 
should not be regulated. Other comments provided studies that showed 
that e-cigarettes deliver nicotine but noted that delivery is dependent 
on the e-cigarette apparatus and liquid type, the rate at which the 
nicotine is delivered, and the user's experience with e-cigarette use 
(Ref. 130).
    (Response) FDA is aware that, although some ENDS and e-liquids are 
marketed as nicotine free, as stated in section VIII.D, studies have 
found that certain types of ENDS do not have consistent quality and the 
labels may not accurately reflect the amount of nicotine in the e-
liquid. The World Health Organization (WHO) also has noted that the 
level of nicotine delivered in currently marketed ENDS varies widely 
depending on product characteristics, user puffing behavior and 
nicotine solution concentration, leaving smokers unaware of the 
nicotine levels they are receiving (Ref. 163). In addition, FDA agrees 
that many factors influence the delivery of nicotine. For example, an 
experienced ENDS user may be exposed to amounts of nicotine similar to 
those delivered by cigarette smoking (Ref. 114). Also, as stated 
earlier, nicotine-free e-liquid that is intended or reasonably expected 
to be used with or for the human consumption of tobacco products in 
most cases would be a component or part of a tobacco product and, 
therefore, within the scope of this rule. These products will be 
evaluated on a case-by-case basis.
    (Comment 127) Many comments discussed the possibility of nicotine 
poisoning due to improper access to, or use of, e-liquids. Most of 
these comments expressed concerns about the growing number of calls to 
poison control centers due to accidental nicotine poisoning. Others 
believed this concern was overstated and noted that many drugs can 
cause poisoning if stored improperly. They stated that the addition of 
child-resistant containers would alleviate this concern. Some also 
noted that e-cigarette users self-titrate the nicotine dosage, so 
concerns about overdosing should be minimal (Ref. 84).
    (Response) FDA is concerned about the risk of nicotine poisoning in 
both users and nonusers. The CDC has reported more than 2,400 calls to 
U.S. poison control centers for e-liquid exposure between September 
2010 and February 2014 (Ref. 164). In another study of 1,700 e-liquid 
exposures reported to U.S. poison control centers from June 2010 
through September 2013, children 5 years of age or younger represented 
the largest proportion of e-liquid exposures and the group with the 
greatest increase in exposures per month in the first three quarters of 
2013 (Ref. 165). Studies show that nicotine in sufficient 
concentrations, either when ingested or in contact with the skin, can 
result in serious or fatal poisoning and is concerning (Refs. 166, 
167). Symptoms of toxicity include nausea, vomiting, seizures, coma, 
cardiovascular instability, respiratory arrest, and sometimes death. 
Although there was disagreement among the comments as to the level of 
nicotine that causes

[[Page 29033]]

poisoning, the nicotine content of many refillable vials could be toxic 
to adults and children regardless of the measurement used. Accordingly, 
elsewhere in this issue of the Federal Register, FDA has made available 
draft guidance, which when final will describe FDA's current thinking 
regarding some appropriate means of addressing the premarket 
authorization requirements for newly deemed ENDS products, including 
recommendations for exposure warnings and child-resistant packaging 
that would help support a showing that the marketing of a product is 
appropriate for the protection of the public health. In addition, FDA 
issued an ANPRM prior to this deeming rule, seeking comments, data, 
research, or other information that may inform regulatory actions FDA 
might take with respect to nicotine exposure warnings and child-
resistant packaging.
    (Comment 128) Some comments compared the poison risks of nicotine 
against other household products, noting that the incidence of nicotine 
poisoning is significantly lower than for other household products 
(Ref. 168).
    (Response) Regardless of the incidence of nicotine poisoning in 
comparison to poisonings attributed to other household products, the 
dramatic rise in nicotine poisoning from e-liquid exposures is very 
concerning. FDA is taking under advisement the submitted data regarding 
nicotine poisoning and suggestions for measures that FDA can take in a 
separate rulemaking to address the issue, including establishment of 
tobacco product manufacturing practice regulations under section 906(e) 
and tobacco product standards under section 907 of the FD&C Act. In 
addition, as stated previously, FDA issued an ANPRM prior to this 
deeming rule seeking comments, data, research, or other information 
that may inform regulatory actions FDA might take with respect to 
nicotine exposure warnings and child-resistant packaging. Moreover, 
elsewhere in this issue of the Federal Register, FDA has made available 
draft guidance, which when final will describe FDA's current thinking 
regarding some appropriate means of addressing the premarket 
authorization requirements for newly deemed ENDS products, including 
recommendations for exposure warnings and child-resistant packaging 
that would help support a showing that the marketing of a product is 
appropriate for the protection of public health.
    (Comment 129) Comments were divided as to whether nicotine is 
dangerous to humans. Some comments stated that liquid nicotine is 
completely benign (and that FDA should not regulate e-cigarettes given 
the lack of harms). They claimed that FDA's findings regarding NRTs 
illustrate that nicotine is not carcinogenic to humans. (See 
``Modifications To Labeling of Nicotine Replacement Therapy Products 
for Over-the-Counter Human Use,'' 78 FR 19718, April 2, 2013.) Other 
comments stated that although nicotine has some side effects, it is 
significantly less hazardous than the toxicants ingested with combusted 
products. Still others claimed that nicotine is very dangerous.
    Comments that claimed that nicotine is dangerous cited studies 
showing that although nicotine may not be a primary carcinogen, it 
likely promotes cancers established through angiogenic (promoting of 
blood vessels in tumors) effects (e.g., Ref. 169). The comments also 
noted that the 2014 Surgeon General's Report stated that the health 
risks of nicotine are more serious than previously thought and that FDA 
should consider this when evaluating the impacts of the newly deemed 
products on vulnerable populations. Others believed that nicotine is so 
dangerous that individuals should be required to obtain a certification 
before being permitted to acquire and handle it.
    (Response) In the proposed deeming rule, FDA recognized the impact 
of nicotine on a youth's brain (see 79 FR 23142 at 23153 and 23154) and 
also noted poisoning concerns. The inhalation of nicotine (i.e., 
nicotine without the production of combustion) is of less risk to a 
user than the inhalation of nicotine delivered by smoke from combusted 
tobacco products. However, limited data suggests that the 
pharmacokinetic properties of inhaled nicotine can be similar to 
nicotine delivered by combusted tobacco products. Thus, inhaled 
nicotine from a non-combustible product may be as addictive as inhaled 
nicotine delivered by combusted tobacco products. Researchers recognize 
that the effects from nicotine exposure by inhalation are likely not 
responsible for the high prevalence of tobacco-related death and 
disease in this country (Refs. 10, 11). Although nicotine has not been 
shown to cause the chronic disease associated with tobacco use, the 
2014 Surgeon General's Report noted that there are risks associated 
with nicotine (Ref. 9 at 111). For example, nicotine at high enough 
doses has acute toxicity (id.). Nicotine exposure during fetal 
development has lasting adverse consequences for brain development 
(id.). Nicotine also adversely affects maternal and fetal health during 
pregnancy, contributing to multiple adverse outcomes such as preterm 
delivery and stillbirth (id.). Further, data suggest that nicotine 
exposure during adolescence may have lasting adverse consequences for 
brain development (id.). Some studies also have found that nicotine can 
have detrimental effects on the cardiovascular system and potentially 
disrupt the central nervous system (Refs. 14, 15). See also section 
VIII.C discussing the increase in poisoning due to accidental nicotine 
ingestion.
    FDA is not stating that nicotine is harmless. Unlike ENDS, which 
have not been reviewed by FDA, the NRT products mentioned in the 
comments are regulated and have undergone premarket review by FDA's 
Center for Drug Evaluation and Research (CDER) and been found to be 
safe and effective before obtaining authorization to enter the market 
(sections 505 and 506 of the FD&C Act). The Agency does not have 
sufficient data to be able to conclude that consumers are inhaling only 
nicotine, and no other chemicals or toxicants, when using ENDS. 
Although ENDS likely do not deliver the same level of toxicants as 
cigarettes, studies show that there are dangers associated with ENDS 
use and that exhaled aerosol is not simply ``water vapor,'' as some 
believe. (See section VIII.C for additional discussion about the 
toxicants in ENDS vapor.)
    (Comment 130) At least one comment suggested that to help address 
the dangers of nicotine and its use in future tobacco products, 
manufacturers registering future products with FDA should provide 
documents demonstrating the accuracy of stated nicotine levels and that 
the products are diacetyl and acetyl propionyl free.
    (Response) FDA agrees with the need to carefully monitor future 
tobacco products and to evaluate the toxicological concern of chemical 
ingredients, such as diacetyl and acetyl propionyl, in e-liquids and 
that statements about the nicotine concentration in the e-liquid as 
well as the amount of nicotine that will be delivered to the user are 
accurate. FDA's review of SE reports and PMTAs under sections 905 and 
910 of the FD&C Act will often include analysis of the chemicals 
included in the products. In addition, the requirements to submit 
ingredient listings under section 904 and HPHC testing data under 
sections 904 and 915 are expected to alert FDA to the existence of 
these HPHCs in e-liquids.
    (Comment 131) Many comments expressed concerns regarding the high

[[Page 29034]]

cost associated with testing for HPHCs in each individual e-liquid and 
e-cigarette product. They suggested that FDA use enforcement 
discretion, as the Agency has done previously, to reduce the regulatory 
burden for e-cigarette manufacturers. For example, they noted that FDA 
has compliance policies for the submission of SE reports for certain 
product modifications and HPHC reporting. To reduce the regulatory 
burden, they suggested that FDA not require ingredient disclosure of 
all unique e-liquid products under section 904(a)(1) of the FD&C Act 
because such a requirement is unreasonable given the many different e-
liquid formulations in these retail establishments. They stated that in 
lieu of ingredient listings, FDA should accept a table of all 
ingredients used in e-liquids along with use-level (concentration) 
ranges (i.e., minimum and maximum percentages) of those ingredients in 
their products. These comments further suggested that FDA allow 
companies to simply amend their ingredients lists when altering 
products rather than requiring them to submit PMTAs.
    (Response) Once this rule becomes effective, newly deemed products 
automatically become subject to chapter IX and all of its provisions 
applicable to tobacco products, without exception. Therefore, all 
manufacturers and importers of the newly deemed products will be 
subject to the requirements under sections 910, 905, and 904 of the 
FD&C Act upon the effective date of this final rule.
    However, FDA has established a compliance policy for certain 
circumstances. See section IV.D describing the compliance policy 
regarding certain provisions and small-scale tobacco product 
manufacturers.

D. Quality Control

    In the NPRM, FDA recognized previous instances of lack of quality 
control for certain e-cigarette products (79 FR 23142 at 23149). FDA 
indicated that the premarket review requirements that will 
automatically apply to the newly deemed products can help to address 
quality control concerns.
    (Comment 132) Many comments expressed concern regarding the lack of 
controls in place for the mixing of e-liquids. They stated that these 
liquids are often mixed by individual consumers or employees of e-
cigarette retail establishments who may lack training or knowledge of 
guidelines for handling such products. Several retailers of e-liquids 
submitted comments stating that they have controls in place to ensure 
the safety of their e-liquids.
    (Response) FDA understands the comments' concerns about the safety 
of e-liquids. As stated previously, FDA issued an ANPRM prior to this 
deeming rule seeking comments, data, research, or other information 
that may inform regulatory actions FDA might take with respect to 
nicotine exposure warnings and child-resistant packaging. Also, 
elsewhere in this issue of the Federal Register, FDA is announcing the 
availability of a draft guidance, which when finalized will provide 
FDA's current thinking regarding some appropriate means of addressing 
the premarket authorization requirements for newly deemed ENDS 
products, including recommendations for exposure warnings and child-
resistant packaging that would help support a showing that the 
marketing of a product is appropriate for the protection of public 
health. FDA also intends to consider these and other issues during its 
premarket review of these products. Further, after the effective date 
of this rule, FDA can exercise its authorities under the Tobacco 
Control Act to take additional steps to address the safety of e-
liquids.
    (Comment 133) Some comments included data regarding the variations 
among the nicotine levels in e-liquids, including data showing that the 
nicotine levels of the products are not accurately reflected in the 
nicotine concentration stated on the labels. For example, one study 
found nicotine content labels to be highly inaccurate and determined 
that products claiming to be nicotine-free actually contained high 
levels of nicotine (Ref. 170). Other comments stated that the 
variations are no longer as significant among the newer e-cigarette 
products, and that newer studies reported more consistent nicotine 
levels (Ref. 171).
    Many comments cited several studies of newer e-cigarettes which 
continued to find wide variability in e-cigarette engineering, 
including nicotine concentrations in e-liquid, that were inconsistent 
with the information contained on the product label (Ref. 16). For 
example, one 2014 study of e-liquid refills found that the actual 
nicotine level of 65 percent of the e-liquids deviated by more than 10 
percent from the nicotine concentrations printed on the labels (Ref. 
17). Other studies found variability among nicotine concentrations, but 
the nicotine levels were equivalent to or lower than advertised (Refs. 
18, 19). In one study, researchers stated that the total amount of 
nicotine in the e-liquid studied was potentially lethal if an 
individual were to drink it or absorb it through the skin (Ref. 18). 
They based this finding on the lethal level of nicotine being in the 10 
to 60 milligram (mg) range; however, other comments claimed the lethal 
dose of nicotine is actually much greater (Ref. 172).
    Some comments expressed concern that this rule does not address the 
possibility of a dangerous contamination of a batch of e-liquid because 
it does not include quality control measures or product standards that 
could prevent such contamination. They believed that FDA's authority to 
establish tobacco product manufacturing requirements or product 
standards in the future was insufficient to address this concern.
    (Response) FDA is aware of the variability of nicotine among 
certain ENDS and that the labeling may not accurately reflect the 
nicotine levels. After this rule becomes effective, FDA has the 
authority to issue tobacco product manufacturing practice regulations 
under section 906(e) of the FD&C Act to address this issue. The PMTA 
process (particularly, the requirement to submit information on 
manufacturing methods) also provides a mechanism through which products 
that are more harmful or addictive than products on the market at the 
time of submission would be denied entrance to the market. Moreover, 
immediately upon the effective date of this rule, if FDA determines 
that an e-liquid has been contaminated and is therefore adulterated 
under section 902 or that it is misbranded under section 903 of the 
FD&C Act because its labeling is false or misleading, it can initiate 
enforcement action such as a seizure, injunction, or criminal 
prosecution.
    (Comment 134) A few comments expressed concern that FDA may limit 
the availability of e-liquids to established manufacturers only and 
prohibit individuals from mixing their own e-liquids. These comments 
stated that they need access to products of reasonable potency, high 
purity, and high quality.
    (Response) This final deeming rule places some restrictions on the 
sale and distribution of tobacco products, such as minimum age 
restrictions, but it does not bar sales to individuals generally.
    (Comment 135) At least one comment noted that, although there have 
been fires due to mishandling of e-cigarette batteries, cases of 
accidental poisoning, and concerns about functionality, the ``de facto 
regulations'' that are in place, ``namely brand equity, potential civil 
liability, and word-of-mouth'' have been effective in helping the 
market evolve and controlling behavior.
    (Response) FDA disagrees. FDA's adverse event reporting system has

[[Page 29035]]

inherent limitations as a measure of the impact of e-cigarettes since 
ENDS are a newly deemed product and reporting adverse events associated 
with tobacco products (including e-cigarettes and other ENDS) is 
voluntary. FDA remains concerned about adverse events associated with 
ENDS use, including overheating and exploding batteries as reported in 
the news, and the vast evidence that accidental nicotine poisoning is 
increasing in the wake of growing e-cigarette use. Toward that end, 
elsewhere in this issue of the Federal Register, FDA has made available 
draft guidance, which when final will describe FDA's current thinking 
regarding some appropriate means of addressing the premarket 
authorization requirements for newly deemed ENDS products, including 
compliance with existing voluntary standards for ENDS batteries. In 
addition, concerns remain regarding quality control, which could impact 
the functionality of these products. FDA believes that the automatic 
statutory provisions that will apply to these products as a result of 
this deeming rule, in conjunction with additional authorities under the 
law that FDA can exercise after the effective date, will help address 
these concerns.
    (Comment 136) At least one comment sought clarification as to why 
FDA expressed concern about quality control issues for e-cigarette 
products but not for combusted products that contain thousands of toxic 
constituents.
    (Response) FDA is concerned about quality control for all tobacco 
products and will continue to monitor these products to determine if 
there are quality control issues. FDA's premarket review of the newly 
deemed products will increase product consistency. For example, FDA's 
oversight of the constituents of e-cigarette cartridges would help to 
ensure quality control related to the chemicals and their quantities 
being aerosolized and inhaled. Quality control issues will also be 
addressed in a tobacco product manufacturing practices regulation that 
FDA intends to issue at a later date. Also, FDA may take enforcement 
action if an ENDS or any other tobacco product is adulterated or 
misbranded within the meaning of the FD&C Act.
    (Comment 137) A few comments expressed concerns regarding the 
quality of e-cigarettes manufactured overseas. They stressed the 
importance of issuing regulations to require the registration of 
foreign establishments so that FDA knows the identity of foreign 
manufacturers and the products they import into the United States.
    (Response) FDA agrees with comments' concerns regarding quality 
control and the safety of ENDS manufactured both domestically and in 
other countries. One of the immediate benefits of deeming ENDS is that 
all newly deemed products, including ENDS, that meet the definition of 
``new tobacco product'' will be subject to the premarket authorization 
requirements in sections 905 and 910 of the FD&C Act. In addition, FDA 
has announced its intention in the Unified Agenda to issue a NPRM that 
would apply the registration and listing requirements of section 905 to 
foreign establishments.
    (Comment 138) Some comments suggested that to properly regulate e-
cigarettes, given their position on the continuum of nicotine-
delivering products, FDA should regulate these products based on the 
size of the manufacturer--which is generally smaller than the size of 
companies that manufacture cigarettes and smokeless tobacco products. 
They also suggested that FDA stagger the compliance periods for 
submission of PMTAs so that smaller companies have additional time to 
prepare their submissions.
    (Response) Section IV.D has additional information about compliance 
periods for small-scale tobacco product manufacturers. FDA's compliance 
policy for the submission of SE reports, SE exemption requests, and 
PMTAs for all manufacturers of deemed products is included in section 
IV.C.
    (Comment 139) One comment recommended that FDA collaborate with 
other Federal Agencies, including the National Institutes of Health 
(NIH), CDC, and the Substance Abuse and Mental Health Services 
Administration (SAMHSA), as well as international agencies including 
the EU, to continue research on tobacco products and increase 
surveillance and other enforcement of quality control and other issues.
    (Response) FDA agrees. FDA intends to continue to review available 
studies and fund studies on tobacco products, including studies on ENDS 
initiation, use (including transitions to other tobacco products and 
multiple use), perceptions, dependence, and toxicity (Ref. 173). FDA 
also has been conducting a series of public workshops to obtain 
additional information on e-cigarettes and their impact on public 
health (79 FR 55815). These workshops will help to inform FDA's 
development of future rules and policies that have an impact on ENDS. 
Additional regulations regarding ENDS will be subject to the 
requirements of the APA.
    (Comment 140) Some comments stated that FDA should regulate 
materials used in the manufacture of e-cigarette components and 
packaging that come into direct contact with e-liquids. They noted that 
improper e-cigarette construction and e-liquid packaging materials 
could also result in hazardous leachates or degradation of products in 
the e-liquid that may become aerosolized and inhaled upon use.
    (Response) With this final rule, FDA is deeming all products, 
except for accessories of newly deemed products, that meet the 
definition of ``tobacco products'' under section 201(rr) of the FD&C 
Act, which includes the components and parts (including packaging of 
such products). FDA will consider the issues raised by the comments 
when it develops a NPRM on tobacco product manufacturing practices.

E. Misperceptions

    In the NPRM, FDA noted its concerns regarding consumer 
misperceptions of currently unregulated products, particularly e-
cigarettes. Many comments provided data to substantiate those concerns 
and others provided data and personal stories regarding the potential 
benefits of e-cigarettes. Other comments indicated that, based on these 
potential benefits, they believed e-cigarettes to be safe tobacco 
products.
    (Comment 141) Many comments stated, but did not provide supporting 
data, that e-cigarettes: (1) Are approximately 99 percent less 
hazardous than cigarettes; (2) are only consumed by smokers and former 
smokers who quit by switching to e-cigarettes; and (3) have not been 
found to create nicotine dependence in any nonsmoker. They also stated 
that there is no evidence that ingesting e-liquid leads to fatalities.
    (Response) As discussed throughout this document, FDA agrees that 
use of ENDS is likely less hazardous for an individual user than 
continued smoking of traditional cigarettes. One self-selected 
comparison reported that across several Japanese brands, under some use 
conditions, ENDS released 1/50th of the level of formaldehyde released 
by cigarettes (Ref. 135). The highest level detected was six times 
lower than the level in cigarette smoke (id.). But other research, 
published as a letter to the editor of the New England Journal of 
Medicine, reported that ENDS operated at 5 volts delivered a mean of 
390+/-90 [mu]g per 10 puff sample which is greater than 150 [mu]g, the 
estimated average delivery of formaldehyde than conventional cigarettes 
(Ref. 128). No formaldehyde-releasing agents were detected when ENDS 
were operated at

[[Page 29036]]

3.3 volts (Ref. 128). A subsequent peer-reviewed article on 5 variable-
power ENDS devices found large variations in formaldehyde delivery 
across devices (Ref. 129). The first device yielded more formaldehyde 
than combustible cigarettes at every power level tested, and the second 
device delivered more formaldehyde at the highest power level tested; 
the remaining three devices delivered less formaldehyde than 
combustible cigarettes at all power levels tested (id.) The same 
research found that aldehyde delivery varied by 750-fold from one ENDS 
device to another (id.). The article referenced in one comment (Ref. 
67) reported that increasing the voltage from 3.2 to 4.8 volts 
increased formaldehyde, acetaldehyde, and acetone levels from 4 to over 
200-fold.
    Nevertheless, as discussed in section VIII.F, evidence shows that 
while most ENDS are consumed by smokers and former smokers (e.g., Refs. 
109, 110), some consumers (including youth and young adults) are 
initiating tobacco use with ENDS. Several studies have found that ENDS 
users, particularly experienced ENDS users, are able to achieve 
nicotine exposures similar to cigarette smokers (Refs. 114, 148, 149, 
150). Although no studies have been done to-date assessing the 
development of dependence among non-smokers, several studies have found 
that ENDS users, particularly experienced ENDS users, are able to 
achieve nicotine exposures similar to cigarette smokers and that 
nicotine is a known addictive substance. Fourth, as discussed in 
section VIII.D, the incidence of nicotine poisoning has been on the 
rise and has resulted in severe poisonings and hospitalization (Ref. 
174). In December 2014, after the close of the comment period for the 
NPRM, media reported the first death of a toddler from accidental 
poisoning from e-liquid (Ref. 175). Regulation of ENDS will help to 
alleviate consumer misperceptions such as those expressed in the 
comments.
    (Comment 142) Many comments stated that e-cigarettes should be 
regulated given their appeal to youth and young adults and the belief 
that e-cigarettes are less harmful than conventional cigarettes. They 
agreed with FDA's concern that a failure to regulate the newly deemed 
products could reinforce consumers' existing confusion and 
misinformation about these products. However, other comments stated 
that FDA's concerns about youth's misperception of the safety of e-
cigarettes should not be a factor in FDA's decision to regulate them. 
They stated that regulation cannot remedy the fact that many youth 
affirmatively disregard available safety information.
    (Response) As FDA stated in its proposal, many people may believe 
that certain tobacco products covered by this rule present fewer health 
risks when compared to that of cigarettes (79 FR 23142 at 23158 and 
23159), which is supported by some of the emerging scientific 
literature demonstrating that some ENDS products, operated at some 
power levels, may have lower delivery of harmful constituents and 
toxicants than that of combusted cigarettes (see discussion on the 
health harms of ENDS in response to Comment 117). In fact, a recent 
telephone survey of 1,014 adults indicates that a majority of American 
adults surveyed (nearly two-thirds, 65 percent) believe e-cigarettes 
are harmful to the health of the people who use them and 23 percent 
believe that they are not harmful (Ref. 176). In addition, 44 percent 
believe that electronic cigarettes are less harmful than combusted 
cigarettes while 32 percent thought they were equally harmful (id.). Of 
particular note, the survey found that ``[t]hose who have ever used e-
cigarettes are significantly less likely than never-users to believe 
that e-cigarettes and marijuana are harmful to the health of people who 
use them, and more likely to believe in the benefits of e-cigarettes 
when it comes to smoking cessation'' (id.).
    Although FDA expects that youth understanding and appreciation of 
the health effects and risks of certain newly deemed tobacco products 
will be improved if they are also FDA-regulated, that is only one of 
the many public health benefits that will accrue from deeming them 
subject to the FD&C Act, as discussed in the NPRM (79 FR 23142 at 23148 
and 23149).
    (Comment 143) Some comments expressed concern that the increase in 
e-cigarette use in places where cigarette smoking is not currently 
allowed creates confusion, particularly among children, who often 
cannot tell the difference between smoking and e-cigarette use. They 
referred to unpublished research and anecdotal evidence indicating that 
when children see pictures of people using e-cigarettes they report 
that someone is smoking.
    Other comments disagreed, stating that e-cigarette use will more 
likely lead to normalization of e-cigarettes rather than cigarettes 
(Ref. 110). They stated that one study found that daily smokers (aged 
18 to 35 years) who observed individuals using e-cigarettes only 
increased the smoker's desire for an e-cigarette, and not for a 
conventional cigarette (Ref. 177).
    (Response) FDA is concerned that the growth in ENDS use, 
particularly among youth and young adults, could lead to the re-
normalization of cigarette smoking. The Surgeon General recognized that 
adolescents are particularly vulnerable to visual cues to smoke and to 
social norms, making this an even greater concern (Ref. 49). FDA 
believes that subjecting ENDS to its tobacco control authorities, and 
requiring compliance with the various statutory and regulatory 
requirements (e.g., ingredient listing and others), will help to 
address the common misunderstanding that these products are safe to 
use.

F. Use as a Cessation Product

    In the preamble to the NPRM, FDA recognized that some consumers may 
use ENDS in tobacco cessation attempts. We note that if an ENDS product 
seeks to be marketed as a cessation product, the manufacturer must file 
an application with FDA's Center for Drug Evaluation and Research 
(CDER) and no ENDS have been approved by FDA as effective cessation 
aids.
    Recently published population-wide data from the CDC's NCHS, which 
provides the first estimates of e-cigarette use among U.S. adults from 
a nationally representative household interview study, indicates that 
current cigarette smokers and recent former smokers (i.e., those 
individuals who quit smoking within the past year) were more likely to 
use e-cigarettes than long-term former smokers (i.e., those individuals 
who quit smoking more than one year ago) and adults who had never 
smoked (Ref. 24). Among current cigarette smokers who had tried to quit 
smoking in the past year, more than one-half had ever tried an e-
cigarette and 20.3 percent were current e-cigarette users (id.).
    (Comment 144) Comments were divided regarding the viability of e-
cigarettes as a smoking cessation product. Some comments contended that 
the actual patterns of e-cigarette use, citing a meta-analysis showing 
the rapid penetration of the youth market and high levels of dual use 
among both adults and adolescents, will lead to a lower probability 
that smokers using e-cigarettes will quit smoking cigarettes (Ref. 16). 
They also cited another study in which, although 85 percent of e-
cigarette users reported that they were using e-cigarettes to quit 
smoking, they were no more likely to have quit smoking than nonusers of 
e-cigarette (Ref. 178).
    However, consumers and manufacturers of e-cigarettes provided 
information showing positive impacts of e-cigarettes on cessation, 
including

[[Page 29037]]

personal anecdotes from former smokers (Ref. 132). For example, they 
cited a 1-year multinational study where researchers found that among 
smokers who were using e-cigarettes at the baseline, 22 percent had 
quit smoking after 1 month and 46 percent had quit smoking after 1 year 
(Ref. 179). In a survey of adults in the United Kingdom who tried to 
quit smoking at least once in the past year, respondents who used e-
cigarettes had a higher quit rate (20 percent) than those who used NRTs 
like patches or gum (10 percent) or those that did not use a cessation 
aid (15 percent) (Ref. 180). These comments also asserted evidence that 
e-cigarette use, at a minimum, leads to decreased cigarette use (e.g., 
Refs. 107, 181). One comment also noted that tribes use e-cigarettes as 
an alternative to smoking and to promote cessation.
    (Response) As we have stated throughout this document, we recognize 
that there is emerging data that some individual smokers may 
potentially use ENDS to transition away from combustible tobacco 
products. For instance, prospective studies of varying duration 
examining the efficacy of e-cigarettes as cessation devices suggest 
their potential to decrease combustible cigarette use as well as 
promote abstinence from combustible cigarettes (Refs. 107, 149, 182, 
183, 184). Three randomized controlled clinical trials (Ref. 107, 149, 
184) report that e-cigarettes may help some smokers to stop smoking. 
The trial that compared e-cigarettes to nicotine replacement therapy 
found verified abstinence in all experimental groups, but no 
significant difference among e-cigarettes, placebo e-cigarettes (i.e., 
e-cigarettes with no nicotine), and nicotine patches in six-month 
abstinence rates (Ref. 184). Achievement of abstinence was 
substantially lower than the optimistic estimates on which the power 
calculation and study sample size were based, and thus, the researchers 
could conclude no more than that ``among smokers wanting to quit, 
nicotine e-cigarettes might be as effective as patches for achieving 
cessation at 6 months'' (id.). It is possible that longer term 
prospective studies may--or may not--demonstrate statistically 
significant cessation outcomes for e-cigarettes in relation to 
conventional nicotine replacement therapies (id). It is noteworthy that 
a third of the participants allocated to the e-cigarettes groups in 
this study reported continued product use at 6 months, suggesting that 
they might have become long-term e-cigarette users (id.). However, some 
systematic reviews of available evidence indicate that there is 
currently insufficient data to draw a conclusion about the efficacy of 
e-cigarettes as a cessation device (Refs. 185, 186). The Cochrane 
Collaboration's systematic review and meta-analysis assessed 
approximately 600 scientific records to include two randomized 
controlled trials and 11 cohort studies on e-cigarettes and smoking 
cessation in their review (Ref. 186). As the Cochrane review judged 
RCTs to be at low risk of bias, the investigators combined results from 
two randomized controlled trials, totaling over 600 people, and 
conducted a quantitative meta-analysis. Results indicated that using e-
cigarettes with nicotine was associated with increased smoking 
cessation as compared with e-cigarettes without nicotine. Investigators 
also found evidence that using e-cigarettes with nicotine also helped 
more smokers reduce the amount they smoked by at least half compared to 
e-cigarettes without nicotine. However, the authors cautioned that 
``the small number of trials, low event rates and wide confidence 
intervals around the estimates mean that our confidence in the result 
is rated `low'.'' (Ref. 186) In addition, the authors observed that 
``the overall quality of the evidence for our outcomes was rated `low' 
or `very low' because of imprecision due to the small number of 
trials'' (id.). Another meta-analysis of the same two trials of e-
cigarettes with and without nicotine found comparable results (Ref. 
187). The authors also reported a pooled estimate of cessation among 
nicotine e-cigarette users, but the lack of non-e-cigarette control 
groups in the studies prevented them from comparing the efficacy of e-
cigarettes against no e-cigarette use and against standard 
interventions for cessation, such as nicotine patches (id.).
    An alternate systematic review and meta-analysis of approximately 
600 scientific records to include 15 cohort studies, 3 cross-sectional 
studies, and two clinical trials (one RCT, one non-RCT) examined the 
association between e-cigarette use and cessation in observational 
epidemiological studies and clinical trials; all 20 studies compared 
smoking cessation rates for e-cigarette users against control groups of 
smokers who did not use e-cigarettes (Ref. 112). This meta-analysis 
found overall that odds of quitting cigarettes were on average 28 
percent lower for smokers who used e-cigarettes than those who did not 
(odds ratio = 0.72, with 95 percent confidence interval 0.57 to 0.91) 
(Ref. 112). Of note, this meta-analysis included chiefly observational 
studies whose control groups were not randomized, and included a wide 
range of designs as well as variable exposures and outcome definitions 
(id.). While some potential confounders were controlled for in most of 
the studies, the investigators acknowledged that there may be other 
unidentified confounders that could be a source of bias. This potential 
bias as well as other limitations described may impact interpretability 
of the overall findings (id.).
    We also note that ENDS have not been approved as effective 
cessation aids. FDA remains committed to supporting long-term 
population-level research that will help fill in current data gaps.
    (Comment 145) At least one comment suggested that FDA provide 
physicians with guidelines about e-cigarette use, including its health 
impact and efficacy as a cessation tool.
    (Response) To the extent the comment is about ENDS products that 
are drugs because they are marketed for cessation, an ENDS product 
marketed for therapeutic purposes is a drug or device subject to FDA's 
regulations and laws for those products.
    (Comment 146) A few comments expressed concern that FDA 
misrepresented certain studies in the NPRM and would not consider 
research released since the issuance of the NPRM, particularly 
regarding the effectiveness of e-cigarettes as a cessation tool.
    (Response) FDA has considered the preliminary evidence regarding 
the effectiveness of ENDS to help smokers quit or to reduce their 
consumption of combusted tobacco products. There is some indication 
that such products may have the potential to help some individual users 
to quit using combusted tobacco products or to reduce their use of such 
products, as reported by scientific literature describing a small 
number of randomized controlled trials evaluating the impact of ENDS 
use on smoking outcomes (Refs. 137, 148, 184) and pilot studies 
evaluating ENDS use on smoking reduction and cessation (Refs. 182, 
183). But other evidence is to the contrary. Beyond the meta-analysis 
discussed in section V(B)(3), a year-long study of over 5,000 20-year-
old Swiss men found that, even after adjusting for nicotine dependence, 
individuals who were smokers at the start of the study and who reported 
e-cigarette use at the end of the study were more likely to still be 
smoking and more likely to have made one or more unsuccessful quit 
attempts at the end of the year than individuals who were smokers at 
the start and who reported no e-cigarette use (Ref. 188). The most 
important consideration is that ENDS are not an

[[Page 29038]]

FDA-approved cessation product. If an ENDS manufacturer wishes to make 
a cessation claim or otherwise market its product for therapeutic 
purposes, the company must submit an application for their ENDS to be 
marketed as a medical product.
    (Comment 147) Some comments expressed concern that e-cigarette 
users are developing an addiction to nicotine while seeking to overcome 
their smoking addiction and that the lack of regulation makes it 
difficult for users to know the nicotine level that they need in their 
e-cigarettes to overcome their addiction. They stated that for 
cigarette smokers who are trying to replace their cigarette-derived 
nicotine with e-cigarettes, ingredient listing and other requirements 
are vital to ensure that users know how much nicotine they are 
ingesting.
    (Response) By deeming ENDS, FDA has ensured that these products are 
now subject to requirements related to ingredient and HPHC reporting, 
among other requirements. In addition, the registration and listing 
requirements and premarket applications will provide FDA with vital 
information as to the extent of ENDS use and how many ENDS products 
consumers are using on a daily basis.
    (Comment 148) Some comments perceived the newer generation of e-
cigarettes to be less addictive than combusted cigarettes and closer in 
profile (including risk profile) to NRTs (Ref. 76). They noted the 
limited number of significant adverse events resulting from e-cigarette 
use and claimed that such adverse events are not distinguishable from 
NRTs (Ref. 184). Some comments also believed that FDA should consider 
the advantages that e-cigarettes have (as compared to NRTs) when 
establishing the regulatory approach for these products, including the 
fact that they offer appealing visual, tactile, and gestural 
similarities to cigarettes, and that e-cigarettes provide quicker 
nicotine delivery than NRTs (Ref. 189).
    (Response) As we have stated throughout this document, we recognize 
that individual smokers may report cessation benefits from ENDS and 
that preliminary research outcomes from randomized controlled trials 
indicate that ENDS may decrease some individuals' cigarette consumption 
and promote cessation. However, the risk profile is likely to be 
different as compared to NRTs, and the long-term risks associated with 
chronic use of ENDS are unknown. Finally, contrary to ENDS, the 
nicotine patch and other NRTs were found to be safe and effective by 
FDA's CDER after reviewing premarket applications containing data and 
information establishing safety and effectiveness. No ENDS has yet been 
approved by CDER.
    (Comment 149) Comments in support of limited or no regulation of e-
cigarettes stated that these products have a positive impact on the 
public health at the population level. They cited online surveys and 
convenience store data showing that most e-cigarette users do not use 
additional tobacco products (see section VIII.H) and claimed that FDA 
cherry-picked the evidence regarding dual use in the NPRM. They also 
claimed FDA did not adequately assess the reduction in smoking that 
would result from increased e-cigarette use and, as a result, the 
Agency underestimated the potential positive impacts of e-cigarettes on 
the public health at the population level.
    (Response) Many provisions of the FD&C Act call for a population-
level public health analysis that takes into account the population as 
a whole, including users and nonusers of tobacco products (e.g., 
section 906(d) of the FD&C Act). Even products that are less toxic than 
combusted tobacco products on an individual user basis may increase 
public health harms if, for example, they encourage nonusers to start 
using tobacco products that can lead to lifelong nicotine addiction.
    As we have stated throughout the document, FDA has examined data 
regarding health harms generally associated with all of the categories 
of tobacco products regulated under this rule (including ENDS, which 
FDA recognizes may potentially provide cessation benefits to some 
individual smokers). FDA is regulating these products in accordance 
with this knowledge and will continue to regulate as we learn more 
about the potential for product-specific health harms. FDA recognizes 
that some ENDS users report that the products have the potential to 
help individual users to quit smoking. However, FDA's responsibility is 
to assess the population health impact of ENDS, including increasing 
youth use, as well as the frequency of dual use of ENDS and combusted 
tobacco products. FDA believes that data from long-term population 
level studies, such as the PATH Study, will help to provide information 
about the overall population health impacts of ENDS.
    (Comment 150) Many comments provided personal stories and peer-
reviewed studies to illustrate the benefits of e-cigarettes as a 
cessation product and to request that FDA treat this product category 
differently based on where the product falls within the continuum of 
nicotine delivering products. For example, they suggested that FDA 
differentiate between substances that contain tobacco and those that 
are derived from tobacco and provide a separate regulatory approach for 
each product category.
    Some comments also suggested that FDA tailor its regulatory 
approach based on the type of electronic apparatus--e.g., advanced 
refillable personal vaporizers (ARPVs) or open-system vapor products 
versus ``cigalike'' products (ready for use products that look like 
cigarettes and are sold in convenience stores). These comments believed 
FDA should only deem ``cigalike'' products that are ready for 
consumption, because they are easily accessible to youth and have been 
associated with quality control issues (see section VIII.D). They noted 
that ARPVs and other open systems are significantly more expensive than 
``cigalike'' products and are only offered in vape or specialty shops. 
They compared this to Option 1 (to deem all cigars) and Option 2 (to 
deem all cigars except premium cigars) and suggested that FDA should 
have provided similar options for regulating different e-cigarettes. 
They also expressed the need for a different regulatory approach for 
ARPVs because they provide users with the best opportunity to cease 
using combusted tobacco products (Ref. 190). However, other comments 
provided focus group research in which smokers rated cigalikes to be 
significantly more satisfying than ARPVs and asked for a minimal 
regulatory approach for cigalikes.
    Further, some comments stated that it was not feasible to regulate 
ARPVs. They stated that the wide varieties of e-liquids available at e-
cigarette retail establishments and the ability of users to customize 
their experience, including by altering the product's voltage/wattage, 
puff duration, coil resistance, cartridge/battery duration, and design 
aesthetics, make oversight, application review, and other regulation 
untenable.
    Other comments stated that, instead of establishing a different 
regulatory approach, FDA should ban ARPVs because there is greater risk 
associated with their use and children may tamper with them. They 
suggested that if FDA does not ban these products, FDA should require 
the disclosure of all ingredients in e-liquids and other vaporized 
nicotine products in both their pre-use and vapor states.
    (Response) To the extent that comments are asserting that FDA 
should not regulate ENDS or subject them to certain provisions, FDA 
disagrees with these comments, especially given that

[[Page 29039]]

ENDS use among youth and young adults is increasing. Although recent 
data on young adults and adults indicate that ENDS users are more 
likely to be former cigarette smokers and current cigarette smokers who 
have tried to quit (e.g., Ref. 24), there is still some use among adult 
non-tobacco users, particularly among young adults. In addition, the 
rapid increase in use among adolescents is concerning. FDA also remains 
concerned that ARPVs present the risk of accidental nicotine poisoning. 
In addition, researchers recently reported that the new generation of 
high voltage ENDS may put users at increased risk of negative health 
effects (Ref. 67) and that ARPVs have the potential for increased abuse 
liability (e.g., Refs. 109, 132, 171). FDA will continue to monitor 
research regarding the health effects of different types of ENDS and 
may tailor the regulatory requirements accordingly.
    (Comment 151) Some comments requested that FDA either exempt e-
cigarette products from the deeming regulation or strike the entire 
proposal for e-cigarettes and replace it with what they considered a 
more science-based approach or with rules that address good 
manufacturing practices and consumer safety, given their potential for 
use as cessation products.
    (Response) FDA disagrees. This final deeming rule is a foundational 
rule that will provide many public health benefits, as described in the 
NPRM (79 FR 23142 at 23148 and 23149), and will provide FDA with 
critical information about the health risks of ENDS and other newly 
deemed products, including data from ingredient listing submissions and 
reporting of HPHCs required under the FD&C Act. Also, once this rule 
becomes effective, newly deemed products may be subject to additional 
regulations. For example, FDA has the authority under section 906(e) of 
the FD&C Act to issue a rule establishing tobacco product manufacturing 
practices, and this authority applies to deemed products. FDA also has 
the authority under section 907 of the FD&C Act to establish product 
standards for deemed products, including requirements with respect to 
packaging. The Agency issued an ANPRM prior to this deeming rule, 
seeking comments, data, research, or other information that may inform 
regulatory actions FDA might take with respect to nicotine exposure 
warnings and the use of child-resistant packaging. In addition, 
elsewhere in this issue of the Federal Register, FDA has made available 
a draft guidance for public comment, which when final will describe 
FDA's current thinking regarding some appropriate means of addressing 
the premarket authorization requirements for newly deemed ENDS 
products, including recommendations for nicotine exposure warnings and 
child-resistant packaging that would help to support a showing that the 
marketing of a product is appropriate for the protection of the public 
health.
    (Comment 152) Some comments stated that e-cigarettes should be 
subject to little or no FDA regulation, because e-cigarettes inhibit 
withdrawal symptoms in users with a history of relapse (Ref. 191) and 
lead to reduction and cessation in asthmatic smokers (Ref. 107).
    (Response) FDA disagrees. Although ENDS may potentially provide 
cessation benefits to individual smokers, no ENDS have been approved as 
effective cessation aids. If an ENDS manufacturer wishes to make a 
cessation claim, the company must submit an application for their ENDS 
to be marketed as a medical product.

G. Modified Risk Claims

    In the NPRM, FDA noted that it expects public health benefits 
through the application of section 911 of the FD&C Act to the newly 
deemed tobacco products. Historically, certain users have initiated and 
continued using certain tobacco products based on unauthorized modified 
risk claims and consumers' unsubstantiated beliefs. Application of 
section 911 will prohibit the introduction into interstate commerce of 
MRTPs unless FDA issues an order permitting their marketing.
    (Comment 153) A few comments expressed concern that imposition of 
section 911 of the FD&C Act will force e-cigarette manufacturers to 
implicitly lie by not permitting them to tell consumers that their 
products are safer alternatives to conventional cigarettes, to 
advertise that they do not contain tobacco, and to state that they are 
``smoke free.'' They added that the public already overwhelmingly 
believes that e-cigarettes are reduced risk products and, therefore, 
the section 911 requirements are irrelevant (Refs. 178, 192). However, 
other comments stated that manufacturers should be prohibited from 
making cessation claims without providing scientific evidence to 
support their efficacy as a cessation mechanism.
    (Response) FDA disagrees with concerns that ENDS manufacturers will 
not be able to make claims that properly represent their products. 
Section 911 is one of the provisions of the statute that applies 
automatically to deemed products. It was included in the FD&C Act to 
protect consumers from manufacturers making invalid or unsubstantiated 
claims, as many had done with respect to their designation of 
cigarettes as ``light,'' ``low,'' or ``mild.'' The mistaken belief that 
``light'' and ``low-tar'' cigarettes were safer than other cigarettes 
prompted many smokers to switch to such products instead of quitting 
altogether. Section 911 will prevent consumers from being similarly 
misled by ensuring a manufacturer may not make unsubstantiated claims. 
Manufacturers that have data to substantiate modified risk claims for a 
particular product can submit an MRTP application so that FDA can 
determine that the product meets the statutory standard and can issue 
an order authorizing it to be marketed as an MRTP.
    As Congress recognized,

[u]nless tobacco products that purport to reduce the risks to the 
public of tobacco use actually reduce such risks, those products can 
cause substantial harm to the public health to the extent that the 
individuals, who would otherwise not consume tobacco products or 
would consume such products less, use tobacco products purporting to 
reduce risk. Those who use products sold or distributed as modified 
risk products that do not in fact reduce risk, rather than quitting 
or reducing their use of tobacco products, have a substantially 
increased likelihood of suffering disability and premature death. 
The costs to society of the widespread use of products sold or 
distributed as modified risk products that do not in fact reduce 
risk or that increase risk include thousands of unnecessary deaths 
and injuries and huge costs to our health care system.

(section 2(37) of the Tobacco Control Act).

    (Comment 154) Some comments believed that e-cigarettes should only 
be authorized as MRTPs, rather than new tobacco products via the PMTA 
or SE pathways, because that would allow them to meet the predominant 
expectations of consumers.
    (Response) FDA disagrees. The Tobacco Control Act requires all new 
tobacco products, including MRTPs, to go through premarket review and 
obtain a marketing authorization order via the PMTA, SE., or SE 
exemption pathways. A manufacturer who wants to sell a product for use 
to reduce harm or risk of tobacco-related disease can also obtain 
authorization to market an MRTP if the manufacturer submits an 
application under section 911 of the FD&C Act and FDA issues such an 
order.
    (Comment 155) A comment suggested that to address unauthorized 
modified risk claims, we add the following language to the final rule: 
No vapor product or alternative nicotine product shall be considered to 
be ``sold or

[[Page 29040]]

distributed for use to reduce harm or the risk of tobacco-related 
disease associated with commercially marketed tobacco products'' solely 
because its label, labeling, or advertising uses the following phrases 
to describe such product and its use: ``not consumed by smoking,'' 
``does not produce smoke,'' ``smokefree,'' ``without smoke,'' ``no 
smoke,'' or ``not smoke.''
    (Response) Section 911 of the FD&C Act requires FDA to assess MRTP 
claims for specific products. Therefore, FDA will evaluate products on 
a case-by-case basis to determine whether they are ``sold or 
distributed for use to reduce harm or the risk of tobacco-related 
disease associated with commercially marketed tobacco product'' as 
stated in section 911. However, we note that e-cigarettes and similar 
ENDS products are not ``smokeless'' products, as the user is inhaling 
constituents (which are different from a smokeless tobacco product, as 
defined in the Tobacco Control Act). In addition, FDA is aware that 
some ENDS might heat their product to a level high enough to cause 
combustion.
    (Comment 156) Many comments stated that the NPRM may promote 
conventional tobacco use because e-cigarette manufacturers will be 
unable to inform smokers that their products are safer alternatives or 
that they do not contain tobacco. They believed the NPRM weakens the 
impact that the e-cigarette industry might otherwise exert on the 
tobacco industry.
    (Response) FDA disagrees. First, this final rule does not prohibit 
ENDS manufacturers from making claims that they are safer than 
conventional tobacco products if they can provide evidence to satisfy 
the requirements and obtain marketing authorization from FDA under 
section 911 of the FD&C Act. Second, FDA believes that ENDS could serve 
as alternatives to combusted tobacco products.

H. Dual and Polytobacco Use

    In the NPRM, FDA noted its concerns that adult consumers may use 
one or more of the proposed deemed products in conjunction with 
cigarettes or other tobacco products. FDA also noted that studies 
suggest that some noncigarette tobacco users may go on to become 
addicted cigarette smokers (79 FR 23142 at 23159).
    It is also recognized that some dual users of ENDS and cigarettes 
may be transitioning away from combustible tobacco use and that such 
transient periods of dual use may not present greater health risks than 
that observed during sole use of combustible tobacco. In a peer-
reviewed study published recently in Cancer Prevention Research, 
investigators evaluated users of a single brand of ``cig-a-like'' ENDS 
and found that both cigarette smokers who switched to using the 
evaluated ENDS products and those who switched to dual use of the 
evaluated ENDS and cigarettes all demonstrated significant reductions 
in exposure to carbon monoxide and the toxicant acrolein (Ref. 194).
    (Comment 157) Many comments expressed concern that the rate of dual 
use of e-cigarettes and combusted tobacco products is high, 
particularly among middle and high school students (Ref. 16). They 
stated that adolescents do not use e-cigarettes as cessation aids but 
rather use them in conjunction with conventional cigarettes (Ref. 193; 
see Ref. 194). They also indicated that this dual use and the fact that 
youth who experiment with e-cigarettes are 7.7 times more likely to 
become established smokers than those who do not experiment (Ref. 116) 
suggest that e-cigarette use leads to increased use of combusted 
tobacco products. However, they noted that we need long-term studies 
like FDA's PATH Study to confirm that assertion. Some comments also 
stated that cigarette smokers who use a second tobacco product even 
occasionally are at higher risk for continued tobacco use (Ref. 195).
    Other comments believed that dual use should not be a concern, 
generally relying upon an Internet study of more than 19,000 e-
cigarette users in which dual users had decreased from 20 to 4 
cigarettes per day by the end of the study (Ref. 109). Some comments 
also expressed the belief that, because clinical studies show that e-
cigarettes deliver only modest concentrations of nicotine to novice e-
cigarettes users (Ref. 196), this would also be the case for nonsmoking 
youth and young adults and, therefore, would make the possibility of 
addiction less likely. Others argued that advanced e-cigarette products 
deliver nicotine more effectively, making adult consumers less likely 
to dual use or revert back to smoking. In addition, they claimed that 
if e-cigarettes were acting as a gateway to cigarette use, the current 
increase in e-cigarette use would lead to a corresponding increase in 
youth cigarette use (which has not occurred). In fact, they said an 
overlap of combusted tobacco and e-cigarette use is necessary if a 
tobacco user begins e-cigarette use to transition away from combusted 
tobacco consumption.
    (Response) FDA is aware of dual use of ENDS and combusted tobacco 
products and is concerned about the potential impact of this practice 
on nicotine addiction and cessation. FDA also is concerned because this 
dual and polytobacco use pattern appears to be common among adolescents 
and young adults (Ref. 197). However, recent CDC NCHS data on young 
adult and adult use patterns of e-cigarettes indicate that former 
smokers and current smokers trying to quit are more likely to use e-
cigarettes than former smokers who quit smoking more than 1 year ago 
and those who had never smoked (Ref. 24). These results indicate that 
dual use of tobacco may also be present during the transitional phase 
when smokers of combusted tobacco products are attempting to quit, 
which is also supported by personal stories included in the comments. 
In addition, the largest study to date in the EU found that e-cigarette 
use was more likely among smokers who had made a quit attempt during 
the past year as compared to those who never smoked (Ref. 109).
    Other studies illustrate that current or former smokers have tried 
e-cigarettes not intending to quit tobacco use, but instead, because 
they are ``Easy to use when I can't smoke'' (Ref. 198) or can be used 
in places where conventional tobacco use is not allowed (Ref. 199). FDA 
remains committed to supporting long-term population-level research, 
such as the PATH Study, that will help elucidate reasons for and 
patterns in tobacco initiation, product switching, and dual use across 
the spectrum of tobacco products on the U.S. market, including ENDS and 
conventional cigarettes.
    (Comment 158) Many comments noted that almost all e-cigarettes 
contain nicotine (Ref. 192). This nicotine delivery varies within and 
across brands (Refs. 200, 201) and by the user's level of experience 
with these products (e.g., Ref. 202). While many comments expressed 
minimal concerns about abuse liability of e-cigarettes, believing that 
users will eventually switch entirely to e-cigarettes, others expressed 
the belief that long-term use of e-cigarettes may lead to addiction in 
youth and young adults.
    (Response) FDA shares similar concerns that youth may initiate 
tobacco use with ENDS, become addicted, and then dual use or move on to 
traditional tobacco products. FDA discussed available data regarding 
dual and polytobacco use in the NPRM and is unaware of long-term 
studies finding that dual or polytobacco users eventually switch to 
using just one tobacco product (79 FR 23142 at 23159 and 23160). 
However, findings from a recent study of 694 participants aged 16 to 26 
years old suggest that youth e-cigarette users might transition to

[[Page 29041]]

smoking traditional cigarettes (Ref. 203). Therefore, FDA remains 
concerned that youth may use one of the newly deemed products, whether 
it be an ENDS or any other tobacco product, and dual use with other 
tobacco products in the future.
    (Comment 159) Some comments urged FDA to evaluate e-cigarettes 
based on their scientific merit and contribution to public health. At 
least one comment felt that certain researchers in the tobacco field 
were biased based on their connections to public health advocates or 
what the comment refers to as ``big tobacco companies.'' Some comments 
stated that FDA only considered journal articles when it should have 
considered other available information.
    (Response) FDA uses the best evidence available from peer reviewed 
journals and other reputable sources to support this rule and fulfill 
our public health mandate. In the context of rulemaking, FDA follows 
the requirements of Executive Orders 12866 and 13563 by basing its 
decisions ``on the best reasonably obtainable scientific, technical, 
economic and other information.'' As stated in the NPRM, we will 
continue to fund research to help us determine the public health 
impacts of ENDS. Long-term studies are not available to conclude that 
ENDS are a proven cessation product or to establish what effect e-
cigarettes have on users who might otherwise quit but instead engage in 
dual use of ENDS and other tobacco products (79 FR 23142 at 23152).

I. Applicability of Section 901

    In the preamble to the NPRM, FDA stated that the rule applies to 
all products that meet the definition of ``tobacco product'' under 
section 201(rr) of the FD&C Act and any future products that meet the 
definition. FDA stated that e-cigarettes meet the definition of 
``tobacco product.''
    (Comment 160) Many comments seeking to exclude e-cigarette products 
from the scope of the deeming rule stated that Congress only meant for 
FDA to regulate products with the greatest threat (i.e., cigarettes and 
smokeless tobacco products). They stated that regulating all tobacco 
products as strictly as cigarettes are regulated is not warranted and 
that the rigid application of the Tobacco Control Act is not consistent 
with public health objectives.
    (Response) FDA disagrees. Congress gave FDA immediate authority 
over certain tobacco products (i.e., cigarettes, smokeless tobacco, 
cigarette tobacco, and roll-your-own tobacco) and the authority to deem 
other products (including ENDS and other products that meet the 
statutory definition of ``tobacco product''). All tobacco products, 
regardless of the category of products, pose a health risk. Further, at 
this time, only some of the restrictions in part 1140 (which, prior to 
the rule, applied only to cigarettes and smokeless tobacco) will apply 
to the newly deemed products. Specifically, while the minimum age and 
identification, vending machine, and free sample provisions will apply 
to the newly deemed products, additional provisions in part 1140 
(including minimum pack size and restrictions on self-service displays, 
sale and distribution of nontobacco items, and sponsorship of events) 
will not apply to the newly deemed products at this time.
    (Comment 161) Many comments expressed concern that Congress did not 
wish to effectively ban e-cigarettes (as they claimed would occur as a 
result of deeming these products), because such a ban violates section 
907(d)(3) of the FD&C Act. They stated that if Congress wanted to ban 
them, they would have done so under their drug authority.
    (Response) FDA is not banning any category of tobacco product by 
issuing this final deeming rule.
    (Comment 162) Many comments claimed that Congress did not intend 
for FDA to strictly apply the Tobacco Control Act requirements to all 
newly deemed products, especially those that do not contain tobacco 
leaf. They believed because e-liquids do not contain tobacco leaf, such 
products should be regulated differently than cigarettes and 
traditional smokeless tobacco products.
    (Response) With this rule, FDA is deeming all products that meet 
the definition of ``tobacco product,'' including e-liquids, to be 
subject to the tobacco product authorities in chapter IX of the FD&C 
Act, to address the public health concerns associated with them. The 
FD&C Act does not include any requirement that a product contain 
``tobacco leaf'' to meet the definition of ``tobacco product'' and be 
deemed under this final rule. As stated previously, FDA is not 
requiring that ENDS and the other newly deemed products comply with all 
of the requirements of part 1140 at this time.
    (Comment 163) Some comments suggested that we need more 
toxicological, epidemiological, and behavioral studies before deeming 
e-cigarettes under section 901. Other comments stated that FDA must 
regulate e-cigarettes despite not having the level of scientific 
evidence that is available for most conventional tobacco products.
    (Response) FDA continues to research and fund studies regarding 
ENDS initiation, use (including transitions to other tobacco products 
and multiple use), perceptions, dependence, and toxicity (Ref. 195). 
FDA also has been conducting a series of public workshops to obtain 
additional information on e-cigarettes and their impact on public 
health (79 FR 55815). These workshops are not necessary to inform this 
deeming rule; however, they may inform FDA's development of future 
rules impacting ENDS. Any additional regulations regarding ENDS will be 
subject to the requirements of the APA.
    (Comment 164) Some comments sought clarification as to FDA's 
authority over e-liquids that do not contain nicotine or other 
chemicals derived from tobacco plants and those e-liquids that contain 
nicotine derived from a nontobacco source (e.g., eggplants or 
tomatoes). Others claimed that FDA does not have regulatory authority 
over e-cigarettes that are refillable and do not contain nicotine, but 
does have authority over e-liquids if the liquid contains nicotine. 
Yet, some said that e-liquids used in e-cigarettes should have an 
entirely new classification, because use of the words ``tobacco 
product'' in marketing materials would cause undue confusion for 
consumers.
    (Response) As stated in section 201(rr) of the FD&C Act, the 
definition of ``tobacco product'' includes any product made or derived 
from tobacco, including any component, part, or accessory of a tobacco 
product. An e-liquid made or derived from tobacco meets this definition 
and, therefore, is subject to FDA's chapter IX authorities. E-liquids 
that do not contain nicotine or other substances derived from tobacco 
may still be components or parts and, therefore, subject to FDA's 
tobacco control authorities, if they are an assembly of materials 
intended or reasonably expected to be used with or for the human 
consumption of a tobacco product and do not meet the definition of 
accessory.
    (Comment 165) Some comments tried to compare pipes and rolling 
papers (which are required to smoke tobacco) with e-cigarettes (which 
are required to ``vape'' e-liquids), stating that e-cigarettes should 
not be regulated. They indicated that, unlike rolling paper which is 
``intended for human consumption'' and therefore a tobacco product 
component, a pipe is ``non-consumable'' and should not be considered a 
tobacco product component. They said that, like pipes, e-cigarettes are 
``non-consumable products'' and, therefore, are not

[[Page 29042]]

components or parts of tobacco products and not subject to regulation. 
They also stated that only the e-liquid is the consumable product and 
should be the only part of the e-cigarette subject to regulation.
    (Response) The definition of ``tobacco product'' as set forth in 
section 201(rr) of the FD&C Act includes all components, parts, and 
accessories of tobacco products (except for raw materials other than 
tobacco used in manufacturing a component, part, or accessory of a 
tobacco product). FDA interprets components and parts of a tobacco 
product to include any assembly of materials intended or reasonably 
expected: (1) To alter or affect the tobacco product's performance, 
composition, constituents or characteristics; or (2) to be used with or 
for the human consumption of a tobacco product. Both e-cigarettes and 
pipes meet this definition. Thus, such products are subject to FDA's 
chapter IX authorities as a result of this rule.
    (Comment 166) Many comments stated that FDA lacks any type of 
meaningful justification for deeming e-cigarettes because e-cigarettes 
do not represent the same level of public health threat as cigarettes. 
They claimed that FDA has the burden of showing a rational basis for 
regulation and that the lack of data showing that these products do not 
cause harm cannot serve as a basis for regulating them. In addition, 
some comments stated that FDA has no justification for regulating 
products simply because they may deliver nicotine. They likened such 
authority to imposing onerous regulations on caffeine, another plant-
derived chemical.
    (Response) FDA disagrees. FDA is deeming these products to address 
public health concerns (79 FR 23142 at 23148 and 23149). ENDS are 
tobacco products. As stated throughout this document, FDA has 
determined that deeming all products meeting the statutory definition 
of ``tobacco product'' will significantly benefit public health. We 
also note that by merely deeming ENDS to be tobacco products, FDA is 
not imposing the same level of regulation as is currently imposed on 
cigarettes. For example, restrictions on self-service displays, sale 
and distribution of nontobacco items, and sponsorship of events will 
not apply to ENDS at this time. FDA will consider the health effects of 
all products before determining whether to issue additional 
regulations.
    (Comment 167) Many comments stated that the NPRM would ban 
virtually all of the e-liquid products and premium vaporizers 
(including mods, tanks, and open systems) and other components or parts 
because manufacturers of such products would not have adequate 
resources to comply with the requirements of the law.
    (Response) FDA disagrees. FDA is not banning any tobacco product 
under this final rule. Rather, FDA is extending its authority to 
regulate such products under section 901 of the FD&C Act. Manufacturers 
of ENDS products were on notice that they could be considered FDA-
regulated tobacco products since the enactment of the Tobacco Control 
Act and the issuance of the Sottera decision shortly thereafter. See 
section VIII.K for additional discussion regarding the Sottera case. 
Therefore, FDA disagrees with any comments referring to this rule as 
banning any categories of tobacco products.
    (Comment 168) Some comments stated that FDA does not have the 
authority to regulate the ingredients that can be used in e-liquids.
    (Response) FDA clarifies that, although it will not be directly 
regulating the individual ingredients in e-liquids at this time, 
sections 905 and 910 of the FD&C Act give FDA authority to review and 
consider ingredients in making determinations on SE reports and PMTAs 
(i.e., the Agency will look at ingredients within a specific e-liquid 
and determine whether the overall tobacco product meets the statutory 
standard for marketing authorization). In addition, section 904 
requires manufacturers to submit a listing of all ingredients added by 
the manufacturer to the tobacco, paper, filter, or other part of each 
tobacco product by brand and by quantity in each brand and subbrand, 
and section 915 of the FD&C Act authorizes FDA to issue a regulation to 
require that ``tobacco product manufacturers, packagers, or importers 
make disclosures relating to the results of the testing of tar and 
nicotine through labels or advertising or other appropriate means, and 
make disclosures regarding the results of the testing of other 
constituents, including smoke constituents, ingredients, or additives, 
that the Secretary determines should be disclosed to the public to 
protect the public health and will not mislead consumers about the risk 
of tobacco-related disease'' (emphasis added).
    (Comment 169) A few comments noted the differences among products 
in the ENDS category in contrast to the relatively uniform category of 
combusted tobacco products. Given these differences and the rapid cycle 
of innovation and product development for ENDS products, they stated 
that FDA cannot use the Tobacco Control Act framework to regulate them.
    (Response) FDA agrees that there are many differences among the 
products in the ENDS category. However, there are many differences 
among combusted tobacco products as well. For example, many cigars are 
wrapped in whole tobacco leaf, whereas cigarettes are not. Waterpipe 
tobacco is consumed in a manner very different from the consumption of 
cigarettes and cigars. The differences among these products do not 
affect the Agency's ability to regulate them in accordance with the 
requirements of the Tobacco Control Act.

J. Definitions

    Several comments suggested that we add definitions specific to e-
cigarettes and their components and parts. Comments stressed the 
importance of defining terms broadly enough to ensure all manufacturers 
of the finished products or components and parts of the finished 
products are covered by the definitions.
    (Comment 170) Some comments suggested that FDA clearly identify 
nomenclature and constituents of ENDS products because ENDS is a much 
broader category than e-cigarettes. Similarly, some comments stated 
that not defining these products would fail to address the exploding 
market of e-cigarettes and their e-cigarette components and parts. They 
also stated that an ENDS definition is necessary so State and local 
governments can use consistent definitions.
    (Response) FDA agrees that there is an expanding market of tobacco 
products that meet the FD&C Act definition of ``tobacco products.'' 
However, FDA does not believe it is necessary to define individual 
categories of tobacco products for purposes of this rule. In fact, by 
deeming ``tobacco products'' generally, it will help ensure that novel 
and future tobacco products are introduced into the market in an 
appropriate and efficient manner. FDA may issue specific definitions at 
a later time if it determines that doing so is appropriate.
    (Comment 171) At least one comment recommended that we establish a 
definition of ``vapor product'' and define it as ``any noncombustible 
tobacco-derived product containing nicotine that employs a heating 
element, power source, electronic circuit, or other electronic, 
chemical or mechanical means, regardless of shape or size, including 
any component thereof, that can be used to produce vapor from nicotine 
in a solution or other form.'' The comment stated that

[[Page 29043]]

several States have adopted variations of this definition and that it 
would provide necessary clarity.
    Likewise, at least one comment suggested that we establish a 
definition of ``alternative nicotine product,'' which would be defined 
as ``any noncombustible tobacco-derived product containing nicotine 
that is intended for human consumption, whether chewed, absorbed, 
dissolved or ingested by any other means.'' The comment stated that 
several States have adopted variations of this definition and that it 
would provide necessary clarity.
    (Response) For the reasons explained previously, FDA finds that it 
is not necessary to add these definitions to the codified for this 
final rule.
    (Comment 172) A few comments suggested that FDA clarify the 
differences between ``liquid nicotine'' and ``e-cigarette liquid (or e-
liquid).'' They noted that, throughout the NPRM, FDA referred to the 
liquid component of e-cigarettes as ``e-cigarette liquid,'' which 
contains nicotine, flavorings, and other ingredients. However, in a few 
instances, FDA referred to ``nicotine solutions'' or ``nicotine 
liquids.'' They asked that we clarify the difference to avoid confusion 
and unintended coverage under chapter IX of the FD&C Act.
    (Response) FDA agrees that clarification is necessary. Liquid 
nicotine does not have flavorings or other ingredients added to it. E-
cigarette liquid (or ``e-liquid'') is a liquid containing nicotine, 
flavorings, and/or other ingredients. This final rule regulates e-
liquid and liquid nicotine that is made or derived from tobacco.
    (Comment 173) Some comments requested that FDA refer to ENDS 
products as vapor products and use definitions that differentiate 
between the products that use combustion and those that use 
vaporization. They stated that this distinction is necessary because 
the potential harms posed by these products are different and consumers 
may believe that vapor products are as dangerous as combusted smoking 
products. One comment provided an example as to how to recategorize 
tobacco products based on their delivery method and combustion. Another 
comment requested that FDA add ``combustion'' to the current definition 
of cigarette to differentiate between combusted and vaporized products.
    (Response) For purposes of this deeming regulation, FDA does not 
believe it is necessary to distinguish between vapor products and 
combusted products. The statutory definition of ``cigarette'' was 
established by Congress and describes conventional cigarettes (section 
900(3) of the FD&C Act). If FDA finds reason to differentiate between 
the combusted and vaporized products for the purpose of future 
regulations, FDA will issue a new NPRM to propose such definitions. In 
addition, FDA is aware that some e-cigarettes are heated to a high 
enough level to cause combustion of the e-liquid.
    (Comment 174) At least one comment suggested that FDA alleviate any 
potential confusion between conventional cigarettes and e-cigarettes by 
adding a third subsection to the proposed definition of ``cigarette'' 
to read as follows: `` `Cigarette' (1) Means a product that: (i) Is a 
tobacco product and (ii) meets the definition of the term ``cigarette'' 
in section 3(1) of the Federal Cigarette Labeling and Advertising Act; 
(2) includes tobacco, in any form, that is functional in the product, 
which, because of its appearance, the type of tobacco used in the 
filler, or its packaging and labeling, is likely to be offered to, or 
purchased by, consumers as a cigarette or as roll-your-own tobacco; and 
(3) does not include a product such as nicotine [or products containing 
nicotine] that is derived from tobacco but does not contain tobacco.''
    (Response) FDA finds that this addition to the cigarette definition 
is unnecessary to prevent confusion between the two product categories. 
The definition of ``cigarette'' in Sec.  1140.3 of this final rule 
conforms to the definition in section 900(3) of the FD&C Act.
    (Comment 175) One comment requested that FDA establish one common 
name for all vapor products, so the manufacturers, distributers, 
importers, and retailers of these products can comply with section 
903(a)(4) of the FD&C Act, which requires that the manufacturer include 
an established name on the product labeling.
    (Response) At this time, FDA has not established a common 
nomenclature for this group of products. FDA will consider these 
comments in determining whether future regulatory action is 
appropriate.

K. Sottera Decision

    In the NPRM, FDA explained that, as set forth in the Sottera 
decision, e-cigarettes that are ``customarily marketed'' are tobacco 
products over which the Agency cannot exercise its tobacco product 
authority until it finalizes a regulation that deems them to be subject 
to chapter IX of the FD&C Act.
    (Comment 176) Some comments provided analysis of the D.C. Circuit's 
decision in Sottera, Inc. v. Food and Drug Administration, 627 F.3d 891 
(D.C. Cir. 2010), which formed part of the basis for FDA's decision to 
deem ``tobacco products'' subject to FDA's tobacco product authorities. 
They took issue with FDA's description of the key points of the case, 
stating that FDA is misreading the holding of Sottera to conclude that 
the court there held that FDA has jurisdiction over e-cigarettes as 
tobacco products because that question was not presented in the case.
    (Response) FDA's analysis of the Sottera decision in the proposed 
deeming rule (79 FR 23142 at 23149 and 23150) was correct. On December 
7, 2010, the D.C. Circuit held that FDA has the authority to regulate 
customarily marketed tobacco products under the Tobacco Control Act and 
products made or derived from tobacco that are marketed for a 
therapeutic purpose under the medical product provisions of the FD&C 
Act. (See Sottera, Inc. v. Food & Drug Administration, 627 F.3d 891 
(D.C. Cir. 2010).) On January 24, 2011, the D.C. Circuit denied the 
government's petitions for rehearing and rehearing en banc (by the full 
court). (See Sottera, Inc. v. FDA, No. 10-5032 (D.C. Cir. Jan. 24, 
2011) (per curiam).) On April 25, 2011, FDA issued a letter to 
stakeholders indicating its intent to deem additional tobacco products, 
including e-cigarettes, to be subject to FDA's authorities in chapter 
IX of the FD&C Act.
    (Comment 177) A few comments claimed that FDA had attempted to ban 
e-cigarettes, the Sottera decision established the legality of e-
cigarettes, and FDA's purported ban was unlawful.
    (Response) FDA disagrees. Prior to the Sottera case, FDA did not 
seek to ban e-cigarettes. Instead, FDA had detained several shipments 
of e-cigarettes and their accessories offered for import by Smoking 
Everywhere and Sottera, Inc. (doing business as NJOY) and eventually 
refused admission into the United States to two of Smoking Everywhere's 
shipments on the ground that the products appeared to be unapproved 
drug/device combination products. FDA did not attempt to categorically 
ban e-cigarettes for sale in the United States but, instead, sought to 
regulate them under its drug/device authorities.
    (Comment 178) A few comments stated that manufacturers are 
marketing e-cigarettes as cessation products and, therefore, they 
should be regulated as cessation products.
    (Response) As stated in the D.C. Circuit's decision in Sottera, e-
cigarettes that are customarily marketed tobacco products are subject 
to FDA's tobacco product authorities. If an e-cigarette

[[Page 29044]]

manufacturer wishes to market its product for a therapeutic purpose, 
the company would be subject to FDA's drug/device authorities and must 
submit an application to be marketed as a medical product.

IX. Effect of Deeming Rule on Vape Shop Manufacturers

    Some comments requested clarification regarding the regulatory 
status of an ENDS retail establishment that sells e-liquids (sometimes 
known as a vape shop). Such establishments sell a variety of products 
including ENDS, replacement pieces, hardware, custom mixed e-liquids, 
and other related accessories.
    If an establishment mixes or prepares e-liquids or creates or 
modifies aerosolizing apparatus for direct sale to consumers for use in 
ENDS, the establishment fits within the definition of ``tobacco product 
manufacturer'' in section 900(20) of the FD&C Act and the combinations 
it mixes and/or prepares are new tobacco products within the meaning of 
section 910(a)(1). For requirements not covered by the compliance 
policy set forth in this section, ENDS retail establishments that meet 
the definition of a manufacturer should refer to the compliance periods 
in tables 2 and 3. As discussed in the Analysis of Impacts (Ref. 204), 
FDA expects that most vape shops will stop mixing e-liquids (and 
preparing other new tobacco products) to avoid being ``manufacturers'' 
under the Tobacco Control Act.
    The definition of ``tobacco product manufacturer'' in section 
900(20) includes ``any person, including any repacker or relabeler, who 
manufactures, fabricates, assembles, processes, or labels a tobacco 
product.'' Additionally, for purposes of section 905, the FD&C Act 
defines ``manufacturing, preparation, compounding, or processing'' to 
include ``repackaging, or otherwise changing the container, wrapper or 
labeling of any tobacco product package from the original place of 
manufacture to the person who makes the final delivery or sale to the 
ultimate consumer or user.'' Section 910(a)(1) defines a ``new tobacco 
product'' as ``any tobacco product (including those products in test 
markets) that was not commercially marketed in the United States as of 
February 15, 2007; or any modification (including a change in design, 
any component, any part, or any constituent, including a smoke 
constituent, or in the content, delivery or form of nicotine, or any 
other additive or ingredient) of a tobacco product where the modified 
product was commercially marketed in the United States after February 
15, 2007.'' Therefore, establishments engaged in mixing or preparing e-
liquids or creating or modifying aerosolizing apparatus for direct sale 
to consumers for use in ENDS are tobacco product manufacturers and, 
consequently, are subject to all of the statutory and regulatory 
requirements applicable to manufacturers.
    The statute authorizes FDA to regulate the manufacture of all new 
products, including those manufactured at the retail level. This is 
important to FDA's ability to protect the public health since products 
manufactured at the retail level pose many of the same public health 
risks as those manufactured upstream and possibly additional risks 
related to the lack of standard manufacturing practices and controls. 
The introduction of statutory controls and oversight into a 
historically unregulated market inevitably will lead to some market 
change and consolidation. FDA recognizes that, with the implementation 
of this final rule, vape shops that meet the definition of tobacco 
product manufacturer may cease engaging in manufacturing activities 
rather than comply with requirements for manufacturers under this final 
rule. However, FDA notes that such entities will have the option to 
continue operating solely as retailers, as some vape shops currently 
do. In addition, as noted earlier, FDA believes that this policy (and 
the deeming rule as a whole) will not stifle innovation but could, 
instead, encourage it. Over time, FDA expects that its premarket review 
authorities will spur creative evolution and help to create a market 
where available products present a lower risk of user and population 
harm, provide a more consistent delivery under varying conditions of 
use, are less likely to lead to initiation of tobacco use, and/or are 
easier to quit. In recent years, ENDS products have proliferated in the 
absence of regulation, in some cases resulting in a lack of quality 
control and consistency, consumer confusion and even availability of 
acutely toxic products. In this context, we expect that changes in the 
market in response to regulation will have significant benefits for 
public health and will be a net benefit overall.
    As the ENDS market continues to evolve, it is important that FDA 
exercise its authority to oversee all establishments engaged in 
manufacturing activities and their products, in order to protect 
consumers and to carry out the public health objectives of the Tobacco 
Control Act.

A. Premarket Requirements (Sections 905 and 910)

    As stated throughout the document, manufacturers of newly deemed 
products that are not grandfathered will be required to obtain 
premarket authorization of their products through one of three 
pathways--PMTA, SE or SE exemption (sections 905 and 910 of the FD&C 
Act). Therefore, ENDS retailers engaged in mixing or preparing e-
liquids or creating or modifying aerosolizing apparatus will be 
required to obtain premarket authorization for each non-grandfathered 
product that they prepare for sale or distribution to consumers. 
However, under the compliance policy laid out in section V.A, FDA does 
not intend to enforce, during specified compliance periods, the 
premarket review requirements including for ENDS retailers that mix or 
prepare the same e-liquids they have been preparing and offering for 
sale as of the effective daterule, or that create or modify 
aerosolizing apparatus resulting in the same products they have been 
creating as of the effective date. An initial compliance period, the 
length of which is dependent on the type of application to be 
submitted, is intended to provide additional time to prepare and submit 
premarket applications. In addition, for the 12 months following this 
initial compliance period, FDA intends to continue the compliance 
policy and does not intend to enforce the premarket review requirements 
if the firm has a pending submission. This means that, during this 12-
month continued compliance period of FDA review, FDA expects that ENDS 
retailers of any kind will sell only those products that are (1) 
grandfathered; (2) authorized by FDA; or (3) tobacco products for which 
the ENDS retailer or another (upstream) manufacturer has submitted a 
marketing application/submission to FDA during the initial compliance 
period. (For PMTAs, the initial compliance period to submit is 24 
months after the final rule effective date.)
    FDA expects that this 12-month continued compliance period of FDA 
review will benefit manufacturers and retailers of newly deemed 
products, including ENDS retailers, since upstream manufacturers that 
submit applications will have a significant incentive to make retailers 
aware of their pending applications/submissions. Specifically, we 
expect that upstream manufacturer suppliers will inform ENDS retailers 
selling their products whether the upstream manufacturer has submitted 
a premarket application for such e-liquids and other ENDS products

[[Page 29045]]

within the initial compliance period such that the retailers can 
benefit from the continued compliance period while FDA reviews such 
applications. FDA expects that manufacturers will have an incentive to 
make retailers aware of which products are the subject of applications, 
which will enable retailers to know whether a marketing application has 
been submitted and whether FDA has acted on an application. In 
addition, retailers may contact suppliers for relevant product 
information. Therefore, after 36 months from the effective date (i.e., 
at the end of the initial compliance period plus 12-month continued 
compliance period), FDA expects that all ENDS retailers will sell only 
those products that are either grandfathered or for which they have, or 
an upstream supplier has, received premarket authorization.

   Table 4--Compliance Policy for Premarket Requirements--ENDS Retail
                             Establishments
------------------------------------------------------------------------
                               24-36 months after     Beyond 36 months
 0-24 months after the rule    the rule goes into    after the rule goes
      goes into effect               effect              into effect
------------------------------------------------------------------------
FDA does not intend to        FDA does not intend   The compliance
 enforce premarket             to initiate           period no longer
 authorization requirements    enforcement action    applies, even if
 for e-liquid products that    for e-liquid          the final mixture
 retailers mix and sell        products that         has a pending
 without marketing             retailers mix and     marketing
 authorization, provided       sell where a          submission/
 that final mixture is the     marketing             application. All
 same as a product the         application has       products for which
 retailer was selling or       been submitted and    a marketing
 offered for sale as of the    is still pending      submission/
 effective date.               for the final         application is
                               mixture.              pending are subject
                                                     to enforcement
                                                     action.
------------------------------------------------------------------------

    As stated previously, because products manufactured at the retail 
level pose many of the same public health risks as those manufactured 
upstream, and possibly additional risks, it is important to enforce the 
statutory requirements for all new products, even those currently 
manufactured by ENDS retailers.
    In general, the FD&C Act provides three pathways that manufacturers 
may use to seek market authorization for a new product: The premarket 
tobacco product application pathway, the SE pathway, and the exemption 
from SE pathway. FDA anticipates that most manufacturers of e-liquids 
and apparatus components/complete delivery systems will seek 
authorization through the PMTA pathway. To obtain marketing 
authorization under the PMTA pathway, manufacturers are required to 
establish, among other things, that permitting their product to be 
marketed would be appropriate for the protection of the public health. 
In establishing this, manufacturers should take into account, and FDA 
will consider, the ways in which the new product is likely to be used. 
For example, PMTAs for these products should contain information on 
whether the product is likely to be used alone or together with other 
legally marketed tobacco products (such as available delivery systems), 
as well as the type and range of the other products with which it is 
likely to be used.
    While the statutory standard will apply to all products for which a 
PMTA is filed, FDA expects that different classes of products may have 
differing likelihoods of success in meeting the standard, by virtue of 
their expected use. As stated previously, to meet the statutory 
standard, PMTAs should contain information on whether a product is 
likely to be used alone or together with other legally marketed 
products and the public health implications of those likely uses. FDA 
has issued a draft guidance on PMTAs for ENDS, published concurrently 
with this final rule, which, when finalized, will explain FDA's current 
thinking regarding some appropriate means of addressing the premarket 
authorization requirements for newly deemed e-liquids and hardware/
apparatus components. FDA intends to act as expeditiously as possible 
with respect to all new applications, while ensuring that statutory 
standards are met.
    To reduce research burdens and increase efficiency for ENDS retail 
establishments that file applications, FDA suggests that ENDS retail 
establishments use master files whenever possible. By obtaining 
permission from a master file holder, manufacturers could reference 
extensive ingredients lists and constituent testing that they otherwise 
would be required to perform themselves for marketing authorization. To 
facilitate this process, elsewhere in this issue of the Federal 
Register, FDA is announcing the availability of a final guidance to 
provide information on how to establish and reference a TPMF. This 
information will help applicants of newly deemed products prepare 
premarket and other regulatory submissions because they can reference 
information in TPMFs rather than develop the information on their own.
    Given the anticipated availability and use of master files (as 
discussed in a separate, final guidance published concurrent with 
Deeming), which allows manufacturers to rely on the data and analysis 
submitted to FDA by separate entities, FDA anticipates that 
manufacturers will, over time, benefit from significantly increased 
efficiencies and reduced costs for complying with the statute. Such a 
system prevents and reduces duplication and allows for manufacturer 
reliance on confidential or sensitive non-public information while 
maintaining its confidentiality, thus saving time and reducing burdens 
for multiple manufacturers. Because of the nature of upstream supply of 
many components for ENDS products, especially e-liquids, FDA 
anticipates that commercial incentives will be sufficient to drive 
manufacturer reliance on the system of master files. We also note that 
at present, FDA understands that, based on the Agency's review of 
publically available information as discussed in section III.C of the 
Analysis of Impacts (Ref. 204), the number of entities engaged in 
upstream production of liquid nicotine and flavors specifically 
developed for use with e-liquids is small, in the range of seven to 
thirteen entities (see earlier discussion in response to comment 34). 
Given the current marketplace, the master file system is likely to 
prove widely appealing and widely utilized by the ENDS industry, 
reducing burden significantly.
    In addition, FDA intends to open public dockets for uniquely 
identified compounds likely to be used in an e-liquid product, such as 
propylene glycol, glycerin, nicotine, colorants, and flavoring agents. 
FDA intends to invite stakeholders to submit to the docket information 
regarding specific compounds, including data, studies, or other files, 
such as data on individual health effects of inhalation exposure, 
animal study data examining exposure to varying levels of compounds 
within e-liquids, or testing the impact of temperature on changes to 
the aerosol constituents. This information could

[[Page 29046]]

then be used to help support applications for premarket review, for 
example, generating information on HPHCs in ENDS products that is then 
submitted as part of a PMTA.

B. Ingredient Listing and HPHC Requirements (Section 904 and 915)

    As of the effective date of this rule, the ingredient listing 
requirements of section 904 of the FD&C Act will apply to manufacturers 
of the newly deemed products, including ENDS retail establishments that 
mix or prepare e-liquids or create or modify aerosolizing apparatus for 
sale or distribution. At this time, FDA intends to limit enforcement to 
finished tobacco products. FDA does not at this time intend to enforce 
these requirements for manufacturers of components and parts of newly 
deemed products that are sold or distributed solely for further 
manufacturing into finished tobacco products. This means that FDA 
generally intends to enforce these requirements with respect to ENDS 
retail establishments that mix or prepare e-liquids or create or modify 
aerosolizing apparatus for sale or distribution directly to consumers 
but not to distributors who sell components for further manufacturing. 
However, if the upstream distributor submits an ingredient list for a 
particular product, FDA does not intend to enforce the ingredient 
listing requirement against an ENDS retailer with respect to that 
particular product. We note that FDA also intends to issue a guidance 
regarding HPHC reporting under section 904(a)(3), and later a testing 
regulation as required by section 915, with enough time for 
manufacturers to report given the 3-year compliance period for HPHC 
reporting. Section 904 (a)(3) requires the submission of a report 
listing all constituents, including smoke constituents, identified as 
harmful or potentially harmful (HPHC) by the Secretary. Section 915 
requires the testing and reporting of the constituents, ingredients, 
and additives the Secretary determines should be tested to protect the 
public health. The section 915 testing and reporting requirements apply 
only after FDA issues a regulation implementing that section, which it 
has not yet done. Until these testing and reporting requirements have 
been established, newly deemed tobacco products (and currently 
regulated tobacco products) are not subject to the testing and 
reporting provisions found under section 915. As noted elsewhere in 
this document, FDA does not intend to enforce the reporting 
requirements under section 904(a)(3) for newly deemed products before 
the close of the 3-year compliance period, even if the HPHC guidance 
and the section 915 regulation are issued well in advance of that time.

C. Registration and Product Listing (Section 905)

    Section 905 of the FD&C Act requires every person who owns or 
operates an establishment engaged in the ``manufacture, preparation, 
compounding, or processing of a tobacco product'' to register its 
establishment with FDA and submit a listing of its tobacco products to 
the Agency. If an ENDS retail establishment engages in these 
activities, section 905 requires the establishment to register and list 
its products with FDA in accordance with this section. These 
requirements apply under the statute for all distinct products 
manufactured, and they enable FDA to assess the landscape of products 
manufactured by these entities. If ENDS retail establishments are 
mixing or preparing e-liquids or creating or modifying aerosolizing 
apparatus for direct sale to consumers, then they will have to list 
each e-liquid combination that they sell. It will be the responsibility 
of the ENDS retail establishment, as a manufacturer, to determine how 
many and which products they plan to manufacture. For shops that 
prepare an expansive array of custom mixes, with many gradations of 
flavor, nicotine strength or other characteristic, this would mean 
identifying, listing, and reporting ingredients for a large number of 
distinct products. In reality, however, we expect that such entities 
will elect to narrow the list of combinations they sell (with more 
limited distinctions in strength and flavor, etc.), since such a 
narrowing will allow them to continue providing custom products and a 
variety of options while simplifying their reporting. However, since 
the time and cost of listing each additional mixture is expected to be 
very low, the reduction will not necessarily be significant. In 
addition, any narrowing may reflect a reduction in products that are 
listed but are not actually sold.

D. Tobacco Health Document Submissions (Section 904)

    Section 904(a)(4) of the FD&C Act requires each tobacco product 
manufacturer or importer, or agent thereof, to submit all documents 
that relate to health, toxicological, behavioral, or physiologic 
effects of current or future products, their constituents (including 
smoke constituents), ingredients, components, and additives. As 
discussed in section IV.D (discussing the compliance policy for small-
scale tobacco product manufacturers), FDA, for an additional 6 months 
following the end of the generally applicable compliance period, does 
not intend to enforce against those small-scale tobacco product 
manufacturers (including ENDS retail establishments) who submit the 
required information.

E. Office of Small Business Assistance

    Under section 901(f) of the FD&C Act, one of FDA's initial 
activities upon passage of the Tobacco Control Act was to establish the 
OSBA within CTP to assist small tobacco product manufacturers and 
retailers in complying with the law. FDA recognizes that the issuance 
of this final deeming rule, including the clarifying information noting 
that ENDS retail establishments are manufacturers subject to this rule, 
may result in many additional small tobacco product entities contacting 
OSBA for assistance. Accordingly, FDA intends to hire additional OSBA 
staff to provide assistance to small tobacco product entities wherever 
possible.

X. Regulation of Other Categories of Products

    FDA is finalizing this rule to deem all products that meet the 
definition of tobacco product in section 201(rr) of the FD&C Act 
(except accessories of newly deemed tobacco products) to be subject to 
FDA's tobacco product authorities. In addition, as stated in the NPRM, 
any future tobacco product that meets the definition in section 201(rr) 
(except accessories of newly deemed tobacco products) will also be 
subject to FDA's authorities under chapter IX of the FD&C Act. 
Regulation of the newly deemed tobacco products is intended to address 
the public health concerns related to these products. A summary of the 
comments regarding dissolvables, gels, pipe tobacco, waterpipe tobacco, 
other alternative products, and future tobacco products is discussed as 
follows. FDA's responses to the comments are also included.

A. Nicotine in Newly Deemed Products

    Comments were split as to the health risks of nicotine and its 
impact on adult tobacco product users.
    (Comment 179) Many comments stated that nicotine is addictive, and 
all products containing nicotine pose a health threat to youth. Some 
also stated that nicotine can have detrimental effects on the 
cardiovascular system and promotes lung carcinomas (Refs. 15, 205). 
Other comments noted that it is generally accepted that nicotine is not 
directly responsible for tobacco-related

[[Page 29047]]

death and disease (Ref. 206) and that the Surgeon General has stated 
that it is the toxic substances in tobacco products (not the nicotine) 
that cause almost all tobacco-related death and disease (Ref. 9).
    (Response) FDA agrees that nicotine is the primary addictive 
substance in tobacco products, as stated in the proposed deeming rule 
(79 FR 23142 at 23180). The Surgeon General has long recognized that 
nicotine is the primary pharmacologic agent of tobacco that can be 
absorbed into the bloodstream and cause addiction (Ref. 1 at 6-9). In 
addition, the Surgeon General has stated that addiction to nicotine is 
the ``fundamental reason that individuals persist in using tobacco 
products, and this persistent use contributes to many diseases'' (Ref. 
2 at 105). While nicotine does not directly cause most smoking-related 
diseases, addiction to the nicotine in tobacco products sustains 
tobacco use, leading to the ingestion of the toxic substances in 
combusted tobacco products and tobacco smoke (Ref. 14). However, 
nicotine, in low doses, is given in different routes of administration 
as nicotine replacement therapies to help consumers to stop smoking, 
when approved for such purposes.
    While the inhalation of nicotine (i.e., nicotine without the 
products of combustion) is of less risk to overall public health than 
the inhalation of nicotine delivered by smoke from combusted tobacco 
products, limited data suggests that the pharmacokinetic properties of 
inhaled nicotine can be similar to nicotine delivered by combusted 
tobacco products. Thus, inhaled nicotine from a non-combustible product 
may be as addictive as inhaled nicotine delivered by combusted tobacco 
products. Researchers recognize that the effects from nicotine exposure 
by inhalation are likely not responsible for the high prevalence of 
tobacco-related death and disease in this country (Refs. 10, 11). 
Although nicotine has not been shown to cause the chronic disease 
associated with tobacco use, the 2014 Surgeon General's report noted 
that there are risks associated with nicotine (Ref. 9 at 111). For 
example, nicotine at high enough doses has acute toxicity (id.). 
Nicotine exposure during fetal development has lasting adverse 
consequences for brain development (id.). Nicotine also adversely 
affects maternal and fetal health during pregnancy, contributing to 
multiple adverse outcomes such as preterm delivery and stillbirth 
(id.). Further, data in animal models suggest that nicotine exposure 
during adolescence may have lasting adverse consequences for brain 
development (id.). Some studies also have found that nicotine can have 
detrimental effects on the cardiovascular system and potentially 
disrupt the central nervous system (Refs. 14, 15). (See also section 
VIII.C discussing the increase in poisoning due to accidental nicotine 
ingestion.)
    (Comment 180) FDA received a large number of comments discussing 
the addictive nature of nicotine and the impact of nicotine on 
adolescents. Several comments stated that research indicates that the 
adolescent brain is more vulnerable to nicotine addiction than the 
adult brain. The comments noted that researchers have found that, 
``most likely owing to its ongoing development, the adolescent brain is 
more vulnerable to the effects of nicotine than the adult brain. 
Adolescents progress faster to nicotine dependence than adults, find 
nicotine more rewarding, underestimate the risks of smoking, and are 
more influenced by smoking behavior in their social milieu.'' (Refs. 
207, 208). One comment noted that animal research showing the 
adolescent brain is particularly vulnerable to nicotine addiction, and 
that adolescents are also less susceptible to withdrawal symptoms, 
creating an all-reward, no-regret system for psychostimulant use (Refs. 
209, 210, 211). Another comment noted that the U.S. Surgeon General has 
found that key symptoms of nicotine dependence--such as withdrawal and 
tolerance--develop in adolescents following even minimal exposure to 
nicotine. Additionally, the comment stated that the Surgeon General's 
2012 report cites one study following occasional adolescent smokers 
that found that a large proportion experienced at least one symptom of 
nicotine dependence upon quitting, even in the first 4 weeks after 
initiating monthly smoking (at least two cigarettes within a 2-month 
period) (Ref. 49 at 24, citing Ref. 212).
    (Response) FDA agrees that given their developmental stage, and the 
fact that brain maturation continues into the mid-twenties, adolescents 
and young adults are more uniquely susceptible to biological, social, 
and environmental influences to use and become addicted to tobacco 
products. If individuals do not start using cigarettes by age 26, they 
are unlikely ever to smoke (Ref. 3). Research shows that 87 percent of 
established adult smokers began smoking before the age of 18 (Ref. 9). 
An analysis by the WHO of studies performed among final-year high 
school students in the United States suggests that fewer than two out 
of five smokers who believe that they will quit within 5 years actually 
do quit. In high-income countries, about 7 out of 10 adult smokers say 
they regret initiating smoking and would like to stop (Ref. 213).
    In addition, FDA agrees that there are data suggesting that the 
adolescent brain is more vulnerable to developing nicotine dependence 
than the adult brain and that there is evidence to suggest that these 
brain changes are permanent (Refs. 49, 214). The Surgeon General 
reported that ``most people begin to smoke in adolescence and develop 
characteristic patterns of nicotine dependence before adulthood'' (Ref. 
3). These youth develop physical dependence and experience withdrawal 
symptoms when they try to quit smoking (id.). As a result, addiction to 
nicotine is often lifelong (Ref. 4). Additionally, youth and young 
adults generally ``underestimate the tenacity of nicotine addiction and 
overestimate their ability to stop smoking when they choose'' (Ref. 5). 
For example, one survey revealed that ``nearly 60 percent of 
adolescents believed that they could smoke for a few years and then 
quit'' (Ref. 7). Research conducted in animal models have indicated 
that exposure to substances such as nicotine can disrupt adolescent 
brain development and may have long-term consequences on executive 
cognitive function and on the risk of developing a substance abuse 
disorder and various mental health problems as an adult (Ref. 8). This 
exposure to nicotine can also have long-term results on decreasing 
attention performance and increasing impulsivity which could in turn 
promote the maintenance of nicotine use behavior (id.).

B. Dissolvables

    FDA noted in the NPRM that it was proposing to deem certain 
dissolvable products (i.e., those dissolvable products that do not 
currently meet the definition of ``smokeless tobacco'' in section 
900(18) of the FD&C Act because they do not contain cut, ground, 
powdered, or leaf tobacco and instead contain nicotine extracted from 
tobacco). We explained that little evidence is available to ascertain 
the pharmacological properties and harmful effects of dissolvable 
tobacco products or compare them with FDA-approved nicotine replacement 
products or other tobacco products. We also noted that certain 
dissolvable smokeless tobacco products, given their candy-like 
appearance, have the potential for unintended poisonings. FDA deems 
these dissolvable products with this final rule.

[[Page 29048]]

    (Comment 181) Comments stated that FDA should not rely on a study 
investigating flavored tobacco products in young adults as evidence 
that dissolvables are more attractive to children. They indicated that 
this study is inapplicable because it only looked at behaviors of 
people 18 years or older.
    (Response) The cited study (Ref. 54) assessed the prevalence of 
flavored tobacco products (including dissolvables) in individuals 18 
and older, which encompasses both young adults and adults. The study 
stated that the products' packaging looks like candy packaging and the 
products often are sold next to candy. FDA believes that these factors 
cause confusion regarding the safety of these novel tobacco products 
for adult consumers as well as children (Ref. 215). In addition, this 
study cited an additional study that concluded that sugar preference is 
greater in youth and young adults (Ref. 53). Accordingly, FDA believes 
it was appropriate to cite to this study as evidence supporting FDA's 
concerns with certain dissolvable products.
    (Comment 182) Some comments expressed concerns regarding possible 
confusion between dissolvable tobacco products and candy and the 
possibility of inadvertent poisonings.
    (Response) FDA agrees that the candy-like appearance of some 
dissolvable products may result in accidental poisonings. As FDA 
discussed in the NPRM, data from 2010 indicates that 13,705 tobacco 
product ingestion cases were reported and more than 70 percent of those 
cases involved infants under a year old (Ref. 215). Although it is 
unclear exactly how many of these cases involved dissolvables, 
smokeless tobacco products (in all forms, including dissolvables) were 
the second most common tobacco product ingested by children, after 
cigarettes (id.).
    (Comment 183) Some comments mentioned that dissolvable tobacco 
products may be easily confused with NRTs and, therefore, should be 
regulated.
    (Response) The Agency finds that FDA regulation of all dissolvable 
products under chapter IX of the FD&C Act will help to alleviate 
potential confusion about the safety and use of these products. 
Products that contain nicotine derived from tobacco, are intended for 
human consumption, and are not marketed for therapeutic purposes, are 
subject to FDA's tobacco product authorities under chapter IX of the 
FD&C Act.
    (Comment 184) Comments provided unpublished data (Ref. 216) 
indicating that dissolvable tobacco products deliver nicotine levels 
sufficient to promote and sustain addiction. They also indicated that 
dissolvable tobacco products have a higher average pH than other 
tobacco products, increasing the amount of absorbable nicotine.
    (Response) FDA acknowledges that information about harmful or 
potentially harmful constituents in such products is sparse, but 
studies indicate that the level of nicotine in dissolvable products may 
differ from cigarettes and may lead to nicotine addiction (Ref. 217). 
These studies support the public health need to regulate all 
dissolvable tobacco products.
    (Comment 185) Comments stated that dissolvable tobacco products are 
safer than other tobacco products and have lower levels of nitrosamines 
than snus or snuff and just slightly higher levels than some NRTs (Ref. 
218). They also provided information that evaluated plasma nicotine 
levels, heart rates, and reduction in cigarette cravings, and found 
that the levels in certain dissolvables were similar to the levels in 
NRTs (Ref. 219).
    (Response) While a continuum of nicotine-delivering products 
exists, deeming all tobacco products will enable the Agency to collect 
information about the ingredients and the health and behavioral effects 
of these products. These products are ``tobacco products'' with the 
potential to addict users and harm children, particularly given their 
candy-like appearance, and are subject to FDA's tobacco control 
authorities upon the effective date of this final rule. FDA also notes 
that NRTs are regulated products and subject to premarket review by 
FDA.

C. Gels

    As proposed, FDA is deeming nicotine gels with this final rule.
    (Comment 186) Some comments agreed that nicotine gels should be 
subject to FDA's chapter IX authorities under the FD&C Act. In support 
of their argument, they provided studies showing that children and 
young adults are more susceptible than adults to nicotine poisoning 
through the skin (Ref. 220).
    (Response) With this final rule, FDA is finalizing its proposal to 
deem all ``tobacco products'' including nicotine gels, which are 
absorbed through the skin. In addition to meeting the definition of 
``tobacco product,'' nicotine gels can be addictive and lead to use of 
other tobacco products that have well-documented risks of tobacco-
related death and disease. Regulating these products also will help, 
among other things, to address consumers' unsubstantiated beliefs that 
non-cigarette tobacco products are safe alternatives to cigarettes.

D. Pipe Tobacco

    FDA proposed to cover pipe tobacco with this deeming rule. FDA 
indicated that pipe tobacco smokers have a risk of tobacco-related 
disease similar to the risk of those who inhale cigar smoke or smoke 
cigarettes (Ref. 221). The Surgeon General also found that pipe and 
cigar smokers experience oral and laryngeal cancer risks similar to 
that of cigarette smokers (Ref. 222). FDA is deeming pipe tobacco with 
this final rule.
    (Comment 187) A few comments provided suggestions as to how FDA 
should define pipe tobacco in this final rule to differentiate it from 
roll-your-own tobacco. For example, comments suggested FDA define pipe 
tobacco to include the moisture measured at the time of packing, the 
amount of reducing sugars, and the fact that it does not use 
reconstituted sheet tobacco or expanded leaf tobacco as part of the 
blend. Others suggested FDA define the term based on the ``consumer's 
reasonable perception of the product'' or include language stating that 
it is ``suitable for use and likely to be offered to, or purchased by, 
consumers as tobacco to be smoked in a pipe.'' Comments also requested 
that FDA enforce against the misuse of pipe tobacco as roll-your-own 
tobacco, regardless of whether it defines pipe tobacco, because 
mislabeled pipe tobacco already meets the definition of cigarette 
tobacco or roll-your-own tobacco.
    (Response) FDA disagrees. The Agency finds that it is not necessary 
to define pipe tobacco in this rule. FDA also notes that it has issued 
Warning Letters for products bearing the package description of ``pipe 
tobacco,'' but that are sold or distributed for use as cigarettes for 
the purposes of chapter IX of the FD&C Act due to the fact that, 
because of its appearance, the type of tobacco used in the filler, or 
its packaging and labeling, it is suitable for use and likely to be 
offered to consumers as cigarettes, and/or likely to be purchased by 
consumers for making cigarettes or intended for use in cigarettes. FDA 
will continue to do so as circumstances warrant.
    (Comment 188) Comments stated that when consumers use pipe tobacco 
for its intended use, it does not have the same public health concerns 
as other tobacco products. They also stated that pipe tobacco users are 
only a small percentage of adults and that only 0.2 percent of minors 
indicate that they are dual users of pipe tobacco and cigarettes (Ref. 
9). They stated that based on these differences, some of the automatic

[[Page 29049]]

deeming provisions should not apply to pipe tobacco. For example, they 
claimed premarket review requirements should not apply to pipe tobacco, 
because manufacturers make changes to maintain consistent taste for 
older populations and not to create ``new'' products.
    Other comments disagreed, citing evidence of the dangers of pipe 
tobacco, as discussed in the NPRM (79 FR 23142 at 23156 and 23168). 
They also expressed concerns that extended use of pipe tobacco releases 
significant amounts of secondhand smoke into the environment.
    (Response) FDA disagrees that pipe smoking is not a public health 
issue. As we stated in the NPRM, studies of pipe tobacco smokers have 
found that their risk of tobacco-related disease is similar to the risk 
in those who inhale cigar smoke or smoke cigarettes (Ref. 221). The 
Surgeon General also previously found that pipe and cigar smokers 
experience oral and laryngeal cancer risks similar to that of a 
cigarette smoker (Ref. 222). While the Surgeon General's report does 
indicate that pipe tobacco smokers may have a lower risk of developing 
cardiovascular disease than cigarette smokers, pipe tobacco users still 
are at risk for these diseases, and those who use both cigarettes and 
pipe tobacco may have even higher levels of risk due to their usage 
patterns (Ref. 9 at 428). Moreover, researchers have found that when 
compared with individuals who have never used tobacco, pipe smokers 
have an increased risk of death from cancers of the lung, oropharynx, 
esophagus, colorectum, pancreas, and larynx, and from coronary heart 
disease, cerebrovascular disease, and COPD (Refs. 32, 221).
    (Comment 189) A few comments expressed concern that retailers who 
blend pipe tobacco would be subject to all FD&C Act requirements for 
manufacturers, preparers, compounders, or processors of tobacco 
products, such as premarket review, and registration and listing. These 
comments requested that retailers blending up to either 3,000 pounds or 
5,000 pounds of pipe tobacco per year be exempt from the requirements 
of the law that apply to manufacturers.
    (Response) All entities that meet the definition of ``tobacco 
product manufacturer'' in section 900(20) of the FD&C Act, including 
retail establishments that blend pipe tobacco, are subject to and must 
comply with all applicable statutory and regulatory requirements for 
tobacco product manufacturers.

E. Waterpipe Tobacco

    The NPRM included waterpipe tobacco as an example of a tobacco 
product that would be covered under this deeming rule. We noted 
concerns regarding the safety of waterpipe tobacco given the nicotine 
and carcinogens in waterpipe tobacco smoke, and the availability of 
waterpipe tobacco in a variety of flavors that could be appealing to 
youth and young adults. FDA's final rule includes waterpipe tobacco in 
the scope of products subject to FDA's tobacco control authorities.
    (Comment 190) One comment requested that FDA clarify whether the 
term ``hookah'' refers to the waterpipe or the tobacco used in the 
waterpipe.
    (Response) In the NPRM, FDA generally used the term ``hookah'' to 
mean waterpipe smoking and ``hookah tobacco'' as the tobacco used in 
the waterpipe. Waterpipe smoking may also be referred to by other names 
such as shisha or narghile. To alleviate any confusion in this final 
rule, FDA has referred to ``waterpipe smoking'' and ``waterpipe 
tobacco'' to cover all types of tobacco smoking using a waterpipe.
    (Comment 191) At least one comment expressed concern about the 
public health risk of herbal waterpipe tobacco, which they assert has 
the same levels of toxicant exposure but without nicotine.
    (Response) FDA's tobacco product authorities under chapter IX of 
the FD&C Act do not extend to substances that are not made or derived 
from tobacco (like herbal waterpipe tobacco), because they do not meet 
the definition of ``tobacco product'' under section 201(rr) of the FD&C 
Act.
1. Dual and Polytobacco Use
    (Comment 192) Many comments expressed concern about the growth in 
dual and polytobacco use among youth and young adults. For example, the 
North Carolina Public Health Association submitted a preliminary 
analysis of the 2013 NCYTS, which indicated that 19.1 percent of high 
school students reported using two or more tobacco products and that 
88.4 percent of high school students who currently are using waterpipe 
tobacco reported using at least one other tobacco product. Some 
comments noted that dual use of waterpipe tobacco and cigarettes is 
more prevalent than exclusive waterpipe tobacco use and that waterpipe 
tobacco users typically smoke cigarettes with greater intensity than 
nonwaterpipe tobacco users (Ref. 222). In fact, dual use of waterpipe 
tobacco and cigarette use is one of the most common tobacco use 
profiles found in young adults age 18 to 24 years (e.g., Ref. 223).
    (Response) FDA remains concerned about the potential for dual and 
polytobacco use, particularly among youth and young adults. As the 
North Carolina research shows, a noncigarette tobacco product (like 
waterpipe tobacco) can be the first product used by new tobacco users 
and there is concern such users could continue using the initial 
product or transition to cigarettes or other tobacco products. There is 
also the concern that existing users could become dual users. 
Accordingly, it is critical to deem these noncigarette tobacco products 
and place restrictions upon them that are appropriate for the 
protection of the public health, including age and identification 
restrictions to help prevent youth use of these products.
2. Popularity
    (Comment 193) Many comments expressed concern about the growing use 
of waterpipe tobacco, particularly among young adults. For example, 
they noted that the percentage of young adults aged 18 to 24 who use 
waterpipe tobacco (7.8 percent) is significantly higher than adult use 
(1.5 percent) (Ref. 224). A few comments suggested that FDA 
overestimated this trend.
    (Response) FDA agrees with the many comments that supported 
regulation of waterpipe tobacco and noted the increase in use among 
young adults. Waterpipe tobacco use continues to increase in 
popularity, particularly among college students, with as many as 40 
percent reporting ever using waterpipe tobacco and 20 percent reporting 
use (i.e., use within the past 30 days) on some college campuses (Refs. 
25, 26).
3. Harms
    (Comment 194) Many comments supplemented the data in the NPRM 
regarding the dangers of smoking waterpipe tobacco. For example, they 
referred to several studies showing significant nicotine, carbon 
monoxide, and other carcinogen intake during waterpipe use (e.g., Refs. 
225, 226, 227, 228). Further, in studies involving the use of 
waterpipes in a hospital research ward, researchers found greater 
carbon monoxide exposure and a different pattern of carcinogen exposure 
for waterpipe tobacco smokers (when compared to cigarette smokers), and 
concluded that exposure to tobacco smoke toxicants during waterpipe use 
is similar qualitatively (though not quantitatively) to cigarette smoke 
(Refs. 229, 230). Comments concluded that waterpipe users have a 
significant risk of smoking-related diseases, but the

[[Page 29050]]

magnitude of the risk depends upon the extent of the use.
    (Response) FDA agrees with this assessment and that it supports 
finalizing its proposal to include waterpipe tobacco in the scope of 
this rule.
    (Comment 195) Many comments included data regarding the increased 
cancer risks associated with waterpipe smoking. For example, 
researchers identified significant associations between waterpipe 
tobacco use and esophageal squamous cell carcinoma and a 6-fold 
increase in risk of lung cancer from waterpipe tobacco use (Refs. 231, 
232). In addition, the existence of tobacco-related toxicants in 
waterpipe tobacco smoke may place users at risk for many of the same 
diseases as cigarette smokers, including a risk of lung cancer and 
respiratory illness (e.g., Refs. 233, 234, 235, 236). While some 
comments maintained that many of these users will use waterpipe tobacco 
only once in their lifetime, these products are growing in popularity 
with youth and young adults and cause tobacco-related death and 
disease.
    Other comments opposed FDA's proposal to regulate waterpipe 
tobacco, claiming that the dangers of waterpipe tobacco use are 
unsupported, that FDA has not adequately reviewed scientific studies, 
and that FDA ignored evidence. They also believed that use of 
disposable mouth piece tips would alleviate the risks of spreading 
communicable diseases through waterpipe use. In addition, they 
indicated that FDA's comparison of a waterpipe smoking session to 
smoking a single cigarette is inherently flawed due to the different 
patterns of use of these tobacco products.
    (Response) Although it is possible that use of disposable mouth 
piece tips could help alleviate the risks of spreading communicable 
diseases through waterpipe use, the products nevertheless present a 
significant risk of smoking-related diseases. Accordingly, FDA is 
finalizing its proposal to include waterpipe tobacco in the scope of 
this rule. Further, although the products have different use 
topographies, FDA continues to believe that a comparison between the 
toxicants emitted during a waterpipe session and cigarette smoking is 
valid and indicative of the dangers associated with waterpipe use. In 
fact, the WHO study group on tobacco regulation has found that a 
waterpipe session can be the equivalent of smoking more than 100 
cigarettes (Ref. 237). Moreover, regardless of the number of waterpipe 
tobacco users who use waterpipe tobacco for more than 1 day, the 
product presents significant health risks and is appropriately included 
in the scope of this rule.
4. Addiction
    (Comment 196) Some comments claimed that waterpipe tobacco smokers 
do not get addicted and, therefore, there is no need for FDA to 
regulate waterpipe tobacco. Others disagreed and claimed that waterpipe 
tobacco is addictive. These comments provided extensive data about the 
significant health effects (including nicotine and toxicant exposure) 
and the highly addictive nature of waterpipe use (e.g., dual use) 
(e.g., Ref. 233).
    (Response) Waterpipe tobacco contains nicotine, which is the 
primary addictive chemical in tobacco products. Researchers have 
observed nicotine dependence characteristics in some users, including 
suppressed cravings to smoke and anxiousness (Refs. 238, 239, 240), 
with one study showing that waterpipe tobacco use suppressed withdrawal 
symptoms just as cigarette smoking suppresses withdrawal symptoms (Ref. 
240).
5. Misunderstanding
    (Comment 197) Consumers stated that waterpipe tobacco should be 
regulated given its appeal to youth and adolescents' belief that it is 
not as harmful as traditional cigarettes. They agreed that a failure to 
regulate the proposed deemed products could reinforce consumers' 
existing confusion and misinformation about these products. However, 
other comments stated that FDA's concerns over youth's misperception of 
the safety of certain tobacco products should not be a factor that FDA 
should consider in deciding whether to regulate them. They stated that 
regulation cannot remedy the fact that certain youth affirmatively 
disregard available safety information. Comments noted that waterpipe 
tobacco users perceive this product to be much less harmful that 
cigarette smoking (Ref. 241), because they mistakenly think that the 
water filters out toxicants from the smoke and the fact that waterpipe 
tobacco use is frequently exempted from clean indoor air laws.
    (Response) While we continue to believe that alleviating 
misperceptions is important, we note that the potential to alleviate 
youth's misperception regarding the toxicity of unregulated tobacco 
products was only one of many public health benefits associated with 
deeming tobacco products, as discussed in the NPRM (79 FR 23142 at 
23148 and 23149). Waterpipe smoking carries health risks similar to 
smoking cigarettes, and waterpipe smoke contains many of the same 
carcinogens and heavy metals as cigarette smoke (79 FR 23142 at 23156 
and 23157). In addition, given that waterpipe tobacco smoking sessions 
last significantly longer than smoking a cigarette, smoking waterpipe 
tobacco could potentially be even more dangerous than smoking a 
cigarette (79 FR 23142 at 23156). Consequently, based on the various 
impacts on public health, FDA believes regulation of waterpipe tobacco 
is important.

F. Additional Novel and Future Tobacco Products

    In the NPRM, FDA proposed to deem additional novel and future 
tobacco products if the products meet the definition of ``tobacco 
product'' in section 201(rr) of the FD&C Act. FDA is finalizing this 
proposal here.
    (Comment 198) Several comments supported deeming all future tobacco 
products. One comment requested that the future regulated products 
should include products that extend beyond buccal or dermal absorption.
    (Response) Future products that meet the definition of ``tobacco 
product'' under section 201(rr) of the FD&C Act, including the 
requirement that they be ``intended for human consumption,'' are deemed 
subject to FDA's chapter IX authorities as a result of this rule. A 
product may be intended for human consumption in a variety of ways, 
such as through the lungs or by buccal or dermal absorption. However, 
future accessories of newly deemed products are not deemed subject to 
chapter IX as a result of this rule.
    (Comment 199) At least one comment cautioned FDA that regulations 
for future products should be based on the continuum of risk to ensure 
that there is continued innovation to reduce harm.
    (Response) FDA recognizes the existence of a continuum of nicotine-
delivering products and will continue to consider this continuum in 
regulating future tobacco products.
    (Comment 202) A few comments stated that FDA should not regulate 
products with de minimis amounts of nicotine derived from tobacco that 
may be used in cosmetics, food, animal feed, or other products, and for 
purposes not related to traditional tobacco use (such as protein). 
Additionally, they stated that these types of products should not have 
to bear the warning, ``This product is derived from tobacco.''
    (Response) With this final rule, FDA deems all products meeting the 
definition of tobacco product, except for accessories of newly deemed 
products, to be subject to FDA's authorities under chapter IX of the 
FD&C Act.

[[Page 29051]]

Determinations about whether particular products meet this definition 
would be made on a case-by-case basis. However, animal feed is a 
veterinary product and not for human consumption and, therefore, would 
not be a tobacco product. Products that contain nicotine derived from 
tobacco meet the definition of a tobacco product under the FD&C Act and 
are required to bear a health warning on packages and in advertisements 
stating: ``WARNING: This product contains nicotine. Nicotine is an 
addictive chemical.'' For products that are made or derived from 
tobacco (but do not contain nicotine), manufacturers may submit a 
certification to FDA and, instead, bear the statement ``This product is 
made from tobacco.'' See section XVI.H for additional information 
regarding this certification.
    (Comment 203) One comment stated that alternative nicotine 
products, such as nicotine toothpicks, have a net positive impact on 
the public health because they pose fewer health and safety risks than 
conventional cigarettes and could help addicted smokers transition to 
less toxic tobacco products. The comment argued that the regulatory 
burden for such products should be proportionately reduced.
    (Response) While FDA recognizes the existence of a continuum of 
nicotine-delivering products, all tobacco products are addictive and 
potentially dangerous and, therefore, should be subject to FDA 
regulation. Therefore, FDA is deeming all tobacco products (except 
accessories of newly deemed tobacco products) subject to the 
requirements of chapter IX of the FD&C Act and requiring certain 
additional provisions (i.e., minimum age and identification, vending 
machine, and health warnings) for covered tobacco products. FDA will 
continue to take this continuum of nicotine-delivering products into 
consideration as it contemplates future regulations of the newly deemed 
products.

XI. Additional Automatic Provisions Applicable to Newly Deemed Products

    In addition to the requirement that non-grandfathered tobacco 
products obtain authorization through one of the three marketing 
pathways, several provisions in the Tobacco Control Act and its 
implementing regulations will automatically apply to the newly deemed 
products as of the effective date of this final rule (79 FR 23142 at 
23148 and 23149). These provisions include:
    (1) Adulteration and misbranding provisions (sections 902 and 903 
of the FD&C Act);
    (2) Ingredient listing and HPHC reporting requirements (sections 
904 and 915 of the FD&C Act);
    (3) Registration and product listing requirements (section 905 of 
the FD&C Act);
    (4) Prohibition against the use of ``light,'' ``low,'' and ``mild'' 
descriptors and products with other unauthorized modified risk claims 
(section 911 of the FD&C Act); and
    (5) Prohibition of free samples of the proposed deemed products (21 
CFR 1140.16(d)).
    Comments regarding these provisions, and FDA's responses to 
comments, are as follows.
    (Comment 204) In the proposed deeming rule, FDA noted that it was 
taking this action to address the public health concerns associated 
with the use of tobacco products. Some comments stated that health 
policies based on tobacco use prevention and cessation are not 
sufficient to protect the public health.
    (Response) FDA is deeming products that meet the definition of 
``tobacco product,'' except accessories of newly deemed tobacco 
products, to address the public health concerns with these products. In 
the NPRM, FDA included discussion of public health benefits to better 
inform the public about the likely results of deeming these tobacco 
products. FDA intends to supplement this final rule with regulations as 
appropriate to protect the public health.

A. Sections 902 and 903--Adulteration and Misbranding

    In the proposed deeming rule, we explained that the adulteration 
and misbranding provisions of sections 902 and 903 of the FD&C Act 
would subject all tobacco products to certain basic requirements. For 
example, their labeling and advertising cannot be false or misleading, 
which will help reduce consumer confusion and misperception. The Agency 
can take enforcement action against any tobacco product that did not 
meet these basic requirements.
    (Comment 205) A large number of comments discussed the 
applicability of sections 902 and 903 of the FD&C Act to the newly 
deemed tobacco products. Most comments expressed general support for 
applying adulteration and misbranding provisions to the newly deemed 
tobacco products. Others supported the application of the provisions 
based on concerns that some e-cigarette manufacturers may not be 
producing their products in sterile conditions. Several comments 
cautioned that the differences between the newly deemed tobacco 
products might result in unwarranted restrictions if the provisions are 
applied mechanically across all product categories. At least one 
comment stated that the adulteration and misbranding provisions should 
not apply to e-cigarettes because there is no evidence that 
adulteration and misbranding currently occurs with those products or 
causes any harm.
    (Response) The adulteration and misbranding provisions of sections 
902 and 903 of the FD&C Act will automatically subject all tobacco 
products to certain basic requirements. For example, their labeling and 
advertising cannot be false or misleading, which will help reduce 
consumer confusion and misperception. FDA will be able to take 
enforcement action against any tobacco product that does not meet these 
basic requirements. For example, if a product is produced in insanitary 
conditions or is contaminated, or if its labeling contains a misleading 
claim, it will be subject to enforcement action, including seizure and 
injunction.

B. Sections 904 and 915--Ingredient Listing and Reporting of HPHCs

    As stated in the NPRM, the newly deemed products will be required 
to comply with the ingredient listing and HPHC reporting requirements 
of sections 904 and 915 of the FD&C Act. FDA intends to issue a 
guidance regarding HPHC reporting, and later a testing and reporting 
regulation as required by section 915, with enough time for 
manufacturers to report given the 3-year compliance period for HPHC 
reporting. As noted elsewhere in this document, FDA does not intend to 
enforce the reporting requirements for newly deemed products before the 
close of the 3-year compliance period, even if the guidance is issued 
well in advance of that time.
    (Comment 206) A couple of comments urged FDA not to require newly 
deemed products to comply with the ingredient and HPHC listing 
requirements. One comment argued that such reports are useless for 
educating consumers, who will invariably use them in an attempt to 
determine the relative risk of each product. Another comment claimed 
that the HPHC and ingredient listing requirements should be abandoned 
because they are not helpful and the cost of producing these reports 
would destroy industry.
    (Response) FDA disagrees with these comments. Ingredient and HPHC 
reporting assist FDA in better understanding the contents of regulated 
products. This information will assist FDA in assessing potential 
health risks and determining if future regulations to

[[Page 29052]]

address these health risks would be appropriate. The FD&C Act directs 
FDA to make certain HPHC information publicly available, but it must do 
so in a way that is understandable and not misleading to lay persons.
    (Comment 207) Several comments discussed ingredient and HPHC 
listing requirements in the context of small businesses and particular 
products. A few comments urged FDA to exempt small businesses that 
manufacture e-cigarettes from the HPHC reporting requirement because 
the testing would impose a large financial burden on them and would 
likely drive them out of business. One comment countered these 
arguments, urging FDA to require manufacturers of all products to 
comply with the ingredient and HPHC listing requirements and not 
provide an exemption for small businesses. The comment argued that the 
size of a business does not change a product's potential health impact 
and that the health benefits of regulation far exceed the costs.
    Other comments focused on ingredient and HPHC listing requirements 
for specific product categories. At least one comment expressed concern 
that HPHC testing would disproportionately affect the premium cigar 
industry, which has a high number of low-volume products, and requested 
that the requirements not apply to small batch or special release 
products. One comment claimed that many of the new tobacco products on 
the market, such as e-cigarettes, are virtually identical with the 
exception of flavoring and nicotine levels and recommended that FDA 
allow for these products to be grouped together for the purposes of 
HPHC testing.
    (Response) With respect to HPHC testing of similar products, FDA 
recognizes that some manufacturers of newly deemed products sell 
products in various flavors or with varying levels of nicotine. 
Manufacturers of these products will be required to test each variation 
for HPHCs, even where the products are otherwise the same. At this 
time, there is little known about the constituents of some newly deemed 
products. HPHC testing will allow FDA to track the level of HPHCs 
across different categories of flavors and by nicotine level. FDA's 
compliance policies for the HPHC requirements are described elsewhere 
in this document.
    (Comment 208) Several comments stated that FDA should establish 
HPHC lists and testing methodology before requiring HPHC testing. One 
comment requested that FDA establish an HPHC list and testing 
methodology for e-cigarettes in the same manner that it did for 
currently regulated tobacco products, including holding public 
workshops, requesting and considering Tobacco Products Scientific 
Advisory Committee recommendations, publishing draft and final lists in 
the Federal Register for public comment, and providing a reasonable 
compliance period for e-cigarette manufacturers. A few comments 
expressed the opinion that FDA should establish separate lists of HPHCs 
for each category of newly deemed tobacco products and not require HPHC 
reporting until the lists and corresponding testing methodologies are 
created and validated. Other comments stated that because not all 
deemed products are likely to have the same HPHCs as currently 
regulated products, testing for all of the constituents would be 
wasteful.
    (Response) As discussed elsewhere in this document, the compliance 
period for HPHC reporting and testing is the effective date of this 
rule plus 3 years. FDA intends to issue a guidance regarding HPHC 
reporting, and later a testing and reporting regulation as required by 
section 915 of the FD&C Act, with enough time for manufacturers to 
report given this compliance period. As noted elsewhere in this 
document, FDA does not intend to enforce the reporting requirements for 
newly deemed products before the close of the 3-year compliance period, 
even if the guidance is issued well in advance of that time.
    (Comment 209) Several comments suggested that manufacturers should 
be required under section 904 of the FD&C Act to include a statement of 
the ingredients and/or nicotine concentration on their product labeling 
as a condition of sale. These comments indicated that consumers could 
use this information to select e-cigarette liquids with decreasing 
nicotine content levels as part of a nicotine replacement therapy to 
quit smoking.
    (Response) Sections 915(b) of the FD&C Act and 206 of the Tobacco 
Control Act give FDA authority to require the disclosure of nicotine 
and certain other information on labeling and by other means. FDA has 
not issued regulations for the currently regulated tobacco products and 
did not propose this in the proposed deeming rule. FDA will consider 
whether it should do so in the future. To the extent the comment is 
about ENDS marketed for smoking cessation, such a product would be 
subject to FDA's drug/device authorities and not subject to FDA's 
tobacco product authorities.
    (Comment 210) Some comments suggested that any HPHC requirement for 
cigars should require analysis of HPHCs in the tobacco (rather than the 
smoke) in a manner similar to that for hand-rolling tobacco. They 
stated that HPHC smoke analysis is neither available nor readily 
producible for most cigars. They also stated that smoking regimens 
recommended for collecting HPHC data for tobacco smoke were developed 
for cigarettes and suggested that cigars are inherently more variable 
than cigarettes. Finally, they stated that the cigar smoke test method 
recommended by the Centre de Coop[eacute]ration pour les Recherches 
Scientifiques Relatives au Tabac in 2005 has produced more variable 
data than that obtained using the comparable test method for 
cigarettes, making it difficult to compare consistent test results for 
cigars.
    (Response) FDA disagrees with the comments. In order to determine 
the HPHC deliveries that each cigar provides, it is important that 
manufacturers submit HPHC data on smoke yields for cigars. HPHC 
quantities in cigar tobacco only would not provide a complete 
understanding of the toxicity of each cigar. As stated by the comments, 
Centre de Coop[eacute]ration pour les Recherches Scientifiques 
Relatives au Tabac (CORESTA) published method 64 in 2005 that describes 
a smoking regimen for cigars. It is not clear that the variability in 
cigar HPHC yields will be greater than that for cigarette yields. 
Variability in HPHC smoke yields is dependent on the smoking regimen, 
analytical method, and batch-to-batch consistency in product 
composition. Therefore, it is expected that the variability in HPHC 
smoke yields from some cigarettes will exceed that for cigars. In any 
case, as with cigarettes, it is important to understand the HPHC 
deliveries in cigar smoke.

C. Section 905--Registration and Listing

    As stated in the NPRM, manufacturers of the newly deemed products 
will be required to comply with section 905(b) of the FD&C Act, which 
requires the registration of any establishment engaged in the 
manufacture, preparation, compounding, or processing of a tobacco 
product. In addition, they must comply with section 905(i) of the FD&C 
Act, which requires registrants to submit a list of all tobacco 
products that are being manufactured, prepared, compounded, or 
processed for commercial distribution. FDA must issue a regulation 
before foreign establishments are required to comply with these 
requirements.
    (Comment 211) Several comments stated that FDA should apply the 
same

[[Page 29053]]

requirements to both foreign and domestic manufacturers of tobacco 
products, including manufacturers of the newly deemed products. They 
expressed concern that FDA has not yet issued a proposed registration 
and listing rule and has not provided a timeframe for a final rule that 
would apply these requirements to foreign establishments. They also 
stated that the absence of registration and listing requirements for 
foreign establishments creates incentives for manufacturers of the 
newly deemed products to move their facilities overseas.
    (Response) As indicated in the Unified Agenda of Spring 2015 (Ref. 
242), FDA plans to issue a proposed registration and listing rule that 
would extend these requirements to foreign tobacco product 
establishments. In addition, upon the effective date of this final 
deeming rule, both foreign and domestic manufacturers will be subject 
to, among other things, adulteration and misbranding restrictions 
(sections 902 and 903 of the FD&C Act); requirements for ingredient 
listing and reporting of HPHCs for all tobacco products (section 904 of 
the FD&C Act); and premarket authorization requirements (sections 905 
and 910 of the FD&C Act).

D. Section 911--Elimination of Low, Light, and Mild, and Other 
Unauthorized Modified Risk Claims

    Section 911 of the FD&C Act is one of the automatic statutory 
provisions that will apply to the newly deemed products on the 
effective date of this regulation. The purpose of this section is to 
prohibit the introduction into interstate commerce of MRTPs, including 
products the label, labeling, or advertising of which uses ``low,'' 
``light,'' or ``mild,'' or other modified risk claims unless FDA issues 
an order authorizing their marketing. This requirement will help 
consumers better understand and appreciate the health risks of the 
newly deemed products. In addition to any applicable premarket review 
under section 910 of the FD&C Act, if a manufacturer wishes to sell a 
MRTP, the company must submit an MRTP application under section 911 and 
receive an FDA order to legally market an MRTP.
    (Comment 212) A number of comments discussed the application of the 
MRTP restrictions to the newly deemed products. Several comments 
argued, as a general matter, that subjecting the newly deemed products 
to section 911 would be an unconstitutional restriction of free speech 
because FDA either has no substantial interest that would be advanced 
by such restrictions or has not demonstrated that restricting modified 
risk claims for these products would advance its substantial interest 
in protecting the public health. A couple of comments argued that the 
brand names of newly deemed products that contain the descriptor 
``low,'' ``light,'' or ``mild'' should be prohibited only where the 
descriptors specifically convey a modified risk claim. These comments 
stated that where ``low,'' ``light,'' or ``mild'' is used and 
understood by consumers to describe something other than a modified 
risk (such as the product's taste), restricting the use of a brand name 
containing one of these terms would be unconstitutional, arbitrary, and 
capricious because the government does not advance any substantial 
interest by doing so. Other comments supported the application of 
section 911 to all newly deemed tobacco products, with some comments 
maintaining that certain e-cigarette companies are currently marketing 
their products using unauthorized modified risk claims.
    (Response) FDA disagrees with the suggestion that subjecting the 
newly deemed products to section 911 would be an unconstitutional 
restriction of free speech. The Sixth Circuit upheld the modified risk 
provisions against a First Amendment challenge to the facial validity 
of the statute in Discount Tobacco v. FDA, 674 F.3d 509, 531-37 (6th 
Cir. 2012). We discuss this issue in depth in section II.B.3.b. FDA has 
and will continue to apply section 911 of the FD&C Act consistent with 
the First Amendment and will take all relevant facts into account on a 
case-by-case basis.
    FDA agrees with comments that supported the application of section 
911 to all newly deemed products. Historically, certain users have 
initiated and continued using certain tobacco products based on 
unauthorized modified risk claims and consumers' unsubstantiated 
beliefs about the relative safety of these products. Section 911 will 
prevent the use of unsubstantiated modified risk claims, which may 
mislead consumers and lead them to initiate tobacco product use or to 
continue using tobacco when they would otherwise quit. This will allow 
for better-informed consumers and help to prevent the use of misleading 
marketing targeted to youth populations.
    (Comment 213) Many comments stated that e-cigarette companies make 
direct and indirect health claims in the marketing and promotion of 
their products (e.g., by posting customer comments and testimonials on 
their Web sites) and that some e-cigarette advertising implies FDA 
approval or endorsement (e.g., use of the FDA logo on labels or 
statements such as ``made in an FDA-approved facility'') (Ref. 151). As 
a result, the comments suggested a number of different actions to curb 
these unsubstantiated or misleading claims, including: (1) Prohibiting 
direct and implied therapeutic claims that e-cigarettes are effective 
cessation products unless there is evidence; (2) using existing 
enforcement authority to prohibit therapeutic, health, and cessation 
claims unless there is evidence of safety and efficacy; (3) working 
with the FTC to prohibit such claims as false advertising until such 
time as there is evidence of safety and efficacy; (4) working with the 
FTC to introduce or strengthen disclosure rules on the Internet (e.g., 
product reviews) to promote transparency; and (5) prohibiting explicit 
or implicit statements that e-cigarettes are approved or endorsed by 
FDA.
    (Response) Under section 911 of the FD&C Act, no person may 
introduce or deliver for introduction into interstate commerce any MRTP 
without an order in effect under section 911(g). Also, a tobacco 
product is misbranded if its label, labeling, or advertising is false 
or misleading in any particular. Therefore, by deeming ENDS and other 
tobacco products, FDA is now authorized to take enforcement action 
against manufacturers who sell and distribute products with 
unsubstantiated MRTP claims, or false or misleading claims on their 
label, labeling, or advertising. Additionally, under section 301(tt) of 
the FD&C Act, anyone making explicit or implicit statements that a 
product is, among other things, ``approved'' or ``endorsed by FDA'' is 
committing a prohibited act. An ENDS product claiming to be an NRT or 
otherwise marketed for therapeutic purposes is a drug or device subject 
to FDA's regulations and laws for those products. Additionally, the 
Agency will consider these comments in the future, and, if FDA 
determines that it is appropriate, will issue additional regulations.

E. Section 919--User Fees

    In 2014, FDA issued a final rule regarding user fees for 
cigarettes, snuff, chewing tobacco, and roll-your-own tobacco, 
including the submission of information needed to calculate and assess 
those user fees (79 FR 39302, July 10, 2014). In that final rule, FDA 
stated that if it deems cigars or pipe tobacco, FDA would respond to 
the NPRM comments regarding user fee provisions for cigars and pipes, 
and revise the user fee regulations (79 FR 39302 at 39305).

[[Page 29054]]

Accordingly, elsewhere in this issue of the Federal Register, FDA is 
issuing a final rule revising the current user fee regulations.
    (Comment 214) Some comments supported applying the user fee 
provisions of the Tobacco Control Act to all tobacco products, 
explaining that application of user fee provisions to all products is 
essential to ensure uniformity and fairness across the regulated 
entities. They also noted that section 919(b)(3) of the FD&C Act states 
that no manufacturer or importer of tobacco products shall be required 
to pay a user fee in excess of the percentage share of such 
manufacturer or importer. Accordingly, they argued that FDA cannot 
assess user fees based on the continuum of nicotine-delivering 
products.
    (Response) Elsewhere in this issue of the Federal Register, FDA is 
issuing a final rule regarding user fees for cigars and pipe tobacco, 
including the submission of information needed to calculate their user 
fee assessments. These comments are addressed in that rule.

F. Tobacco Control Act, Section 102--Prohibition Against Free Samples

    In this final rule, FDA is not modifying the existing restriction 
on distributing free samples of tobacco products (21 CFR 1140.16(d)). 
As a result, this restriction will prohibit the distribution of free 
samples of newly deemed tobacco products, as required by section 102 of 
the Tobacco Control Act. See section II.B.3.a for discussion regarding 
the constitutionality of this free sample prohibition.
    FDA understands concerns from some retailers about the effect that 
a ban on free samples would have on their ability to promote new 
products. FDA wishes to clarify that allowing prospective adult buyers 
to smell or handle one of the newly deemed products is not considered 
distribution of a ``free sample'' as long as the free product is not 
actually consumed, in whole or in part, in the retail facility and the 
prospective buyer does not leave the facility with a free tobacco 
product. For example, affording adult consumers the opportunity to 
handle a cigar will give them the ability to feel the resistance of the 
cigar's structure and allow them to clearly see the color of the 
product, which is an indication of the fermentation period for the 
tobacco. Handling the product also will allow users to capture the 
aroma of a cigar and the box (if the cigar is sold in a package). 
However, if the prospective buyer lights and draws or puffs on the 
cigar to keep it lit, or otherwise uses the free cigar or leaves the 
retail establishment with a free cigar (partially used or intact 
whole), this would constitute a ``free sample'' in violation of the 
restriction on free samples mandated by section 102 of the Tobacco 
Control Act. We believe that, in most circumstances, other retail 
facilities, including ENDS retail establishments, can similarly allow 
customers to touch, hold, and smell their products without violating 
the free sample ban. We note that nothing in this policy should be 
construed to alter or amend the regulation implementing the free sample 
ban at Sec.  1140.16.
    (Comment 215) A large number of comments discussed whether FDA 
should allow the continued distribution of free samples of the newly 
deemed tobacco products. Most comments expressed general support for 
the ban on free samples, citing concerns that such samples serve as a 
gateway for youth tobacco initiation. Several comments argued that 
there is no reason to believe that free samples of pipe tobacco and 
premium cigars encourage youth initiation because the samples are 
distributed almost exclusively in adult-only retail operations. One 
comment claimed that because epidemiological data suggest that the 
majority of premium cigar smokers fall into a category where there is 
no significant difference in the incidence of disease compared to 
never-smokers, banning free samples of premium cigars would have no 
corresponding benefit even if it did reduce youth initiation. This 
comment also claimed that it would similarly not help prevent youth 
access because they assert that, as indicated in a recent SAMHSA 
survey, there is no evidence that youth obtain premium cigars at all, 
let alone as free samples from retailers.
    Several comments, referring specifically to pipe tobacco, premium 
cigars, and e-cigarettes, stated that, in light of the lack of evidence 
that youth obtain free samples of their products, banning these 
samples, which are a vital part of their industries, would only hurt 
sales and small businesses without a corresponding public health 
benefit. Comments referring to premium cigars and pipe tobacco stated 
that free samples of these products are necessary to entice adult 
consumers to purchase what are frequently unique and sometimes 
expensive products. Comments on e-cigarettes argued that, because their 
products are new, free samples are necessary to convince cigarette 
users to switch to them.
    One comment argued that FDA's proposed ban on free samples 
impermissibly restricts commercial speech that is protected by the 
First Amendment. The comment stated that while the court in Discount 
Tobacco City & Lottery v. United States upheld the Tobacco Control 
Act's sampling ban on cigarettes, the evidence the court used to uphold 
that ban does not support the same ban for the newly deemed tobacco 
products. The comment argued that FDA has presented no evidence that 
samples of these products lead to youth initiation and, therefore, the 
Agency would not be advancing a legitimate government interest with 
this ban. Additionally, the comment suggested that even if the ban did 
advance a legitimate government interest, FDA could achieve the same 
results through less restrictive means, such as by allowing samples in 
qualified adult-only facilities, as FDA does with smokeless tobacco.
    (Response) FDA disagrees with the assertions that the proposed ban 
on free samples would hurt businesses without corresponding public 
health benefits or that this prohibition impermissibly restricts 
commercial speech. This prohibition will eliminate a pathway for youth 
to access tobacco products, which can help reduce youth initiation and 
therefore short-term and long-term morbidity and mortality resulting 
from these products. The IOM has stated that free samples of cigarettes 
``encourage experimentation by minors with a risk free and cost-free 
way to satisfy their curiosity'' (Ref. 30). While the IOM was speaking 
in the context of cigarettes, FDA believes that the same rationale 
applies to the newly deemed products. In addition, the U.S. Court of 
Appeals for the Sixth Circuit held that the free sample ban as applied 
to cigarettes does not violate the First Amendment. The court 
recognized that FDA has provided ``extensive'' evidence that free 
tobacco samples constitute an ``easily accessible source'' for youth 
(Discount Tobacco City & Lottery, Inc. v. United States, 674 F.3d 509, 
541 (6th Cir. 2012) (citing 61 FR 44396 at 44460, August 28, 1996), 
cert. denied sub nom. Am. Snuff Co., LLC v. United States, 133 S. Ct. 
1966 (2013)). Moreover, the panel unanimously found that the ban 
``embodie[d] a narrow fit between the harm articulated and the 
restrictions employed'' (id.). See section II.B.3.a for more detailed 
discussion of the constitutionality of the free sample prohibition.
    FDA understands concerns from cigar retailers about the effect that 
a ban on free samples would have on their ability to promote new 
products. FDA wishes to clarify that allowing prospective adult buyers 
to smell or handle a cigar is not considered the distribution of a

[[Page 29055]]

``free sample'' as long as the product is not actually consumed, in 
whole or in part, in the retail facility and the prospective buyer does 
not leave the facility with a free tobacco product. Affording adult 
consumers the opportunity to handle the product will give them the 
ability to feel the resistance of the cigar's structure, and allow them 
to clearly see the color of the product, which is an indication of the 
fermentation period for the tobacco. It also will allow users to 
capture the aroma of the cigar and the box (if the cigar is sold in a 
package). However, if the prospective buyer lights and draws or puffs 
on the free cigar or otherwise uses the free cigar or leaves the retail 
establishment with a free cigar (partially used or intact whole), this 
would constitute a ``free sample'' in violation of the ban on free 
samples mandated by section 102 of the Tobacco Control Act. We believe 
that, in most circumstances, other retail facilities, including ENDS 
retail establishments, can similarly allow customers to touch, hold, 
and smell their products without violating the free sample ban.

XII. Requests for Additional Regulations Applicable to Newly Deemed 
Products

    In the NPRM, FDA noted that certain provisions would automatically 
apply to the newly deemed products and that the Agency was proposing 
additional restrictions that also would apply to covered tobacco 
products. FDA also noted that after the final rule becomes effective, 
the Agency would have the authority to issue additional regulations 
applicable to the newly deemed products, including product standards 
under section 907 of the FD&C Act. Many stakeholders submitted comments 
and data regarding the need for additional requirements and 
restrictions for the newly deemed products. Some of these requests 
would require a separate NPRM, and they will help inform FDA as it 
considers additional regulations for newly deemed products.

A. Ban on Flavored Tobacco Products

    FDA received numerous comments regarding flavored tobacco products, 
including comments expressing concerns regarding the impact of flavors 
on youth and young adults and preliminary data regarding some 
individuals' use of flavored ENDS products to transition away from 
combusted tobacco use. FDA's summary of comments and data regarding 
flavored tobacco products is included in section V.B of this document. 
FDA's responses to comments regarding a possible ban on flavored 
tobacco products are included below.
    (Comment 216) Many comments suggested that FDA include a ban on 
flavored tobacco products with this final rule. Other comments 
suggested that FDA continue to allow the sale of fruit or candy-
flavored e-cigarettes, because they aid cigarette smokers in decreasing 
cigarette use and in smoking cessation. These comments generally relied 
on a research article that found that most e-cigarette users switched 
between flavors on a daily basis or within the day, with former smokers 
switching more frequently than current smokers, and that respondents 
indicated that flavor variety was ``very important'' in reducing or 
quitting smoking (Ref. 62). This survey also noted that almost half of 
respondents indicated that a reduction in available flavors would 
``increase craving[s] for tobacco cigarettes and would make reducing or 
completely substituting smoking less likely'' (id.). Therefore, they 
believed that FDA should not sacrifice adults' use of flavored tobacco 
products in an attempt to prevent children from using flavored tobacco 
products. These comments also noted that flavors are used in other 
legally marketed products including nicotine replacement therapies 
(NRTs), which are FDA-approved products.
    (Response) FDA is not banning flavored tobacco products with this 
final deeming rule. To address concerns with the growing flavored cigar 
market and its impact on youth and young adult initiation with tobacco 
products, FDA is announcing here that it intends to issue in the future 
a proposed product standard that would prohibit characterizing flavors 
in all cigars, including cigarillos and little cigars.
    As discussed in section VIII.F of this document, we recognize that 
there is evidence that some individual former smokers may now report 
using ENDS (Ref. 24). However, the study referred to in the comments 
(Ref. 62) examined self-selected research subjects who were recruited 
through an e-cigarette Web site. All respondents were either former 
smokers (91.2 percent) or current smokers (8.8 percent); both groups 
had smoked on average 22 years before beginning to use ENDS. The 
article did not consider whether either the self-selection or the 
demographic profile of the respondents might affect the applicability 
of its results to any larger population. Moreover, the study did not 
address the question of whether study participants would have increased 
cigarette use if there were no available flavored ENDS or if the 
variety of flavored ENDS were limited. If additional evidence emerges 
that flavored ENDS make it more likely that smokers switch completely 
to ENDS, such evidence submitted as part of a PMTA would help support 
that application, as part of the analysis of whether the marketing of 
the product is appropriate for the protection of public health.
    Further, new data shows continued growth in youth and young adult 
usage of flavored tobacco products. FDA has balanced those concerns 
with preliminary data showing that some adults may potentially use 
flavored ENDS to transition from combusted tobacco use when developing 
the compliance policy for premarket review.
    (Comment 217) Many comments responded to FDA's request for data, 
research, and information regarding the characteristics or factors it 
should consider in determining whether a particular tobacco product is 
a ``cigarette'' as defined in section 900(3) of the FD&C Act and, 
consequently, subject to the prohibition against characterizing 
flavors, despite being labeled as a little cigar or other noncigarette 
tobacco product. Several comments stated that little cigars are being 
marketed and used as cigarettes and, therefore, FDA should communicate 
that such products are subject to the cigarette flavor ban. Other 
comments provided information regarding the differences between 
cigarettes and little cigars or other noncigarette tobacco products and 
indicated that such products should not be subject to the cigarette 
flavor ban.
    (Response) FDA understands and appreciates comments regarding the 
role that flavored little cigars, or similar products, might play on 
initiation of tobacco product use and dual use. FDA will continue to 
determine whether a product is a ``cigarette'' under the FD&C Act and 
subject to the statutory flavor ban on a case-by-case basis.
    (Comment 218) One comment stated that section 907(d)(3) of the FD&C 
Act, which prohibits FDA from banning certain enumerated tobacco 
products, demonstrates that Congress did not intend to grant FDA the 
power to ban any tobacco product by any means, including by enacting a 
product standard that would be a tantamount ban of newly deemed 
products, especially when some of these products present lower risks of 
death and disease than the specifically enumerated ones. Some comments 
also referred to the difficulty in defining ``characterizing flavor'' 
in the context of instituting a ban on flavored newly deemed tobacco 
products.

[[Page 29056]]

    (Response) If FDA decides to issue a product standard, it will do 
so in accordance with section 907 of the FD&C Act. Because FDA is not 
banning flavored tobacco products with this final deeming rule, it is 
not necessary to consider whether and how to define ``characterizing 
flavor.''

B. Additional Access Restrictions

    (Comment 219) Some comments suggested that FDA require face-to-face 
sales for all covered tobacco products, as it does for sales of 
cigarettes and smokeless tobacco, as provided in Sec.  1140.14(a)(3). 
For example, they suggested that FDA ban self-service displays for 
newly deemed tobacco products. They expressed concern that treating 
cigarettes and smokeless tobacco differently from other tobacco 
products would lead to confusion for retailers and complicate retailer 
training programs.
    (Response) FDA will continue to monitor this issue and, if it 
determines that it is appropriate for the protection of public health 
to extend the self-service display prohibition to newly deemed tobacco 
products, the Agency will issue a new NPRM in accordance with the APA.
    (Comment 220) Some comments suggested that we simultaneously issue 
this final rule with an ANPRM seeking additional information to draft a 
proposal that would apply the additional restrictions in part 1140 
(e.g., ban on self-service displays, the sale and distribution of 
nontobacco items, and the sponsorship of events) to newly deemed 
products.
    (Response) FDA is taking this comment under advisement. If FDA 
decides to issue such a proposal, the Agency will comply with the 
requirements of the APA.
    (Comment 221) A few comments requested that FDA regulate all 
dissolvables and other newly deemed products in the same manner it 
regulates other tobacco products, including application of all of the 
marketing and advertising restrictions in part 1140.
    (Response) At this time, FDA is subjecting newly deemed products to 
the automatic requirements and covered tobacco products to the 
additional provisions (i.e., age and identification requirements, 
vending machine restrictions, and health warning requirements) 
discussed in this final rule. However, if FDA later determines that 
extending such marketing and advertising restrictions to the newly 
deemed products is appropriate and meets the applicable standard in 
section 906(d), FDA will comply with the requirements of the APA when 
implementing such restrictions.

C. Nicotine Exposure Warnings

    (Comment 222) Many comments expressed concern about the increase in 
nicotine poisonings due to accidental ingestion of e-liquids and 
offered suggestions to address this issue: (1) Set a maximum nicotine 
content level for e-liquids; (2) require the use of child-resistant 
containers; (3) require a poison warning on the packaging and point of 
sale for liquid-based products; and (4) set a limit on the allowable 
speed of flow of the product from its container (e.g., by requiring a 
flow-restricting apparatus on the opening of the container or requiring 
a rigid container to prevent quick dispensing of product by squeezing 
the container).
    (Response) FDA expressed similar concerns about the increase in 
nicotine poisonings in the NPRM and section VIII.D. Once this final 
rule becomes effective, FDA has authority to issue additional 
regulations to address these concerns. In addition, FDA has issued an 
ANPRM prior to this deeming rule, seeking comments, data, research, or 
other information that may inform regulatory actions FDA might take 
with respect to nicotine exposure warnings and the use of child-
resistant packaging. Moreover, elsewhere in this issue of the Federal 
Register, FDA has made available draft guidance, which when final will 
describe FDA's current thinking regarding some appropriate means of 
addressing the premarket authorization requirements for newly deemed 
ENDS products, including recommendations for nicotine exposure warnings 
and child-resistant packaging that would help to support a showing that 
the marketing of a product is appropriate for the protection of the 
public health.

XIII. Severability

    This rule is being finalized with several changes from the NPRM. 
Specific comments regarding proposed codified language, and FDA's 
responses to those comments, are included in section VII.
    In accordance with section 5 of the Tobacco Control Act, FDA 
considers and intends the extension of its authorities over all tobacco 
products and the various requirements and prohibitions established by 
this rule to be severable. It is FDA's interpretation and position that 
the invalidity of any provision of this rule shall not affect the 
validity of any other part of this rule. In the event any court or 
other lawful authority were to temporarily or permanently invalidate, 
restrain, enjoin, or suspend any provision of this final rule, FDA 
would conclude that the remaining parts continue to be valid. As stated 
in section 5 of the Tobacco Control Act, if certain applications of 
this rule to persons or circumstances (discussed in the preamble or 
otherwise) are held to be invalid, application of such provisions to 
any other person or circumstance will not be affected and will continue 
to be enforced to the fullest extent possible. Each provision of the 
rule is independently supported by data and analysis as described or 
referenced in this preamble and, if issued separately, would remain a 
proper exercise of FDA authority.

XIV. Description of the Final Rule--Part 1100

    In the NPRM, FDA explained that new part 1100 would describe the 
scope of FDA's authority over tobacco products, the requirements that 
would apply to tobacco products, applicable definitions, and the 
effective date of the rule. We consider and intend the extension of our 
authorities over tobacco products and the various requirements and 
prohibitions established by this rule to be severable.

A. Section 1100.1--Scope

    FDA selects Option 1 with this final rule, deeming all cigars 
(rather than a subset), which has been applied throughout the codified 
text for parts 1100, 1140, and 1143. Therefore, this section now states 
that in addition to FDA's authority over cigarettes, cigarette tobacco, 
roll-your-own tobacco, and smokeless tobacco, FDA deems all other 
products meeting the definition of ``tobacco product'' under section 
201(rr) of the FD&C Act, except accessories of such other tobacco 
products, to be subject to chapter IX of the FD&C Act. The definition 
of ``accessory'' is now included in Sec.  1100.3 (as discussed in 
section VI.A).

B. Section 1100.2--Requirements

    Because FDA selected Option 1 for the scope of the deeming rule, 
Sec.  1100.2 states that cigarettes, cigarette tobacco, roll-your-own 
tobacco, smokeless tobacco are subject to chapter IX of the FD&C Act 
and its implementing regulations. In addition, this section states that 
FDA has deemed all other tobacco products, except accessories of such 
other tobacco products, subject to chapter IX of the FD&C Act and its 
implementing regulations.

C. Section 1100.3--Definitions

    FDA requested comment on definitions for cigar, covered cigar, and 
tobacco product. Because we are

[[Page 29057]]

selecting Option 1 deeming all cigars (rather than a subset) with this 
final rule, comments regarding the definition of covered cigar are no 
longer relevant to this rulemaking. In addition, FDA received many 
comments regarding components, parts, and accessories, including how 
they should be defined and the application of requirements to these 
objects. We have added definitions of ``component or part'' and 
``accessory'' to this section. The discussion of this language is 
included in section VI.A.

XV. Description of the Final Rule--Part 1140

    Currently, part 1140 generally applies to cigarettes, cigarette 
tobacco, roll-your-own tobacco, and smokeless tobacco. FDA proposed 
additional provisions to apply to ``covered tobacco products'' (namely, 
the requirement to prohibit the sale and distribution of products to 
individuals under 18 years of age and the prohibition on vending 
machine sales except in adult-only facilities). As stated elsewhere in 
this document, ``covered tobacco product'' means any tobacco product 
deemed to be subject to the FD&C Act pursuant to Sec.  1100.2, but 
excludes any component or part that is not made or derived from 
tobacco. FDA is finalizing these requirements without substantive 
change. FDA intends to update the current guidance documents for civil 
money penalties and frequently asked questions to reflect that 
violations of health warning requirements may lead to the issuance of 
civil money penalties. We consider and intend the extension of our 
authorities over tobacco products and the various requirements and 
prohibitions established by this rule to be severable.

A. Section 1140.1--Scope

    The NPRM offered several amendments to part 1140 in order to apply 
select existing sale and distribution restrictions, including age, 
identification, and vending machine provisions, to address youth access 
to the deemed tobacco products. As currently written, part 1140 
generally applies to cigarettes, cigarette tobacco, roll-your-own 
tobacco, and smokeless tobacco products. Accordingly, FDA is finalizing 
this rule to add the phrase ``and covered tobacco products'' to Sec.  
1140.1(a) and (b) to ensure the products are subject to select existing 
restrictions and access provisions. We also have added language to 
Sec.  1140.1(a) to clarify the scope of Sec.  1140.16(d).

B. Section 1140.2--Purpose

    This final rule adds ``and covered tobacco products'' to indicate 
that the purpose of this part is to establish restrictions on the sale, 
distribution, and access to covered tobacco products in addition to 
those restrictions in place for cigarettes and smokeless tobacco. 
Therefore, the final rule states that retailers of the newly deemed 
covered tobacco products may not sell them to individuals under 18 
years of age and requires retailers of covered tobacco products to 
verify the purchaser's birth date by reviewing the individual's 
photographic identification. However, as noted in Sec.  
1140.14(b)(2)(ii), a retailer is not required to verify the age of any 
person who is more than 26 years of age. In addition, Sec.  
1140.14(b)(3) prohibits the sale of covered tobacco products using an 
electronic or mechanical device such as a vending machine, unless it is 
located in a facility where the retailer ensures that no person younger 
than 18 years of age is present, or permitted to enter, at any time. 
FDA does not intend for section 1140.14(b)(3) to prohibit the sale of 
tobacco products via the Internet, but the sale of covered tobacco 
products via any medium, including the Internet, must only be to 
persons 18 years of age or older. Therefore, any sale of covered 
tobacco products over the Internet must comply with the minimum age and 
identification requirements in this rule.

C. Section 1140.3--Definitions

    In the NPRM, we sought comments on definitions of the following 
terms: Cigar, cigarette, cigarette tobacco, covered tobacco product, 
distributor, importer, nicotine, package, point of sale, retailer, 
smokeless tobacco, and tobacco product. FDA received many comments 
regarding whether e-liquids and components, parts, and accessories are 
tobacco products. FDA also received many comments regarding the need to 
define components, parts, and accessories, which resulted in the 
addition of definitions of ``component or part'' and ``accessory'' in 
Sec.  1140.3. The discussion of this language in included in section 
VI.A. Further, we revised the definition of ``package'' to refer to 
``package or packaging.'' We also added a definition of ``roll-your-
own'' to provide further clarity to the definition of ``cigarette.''

D. Section 1140.10--General Responsibilities of Manufacturers, 
Distributors, and Retailers

    With the selection of Option 1, Sec.  1140.10 now provides that 
manufacturers, distributors, importers, and retailers are responsible 
for ensuring that the covered tobacco products (in addition to 
cigarettes and smokeless tobacco) they manufacture, label, advertise, 
package, distribute, import, sell, or otherwise hold for sale comply 
with all applicable requirements in part 1140. The revisions to 
Sec. Sec.  1140.10 and 1140.14 clarify that the minimum age and 
identification requirements and vending machine restrictions apply to 
the newly deemed covered tobacco products.
    Previously, Sec.  1140.10 stated that each manufacturer, 
distributor, importer, and retailer is responsible for ensuring that 
its products comply with all applicable requirements under part 1140. 
FDA proposed to add ``and covered tobacco products'' to the existing 
language of this section to clarify that the provision also applies to 
``covered tobacco products'' as defined in Sec.  1140.3. In addition, 
FDA proposed that Sec.  1140.10 cover importers, because the Tobacco 
Control Act defines ``tobacco product manufacturer'' to include 
importers (section 900(20) of the FD&C Act), signaling Congress' intent 
for tobacco product importers to be subject to requirements like those 
in Sec.  1140.10. FDA is finalizing this section as drafted in the 
NPRM.

E. Section 1140.14--Additional Responsibilities of Retailers

    FDA proposed to divide this section into responsibilities for 
retailers of cigarettes and smokeless tobacco products and 
responsibilities for retailers of covered tobacco products. FDA is 
finalizing this section as drafted in the NPRM. Therefore, upon the 
effective date of this final rule, Sec.  1140.14(a)(1) through (a)(5) 
will provide the retailer's responsibilities for the sale of cigarettes 
and smokeless tobacco. Section 1140.14(b)(1) through (b)(3) will 
provide the retailer's responsibilities for the sale of newly deemed 
products.

F. Comments and Responses Regarding Minimum Age and Identification 
Requirements

    In the NPRM, FDA sought comment regarding whether to prohibit the 
sale of newly deemed products to individuals under 18 years of age and 
to require photographic identification for individuals aged 26 and 
under (which are the same requirements that currently apply to 
cigarettes and smokeless tobacco). FDA discussed the benefits of a 
uniform minimum age and identification requirement, including: (1) 
Decreasing youth access to tobacco products in another jurisdiction 
with less stringent requirements; (2) addressing youth misperceptions 
that tobacco products without minimum age or identification 
requirements are safer; and (3) increasing the ease with which 
retailers can comply with minimum age

[[Page 29058]]

and identification requirements for covered tobacco products (79 FR 
23142 at 23160 23162). In addition, we expressed our intention to use 
an aggressive nationwide enforcement program to increase compliance and 
deter youth consumption of tobacco products (79 FR 23142 at 23160).
    Nearly all comments supported a minimum age and identification 
requirement for the newly deemed tobacco products. FDA is finalizing 
these requirements without change. FDA also intends to update the 
current guidance documents for civil money penalties and frequently 
asked questions to reflect that violation of these provisions may lead 
to the imposition of civil money penalties. A summary of comments 
regarding these provisions, and FDA's responses, is included in the 
following paragraphs.
    (Comment 223) Many comments supported FDA's proposal due to the 
fact that many of the newly deemed products are easily available. For 
example, they noted that tobacco industry documents refer to the 
increased frequency with which self-service tobacco products are 
stolen, and some of the proposed deemed products (e.g., cigars) are 
frequently sold in self-service displays (Ref. 243). They expressed 
concern that self-service displays increase the likelihood that minors 
will have access to tobacco products.
    (Response) FDA agrees that the newly deemed tobacco products are 
readily available to consumers. FDA finds that the age and 
identification restrictions that are included in this final rule (Sec.  
1140.14) will help to limit youth access to the newly deemed tobacco 
products. In the event that FDA determines that extending the 
prohibition on self-service displays (Sec.  1140.16(c)) to the newly 
deemed products is appropriate and meets the applicable standard in 
section 906(d), FDA will issue a new NPRM and seek comment.
    (Comment 224) Many comments supported the minimum age and 
identification requirements for covered tobacco products based on 
increased youth use of newly deemed products and the impact of nicotine 
on youth. They noted that, according to the CDC, e-cigarette use among 
youth doubled from 2011 to 2012, with 1.78 million high school and 
middle school students having ever used e-cigarettes (Ref. 108). Others 
noted that the 2012 Surgeon General's report stated that youth are more 
sensitive to developing nicotine dependence than adults (Ref. 49). In 
addition, other comments stated that because minimum age and 
identification requirements for covered tobacco products vary among the 
states, a uniform age requirement would help prevent youth from 
accessing tobacco products in a neighboring state with less stringent 
requirements.
    (Response) FDA agrees with comments supporting the implementation 
of minimum age and identification requirements for covered tobacco 
products. As we noted in the NPRM, the goal of the minimum age 
restriction is to limit youth access to the newly deemed tobacco 
products. FDA concludes that the restrictions included with this final 
deeming rule are appropriate for the protection of the public health 
because they will reduce youth access to and, therefore, likely limit 
use of tobacco products.
    (Comment 225) Several comments recommended that FDA raise the 
minimum age to purchase tobacco products to 21 years old. They claimed 
that a higher minimum age would restrict youth access to social sources 
of tobacco products because minors tend to have less contact in their 
social network with 21-year-olds than with 18-year-olds (Ref. 244). 
They also suggested that the minimum age and identification requirement 
should mirror the minimum age requirement for alcohol and marijuana 
purchases in some States.
    (Response) FDA has determined that minimum age and identification 
restrictions, which will apply to all covered tobacco products, are 
appropriate for the protection of public health. FDA also will continue 
to provide prevention and tobacco product risk awareness campaigns 
targeted to youth and young adults. Although section 906(d)(3)(ii) 
precludes FDA from raising the minimum age of sale of tobacco products, 
section 104 of the Tobacco Control Act required FDA to conduct a study 
on the public health implications of raising the minimum age of sale of 
tobacco products. This study's report was published (Ref. 245) and can 
be found at: http://www.iom.edu/Reports/2015/TobaccoMinimumAgeReport.aspx.
    (Comment 226) Several comments discussed Internet sales of tobacco 
products. Some comments favored a ban on Internet sales for all tobacco 
products, some supported a ban on only certain tobacco products, and 
others opposed a ban on Internet sales of any tobacco products.
    (Response) As explained elsewhere, under this rule, retailers may 
not sell covered tobacco products (through any medium, including the 
Internet) to individuals under 18 years of age. FDA will continue to 
actively enforce the minimum age restriction for Internet sales. FDA 
will consider these comments in the future and continue to assess 
whether additional access restrictions would be appropriate.
    (Comment 227) Several comments recommended that FDA impose stiff 
penalties for noncompliance with minimum age and identification 
requirements and institute youth tobacco prevention campaigns and other 
actions to effectively reduce youth access to tobacco products.
    (Response) As noted in the NPRM, FDA believes that combining the 
minimum age and identification restriction with comprehensive and 
consistent enforcement, both at the Federal level and in partnership 
with States, will decrease the likelihood of youth smoking initiation 
(79 FR 23142 at 23161). In addition, FDA will continue to invest in a 
number of public education campaigns to help educate the public--
especially youth--about the dangers of tobacco products.
    (Comment 228) Several comments recommended that FDA prohibit the 
sale of tobacco product components, parts, and accessories (not just 
covered tobacco products), including ENDS, to minors under 18 years of 
age to provide consistency across the country.
    (Response) FDA disagrees. FDA concludes that the application of 
minimum age requirements and vending machine requirements to covered 
tobacco products, together with its regulation of components and parts 
of newly deemed products, will protect the public from the dangers of 
tobacco use, discourage initiation, and encourage cessation of use of 
such products.
    (Comment 229) A few comments suggested that FDA prohibit cigar 
sales to individuals under 18 years of age, except for minors serving 
in the U.S. military. They argued that there are greater health hazards 
for military personnel than using tobacco products.
    (Response) We disagree with the suggestion that we provide an 
exception for minors in the military. Military personnel face the same 
risk of tobacco-related death and disease as civilians. As FDA stated 
in the preamble, cigars can contain greater levels of nicotine than 
cigarettes; cigar smoking is strongly related to certain cancers; and 
in certain circumstances, cigars may be as harmful to a person's health 
as cigarettes (79 FR 23142 at 23151, 23156).
    (Comment 230) Some comments suggested that retailers record and 
retain copies of each purchaser's unexpired driver's license (if the 
document includes a photo), an armed forces identification card, or a 
valid passport as an acceptable identification to verify a purchaser's 
minimum age. Other

[[Page 29059]]

comments recommended that FDA implement a registration requirement for 
mail order sale of tobacco products and require carriers to verify that 
the seller sending out packages is registered before accepting the 
packages for delivery.
    (Response) The requirements for photo identification are included 
in Sec.  1140.14(b)(2). Retailers may choose any method of 
identification verification that complies with this provision. FDA 
finds that these requirements are appropriate for the protection of the 
public health and declines to adopt the recommendations for additional 
requirements at this time. However, we will continue to assess whether 
additional requirements regarding identification are appropriate.

G. Comments and Responses Regarding Vending Machines

    Consistent with the minimum age and identification provisions, FDA 
proposed to ban the sale of covered tobacco products in vending 
machines (i.e., requiring face-to-face transactions in retail 
facilities) unless the vending machine is located in a facility where 
the retailer ensures that individuals under 18 years of age are 
prohibited from entering at any time. FDA is finalizing this 
requirement without change in Sec.  1140.14. Therefore, upon the 
effective date of this final rule, covered tobacco products, including 
ENDS and cigars, may not be sold in electronic or mechanical devices 
such as vending machines unless the device is in an adult-only 
facility. This restriction is appropriate for the protection of the 
public health because it will eliminate one more method of youth access 
to tobacco products.
    A summary of the comments regarding these provisions, and FDA's 
responses to them, is included in the following paragraphs.
    (Comment 231) Multiple comments supported restricting vending 
machines sales to adult-only facilities. They asserted that FDA's 
discussion of this issue demonstrates that the vending machine 
restriction serves the stated public health purpose of the regulation. 
Other comments stated that FDA's rationale for this restriction for 
cigarettes and smokeless tobacco also applies to the newly deemed 
tobacco products.
    (Response) FDA agrees that there is a public health benefit to 
limiting vending machines to adult-only facilities. As we stated in the 
NPRM, studies show that youth are able to access tobacco products in 
vending machines (79 FR 23142 at 23162). Therefore, the vending machine 
restrictions are important in preventing youth from gaining access to 
these products.
    (Comment 232) Several comments suggested that FDA prohibit all 
vending machine sales of all tobacco products.
    (Response) FDA disagrees with prohibiting all vending machine sales 
of all tobacco products. Sections 1140.14(a)(3) and 1140.14(b)(3) 
permit the sale of cigarettes and smokeless tobacco products and 
covered tobacco products, respectively, in a non-face-to-face exchange 
with the assistance of a mechanical device as long as the retailer 
ensures that no person younger than 18 years of age is present, or 
permitted to enter, at any time. FDA is permitting adult-only 
facilities to sell tobacco products in a vending machine because these 
locations employ safeguards to prohibit entry to individuals less than 
18 years of age. FDA is not seeking to ban adult access to legally 
marketed tobacco products.
    (Comment 233) Several comments recommended that FDA subject tobacco 
product components, parts, and accessories (particularly e-cigarettes) 
to the proposed vending machine restrictions. These comments expressed 
concern regarding exploding tanks and nicotine poisoning due to 
accidental e-liquid exposure.
    (Response) FDA agrees that these tobacco product components and 
parts can pose public health concerns. At this time, FDA has determined 
that it is appropriate for the protection of the public health to 
restrict impersonal modes of sale of nicotine-containing components and 
parts in vending machines. However, FDA has concluded that it is not 
warranted at this time to impose the vending machine restrictions on 
components or parts that are not made or derived from tobacco as they 
will only be able to deliver nicotine to users by combining them with 
covered tobacco products that are subject to the vending machine 
restriction (and, therefore, youth cannot access). Accordingly, FDA 
believes that the public health will be protected by applying the 
vending machine restrictions to components and parts that contain 
nicotine or tobacco in order to prevent youth access to these products.
    (Comment 234) Some comments suggested that the deeming rule include 
a ban on Internet sales. These comments asserted that manufacturers and 
retailers are not enforcing age verification effectively and that youth 
are able to purchase tobacco products when they are not in the physical 
presence of the seller. Several comments also recommended that FDA 
require retailers to verify the age of purchasers of newly deemed 
tobacco products using methods similar to those found in the Prevent 
All Cigarette Trafficking (PACT) Act of 2009 (which ensures the 
collection of Federal, State, and local tobacco taxes on cigarettes and 
smokeless tobacco sold via the Internet or mail order sales). Other 
comments opined that neither the PACT Act nor State laws have been 
effective in preventing youth access to tobacco products.
    (Response) Under this rule, retailers may not sell covered tobacco 
products (through any medium) to individuals under 18 years of age. FDA 
will continue to actively enforce the minimum age restriction for mail 
order sales and Internet sales. FDA will continue to assess whether 
additional access restrictions would be appropriate.
    (Comment 235) A few comments stated that because newly deemed 
tobacco products are generally not sold in vending machines, there will 
be little impact from the proposed vending machine restrictions.
    (Response) FDA disagrees. As discussed in the NPRM (79 FR 23142 at 
23162), FDA expects that the vending machine restrictions will have a 
positive impact by preventing some youth from accessing tobacco 
products. Therefore, FDA concludes that this restriction is appropriate 
for the protection of the public health.
    (Comment 236) A few comments stated that FDA should permit tobacco 
product sales through vending machines in all locations. They noted 
that technological advancements now allow for accurate non-face-to-face 
age verification, including electronic age and identity verification 
(EAIV) technology and that the PACT Act already requires retailers to 
verify a tobacco product purchaser's name, birth date, and address 
through an EAIV database prior to accepting a delivery order.
    (Response) FDA disagrees. We explained in the NPRM that other types 
of vending machine restrictions, such as electronic locking devices on 
vending machines, have not sufficiently limited youth access to tobacco 
products (79 FR 23142 at 23162). In addition, vending machines may be 
located in facilities that are not as sophisticated as the common 
carriers or Internet sellers that are subject to the PACT Act, or these 
retailers may not have the financial resources to update their vending 
machines to incorporate EAIV technology. Therefore, FDA concludes that 
the vending machine restriction is appropriate for the protection of 
public health.

[[Page 29060]]

XVI. Description of the Final Rule--Part 1143

    In the proposed deeming rule, FDA proposed to add part 1143, which 
would mandate the use of ``required warning statements'' for covered 
tobacco products, as well as for roll-your-own and cigarette tobacco, 
for which health warnings are not already required by Federal statutes 
or regulations. As stated throughout this document, FDA has selected 
Option 1 with this final rule. Therefore, these requirements apply to 
all newly deemed covered tobacco products, including premium and other 
types of cigars. We consider and intend the extension of our 
authorities over tobacco products and the various requirements and 
prohibitions established by this rule to be severable.

A. Section 1143.1--Definitions

    In the NPRM, FDA sought comment on definitions for the following 
terms: Cigar, covered cigar, covered tobacco product, package, required 
warning statement, and roll-your-own tobacco. As stated throughout this 
document, FDA has selected Option 1 as the scope of this rule. 
Therefore, the definition of covered cigar is unnecessary and has been 
removed from this section. We also added definitions of point-of-sale, 
retailer, and tobacco product. These terms are used in part 1143 and 
were already included in parts 1100 and 1140.
    FDA received many comments regarding the need to define components, 
parts, and accessories, which resulted in the addition of definitions 
of ``component or part'' and ``accessory'' in Sec.  1140.3. The 
discussion of this language in included in section VI.A. In addition, 
we included a definition of ``cigarette tobacco'' given that the health 
warning requirements apply to covered tobacco products, roll-your-own 
tobacco, and cigarette tobacco. We also have added a definition of 
``principal display panels'' to address comments suggesting that a 
definition was necessary to comply with this part. The term ``principal 
display panels'' is defined as the panels of a package that are most 
likely to be displayed, presented, shown, or examined by the consumer.

B. Section 1143.3--Required Warning Statement Regarding Addictiveness 
of Nicotine

    Proposed Sec.  1143.3 included a requirement that any person who 
manufactures, sells, offers to sell, distributes, or imports for sale 
or distribution within the United States, cigarette tobacco, roll-your-
own tobacco and covered tobacco products other than cigars must include 
the following warning statement on each product package and in each 
advertisement: ``WARNING: This product contains nicotine derived from 
tobacco. Nicotine is an addictive chemical.'' The NPRM provided that a 
manufacturer could submit a certification that its tobacco product does 
not contain nicotine and notify FDA that it intends to use the 
alternative warning statement: ``This product is derived from 
tobacco.'' FDA also proposed size and placement requirements for the 
use of this warning statement on packages and in advertisements.
    Upon review of the comments, FDA is revising the language of this 
warning to read: ``WARNING: This product contains nicotine. Nicotine is 
an addictive chemical.'' The alternative warning statement is also 
revised to read: ``This product is made from tobacco.'' This warning 
will be required to appear on at least 30 percent of the two principal 
display panels of the package and at least 20 percent of the area of 
the advertisement. We also added language to Sec.  1143.3(a) to clarify 
that the warning statement must be printed in at least 12-point font 
size in order to be clear and legible.
    Further, we added language to Sec.  1143.3(a)(3)(ii) to clarify 
when a retailer of any tobacco product covered by paragraphs (a)(1) and 
(2) of this section will not be in violation of this section for 
packaging that does not comply with these requirements. This final rule 
provides that a retailer will not be in violation if the package: (1) 
Contains a health warning; (2) is supplied to the retailer by a tobacco 
product manufacturer, importer, or distributor, who has the required 
state, local, or TTB-issued license or permit, if applicable 
(consistent with the language in Sec.  1143.5(a)(4)(ii)); and (3) is 
not altered by the retailer in a way that is material to the 
requirements of this section.
    In addition, in response to comments regarding minimum font size 
for advertisements, we have revised Sec.  1143.3(b)(2)(ii) to include a 
12-point minimum font size for the warnings on advertisements. We note 
that the warning also needs to occupy ``the greatest possible portion 
of the warning area set aside for the required text.'' Therefore, a 
print advertisement would require a much larger font size in order to 
comply with this requirement.
    Given that comments expressed uncertainty as to how the self-
certification process in Sec.  1143.3(c) would work, we also included 
language in this section to further clarify this process. This section 
now provides that the certification statement can be submitted by the 
tobacco product manufacturer to FDA. FDA recommends that all data used 
to support the self-certification, or copies of the data, be maintained 
at the manufacturing facility or another location that is reasonably 
accessible to the manufacturer and to any officers or employees duly 
designated by the Secretary, which includes FDA employees. These data, 
including data not stored at the inspected facility, should be made 
readily available for copying or inspection by an officer or employee 
duly designated by the Secretary. Manufacturers interested in 
submitting a certification statement may contact CTP at 1-877-CTP-1373 
for more information regarding this submission.
    Further, in response to comments, we added Sec.  1143.3(d), which 
states that, if a product package is too small or otherwise unable to 
accommodate a label with sufficient space to bear such information, it 
will be exempt from the requirement to place the warning statement 
directly on the product package if the warning appears on the outer 
carton or other outer container or wrapper or on a tag otherwise 
permanently affixed to the tobacco product package. Under this 
provision, the warning statement must be printed using the 
specifications required in Sec.  1143.3(a)(1) and (a)(2). In these 
cases, the outer carton, outer container, wrapper, or tag would serve 
as the location for the principal display panels. If a tag is used for 
the principal display panels, both sides of the tag must be visible to 
the consumer. The warning statements must be printed on both sides of 
the tag to comply with Sec.  1143.3(a)(2).
    We also note that this requirement in Sec.  1143.3 applies to 
cigarette tobacco, roll-your-own tobacco, and covered tobacco products 
other than cigars. Both cigarette tobacco and roll-your-own tobacco are 
defined in Sec.  1143.1. This warning requirement does not apply to 
smokeless tobacco products. Smokeless tobacco products must meet the 
warnings requirements in CSTHEA (15 U.S.C. 4401 et seq.).

C. Section 1143.5--Required Warning Statements for Cigars

    In Sec.  1143.5, FDA proposed warnings for the cigars that would be 
covered under this final rule. In addition to the addictiveness 
warning, FDA proposed that all cigars (except those sold individually 
and not in product packages) would be required to include

[[Page 29061]]

the following warnings on packages and in advertisements:
     WARNING: Cigar smoking can cause cancers of the mouth and 
throat, even if you do not inhale.
     WARNING: Cigar smoking can cause lung cancer and heart 
disease.
     WARNING: Cigars are not a safe alternative to cigarettes.
     WARNING: Tobacco smoke increases the risk of lung cancer 
and heart disease, even in nonsmokers.

FDA also proposed size and placement requirements for the warning 
statements on packages and in advertisements. FDA is finalizing these 
warning requirements in accordance with Option 1 deeming all cigars 
(rather than a subset). Further, FDA is adding an additional warning 
statement (WARNING: Cigar use while pregnant can harm you and your 
baby.) with an optional alternative statement (SURGEON GENERAL WARNING: 
Tobacco Use Increases the Risk of Infertility, Stillbirth and Low Birth 
Weight) as discussed in section XVI.H.16.
    Therefore, the full list of required warnings for use on cigar 
packages and in cigar advertisements is as follows:
     WARNING: This product contains nicotine. Nicotine is an 
addictive chemical.
     WARNING: Cigar smoking can cause cancers of the mouth and 
throat, even if you do not inhale.
     WARNING: Cigar smoking can cause lung cancer and heart 
disease.
     WARNING: Cigars are not a safe alternative to cigarettes.
     WARNING: Tobacco smoke increases the risk of lung cancer 
and heart disease, even in nonsmokers.
     WARNING: Cigar use while pregnant can harm you and your 
baby. (Or, as an optional alternative statement: SURGEON GENERAL 
WARNING: Tobacco Use Increases the Risk of Infertility, Stillbirth and 
Low Birth Weight.)

The health warnings are required to appear on at least 30 percent of 
each of the two principal display panels of the package and on at least 
20 percent of the area of the print advertisements and other 
advertisements with a visual component. As we did for Sec.  
1143.3(a)(2)(ii) and (b)(2)(ii), we added language to Sec.  
1143.5(a)(2)(ii) and (b)(2)(ii) to clarify that the font used for 
warnings on packaging and advertisements must be at least 12-point font 
size in order to be clear and legible. We note that the warning also 
must occupy ``the greatest possible portion of the warning area set 
aside for the required text.'' Therefore, a print advertisement would 
require a much larger font size in order to comply with this 
requirement.
    For packages, the six warnings for cigars (five specifically for 
cigars and the one addictiveness warning) will be required to be 
randomly displayed in each 12-month period, in as equal a number of 
times as is possible on each brand of cigar sold in product packaging 
and randomly distributed in all areas of the United States. This random 
display and distribution must be done in accordance with a warning plan 
submitted to, and approved by, FDA. For advertisements, the warnings 
must be rotated quarterly in alternating sequence in each advertisement 
for each brand of cigar in accordance with a warning plan submitted to, 
and approved by, FDA. Warning plans must be submitted for FDA review 
and approval by responsible manufacturers, distributors, importers, and 
retailers by 1 year after the date of publication of the final rule 
(however, all other part 1143 requirements shall take effect 2 years 
after the publication date of this final rule).
    In the NPRM, FDA did not have a separate section (with its own 
effective date) explicitly requiring the submission of warning plans 
with its own effective date. Rather, the sections of part 1143 
requiring random display and distribution of warning statements for 
packaging and quarterly rotation of warning statements for 
advertisements (for which FDA proposed a 2-year effective date) stated 
that such random display and distribution and quarterly rotation be 
done in accordance with a warning plan submitted to and approved by 
FDA. Thus, those provisions implicitly required that submission of the 
warning plan and approval by FDA be done prior to the 2-year effective 
date by which manufacturers must comply with the plan. FDA has added 
Sec.  1143.5(c)(3) to specifically include the requirement to submit a 
proposed warning plan. (See section XVI.H.17 for additional information 
regarding the warning plan requirement and timeframe for submission.)
    The same warning statement requirements will apply to cigars sold 
individually and not in product packages.\15\ However, instead of being 
required to place warnings directly on these product packages, 
retailers will be required to post signage at the point of sale listing 
the six warnings (five specifically for cigars and one addictiveness 
warning) on a minimum of 8.5 x 11 inch sign. The rule requires that the 
sign be placed on or within 3 inches of each cash register where 
payment is made and the sign is unobstructed in its entirety and can be 
easily read by each consumer making a purchase.
---------------------------------------------------------------------------

    \15\ In general, pursuant to the Internal Revenue Code at 26 
U.S.C. 5751, a tobacco product cannot be sold at retail unless it is 
in the package in which the product is removed, upon payment of 
Federal excise tax, from the factory or from customs custody. 
Section 5751(a)(3) and TTB regulations at 27 CFR 46.166(a) state 
that tobacco products may be sold, or offered for sale, at retail 
from such packages, provided the products remain in the packages 
until removed by the customer or in the presence of the customer.
---------------------------------------------------------------------------

D. Section 1143.7--Language Requirements for Required Warning 
Statements

    Consistent with section 3(b) of CSTHEA (15 U.S.C. 4402(b)), FDA 
proposed in Sec.  1143.7 that the warning statement appear in the 
English language, with two exceptions. First, under Sec.  1143.7(a), if 
an advertisement appears in a non-English language publication, the 
required warning statement would be required to appear in the 
predominant language (i.e., the primary language used in the 
nonsponsored content) of the publication. Second, under Sec.  
1143.7(b), if an advertisement is in an English language publication 
but the advertisement is presented in a language other than English, 
the required warning statement would be required to appear in the same 
foreign language as that principally used in the advertisement. FDA is 
finalizing this section as proposed in the NPRM with one change; given 
that FDA has noted throughout this document that the health warning 
requirements apply to advertisements in any medium, we have changed the 
references from ``publication'' to ``medium'' in this section.

E. Section 1143.9--Irremovable or Permanent Required Warning Statements

    FDA proposed that the warning statements for covered tobacco 
products be indelibly printed on or permanently affixed to packages and 
advertisements. FDA is finalizing this requirement without change.

F. Section 1143.11--Does Not Apply to Foreign Distribution

    FDA proposed to limit the applicability of the health warning 
requirements by clarifying that they would not apply to manufacturers 
or distributors of tobacco products that do not manufacture, package, 
or import the products for sale or distribution within the United 
States. FDA is finalizing this requirement.

[[Page 29062]]

G. Section 1143.13--Effective Date

    In the NPRM, FDA sought comment regarding the effective date of the 
health warning requirements. FDA proposed that these requirements would 
take effect 24 months after the date that the final rule publishes in 
the Federal Register and all products manufactured on or after the 
effective date must include the required warning statements on their 
labels.
    This means that:
     After the effective date, no manufacturer, packager, 
importer, distributor, or retailer of cigarette tobacco, roll-your-own 
tobacco, cigars, or other covered tobacco products may advertise any 
such product if the advertisement does not comply with this rule;
     After the effective date, no person may manufacture for 
sale or distribution within the United States any such product the 
package of which does not comply with this rule;
     Beginning 30 days after the effective date, a manufacturer 
may not introduce into domestic commerce, any such product, 
irrespective of the date of manufacture, if its package does not comply 
with this rule;
     After the effective date, a distributor or retailer may 
not sell, offer to sell, distribute, or import for sale or distribution 
within the United States any such product the package of which does not 
comply with this regulation, unless the covered tobacco product was 
manufactured prior to the effective date; and
     After the effective date, however, a retailer may sell 
covered tobacco products in packages of which do not have a required 
warning if the retailer demonstrates it falls outside the scope of this 
rule as described in Sec. Sec.  1143.3(a)(3) and 1143.5(a)(4).
    In addition to proposed Sec.  1143.13, we added paragraph (b) 
indicating that the requirement to submit a warning plan pursuant to 
Sec.  1143.5(c)(3), describing the random display and distribution of 
warning statements on cigar packages and the quarterly rotation of 
warning statements in cigar advertisements, will take effect 12 months 
after the date of publication of this final rule. FDA is establishing 
this effective date at 12 months before the effective date of the 
required warnings for cigars described under part 1143 (24 months after 
the publication of the final rule) because the Agency anticipates that 
there will be a need for communication with submitters during its 
review of the warning plan submissions. This submission deadline also 
helps FDA to ensure that its surveillance program for compliance with 
the warning label requirements under section 1143 is implemented as of 
the effective date of 24 months after the publication of the final 
rule. FDA intends to work with manufacturers, importers, distributors, 
and retailers to get an approved warning plan in place. Cigar entities 
may wish to contact FDA to discuss the submission of their warning 
plans in order to make the subsequent approval process more orderly and 
efficient. See section XVI.H.17 for additional information regarding 
the warning plan requirement.

H. Comments and Responses Regarding Required Warning Statements

1. General
    (Comment 237) Several comments urged FDA to clearly define 
``advertisement'' in the final rule as it is unclear what constitutes 
an advertisement that must contain the required warning statements. At 
least one comment suggested that the final rule contain language 
explaining that any statement regarding the availability of tobacco 
products in a store does not by itself constitute an advertisement.
    (Response) FDA does not believe it is necessary to include a 
definition of ``advertisement'' in this final rule, but notes that for 
purposes of this rule, the term ``advertisement'' should be interpreted 
broadly and should be interpreted to include statements regarding the 
availability of tobacco products.
    In addition, advertisements subject to this final rule may appear 
in or on, for example, promotional materials (point-of-sale or non-
point-of-sale), billboards, posters, placards, published journals, 
newspapers, magazines, other periodicals, catalogues, leaflets, 
brochures, direct mail, shelf-talkers, display racks, Internet Web 
pages, television, electronic mail correspondence, and also include 
those communicated via mobile telephone, smartphone, microblog, social 
media Web site, or other communication tool; Web sites, applications, 
or other programs that allow for the sharing of audio, video, or 
photography files; video and audio promotions; and items not subject to 
the sale or distribution ban in Sec.  1140.34. FDA intends to provide 
guidance on how to comply with the health warning requirements on 
unique types of media.
    (Comment 238) Several comments noted that the proposed cigar 
warnings are appropriate for the protection of public health. The 
comments noted that the rule would enhance public health by extending 
the labeling requirements beyond the seven manufacturers currently 
required to use them under the FTC consent decrees, by providing for 
random display on cigar packages and rotation in advertisements, and by 
requiring point-of-sale warnings for cigars sold individually that are 
not packaged. The comment also noted that the substance of each warning 
is strongly supported by the available scientific evidence. However, 
several comments took issue with the proposed warnings for premium 
cigars, claiming that they lack a sound scientific basis.
    (Response) FDA finds there is a strong scientific basis to require 
health warnings on cigar packages and in cigar advertisements (as well 
as on signs for unpackaged cigars), which was extensively discussed in 
the NPRM (79 FR 23142 at 23167 through 23170).
    (Comment 239) Several comments stated that the NPRM is unclear 
regarding the requirement to develop and submit rotation plans for 
warnings signs required where cigars are sold individually and not in a 
product package. One comment stated that the final rule should make 
clear that this obligation falls on cigar manufacturers and not on 
retailers that sell cigars. Another comment stated that retailers 
should be responsible for creating and posting the point of sale signs.
    (Response) To clarify, retailers of cigars sold individually and 
not in product packaging are not required to submit a warning plan for 
warnings on packages, because the warning signs posted at a retailer's 
point-of-sale would include all six warnings applicable to cigars, as 
we have noted above in our discussion of Sec.  1143.5(c)(1). Cigar 
retailers would be responsible for creating and posting these signs in 
accordance with Sec.  1143.5(a)(3)(i)-(iv). Therefore, there is no need 
to rotate these health warnings, nor is it necessary to submit a 
rotational warning plan for them. However, manufacturers must submit a 
warning plan for advertisements, as the rule requires manufacturers of 
all cigars to include warnings in advertisements that must be rotated 
quarterly in alternating sequence in each advertisement for each brand 
of cigar. Similarly, retailers who are responsible for or direct their 
own cigar advertising must submit a warning plan for those 
advertisements.
    (Comment 240) One comment suggested that FDA adopt labeling rules, 
similar to those proposed for premium cigars, for e-cigarette products 
that are sold without packaging (i.e., require signage at the point of 
sale for stores selling e-cigarettes rather than require labels on 
their packages).
    (Response) Unlike cigars sold individually and not in product

[[Page 29063]]

packages, ENDS and any e-liquids containing nicotine that are sold 
separately are sold in some sort of packaging on which the 
addictiveness warning can be provided. Therefore, it is not necessary 
at this time to instead require warnings at the point-of-sale. The 
warning requirements in this final rule are appropriate for the 
protection of the public health because they provide information to the 
consumers each time they use the product.
2. Continuum of Risk
    (Comment 241) Several comments asserted that different product 
categories should carry different health warnings relative to the 
health risk the products present to adult consumers. They also thought 
that, in view of the continuum of risk, the size of the proposed 
addictiveness warning on e-cigarettes and other noncombusted products 
is too large and the location too prominent. For example, one comment 
suggested that FDA require that this warning be smaller for these 
products than for smokeless tobacco products (i.e., 20 percent of the 
principal display panel) and it should appear only on one of the 
principal display panels of the package. Another comment noted that, 
because of its relative size and placement, the proposed e-cigarette 
warning could deter combusted cigarette smokers from switching to a 
noncombusted product based on a misunderstanding of the relative risks 
of smoking versus electronic and noncombusted products. This comment 
suggested that the warning on e-cigarettes should be no larger or more 
prominently located than the currently required cigarette warnings.
    (Response) FDA disagrees. As discussed in section VIII, though FDA 
recognizes the existence of a continuum of nicotine-delivering 
products, all tobacco products are addictive and potentially dangerous. 
There is a public health benefit to warning consumers regarding the 
addictiveness of nicotine, regardless of how it is delivered. Numerous 
studies show that the likelihood that warnings are seen and noticed 
depends upon their size and position. (Refs. 36, 37, 38, 39; see 
section II.B.4). In addition, as mentioned in section VIII.C, study 
results have been inconclusive about the effects of ENDS products on 
the population. FDA does not believe, at this time, that it has 
sufficient evidence about the risks of ENDS products to justify the use 
of different warnings sizes and to determine the appropriate size for 
each product category. FDA will continue to monitor research regarding 
the health effects of different types of ENDS.
    As to the comment that e-cigarette warnings should be no larger or 
more prominently located than currently required for cigarettes, the 
final rule requires the warnings to appear on at least 30 percent of 
the two principal display panels of the package, and at least 20 
percent of the area of advertisements. These are the same warning sizes 
that Congress established for smokeless tobacco in the Tobacco Control 
Act. 15 U.S.C. 4402(a)(2)(A), (b)(2)(A). In the same Act, Congress 
prescribed an even larger size for cigarette warnings: 50 percent on 
the front and rear panels of cigarette packaging (and the same 20 
percent size for cigarette advertisements) (id. Sec.  1333(a)(2), 
(b)(2)). However, the larger warning sizes required for cigarettes have 
not yet been implemented because the final rule was challenged in 
court, and on August 24, 2012, the United States Court of Appeals for 
the District of Columbia Circuit vacated the rule and remanded the 
matter to the Agency. R.J. Reynolds Tobacco Co., v. Food & Drug 
Administration, 696 F.3d 1205 (D.C. Circuit 2012), overruled on other 
grounds by Am. Meat Inst. v. U.S. Dep't of Agric., 760 F.3d 18, 25 
(D.C. Cir. 2014) (en banc). On December 5, 2012, the Court denied the 
government's petition for panel rehearing and rehearing en banc, and 
FDA decided not to seek further review of the Court's ruling. FDA is 
conducting research that aims to support a new rulemaking consistent 
with the Tobacco Control Act (see Generic Clearance for the Collection 
of Qualitative Data on Tobacco Products and Communications (OMB Control 
Number 0910-0796) and Pretesting of Tobacco Communications (OMB Control 
Number 0910-0674)). For smokeless tobacco packaging, the warning labels 
must be located on the two principal display panels and cover at least 
30 percent of each panel (15 U.S.C. 4402(a)(2)(A)), which is consistent 
with the warning labels required for newly deemed tobacco products.
    (Comment 242) Several comments stated that informing consumers that 
tobacco products are addictive by requiring an addictiveness warning 
does not fulfill any useful public health goal. These comments believed 
that it is misleading to describe all nicotine-containing products as 
addictive without describing the relative risk of the products.
    (Response) FDA disagrees. The addictive nature of tobacco products 
has been well documented. The Surgeon General has long recognized the 
addictive nature of tobacco products due to the presence of nicotine, 
which is highly addictive and can be absorbed into the bloodstream 
(Ref. 1). Congress also expressed concern about the addictiveness of 
these ``inherently dangerous products'' (section 2(2) of the Tobacco 
Control Act). Because the covered tobacco products are made or derived 
from tobacco and most (if not all) contain nicotine, they are likely 
addictive (Refs. 14, 246, 247, 248, 249). For products that do not 
contain nicotine (i.e., no nicotine at detectable levels), the rule 
provides for an alternative warning statement, ``This product is made 
from tobacco.''
    Consumers, especially youth and young adults, wrongly believe that 
many tobacco products covered by this rule are less addictive than 
cigarettes; systematically underestimate their vulnerability to 
becoming addicted to nicotine and the use of tobacco products; and 
overestimate their ability to stop using tobacco products when they 
choose (79 FR at 23158-59, 23166). The addictiveness warning will help 
consumers understand and appreciate the consequences of using tobacco 
products. The addictiveness warning will help ensure that youth and 
young adults, who may be more susceptible to the addictiveness of 
nicotine, have a greater awareness of the presence of nicotine and the 
addictiveness of these products before they might become addicted.
    Additionally, any manufacturer that wishes can submit an MRTP 
application to FDA to show that its product is less hazardous than 
another tobacco product. When the Tobacco Control Act was passed, 
Congress found that unless tobacco products that purport to reduce the 
risks to the public of tobacco use actually reduce such risks, those 
products can cause substantial harm to the public health (section 2(37) 
of the Tobacco Control Act). Furthermore, Congress noted that the 
dangers of products sold or distributed as MRTPs that do not in fact 
reduce risk are so high that FDA must ensure that statements about 
MRTPs are complete, accurate, and relate to the overall disease risk of 
the product (section 2(40) of the Tobacco Control Act). Accordingly, 
Congress determined that manufacturers must demonstrate that such 
products meet a series of rigorous criteria, and will benefit the 
health of the population as a whole before they may be marketed to 
reduce the harm or the risk of tobacco-related disease or to reduce 
exposures to harmful substances associated with tobacco products 
(section 911 of the FD&C Act (21 U.S.C. 387k)). If new research on the 
relative risks presented by the use of smokeless

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tobacco products and ENDS products emerges, FDA may consider proposing 
changes to the warning label requirements. If it does, the Agency will 
initiate a new rulemaking in accordance with the APA.
3. Warning Requirements for Other Media
    (Comment 243) Several comments stated that FDA should clarify the 
application of the proposed warnings to television and radio 
advertisements, as well as in catalogs, on Internet sites, and on 
social media. One comment recommended that advertisers be required to 
include a voiceover stating the warning out loud, in a clear, 
conspicuous, and neutral manner. Another comment suggested that FDA 
clarify in the final regulation that Sec.  1143.3(b) applies only to 
print advertising and not to radio and broadcast advertising.
    (Response) FDA clarifies that Sec.  1143.3(b)(1) applies to 
cigarette tobacco, roll-your-own tobacco, and covered tobacco products 
except for cigars as they have their own warning requirements as 
enumerated in Sec.  1143.5(b)(1). The FCLAA (15 U.S.C. 1331 et seq.), 
as modified by the Little Cigar Act of 1973 (Pub. L. 93-109), makes it 
unlawful to advertise ``cigarettes'' and ``little cigars'' on any 
medium of electronic communication subject to the jurisdiction of the 
Federal Communications Commission (15 U.S.C. 1333). In 1986, Congress 
enacted CSTHEA (15 U.S.C. 4401 et seq.), extending the broadcast ban to 
include advertisements for smokeless tobacco products.
    FDA further clarifies that the requirements to include a warning in 
Sec.  1143.3(b)(1) and Sec.  1143.5(b)(1) apply to all forms of 
advertising, regardless of the medium in which it appears, for 
cigarette tobacco, roll-your-own tobacco, and covered tobacco products, 
including cigars. This final rule applies to advertisements appearing 
in or on, for example, promotional materials (point-of-sale and non-
point-of-sale), billboards, posters, placards, published journals, 
newspapers, magazines, other periodicals, catalogues, leaflets, 
brochures, direct mail, shelf-talkers, display racks, Internet Web 
pages, television, electronic mail correspondence, or be communicated 
via mobile telephone, smartphone, microblog, social media Web site, or 
other communication tool; Web sites, applications, or other programs 
that allow for the sharing of audio, video, or photography files; video 
and audio promotions; and items not subject to the sale or distribution 
restriction in Sec.  1140.34. Accordingly, the language of Sec. Sec.  
1143.3(b)(2) and 1143.5(b)(2) have been changed to clarify that the 
formatting requirements only apply to print advertisements and other 
advertisements with a visual component. FDA intends to provide guidance 
on how to comply with the health warning requirements on unique types 
of media.
4. Appropriateness of Required Warnings To Protect Public Health
    (Comment 244) In response to FDA's request in the NPRM, comments 
included data and research regarding the effectiveness of health 
warnings. They submitted research indicating a need for accurate health 
warnings that are large enough to be readable (Refs. 3, 40) and grab 
the consumer's attention (Ref. 40). Comments also submitted research 
indicating that warning labels influence and increase awareness of the 
health risks associated with tobacco (Ref. 36, 37, 250) and discourage 
initiation in nonsmoking youth (Ref. 251). One comment cited other 
research which found that novel information presented to smokers was 
associated with greater relevance of the message and motivation to quit 
(Ref. 252).
    (Response) FDA agrees that health warnings are an effective means 
to help consumers understand and appreciate the risks of using tobacco 
products.
    (Comment 245) Many comments supported the requirement for all 
tobacco products to contain health warnings. For example, one comment 
cited WHO's 2011 report on the Global Tobacco Epidemic, which states 
that effective warning labels increase smokers' awareness of health 
risks and increase the likelihood they will think about reducing 
tobacco consumption and quitting (Ref. 253). The comment also cited a 
cohort study of textual warnings in the United Kingdom, before and 
after they were enhanced in 2003 to meet the minimum FCTC standard 
(Ref. 37). This study found that, after the enhanced warnings were 
implemented, UK smokers were more likely to think about quitting, to 
think about the health risks of smoking, and to be deterred from having 
a cigarette compared to smokers in Australia and the United States 
where smaller warnings did not conform to FCTC standards. Another 
comment stated that required warning statements on packages and 
advertisements should provide needed information to consumers in a 
conspicuous and clear manner.
    (Response) FDA agrees. Health warnings on packages and 
advertisements help consumers to understand and appreciate the health 
risks of tobacco use and have a number of advantages. The frequency of 
exposure is high. In addition, package warnings are delivered both at 
the time of tobacco product use and at the point of purchase. Thus, the 
messages are delivered to tobacco users at the two most important 
times--when users are considering using or purchasing the tobacco 
product. The messages on packages also help the public at large, 
including potential tobacco users, better understand and appreciate the 
health and addictiveness risks of using the products. (See In re 
Lorillard et al., 80 FTC 455 (1972); FCLAA; CSTHEA.)
5. Staleness of Warnings
    (Comment 246) Several comments noted that requiring only a single 
health warning for some newly deemed tobacco products does not allow 
for rotation and the warning will likely grow stale, resulting in 
little to no effect on consumers. They argued that FDA should require 
multiple warnings for the newly deemed products to allow for rotation 
and to maintain their effectiveness. Additionally, comments urged FDA 
to revise this warning and the other required health warnings as new 
evidence emerges on the health risks associated with tobacco products.
    (Response) FDA acknowledges that the use of a single health warning 
for some newly deemed tobacco products could allow the warning to grow 
stale over time. While FDA declines to add additional warnings at this 
time, FDA issued an ANPRM prior to this deeming rule, seeking comments, 
data, research, or other information that may inform regulatory actions 
FDA might take with respect to nicotine exposure warnings. FDA also 
intends to conduct research and keep abreast of scientific developments 
regarding the efficacy of the final health warnings and the ways in 
which their efficacy could be improved. FDA will use the results of 
this monitoring and research to help determine whether any of the 
warning statements should be revised, or if any additional warning 
statements should be added, in a future rulemaking.
6. Other Format Issues
    (Comment 247) There were several comments on the general format of 
the health warnings. One comment stated that the warning provisions 
should require black text on a bright yellow background. According to 
the comment, researchers have found that yellow seizes attention, is 
the most noticeable, is the color the eye perceives fastest, and 
universally signals warning or danger (Refs. 254, 255). Another comment 
suggested that the front of the

[[Page 29065]]

package should include a short and explicit warning statement that is 
large enough to be readily visible and readable, and the back of the 
package should contain a warning large enough to more fully develop the 
basis for the front warning statement. The comment noted that the 
combination of short and salient health claims on the front of the 
package with more fully developed health information on the back would 
produce better consumer awareness and understanding, and greater 
believability of the health claim in the mind of the consumer. Finally, 
several comments stated that newly deemed products should be required 
to display large graphic warnings.
    (Response) FDA declines to make these suggested changes at this 
time. The format requirements included with this final rule are similar 
to those included in a 2001 EU directive, which have been shown to 
increase the effectiveness of health warnings. EU Directive 2001/37/EC 
requires that tobacco warnings in all member countries meet certain 
minimum standards that are similar to those that FDA is finalizing here 
(i.e., the EU required health warnings comprise 30 percent of the area 
on the front of package and 40 percent on the back of the package; are 
in black Helvetica bold type on a white background; occupy the greatest 
possible proportion of the warning area set aside for the text 
required; and messages are centered in the warning area and surrounded 
by a black border of 3 to 4 millimeters (mm) in width). Before the 2001 
Directive, warnings in most EU countries were very small and general. 
In one study conducted for the European Commission, a majority of 
respondents stated that the Directive's new warning format was more 
effective and more credible than the previous format (Ref. 256). A 
study of Spanish university students also concluded that text warnings 
based on the Directive significantly increased perceptions of the risk 
of tobacco products (Ref. 257). Additionally, studies showed that the 
requirement that the warnings appear in black text on a white 
background or white text on a black background improved the legibility 
and noticeability of the warnings (Refs. 7, 38).
    FDA believes that the prescribed format of the health warnings will 
be effective in helping consumers better understand and appreciate the 
risks of these products. However, FDA intends to conduct research and 
keep abreast of scientific developments regarding the efficacy of the 
final health warnings and the ways in which their efficacy could be 
improved. If FDA determines that modification of the format 
requirements is appropriate, we will consider changing these 
requirements in a future rulemaking.
    (Comment 248) FDA received a large number of comments regarding the 
size of the required health warnings. Several comments agreed with the 
format requirements proposed in the rule. One comment cited a study 
concluding that youth and adults are more likely to recall larger 
warnings, rate larger warnings as having greater impact, and often 
equate the size of the warning with the magnitude of the risk (Ref. 
36). The comment also stated that requiring health warnings that cover 
at least 30 percent of the front and back of cigarette packages is 
consistent with the FCTC.
    Several comments argued that the required health warnings are too 
large. One comment stated that if the warnings are too large, they 
could have the unintended effect of making consumers numb to the 
warning message or otherwise lead to consumers ignoring the warning. 
Another comment stated that the size of FDA's proposed addictiveness 
warning should be evaluated in the context of the other information 
that already appears on the packaging of noncombusted tobacco products. 
This comment asserted that packaging for certain newly deemed products 
includes detailed warnings and other information important to reduce 
risks from inappropriate use or handling of the product and that such 
information may not fit on the package if the proposed health warning 
occupies 30 percent of the principal display.
    Several comments stated that the proposed warning statement should 
not be required on cigars sold individually and not in product 
packages. One cigar retailer stated that requiring warnings on 30 
percent of the principal display panels would be excessive. The comment 
believed that a health warning covering 30 percent of each cigar box 
would be excessive when there are multiple boxes, particularly when 
combined with the requirement for a warning sign at the point of sale. 
Another comment asserted that the size of the proposed health warnings 
would be inconsistent with the First Amendment.
    Other comments argued that FDA should require larger health 
warnings. One comment stated that numerous studies show that youth and 
adults are more likely to recall larger warning messages and rate 
larger messages as having a greater impact (Ref. 37). Another comment 
stated that the FCTC suggests that warnings should cover 50 percent or 
more of a pack's principal surface, a standard adopted by a number of 
countries.
    (Response) FDA finds that the required size of the health warnings 
is appropriate for the protection of public health. The IOM, Congress, 
and Article 11 of the FCTC recognize the importance of having the 
warnings cover at least 30 percent of the area of the principal display 
panels, and users are more likely to recall warnings that are a larger 
size and that appear on the front/major surfaces of the tobacco package 
(Ref. 7). The 30-percent warning label area requirement for product 
packages is also consistent with the size requirements for similar 
text-only warnings for smokeless tobacco mandated by Congress in CSTHEA 
(15 U.S.C. 4402(a)(2)(A)). FDA does not believe that the 30-percent 
warning label area requirement will make consumers numb to the warning 
message. Rather, FDA believes that the size of the warnings will be 
effective in helping consumers better understand and appreciate the 
critical information presented by the health warning.
    FDA also believes that the 30-percent warning label area 
requirement is consistent with the First Amendment (as discussed in 
section II.B). Although the warning will occupy at least 30 percent of 
the packaging, there will remain sufficient space for additional 
warnings, manufacturer instructions, and branding. However, FDA intends 
to conduct research and keep abreast of scientific developments 
regarding the efficacy of the health warnings in the final rule and the 
ways in which their efficacy could be improved. If FDA determines that 
larger warnings would be more effective for these newly deemed 
products, the Agency will issue a new NPRM in accordance with the APA.
    (Comment 249) Comments stated that FDA should not require 
manufacturers to use a font size that occupies the greatest possible 
proportion of the warning area because that would leave limited, if 
any, white space and may prove to be illegible. These comments 
suggested that FDA reduce the font size requirement to be consistent 
with smokeless tobacco warnings, which are required to take up 60 to 70 
percent of the warning area.
    (Response) FDA disagrees. Newly deemed tobacco products are sold in 
a variety of packaging sizes. By requiring the font size to be at least 
12-point font, FDA is ensuring that the required warning statement will 
be noticed by consumers regardless of the package size. Further, FDA 
believes that this requirement will leave adequate background space so 
that the warning is

[[Page 29066]]

legible. The format requirements are similar to those included in a 
2001 EU directive (requiring warnings to occupy the greatest possible 
portion of the warning area set aside for the required text), which 
have been shown to increase the effectiveness of health warnings, as 
further discussed in this section of the document. FDA is not aware of 
any legibility issues with the EU health warnings and does not expect 
any legibility issues with the health warnings included in this final 
rule.
    The size of the warning clearly matters, as recall increases 
significantly with font size (Ref. 258). In a study on recall of health 
warnings in smokeless tobacco ads, conducted with 895 young males, 63 
percent of participants recalled a high contrast warning in 10-point 
font; doubling the font size for the warning to a 20-point font 
increased recall from 63 percent to 76 percent representing a 20 
percent improvement in recall (id.). Research on cigarette package 
warnings confirms that larger warnings are better noticed and more 
likely to be recalled (Ref. 7 at App. C-3; Refs. 38, 49). These studies 
support FDA's conclusion that requiring the proposed warnings to appear 
in at least 12-point font size will improve their noticeability.
    (Comment 250) At least one comment believed that requiring warnings 
to occupy at least 20 percent of the area of an advertisement would 
result in warning statements that, while visible, are more likely to be 
ignored. This comment suggested that appropriate warning statements be 
presented in a minimum font size (e.g., no smaller than 11-point type).
    (Response) FDA is unaware of any evidence stating that a health 
warning occupying at least 20 percent of the area of an advertisement 
is likely to be ignored. Nevertheless, to ensure that the statements 
are visible and effectively conveying information, FDA is finalizing 
Sec. Sec.  1143.3(b)(2)(ii) and 1143.5(b)(2)(ii) to require a minimum 
12-point font size for the health warnings on advertisements. Moreover, 
the requirement that the warning statement occupy at least 20 percent 
of the area of the advertisement is the same as the statutory 
requirement for press and poster advertisements for smokeless tobacco 
products (section 3(b)(2)(B) of CSTHEA (15 U.S.C. 4402(b)(2)(B))).
    (Comment 251) At least one comment expressed concern with the font 
requirements of the labeling provisions because they require businesses 
to purchase a software package that provides either or both of the 
prescribed fonts (Helvetica and Arial), and these are proprietary 
fonts.
    (Response) FDA disagrees. Both Helvetica and Arial fonts are 
included in common printing software. Thus, the requirement that 
manufacturers use Helvetica or Arial font should not cause them to 
incur any additional costs. However, we also have included language 
throughout part 1143, which allows manufacturers to use other similar 
sans serif fonts in order to provide additional flexibility while still 
ensuring that the warnings are conspicuous and legible to consumers.
    (Comment 252) Many comments argued for different formatting 
requirements for the health warnings. Some suggested that they should 
be consistent with the current FTC Consent Decree, which requires that 
health warnings be clear and conspicuous in relation to the other 
communications on the packaging and be presented in a black box format 
to attract consumer attention. One comment stated that FDA should 
accept alternative warning sizes, placements, and font sizes for 
different packaging sizes and configurations, as long as the warning is 
clear and conspicuous. This comment urged FDA to be flexible about the 
size and placement of the warnings on deemed products, some of which 
are offered in packaging sizes and configurations very different from 
cigarette and smokeless tobacco packaging. This comment also noted that 
it can be difficult to identify the two principal display panels.
    (Response) FDA disagrees. FDA has concluded that the formatting 
requirements for the health warnings, which are similar to the 
requirements for smokeless products and similar to those suggested by 
FCTC, are appropriate for the protection of the public health. In 
addition, we have added language to this final rule which recognizes 
that if a product package is too small to bear the required warning 
statement, the manufacturer of the product can include the warning 
statement on the outer carton or on a hang tag attached to the product 
package.
    To clarify how to determine the principal display panels, FDA is 
defining ``principal display panels'' of a product package as the 
panels of a package that are most likely to be displayed, presented, 
shown or examined by the consumer. In addition, the principal display 
panels should be large enough to accommodate all mandatory label 
information in a clear and conspicuous manner. The principal display 
panels may be on an outer carton for small vials holding e-liquids.
7. Waterpipe Tobacco
    (Comment 253) One comment argued that the required warning should 
not be applied to hookah (or waterpipe tobacco) because there is a lack 
of substantial scientific evidence of the addictiveness of this 
product. The comment expressed the belief that the majority of 
waterpipe tobacco smokers in the United States use the product once a 
week or less. Another comment asserted that studies of noncigarette 
products, including waterpipe tobacco, show that these products are 
perceived to present less risk of harm and addictiveness, thereby 
encouraging use among young adults. The comment added that strong 
warnings regarding the addictiveness of all tobacco products may reduce 
trial and use in vulnerable populations (Ref. 259).
    (Response) FDA disagrees that the addictiveness warning should not 
be applied to waterpipe tobacco. Waterpipe tobacco contains nicotine, 
which is the primary addictive chemical in tobacco products. 
Researchers have observed nicotine dependence characteristics in some 
users (Refs. 238, 239, 240), with one study showing that waterpipe 
tobacco use suppressed withdrawal symptoms just as cigarette smoking 
suppresses withdrawal symptoms (Ref. 240). Because waterpipe smoking 
sessions last longer than smoking a cigarette and there is increased 
smoke volume, a single session of waterpipe smoking (which typically 
lasts 20 to 80 minutes) likely exposes users to more nicotine than 
smoking a cigarette (which typically takes 5 to 7 minutes). Indeed, a 
meta-analysis of studies regarding waterpipe use showed that a single 
episode of waterpipe use is associated with exposure to 1.7 times the 
nicotine in a single cigarette.
    FDA agrees that there is consumer confusion about the addictiveness 
of waterpipe tobacco. Whereas studies have shown that cigarette and 
waterpipe tobacco smoking deliver similar nicotine levels, one study 
showed that 46.3 percent of high school students wrongly believed that 
waterpipe tobacco is less addictive or less harmful than cigarettes, 
and one-third of these students wrongly believed that the product had 
less nicotine, no nicotine, or was generally less addictive than 
cigarettes (Ref. 260). Mistaken beliefs that waterpipe tobacco smoking 
is ``safer or less addictive than cigarettes'' were more prevalent 
among those who had ever used waterpipe tobacco (78.2 percent) compared 
to nonusers (31.6 percent) (Ref. 260). A study of nearly 2,000 
university students found that waterpipe tobacco was considered by

[[Page 29067]]

those students to be less addictive than e-cigarettes, marijuana, cigar 
products, smokeless tobacco, and cigarettes (Ref. 261). Research found 
that college students who had used waterpipes within the past 30 days 
considered them less addictive and less harmful than never-users did 
(Ref. 26). Similarly, another study found that ``[freshmen college] 
students who used waterpipes and cigars perceived them as less harmful 
than regular cigarettes'' (Ref. 262). Moreover, research has shown that 
such false beliefs about product risks can be a significant predictor 
of subsequent use behavior (Refs. 263, 264). For instance, adolescents 
with the lowest perceptions of short-term risks related to smoking were 
2.68 times more likely to initiate smoking (Ref. 264). We note that the 
Surgeon General's 2014 Report provides an objective discussion of 
nicotine and addiction, where ``nicotine addiction develops as a 
neurobiologic adaptation to chronic nicotine exposure. However, all 
forms of nicotine delivery do not pose an equal risk in establishing or 
maintaining nicotine addiction'' (Ref. 9 at 112). Thus, pattern of use 
is a factor in the facilitation of addiction.
    (Comment 254) One comment stated that FDA should require the 
addictiveness warning on all components of waterpipe tobacco use, 
including those products without nicotine or tobacco.
    (Response) FDA disagrees. FDA finds that requiring health warnings 
on covered tobacco products only (and not on the components and parts 
that are not made or derived from tobacco) is appropriate to protect 
the public health, because youth and young adults will not be able to 
use such components and parts, and potentially suffer the consequences 
of tobacco use, without also using the covered tobacco product. In the 
event that FDA later determines it is appropriate for the protection of 
the public health to extend the warning requirements to components and 
parts that are not made or derived from tobacco, the Agency will 
initiate a new rulemaking in accordance with APA requirements.
8. Dissolvable Products
    (Comment 255) One comment suggested that FDA recognize all 
dissolvable tobacco products as smokeless tobacco products for the 
purpose of warning label regulation and, as a result, subject all 
dissolvables to the smokeless warning requirements in section 204 of 
the Tobacco Control Act.
    (Response) ``Smokeless tobacco product'' is defined in section 
900(18) of the FD&C Act and for purposes of the warning requirements in 
CSTHEA (as amended by the Tobacco Control Act) as ``any tobacco product 
that consists of cut, ground, powdered, or leaf tobacco and that is 
intended to be placed in the oral or nasal cavity.'' Some dissolvable 
tobacco products do not meet the definition of ``smokeless tobacco 
product'' because they do not contain cut, ground, powdered, or leaf 
tobacco; instead, these products contain nicotine extracted from 
tobacco. These products are the dissolvable products covered by this 
final rule. Because they do not meet the statutory definition of a 
smokeless tobacco product, FDA cannot recognize them as such, as 
suggested by the comments. If FDA determines that the warning 
statements for any type of dissolvable product should be revised, or if 
any additional warning statements should be added to them, the Agency 
will initiate a new rulemaking in accordance with APA requirements.
    (Comment 256) One comment stated that the use of an addictiveness 
warning would serve to protect the public health by more clearly 
identifying dissolvable products as addictive tobacco products and 
differentiating them from candy.
    (Response) FDA agrees. Certain tobacco products have a candy-like 
appearance, frequently are sold next to candy, and are packaged in a 
way that makes them more attractive to children, which can mislead 
consumers to think that they are, in fact, candy (Refs. 54, 215). The 
addictiveness warning will clearly identify these products as tobacco 
products and help differentiate them from candy.
9. Premium Cigars and Unpackaged Cigars
    (Comment 257) Several comments stated that not requiring warnings 
on premium cigars and those sold individually and without product 
packages would greatly diminish the effectiveness of the cigar 
warnings. One comment stated there are many instances where cigars are 
purchased as gifts and, in those instances, the recipients would not 
see these warnings. One comment also stated that if a purchaser 
receives with the premium cigar any wrapper, container, pack or bag, 
then FDA should require that it include a health warning. This would 
ensure that if the premium cigar is given for a celebratory occasion, 
or if a minor obtained a premium cigar from an adult and did not see 
the point-of-sale warning, the user would be warned of the health 
risks. Another comment stated that the warning labels should be 
permanently affixed to or inside the cellophane wrappers in which the 
cigars are sold and in a way that is clearly visible to potential 
purchasers.
    (Response) FDA understands these concerns. However, for those 
cigars sold individually and not in a product package, the placement of 
warnings at the point of sale will be adequate to disseminate the 
required health information and is appropriate for the protection of 
the public health. For cigars that are sold in cellophane wrappers, 
these wrappers are considered packaging and, under this final rule, 
must include the required cigar warnings. In addition, FDA notes that 
youth attempting to purchase these cigars would be prohibited from 
doing so under the minimum age requirements included in this final 
rule.
    (Comment 258) One comment expressed concern that the NPRM did not 
provide for warnings where premium cigars and cigars sold individually 
and without product packaging are sold online. The comment suggested 
that these cigars should either not be allowed to be sold individually 
or that individual cigars should be required to be packaged and include 
a warning label.
    (Response) Under the Internal Revenue Code and TTB regulations, 
cigars that are taxpaid upon removal from the factory or release from 
customs custody must be in the packages in which they will be delivered 
to the ultimate consumer (bearing any marks or notices required by the 
Internal Revenue Code and TTB regulations) at the time of removal, and 
must remain in those consumer packages until taken from the package by 
the consumer or in the presence of the consumer. Removing taxpaid 
cigars from the package, other than in the presence of the waiting 
consumer, is a violation of the Internal Revenue Code. Cigars may 
nonetheless be sold individually, provided that the individual product 
packaging meets the requirements of the IRC and TTB regulations. An 
online retailer sending such individual cigars purchased online can 
comply with FDA's requirements by placing the warning statement on the 
box or container that is used to ship the product. In addition, FDA 
clarifies that the warning requirements apply to all forms of 
advertising, regardless of the medium in which they appear. As stated 
previously, advertisements subject to this final rule may appear in or 
on, for example, promotional materials (point-of-sale and non-point-of-
sale), billboards, posters, placards, published journals, newspapers, 
magazines, other periodicals, catalogues, leaflets, brochures, direct 
mail, shelf-talkers, display racks, Internet Web pages, television, 
electronic mail

[[Page 29068]]

correspondence, or be communicated via mobile telephone, smartphone, 
microblog, social media Web site, or other communication tool; Web 
sites, applications, or other programs that allow for the sharing of 
audio, video, or photography files; video and audio promotions; and 
items subject to the sale or distribution restriction in Sec.  1140.34. 
As stated in Sec.  1143.5(b)(2), the formatting requirements only apply 
to advertisements with a visual component. FDA intends to provide 
guidance on how to comply with the health warning requirements on 
unique types of media.
    (Comment 259) One comment stated that premium cigars sold 
individually should include a health warning on the cigar tube, if 
applicable, or FDA should require retailers to provide a paper warning 
to the purchaser or put cigars in bags that are pre-printed with the 
warning labels.
    (Response) It is unclear exactly how this comment intends to affix 
the warning to the premium cigar. If this comment is referring to 
affixing a warning to the cigar tube, this may damage the cigar and, 
therefore, is impractical. If this comment is seeking to add the 
warning to the tube that packages some individual cigars, FDA does not 
believe this is appropriate. Cigars sold individually in product 
packages, including cigars sold in tubes, must comply with the warning 
statement requirements for packaging. For cigars sold individually and 
not in product packages, the required warning statements must instead 
be posted at the retailer's point of sale. FDA believes that the point 
of sale signage requirement will ensure that premium cigar purchasers, 
as well as purchasers of other individual cigars, receive the required 
health warnings while allowing persons selling or distributing the 
cigars to maintain existing business practices.
    (Comment 260) One comment expressed concern about retailers having 
to forfeit counter space for the placement of health warnings for 
cigars sold individually and not in product packages. The comment 
stated that this space is reserved for some of the most profitable 
items for sale in convenience stores. The comment also stated that the 
U.S. Circuit Court of Appeals for the District of Columbia struck down 
a similar, judicially imposed warning requirement that required 
retailers to set aside valuable retail space to display a point-of-sale 
sign. (United States v. Philip Morris USA Inc., 566 F.3d 1095 (D.C. 
Cir. 2009).)
    (Response) FDA believes that the point-of-sale warnings are 
necessary and appropriate for the protection of public health. FDA 
notes that the requirement only applies where cigars are sold 
individually and unpackaged, and will ensure that consumers of these 
products are exposed to the same health warnings as consumers of other 
cigar products. FDA also believes the point-of-sale warnings are 
necessary to prevent manufacturers and retailers of cigars from 
circumventing the warning requirement by selling their products without 
packaging.
    Moreover, the United States v. Philip Morris holding cited in the 
comment was not on the merits and in any event is not applicable here. 
That case involved corrective statements mandated in a civil Racketeer 
Influenced and Corrupt Organizations Act (RICO) case brought against 
the United States' major cigarette companies. After finding the 
defendants liable for racketeering and fraud, the lower court issued an 
injunction that required the defendants to disseminate public 
statements in order to prevent and restrain future fraud. The 
statements were required to appear in various types of media--including 
large-point-of-sale signs present at the checkout counter of retailers 
that participated in defendants' ``participating retailer'' programs. 
On appeal, noting that the retailers were not involved in the RICO 
litigation but were negatively affected by the injunctive remedy, and 
had not had the opportunity to present arguments against the point-of-
sale location before the lower court ruled, the appellate court vacated 
the point-of-sale requirement on due process grounds, and remanded for 
further consideration by the lower court. Philip Morris USA Inc., 566 
F.3d at 1141-42. The appellate court did not rule on whether mandatory 
point-of-sale corrective statements in valuable retail space are 
permissible under the RICO statute, but simply ruled that before the 
district court could impose such a requirement, the RICO statute 
required ``considering the rights of third parties and existing 
contracts'' (id. at 1145). By contrast, these warning requirements are 
being issued under the Tobacco Control Act, not the RICO statute; and 
are the product of notice-and-comment rulemaking.
10. Cigarettes and Roll-Your-Own
    (Comment 261) Some comments stated that FDA should conform the 
proposed health warnings for cigarette tobacco and roll-your-own 
tobacco to the federally mandated health warnings for cigarettes 
required by section 4(s) of FCLAA and to health warnings that FDA 
mandates for cigarettes in the future.
    (Response) FDA disagrees. Cigarette tobacco and roll-your-own 
tobacco do not meet the definition of the term ``cigarette'' in section 
3(1) of FCLAA. Because cigarette tobacco and roll-your-own tobacco are 
not cigarettes as defined by FCLAA, they do not need to comply with 
section 4 of FCLAA requiring cigarette warnings and, therefore, do not 
contain any warning to alert consumers of the health effects of these 
products. Instead, the Tobacco Control Act defines cigarette tobacco 
and roll-your-own tobacco in sections 900(4) and 900(15) of the FD&C 
Act, respectively. The lack of a warning on these tobacco products may 
lead consumers to believe that they are safe products. Therefore, with 
this final rule, FDA is requiring that manufacturers of such products 
comply with the addiction warning in Sec.  1143.3 and any other future 
health warnings that FDA mandates for these products, where 
appropriate.
    (Comment 262) Some comments expressed concern about the following 
warning as applied to pipe tobacco products: ``WARNING: This product 
contains nicotine derived from tobacco. Nicotine is an addictive 
chemical.'' They stated that this warning is not appropriate for these 
products because the first sentence of the warning suggests that it is 
targeted at e-cigarettes whose nicotine is derived from tobacco, not 
tobacco itself. Other comments expressed concern that the word 
``derived'' would not be well understood by the majority of consumers 
and introduced unnecessary complexity. They also noted that the 
statement that the nicotine is derived from tobacco does not provide 
information that is relevant to the user's health. One comment 
suggested a number of changes to the proposed addiction warning, 
including a simpler alternative: ``WARNING: This product contains 
nicotine. Nicotine is an addictive chemical.''
    (Response) FDA agrees with concerns using the word ``derived.'' FDA 
has concluded that the suggested warning statement ``WARNING: This 
product contains nicotine. Nicotine is an addictive chemical'' is a 
more appropriate warning label because it provides an accurate warning 
for both products that contain leaf tobacco and products that contain 
nicotine derived from tobacco. It is also clearer and does not 
introduce unnecessarily complex terms that may make it more difficult 
for consumers to understand and appreciate the risks of addiction. 
Similarly, FDA is revising the alternative statement to

[[Page 29069]]

read ``This product is made from tobacco.'' to remove use of the word 
``derived,'' which may not be easily understood. However, FDA disagrees 
with comments stating that this warning should not be required on pipe 
tobacco packages because pipe tobacco contains nicotine, which is the 
primary addictive constituent in tobacco products.
    Thus, FDA has changed Sec.  1143.3(a)(1) to require that for 
cigarette tobacco, roll-your-own tobacco, and covered tobacco products 
other than cigars, it is unlawful for any person to manufacture, 
package, sell, offer to sell, distribute, or import for sale or 
distribution within the United States such product unless the tobacco 
product bears the following required warning statement on each product 
package label: ``WARNING: This product contains nicotine. Nicotine is 
an addictive chemical.''
11. Addictiveness Warning
    (Comment 263) One comment stated that the need to inform consumers 
about the addictiveness of nicotine has been implicitly recognized by a 
number of manufacturers of e-cigarette products. The comment stated 
that a recent investigation by the staff of 11 U.S. Senators and 
Representatives of the practices of 9 of the largest e-cigarette 
manufacturers revealed that, although their product warning labels 
``lack uniformity and may confuse consumers,'' 6 of the 9 companies 
included some form of nicotine warning as part of their packaging or 
instructions for use, in addition to the nicotine warning these 
companies included to satisfy California's Proposition 65 (see Ref. 
31). Although the warnings are not as comprehensive as FDA's required 
health warnings in terms of size and prominence, they reflect the 
companies' own recognition that their products are addictive and that 
consumers should be informed of their addictive properties.
    (Response) Requiring health warnings on all newly deemed tobacco 
products will help consumers better understand and appreciate the 
addictive properties of these products.
    (Comment 264) Some comments questioned whether large cigars, 
particularly premium cigars, should be required to carry an addiction 
warning because users do not inhale the cigar smoke.
    (Response) Regardless of whether cigar smokers inhale, they are 
still subject to the addictive effects through nicotine absorption 
(Refs. 32, 34). Cigar smoke dissolves in saliva, allowing the smoker to 
absorb sufficient nicotine to create dependence, even if the smoke is 
not inhaled (Refs. 34, 35). Therefore, consumers using premium or other 
cigars can become addicted to cigars given the absorption of nicotine. 
Accordingly, FDA finds that it is appropriate for the protection of the 
public health to require this warning on all cigars.
12. Alternative Statement/Certification for Products Without Nicotine: 
``This Product Is Derived From Tobacco.''
    (Comment 265) Several comments expressed concern about requiring a 
tobacco product that does not contain nicotine to have an alternate 
health warning stating that, ``this product is derived from tobacco.'' 
These comments stated that future products that are not derived from 
tobacco would fall outside of FDA's jurisdiction and, therefore, would 
not be required to include this statement on product packages.
    (Response) FDA agrees. If a product is not made or derived from 
tobacco, it would not be required to bear the alternative statement. 
However, if a product is made or derived from tobacco but does not 
contain nicotine, the product is required to bear the alternative 
statement. As discussed in section XVI.B, FDA is revising this 
alternative statement to read ``This product is made from tobacco.''
    (Comment 266) Several comments stated that FDA should not permit 
use of the alternate statement ``This product is derived from tobacco'' 
because there are studies showing instances of e-cigarette products 
being labeled as zero nicotine and actually containing nicotine (Refs. 
20, 170).
    (Response) FDA disagrees. If a tobacco product manufacturer has 
mislabeled its product to indicate that it does not contain nicotine 
when in fact it actually does, the manufacturer will be subject to 
enforcement action for misbranding and the product will be required to 
bear the addictiveness warning (instead of the alternative statement).
    (Comment 267) A few comments suggested that the alternative warning 
statement will cause consumer confusion because most people believe 
nicotine causes cancer and the alternative statement suggests there is 
a difference in the health risks based on solely the presence of 
nicotine. Other comments stated that the alternative statement should 
not use the term ``tobacco product'' because e-cigarettes do not 
contain tobacco leaf. These comments also stated that the words 
``tobacco product'' could also potentially cause confusion because 
consumers do not consider e-cigarettes to be tobacco products.
    (Response) FDA disagrees that the language in the alternative 
statement will cause confusion. The alternative statement does not use 
the term ``tobacco product'' and does not state that any ENDS product 
contains tobacco. Instead, the alternative statement included with this 
final rule states: ``This product is made from tobacco.''
    FDA is not aware of any currently marketed tobacco product that 
does not contain nicotine. If such a product is introduced in the 
future, FDA believes it is important that both consumers and retailers 
be alerted that, although it may not contain nicotine, it is 
nevertheless a tobacco product. From a public health perspective, FDA 
believes that it is important to convey this factual information to 
consumers because tobacco products (i.e., products made or derived from 
tobacco) could contain other addictive chemicals (like anabasine or 
nornicotine) and/or dangerous toxicants and can be psychologically 
addictive as well. For example, users of de-nicotinized cigarettes 
consistently report a significant degree of subjective satisfaction 
(Refs. 265, 266, 267). The alternative warning statement is especially 
important in light of the recent proliferation of novel tobacco 
products (e.g., dissolvables that may appear like candy) that do not 
resemble traditional tobacco products, and therefore, which consumers 
may not know are made from tobacco. As the comments noted, some 
consumers are not even aware that e-cigarettes are tobacco products.
    FDA believes that the fact that a product without nicotine is made 
from tobacco is important factual information that should be conveyed 
to both consumers and retailers. In addition to providing consumers 
with significant information that could affect their health, the 
statement will help ensure that retailers are aware that the product is 
and must be treated as a tobacco product. This will result in increased 
retailer compliance with the minimum age and photo identification 
requirements, as well as other applicable requirements. FDA believes 
that this factual alternative statement is the simplest, least 
burdensome, and yet effective way to inform both consumers and 
retailers that, despite the absence of nicotine, the product is still a 
tobacco product that, like other tobacco products, may not be purchased 
by or sold to persons under the age of 18 and requires the presentation 
and examination of a photo identification card.

[[Page 29070]]

13. Warning: Cigars Are Not a Safe Alternative to Cigarettes
    (Comment 268) A few comments noted that evidence indicates there is 
a widespread perception, particularly among young people, that cigars 
are less hazardous than cigarettes and this perception may be 
contributing to the increased incidence of cigar smoking. According to 
the comments, one study found that adult cigar smokers in general are 
three times more likely to believe cigars are a safe alternative to 
cigarettes compared to those who do not smoke cigars (Ref. 268). They 
also cited an online survey of college students at six colleges in the 
southeastern United States, which found that smokers of little cigars 
and cigarillos ``were more likely to report perceiving the harm of 
little cigars, cigarillos, and cigars to be less than that of 
cigarettes'' when compared to nonusers (Ref. 269). In addition, a study 
of middle school and high school students in Massachusetts found that 
34.9 percent of current youth cigar users agreed that ``cigars are not 
as bad for you as cigarettes,'' while only 12.2 percent of the total 
study population of students agreed with the statement (Ref. 270). The 
comments also cited a similar study that included a focus group study 
of 230 middle school, high school, and college students, which found 
that 30 percent of teen cigar users made the statement that, compared 
to cigarettes, cigars are less risky, and only 10 percent of teens with 
no cigar experience made that statement (Ref. 271).
    (Response) FDA agrees that there is an unsubstantiated perception, 
especially among young people, that cigars are less hazardous than 
cigarettes (see 79 FR at 23158). This warning requirement will help to 
consumers understand and appreciate the risks of cigars.
14. Warning: Tobacco Smoke Increases the Risk of Lung Cancer and Heart 
Disease, Even in Nonsmokers
    (Comment 269) The comments differed as to whether the warning 
``Tobacco Smoke Increases the Risk of Lung Cancer and Heart Disease, 
Even in Nonsmokers'' was appropriate. Some comments thought that the 
health warning was appropriate. At least one noted that a causal 
relationship exists between secondhand smoke exposure and lung cancer 
among lifetime nonsmokers, and individuals living with smokers had a 20 
to 30 percent increase in the risk of developing lung cancer from 
secondhand exposure (Ref. 272 at 445). They stated that, since all 
cigars produce higher levels of toxicants than cigarette smoke, the 
science clearly supports the proposed warning.
    However, several other comments stated that the scientific evidence 
does not support the claim that ``secondhand smoke causes premature 
death and disease in youth and in adults who do not smoke.'' One of 
these comments stated that the epidemiological links between ``being 
married to a smoker'' and increased disease are tenuous at best. While 
these comments agreed that on a per-stick basis, cigars can produce 
larger amounts of environmental tobacco smoke than do cigarettes, they 
stated that it is not accurate to conclude that this exposes household 
members to a considerable involuntary health risk.
    (Response) FDA agrees with the comments stating that this warning 
is appropriate for the protection of the public health. It is well 
established that secondhand smoke causes premature death and disease in 
youth and in adults who do not smoke (Ref. 272 at 445, 532). Adult 
exposure to secondhand smoke has immediate adverse effects on the 
cardiovascular system and causes lung cancer and coronary heart disease 
(id.). Tobacco smoke contains over 7,000 compounds, and there are more 
than 70 carcinogens in sidestream and mainstream smoke generated from 
cigars (Refs. 9, 70, 273). Mainstream cigar smoke is the smoke that one 
draws into his or her mouth from the butt end or mouthpiece of a cigar; 
whereas sidestream cigar smoke is the smoke emitted from the burning 
cone of a cigar during the interval between puffs (Ref. 69 at 65). 
Cigar smoke ``tar'' appears to be at least as carcinogenic as cigarette 
smoke ``tar'' (Ref. 272). The Surgeon General recently reiterated that 
cigar smoke contains the same toxic substances as cigarette smoke, with 
varying concentrations of these constituents found in different types 
and sizes of cigars (Ref. 69 at 17-18; Ref. 272 at 362).
    There is a causal relationship between lung cancer and secondhand 
smoke. Exposure of nonsmokers to secondhand smoke also has been shown 
to cause a significant increase in urinary levels of metabolites of 
tobacco-specific nitrosamines, a carcinogen that specifically links 
exposure to secondhand smoke with an increased risk for lung cancer 
(Ref. 69 at 65). All cigars produce higher levels of carcinogenic 
tobacco-specific nitrosamines per gram in mainstream cigar smoke than 
cigarettes produce in mainstream cigarette smoke (id. at 75-76). Cigar 
smoke also produces measurable amounts of lead and cadmium (id. at 75-
76). Little cigars with filter tips and regular cigars contain higher 
levels of certain nitrosamines in sidestream smoke than do filtered tip 
cigarettes (Ref. 69 at 81).
    The Surgeon General has reiterated that there is considerable 
evidence that certain nitrosamines are major factors in the development 
of lung cancer (Ref. 272 at 30). According to the Surgeon General, the 
evidence is sufficient to infer a causal relationship between 
secondhand smoke exposure and lung cancer among lifetime nonsmokers 
(Ref. 272 at 434). Individuals living with smokers have a 20 to 30 
percent increase in risk of developing lung cancer from secondhand 
exposure (id. at 445). Although data particular to cigars are not 
available, FDA believes it is reasonable to expect that cigar smoke 
would produce similar effects as cigarette smoke, given that data from 
the National Cancer Institute (NCI) cigar monograph shows that some 
carcinogens determined to cause lung cancer are present at higher 
levels in cigar smoke than in cigarette smoke and are present at levels 
comparable to other carcinogens linked to lung cancer (Ref. 69 at 76-
93).
    There is also a causal relationship between secondhand smoke and 
heart disease. The health warning statement indicating that tobacco 
smoke can cause heart disease is thoroughly supported by the evidence 
reiterated in reports from the Surgeon General. FDA believes it is 
reasonable to conclude that this finding would produce similar effects 
with respect to secondhand cigar smoke exposure based on the similar 
smoke profiles for cigars and cigarettes, the risk of coronary heart 
disease associated with active cigar smoking, and the low levels of 
toxicant exposure that can cause coronary heart disease (Ref. 272).
    In a 2006 Surgeon General's report regarding the health effects of 
exposure to secondhand smoke, the evidence demonstrated that exposure 
of adults to secondhand smoke had immediate adverse effects on the 
cardiovascular system and caused coronary heart disease (id. at 11). 
Secondhand smoke increased the risk of coronary heart disease nearly as 
much as active heavy smoking. In fact, the estimated increase in risk 
of coronary heart disease from exposure to secondhand smoke was 25 to 
30 percent above that of unexposed persons (id. at 519; Ref. 273 at 
532). Based on these data, the Surgeon General concluded that ``the 
evidence is sufficient to infer a causal relationship between exposure 
to secondhand smoke and increased risks of coronary heart disease 
morbidity and mortality among both men and women'' (Ref. 272 at 15). 
The IOM agreed, concluding that there is a causal relationship between

[[Page 29071]]

secondhand smoke exposure and cardiovascular disease, as well as a 
causal relationship between secondhand smoke exposure and acute 
myocardial infarction (Ref. 275 at 219).
    Even a relatively brief exposure to secondhand tobacco smoke can 
lead to heart disease, as some studies have demonstrated. The IOM found 
there is compelling circumstantial evidence that a relatively brief 
exposure to secondhand smoke can bring about an acute coronary event 
(id. at 220).
    Given that the effects of secondhand smoke on coronary heart 
disease are linked to the combustion of tobacco itself, FDA concludes 
that exposure to secondhand cigar smoke can cause the same or similarly 
dangerous effects as exposure to secondhand cigarette smoke. Thus, FDA 
believes the warning statement that ``Tobacco smoke increases the risk 
of lung cancer and heart disease, even in nonsmokers'' is appropriate 
for the protection of the public health.
15. Warning: Cigar Smoking Can Cause Cancers of the Mouth and Throat, 
Even if You Do Not Inhale
    (Comment 270) Several comments disagreed with FDA's rationale for 
the warning ``Cigar smoking can cause cancers of the mouth and throat, 
even if you do not inhale.'' These comments noted that the rationale 
depends almost exclusively on Monograph 9 from the National Cancer 
Institute, which did not distinguish among cigar types and, therefore, 
should not be required for premium cigars. They also stated that cigars 
are safe products if users do not inhale the smoke, as illustrated by 
experimental data showing minimal toxicity because cigar smokers do not 
inhale (Refs. 32, 74).
    (Response) FDA disagrees. The fact that Monograph 9 did not 
distinguish among types of cigars does not mean that it only applies to 
certain cigar types. In fact, the statement in the Monograph applied to 
all types of cigars. Any cigar use exposes the mouth and throat to 
tobacco smoke and can cause several different types of cancer even 
without inhalation (Refs. 69, 104). For example, one study found an 
increased risk of head and neck cancers for those who do not smoke 
cigarettes but had previously smoked cigars (Ref. 104).
    While inhaling cigar smoke poses higher risk rates than not 
inhaling, significant risk still exists for those who do not inhale. In 
addition, most cigar smokers do inhale some amount of smoke and are not 
aware that they are doing it, including those who do not intend to 
inhale (Ref. 33).
16. Reproductive Health Warning for Cigars
    In the proposed deeming rule, FDA proposed to require four of the 
five warnings already included on most cigar packages and in most cigar 
advertisements as a result of settlement agreements between the FTC and 
the seven largest U.S. cigar manufacturers. (See, e.g., In re Swisher 
International, Inc., Docket No. C-3964.) FDA proposed not to require 
the fifth warning (SURGEON GENERAL WARNING: Tobacco Use Increases the 
Risk of Infertility, Stillbirth and Low Birth Weight) because although 
cigarette smoke causes these health effects (and cigar smoke is similar 
to cigarette smoke), the Agency stated it was not aware of studies 
specifically linking cigars to all three reproductive effects. FDA 
requested comment on its proposal to require the use of only four of 
the five current FTC warnings for cigars.
    During the comment period, FDA received several comments 
encouraging FDA to reconsider its proposal and finalize the rule to 
include all five warnings. In response to these comments, FDA 
reconsidered whether to require use of the FTC reproductive health 
warning. While FDA agrees that FTC's general warning statement 
``Tobacco Use Increases the Risk of Infertility, Stillbirth and Low 
Birth Weight'' is a factually correct statement and recognizes that 
cigar smoke is similar to cigarette smoke in both chemical content and 
effects, on balance, FDA prefers a warning that is specific to cigars. 
Therefore, FDA has reconsidered the issue and is including a fifth 
warning statement to read ``WARNING: Cigar Use While Pregnant Can Harm 
You and Your Baby.'' which is well supported by direct evidence and is 
appropriate for the protection of the public health. However, FDA is 
also allowing manufacturers to use the FTC warning, which is 
appropriate for the protection of the public health, as an optional 
alternative to the new reproductive health warning.
    The FTC warning is about tobacco smoke generally, and the statement 
itself is well supported by scientific evidence. Researchers have 
confirmed that smoking causes negative effects on fertility, 
pregnancies, and infants and children born to women who smoke. For 
example, cigarette smoking increases rates of preterm delivery, 
shortened gestation, and orofacial clefts, and studies have indicated 
that women who smoke are twice as likely to have low birth weight 
infants as women who do not smoke (Ref. 9 at p. 499; Ref. 275 at pp. 
569, 576). In addition, scientific evidence supports that women who 
smoke have an increased risk of infertility and stillbirth (Ref. 276). 
It also causes an increased risk of sudden infant death syndrome (SIDS) 
for infants whose mothers smoke during and after pregnancy (Ref. 275 at 
pp. 587 and 601). In addition, scientific evidence supports the 
conclusion that cigar smoke has similarly toxic effects. NCI's 
Monograph 9 states:

there is no reason to expect that cigar smoke would be any less 
toxic for the mother or fetus. Regular cigar smoking, particularly 
with inhalation, should be presumed to have risks similar to that of 
cigarette smoking for the pregnant smoker.

(Ref. 69 at 10). On balance, FDA prefers a warning that is specific to 
cigars, so FDA is finalizing this rule with different warning language 
specifically relating to cigars that the Agency concludes is 
appropriate for the protection of the public health. However, given the 
accuracy of the original FTC warning on its face, given that cigar 
smoke contains and delivers the same harmful constituents as cigarette 
smoke, and given extensive evidence that cigar smoke has similar 
physiological effects on the body, it is also appropriate for the 
protection of the public health for FDA to allow the use of the 
optional alternative (SURGEON GENERAL WARNING: Tobacco Use Increases 
the Risk of Infertility, Stillbirth and Low Birth Weight) to the 
reproductive health warning.
    FDA selected the new warning language for several reasons. First, 
FDA finds that this warning is supported by direct scientific evidence 
that nicotine adversely affects maternal and fetal health (Ref. 9). 
Second, this warning uses the term ``cigar use'' rather than ``tobacco 
use,'' because the warning would appear on cigars only. Third, FDA 
finds that this is powerful and comprehensible phrasing, which will be 
understandable to a wide audience. Nevertheless, FDA recognizes that 
many cigar manufacturers currently use FTC's truthful warning on the 
reproductive risks of tobacco smoke. Therefore, FDA is also allowing an 
optional alternative (SURGEON GENERAL WARNING: Tobacco Use Increases 
the Risk of Infertility, Stillbirth and Low Birth Weight) to the 
reproductive health warning to comply with the warning requirements for 
cigars. FDA expects that allowing the optional alternative will benefit 
entities bound by the FTC consent decrees.
    (Comment 271) Comments from cigar makers contended that because the 
NPRM and the FTC consent orders both required five warnings, but not 
the same

[[Page 29072]]

five warnings, manufacturers would not be able to use one set of 
warnings to comply with both regimes. As one comment put it, ``For 
example, manufacturers could not ensure a random display of FDA's five 
warnings `in as equal a number of times as is possible,' as required by 
the NPRM, while including the reproductive effects warning required by 
FTC in that random distribution.'' This comment went on to state that a 
reproductive warning for cigars is also required by California's 
Proposition 65, and added that in response to an inquiry from FTC at 
the time of the FTC consent orders, the California Attorney General 
agreed that ``compliance with the FTC Consent Order will result in 
compliance with Proposition 65.'' (Comments of Altria Client Services 
Inc. on behalf of John Middleton Co., FDA-2014-N-0189-79814.)
    Other comments urged that there is scientific support to require a 
reproductive warning for cigars. For example, one comment asserted that 
this warning is based on data related to cigarette smoke, and given 
that cigarette smoke is very similar to cigar smoke, and in many cases, 
cigar smoke is more dangerous than cigarette smoke, it is a logical 
conclusion that this warning is appropriate for cigars. Another comment 
noted that the 2014 U.S. Surgeon General Report on tobacco use devotes 
an entire chapter to the health effects of nicotine and documents that 
nicotine crosses the placenta and concentrates in the fetus (Ref. 9). 
The comment also noted that nicotine constricts vessels and thus limits 
the amount of nutrients and oxygen delivered to the fetus.
    (Response) While FDA is unaware of data directly and explicitly 
linking cigar smoke to such reproductive issues, FDA recognizes the 
similarities between cigarette smoke and cigar smoke. On balance, FDA 
prefers a warning specific to cigars. However, as noted previously, FDA 
is allowing an optional alternative (SURGEON GENERAL WARNING: Tobacco 
Use Increases the Risk of Infertility, Stillbirth and Low Birth Weight) 
to the reproductive health warning to comply with the warning 
requirements for cigars. FDA expects that allowing the optional 
alternative will benefit entities bound by the FTC consent decrees.
    (Comment 272) One comment expressed concern that the exclusion of 
the reproductive effects warning in a final rule (i.e., the FTC warning 
that states ``Tobacco Use Increases The Risk Of Infertility, Stillbirth 
And Low Birth Weight''), and the subsequent advertising and sale of 
cigar packages without the warning, could result in claims that the FTC 
consent orders have been violated. The comment requested that FDA 
ensure that the absence of such warning in any final rule will not 
result in a claim that the FTC consent orders have been violated.
    (Response) In the NPRM, FDA indicated that it planned to consult 
with FTC ``to harmonize national requirements for health warnings on 
cigar product packages and in advertisements'' (79 FR 23142 at 23163). 
As noted previously, FDA has given careful consideration to the 
comments and the scientific evidence on this issue and has decided to 
require a reproductive health warning for cigars, and the Agency has 
discussed this evidence and decision with FTC. At this time, FDA is not 
aware of any concerns from FTC regarding the cigar warnings included 
with this final rule.
17. Rotation of Warnings on Advertisements
    (Comment 273) Several comments stated that rotational warning 
requirements should be simple, streamlined, and easily administrated, 
especially for small businesses. One comment suggested that it should 
be sufficient to print equal numbers of labels containing all six 
warnings and rely on the randomness of market distribution patterns 
without the administrative burden of demonstrating to FDA in a written 
rotational plan, and in subsequent facility inspections, that FDA can 
determine that each different warning was equally displayed to each 
consumer for each brand during a 12-month period.
    (Response) While FDA recognizes that the random display and 
distribution of warning statements on cigar product packages and the 
rotation of statements on advertisements can result in administrative 
and financial costs for cigar manufacturers, FDA does not believe it 
would be sufficient to rely on the randomness of market distribution 
patterns. Relying on random distribution would not ensure that the 
different health warning messages are reaching as many individuals as 
possible, and the health warnings may grow stale from overuse if 
repeated too many times for the same individual. Thus, FDA is requiring 
warning statements for cigar packages to be randomly displayed in each 
12-month period in as equal a number of times as possible on each brand 
of cigar. The required warning statements also are required to be 
randomly distributed in all areas of the United States in which the 
product is marketed. The random display and distribution of required 
warning statements for cigar packages must be carried out in accordance 
with a warning plan submitted by the cigar manufacturer, importer, 
distributor, or retailer to, and approved by FDA.
    FDA is also requiring that the required warning statements be 
rotated quarterly in alternating sequence in each advertisement for 
each brand of cigar, regardless of whether the cigar is sold in product 
packaging. This rotation of warning statements in cigar advertisements 
also must be done in accordance with a warning plan submitted to FDA by 
the cigar manufacturer, importer, distributor, or retailer to, and 
approved by FDA. As stated in Sec.  1143.5(c)(3) of this final rule, 
each person required to randomly display and distribute or rotate 
warnings in accordance with an FDA-approved plan under this part must 
submit a proposed warning plan to FDA no later than either 12 months 
after [date of publication of final rule], or 12 months before 
advertising or commercially marketing a product that is subject to such 
requirement, whichever is later. This 12-month submission timeframe 
provides cigar entities time to develop and submit warning plans to 
FDA. FDA encourages firms to submit warning plans any time within this 
12-month period, and FDA plans to begin reviewing warning plans as soon 
as they are received. FDA is establishing this effective date at 12 
months before the effective date of the required warnings for cigars 
described under part 1143 (24 months after the publication of the final 
rule) because the Agency anticipates that there will be a need for 
communication with submitters during its review of the warning plan 
submissions. This submission effective date also helps FDA to ensure 
that its surveillance program for compliance with the warning label 
requirements under Sec.  1143 is implemented as of the effective date 
of 24 months after the publication of the final rule.
    FDA intends to work with manufacturers, importers, distributors, or 
retailers to get an approved warning plan in place. Cigar entities may 
wish to contact FDA to discuss the submission of their warning plans in 
order to make the approval process more orderly and efficient. FDA's 
review and approval of a warning plan enables the Agency to more 
effectively conduct surveillance and inspection activities to ensure 
compliance with the warning label requirements under Sec.  1143, once 
effective, by providing a guide regarding the expected rotation of the 
various warnings as required by the regulation. In addition, the review 
and approval

[[Page 29073]]

process will help manufacturers, importers, distributors, and retailers 
understand the requirements under this part; and help cigar entities 
minimize potential economic loss from the commercial distribution of 
nonconforming products in the market.
    Additionally, FDA believes that it will be able to complete its 
review of the submitted warning plans by the effective date of the 
required cigar warnings. In FDA's experience with the review of warning 
plans for smokeless tobacco products, no smokeless tobacco product 
manufacturer, importer, distributor, or retailer was delayed or 
prevented from advertising or distributing smokeless tobacco products 
due to FDA's review of its warning plan, and FDA does not anticipate a 
different outcome here. FDA intends to issue a guidance document within 
12 months after publication of the final rule to assist the cigar 
industry with the requirements for the submission of warning plans. In 
addition, if FDA receives a higher volume of warning plans than 
anticipated, and determines that it will not be able to review and 
approve submitted warning plans by the 24-month effective date, FDA may 
also consider implementing a compliance policy to ensure that cigar 
entities are not delayed or prevented from advertising or distributing 
cigars due to FDA's review of their warning plans.
    These requirements are consistent with those established by 
Congress in the Tobacco Control Act for currently regulated tobacco 
products. Section 3 of CSTHEA (as amended by section 204 of the Tobacco 
Control Act) requires the random distribution and rotation of warnings 
for smokeless tobacco products. Further, rotation of cigar warning 
statements already occurs under the FTC consent decrees. The WHO also 
has recognized the need to rotate health warnings for tobacco products. 
The WHO's FCTC, evidence of a strong worldwide consensus regarding a 
regulatory strategy for addressing the serious negative impacts of 
tobacco products, calls for warnings that are ``rotating'' and ``large, 
clear, visible and legible'' (WHO FCTC article 11.1(b)).
    (Comment 274) One comment stated that the proposed requirement that 
the warning statements be permanent or irremovable is ambiguous and 
does not specifically address whether labels applied by manufacturers 
(which manufacturers intend not to be removed but technically are 
removable) are compliant with the rule.
    (Response) Section 1143.9 requires that the health warnings be 
indelibly printed on or permanently affixed to packages and 
advertisements. If a warning statement can be removed, then it is not 
permanent and does not meet the requirements of Sec.  1143.9. Removable 
or impermanent warnings on packages and in advertisements could become 
separated from the package or advertisement and thus would not meet the 
requirement that they be conspicuous on the package or advertisement. 
Removable warnings would run counter to FDA's purpose of effectively 
conveying risk information to consumers.
18. Warnings for E-Liquids
    (Comment 275) Several comments recommended that FDA require 
multiple and rotating warnings on all e-liquids that contain nicotine. 
They stated the potential consequences of nicotine use need to be 
listed explicitly, as explicit warnings are associated with greater 
perception of potential danger than vague or general warnings (Ref. 
277). Suggestions for e-cigarette warning label content included: (1) 
Toxicity and potential lethality of nicotine; (2) danger to skin and 
eyes; (3) danger from ingestion of nicotine liquids; (4) other 
potential health hazards, including burns and explosions, from ENDS 
use; (5) keep out of reach of children; (6) information about the 
heating mechanism (coil) and energy source (battery); (7) information 
about overheating or overuse, including risk of fire (if applicable); 
(8) warnings or precautions about use in or near water as well as any 
electrical shocks; and (9) warnings and instructions about replacing 
components and parts.
    Another comment believed the Agency should consider requiring 
manufacturers of e-cigarettes to provide additional information for 
consumers in e-cigarette packaging, and as appropriate, for other newly 
deemed tobacco products. The comment suggested that this information 
could be presented using communication principles similar to those used 
in ``Drug Facts'' for over-the-counter drugs and should include 
information such as the nicotine addiction warning, age limits, 
warnings about danger to children and pets, and information about use 
during pregnancy and breast feeding.
    (Response) At this time, FDA finds it is appropriate for the 
protection of the public health to require the warning regarding the 
addictiveness of nicotine on ENDS. However, as we have stated 
previously, this deeming regulation is a foundational rule, affording 
the Agency the ability to publish additional regulations as necessary 
and appropriate for the protection of the public health. FDA remains 
concerned about all of the health risks and hazards listed in this 
comment and will be focusing efforts and resources on future efforts to 
prevent nicotine poisoning in both users and nonusers. Therefore, FDA 
issued an ANPRM prior to this deeming rule, seeking comments, data, 
research, or other information that may inform regulatory actions FDA 
might take with respect to nicotine exposure warnings and the use of 
child-resistant packaging. In addition, elsewhere in this issue of the 
Federal Register, FDA has made available draft guidance for public 
comment, which when final will represent FDA's current thinking 
regarding some appropriate means of addressing the premarket 
authorization requirements for newly deemed ENDS products, including 
recommendations for exposure warnings and child-resistant packaging 
that would help to support a showing that the marketing of a product is 
appropriate for the protection of public health.
    (Comment 276) Several comments noted that FDA should establish 
alternative methods for providing health warnings on tobacco products 
with small packages, such as e-cigarettes. One comment noted that FDA 
has created special rules for small food packages and small over-the-
counter drug packages where the size of the package prevents the 
manufacturer from satisfying certain mandatory labeling requirements. 
This comment suggested that FDA implement similar alternatives for 
displaying warnings on small e-cigarette packages, and that the warning 
on advertising materials should not exceed 10 percent of the area of 
the advertisement. Another comment asserted that many e-liquids are 
packaged in relatively small 10 milliliter vials and that FDA should 
consider package size and design when mandating health warnings.
    (Response) To address the issue of tobacco products with small 
packages, we have added Sec.  1143.3(d) to this final rule, which 
states that a tobacco product that would otherwise be required to bear 
the warning in Sec.  1143.3(a)(1) but is too small or otherwise unable 
to accommodate a label with sufficient space to bear the information is 
exempt from compliance with the requirement provided the information 
and specifications required under Sec.  1143.3(a)(1) and (a)(2) appear 
on the carton or other outer container or wrapper if the carton, outer 
container, or wrapper has sufficient space to bear such information, or 
appears on a tag otherwise permanently affixed to the tobacco product 
package. In these cases, the carton, outer container, wrapper, or tag 
will serve as the location of the

[[Page 29074]]

principal display panels. For example, FDA is aware that e-liquids are 
frequently sold in small vials that may be unable to accommodate a 
label with sufficient space to bear a health warning. In addition, 
small boxes of replacement cartridges will be required to carry a 
warning if they contain nicotine or tobacco, or are otherwise made or 
derived from tobacco, and, therefore, are covered tobacco products. 
Such products also may not have sufficient space to bear a health 
warning. In these cases, a manufacturer could include such information 
on the carton or other outer container or wrapper if the carton, outer 
container, or wrapper has sufficient space to bear the information, or 
appear on a tag that is permanently affixed to the tobacco product 
package. With respect to the part of this comment stating that health 
warnings on advertising materials should not exceed 10 percent of the 
area of the advertisement, see the NPRM (79 FR 23142 at 23164) for 
additional discussion regarding the need for prominent health warnings.

XVII. National Environmental Policy Act

    The Agency has carefully considered the potential environmental 
effects of deeming products to be subject to the FD&C Act and the age 
and identification restrictions. FDA has concluded that the actions 
will not have a significant impact on the human environment, and that 
an environmental impact statement is not required. The Agency's finding 
of no significant impact and the evidence supporting that finding, 
contained in an environmental assessment, may be seen in the Division 
of Dockets Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday 
through Friday.
    FDA's responses to comments regarding the proposed Environmental 
Assessment are included in the following paragraphs.
    (Comment 277) One comment stated that FDA erroneously relied upon 
the environmental impact analyses required by the National 
Environmental Policy Act (NEPA), suggesting that the Agency should 
review and analyze the total environmental impact of the rule.
    (Response) FDA disagrees. The analysis of a regulation's 
environmental impact is governed by NEPA, which requires FDA to assess, 
as an integral part of its decisionmaking process, the environmental 
impacts of any proposed Federal action to ascertain the environmental 
consequences of that action on the quality of the human environment and 
to ensure that the interested and affected public is appropriately 
informed. FDA satisfied these requirements with the preparation of a 
proposed environmental assessment and a final environmental assessment 
(Ref. 278).
    (Comment 278) One comment requested that FDA issue a new 
Environmental Assessment due to ``the loss of irreplaceable cultural 
historical resources that directly relate to the heritage of the [Ybor 
City National Historic Landmark] District, the City of Tampa, the State 
of Florida[, and] the United States of America.''
    (Response) FDA denies this request. FDA prepared its Environmental 
Assessment in accordance with the requirements of 21 CFR part 25. FDA 
properly accounted for all potential environmental consequences of that 
action on the quality of the human environment. Therefore, a new 
Environmental Assessment is unnecessary and contrary to the 
requirements of NEPA (Ref. 279).

XVIII. Analysis of Impacts

    We have examined the impacts of the final rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Public 
Law 104-4). Executive Orders 12866 and 13563 direct us to assess all 
costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety, and other advantages; distributive impacts; and 
equity). We have developed a comprehensive Economic Analysis of Impacts 
that assesses the impacts of the final rule. We believe that this final 
rule is a significant regulatory action as defined by Executive Order 
12866.
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. We find that the final rule will have a significant economic 
impact on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires 
us to prepare a written statement, which includes an assessment of 
anticipated costs and benefits, before issuing ``any rule that includes 
any Federal mandate that may result in the expenditure by State, local, 
and tribal governments, in the aggregate, or by the private sector, of 
$100,000,000 or more (adjusted annually for inflation) in any one 
year.'' The current threshold after adjustment for inflation is $144 
million, using the most current (2014) Implicit Price Deflator for the 
Gross Domestic Product. This final rule would result in a 1-year 
expenditure that meets or exceeds this amount.
    This final rule finalizes Option 1 of the NPRM, which deems all 
products meeting the statutory definition of ``tobacco product,'' 
except accessories of a newly deemed tobacco product, to be subject to 
chapter IX of the FD&C Act. This final rule also finalizes additional 
provisions that would apply to certain newly deemed products as well as 
to certain other tobacco products. Once deemed, tobacco products become 
subject to the FD&C Act and its implementing regulations. The FD&C Act 
requirements that will apply to newly deemed products include 
establishment registration and product listing, ingredient listing, 
submissions prior to the introduction of new products, and labeling 
requirements. Free samples of newly deemed tobacco products will also 
be prohibited. The additional provisions of this final rule include 
minimum age and identification requirements, vending machine 
restrictions, and required warning statements for packages and 
advertisements.
    While FDA currently has authority to regulate cigarettes, cigarette 
tobacco, roll-your-own tobacco, and smokeless tobacco under chapter IX 
of the FD&C Act, under the final rule, all additional tobacco products 
that meet the statutory definition, except accessories of those newly 
deemed tobacco products, will be subject to chapter IX of the FD&C Act 
and its implementing regulations.\16\ These products include cigars, 
pipe tobacco, waterpipe tobacco, ENDS (including e-cigarettes), and 
other novel tobacco products such as certain dissolvable products and 
gels. These products further include components and parts of the newly 
deemed products, including pipes, e-liquids, atomizers, batteries, 
cartomizers (atomizer plus replaceable fluid-filled cartridge), tank 
systems, flavors for e-liquids, vials that contain e-liquids, 
programmable software, flavor enhancers for waterpipe tobacco, 
waterpipe cooling attachments, water

[[Page 29075]]

filtration base additives, flavored waterpipe tobacco charcoals, and 
waterpipe bowls, valves, hoses, and heads.
---------------------------------------------------------------------------

    \16\ As stated in section 201(rr) of the Federal Food, Drug, and 
Cosmetic Act in relevant part, a tobacco product: (1) Means any 
product made or derived from tobacco that is intended for human 
consumption, including any component, part, or accessory of a 
tobacco product (except for raw materials other than tobacco used in 
manufacturing a component, part, or accessory of a tobacco product); 
and (2) Does not mean an article that is a drug under section 
201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
321(g)(1)), a device under section 201(h) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 321(h)), or a combination product 
described in section 503(g) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 353(g)).
---------------------------------------------------------------------------

    The final deeming action differs from most public health 
regulations in that it is an enabling regulation. In addition to 
directly applying the substantive requirements of chapter IX of the 
FD&C Act and its implementing regulations to newly deemed tobacco 
products, it enables FDA to issue further regulations related to such 
products that are appropriate for the protection of the public health. 
We expect that asserting our authority over these tobacco products will 
enable us to propose further regulatory action in the future as 
appropriate, and those actions will have their own costs and benefits. 
Without deeming these products to be subject to the FD&C Act, FDA would 
lack the authority to require manufacturers to provide, for example, 
vital ingredient and health information about them. We would also lack 
the authority to take regulatory action with respect to them, if we 
determined it was appropriate to do so.
    The direct benefits of making each of the newly deemed tobacco 
products subject to the requirements of chapter IX of the FD&C Act are 
difficult to quantify, and we cannot predict the size of these benefits 
at this time. Among other effects, new products will be subject to an 
evaluation to ensure they meet the appropriate public health standard 
for the pathway before they can be marketed, labeling cannot contain 
misleading statements, and FDA will be made aware of the ingredients in 
newly deemed tobacco products. If, without the final rule, new products 
would pose substantially greater health risks than those already on the 
market, the premarket requirements made effective by this final rule 
would keep such products from appearing on the market and worsening the 
health effects of tobacco product use. The warning statements required 
by this final rule will help consumers better understand and appreciate 
the risks and characteristics of tobacco products.
    The final rule as a whole will impose costs in the form of 
registration, submission, and labeling requirements. Manufacturers of 
newly deemed products, as well as some manufacturers of currently 
regulated products, will need to comply with the warning label 
provisions, which will impose additional costs, including costs for 
signs with warnings at point-of-sale for cigars sold singly without 
packaging. There will be potential costs for removing non-compliant 
point-of-sale advertising and complying with vending machine 
restrictions.
    The primary estimate for the present value of total quantified 
costs over 20 years is approximately $988 million at a 3 percent 
discount rate and $817 million at a 7 percent discount rate. The 
quantified costs of the final rule can also be expressed as annualized 
values, as shown in table 1. Unquantified costs which may be 
attributable to this final rule include: Some consumer costs for users 
of the newly deemed products due to loss of product variety or higher 
prices; recordkeeping costs for exporters of deemed tobacco products; 
compliance costs for components and parts other than complete pipes, 
waterpipes, and ENDS delivery systems; the cost of testing and 
reporting for HPHCs; the cost of any clinical testing that may 
potentially be conducted to support SE reports; market adjustment 
(friction) costs and lost producer surplus associated with product 
consolidation, exit of manufacturers, and the switch to pure retailing 
among retailers such as vape shops who currently engage in 
manufacturing activities.

                                             Table 5--Summary of Quantified Costs Over 20 Years ($ million)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                            Lower bound                     Upper bound     Lower bound                     Upper bound
                                                               (3%)        Primary  (3%)       (3%)            (7%)        Primary  (7%)       (7%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Present Value of Private Sector Costs...................           517.7           783.7         1,109.8           450.4           670.9           939.8
Present Value of Government Costs \1\...................           204.6           204.6           204.6           145.7           145.7           145.7
Present Value of Total Costs............................           722.3           988.2         1,314.4           596.1           816.5         1,085.4
Annualized Value of Private Sector Costs................            34.8            52.7            74.6            42.5            63.3            88.7
Annualized Value of Government Costs \1\................            13.8            13.8            13.8            13.8            13.8            13.8
Annualized Value of Total Costs.........................            48.5            66.4            88.3            56.3            77.1           102.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ FDA costs represent an opportunity cost, but this rule will not result in changes to overall FDA accounting costs, the size of the federal budget,
  or the total amount of tobacco industry user fees.

    Because it is not possible to compare benefits and costs directly 
when the benefits are not quantified, we employ a breakeven approach. 
For the reasons provided elsewhere in this preamble and in the analysis 
of impacts, FDA has concluded that the benefits of the final rule 
justify the costs.
    In addition to the benefits and costs of this final rule, we assess 
the benefits and costs of four different approaches. These approaches 
consist of regulatory alternatives (i.e., alternatives to the rule) as 
well as enforcement options (i.e., periods of time during which FDA 
does not intend to enforce certain requirements). First, we assess the 
regulatory alternative of exempting premium cigars from regulation. 
Second, we assess two hybrid regulatory alternatives/enforcement 
options of providing either a 36-month or 12-month compliance period 
for labeling changes. Lastly, we assess the enforcement option of not 
extending the premarket review compliance policy to new flavored 
tobacco products (other than tobacco flavored products).\17\ For the 
sake of simplicity only, we have referred to these four approaches as 
``alternatives to the rule.''
---------------------------------------------------------------------------

    \17\ Throughout the final RIA, any reference to ``flavored 
tobacco products'' means flavored products other than tobacco 
flavor.
---------------------------------------------------------------------------

    In addition to the above alternatives, comments discussed changing 
the grandfather date as an alternative. FDA has decided not to include 
this option in the analysis of alternatives because we determined that 
the Agency lacks the authority to change the grandfather date.
    Primary estimates of the costs of the regulatory alternatives 
appear as present values and annualized values in table 6.

[[Page 29076]]

   Table 6--Primary Estimate of Quantified Costs for Regulatory Alternatives (Present and Annualized Values, $
                                                  million) \1\
----------------------------------------------------------------------------------------------------------------
                                                   Present value   Present value    Annualized      Annualized
                   Alternative                         (3%)            (7%)         value  (3%)     value  (7%)
----------------------------------------------------------------------------------------------------------------
1--Exempt Premium Cigars from Regulation........             959             794              64              75
2a--36-month compliance period for labeling                  968             797              65              75
 changes........................................
Final Rule and Compliance Period................             988             817              66              77
2b--12-month compliance period for labeling                1,043             871              70              82
 changes........................................
3--Do not extend the premarket review compliance           1,141             961              77              91
 policy to new flavored tobacco products........
----------------------------------------------------------------------------------------------------------------
\1\ Nonquantified benefits are described in the text.

    In addition to the social costs described in this document, the 
final rule would lead to distributional effects, such as: Reduced 
revenues for firms in affected sectors, payment of user fees, and 
potential changes in tax revenues.
    Domestic tobacco product manufacturers, tobacco product importers, 
and vape shops are the businesses primarily affected by this rule; most 
of these businesses are small. We focus the quantitative analysis of 
small entities on manufacturers and importers of cigars and ENDS 
products. We note that most pipe tobacco and waterpipe tobacco 
manufacturers and importers are also small, and we expect the impact on 
them to be similar to the impact on cigar manufacturers and importers. 
Even though user fees are a transfer payment and not a societal cost, 
they are a cost from the standpoint of the cigar and pipe manufacturers 
who must pay them under this final rule and have been included in the 
estimated burden for cigar manufacturers and importers. Estimated costs 
per cigar manufacturer or importer are $278,000 to $397,000 in the 
first year, $292,000 to $411,000 in the second year, and $235,000 to 
$257,000 in the third year. (The inclusion of user fees in these 
estimates will cause costs to be overstated for manufactures and 
importers who also manufacture currently regulated products. In 
addition, costs will vary by firm size as user fees are based on market 
share). Estimated costs per ENDS manufacturer or importer are $827,000 
to $1.21 million in the first year, $832,000 to $1.21 million in the 
second year, and $22,000 to $64,000 in subsequent years. Although we do 
not quantitatively examine the financial effects on vape shops, we 
expect the proportion of vape shops that mix e-liquids may fall during 
the initial compliance policy period for submission and FDA receipt of 
PMTAs. After this initial compliance policy period, we expect that most 
vape shops will continue to operate but those that have not already 
switched pure retailing will likely do so. Regulatory alternatives that 
would reduce costs are analyzed as potential regulatory relief options 
for small businesses.
    The Economic Analysis of Impacts of the final rule performed in 
accordance with Executive Order 12866, Executive Order 13563, the 
Regulatory Flexibility Act, and the Unfunded Mandates Reform Act is 
available at http://www.regulations.gov under the docket number(s) for 
this final rule (Ref. 204) and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

XIX. Paperwork Reduction Act of 1995

    This final rule contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). The 
title, description, and respondent description of the information 
collection provisions are shown in the following paragraphs with an 
estimate of the annual reporting and recordkeeping burden. Included in 
the estimate is the time for reviewing instructions, searching existing 
data sources, gathering and maintaining the data needed, and completing 
and reviewing each collection of information.
    Title: Deeming Tobacco Products To Be Subject to the Federal Food, 
Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and 
Tobacco Control Act; Restrictions on the Sale and Distribution of 
Tobacco Products and Required Warning Statements for Tobacco Products.
    Description: On June 22, 2009, the President signed the Tobacco 
Control Act into law. In this rule, the Agency is extending FDA's 
``tobacco product'' authorities in the FD&C Act to all other categories 
of products meeting the statutory definition of ``tobacco product'' in 
section 201(rr) of the FD&C Act, excluding accessories of deemed 
tobacco products. (Two options were presented in the NPRM. Under Option 
1, all products meeting the definition of a ``tobacco product,'' except 
accessories of newly deemed tobacco products, would be deemed. Option 2 
was the same as Option 1, except a subset of cigars known as ``premium 
cigars'' would be excluded. After thorough review of the comments and 
the scientific evidence, FDA has concluded that Option 1 more 
effectively protects the public health and therefore has made that the 
scope of the final rule.) The rule also prohibits the sale of covered 
tobacco products to individuals under the age of 18 and prohibits the 
sale of covered tobacco products using the assistance of any retail-
based electronic or mechanical device (such as a vending machine) 
except in facilities where the retailer ensures that no person younger 
than 18 years of age is present, or permitted to enter, at any time. 
The requirement that a retailer sell covered tobacco products in only a 
direct, face-to-face exchange without the assistance of electronic or 
mechanical devices is not intended to prevent the sale of tobacco 
products via the Internet, but the sale of covered tobacco products via 
any medium (including the Internet) must only be to persons 18 years of 
age or older.
    The rule also provides that manufacturers, distributors, importers, 
and retailers are responsible for ensuring that the covered tobacco 
products (in addition to cigarettes and smokeless tobacco) they 
manufacture, label, advertise, package, distribute, import, sell, or 
otherwise hold for sale comply with all applicable requirements.
    In addition, elsewhere in this issue of the Federal Register, FDA 
has made available a final guidance to provide information on how to 
establish and reference a Tobacco Product Master File (TPMF). TPMFs are 
expected to reduce the burden on applicants preparing premarket and 
other regulatory submissions because they can reference information in 
TPMFs rather than develop the information on their own.

[[Page 29077]]

Currently, FDA does allow for the submission and use of information to 
be incorporated by reference similar to master file programs for other 
FDA-regulated products.

A. Responses to Comments Regarding Proposed Collection of Information

1. Whether the Proposed Collection of Information Is Necessary for the 
Proper Performance of FDA's Functions, Including Whether the 
Information Will Have Practical Utility
    (Comment 279) We received several comments regarding the practical 
utility of the information to be collected by FDA under the proposed 
regulations. The main concern among comments was that some of the 
requirements impose significant administrative burdens without 
generating useful information. Also, the comments believed that FDA is 
predicting that the paperwork burden will force almost all of the e-
cigarette products to come off the market because manufacturers will go 
out of business.
    (Response) FDA's regulation of the newly deemed products and the 
information the Agency is seeking will benefit the public health. As 
FDA discussed in the NPRM, deeming all tobacco products to be subject 
to chapter IX of the FD&C Act will provide FDA with critical 
information regarding the health risks of the products. FDA has not 
received any data indicating that regulation ``will destroy almost all 
of the e-cigarette products on the market.'' We also note that FDA is 
announcing a compliance policy for small-scale tobacco product 
manufacturers, offering them targeted relief to address concerns that 
small manufacturers may need additional time to comply with certain 
requirements of the deeming rule, as discussed in section IV.D. This 
compliance policy will provide small-scale tobacco product 
manufacturers (i.e., those manufacturers with 150 employees or fewer 
and $5,000,000 or less in annual revenues) with additional time to 
submit ingredient listing information (under section 904(a)(1)) and 
health documents (under section 904(a)(4)). This policy also provides 
that, for the first 30 months following the effective date of the rule, 
small-scale tobacco product manufacturers may receive extensions of 
time for providing responses to SE deficiency letters.
    (Comment 280) One comment stated that FDA's proposed regulation is 
unnecessary and does not address any valid need in society. It also 
stated that the PRA should set limits on regulations that do not 
provide significant return to the U.S. population. Another comment 
asked that FDA not stifle advertisements, nor saddle the industry with 
unnecessary testing and reporting standards that stifle innovation and 
increase costs.
    (Response) FDA disagrees with comments suggesting that FDA's rule 
will have such effects on industry or the nation. FDA finds that 
deeming tobacco products and applying the automatic provisions of the 
FD&C Act in accordance with this final rule will result in significant 
public health benefits and that the additional restrictions imposed by 
this rule are appropriate for the protection of the public health. For 
example, benefits that will arise as a result of deeming ENDS, 
including FDA review of premarket submissions/applications for new 
tobacco products in the United States pursuant to sections 905 and 910 
of the FD&C Act, which will result in increased product consistency. 
FDA expects to receive premarket submissions/applications from ENDS 
manufacturers that will allow the Agency to determine whether a new 
product is substantially equivalent to a valid predicate product, 
exempt from SE., or appropriate for the protection of the public 
health.
2. Accuracy of FDA's Estimate of the Burden of the Proposed Collection 
of Information, Including the Validity of the Methodology and 
Assumptions Used
    (Comment 281) Many comments argued that their products could be 
driven from the market due to the paperwork reporting requirements and 
FDA's authorization process. The comments claimed that many companies 
(particularly e-cigarette companies) lack experience or the systems in 
place to comply with the NPRM and that the premarket requirements would 
discourage the development of new products. They also said that 
requirements like labeling and registration would be unfeasible for 
small producers lacking the experience of navigating this regulatory 
environment.
    (Response) FDA expects that the greater regulatory certainty 
created by the premarket review process will help companies to invest 
in creating novel products that benefit the health of the population as 
a whole, with greater confidence that the improved products in which 
they have invested will enter the market without having to compete 
against equally novel products that do not have to meet the same basic 
requirements. We also note that FDA is announcing a compliance policy 
for small-scale tobacco product manufacturers, offering them targeted 
relief in certain areas to address concerns that small manufacturers 
may need additional time to comply with certain requirements of the 
FD&C Act, as discussed in section IV.D. This compliance policy will 
provide small-scale tobacco product manufacturers (i.e., those 
manufacturers with 150 employees or fewer and $5,000,000 or less in 
annual revenues) with additional time to submit ingredient listing 
information (under section 904(a)(1)) and health documents (under 
section 904(a)(4)). This policy also provides that, for the first 30 
months following the effective date of the rule, small-scale tobacco 
product manufacturers may receive extensions of time for providing 
responses to SE deficiency letters.
    (Comment 282) Several comments stated that the PMTA process imposes 
a number of burdens on manufacturers, the most onerous burden being the 
requirement for scientific investigations.
    (Response) In the NPRM (79 FR 23142 at 23176), FDA included 
discussion intended to supplement and clarify the requirement for 
scientific investigations. As we noted, FDA expects that, in some 
cases, it will be possible for an applicant to obtain a PMTA marketing 
order without conducting new nonclinical or clinical studies where 
there is an established body of evidence regarding the public health 
impact of the product. Therefore, FDA believes that certain categories 
of PMTAs may not require significant financial and administrative 
resources associated with clinical investigations. Elsewhere in this 
issue of the Federal Register, FDA is announcing the availability of a 
draft guidance, which when final will provide the Agency's current 
thinking regarding some appropriate means of addressing the premarket 
authorization requirements for newly deemed ENDS products, including 
the need for ``clinical studies'' for the purposes of preparing PMTAs 
for ENDS. In addition, elsewhere in this issue of the Federal Register, 
FDA has made available a final guidance to provide information on how 
to establish and reference a Tobacco Product Master File. TPMFs are 
expected to reduce the burden on applicants preparing premarket and 
other regulatory submissions.
    We also note that FDA is announcing an enforcement policy for 
small-scale tobacco product manufacturers, offering them targeted 
relief in certain areas to address concerns that smaller manufacturers 
may have, as discussed in section IV.D. This compliance policy will 
provide small-scale tobacco product manufacturers (i.e., those 
manufacturers with 150 employees or

[[Page 29078]]

fewer and $5,000,000 or less in annual revenues) with additional time 
to submit ingredient listing information (under section 904(a)(1)) and 
health documents (under section 904(a)(4)). This policy also provides 
that, for the first 30 months following the effective date of the rule, 
small-scale tobacco product manufacturers may receive extensions of 
time for providing responses to SE deficiency letters.
    (Comment 283) Several comments expressed concern that FDA failed to 
provide any data on the number or type of e-cigarette businesses 
currently operating in the United States. According to the comments, 
there are at least 1,250 businesses. Other comments estimated that 
there are 14,000 to 16,000 e-cigarette retail outlets in the United 
States. They stated that these small manufacturing entities will not be 
able to participate in the PMTA process and most will go out of 
business.
    (Response) At the time of the NPRM, FDA did not have precise 
estimates for ENDS products. Now that we have more data, the Agency is 
estimating the numbers for ENDS liquids and delivery systems elsewhere 
in the PRA section. As stated previously, FDA believes the TPMF process 
will help companies as they can reference information in TPMFs rather 
than develop the information on their own. Additionally, the 
enforcement policy for small-scale tobacco product manufacturers will 
assist small manufacturers. This compliance policy will provide small-
scale tobacco product manufacturers (i.e., those manufacturers with 150 
employees or fewer and $5,000,000 or less in annual revenues) with 
additional time to submit ingredient reporting (under sections 904 and 
915) and health documents (under section 904). This policy also 
provides that small-scale tobacco product manufacturers may receive 
extensions of time for providing responses to SE deficiency letters.
    (Comment 284) Some comments noted that the NPRM made it appear that 
FDA would not allow any SE reports to be submitted for e-cigarette 
products, as there were only about a half dozen first generation e-
cigarette products that were sold in the United States in February 2007 
(the grandfather date), and those products are not substantially 
equivalent to any of today's products. Comments stated that applicants 
would then need to submit PMTAs and estimated that each PMTA would cost 
a successful applicant between $3 and $20 million.
    (Response) The FD&C Act provides three pathways for obtaining FDA 
authorization to market a new tobacco product. Where a new product does 
not meet the requirements for SE exemption under section 905(j)(3) and 
does not have an appropriate predicate under section 905(j)(1)(A)(i) or 
is otherwise unable make a showing supporting a finding of SE., the 
manufacturer of the new product must submit a PMTA. As FDA stated in 
the NPRM, the Agency expects that some applicants may not need to 
engage in resource-intensive clinical investigations and provide long-
term data to prepare and submit a complete PMTA. In addition, elsewhere 
in this issue of the Federal Register, FDA has made available draft 
guidance, which when final will describe FDA's current thinking 
regarding some appropriate means of addressing the premarket 
authorization requirements for newly deemed ENDS products, including 
the need for clinical studies for the purposes of preparing PMTAs for 
ENDS.
    (Comment 285) Several comments argued that FDA has greatly 
underestimated the total number of e-liquid products that are on the 
market. According to one comment, there are nearly 1,700 e-cigarette 
and e-liquid businesses on record, which does not include the many 
companies that manufacture hardware components used in ARPVs. One 
comment stated that a recent study found that greater than 34,000 
different e-liquid products alone were sold on the Internet (i.e. 7,764 
unique brand flavors averaging 4.4 different nicotine levels per brand) 
not including different vegetable glycerin/propylene glycol water 
levels or components in 466 identified different e-cigarette brands. 
Several comments estimated that there are 5,000 to 15,000 e-liquid 
producers and e-cigarette retail establishments in the United States. 
Other comments projected that there are at least 100,000 e-cigarette 
products currently on the market.
    Similarly, some commenters felt that FDA grossly underestimated the 
number of responses for certain proposed information collections. For 
example, they noted that the NPRM states that FDA expects only 25 new 
product applications from e-cigarette manufacturers. They claimed that 
FDA has either miscalculated the number of distinct brands and types of 
e-cigarettes on the market, or the Agency expects most manufacturers to 
exit the market rather than submit product applications.
    (Response) We have revised our estimates to reflect the most recent 
information available at the time of drafting this final analysis. FDA 
estimates the average number of vape shops that meet the definition of 
a manufacturer are 4,250. FDA also estimates that there will be 186 
other manufacturers and 14 importers of ENDS products.
    (Comment 286) Many comments said that FDA's estimates of the 
burdens imposed by the rule's information collection requirements are 
understated. Specifically, they stated that the Agency's estimates of 
the number of respondents in the category of ``other tobacco, e-
cigarettes, and nicotine product manufacturers,'' as well as the number 
of products on the market manufactured by these companies, were off by 
orders of magnitude.
    (Response) Based on the comments and other evidence, FDA estimates 
there will be 186 manufacturers of ENDS products. Regarding the number 
of products, the number will depend on what type of submission is being 
sent to FDA. The burden charts in this section detail the current 
estimates FDA believes to be accurate.
    (Comment 287) Some comments indicated that FDA equates the time and 
financial burden of preparing a PMTA with an SE application, but the 
PMTA requirements are significantly more burdensome than SE 
requirements, and it is completely unreasonable to allocate the same 
amount of man-hours needed to successfully complete a PMTA and an SE 
application.
    (Response) The Agency has revised the estimated burden per PMTA 
response to an average of 1,500 hours to complete a PMTA. In reaching 
this average, FDA considered efficiencies achieved through manufacturer 
experience, application overlap, economies of scale, incorporation of 
evidence by reference, and other means including availability of the SE 
FAQ guidance. Based on this information, FDA believes an SE submission 
will take considerably less time and money. If the manufacturer is 
unable to show that its product is substantially equivalent to a 
predicate product or that its product is exempt from SE., then the 
manufacturer must submit a PMTA. The requirements of a PMTA may vary 
based on the type and complexity of the product.
    (Comment 288) One comment said that FDA erred in its estimate of 
the in-house cost burdens imposed by the proposed information 
collections. The comment said internal costs can only be excluded when 
estimating the burden of an information collection if such costs are 
related to ``usual and customary'' activities. In this case, the 
comment believed FDA did not consider the types of internal costs that 
will be incurred by companies to comply with the information 
collections.
    (Response) FDA disagrees with this comment. The Agency was thorough 
in

[[Page 29079]]

its identification of usual and customary activities. The Agency used 
various existing data sources and considered all the costs associated 
with the collections of information. In reaching this average cost, FDA 
considered efficiencies achieved through manufacturer experience, 
application overlap, economies of scale, incorporation of evidence by 
reference, and other means.
    (Comment 289) A few comments stated that most of the cost burden 
created by paperwork requirements will fall upon consumers, as hundreds 
of thousands of American consumers would lose access to what the 
comments state are ``low-risk products'' that have allowed consumers to 
quit smoking. They said FDA should take into consideration small 
business and consumer stakeholders' suggested alternatives to minimize 
the NPRM's potential impact.
    (Response) FDA disagrees with these comments. This final rule will 
prevent new products from entering the market that are not appropriate 
for the protection of the public health, are not substantially 
equivalent to a valid predicate product, or are not exempt from SE. We 
also note that FDA is announcing a compliance policy for small-scale 
tobacco product manufacturers, offering them targeted relief in certain 
areas to address concerns that smaller manufacturers may need 
additional time to comply with certain requirements of the FD&C Act, as 
discussed in section IV.D. This compliance policy will provide small-
scale tobacco product manufacturers (i.e., those manufacturers with 150 
employees or fewer and $5,000,000 or less in annual revenues) with 
additional time to submit ingredient listing information (under section 
904(a)(1)) and health documents (under section 904(a)(4)). This policy 
also provides that, for the first 30 months following the effective 
date of the rule, small-scale tobacco product manufacturers may receive 
extensions of time for providing responses to SE deficiency letters.
    (Comment 290) Several comments stated that FDA significantly 
underestimated the burden on the tobacco industry. The Agency estimated 
that 13,745 products will be affected by the NPRM and almost 90 percent 
of them were cigars and pipe tobacco. They noted that FDA estimated 
that up to 7,869 products will submit SE reports within the first 24 
months after the rule is finalized, which they believed was very low, 
especially given the February 15, 2007, grandfather date.
    (Response) FDA used available public information to estimate the 
burden on the tobacco industry and the comments did not provide 
empirical evidence of a different number of affected products. However, 
based on experience with currently regulated products and changes in 
the industry we have revised the burden accordingly. The Agency also 
finds that these comments have not provided evidence as to why the 
grandfather date will cause applicants to submit more SE applications 
than FDA estimated.
    (Comment 291) One comment argued that FDA has greatly 
underestimated the number of premium cigar products that will be 
subject to premarket review. According to the comment, premium cigar 
makers are distinct from other tobacco product manufacturers in the 
number of products they market and the volume of those lines. This 
comment stated that the average number of cigars produced for any given 
product in a year is 32,655, with 33.6 percent of reported annual 
production rates at or below 10,000 units.
    Several other comments argued that the typical premium cigar 
manufacturer may have over 100 unique stock keeping units (SKUs) and 
typically will turn over about 15 percent of those SKUs in any given 
year. Their data indicates there are at least 10,000 and maybe as many 
as 20,000 unique SKUs in the United States, which would add to FDA's 
workload for evaluating new product applications. They also estimated 
that the premium hand-rolled cigar category alone could generate 
numbers in excess of 10,000 new product applications.
    Other comments stated that the premarket application process will 
be costly and time consuming for cigar manufacturers and will likely 
result in many different kinds of newly deemed tobacco products being 
removed from the marketplace. The constant variation in the cigar 
tobacco used to make premium cigars will create significant regulatory 
burdens and costs for cigar manufacturers to be constantly submitting 
premarket applications. Comments stated that cigar manufacturers that 
are unable to bear the cost of applications will cease bringing new 
products to the marketplace.
    The comments expressed similar concerns regarding e-cigarettes, 
stating that each e-cigarette manufacturer would need to submit a PMTA 
for every brand of e-cigarette currently being sold and new e-
cigarettes introduced into the marketplace. Small manufacturers may not 
have the financial resources to submit PMTAs, which will result in the 
removal of e-cigarettes from the marketplace. The end result of the 
PMTA process will be a significant negative impact on small businesses.
    (Response) The FD&C Act provides for three marketing pathways for 
new tobacco products--SE to a valid predicate product, exemption from 
SE., and PMTA. If the manufacturer is unable to show that its product 
is substantially equivalent to a valid predicate product or that its 
product is exempt from SE., then the firm must submit a PMTA. The 
requirements and costs of a PMTA may vary based on the type and 
complexity of the product. For example, where there is limited 
understanding of a product's potential impact on public health, several 
nonclinical and clinical studies may be required for market 
authorization. In such case, the requirements and cost of the PMTA 
likely would be higher than for a product in which there is already 
substantial scientific data on the potential public health impact.
    (Comment 292) Many comments noted that FDA included a small number 
of PMTAs for e-cigarette products in its analysis. Some comments stated 
that if this is the case, FDA's estimates would probably include only a 
fraction of the products that are believed to be used to stop smoking 
cigarettes. They commented that the cost burdens of the paperwork 
requirements will result in an unnecessary price increase for the 
consumer and the PMTA requirements will limit the availability of e-
cigarettes to addicted smokers trying to quit. Their concern is the 
burden of the paperwork would fall on both merchants and consumers.
    (Response) FDA disagrees with these comments. The Agency's 
intention is not to impose additional costs to consumers but, instead, 
to prevent new products from entering the market that are not 
appropriate for the protection of the public health, are not 
substantially equivalent to a predicate product, or are not exempt from 
SE. Per Agency experience and updates in the industry, FDA has updated 
the number of ENDS products we estimate will submit a PMTA.
    (Comment 293) Some comments disagreed with FDA's estimate that it 
expects only one ``other tobacco, e-cigarette and nicotine product 
manufacturers'' respondent to submit an annual health and toxicological 
report and its estimate that there would only be one respondent to 
self-certify that its product does not contain nicotine. They stated 
that there may be hundreds of e-liquid manufacturers self-certifying 
for use of the alternative statement, because it is standard industry 
practice to offer 0 milligram nicotine flavors in vials.

[[Page 29080]]

    (Response) At this time, we do not have sufficient evidence to 
warrant revising the burden estimates.
    (Comment 294) Many comments stated that FDA's estimates do not 
reflect the realities of the market and FDA's estimates assume that 
most of these small companies will be forced to exit the industry 
because of the high compliance and paperwork burdens envisioned by the 
NPRM. However, others believed that as the market evolves, many 
companies will continue to operate and comply with FDA's regulations.
    Further, many other comments stated that, at best, FDA's estimate 
that there are only 140 to 188 potential respondents in the category of 
``other tobacco, e-cigarettes, and nicotine product manufacturers'' is 
``egregiously off target'' based on the available evidence. They 
believed that the entire industry will be eliminated as a result of the 
regulatory and paperwork burdens in the NPRM. They also noted that the 
reason for the difference between 140 and 188 in the Analysis of 
Impacts and PRA sections is unclear.
    (Response) There is a high level of uncertainty in the number of 
manufacturers of ENDS. FDA is required to estimate burden as part of 
the PRA analysis. As many comments describe, the industry is ever 
changing; during the time that the NPRM was in review, and since the 
NPRM was published, the ENDS industry has grown. The comments on the 
number of ENDS manufacturers provided industry estimates rather than 
concrete data sources. In the case of non-retail manufacturers, the 
comment did not always specify whether the cited numbers included both 
domestic and foreign manufacturers, or only domestic manufactures. 
Therefore, considerable uncertainty remains as to the number of 
domestic non-retail manufacturers. Similarly, the comments did not 
address the number of non-retail importers. In the Regulatory Impact 
Analysis (RIA) for this final rule, based on logo counts from trade 
association Web sites and FDA listening sessions, it is estimated that 
there are 168 to 204 formal manufacturers of ENDS products (not 
including ENDS retail establishments that meet the definition of a 
manufacturer). For the PRA analysis, we took the average for a total of 
186 manufacturers. We also estimate that there are 14 importers of ENDS 
products.
    (Comment 295) Many comments stated that it would not be possible to 
complete a PMTA within 24 months after the effective date of the final 
rule and that it is an insufficient amount of time for manufacturers to 
conduct any required clinical studies in support of a PMTA.
    (Response) As stated throughout this document, FDA is providing a 
24-month compliance period for manufacturers to submit (and for FDA to 
receive) a PMTA. If manufacturers submit the appropriate applications 
during this compliance period, FDA will not enforce against those 
manufacturers continuing to market their products without FDA 
authorization for a certain time period. For products using the PMTA 
pathway, this compliance period closes 36 months after the effective 
date. Once the continued compliance period ends, FDA intends to 
actively monitor and enforce the premarket authorization requirements 
regarding products on the market without authorization even if the 
respective submission is still under review. As noted previously, FDA 
expects that, in some cases, it will be possible for an applicant to 
obtain a PMTA order without conducting any new nonclinical or clinical 
studies where there is an established body of evidence regarding the 
public health impact of the product. Therefore, FDA believes that many 
PMTAs may not require significant administrative resources associated 
with clinical investigations.
    (Comment 296) Several comments noted that if FDA requires health 
documents from manufacturers and importers of newly deemed tobacco 
products, the Agency should establish a similar production timeline as 
it did for currently regulated products (i.e., cigarettes, cigarette 
tobacco, smokeless tobacco, and roll-your-own tobacco) and only require 
production of health documents developed during the 6-month period 
following the effective date of the regulation.
    (Response) As stated in the compliance date tables, the compliance 
period for manufacturers of products currently on the market to submit 
health documents is 6 months after the effective date of the final 
rule. Manufacturers of products entering the market after the effective 
date of the final rule must comply within 90 days before delivery of 
the product for introduction into interstate commerce. With this final 
rule, FDA also is announcing that it will extend the compliance period 
for an additional 6 months from the effective date to allow small-scale 
tobacco product manufacturers time to organize, compile, and digitize 
documents. Additionally, as stated elsewhere, FDA generally does not 
intend to take enforcement action regarding the submission of all such 
documents at this time so long as a specified set of documents are 
submitted by [the effective date plus 6 months]. FDA will publish 
additional guidance that specifies the scope of such documents with 
sufficient advance time for manufacturers and importers to prepare 
their submissions.
    (Comment 297) Some comments stated that FDA has underestimated the 
number of other tobacco product manufacturers that will submit the 
required health documents.
    (Response) FDA based this burden estimate on the existing 
collection that applies to tobacco products currently subject to the 
FD&C Act and FDA experience. The comments did not provide a basis or an 
estimate of other tobacco product manufacturers for FDA to utilize in 
its review, and the Agency is not aware of any information that 
warrants changing this estimate. We note that at this time, FDA intends 
to limit enforcement to finished tobacco products. A finished tobacco 
product refers to a tobacco product, including all components and 
parts, sealed in final packaging intended for consumer use (e.g., 
filters, filter tubes, e-cigarettes, or e-liquids sold separately to 
consumers or as part of kits). FDA does not at this time intend to 
enforce this requirement for components and parts of newly deemed 
products that are sold or distributed solely for further manufacturing 
into finished tobacco products. However, any component or part of a 
newly deemed tobacco product that is sold directly to consumers as a 
``finished tobacco product'' will be required to comply with the 
premarket review requirements discussed throughout this document.
    (Comment 298) Some comments stated that e-liquid companies should 
be allowed to amend their ingredient lists if they add or remove 
ingredients or increase the maximum concentration of any of their 
current ingredients in any of their products, rather than submit a new 
ingredient list for the new product.
    (Response) Ingredient listings contain important data that enable 
FDA to gain better understanding of the contents of regulated products. 
This information will assist FDA in assessing potential health risks 
and determining if future regulations to address these health risks are 
warranted. In addition, when an e-liquid manufacturer adds or removes 
ingredients from a product, it becomes a ``new tobacco product.''
    (Comment 299) Several comments disagreed with FDA's proposed 
premarket review burdens for pipe tobacco manufacturers. At least one 
comment indicated that FDA's proposed estimate that it will receive 
only one

[[Page 29081]]

new product application for pipe tobacco products grossly 
underestimates the number of brands of pipe tobacco that have entered 
the market since 2007 or indicates that the Agency expects all but one 
manufacturer to voluntarily stop production of new pipe tobacco 
products without submitting an SE report or PTMA application. In 
addition, the comments stated that pipe tobacco manufacturers will 
incur cost and time burdens if they are required to submit PMTAs for 
each new blend of pipe tobacco that they manufacture, including 
millions of dollars per year in research to prepare the PMTAs.
    (Response) At this time, FDA finds there is insufficient evidence 
to increase the burden estimates. FDA believes that pipe tobacco 
manufacturers will utilize the SE and SE exemption pathways. We believe 
they are manufactured similarly with few, if any, modifications and 
many of the ingredients and suppliers are the same as those utilized in 
previous years.
    (Comment 300) Several comments pointed out inconsistencies between 
the PRA and Analysis of Impacts sections in the NPRM. They noted that 
the Analysis of Impacts clearly states that FDA does not have an 
estimate of e-cigarette entities that would register with FDA. If FDA 
could not estimate the number of affected entities in the Analysis of 
Impacts, they believed this should also be reflected in the PRA 
section. In addition, they stated that the estimated number of PMTAs 
(25) in the PRA section contradicts the number of estimated PMTAs in 
the Analysis of Impacts.
    (Response) The RIA and PRA analyses are conducted to fulfill 
different purposes and must adhere to different requirements; as a 
result, the two analyses would rarely, if ever, be the same. For 
example, the time horizons for the analyses are typically different. 
Information collections are approved for a up to a 3-year period and 
are reanalyzed every time they are up for extension, whereas a 
prospective RIA is conducted before a rule is issued using a time 
horizon chosen to capture the most important effects of the rule 
(generally 20 years). If estimates differ from year to year, the RIA 
will often explicitly identify how the estimates vary, whereas the PRA 
analysis will most often use an average or the estimate for the current 
year. Regulatory impact analyses also tend to make more frequent use of 
ranges rather than point estimates.
    As referenced previously, there is a high level of uncertainty in 
the number of manufacturers for ENDS. In the RIA for this final rule, 
based on logo counts from trade association Web sites and FDA listening 
sessions, it is estimated that there are 168 to 204 formal 
manufacturers of ENDS products. For the PRA analysis, we took the 
average of 168 and 204 for a total of 186 manufacturers. We also 
estimate that there are 14 importers of ENDS products.
    (Comment 301) A number of comments also noted that FDA should be 
required to estimate and report the full social costs of eliminating 
what they considered to be beneficial products from the market where 
the manufacturers are unable to afford the PMTA costs.
    (Response) FDA is not aware of any evidence indicating that such 
social costs will accrue. Nevertheless, such estimates are outside the 
scope of the PRA analysis.
3. Ways To Enhance the Quality, Utility, and Clarity of the Information 
To Be Collected
    (Comment 302) One comment stated that FDA has not consulted with 
industry nor has the Agency audited industry recordkeeping to support 
the assumption that manufacturers have enough information to prepare SE 
reports.
    (Response) FDA's proposed burden estimates are based on information 
available at the time of preparing the NPRM. If interested parties have 
evidence that warrants revising these burden estimates, they were 
requested to submit such evidence during the comment period for FDA to 
take into account when preparing final burden estimates.
    (Comment 303) One comment recommended that the Office of 
Information and Regulatory Affairs (OIRA) should void the proposed 
regulations as they relate to e-cigarettes, that OIRA and FDA should 
urge Congress to work with FDA to create a new regulatory framework for 
e-cigarettes, and, at the very least, that OIRA require that FDA 
prepare new estimates of the paperwork burdens.
    (Response) FDA disagrees with this comment. FDA has estimated the 
PRA burdens with the best evidence that is currently available. In 
addition, as stated in the NPRM and throughout this final rule, the 
deeming provisions are beneficial to the public health and the 
additional provisions are appropriate for the protection of the public 
health.
4. Ways To Minimize the Burden of the Collection of Information on 
Respondents, Including Through the Use of Automated Collection 
Techniques, When Appropriate, and Other Forms of Information Technology
    (Comment 304) One comment asserted that, under the PRA, a review of 
regulations should include an attempt to ensure that the paperwork is 
not unduly burdensome. The comment also stated that FDA appears to be 
ignoring the greatest cost of the paperwork burden (i.e., most 
manufacturers will find the paperwork burden to be so great that they 
will abandon products or their entire businesses without attempting to 
comply with the requirements). They argued that FDA should follow the 
requirements as stated in the PRA and limit data collection to 
information that is useful and dependable.
    (Response) FDA disagrees with this comment. FDA has faithfully 
complied with the all aspects of the PRA and any other applications 
laws and regulations.

B. Existing Burdens Associated With Tobacco Products Currently Subject 
to the FD&C Act (i.e., Cigarettes, Cigarette Tobacco, Roll-Your-Own 
Tobacco, and Smokeless Tobacco) With Approved OMB Control Numbers

    The information collection requirements referenced in this section 
are amending currently approved information collections. Once the rule 
is finalized, the associated collections of information will be 
submitted to OMB for approval as revisions to the currently approved 
information collections. After submission to OMB, the revised 
collections and associated documents can be viewed at OMB's public Web 
site (http://www.reginfo.gov).
    The burden estimates found in this section include existing 
collections that have been approved by OMB and cover tobacco products 
that are currently subject to the FD&C Act (i.e., cigarettes, cigarette 
tobacco, roll-your-own tobacco, and smokeless tobacco). In developing 
the burden estimates for newly deemed tobacco products, FDA based the 
estimates on the existing collections that currently cover cigarettes, 
cigarette tobacco, roll-your-own tobacco, and smokeless tobacco.
1. Tobacco Product Establishment Registration and Submission of Certain 
Health Information (OMB Control Number 0910-0650)
    Description of Respondents: The respondents to this collection of 
information are manufacturers or importers, or agents thereof, of new 
and currently regulated tobacco products

[[Page 29082]]

who are required to make submissions to FDA under section 904 of the 
FD&C Act, including the submission of an initial list of all 
ingredients in their tobacco products and the submission of information 
whenever additives or their quantities are changed. The respondents to 
this collection are also persons engaged in the manufacture, 
preparation, compounding, or processing of a tobacco product or tobacco 
products who must register their establishments and submit a list of 
all tobacco products being manufactured, prepared, compounded, or 
processed by that person for commercial distribution at the time of 
registration under section 905 of the FD&C Act.
    Section 101 of the Tobacco Control Act amended the FD&C Act by 
adding sections 905 and 904. Section 905(b) of the FD&C Act requires 
that every person who owns or operates any establishment in any State 
engaged in the manufacture, preparation, compounding, or processing of 
a tobacco product or tobacco products register with FDA the name, 
places of business, and all establishments owned or operated by that 
person. Section 905(i)(1) of the FD&C Act requires that all 
registrants, at the time of registration, must submit to FDA a list of 
all tobacco products that are being manufactured, prepared, compounded, 
or processed by that person for commercial distribution, along with 
certain accompanying consumer information and other labeling for such 
products and a representative sampling of advertisements.
    If an ENDS retail establishment engages in these activities, it 
will be required to register and list their products with FDA. These 
requirements apply under the statute for all distinct products 
manufactured, and they enable FDA to assess the landscape of products 
manufactured by these entities. If ENDS retail establishments are 
custom mixing e-liquids and/or other ENDS products or components, then 
they will have to list each combination that they sell. For such 
establishments to continue to engage in mixing after this rule becomes 
effective, they would need to satisfy the requirements for 
manufacturers and the premarket authorization of new tobacco products 
as a result of this final rule. We note, however, that FDA does not 
intend to enforce the premarket authorization requirements during 
staggered compliance periods following the effective date, as stated 
previously in this preamble to this rule.
    Section 904(a)(1) of the FD&C Act requires each tobacco product 
manufacturer or importer, or agent thereof, to submit a listing of all 
ingredients, including tobacco, substances, compounds, and additives 
that are added by the manufacturer to the tobacco, paper, filter, or 
other part of each tobacco product by brand and by quantity in each 
brand and subbrand. Section 904(c) of the FD&C Act also requires 
submission of information whenever additives or their quantities are 
changed.
    As previously referenced in section IV, for small-scale tobacco 
product manufacturers, FDA is providing a one-time allowance of an 
additional 6 months after the effective date of this final rule for 
initial reporting of ingredients. This regulatory relief is only for 
small-scale tobacco product manufacturers.
    FDA issued guidance documents on both (1) Registration and Product 
Listing for Owners and Operators of Domestic Tobacco Product 
Establishments (74 FR 58298, November 12, 2009) and (2) Listing of 
Ingredients in Tobacco Products (74 FR 62795, December 1, 2009) to 
assist persons making these submissions to FDA under the FD&C Act. 
Although electronic submission of registration, product listing, and 
ingredient listing information are not required, FDA strongly 
encourages electronic submission to facilitate efficiency and 
timeliness of data management and collection. To that end, FDA designed 
the eSubmitter application, and then the FDA FURLS, to streamline the 
data entry process for registration, product listing, and ingredient 
listing. This tool allows for importation of large quantities of 
structured data, attachments of files (e.g., in PDFs and certain media 
files), and automatic acknowledgement of FDA's receipt of submissions. 
FDA also developed paper forms (Form FDA 3741--Registration and Listing 
for Owners and Operators of Domestic Tobacco Product Establishments and 
Form FDA 3742--Listing of Ingredients in Tobacco Products) as 
alternative submission tools. Both the FURLS and the paper forms can be 
accessed at http://www.fda.gov/tobacco. FDA estimates the additional 
annual burden for the information collection as a result of this rule 
as follows:

                                                     Table 7--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
                  Activity                       Number of     responses per   Total annual     Average burden per response  (in hours)     Total hours
                                                respondents   respondent \2\     responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
                            Tobacco Product Establishment Initial First Year Registration (electronic and paper submission):
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cigar Entities (Including Large and Small,               221               1             221  2.........................................             442
 and Importers).
Pipe and Waterpipe Tobacco Entities                       96               1              96  2.........................................             192
 (Including Importers (22)).
Other Tobacco, E-Cigarettes, and Nicotine                193               1             193  2.........................................             386
 Product Entities and ENDS Products
 Importers (7) \3\.
Vape shops that qualify as manufacturers \4\           4,250               1           4,250  2.........................................           8,500
                                             -----------------------------------------------------------------------------------------------------------
    Total Tobacco Product Establishment       ..............  ..............  ..............  ..........................................           9,520
     Initial First Year Registration.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                 Tobacco Product Establishment Recurring Registration (electronic and paper submission):
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cigar Entities (Including Large and Small,               221               1             221  0.20 (12 minutes).........................              44
 and Importers).
Pipe and Waterpipe Tobacco Entities                       96               1              96  0.20 (12 minutes).........................              19
 (Including Importers (22)).
Other Tobacco, E-Cigarettes, and Nicotine                193               1             193  0.20 (12 minutes).........................              39
 Product Entities and ENDS Products
 Importers (7) \3\.

[[Page 29083]]

 
Vape shops that qualify as manufacturers \4\           4,250               1           4,250  0.20 (12 minutes).........................             850
                                             -----------------------------------------------------------------------------------------------------------
Total Tobacco Product Establishment           ..............  ..............  ..............  ..........................................             952
 Recurring Registration.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                      Tobacco Product Listing Initial First Year (electronic and paper submission):
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cigar Entities (Including Large and Small,               221               1             221  2.........................................             442
 and Importers).
Pipe and Waterpipe Tobacco Entities                       96               1              96  2.........................................             192
 (Including Importers (22)).
Other Tobacco, E-Cigarettes, and Nicotine                193               1             193  2.........................................             386
 Product Entities and ENDS Products
 Importers (7)) \3\.
Vape shops that qualify as manufacturers \4\           4,250               1           4,250  2.........................................           8,500
                                             -----------------------------------------------------------------------------------------------------------
    Total Hours Tobacco Product Listing       ..............  ..............  ..............  ..........................................           9,520
     Initial First Year.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                          Tobacco Product Listing Recurring (electronic and paper submission):
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cigar Entities (Including Large and Small,               221               2             442  0.40 (24 minutes).........................             177
 and Importers).
Pipe and Waterpipe Tobacco Entities                       96               2             192  0.40 (24 minutes).........................              77
 (Including Importers (22)).
Other Tobacco, E-Cigarettes, and Nicotine                193               2             386  0.40 (24 minutes).........................             154
 Product Entities and ENDS Products
 Importers (7) \3\.
Vape shops that qualify as manufacturers \4\           4,250               2           8,500  0.40 (24 minutes).........................           3,400
                                             -----------------------------------------------------------------------------------------------------------
    Total Hours Tobacco Product Listing       ..............  ..............  ..............  ..........................................           3,808
     Recurring.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                      Obtaining a Dun and Bradstreet (DUNS) Number:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cigar Entities (Including Large and Small,               221               1             221  0.5 (30 minutes)..........................             111
 and Importers).
Pipe and Waterpipe Tobacco Entities                       96               1              96  0.5 (30 minutes)..........................              48
 (Including Importers (22)).
Other Tobacco, E-Cigarettes, and Nicotine                193               1             193  0.5 (30 minutes)..........................              97
 Product Entities and ENDS Products
 Importers (7) \3\.
Vape shops that qualify as manufacturers \4\           4,250               1           4,250  0.5 (30 minutes)..........................           2,125
                                             -----------------------------------------------------------------------------------------------------------
    Total Hours Obtaining DUNS Number.......  ..............  ..............  ..............  ..........................................           2,381
                                             -----------------------------------------------------------------------------------------------------------
        Total Hours Registration, Product     ..............  ..............  ..............  ..........................................          26,181
         Listing, and DUNS Number.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                          Tobacco Product Ingredient Listing (electronic and paper submission):
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cigar Entities (Including Large and Small,               329            5.38           1,770  3.........................................           5,310
 and Importers).
Pipe and Waterpipe Tobacco Entities                      117           20.62           2,413  3.........................................           7,239
 (Including Importers (43)).
Other Tobacco, E-Cigarettes, and Nicotine                200           11.40           2,280  3.........................................           6,840
 Product Entities and ENDS Products
 Importers (7) \3\.
Vape shops that qualify as manufacturers \4\           4,250           11.73          49,853  1.........................................          49,853
                                             -----------------------------------------------------------------------------------------------------------
    Total Hours Submitting Product            ..............  ..............  ..............  ..........................................          69,242
     Ingredient Listing.
                                             -----------------------------------------------------------------------------------------------------------
        Total Burden Tobacco Product          ..............  ..............  ..............  ..........................................         121,604
         Establishment Registration and
         Submission of Certain Health
         Information.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ This number is estimated to be the total annual responses divided by the number of respondents, rounded to the nearest tenth.
\3\ Importers are included throughout this Table 7 to the extent that they engage in the manufacture, preparation, compounding, or processing of tobacco
  products, which includes repackaging or otherwise changing the container, wrapper, or labeling of any tobacco product package in furtherance of the
  distribution of the tobacco product from the original place of manufacturer to the person who makes final delivery or sale to the ultimate consumer or
  use.
\4\ FDA assumes that vape shops will register and list only during the first two years after the rule becomes effective.

[[Page 29084]]

    Based on aggregate information obtained from the TTB, in 2013 there 
were 113 domestic manufacturers of cigars, 216 importers of cigars, 74 
manufacturers of pipe (including waterpipe) tobacco, and 43 importers 
of pipe (including waterpipe) tobacco who will be required to register 
under section 905 of the FD&C Act. For the purposes of this analysis, 
FDA estimates that the majority of the 4,250 vape shops that qualify as 
manufacturers will only register and list in the first two years after 
the rule becomes effective. In addition, FDA estimates that 186 ENDS 
manufacturers will be required to register under section 905 of the 
FD&C Act.
    Product listing information is provided at the time of 
registration. Currently, registration and listing requirements only 
apply to domestic establishments engaged in the manufacture, 
preparation, compounding, or processing of a tobacco product. This 
includes importers to the extent that they engage in the manufacture, 
preparation, compounding, or processing of a tobacco product, including 
repackaging or otherwise changing the container, wrapper, or labeling 
of any tobacco product package.\18\ Foreign establishments are not 
required to register and list until FDA issues regulations establishing 
such requirements in accordance with section 905(h) of the FD&C Act. To 
account for the foregoing, we include both domestic manufacturing 
establishments and importers in our estimates. Specifically, for the 
PRA analysis, we have used the midpoint between TTB permit counts for 
manufacturers and permit counts for manufacturers and importers as a 
likely overestimate of the number of entities that need to comply with 
registration and product listing (The Analysis of Impacts includes 
importers in the upper bound.)
---------------------------------------------------------------------------

    \18\ Under the Internal Revenue Code, the manufacture, 
preparation, compounding, or processing of a tobacco product may 
require a permit as a manufacturer of tobacco products. As we 
understand TTB's permitting requirements, entities lacking a 
manufacturer permit, including importers, may not engage in any of 
the listed activities, including repackaging tobacco products after 
such products are released from customs custody. It is unclear 
whether TTB would require a manufacturer permit for all activities 
for which FDA would determine the entity must register and list; 
because there may be some entities with import permits for which FDA 
would conclude registration is necessary, FDA includes those numbers 
as part of its upper-bound estimate of affected entities.
---------------------------------------------------------------------------

    The PRA burden estimates have been updated to fully incorporate the 
use of an electronic system known as FURLs for submitting registration 
and product listing information to FDA. With the FURLs system, 
manufacturers can enter information quickly and easily. For example, 
product label pictures can be uploaded directly and we anticipate that 
most, if not all companies, already have electronic versions of their 
labels for printing, sales, or marketing purposes. We anticipate that 
initial entity registration will take 2 hours and initial product 
listing will take an additional 2 hours per entity.
    FDA estimates that the initial first year submission of 
registration information required by section 905 of the FD&C Act will 
take 2 hours per establishment, with a total of 4,760 establishments 
that will be required to register under this rule, for a total of 9,520 
hours (4,760 x 2).
    The estimate for the number of product listing submissions for 
cigars is derived by using product counts from two retail Web sites: 
http://www.cigarsinternational.com/ and http://www.pipesandcigars.com/. 
These two large Internet retailers had larger product offerings than 
other sites reviewed and sell both mass-market and specialty products. 
Estimates of product formulations and product-package combinations for 
cigars are centered over the product counts from the two Web sites. To 
derive the product listing count for pipe tobacco, we count the 
products on a Web site with a broad product offering, http://www.pipesandcigars.com/. We estimate formulations with the number of 
the product names and product-packages with the number of product-
package combinations. FDA derives the product listing estimate for ENDS 
products by consulting experts at FDA's CTP who cataloged the ENDS 
products currently available on five Web sites and in scanner data from 
Nielsen. FDA estimates that the initial first year submission of 
product listing information required by section 905 of the FD&C Act 
will take 2 hours per submission for 4,760 submissions/annual responses 
for a total of 9,520 hours.
    Once information is entered into FURLs, the twice yearly 
confirmation of annual registration and product listing updates is 
simplified as all information previously entered is maintained in the 
system. Therefore, we expect the recurring burden of subsequent years 
for updating registration and product listing information will take 1 
hour annually per establishment (12 minutes for registration and 48 
minutes for product listing). The total hours are 4,760 (952 updating 
registration and 3,808 product listing).
    FDA estimates that obtaining a DUNS number will take 30 minutes. 
FDA assumes that all the establishment facilities that will be required 
to register under section 905 of the FD&C Act would obtain a DUNS 
number, with a total of 4,760 establishments that would need to obtain 
this number. The total burden to obtain a DUNS number is 26,181 hours.
    FDA estimates that the submission of ingredient listing information 
as required by section 904 of the FD&C Act will take 3 hours per 
tobacco product based on the estimates found in the existing 
collection. The Agency estimates that approximately 56,316 ingredient 
listings/annual responses will be submitted annually based on the 
methodology used for estimating the number of product listing 
submissions described in this section. The total ingredient listing 
reporting is 69,242 hours. FDA estimates that the total burden for 
tobacco product establishment registration and ingredient listing 
reporting is 121,604 hours.
2. Tobacco Health Document Submission (OMB Control Number 0910-0654)
    Description of Respondents: Respondents to this collection of 
information are tobacco product manufacturers or, importers, or agents 
thereof, who will submit all documents to FDA developed after June 22, 
2009, that relate to health, toxicological, behavioral, or physiologic 
effects of current or future tobacco products. As stated elsewhere, 
however, FDA generally does not intend to take enforcement action 
regarding the submission of all such documents at this time so long as 
a specified set of documents are submitted by [the effective date plus 
6 months]. FDA will publish additional guidance that specifies the 
scope of documents that manufacturers and importers will be required to 
submit by [the effective date plus 6 month], with sufficient advance 
time for manufacturers and importers to prepare their submissions.
    Section 904(a)(4) of the FD&C Act requires each tobacco product 
manufacturer or importer, or agent thereof, to submit all documents to 
FDA developed after June 22, 2009, that relate to health, 
toxicological, behavioral, or physiologic effects of current or future 
tobacco products, their constituents (including smoke constituents), 
ingredients, components, and additives (tobacco health documents). To 
address concerns of certain small businesses relating to the tobacco 
health documents requirement, FDA is extending the compliance period 
for small-scale tobacco product

[[Page 29085]]

manufacturers for an additional 6 months following the end of the 
generally applicable compliance period to allow submitters time to 
organize, compile, and digitize documents.
    FDA is collecting the information submitted under section 904(a)(4) 
of the FD&C Act through an electronic portal and through a paper form 
(Form FDA 3743) for those individuals who choose not to use the 
electronic portal.
    FDA estimates the additional annual burden for the information 
collection as a result of this rule as follows:

                                 Table 8--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                     Number of       Number of     Total annual     burden per
            Activity                respondents    responses per     responses     response  (in    Total hours
                                                    respondent                        hours)
----------------------------------------------------------------------------------------------------------------
Cigar Manufacturers (Including                 2               4               8              50             400
 Large and Small)...............
Pipe and Waterpipe Tobacco                     1               4               4              50             200
 Manufacturers..................
Other Tobacco, E-Cigarettes, and               1               4               4              50             200
 Nicotine Product Manufacturers
 ENDS...........................
Importers of Cigars and Pipe                   1               4               4              50             200
 Tobacco Who Are Considered
 Manufacturers..................
Importers of Other Tobacco, E-                 1               4               4              50             200
 Cigarettes, and Nicotine
 Product Manufacturers ENDS.....
                                 -------------------------------------------------------------------------------
    Total Hours Health Document   ..............  ..............  ..............  ..............           1,200
     Submission.................
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA estimates that a tobacco health document submission for cigars, 
pipe and waterpipe tobacco, other tobacco, tobacco importers, and 
importers of ENDS required by section 904(a)(4) of the FD&C Act, will 
take approximately 50 hours per submission based on the existing 
collection that applies to tobacco products currently subject to the 
FD&C Act and FDA experience. To derive the number of respondents for 
this provision, FDA assumes that very few manufacturers or importers, 
or agents thereof, would have health documents to submit. Therefore, 
the Agency estimates that approximately six submissions (two for cigar 
manufacturers, one for pipe and waterpipe tobacco manufacturers, one 
for other tobacco product manufacturers, and one for tobacco importers, 
and one for importers of ENDS who are considered manufacturers) will be 
submitted on an annual basis. FDA estimates the total number of hours 
is 1,200 hours (6 submissions multiplied by 4 times per year multiplied 
by 50 average burden hours).
3. Exemptions From Substantial Equivalence Requirements (OMB Control 
Number 0910-0684)
    Description of Respondents: Respondents to this collection of 
information are manufacturers of deemed tobacco products who are 
requesting an exemption from the SE requirements of the FD&C Act.
    In a final rule that published on July 5, 2011, FDA established 
procedures for manufacturers to request exemptions from the SE 
requirements of the Tobacco Control Act (SE exemptions final rule). The 
SE exemptions final rule was issued under section 905(j)(3) of the FD&C 
Act, which provides that FDA may exempt from the requirements relating 
to the demonstration of SE tobacco products that are modified by adding 
or deleting a tobacco additive, or increasing or decreasing the 
quantity of an existing tobacco additive, if FDA determines that: (1) 
Such modification would be a minor modification of a tobacco product 
that can be sold under the FD&C Act, (2) a report is not necessary to 
ensure that permitting the tobacco product to be marketed would be 
appropriate for protection of the public health, and (3) an exemption 
is otherwise appropriate.
    The exemption request may be made only by the manufacturer of a 
legally marketed tobacco product for a minor modification to that 
manufacturer's product, and the request (and supporting information) 
must be submitted in an electronic format that FDA can process, review, 
and archive. In addition, the request and all supporting information 
must be legible and in (or translated into) the English language.
    An exemption request must be submitted with supporting 
documentation and contain:
     The manufacturer's address and contact information;
     identification of the tobacco product(s);
     a detailed explanation of the purpose for the 
modification;
     a detailed description of the modification, including a 
statement as to whether the modification involves adding or deleting a 
tobacco additive, or increasing or decreasing the quantity of an 
existing tobacco additive;
     a detailed explanation of why the modification is a minor 
modification of a tobacco product that can be sold under the FD&C Act;
     a detailed explanation of why a report under section 
905(j)(1)(A)(i) intended to demonstrate SE is not necessary to ensure 
that permitting the tobacco product to be marketed would be appropriate 
for the protection of the public health;
     a certification summarizing the supporting evidence and 
providing the rationale for why the modification does not increase the 
tobacco products appeal to or use by minors, toxicity, addictiveness, 
or abuse liability;
     other information justifying an exemption; and
     an environmental assessment under part 25 (21 CFR part 25) 
prepared in accordance with Sec.  25.40.
    This information will enable FDA to determine whether the exemption 
request is appropriate for the protection of the public health. There 
is also a procedural mechanism for rescinding an exemption if FDA finds 
the exemption is not appropriate for the protection of the public 
health. In general, FDA will rescind an exemption only after providing 
the manufacturer notice of the rescission and an opportunity for an 
informal hearing under part 16 (21 CFR part 16). However, FDA may 
rescind an exemption prior to notice and opportunity for a hearing 
under part 16 if the continuance of the exemption presents a serious 
risk to public health. In that case, FDA would provide the manufacturer 
an opportunity for a

[[Page 29086]]

hearing as soon as possible after the rescission.
    FDA reviews the information submitted in support of the request and 
determines whether to grant or deny the request based on whether the 
criteria specified in the statute are satisfied. FDA may request 
additional information from the manufacturer if necessary to make the 
determination. If the manufacturer fails to respond within the 
timeframe requested, FDA will consider the exemption request withdrawn.
    FDA estimates the additional annual burden for the information 
collection as a result of this rule as follows:

    Table 9--Estimated Annual Reporting Burden (When Manufacturers Choose to Seek Exemption From Substantial
                                                Equivalence) \1\
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                     Number of       Number of     Total annual     burden per
   21 CFR Section and activity      respondents    responses per     responses     response (in     Total hours
                                                  respondent \2\                      hours)
----------------------------------------------------------------------------------------------------------------
     Sec.   1107.1(b) Optional Preparation of Tobacco Product Exemption From Substantial Equivalence Request
                        Including Sec.   25.40 Preparation of an Environmental Assessment
----------------------------------------------------------------------------------------------------------------
Cigar Manufacturers (Including               196               1             196              24           4,704
 Large, Small, and Importers)...
Pipe and Waterpipe Tobacco                   105               1             105              24           2,520
 Manufacturers (Including
 Importers).....................
Other Tobacco, E-Cigarettes, and              18               1              18              24             432
 Nicotine Product Manufacturers
 (ENDS and Delivery Systems
 (Including Importers)).........
                                 -------------------------------------------------------------------------------
    Total Hours (Sec.             ..............  ..............  ..............  ..............           7,656
     1107.1(b)).................
----------------------------------------------------------------------------------------------------------------
      Sec.   1107.1(c) Preparation of Additional Information for Tobacco Product Exemption From Substantial
                                              Equivalence Request:
----------------------------------------------------------------------------------------------------------------
Cigar Manufacturers (Including                59               1              59               3             177
 Large, Small, and Importers)...
Pipe and Waterpipe Tobacco                    32               1              32               3              96
 Manufacturers (Including
 Importers).....................
Other Tobacco, E-Cigarettes, and               3               1               3               3               9
 Nicotine Product Manufacturers
 (ENDS and Delivery Systems
 (Including Importers)).........
                                 -------------------------------------------------------------------------------
    Total Hours (Sec.             ..............  ..............  ..............  ..............             282
     1107.1(c)).................
----------------------------------------------------------------------------------------------------------------
 Section 905(j)(1)(A)(ii) of the FD&C Act: If exemption granted, report submitted to demonstrate tobacco product
is modified under section 905(j)(3), modifications are to a product that is commercially marketed and compliant,
              and modifications covered by exemptions granted by Secretary under section 905(j)(3):
----------------------------------------------------------------------------------------------------------------
Cigar Manufacturers (Including               293               1             293               3             879
 Large, Small, and Importers)...
Pipe and Waterpipe Tobacco                   156               1             156               3             468
 Manufacturers (including
 importers).....................
Other Tobacco, E-Cigarettes, and              26               1              26               3              78
 Nicotine Product Manufacturers
 (ENDS and Delivery Systems
 (Including Importers)).........
                                 -------------------------------------------------------------------------------
    Total Hours (section          ..............  ..............  ..............  ..............           1,425
     905(j)(1)(A)(ii))..........
----------------------------------------------------------------------------------------------------------------
        Total Hours Exemptions    ..............  ..............  ..............  ..............           9,363
         From Substantial
         Equivalence
         Requirements...........
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ This number is estimated to be the total annual responses divided by the number of respondents, rounded to
  the nearest hundredth.

    The estimated average burden per response (in hours) is based on 
the burdens associated with the existing information collection that 
applies to tobacco products currently subject to the FD&C Act (i.e., 
cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless 
tobacco). FDA estimates that we will receive 319 exemption requests 
under Sec.  1107.1(b) for 24 hours per response including EA for a 
total of 7,656 hours. Since an EA is required for each Sec.  1107.1(b) 
(Optional Preparation of Tobacco Product Exemption From Substantial 
Equivalence Request), the burden per response for EAs (12 hours) has 
been combined with the 12 hours for an SE request for a total of 24 
hours.
    FDA estimates, based on the existing information collection that 
applies to tobacco products currently subject to the FD&C Act, we will 
receive 94 submissions requiring additional information in support of 
the initial exemption request, and it is expected that it will take an 
average of 3 hours to prepare the additional information for a total of 
282 hours.
    FDA estimates that 475 respondents will prepare 475 responses and 
each response will take approximately 3 hours to prepare, as required 
by section 905(j)(1)(A)(ii), for a total of 1,425 hours. This 
collection of information requires a manufacturer to submit a report at 
least 90 days prior to making an introduction or delivery for 
introduction into interstate commerce for commercial distribution of a 
tobacco product. Section 905(j)(1)(A)(ii) of the FD&C Act states that 
if an exemption has been requested and granted, the manufacturer

[[Page 29087]]

must submit to FDA a report that demonstrates that the tobacco product 
is modified within the meaning of section 905(j)(3), the modifications 
are to a product that is commercially marketed and in compliance with 
the requirements of the FD&C Act, and all of the modifications are 
covered by exemptions granted by the Secretary pursuant to section 
905(j)(3). FDA estimated the total hours for exemptions from 
Substantial Equivalence Requirements would be 9,363 hours.
    FDA's estimates are based on full analysis of economic impacts 
(Ref. 204) and information gathered from other FDA-regulated products.
4. Reports Intended To Demonstrate the Substantial Equivalence of a New 
Tobacco Product (OMB Control Number 0910-0673)
    Description of Respondents: Respondents to this collection of 
information are manufacturers of deemed tobacco products who seek to 
submit a report to FDA demonstrating that a tobacco product is 
substantially equivalent to a valid predicate product under section 
905(j)(1)(A)(i) of the FD&C Act.
    Section 905(j)(1) of the FD&C Act authorizes FDA to establish the 
form and manner of the submission. FDA issued guidance intended to 
assist persons submitting reports under section 905(j) of the FD&C Act 
and to explain, among other things, FDA's interpretation of the 
statutory sections related to SE (see the Guidance for Industry and FDA 
Staff entitled ``Section 905(j) Reports: Demonstrating Substantial 
Equivalence for Tobacco Products'' (76 FR 789, January 6, 2011)).
    Under the recently issued guidance, which published in the Federal 
Register of September 8, 2015, entitled, ``Demonstrating the 
Substantial Equivalence of a New Tobacco Product: Responses to 
Frequently Asked Questions'' (Edition 2), FDA is recommending that 
certain modifications might be addressed in either a ``Same 
Characteristics SE Report'' or ``Product Quantity Change Report.'' In 
some circumstances manufacturers may be able to submit a shorter SE 
report. In particular, if a tobacco product is distinct (e.g., it has a 
different name), but has the same characteristics as a valid predicate 
product, manufacturers may submit a Same Characteristics SE Report. If 
the only change to the tobacco product is a change to product quantity, 
and the per-weight composition inside the package remains identical, 
the manufacturer may submit a Product Quantity Change SE Report. FDA's 
CTP estimates that it will take less time to prepare those shorter SE 
reports.
    When groups of full or product quantity change SE reports have 
identical content, they may be bundled; when a group of similar reports 
are bundled, the subsequent bundled reports are expected to take less 
time to prepare than the initial report.
    FDA recognizes that many manufacturers of newly deemed products may 
be at the inception of their businesses. Therefore, FDA is announcing 
that the Agency may grant extension requests made by small-scale 
tobacco product manufacturers for SE Reports that need additional time 
to respond to deficiency letters for the first 30 months following the 
effective date of this rule.
    FDA estimates the additional annual burden for the information 
collection as a result of this rule as follows:

                                 Table 10--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                     Number of       Number of     Total annual     burden per
            Activity                respondents    responses per     responses     response (in     Total hours
                                                  respondent \2\                      hours)
----------------------------------------------------------------------------------------------------------------
         Full SE Initial Sections 905(j)(1)(A)(i) and 910(a) and Sec.   25.40 Environmental Assessments:
----------------------------------------------------------------------------------------------------------------
Cigar Manufacturers (Including               168               1             168             300          50,400
 Large, Small, and Importers)...
Pipe and Waterpipe Tobacco                   151               1             151             300          45,300
 Manufacturers (Including
 Importers).....................
Other Tobacco, E-Cigarettes, and              16               1              16             300           4,800
 Nicotine Product Manufacturers
 (ENDS and Delivery Systems
 (Including Importers)).........
                                 -------------------------------------------------------------------------------
    Total Hours (sections         ..............  ..............  ..............  ..............         100,500
     905(j)(1)(A)(i) and 910(a))
----------------------------------------------------------------------------------------------------------------
             Full SE Bundled 905(j)(1)(A)(i) and 910(a) and Sec.   25.40 Environmental Assessments:
----------------------------------------------------------------------------------------------------------------
Cigar Manufacturers (Including               151               1             151              90          13,590
 Large, Small, and Importers)...
Pipe and Water Tobacco                        83               1              83              90           7,470
 Manufacturers (Including
 Importers).....................
Other Tobacco, E-Cigarettes, and              16               1              16              90           1,440
 Nicotine Product Manufacturers
 (ENDS and Delivery Systems
 (Including Importers)).........
                                 -------------------------------------------------------------------------------
    Total Hours.................  ..............  ..............  ..............  ..............          22,500
----------------------------------------------------------------------------------------------------------------
                   Same Characteristics SE Report and Sec.   25.40 Environmental Assessments:
----------------------------------------------------------------------------------------------------------------
Cigar Manufacturers (Including               285               1             285              47          13,395
 Large, Small, and Importers)...
Pipe and Waterpipe Tobacco                   132               1             132              47           6,204
 Manufacturers (Including
 Importers).....................
Other Tobacco, E-Cigarettes, and               1               1               1              47              47
 Nicotine Product Manufacturers
 (ENDS and Delivery systems
 (Including Importers)).........
                                 -------------------------------------------------------------------------------

[[Page 29088]]

 
    Total Same Characteristics..  ..............  ..............  ..............  ..............          19,646
----------------------------------------------------------------------------------------------------------------
                   Product Quantity Change Initial and Sec.   25.40 Environmental Assessments:
----------------------------------------------------------------------------------------------------------------
Cigar Manufacturers (Including               108               1             108              87           9,396
 Large, Small, and Importers)...
Pipe and Waterpipe Tobacco                    30               1              30              87           2,610
 Manufacturers (Including
 Importers).....................
Other Tobacco, E-Cigarettes, and               1               1               1              87              87
 Nicotine Product Manufacturers
 (ENDS and Delivery systems
 (Including Importers)).........
                                 -------------------------------------------------------------------------------
    Total Product Quantity        ..............  ..............  ..............  ..............          12,093
     Change Initial.............
----------------------------------------------------------------------------------------------------------------
                   Product Quantity Change Bundled and Sec.   25.40 Environmental Assessments:
----------------------------------------------------------------------------------------------------------------
Cigar Manufacturers (Including                42               1              42              62           2,604
 Large, Small, and Importers)...
Pipe and Waterpipe Tobacco                    12               1              12              62             744
 Manufacturers (Including
 Importers).....................
Other Tobacco, E-Cigarettes, and               1               1               1              62              62
 Nicotine Product Manufacturers
 (ENDS and Delivery systems
 (Including Importers)).........
                                 -------------------------------------------------------------------------------
    Total Product Quantity        ..............  ..............  ..............  ..............           3,410
     Change.....................
                                 -------------------------------------------------------------------------------
        Total Hours (``Reports    ..............  ..............  ..............  ..............         158,149
         Intended to Demonstrate
         the Substantial
         Equivalence of a New
         Tobacco Product'').....
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ This number is estimated to be the total annual responses divided by the number of respondents, rounded to
  the nearest hundredth.

    FDA has based these estimates on the full analysis of economic 
impacts (Ref. 204) and experience with the existing information 
collection that applies to tobacco products currently subject to the 
FD&C Act (i.e., cigarettes, cigarette tobacco, roll-your-own tobacco, 
and smokeless tobacco). In addition, anyone submitting an SE report is 
required to submit an environmental assessment under Sec.  25.40.
    The burden for environmental reports has been included in the 
burden per response for each type of SE report.
    FDA estimates that 335 respondents will prepare and submit 335 
section 905(j)(1)(A)(i) Full SE Initial reports each year and that it 
will take a manufacturer approximately 300 hours per report to prepare 
the reports of SE and environmental assessment for a new tobacco 
product.
    FDA estimates that we will receive 335 Full SE Initial reports for 
a total of 100,500 hours. We estimate 250 Full SE Bundled Reports for a 
total of 22,500 hours. FDA estimates that we will receive 418 Same 
Characteristics SE Reports for a total of 19,646 hours. FDA estimates 
receiving 139 Initial Product Quantity Change reports for a total of 
12,093 hours. We estimate receiving 55 Product Quantity Change Bundled 
SE reports for a total of 3,410 hours. Based on FDA's experience with 
environmental assessments (EAs) for currently regulated tobacco 
products, we expect industry to spend 80 hours to prepare an 
environmental assessment for a full SE Report, but less time to prepare 
an environmental assessment for shorter SE reports.
    Therefore, FDA estimates the burden for submission of SE 
information will be 158,149 hours.
5. Electronic Importer's Entry Notice (OMB Control Number 0910-0046)
    Description of Respondents: Respondents to this collection of 
information are importers of tobacco products being imported or offered 
for import into the United States whose products meet the same 
requirements of the Tobacco Control Act as domestic tobacco products.
    With the passage of the Tobacco Control Act, section 801 of the 
FD&C Act (21 U.S.C. 381) was amended to add tobacco products to the 
inventory of FDA-regulated products. The revised section 801 charges 
the Secretary of Health and Human Services, through FDA, with the 
responsibility of assuring that foreign-origin, FDA-regulated foods, 
drugs, cosmetics, medical devices, radiological health, and tobacco 
products being imported or offered for import into the United States 
meet the same requirements of the FD&C Act as domestic products and for 
preventing products from entering the country if they are not in 
compliance. The discharge of this responsibility involves close 
coordination and cooperation between FDA headquarters and field 
inspectional personnel and the U.S. Customs and Border Protection 
(CBP). This collection of information is being used by FDA to review 
and prevent imported products from entering the United States if the 
products do not meet the same requirements of the FD&C Act as do 
domestic products.
    Until October 1995, importers were required to file manual entry on 
OMB-approved forms, which were accompanied by related documents. 
Information provided by these forms included information such as 
country of origin, name of the importing vessel, entry number (assigned 
by CBP), port of entry, the port of lading and unlading, value in U.S. 
dollars, shipper or manufacturer, importer of record, original 
consignee, broker, broker's

[[Page 29089]]

reference number and CBP house box number, bill of lading numbers, and 
location of goods. FDA stopped using these paper forms effective 
October 1, 1995, to eliminate duplication of information and to reduce 
the paperwork burden both on the import community and FDA. The Agency 
then developed and implemented an automated nationwide entry processing 
system, which enabled FDA to more efficiently obtain and process the 
information it requires to fulfill its regulatory responsibility.
    Most of the information FDA requires to carry out its regulatory 
responsibilities under section 801 of the FD&C Act is already provided 
electronically by filers to CBP. Because CBP relays this data to FDA 
using an electronic interface, the majority of data submitted by the 
entry filer need be done only once.
    FDA estimates the additional annual burden for the information 
collection as a result of this rule as follows:

                                                     Table 11--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
                  Activity                       Number of     responses per   Total annual     Average burden per response (in hours)      Total hours
                                                respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Importers of Cigars who are Considered                   216             159          34,344  0.14 (8\1/2\ minutes)                                4,808
 Manufacturers.
Importers of Pipe and Waterpipe Tobacco Who               43             123           5,289  0.14 (8\1/2\ minutes)                                  740
 Are Considered Manufacturers.
Importers Other Tobacco, E-Cigarettes, and                14              68             952  0.14 (8\1/2\ minutes)                                  133
 Nicotine Product Manufacturers (ENDS).
                                             -----------------------------------------------------------------------------------------------------------
    Total Hours Importation of Tobacco        ..............  ..............  ..............  ..........................................           5,681
     Products.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA estimates the burden hours to be 5,681 burden hours (4,808 + 
740 + 133 hours). This reflects the addition of the newly deemed 
tobacco products to the list of FDA's regulated products. When testing 
the use of electronic and paper forms, FDA determined that the average 
time for completing either electronic or manual entries was the same.
    Based on the original data collected by FDA when the importer entry 
notice information collection was most recently approved, it is 
expected that each respondent will take 0.14 hour (8\1/2\ minutes) to 
respond. The estimated hours per response are expected to remain the 
same for tobacco importers.
    FDA estimates that there will be no additional costs to provide 
import data electronically to FDA, as filers already have equipment and 
software in place to enable them to provide data to CBP via the 
automated system. Therefore, no additional software or hardware need be 
developed or purchased to enable filers to file the FDA data elements 
at the same time they file entries electronically with CBP.
6. Exports: Notification and Recordkeeping Requirements (OMB Control 
Number 0910-0482)
    Description of Respondents: Respondents are manufacturers, 
distributors, and other persons who export tobacco products not 
intended for sale in the United States.
    In a rule published on February 2, 2012 (77 FR 5171), FDA amended 
certain of its general regulations to include tobacco products, where 
appropriate, in light of FDA's authority to regulate these products 
under the Tobacco Control Act (conforming amendments rule). The 
conforming amendments rule subjects tobacco products to the same 
general requirements that apply to other FDA-regulated products, where 
appropriate.
    The conforming amendments rule amended 21 CFR 1.101(b), among other 
sections, to require persons who export human drugs, biologics, 
devices, animal drugs, foods, cosmetics, and tobacco products that may 
not be sold in the United States to maintain records demonstrating 
their compliance with the requirements in section 801(e)(1) of the FD&C 
Act. Section 801(e)(1) requires exporters to keep records demonstrating 
that the exported product: (1) Meets with the foreign purchaser's 
specifications; (2) does not conflict with the laws of the foreign 
country; (3) is labeled on the outside of the shipping package that is 
intended for export; and (4) is not sold or offered for sale in the 
United States. These criteria also could be met by maintaining other 
documentation, such as letters from a foreign government agency or 
notarized certifications from a responsible company official in the 
United States stating that the exported product does not conflict with 
the laws of the foreign country.
    FDA estimates the annual burden for the information collection as a 
result of this rule as follows:

                                                   Table 12--Estimated Annual Recordkeeping Burden 1 2
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                      Average burden
                         Activity                              Number of      Number of records     Total annual    per recordkeeping     Total hours
                                                             recordkeepers     per recordkeeper       records           (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    21 CFR 1.101(b):
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cigar Manufacturers (Large and Small)....................                 57                  3                171                 22              3,762
Pipe and Waterpipe Tobacco Manufacturers.................                 37                  3                111                 22              2,442
Other Tobacco, E-Cigarettes, and Nicotine Product                         93                  3                279                 22              6,138
 Manufacturers (ENDS)....................................
                                                          ----------------------------------------------------------------------------------------------

[[Page 29090]]

 
    Exports: Notification and Recordkeeping Requirements.  .................  .................  .................  .................             12,342
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ At publication of the NPRM, the burden for these activities were under OMB control number 0910-0690. The burden has since been transferred to OMB
  control number 0910-0482.

    The Agency has estimated the number of respondents and burden hours 
associated with the recordkeeping requirements by reviewing Agency 
records and using Agency expert resources who have experience and 
information regarding tobacco product exporters. FDA estimates that 187 
establishments (50 percent of all the tobacco manufacturers listed in 
the collection of information under OMB Control Number 0910-0046 in 
this document who manufacture cigars, pipe tobacco, waterpipe, other 
tobacco products, and ENDS) could be involved in the exporting of all 
tobacco products annually. Based on previous recordkeeping estimates 
for the exporter's reporting burden in the existing OMB-approved 
collection of information (OMB Control Number 0910-0482, ``Export 
Notification and Recordkeeping Requirements''), each establishment will 
maintain an average of three records per year, and it will take each 
recordkeeper an average of 22 hours per recordkeeper to maintain each 
record. The Agency estimates 12,342 burden hours will be needed for 
tobacco product exporters to create and maintain records demonstrating 
compliance with section 801(e)(1) of the FD&C Act.
7. Establishing That a Tobacco Product Was Commercially Marketed in the 
United States as of February 15, 2007 (OMB Control Number 0910-0775)
    Description of Respondents: Respondents to this collection of 
information are manufacturers of tobacco products who wish to 
demonstrate that their tobacco product was commercially marketed in the 
United States on February 15, 2007, and is a grandfathered product not 
subject to premarket review.
    On September 29, 2014, FDA published the guidance document entitled 
``Establishing That a Tobacco Product Was Commercially Marketed in the 
United States as of February 15, 2007''. This guidance provides 
information on how a manufacturer may demonstrate that a tobacco 
product was commercially marketed in the United States on February 15, 
2007, and is, therefore, a grandfathered product not subject to 
premarket review. The guidance recommends that the manufacturer provide 
evidence that may include, among other things, dated copies of 
advertisements, dated catalog pages, dated promotional material, and 
dated bills of lading. FDA recommends that the manufacturer submit 
adequate information to demonstrate that the tobacco product was 
commercially marketed in the United States on February 15, 2007.
    The estimate for the number of hours in the existing collection is 
FDA's estimate of how long it might take one to review, gather, and 
submit dated information if making a request for an Agency 
determination.
    FDA estimates the annual burden for the information collection as a 
result of this rule as follows:

                                 Table 13--Estimated Annual Reporting Burden 1 2
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                     Number of       Number of     Total annual     burden per
            Activity                respondents    responses per     responses     response (in     Total hours
                                                    respondent                        hours)
----------------------------------------------------------------------------------------------------------------
Cigar Manufacturers (including                 1               1               1               5               5
 large and small cigars and
 importers).....................
Pipe Tobacco Manufacturers                     1               1               1               5               5
 (Including Importers)..........
Other Tobacco, E-Cigarettes, and               1               1               1               5               5
 Nicotine Product Manufacturers
 (Including Importers)..........
                                 -------------------------------------------------------------------------------
    Total Hours Establishing      ..............  ..............  ..............  ..............              15
     that a Tobacco Product was
     Commercially Marketed in
     the United States as of
     February 15, 2007..........
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ At publication of the NPRM, this collection was not yet approved by OMB. On September 8, 2014, OMB approved
  the information collection for 3 years.

    Based on FDA's experiences to date, and given that stand-alone 
grandfather submissions are purely voluntary, FDA does not anticipate 
that many manufacturers will make such submissions, but this option is 
available. As such, we assigned one respondent annually per type of 
product FDA estimates it will take a manufacturer approximately 5 hours 
to complete and submit for FDA review the evidence required by this 
collection of information for a total of 15 hours.

C. Burdens Associated With Tobacco Products Currently Subject to the 
FD&C Act But Not Yet Approved by OMB

    The information collections described in this section also involve 
collections that have been previously made available for public comment 
because they involved tobacco products currently subject to chapter IX 
of the FD&C Act. However, these information collections have not yet 
been approved by OMB.

[[Page 29091]]

    FDA based the estimates on the existing collections that were 
previously made available for comment.
     Applications for Premarket Review of New Tobacco Products
    Description of Respondents: The respondents to this collection of 
information are manufacturers who seek a marketing authorization order 
under section 910(c)(1)(A)(i) of the FD&C Act.
    On September 28, 2011, FDA announced the availability of a draft 
guidance entitled ``Applications for Premarket Review of New Tobacco 
Products''. This guidance, when finalized, will represent the Agency's 
current thinking on the topic. Section 910(a)(1) of the FD&C Act 
defines a ``new tobacco product'' as a tobacco product that was not 
commercially marketed in the United States on February 15, 2007, or 
modification (including a change in design, any component, any part, or 
any constituent, including a smoke constituent, or in the content, 
delivery or form of nicotine, or any other additive or ingredient) of a 
tobacco product where the modified product was commercially marketed in 
the United States after February 15, 2007. An order under section 
910(c)(1)(A)(i) of the FD&C Act is required prior to marketing a new 
tobacco product. This requirement applies unless the product has been 
shown to be substantially equivalent to a valid predicate product or is 
exempt from SE.
    Section 910(b) of the FD&C Act states that a PMTA shall contain 
full reports of all investigations of health risks; a full statement of 
all components, ingredients, additives, and properties, and of the 
principle or principles of operation of such tobacco product; a full 
description of methods of manufacturing and processing (which includes; 
a listing of all manufacturing, packaging, and control sites for the 
product); an explanation of how the product complies with applicable 
tobacco product standards; samples of the product and its components; 
and labeling.
    FDA also encourages persons who would like to study their new 
tobacco product to meet with the OS in CTP to discuss their 
investigational plan. The request for a meeting should be sent in 
writing to the Director of CTP's OS and should include adequate 
information for FDA to assess the potential utility of the meeting and 
to identify FDA staff necessary to discuss agenda items. FDA is 
required to deny a PMTA and issue an order that the product may not be 
introduced or delivered for introduction into interstate commerce under 
section 910(c)(1)(A)(ii) of the FD&C Act if FDA finds that:
     The manufacturer has not shown that the product is 
appropriate for the protection of the public health,
     the manufacturing, processing, or packing methods, 
facilities, or controls do not conform to good manufacturing practices 
issued under section 906(e) of the FD&C Act,
     the labeling is false or misleading in any particular, or
     the manufacturer has not shown that the product complies 
with any tobacco product standard in effect under section 907 of the 
FD&C Act.
    FDA estimates the annual burden for the information collection as a 
result of this rule as follows:

                                 Table 14--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                     Number of       Number of     Total annual     burden per
            Activity                respondents    responses per     responses     response (in     Total hours
                                                    respondent                        hours)
----------------------------------------------------------------------------------------------------------------
Obtaining an FDA Order Authorizing Marketing of Tobacco Product (the application) and Sec.   25.40 Environmental
                                                  Assessments:
----------------------------------------------------------------------------------------------------------------
Other Tobacco, E-Cigarettes, and             200            3.75             750           1,713       1,284,750
 Nicotine Product Manufacturers
 (ENDS Liquids and ENDS Delivery
 Systems (Including Importers)).
    Total Hours Obtaining an FDA  ..............  ..............  ..............  ..............       1,284,750
     Order Authorizing Marketing
     of Tobacco Product (the
     application)...............
----------------------------------------------------------------------------------------------------------------
                Request for Meeting with CTP's Office of Science to Discuss Investigational Plan:
----------------------------------------------------------------------------------------------------------------
Other Tobacco, E-Cigarettes, and             200               1             200               4             800
 Nicotine Product Manufacturers
 (ENDS Liquids and ENDS Delivery
 Systems (Including Importers)).
    Total Hours Request for       ..............  ..............  ..............  ..............             800
     Meeting with CTP's Office
     of Science to Discuss
     Investigational Plan.......
        Total Hours               ..............  ..............  ..............  ..............       1,285,550
         ``Applications for
         Premarket Review of New
         Tobacco Products''.....
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA estimates that it will take each respondent approximately 1,500 
hours to prepare a PMTA seeking an order from FDA allowing the 
marketing of a new tobacco product. FDA also estimates that it would on 
average take an additional 213 hours to prepare an environmental 
assessment in accordance with the requirements of Sec.  25.40, for a 
total of 1,713 hours per PMTA application. This average represents a 
wide range of hours that will be required for these applications under 
different circumstances, with some requiring more hours (e.g., as many 
as 5,000 hours for early applications that involve complex products and 
for which the company has no experience conducting studies or preparing 
analysis of public health impacts, or for which reliance on master 
files is not possible) as well as many requiring fewer hours (e.g., as 
few as 50 hours for applications for products that are very similar to 
other new products).
    Although FDA has decreased the burden per each PMTA, we have 
increased the number of expected responses for ENDS manufacturers. We 
attribute this increase to the rapid growing ENDS market since the NPRM 
was published. FDA's estimate includes anticipated burden for the 
writing of an application, including intracompany edits and approvals. 
FDA also estimates the number of PMTAs that FDA expects to receive 
annually will be 750 (642 ENDS Liquids and 108 ENDS Delivery Systems).
    We are clarifying here that a PMTA may require one or more types of 
studies including chemical analysis,

[[Page 29092]]

nonclinical studies, and clinical studies. FDA expects that chemical 
and design parameter analysis would include the testing of applicable 
HPHCs and nonclinical analysis would include literature synthesis and, 
as appropriate, some combination of in vitro or in vivo studies, and 
computational analyses. For the clinical study component, one or more 
types of studies may be included to address, as needed, perception, use 
pattern, or health impact. It is possible that an applicant may not 
need to conduct any new nonclinical or clinical studies. We note that 
for most applications, FDA does not expect that applicants will include 
randomized clinical trials, like those conducted to support drug and 
device approvals.
    For tobacco products already on the market at the time of the final 
rule, much of the information required to support a PMTA may be 
obtained from previously published research on similar products. 
Therefore, FDA expects that a large portion of applications may be 
reviewed with no or minimal new nonclinical or clinical studies being 
conducted to support an application. In contrast, nonclinical and 
clinical studies may be required for market authorization of a new 
product for which there is limited understanding of its potential 
impact on the public health. The range of hours involved to compile 
these two types of applications would be quite variable.
    FDA anticipates that the 200 potential respondents to this 
collection may need to meet with CTP's Office of Science to discuss 
their investigational plans. To request this meeting, applicants should 
compile and submit information to FDA for meeting approval. FDA 
estimates that it will take approximately 4 hours to compile this 
information, for a total of 800 hours additional burden (200 
respondents x 4 hours).
    Therefore, the total annual burden for submitting PMTA applications 
is estimated to be 1,285,550 hours. FDA's estimates are based on the 
corresponding information collection estimates that apply to tobacco 
products currently subject to the FD&C Act and an assumption that 
manufacturers would submit applications for the premarket review of 
tobacco products.

D. New Collections of Information That Apply Only to Deemed Tobacco 
Products

1. Exemption From the Required Warning Statement Requirement
    Description of Respondents: Respondents are manufacturers who, to 
obtain an exemption from the required addictiveness warning, certify to 
FDA that their product does not contain nicotine and that the 
manufacturer has data to support that assertion.
    This rule contains a new information collection that pertains to an 
exemption process related to the requirement to include the warning 
statement in Sec.  1143.3(a)(1). Section1143.3(c) will provide an 
exemption to the manufacturer of a product that otherwise would be 
required to include the warning statement in Sec.  1143.3(a)(1) on its 
packages and in its advertisements, i.e., ``WARNING: This product 
contains nicotine. Nicotine is an addictive chemical.'' This warning 
will be required to appear on at least 30 percent of the two principal 
display panels of the package and on at least 20 percent of the area of 
the advertisement.
    To obtain an exemption from this requirement, a manufacturer would 
be required to certify to FDA that its product does not contain 
nicotine and that the manufacturer has data to support that assertion. 
For any product that obtains this exemption, the section requires that 
the product bear the statement: ``This product is made from tobacco.'' 
The parties that package and label such products will share 
responsibility for ensuring that this alternative statement is included 
on product packages and in advertisements. The rule will permit 
companies to obtain an exemption from this warning requirement in the 
event that such tobacco products are developed in the future.
    FDA estimates the annual burden for the information collection as a 
result of this rule as follows:

                                 Table 15--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                     Number of       Number of     Total annual     burden per
            Activity                respondents    responses per     responses     response  (in    Total hours
                                                    respondent                        hours)
----------------------------------------------------------------------------------------------------------------
Certification Statement.........               1               1               1              20              20
                                 -------------------------------------------------------------------------------
    Total Exemptions From the     ..............  ..............  ..............  ..............              20
     Required Warning Statement
     Requirement................
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The estimated average burden per response is based on information 
collection estimates that apply to tobacco products currently subject 
to the FD&C Act. Although very few certifications are expected for 
tobacco products that do not contain nicotine, FDA estimates that the 
number of certification submissions could rise if the Agency decides in 
the future to address not only nicotine, but any other addictive 
substances.
    The estimated hours listed in the burden table for certification 
submissions reflect the time needed to test the product for nicotine 
and to prepare and submit the self-certification request. FDA expects 
that these types of certifications will be very rare and estimates that 
the Agency will receive on average one submission per year.
    FDA concludes that the labeling statements in Sec. Sec.  
1143.3(a)(1) and 1143.5(a)(1) and the alternative statement in Sec.  
1143.3(c) (i.e., ``This product is made from tobacco'') are not subject 
to review by OMB because they do not constitute a ``collection of 
information'' under the PRA (44 U.S.C. 3501-3520). Rather, these 
labeling statements are a ``public disclosure'' of information 
originally supplied by the Federal Government to the recipient for the 
purpose of ``disclosure to the public'' (5 CFR 1320.3(c)(2)).
2. Submitting Warning Plans for Cigar Manufacturers, Importers, 
Distributors, and Retailers
    Description of Respondents: The respondents to this collection of 
information are manufacturers, importers, distributors, and retailers 
of cigar products who will be required to submit warning plans for 
cigars to FDA.
    The requirement for submission of warning plans for cigar products, 
and the specific requirements relating to the random display and 
distribution of required warning statements on cigar

[[Page 29093]]

packaging and quarterly rotation of required warning statements in 
alternating sequence on cigar product advertising, appear in Sec.  
1143.5(c).
    The six warnings for cigars (five specifically for cigars and the 
one addictiveness warning) will be required to be randomly displayed in 
each 12-month period, in as equal a number of times as is possible on 
each brand of cigar sold in product packaging and be randomly 
distributed in all areas of the United States in which the product is 
marketed accordance with a warning plan submitted to and approved by 
FDA. For advertisements, the warning statements must be rotated 
quarterly in alternating sequence in each advertisement for each brand 
of cigar in accordance with a warning plan submitted to and approved by 
FDA.
    For cigar products that are on the market as of the publication 
date of the final rule, the effective date for the requirement to 
submit warning plans by responsible manufacturers, distributors, 
importers, and retailers is 1 year after the date of publication of the 
final rule. FDA is establishing this effective date 1 year before the 
effective date of the remainder of the part 1143 requirements because 
the Agency anticipates that there will be a need for considerable 
communication with submitters during its review of the warning plan 
submissions. FDA will work with the submitters to ensure that the plans 
submitted meet the established criteria for approval under part 1143. 
FDA also intends to update the warning plan draft guidance and 
information collection, which currently pertains to smokeless tobacco 
products, to assist manufacturers, importers, distributors, and 
retailers of cigars with the submission of warning plans. The 
information collection in this draft guidance is approved under OMB 
Control Number 0910-0671. The draft guidance document discusses, among 
other things: The statutory requirement to submit a warning plan; 
definitions; who submits a warning plan; the scope of a warning plan; 
when to submit a warning plan; what information should be submitted in 
a warning plan; where to submit a warning plan; and what approval of a 
warning plan means.
    The warning statements on cigar packaging must be randomly 
displayed in each 12-month period, in as equal a number of times as is 
possible on each brand of cigar sold and are required to be randomly 
distributed in all areas of the United States in which the product is 
marketed in accordance with a warning plan submitted by the responsible 
cigar manufacturer, importer, distributor, or retailer to and approved 
by FDA.
    To clarify, retailers of cigars sold individually and not in 
product packaging are not required to submit a warning plan for 
warnings on packages, because the warning signs posted at a retailer's 
point-of-sale would include all six warnings applicable to cigars, as 
we have noted in Sec.  1143.5(c)(1). Therefore, it is not necessary to 
submit a rotational warning plan for them. However, manufacturers, 
distributors, and those retailers who are responsible for or direct the 
health warning of the advertisements of such products must submit a 
warning plan for their advertisements for FDA approval. The rule 
requires them to include warnings on advertisements, and the warnings 
that must be rotated quarterly in alternating sequence in each 
advertisement for each brand of cigar, in accordance with an FDA 
approved warning plan.
    FDA is also requiring that the required warning statements be 
rotated quarterly in alternating sequence in each advertisement for 
each brand of cigar, regardless of whether the cigar is sold in product 
packaging. This rotation of warning statements in cigar advertisements 
also must be done in accordance with a warning plan submitted by the 
responsible cigar manufacturer, importer, distributor, or retailer to 
and approved by FDA.
    FDA estimates the annual burden for the information collection as a 
result of this rule as follows:

                                 Table 16--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                     Number of       Number of     Total annual     burden per
       Cigar warning plan           respondents    responses per     responses     response  (in    Total hours
                                                    respondent                        hours)
----------------------------------------------------------------------------------------------------------------
Manufacturers, Importers, and                329               1             329             120          39,480
 Retailers......................
                                 -------------------------------------------------------------------------------
    Total Cigar Warning Plan....  ..............  ..............  ..............  ..............          39,480
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The burden estimates are based on FDA's experience with smokeless 
warning plans and the associated information collection (OMB Control 
Number 0910-0671) as well as warning plans for cigarettes submitted to 
the FTC prior to the implementation of the Tobacco Control Act on June 
22, 2009.
    We estimate 329 entities will submit warning plans, and it will 
take an average of 120 hours per respondent to prepare and submit a 
warning plan for packaging and advertising for a total of 39,480 hours.
3. Small-Scale Manufacturer Report
    Description of Respondents: The respondents to this collection of 
information are manufacturers known as ``small-scale tobacco product 
manufacturers.''
    As discussed in section IV, FDA requested comment on the ability of 
smaller manufacturers of newly deemed tobacco products to fully comply 
with the requirements of the FD&C Act and how FDA might be able to 
address those concerns. Considering the comments and FDA's finite 
enforcement resources, the Agency's view is that those resources may 
not be best used in immediately enforcing the provisions of this rule 
against certain manufacturers that are small-scale tobacco product 
manufacturers and that fail to comply with certain requirements of the 
FD&C Act. FDA retains discretion in all cases to conduct an 
individualized inquiry and to consider any and all relevant facts in 
determining whether to bring an enforcement action.
    Generally, FDA considers a ``small-scale tobacco product 
manufacturer'' to be a manufacturer of any regulated tobacco product 
that employs 150 or fewer full-time equivalent employees and has annual 
total revenues of $5,000,000 or less. FDA considers a manufacturer to 
include each entity that it controls, is controlled by, or is under 
common control with such manufacturer. To help make FDA's individual 
enforcement decisions more efficient, a manufacturer may voluntarily 
submit information regarding employment and revenues. FDA does not 
believe a large number of

[[Page 29094]]

manufacturers who fit the criteria of a small-scale tobacco product 
manufacturer would submit the voluntary information.
    FDA estimates that there are approximately 75 small-scale 
manufacturers who will voluntarily submit information. FDA believes it 
will take respondents 2 hours to voluntarily submit information 
regarding employment and revenues for a total of 150 hours.
    FDA has estimated the burden for submitting the ``small-scale 
tobacco product manufacturer'' annual report as follows:

                                 Table 17--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                     Number of       Number of     Total annual     burden per
            Activity                respondents    responses per     responses     response  (in    Total hours
                                                    respondent                        hours)
----------------------------------------------------------------------------------------------------------------
Small-Scale Manufacturer                      75               1              75               2             150
 Reporting......................
                                 -------------------------------------------------------------------------------
    Total Small-Scale             ..............  ..............  ..............  ..............             150
     Manufacturer Report........
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The total burden for these new collections of information in this 
rulemaking is 1,621,212 reporting hours (121,604 + 1,200 + 9,363 + 
158,149 + 5,681 + 15 + 1,285,550 + 20 + 39,480 + 150) and 12,342 
recordkeeping hours for a total of 1,633,554 burden hours.
    The information collection provisions in this final rule have been 
submitted to OMB for review as required by section 3507(d) of the 
Paperwork Reduction Act of 1995.
    Before the effective date of this final rule, FDA will publish a 
notice in the Federal Register announcing OMB's decision to approve, 
modify, or disapprove the information collection provisions in this 
final rule. An Agency may not conduct or sponsor, and a person is not 
required to respond to, a collection of information unless it displays 
a currently valid OMB control number.

XX. Executive Order 13132; Federalism

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the rule 
does not contain policies that have substantial direct effects on the 
States, on the relationship between the National Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. Accordingly, the Agency has concluded 
that the rule does not contain policies that have federalism 
implications as defined in the Executive Order and, consequently, a 
federalism summary impact statement is not required.

XXI. Executive Order 13175; Tribal Consultation

    In accordance with Executive Order 13175, FDA has consulted with 
Tribal Government officials. FDA sought comment from Tribal Governments 
on April 25, 2014, and conducted a consultation with tribes via Webinar 
regarding the NPRM on May 29, 2014. FDA received one comment from a 
tribe stating that FDA failed to ensure meaningful and timely input 
from tribal officials as required by Executive Order 13175 and 
requesting tribal consultation in relation to existing premarket review 
activities for cigarettes, roll-your-own tobacco, and smokeless 
tobacco. In response, FDA conducted a face-to-face meeting with the 
tribe regarding the NPRM on January 21, 2015. FDA has determined that 
this final rule does not have tribal implications under Executive Order 
13175, because it does not, to our knowledge, have a substantial direct 
effect on one or more Indian tribes, on the relationship between the 
Federal Government and Indian tribes, or on the distribution of power 
and responsibilities between the Federal Government and Indian tribes, 
nor does it impose substantial direct compliance costs.
    (Comment 305) One comment stated that FDA failed to ensure 
meaningful and timely input from tribal officials as required by 
Executive Order 13175 and the HHS Consultation Policy. The comment 
acknowledged FDA's ``Dear Tribal Leader'' letter and Webinar and 
requested a face-to-face meeting between FDA and its tribe in relation 
to existing premarket review activities for cigarettes, roll-your-own 
tobacco, and smokeless tobacco.
    (Response) FDA adheres to Executive Order 13175 and the HHS 
Consultation Policy. FDA is committed to meaningful consultation with 
federally recognized tribes on FDA's implementation and enforcement of 
the Tobacco Control Act. As a result of the tribe's inquiry, FDA 
participated in a face-to-face meeting.
    (Comment 306) One comment encouraged FDA to respect tribal 
sovereignty in its enforcement of the tobacco regulation. The comment 
recommended that FDA provide both training and funding opportunities to 
tribal governments to alleviate the economic burdens stemming from 
enforcement of the rule. The comment urged FDA to make certain the 
regulatory burdens do not limit the economic viability of tribal 
operations.
    (Response) FDA recognizes tribal sovereignty and tribal self-
regulation and will work in partnership with tribal leaders to monitor 
compliance with this rule. As explained in this rule, FDA is 
implementing this rule to protect public health. However, FDA 
recognizes that compliance with many of the automatic provisions may be 
challenging at first for entities that are new to Federal public health 
regulation and as a result, provided compliance policies relating to 
provisions such as premarket authorizations and provided additional 
time to comply with certain requirements of the FD&C Act for small-
scale tobacco manufacturers. FDA will provide training and other 
opportunities to tribal governments after the rule is finalized.

XXII. References

    The following references are on display in the Division of Dockets 
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persons between 9 a.m. and 4 p.m. Monday through Friday; they are also 
available electronically at http://www.regulations.gov. FDA has 
verified the Web site addresses, as of the date this document publishes 
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``Research-Based Guidelines for Warning Design and Evaluation,'' 
Applied Ergonomics, 33(3):219-230, 2002.
278. Environmental Assessment for Regulations (21 CFR 1100, 1140, 
and 1143) to deem tobacco products meeting the statutory definition 
of ``tobacco product'' to be subject to the Federal Food, Drug, and 
Cosmetic Act, to revise existing regulations to include

[[Page 29102]]

restrictions on the sale and distribution of covered tobacco 
products, and to require the use of health warning statements for 
cigarette tobacco, roll-your-own tobacco, and covered tobacco 
products.
279. Finding of No Significant Impact for Regulations (21 CFR 1100, 
1140, and 1143) to deem tobacco products meeting the statutory 
definition of ``tobacco product'' to be subject to the Federal Food, 
Drug, and Cosmetic Act, to revise existing regulations to include 
restrictions on the sale and distribution of covered tobacco 
products, and to require the use of health warning statements for 
cigarette tobacco, roll-your-own tobacco, and covered tobacco 
products.

List of Subjects

21 CFR Part 1100

    Smoking, Tobacco.

21 CFR Part 1140

    Advertising, Labeling, Smoking, Tobacco.

21 CFR Part 1143

    Advertising, Labeling, Packaging and containers, Smoking, Tobacco.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR 
chapter I is amended as follows:

0
1. Add part 1100 to subchapter K to read as follows:

PART 1100--TOBACCO PRODUCTS SUBJECT TO FDA AUTHORITY

Sec.
1100.1 Scope.
1100.2 Requirements.
1100.3 Definitions.

    Authority:  21 U.S.C. 387a(b), 387f(d) and Pub. L. 111-31.

Sec.  1100.1  Scope.

    In addition to FDA's authority over cigarettes, cigarette tobacco, 
roll-your-own tobacco, and smokeless tobacco, FDA deems all other 
products meeting the definition of tobacco product under section 
201(rr) of the Federal Food, Drug, and Cosmetic Act, except accessories 
of such other tobacco products, to be subject to the Federal Food, 
Drug, and Cosmetic Act.

Sec.  1100.2  Requirements.

    Cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless 
tobacco are subject to chapter IX of the Federal Food, Drug, and 
Cosmetic Act and its implementing regulations. FDA has deemed all other 
tobacco products, except accessories of such other tobacco products, 
subject to chapter IX of the Federal Food, Drug, and Cosmetic Act and 
its implementing regulations.

Sec.  1100.3  Definitions.

    For the purposes of this part:
    Accessory means any product that is intended or reasonably expected 
to be used with or for the human consumption of a tobacco product; does 
not contain tobacco and is not made or derived from tobacco; and meets 
either of the following:
    (1) Is not intended or reasonably expected to affect or alter the 
performance, composition, constituents, or characteristics of a tobacco 
product; or
    (2) Is intended or reasonably expected to affect or maintain the 
performance, composition, constituents, or characteristics of a tobacco 
product but
    (i) Solely controls moisture and/or temperature of a stored tobacco 
product; or
    (ii) Solely provides an external heat source to initiate but not 
maintain combustion of a tobacco product.
    Component or part means any software or assembly of materials 
intended or reasonably expected:
    (1) To alter or affect the tobacco product's performance, 
composition, constituents, or characteristics; or
    (2) To be used with or for the human consumption of a tobacco 
product. Component or part excludes anything that is an accessory of a 
tobacco product.
    Package or packaging means a pack, box, carton, or container of any 
kind or, if no other container, any wrapping (including cellophane), in 
which a tobacco product is offered for sale, sold, or otherwise 
distributed to consumers.
    Tobacco product. As stated in section 201(rr) of the Federal Food, 
Drug, and Cosmetic Act in relevant part, a tobacco product:
    (1) Means any product made or derived from tobacco that is intended 
for human consumption, including any component, part, or accessory of a 
tobacco product (except for raw materials other than tobacco used in 
manufacturing a component, part, or accessory of a tobacco product); 
and
    (2) Does not mean an article that is a drug under section 201(g)(1) 
of the Federal Food, Drug, and Cosmetic Act, a device under section 
201(h) of the Federal Food, Drug, and Cosmetic Act, or a combination 
product described in section 503(g) of the Federal Food, Drug, and 
Cosmetic Act.

PART 1140--CIGARETTES, SMOKELESS TOBACCO, AND COVERED TOBACCO 
PRODUCTS

0
2. The authority citation for 21 CFR part 1140 continues to read as 
follows:

    Authority:  21 U.S.C. 301 et seq., Sec. 102, Pub. L. 111-31, 123 
Stat. 1776.

0
3. Revise the heading to part 1140 as set forth above.

0
4. Revise Sec.  1140.1 to read as follows:

Sec.  1140.1  Scope.

    (a) This part sets out the restrictions under the Federal Food, 
Drug, and Cosmetic Act on the sale, distribution, and use of 
cigarettes, smokeless tobacco, and covered tobacco products. Section 
1140.16(d) sets out restrictions on the distribution of free samples 
for cigarettes, smokeless tobacco, and other tobacco products (as such 
term is defined in section 201 of the Federal Food, Drug, and Cosmetic 
Act).
    (b) The failure to comply with any applicable provision in this 
part in the sale, distribution, and use of cigarettes, smokeless 
tobacco, covered tobacco products, or other tobacco products renders 
the product misbranded under the Federal Food, Drug, and Cosmetic Act.
    (c) References in this part to regulatory sections of the Code of 
Federal Regulations are to chapter I of title 21, unless otherwise 
noted.

0
5. Revise Sec.  1140.2 to read as follows:

Sec.  1140.2  Purpose.

    The purpose of this part is to establish restrictions on the sale, 
distribution, and use of cigarettes, smokeless tobacco, and covered 
tobacco products in order to reduce the number of children and 
adolescents who use these products, and to reduce the life-threatening 
consequences associated with tobacco use.

0
6. Revise Sec.  1140.3 to read as follows:

Sec.  1140.3  Definitions.

    For the purposes of this part:
    Accessory means any product that is intended or reasonably expected 
to be used with or for the human consumption of a tobacco product; does 
not contain tobacco and is not made or derived from tobacco; and meets 
either of the following:
    (1) Is not intended or reasonably expected to affect or alter the 
performance, composition, constituents, or characteristics of a tobacco 
product; or
    (2) Is intended or reasonably expected to affect or maintain the 
performance, composition, constituents, or characteristics of a tobacco 
product but
    (i) Solely controls moisture and/or temperature of a stored 
product; or
    (ii) Solely provides an external heat source to initiate but not 
maintain combustion of a tobacco product.
    Cigarette. (1) Means a product that:

[[Page 29103]]

    (i) Is a tobacco product and
    (ii) Meets the definition of the term ``cigarette'' in section 3(1) 
of the Federal Cigarette Labeling and Advertising Act; and
    (2) Includes tobacco, in any form, that is functional in the 
product, which, because of its appearance, the type of tobacco used in 
the filler, or its packaging and labeling, is likely to be offered to, 
or purchased by, consumers as a cigarette or as roll-your-own tobacco.
    Cigarette tobacco means any product that consists of loose tobacco 
that is intended for use by consumers in a cigarette. Unless otherwise 
stated, the requirements applicable to cigarettes under this chapter 
also apply to cigarette tobacco.
    Component or part means any software or assembly of materials 
intended or reasonably expected:
    (1) To alter or affect the tobacco product's performance, 
composition, constituents, or characteristics; or
    (2) To be used with or for the human consumption of a tobacco 
product. Component or part excludes anything that is an accessory of a 
tobacco product.
    Covered tobacco product means any tobacco product deemed to be 
subject to the Federal Food, Drug, and Cosmetic Act under Sec.  1100.2 
of this chapter, but excludes any component or part that is not made or 
derived from tobacco.
    Distributor means any person who furthers the distribution of a 
tobacco product, whether domestic or imported, at any point from the 
original place of manufacture to the person who sells or distributes 
the product to individuals for personal consumption. Common carriers 
are not considered distributors for the purposes of this part.
    Importer means any person who imports any tobacco product that is 
intended for sale or distribution to consumers in the United States.
    Manufacturer means any person, including any repacker and/or 
relabeler, who manufactures, fabricates, assembles, processes, or 
labels a finished tobacco product.
    Nicotine means the chemical substance named 3-(1-Methyl-2-
pyrrolidinyl)pyridine or C[10]H[14]N[2], including any salt or complex 
of nicotine.
    Package or packaging means a pack, box, carton, or container of any 
kind or, if no other container, any wrapping (including cellophane) in 
which a tobacco product is offered for sale, sold, or otherwise 
distributed to consumers.
    Point of sale means any location at which a consumer can purchase 
or otherwise obtain tobacco products for personal consumption.
    Retailer means any person who sells tobacco products to individuals 
for personal consumption, or who operates a facility where vending 
machines or self-service displays are permitted under this part.
    Roll-your-own tobacco means any tobacco product that, because of 
its appearance, type, packaging, or labeling, is suitable for use and 
likely to be offered to, or purchased by, consumers as tobacco for 
making cigarettes.
    Smokeless tobacco means any tobacco product that consists of cut, 
ground, powdered, or leaf tobacco and that is intended to be placed in 
the oral or nasal cavity.
    Tobacco product. As stated in section 201(rr) of the Federal Food, 
Drug, and Cosmetic Act in relevant part, a tobacco product:
    (1) Means any product made or derived from tobacco that is intended 
for human consumption, including any component, part, or accessory of a 
tobacco product (except for raw materials other than tobacco used in 
manufacturing a component, part, or accessory of a tobacco product) and
    (2) Does not mean an article that is a drug under section 201(g)(1) 
of the Federal Food, Drug, and Cosmetic Act, a device under section 
201(h) of the Federal Food, Drug, and Cosmetic Act, or a combination 
product described in section 503(g) of the Federal Food, Drug, and 
Cosmetic Act.

0
7. Revise Sec.  1140.10 to read as follows:

Sec.  1140.10  General responsibilities of manufacturers, distributors, 
and retailers.

    Each manufacturer, distributor, importer, and retailer is 
responsible for ensuring that the cigarettes, smokeless tobacco, or 
covered tobacco products it manufactures, labels, advertises, packages, 
distributes, imports, sells, or otherwise holds for sale comply with 
all applicable requirements under this part.

0
8. Revise Sec.  1140.14 to read as follows:

Sec.  1140.14  Additional responsibilities of retailers.

    (a) In addition to the other requirements under this part, each 
cigarette and smokeless tobacco retailer is responsible for ensuring 
that all sales of cigarettes or smokeless tobacco to any person comply 
with the following requirements:
    (1) No retailer may sell cigarettes or smokeless tobacco to any 
person younger than 18 years of age;
    (2)(i) Except as otherwise provided in paragraph (a)(2)(ii) of this 
section and in Sec.  1140.16(c)(2)(i), each retailer must verify by 
means of photographic identification containing the bearer's date of 
birth that no person purchasing the product is younger than 18 years of 
age;
    (ii) No such verification is required for any person over the age 
of 26;
    (3) Except as otherwise provided in Sec.  1140.16(c)(2)(ii), a 
retailer may sell cigarettes or smokeless tobacco only in a direct, 
face-to-face exchange without the assistance of any electronic or 
mechanical device (such as a vending machine);
    (4) No retailer may break or otherwise open any cigarette or 
smokeless tobacco package to sell or distribute individual cigarettes 
or a number of unpackaged cigarettes that is smaller than the quantity 
in the minimum cigarette package size defined in Sec.  1140.16(b), or 
any quantity of cigarette tobacco or smokeless tobacco that is smaller 
than the smallest package distributed by the manufacturer for 
individual consumer use; and
    (5) Each retailer must ensure that all self-service displays, 
advertising, labeling, and other items, that are located in the 
retailer's establishment and that do not comply with the requirements 
of this part, are removed or are brought into compliance with the 
requirements under this part.
    (b) Notwithstanding the requirements in paragraph (a) of this 
section and in addition to the other requirements under this part, each 
retailer of covered tobacco products is responsible for ensuring that 
all sales of such covered tobacco products to any person comply with 
the following requirements:
    (1) No retailer may sell covered tobacco products to any person 
younger than 18 years of age;
    (2)(i) Except as otherwise provided in paragraph (a)(2)(ii) of this 
section and in Sec.  1140.16(c)(2)(i), each retailer must verify by 
means of photographic identification containing the bearer's date of 
birth that no person purchasing the product is younger than 18 years of 
age;
    (ii) No such verification is required for any person over the age 
of 26; and
    (3) A retailer may not sell covered tobacco products with the 
assistance of any electronic or mechanical device (such as a vending 
machine), except in facilities where the retailer ensures that no 
person younger than 18 years of age is present, or permitted to enter, 
at any time.

0
9. Add part 1143 to subchapter K to read as follows:

PART 1143--MINIMUM REQUIRED WARNING STATEMENTS

Sec.

[[Page 29104]]

1143.1 Definitions.
1143.3 Required warning statement regarding addictiveness of 
nicotine.
1143.5 Required warning statements for cigars.
1143.7 Language requirements for required warning statements.
1143.9 Irremovable or permanent required warning statements.
1143.11 Does not apply to foreign distribution.
1143.13 Effective date.

    Authority:  21 U.S.C. 387a(b), 387f(d).

Sec.  1143.1  Definitions.

    For purposes of this part:
    Accessory means any product that is intended or reasonably expected 
to be used with or for the human consumption of a tobacco product; does 
not contain tobacco and is not made or derived from tobacco; and meets 
either of the following:
    (1) Is not intended or reasonably expected to affect or alter the 
performance, composition, constituents, or characteristics of a tobacco 
product; or
    (2) Is intended or reasonably expected to affect or maintain the 
performance, composition, constituents, or characteristics of a tobacco 
product but
    (i) Solely controls moisture and/or temperature of a stored tobacco 
product; or
    (ii) Solely provides an external heat source to initiate but not 
maintain combustion of a tobacco product
    Cigar means a tobacco product that:
    (1) Is not a cigarette and
    (2) Is a roll of tobacco wrapped in leaf tobacco or any substance 
containing tobacco.
    Cigarette tobacco means any product that consists of loose tobacco 
that is intended for use by consumers in a cigarette. Unless otherwise 
stated, the requirements applicable to cigarettes under this chapter 
also apply to cigarette tobacco.
    Component or part means any software or assembly of materials 
intended or reasonably expected:
    (1) To alter or affect the tobacco product's performance, 
composition, constituents, or characteristics; or
    (2) to be used with or for the human consumption of a tobacco 
product. Component or part excludes anything that is an accessory of a 
tobacco product.
    Covered tobacco product means any tobacco product deemed to be 
subject to the Federal Food, Drug, and Cosmetic Act pursuant to Sec.  
1100.2 of this chapter, but excludes any component or part that is not 
made or derived from tobacco.
    Package or packaging means a pack, box, carton, or container of any 
kind or, if no other container, any wrapping (including cellophane), in 
which a tobacco product is offered for sale, sold, or otherwise 
distributed to consumers.
    Principal display panels means the panels of a package that are 
most likely to be displayed, presented, shown, or examined by the 
consumer.
    Point of sale means any location at which a consumer can purchase 
or otherwise obtain tobacco products for personal consumption.
    Retailer means any person who sells tobacco products to individuals 
for personal consumption, or who operates a facility where vending 
machines or self-service displays are permitted under this part.
    Required warning statement means a textual warning statement 
required to be on packaging and in advertisements for cigarette 
tobacco, roll-your-own tobacco, cigars, and other covered tobacco 
products.
    Roll-your-own tobacco means any tobacco product that, because of 
its appearance, type, packaging, or labeling, is suitable for use and 
likely to be offered to, or purchased by, consumers as tobacco for 
making cigarettes.
    Tobacco product. As stated in section 201(rr) of the Federal Food, 
Drug, and Cosmetic Act in relevant part, a tobacco product:
    (1) Means any product made or derived from tobacco that is intended 
for human consumption, including any component, part, or accessory of a 
tobacco product (except for raw materials other than tobacco used in 
manufacturing a component, part, or accessory of a tobacco product) and
    (2) Does not mean an article that is a drug under section 201(g)(1) 
of the Federal Food, Drug, and Cosmetic Act, a device under section 
201(h) of the Federal Food, Drug, and Cosmetic Act, or a combination 
product described in section 503(g) of the Federal Food, Drug, and 
Cosmetic Act.

Sec.  1143.3  Required warning statement regarding addictiveness of 
nicotine.

    (a) Packages. (1) For cigarette tobacco, roll-your-own tobacco, and 
covered tobacco products other than cigars, it is unlawful for any 
person to manufacture, package, sell, offer to sell, distribute, or 
import for sale or distribution within the United States such product 
unless the tobacco product package bears the following required warning 
statement on the package label: ``WARNING: This product contains 
nicotine. Nicotine is an addictive chemical.''
    (2) The required warning statement must appear directly on the 
package and must be clearly visible underneath any cellophane or other 
clear wrapping as follows:
    (i) Be located in a conspicuous and prominent place on the two 
principal display panels of the package and the warning area must 
comprise at least 30 percent of each of the principal display panels;
    (ii) Be printed in at least 12-point font size and ensures that the 
required warning statement occupies the greatest possible proportion of 
the warning area set aside for the required text;
    (iii) Be printed in conspicuous and legible Helvetica bold or Arial 
bold type (or other sans serif fonts) and in black text on a white 
background or white text on a black background in a manner that 
contrasts by typography, layout, or color, with all other printed 
material on the package;
    (iv) Be capitalized and punctuated as indicated in paragraph (a)(1) 
of this section; and
    (v) Be centered in the warning area in which the text is required 
to be printed and positioned such that the text of the required warning 
statement and the other information on the principal display panel have 
the same orientation.
    (3) A retailer of any tobacco product covered by paragraphs (a)(1) 
and (2) of this section will not be in violation of this section for 
packaging that:
    (i) Contains a health warning;
    (ii) Is supplied to the retailer by the tobacco product 
manufacturer, importer, or distributor, who has the required state, 
local, or Alcohol and Tobacco Tax and Trade Bureau (TTB)-issued license 
or permit, if applicable, and
    (iii) Is not altered by the retailer in a way that is material to 
the requirements of this section.
    (b) Advertisements. (1) For cigarette tobacco, roll-your-own 
tobacco, and covered tobacco products other than cigars, it is unlawful 
for any such tobacco product manufacturer, packager, importer, 
distributor, or retailer of the tobacco product to advertise or cause 
to be advertised within the United States any tobacco product unless 
each advertisement bears the required warning statement specified in 
paragraph (a)(1) of this section.
    (2) For print advertisements and other advertisements with a visual 
component (including, for example, advertisements on signs, shelf-
talkers, Internet Web pages, and electronic mail correspondence), the 
required warning statement must appear in the upper portion of the area 
of the advertisement within the trim area as follows:
    (i) Occupy at least 20 percent of the area of the advertisement;
    (ii) Appear in at least 12-point font size and ensures that the 
required warning statement occupies the greatest

[[Page 29105]]

possible proportion of the warning area set aside for the required 
text;
    (iii) Appear in conspicuous and legible Helvetica bold or Arial 
bold type (or other similar sans serif fonts) and in black text on a 
white background or white text on a black background in a manner that 
contrasts by typography, layout, or color, with all other material on 
the advertisement;
    (iv) Be capitalized and punctuated as indicated in paragraph (a)(1) 
of this section;
    (v) Be centered in the warning area in which the text is required 
to appear and positioned such that the text of the required warning 
statement and the other textual information in the advertisement have 
the same orientation; and
    (vi) Be surrounded by a rectangular border that is the same color 
as the text of the required warning statement and that is not less than 
3 millimeters (mm) or more than 4 mm.
    (3) This paragraph (b) applies to a retailer only if that retailer 
is responsible for or directs the health warning required under the 
paragraph. However, this paragraph does not relieve a retailer of 
liability if the retailer displays, in a location open to the public, 
an advertisement that does not contain a health warning or contains a 
health warning that has been altered by the retailer in a way that is 
material to the requirements of this section.
    (c) Self-certification. A tobacco product that would otherwise be 
required to bear the warning in paragraph (a)(1) of this section but 
does not contain nicotine is not required to bear the warning in 
paragraph (a)(1) of this section on packages or advertisements if the 
tobacco product manufacturer has submitted to FDA a confirmation 
statement certifying to be true and accurate that the product does not 
contain nicotine and that the tobacco product manufacturer has data to 
support that assertion. Any product not required to bear the warning in 
paragraph (a)(1) of this section must include the statement ``This 
product is made from tobacco.'' on all packages and advertisements in 
accordance with the requirements of this part.
    (d) Small packages. A tobacco product that would otherwise be 
required to bear the warning in paragraph (a)(1) of this section but is 
too small or otherwise unable to accommodate a label with sufficient 
space to bear such information is exempt from compliance with the 
requirement provided that the information and specifications required 
under paragraphs (a)(1) and (2) of this section appear on the carton or 
other outer container or wrapper if the carton, outer container, or 
wrapper has sufficient space to bear the information, or appear on a 
tag otherwise firmly and permanently affixed to the tobacco product 
package. In such cases, the carton, outer container, wrapper, or tag 
will serve as the location of the principal display panels.

Sec.  1143.5  Required warning statements for cigars.

    (a) Packages. (1) It is unlawful for any person to manufacture, 
package, sell, offer to sell, distribute, or import for sale or 
distribution within the United States any cigar product unless the 
product package bears one of the following required warning statements 
on the package label:
    (i) WARNING: Cigar smoking can cause cancers of the mouth and 
throat, even if you do not inhale.
    (ii) WARNING: Cigar smoking can cause lung cancer and heart 
disease.
    (iii) WARNING: Cigars are not a safe alternative to cigarettes.
    (iv) WARNING: Tobacco smoke increases the risk of lung cancer and 
heart disease, even in nonsmokers.
    (v)(A) WARNING: Cigar use while pregnant can harm you and your 
baby.; or
    (B) SURGEON GENERAL WARNING: Tobacco Use Increases the Risk of 
Infertility, Stillbirth and Low Birth Weight.
    (vi) WARNING: This product contains nicotine. Nicotine is an 
addictive chemical.
    (2) Each required warning statement must appear directly on the 
package and must be clearly visible underneath any cellophane or other 
clear wrapping as follows:
    (i) Be located in a conspicuous and prominent place on the two 
principal display panels of the package and the warning area must 
comprise at least 30 percent of each of the principal display panels;
    (ii) Appear in at least 12-point font size and ensure that the 
required warning statement occupies the greatest possible proportion of 
the warning area set aside for the required text;
    (iii) Be printed in conspicuous and legible Helvetica bold or Arial 
bold type (or other similar sans serif fonts) and in black text on a 
white background or white text on a black background in a manner that 
contrasts by typography, layout, or color, with all other printed 
material on the package;
    (iv) Be capitalized and punctuated as indicated in paragraph (a)(1) 
of this section; and
    (v) Be centered in the warning area in which the text is required 
to be printed and positioned such that the text of the required warning 
statement and the other information on that principal display panel 
have the same orientation.
    (3) No person may manufacture, package, sell, offer to sell, 
distribute, or import for sale or distribution within the United States 
any cigar without a required warning statement, except for cigars that 
are sold individually and not in a product package. For cigars that are 
sold individually and not in a product package, the required warning 
statements must be posted at the retailer's point-of-sale in accordance 
with the following:
    (i) All of the warnings in paragraph (a) of this section must be 
placed on a sign that is a minimum of 8.5 x 11 inches, posted on or 
within 3 inches of each cash register where payment may be made so that 
the sign(s) are unobstructed in their entirety and can be read easily 
by each consumer making a purchase;
    (ii) The sign must be clear, legible, and conspicuous and be 
printed in black Helvetica bold or Arial bold type (or other similar 
sans serif fonts) against a solid white background in at least 17 point 
type with appropriate space between the warning statements;
    (iii) Be printed in a manner that contrasts by typography, layout, 
or color, with all other printed material; and
    (iv) Be capitalized and punctuated as indicated in paragraph (a)(1) 
of this section.
    (4) A retailer of any cigar covered by paragraphs (a)(1) and (2) of 
this section will not be in violation of this section for packaging 
that:
    (i) Contains a health warning;
    (ii) Is supplied to the retailer by the tobacco product 
manufacturer, importer, or distributor who has the required state, 
local, or Alcohol and Tobacco Tax and Trade Bureau (TTB)-issued license 
or permit, if applicable, and
    (iii) Is not altered by the retailer in a way that is material to 
the requirements of this section.
    (b) Advertisements. (1) It is unlawful for any tobacco product 
manufacturer, packager, importer, distributor, or retailer of cigars to 
advertise or cause to be advertised within the United States any cigar 
unless each advertisement bears one of the required warning statements 
specified in paragraph (a)(1) of this section.
    (2) For print advertisements and other advertisements with a visual 
component (including, for example, advertisements on signs, shelf-
talkers, Internet Web pages, and electronic mail correspondence), each 
required warning statement must appear in the upper

[[Page 29106]]

portion of the area of the advertisement within the trim area as 
follows:
    (i) Occupy at least 20 percent of the area of the advertisement;
    (ii) Appear in at least 12-point font size that ensures that the 
required warning statement occupies the greatest possible proportion of 
the warning area set aside for the text required;
    (iii) Appear in conspicuous and legible Helvetica bold or Arial 
bold type (or other similar sans serif fonts) and in black text on a 
white background or white text on a black background in a manner that 
contrasts by typography, layout, or color, with all other material on 
the advertisement;
    (iv) Be capitalized and punctuated as indicated in paragraph (a)(1) 
of this section;
    (v) Be centered in the warning area in which the text is required 
to appear and positioned such that the text of the required warning 
statement and the other textual information in the advertisement have 
the same orientation; and
    (vi) Be surrounded by a rectangular border that is the same color 
as the text of the required warning statement and that is not less than 
3 mm or more than 4 mm.
    (3) This paragraph (b) applies to a retailer only if that retailer 
is responsible for or directs the warning statements required under the 
paragraph. However, this paragraph does not relieve a retailer of 
liability if the retailer displays, in a location open to the public, 
an advertisement that does not contain a health warning or contains a 
health warning that has been altered by the retailer in a way that is 
material to the requirements of this section.
    (c) Marketing requirements. (1) Except for cigars sold individually 
and not in a product package, the warning statements required for 
packages in paragraph (a)(1) of this section must be randomly displayed 
in each 12-month period, in as equal a number of times as is possible 
on each brand of cigar sold in product packaging and be randomly 
distributed in all areas of the United States in which the product is 
marketed in accordance with a plan submitted by the cigar manufacturer, 
importer, distributor, or retailer to, and approved by, the Food and 
Drug Administration.
    (2) The warning statements required for advertisements in paragraph 
(a)(1) of this section must be rotated quarterly in alternating 
sequence in each advertisement for each brand of cigar in accordance 
with a plan submitted by the cigar manufacturer, importer, distributor, 
or retailer to, and approved by, the Food and Drug Administration.
    (3) Each person required to randomly display and distribute or 
rotate warnings in accordance with an FDA-approved plan under this part 
shall submit a proposed warning plan to FDA no later than either 12 
months after May 10, 2016, or 12 months before advertising or 
commercially marketing a product that is subject to such requirement, 
whichever is later.

Sec.  1143.7  Language requirements for required warning statements.

    The text in each warning statement required in Sec.  1143.3 or 
Sec.  1143.5 must be in the English language, except as follows:
    (a) In the case of an advertisement that appears in a non-English 
medium, the text in the required warning statement must appear in the 
predominant language of the medium whether or not the advertisement is 
in English, and;
    (b) In the case of an advertisement that appears in an English 
language medium but that is not in English, the text in the required 
warning statement must appear in the same language as that principally 
used in the advertisement.

Sec.  1143.9  Irremovable or permanent required warning statements.

    The warning statements required by this section must be indelibly 
printed on or permanently affixed to the package or advertisement. 
These warnings, for example, must not be printed or placed on a product 
label affixed to a clear outer wrapper that is likely to be removed to 
access the product within the package.

Sec.  1143.11  Does not apply to foreign distribution.

    The provisions of this part do not apply to a manufacturer or 
distributor of tobacco products that does not manufacture, package, or 
import tobacco products for sale or distribution within the United 
States.

Sec.  1143.13  Effective date.

    (a) Except as stated in paragraph (b) of this section, this part 
will take effect 24 months after May 10, 2016. The effective date will 
be with respect to the date of manufacture, provided that, in any case, 
beginning 30 days after the effective date, a manufacturer may not 
introduce into the domestic commerce of the United States any product, 
irrespective of the date of manufacture, that is not in conformance 
with this part.
    (b) The requirement to submit a warning plan to FDA under Sec.  
1143.5(c)(3) will take effect 12 months after May 10, 2016.

    Dated: May 3, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-10685 Filed 5-5-16; 8:45 am]
 BILLING CODE 4164-01-P