FDA Deems Certain Tobacco Products 
Subject to FDA Authority, Sales and 
Distribution Restrictions, and Health 
Warning Requirements for Packages 
and Advertisements (Revised)* 
Guidance for Industry  
Small Entity Compliance Guide 
Comments may be submitted at any time for Agency consideration. Electronic comments may be 
submitted to https://www.regulations.gov. Alternatively, submit written comments to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, Room 1061, Rockville, MD 20852. All comments should be identified with the docket 
number listed in the notice of availability that publishes in the Federal Register. For questions 
regarding this guidance, contact the Center for Tobacco Products at (Tel) 1-877- CTP-1373  
(1-877-287-1373) Monday-Friday, 9 a.m.  4 p.m. EDT. 
Additional copies are available online at 
https://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm. 
You may send an e-mail request to SmallBiz.Tobacco@fda.hhs.gov to receive an electronic copy 
of this guidance. You may send a request for hard copies to U.S. Food and Drug Administration, 
Center for Tobacco Products, Attn: Office of Small Business Assistance, Document Control 
Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-2000. 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Tobacco Products 
March 2023 
*This is the seventh revision to the first edition of this guidance, which issued in May 2016.
Revisions are noted by date at the end of the guidance. Contains Nonbinding Recommendations 
Table of Contents 
Guidance for Industry .................................................................................................................. 1 
Small Entity Compliance Guide .................................................................................................. 1 
Guidance for Industry .................................................................................................................. 2 
Small Entity Compliance Guide .................................................................................................. 2 
I.  INTRODUCTION ................................................................................................................. 2 
II.  DESCRIPTION OF THE RULE ......................................................................................... 3 
A.  Background .................................................................................................................... 3 
B.  Automatic Provisions of the Tobacco Control Act and FDAs Tobacco Regulations
.......................................................................................................................................... 7 
C.  Restrictions on the Sale and Distribution of Tobacco Products to Minors .............. 7 
D.  Required Warning Statement(s) on Labels and Advertisements .............................. 8 
E.  Required Warning Label Statement on Packages ...................................................... 8 
1.  Nicotine Addictiveness Warning Label Statement for Cigarette Tobacco, RYO 
Tobacco, and Covered Tobacco Products (Except Cigars) ..................................... 8 
2.  Minimum Required Warning Label Statements for Cigar Packages ..................... 10 
F.  Required Warning Statement on Advertisements .................................................... 11 
1.  Nicotine Addictiveness Warning Statement for Cigarette Tobacco, RYO Tobacco, 
and All Covered Tobacco Products (Except Cigars) ............................................. 11 
2.  Minimum Required Warning Label Statements for Cigar Advertisements ............ 12 
G.  Self-certification and Alternative Required Warning Statement ............................ 13 
H.  Retailer Warning Statement Exceptions ................................................................... 14 
1.  Package or Packaging ............................................................................................ 14 
2.  Advertisements ........................................................................................................ 14 
III. QUESTIONS AND ANSWERS ......................................................................................... 15 
A.  Deeming of Tobacco Products .................................................................................... 15 
B.  Age and Identification Restrictions ............................................................................ 24 
C.  Health Warning Requirements ................................................................................... 26 
Table A. Compliance With Various Automatic Provisions ............................................. 32 
Table B. Compliance Periods for Other Provisions .......................................................... 36 
 
i  Contains Nonbinding Recommendations 
FDA Deems Certain Tobacco 
Products Subject to FDA Authority, 
Sales and Distribution Restrictions, 
and Health Warning Requirements 
1
Guidance for Industry  
Small Entity Compliance Guide 
This guidance represents the current thinking of the Food and Drug Administration (FDA or 
Agency) on this topic. It does not establish any rights for any person and is not binding on FDA 
or the public. You can use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff 
responsible for this guidance as listed on the title page. 
I.  INTRODUCTION 
This Small Entity Compliance Guide is intended to help small businesses understand and comply 
with FDAs final rule deeming tobacco products to be subject to the Federal Food, Drug, and 
Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control 
Act (Tobacco Control Act) (the Deeming Rule). The Deeming Rule extends FDAs tobacco 
product authorities in chapter IX of the FD&C Act to include all tobacco products,2 except 
 
1 This guidance was prepared by the Office of Regulations in the Center for Tobacco Products (CTP) at FDA. 
2 At the time this guidance was originally published, the statutory term tobacco product in section 201(rr) of the 
FD&C Act was limited to products made or derived from tobacco.  On March 15, 2022, the Consolidated 
Appropriation Act of 2022 (CAA), amended the definition of the term tobacco product in 201(rr)(1) of the FD&C 
Act to include products that contain nicotine from any source. It further amended the definition to exclude articles 
that are foods under section 201(f) of the FD&C Act if such articles contain no nicotine or no more than trace 
amounts of naturally occurring nicotine. Under section 901(b) of the FD&C Act, as amended by the CAA, tobacco 
products containing nicotine that is not made or derived from tobacco are subject to Chapter IX without needing to 
be deemed by regulation. Therefore, tobacco products containing nicotine not made or derived from tobacco are not 
deemed tobacco products and this guidance is not applicable to them.  Accordingly, this document will continue to 
2  Contains Nonbinding Recommendations 
accessories of newly deemed tobacco products. The Deeming Rule also prohibits the sale of 
covered tobacco products to individuals under the age of 183, prohibits vending machine sales 
unless sold in adult-only facilities, and requires warning labels on packages and advertisements.  
These provisions are discussed in detail, below. 
The Agency prepared this Small Entity Compliance Guide in accordance with section 212 of the 
Small Business Regulatory Enforcement Fairness Act (Pub. L. 104-121). 
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities. Instead, guidance documents describe the Agencys current thinking on a topic 
and should be viewed only as recommendations, unless specific regulatory or statutory 
requirements are cited. The use of the word should in Agency guidance documents means that 
something is suggested or recommended, but not required. 
II.  DESCRIPTION OF THE RULE 
A.  Background 
The Tobacco Control Act, enacted on June 22, 2009, amends the FD&C Act and 
provides FDA with the authority to regulate tobacco products (Pub. L. 111 31, 123 
Stat. 1776). Cigarettes, cigarette tobacco, roll-your-own (RYO) tobacco, and 
smokeless tobacco were immediately subject to the provisions of the Tobacco 
Control Act and FDAs regulatory authority. As for other types of tobacco products, 
section 901(b) of the FD&C Act (21 U.S.C. 387a(b)) grants FDA authority to deem 
those products subject to the law as well. In addition to the provisions in the FD&C 
Act, and implementing regulations that apply automatically to the newly deemed 
products, FDA may require restrictions on the sale and distribution of a tobacco 
product if FDA determines such restrictions are appropriate for the protection of 
public health (section 906(d) of the FD&C Act (21 U.S.C. 387f(d))). Pursuant to 
these authorities, FDA published a proposed rule on April 25, 2014, seeking to 
deem all products that meet the statutory definition of tobacco product set forth in 
section 201(rr) of the FD&C Act (21 U.S.C. 321(rr)),4 with the exception of 
accessories of newly deemed products, and proposed additional provisions 
requiring warning statements and other restrictions on the sale and distribution of 
tobacco products (79 FR 12342). After review and consideration of comments on 
the proposed rule, the Deeming Rule was published. 
 
reflect the definition of tobacco product in 201(rr)(1) that was in effect at the time the Deeming Rule was 
promulgated to avoid confusion about the scope of products that are subject to the Deeming Rule.   
3 The federal minimum age of sale has since increased to 21. See Further Consolidated Appropriations Act, 2020, 
Pub. L. No. 116-94,  603 (2019). 
4 See fn. 2 
3  Contains Nonbinding Recommendations 
The statutory definition of tobacco product in section 201(rr)(1) of the FD&C Act5 
reads: 
The term tobacco product 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). 
Products that meet the statutory definition of drug (section 201(g)(1)), device 
(section 201(h)), or combination product (section 503(g)); or a food under (section 
201(f)) if such article contains no nicotine, or no more than trace amounts of 
naturally occurring nicotine are excluded from the definition of tobacco product 
(section 201(rr)(2) and (5)) of the FD&C Act.6 
Otherwise, all products made or derived from tobacco and intended for human 
consumption  including components and parts of tobacco products whether or not 
they are themselves made or derived from tobacco  fall under the definition of 
tobacco product. Under the Deeming Rule, all tobacco products, except for 
accessories of newly deemed tobacco products are now subject to the Tobacco 
Control Act and the regulations issued by FDA under the FD&C Act. These 
products include a number of widely used and previously unregulated products, 
such as cigars, pipe tobacco, waterpipes (or hookah), dissolvable products, e-
cigarettes and other electronic nicotine delivery systems (ENDS), collectively, the 
newly deemed products.7 
For the purposes of the Deeming Rule, the following terms are defined as follows: 
  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 
 
5 Id. 
6 Id. 
7 The requirements set forth in the Deeming Rule will also apply to future products that meet the statutory definition 
of tobacco product, except accessories of newly deemed products. However, tobacco products containing nicotine 
that is not made or derived from tobacco are not subject to the Deeming Rule because under section 901(b) of the 
FD&C Act (as amended by the CAA), such products are subject to Chapter IX without needing to be deemed by 
regulation. See fn 2.   
4  Contains Nonbinding Recommendations 
(ii)  Solely provides an external heat source to initiate but not maintain 
combustion of a tobacco product (parts 1100, 1140, 1143 (21 CFR 
parts 1100, 1140, 1143)). 
  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 (part 
1143). 
  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; 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 (part 
1140). 
  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 (parts 1140, 1143). 
  Component or part means any software or assembly of materials intended or 
reasonably expected: (1) to alter or affect the tobacco products 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 (parts 1100, 1140, 1143). 
  Covered tobacco product means any tobacco product deemed to be subject to 
the FD&C Act pursuant to  1100.2 of this chapter (i.e., subchapter K), but 
excludes any component or part that is not made or derived from tobacco (parts 
1140, 1143). 
  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 part 1140 (part 1140). 
  Importer means any person who imports any tobacco product that is intended 
for sale or distribution to consumers in the United States (part 1140). 
  Manufacturer means any person, including any repacker and/or relabeler, who 
manufactures, fabricates, assembles, processes, or labels a finished tobacco 
product (part 1140). 
5  Contains Nonbinding Recommendations 
  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 (part 1140). 
  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 (parts 
1100, 1140, 1143). 
  Point of sale means any location at which a consumer can purchase or 
otherwise obtain tobacco products for personal consumption (parts 1140, 
1143). 
  Principal display panels means the panels of a package that are most likely to 
be displayed, presented, shown, or examined by the consumer (part 1143). 
  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 (part 1143). 
  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 (parts 1140, 1143). 
  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 (parts 
1140, 1143). 
  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 (part 1140). 
  Tobacco product As stated in section 201(rr) of the FD&C 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 under the Federal Food, Drug, and Cosmetic Act 
is a drug (section 201(g)(1)); a device (section 201(h)); a combination product 
(section 503(g)); or a food (section 201(f)) if such article contains no nicotine, 
or no more than trace amounts of naturally occurring nicotine (parts 1100, 
1140, 1143). 8 
 
8 See fn 2. 
6  Contains Nonbinding Recommendations 
B.  Automatic Provisions of the Tobacco Control Act and FDAs Tobacco Regulations 
Upon the effective date of the Deeming Rule (i.e., 90 days from the date of 
publication), the newly deemed products will be subject to the FD&C Act 
provisions and FDA regulations that apply to tobacco products, such as those 
covering: 
1.  Adulterated or misbranded tobacco products; 
2.  Required submission of ingredient listing and reporting of harmful and 
potentially harmful constituents (HPHCs); 
3.  Required registration of tobacco product manufacturing establishments and 
product listing; 
4.  Prohibition against sale and distribution of modified risk tobacco products 
unless FDA issues an order authorizing their marketing; 
5.  Prohibition on the distribution of free samples (same as cigarettes); and 
6.  Premarket authorizations/orders for new tobacco products. 
Dates for compliance with the automatic provisions, along with descriptions of the 
provisions and sources for further information are provided throughout this 
guidance document and in Table A below. 
C.  Restrictions on the Sale and Distribution of Tobacco Products to Minors9 
The Deeming Rule also amends the Code of Federal Regulations, 21 CFR part 
1140, to prohibit the sale of covered tobacco products to persons under the age of 
18 and requires retailers of covered tobacco products to verify the purchaser's birth 
date by reviewing the individual's photographic identification ( 1140.14). The 
Deeming Rule defines covered tobacco product to include all tobacco products that 
are subject to the Deeming Rule, but excludes any component or part that is not 
made or derived from tobacco ( 1140.3).  Therefore, the definition of covered 
tobacco products includes all deemed tobacco products, including components and 
parts, made or derived from tobacco. 
To comply with the age and identification verification requirements, retailers are 
required to verify a purchaser is at least 18 years of age by reviewing the 
purchasers photographic identification. However, retailers are not required to 
verify the age of any person who is more than 26 years of age ( 1140.14(b)(2)(ii)). 
The Deeming Rule also amends part 1140 to prohibit the sale of covered tobacco 
products through the assistance of any electronic or mechanical device (such as a 
vending machine), except in facilities where the retailer ensures that no person 
 
9 See supra footnote 2. The Further Consolidated Appropriations Act, 2020, instructs FDA to issue a final rule to 
update all references to persons younger than 18 years of age in subpart B of part 1140 of title 21, [C.F.R.], and to 
update the relevant age verification requirements under such part 1140 to require age verification for individuals 
under the age of 30. 
7  Contains Nonbinding Recommendations 
younger than 18 years of age is present, or permitted to enter, at any time 
( 1140.14(b)(3)).  
The prohibition on the distribution of free samples applies to all newly deemed 
tobacco products, including their components and parts, but not their accessories. 
D.  Required Warning Statement(s) on Labels and Advertisements 
The Deeming Rule requires that the packages and advertisements of all cigarette 
tobacco, RYO tobacco, and covered tobacco products bear an addictiveness 
warning label statement (as described in sections II.E.1 and II.F.1 below). In 
addition to the addictiveness warning label statement, cigar packaging and 
advertising are also required to include additional warning label statements (as 
described in sections II.E.2 and II.F.2 below). For cigarette tobacco, roll your own 
tobacco, and covered tobacco products10 that do not contain nicotine there is an 
alternative warning label statement for packages and advertisements (as described 
in section II.G below). On product packaging, the required warning(s) must appear 
on the two principal display panels of the package. 
On July 7, 2020, the D.C. Circuit found that FDA needed to more closely consider 
whether the health warnings would likely affect the number of tobacco users for 
cigars and pipe tobacco, and remanded the case to the district court for further 
proceedings consistent with that decision. See Cigar Assn of America v. FDA, 964 
F.3d 56, 64-65 (D.C. Cir. 2020). The district court has vacated and remanded the 
health warnings for cigars and pipe tobacco. Cigar Assn of America FDA, No. 
1:16-cv-01460, ECF 228 (D.D.C. Sept. 11, 2020). Accordingly, FDA will not seek 
to enforce the warning requirements for cigars and pipe tobacco at this time. In 
addition, the agency does not intend to enforce the labeling requirements under 
sections 903(a)(2) and 920(a) for cigars and pipe tobacco at this time. See 
Compliance Policy for Certain Labeling and Warning Statement Requirements for 
Cigars and Pipe Tobacco (August 2018). 
E.  Required Warning Label Statement on Packages 
1. Nicotine Addictiveness Warning Label Statement for Cigarette Tobacco, RYO 
Tobacco, and Covered Tobacco Products (Except Cigars) 
For cigarette tobacco, RYO tobacco, and covered tobacco products other than 
cigars,11 the Deeming Rule requires that the tobacco product package bear the 
 
10 Components or parts that are not made or derived from tobacco do not meet the definition of 
covered tobacco product, and would not be required to carry an addiction warning or submit a 
self-certification. 
11 The cigar warning statement requirements for packages and advertisements are covered in 
detail below. 
8  Contains Nonbinding Recommendations 
following required warning label statement on packages: WARNING: This 
product contains nicotine. Nicotine is an addictive chemical. 
This required warning statement must appear on all cigarette tobacco, RYO 
tobacco, and covered tobacco product package labels.  It is unlawful for any person 
to manufacture, package, sell, offer to sell, distribute, or import for sale or 
distribution within the United States these products without the required warning 
label statement on the tobacco product package ( 1143.3(a)(1)). 
Section 1143.3(a)(2) provides that the required warning statement on package labels 
must also appear directly on the package, and be clearly visible underneath any 
cellophane or other clear wrapping as follows: 
  Be displayed in a conspicuous and prominent place on the two principal 
display panels of the package; 
  Comprise at least 30 percent of each of the principal display panels (warning 
label area); 
  Be printed in at least 12-point font size and must occupy the greatest possible 
proportion of the warning label area set aside for the required text; 
  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; 
  Be capitalized and punctuated as indicated in  1143.3(a)(1); and 
  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 panels have the same orientation. 
A special provision in  1143.3(d) applies to packages that are too small to display 
the required warning statement. A covered tobacco product that is too small or 
otherwise unable to accommodate a label must contain the information and 
specifications required under 
 1143.3(a)(1) and (2) on one of the following: 
  The covered tobacco product carton 
  The outer container or wrapper that provides sufficient space to bear the 
information 
  On a tag firmly and permanently affixed to the tobacco product package 
The carton, outer container, wrapper, or tag will serve as the location of the 
principal display panels. 
9  Contains Nonbinding Recommendations 
2. Minimum Required Warning Label Statements for Cigar Packages 
For cigars,  1143.5(a)(1) of the Deeming Rule requires that the tobacco product 
package bear one of the following required warning statements on the package 
label: 
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 
SURGEON GENERAL WARNING: Tobacco Use Increases the Risk of Infertility, 
Stillbirth and Low Birth Weight.12 
WARNING: This product contains nicotine. Nicotine is an addictive chemical. 
These required warning statements must appear on all cigar package labels if the 
cigar product is manufactured, packaged, sold, offered for sale, distributed, or 
imported for sale or distribution within the United States ( 1143.5(a)(1)).13 
These required warning statements must also meet the same requirements that apply 
to cigarette tobacco, RYO tobacco, and other covered tobacco products, with 
respect to font, text, size, placement and formatting of the package labels 
( 1143.5(a)(2)). 
An exception exists for cigars that are sold individually, and not in a product 
package. In this circumstance, the retailer must display all six of the required 
warning statements on a sign posted at the point-of-sale ( 1143.5(a)(3)). 
The sign must meet the following requirements, as described in  1143.5(a)(3): 
  The sign must be at least 8.5  11 inches in size. 
  The sign must be clear, legible, and conspicuous. 
 
12 You may choose to display either one of the warning statements regarding reproductive health. FDA is allowing 
the use of the reproductive health warning statement as required by the Federal Trade Commission (FTC) consent 
decrees as an optional alternative to the fifth FDA warning, WARNING: Cigar use while pregnant can harm you 
and your baby. FDA expects that providing this optional alternative will benefit entities bound by the FTC consent 
decrees, and the statement is appropriate for the protection of public health. 
13 See guidance, Compliance Policy for Required Warning Statements on Small-Packaged Cigars (August 2018), 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/compliance-policy-required-warning-
statements-small-packaged-cigars. 
10  Contains Nonbinding Recommendations 
  The sign must 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 
font size with appropriate spacing between the warning statements. 
  The required warning statements must be printed in a manner that contrasts by 
typography, layout, or color, with all other printed material. 
  The required warning statements must be capitalized and punctuated as 
indicated in  1143.5(a)(1). 
The sign must be posted according to the following requirements stated in 
 1143.5(a)(3): 
  The sign must be posted on or within 3 inches of each cash register where 
payment may be made. 
  The sign(s) must be unobstructed in its entirety and can be read easily by each 
consumer making a purchase. 
Section 1143.5(c)(1) provides that except for cigars sold individually and not in a 
product package, the six required warning statements 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. The six warning statements must also be 
randomly distributed in all areas of the United States where the product is marketed, 
in accordance with a plan submitted by the responsible cigar manufacturer, 
importer, distributor, or retailer to, and approved by, FDA. 
On July 7, 2020, the D.C. Circuit found that FDA needed to more closely consider 
whether the health warnings would likely affect the number of tobacco users for 
cigars and pipe tobacco, and remanded the case to the district court for further 
proceedings consistent with that decision. See Cigar Assn of America v. FDA, 964 
F.3d 56, 64-65 (D.C. Cir. 2020). The district court has vacated and remanded the 
health warnings for cigars and pipe tobacco. Cigar Assn of America FDA, No. 
1:16-cv-01460, ECF 228 (D.D.C. Sept. 11, 2020). Accordingly, FDA will not seek 
to enforce the warning requirements for cigars and pipe tobacco at this time. In 
addition, the agency does not intend to enforce the labeling requirements under 
sections 903(a)(2) and 920(a) for cigars and pipe tobacco at this time. See 
Compliance Policy for Certain Labeling and Warning Statement Requirements for 
Cigars and Pipe Tobacco (August 2018). 
F.  Required Warning Statement on Advertisements 
1. Nicotine Addictiveness Warning Statement for Cigarette Tobacco, RYO Tobacco, 
and All Covered Tobacco Products (Except Cigars) 
Section 1143.3(b) provides that for cigarette tobacco, RYO tobacco, and covered 
tobacco products other than cigars, the required addictiveness warning statement 
from  1143.3(a)(1) must be displayed on advertisements. Advertisements include 
print advertisements and other advertisements with a visual component (including, 
for example, advertisements on signs, shelf- talkers, Internet Web pages, and 
11  Contains Nonbinding Recommendations 
electronic mail correspondence). On print advertisements and other advertisements 
with a visual component, the required warning statement, as described in 
 1143.5(b)(2), must: 
  Appear on the upper portion of the advertisement within the trim area. 
  Occupy at least 20 percent of the area of the advertisement (warning area). 
  Be printed 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 warning statement. 
  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 advertisement. 
  Be capitalized and punctuated. 
  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 
textual information in the advertisement have the same orientation. 
  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. 
2. Minimum Required Warning Label Statements for Cigar Advertisements 
Advertisements for cigars must include one of the six required warning statements 
from  1143.5(a)(1). As there are six required warning statements for cigars, these 
warning statements must be rotated quarterly in advertisements, in alternating 
sequence, for each brand of cigar in accordance with a warning plan14 submitted by 
the responsible cigar manufacturers, importers, distributors, or retailers to, and 
approved by, the FDA ( 1143.5(c)). Cigar advertisements must follow the same 
format and content requirements as described above for cigarette tobacco, RYO 
tobacco, and other covered tobacco products ( 1143.5(b)). 
On July 7, 2020, the D.C. Circuit found that FDA needed to more closely consider 
whether the health warnings would likely affect the number of tobacco users for 
cigars and pipe tobacco, and remanded the case to the district court for further 
proceedings consistent with that decision. See Cigar Assn of America v. FDA, 964 
F.3d 56, 64-65 (D.C. Cir. 2020). The district court has vacated and remanded the 
health warnings for cigars and pipe tobacco. Cigar Assn of America v. FDA, No. 
1:16-cv-01460, ECF 228 (D.D.C. Sept. 11, 2020). Accordingly, FDA will not seek 
to enforce the warning requirements for cigars and pipe tobacco at this time. In 
addition, the agency does not intend to enforce the labeling requirements under 
sections 903(a)(2) and 920(a) for cigars and pipe tobacco at this time. See 
 
14 See guidance entitled, Submission of Warning Plans for Cigars (August 2018), https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/submission-warning-plans-cigars. 
12  Contains Nonbinding Recommendations 
Compliance Policy for Certain Labeling and Warning Statement Requirements for 
Cigars and Pipe Tobacco (August 2018). 
G. Self-certification and Alternative Required Warning Statement 
The nicotine addictiveness warning statement required on packages and 
advertisements in  1143.3(a)(1) for cigarette tobacco, roll your own tobacco, and 
covered tobacco products other than cigars is not required where such products do 
not contain nicotine15 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 (e.g., no nicotine at detectable levels) and that the tobacco product 
manufacturer has data to support that assertion. The alternative statement, under 
 1143.3(c), for applicable package labels and advertisements reads: This product 
is made from tobacco. This statement must appear on at least 30 percent of the two 
principal display panels of the package and at least 20 percent of the upper area of 
the advertisement as described in  1143.3(a) and (b). 
If you have any questions on the self-certification, you can contact FDA at: 1-877-
CTP-1373. Please submit your self-certification statement to the following address 
at FDA: 
Food and Drug Administration  
Center for Tobacco Products 
Office of Compliance and Enforcement Document Control Center 
Building 71, Room G335  
10903 New Hampshire Avenue  
Silver Spring, MD 20993-0002 
On July 7, 2020, the D.C. Circuit found that FDA needed to more closely consider 
whether the health warnings would likely affect the number of tobacco users for 
cigars and pipe tobacco, and remanded the case to the district court for further 
proceedings consistent with that decision. See Cigar Assn of America v. FDA, 964 
F.3d 56, 64-65 (D.C. Cir. 2020). The district court has vacated and remanded the 
health warnings for cigars and pipe tobacco. Cigar Assn of America FDA, No. 
1:16-cv-01460, ECF 228 (D.D.C. Sept. 11, 2020). Accordingly, FDA will not seek 
to enforce the warning requirements for cigars and pipe tobacco at this time. In 
addition, the agency does not intend to enforce the labeling requirements under 
sections 903(a)(2) and 920(a) for cigars and pipe tobacco at this time. See 
Compliance Policy for Certain Labeling and Warning Statement Requirements for 
Cigars and Pipe Tobacco (August 2018). 
 
15 As stated previously in footnote 8, components or parts that are not made or derived from tobacco do not meet the 
definition of covered tobacco product, and would not be required to carry an addiction warning or submit a self- 
certification. 
13  Contains Nonbinding Recommendations 
H. Retailer Warning Statement Exceptions 
1. Package or Packaging 
The Deeming Rule (in  1143.3(a)(3) and 1143.5(a)(4)) provides that a retailer of 
any tobacco product covered by  1143.3(a)(1) and (a)(2) and 1143.5(a)(1) and 
(a)(2), respectively, will not be in violation of these sections for packaging that: 
  Contains a health warning 
  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 
  Is not altered by the retailer in a way that is material to the requirements of 
 1143.3(a) and 1143.5(a) 
2. Advertisements 
The warning statement requirement for advertisements outlined in  1143.3(b) and 
1143.5(b) apply to a retailer only if that retailer is responsible for or directs the 
health warning required under the paragraph. However, this 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 
  Contains a health warning that has been altered by the retailer in a way that is 
material to the requirements of  1143.3(b) and 1143.5(b) 
On July 7, 2020, the D.C. Circuit found that FDA needed to more closely consider 
whether the health warnings would likely affect the number of tobacco users for 
cigars and pipe tobacco, and remanded the case to the district court for further 
proceedings consistent with that decision. See Cigar Assn of America v. FDA, 964 
F.3d 56, 64-65 (D.C. Cir. 2020). The district court has vacated and remanded the 
health warnings for cigars and pipe tobacco. Cigar Assn of America v. FDA, No. 
1:16-cv-01460, ECF 228 (D.D.C. Sept. 11, 2020). Accordingly, FDA will not seek 
to enforce the warning requirements for cigars and pipe tobacco at this time. In 
addition, the agency does not intend to enforce the labeling requirements under 
sections 903(a)(2) and 920(a) for cigars and pipe tobacco at this time. See 
Compliance Policy for Certain Labeling and Warning Statement Requirements for 
Cigars and Pipe Tobacco (August 2018). 
14  Contains Nonbinding Recommendations 
III.  QUESTIONS AND ANSWERS 
A.  Deeming of Tobacco Products 
1.  Where can I find the Deeming Rule and any additional explanation? 
The Deeming Rule is codified in the Code of Federal Regulations at 21 CFR parts 
1100 (the deeming provisions), 1140 (sales and distribution restrictions), and 1143 
(warning label requirements). You can also find a detailed explanation of all the 
provisions in the preamble to the Deeming Rule in the Federal Register or at CTPs 
Deeming Rule webpage: https://www.fda.gov/tobacco-products/rules-regulations-
and-guidance/fdas-deeming-regulations-e-cigarettes-cigars-and-all-other-tobacco-
products. 
2.  What products are deemed subject to FDAs authority by the Deeming 
Rule? 
Under the Deeming Rule, all products that meet the statutory definition of tobacco 
product in section 201(rr) of the FD&C Act are subject to FDAs authority to 
regulate tobacco products except for accessories of newly deemed tobacco 
products.16 Section 201(rr) of the FD&C Act defines tobacco product 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). However, a product that is a drug under section 201(g)(1), a 
device under section 201(h), or a combination product, as described in section 
353(g) of the FD&C Act, or a food under section 201(g) where it contains no 
nicotine, or no more than trace amounts of naturally occurring nicotine is not a 
tobacco product and is not subject to FDA authority to regulate tobacco products 
(but may be subject to FDA authority to regulate drugs, devices, and combination 
products). 
Cigarettes, smokeless tobacco, cigarette tobacco, and RYO tobacco and their 
components, parts, and accessories are tobacco products and have been subject to 
the FDA authority since the Tobacco Control Act was enacted in 2009. With the 
Deeming Rule, FDAs tobacco product authorities are extended to all other tobacco 
products that were not previously regulated, except accessories of newly deemed 
tobacco products. The newly deemed products include electronic nicotine delivery 
systems (ENDS), cigars, pipe tobacco, cigar tobacco, pipes, waterpipe tobacco, and 
dissolvable nicotine products that do not meet the definition of smokeless tobacco, 
among others. 
 
16 See fn 2. 
15  Contains Nonbinding Recommendations 
3.  Does the Deeming Rule deem components, parts, and accessories subject to 
FDAs tobacco product authorities? 
Under the Deeming Rule, components and parts of the newly deemed tobacco 
products are subject to FDAs tobacco product authorities, but the accessories of 
newly deemed tobacco products are not. Components, parts, and accessories of 
cigarettes, cigarette tobacco, RYO tobacco, and smokeless tobacco are already 
subject to FDA authority. 
4.  How does the Deeming Rule define a component or part? How is that 
different from an accessory? 
The Deeming Rule defines component or part and accessory. Accessory is defined 
in  1100.3 as follows: 
  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 is defined in  1100.3 as follows: 
  Component or part means any software or assembly of materials intended or 
reasonably expected: (1) to alter or affect the tobacco products 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. 
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 
16  Contains Nonbinding Recommendations 
  Flavors 
  Programmable software 
Similarly, the following is a nonexhaustive list of examples of components and 
parts used with waterpipe tobacco: 
  Flavor enhancers and the vial 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 
charcoals 
  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 poker 
  Shisha oyster forks 
  Tongs 
  Bags. 
The following is a nonexhaustive list of examples of objects used with e-cigarettes 
or other ENDS that would likely be considered accessories: 
  Screwdrivers 
  Lanyards. 
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, FDA is only examining a distinct subset of packaging 
materials that are intended or reasonably expected to alter or affect the tobacco 
products performance, composition, constituents, or characteristics. Packaging 
materials that are not intended or reasonably expected to alter or affect the tobacco 
products performance, composition, constituents, or characteristics are not 
components or parts of a tobacco product. 
For example, a vial containing an e-liquid is a component or part of the tobacco 
product, as it is intended or reasonably expected to alter or affect the tobacco 
products performance, composition, constituents, or characteristics, such as by 
leaching chemicals into the e-liquid itself, whereas a hard plastic blister pack in 
which the vial of e-liquid is distributed and sold to consumers is not. 
17  Contains Nonbinding Recommendations 
5.  Are products that are a drug, device, combination product, or food covered 
by the Deeming Rule? 
No. Products that meet the FD&C Act definition of drug, device, or combination 
product are excluded from the definition of tobacco product and are not subject to 
FDAs tobacco authority (section 201(rr)(2) of the FD&C Act). Articles that are 
foods are excluded from the definition of tobacco products under section 201(f) of 
the FD&C Act if such articles contain no nicotine or no more than trace amounts of 
naturally occurring nicotine.17 See section 201(g)(1) of the FD&C Act for the 
definition of drug, section 201(h) of the FD&C Act for the definition of device, 
section 503 of the FD&C Act for the definition of combination product, and section 
201(f) of the FD&C Act. A tobacco product may not be marketed in combination 
with any other product regulated by FDA (drug, biologic, food, cosmetic, medical 
device, or a dietary supplement) (section 201(rr)(4) of the FD&C Act).  
6.  When does part 1100, which deems certain tobacco products to be subject 
to the tobacco product authorities in the FD&C Act, become effective? 
Part 1100 took effect on August 8, 2016, which was 90 days after the Deeming Rule 
was published. As of that date, newly deemed products became automatically 
subject to all provisions in the FD&C Act and FDA regulations applicable to 
tobacco products. However, for certain provisions that require labeling changes or 
information submission to the Agency, FDA has provided an extended compliance 
date, before which the Agency does not intend to enforce such provisions. These 
compliance timeframes will provide time after the effective date for firms to come 
into compliance with those provisions of the law. See Tables A and B, below, for a 
list of provisions and the compliance dates. 
7.  Once products are deemed, what additional statutory and regulatory 
restrictions will they be subject to? 
The newly deemed products are subject to the FDAs tobacco product authorities in 
Chapter IX of the FD&C Act and FDAs existing regulations for tobacco products, 
as well as parts 1100, 1140, and 1143, and any future applicable regulations issued 
under FDAs tobacco product authorities. Part 1100 deems certain tobacco products 
to be subject to the tobacco product authorities in the FD&C Act. Part 1140 extends 
the requirement to prohibit the sale and distribution of products to individuals under 
1818 to covered tobacco products, prohibits vending machine sales of covered 
tobacco products except in adult-only facilities, and prohibits the distribution of free 
samples of newly deemed products. Part 1143 mandates the use of required warning 
statements for covered tobacco products, as well as for RYO and cigarette tobacco. 
 
17See fn 2. 
18 See supra footnotes 3 & 7. 
18  Contains Nonbinding Recommendations 
8.  Can FDA take action against newly deemed tobacco products that are 
adulterated or misbranded? 
Yes. FDA can take action against newly deemed tobacco products that are 
adulterated or misbranded. 
9.  Do newly deemed tobacco products need to have premarket authorization 
prior to commercial distribution? 
A newly deemed product that is considered a new tobacco product19 is required to 
have premarket authorization prior to commercial distribution. Grandfathered 
products (products that were commercially marketed  other than exclusively in test 
markets  in the United States as of February 15, 2007) are not considered new 
tobacco products and thus are not subject to the premarket authorization 
requirements of the statute. 
10. How does FDA intend to enforce the premarket requirements for newly 
deemed products that are currently marketed as of the effective date of the 
Deeming Rule, but are not grandfathered products? 
Section 910 of the FD&C Act requires FDA authorization in order to market a new 
tobacco product. The FD&C Act provides three pathways for obtaining premarket 
authorization: substantial equivalence (SE) exemptions; SE reports; and premarket 
tobacco applications (PMTAs). 
Tobacco products that were on the market as of February 15, 2007, are 
grandfathered and do not require premarket authorization. FDA has published 
guidance relating to the premarket authorization pathways. Please reference CTPs 
guidance page for additional information: https://www.fda.gov/tobacco-
products/rules-regulations-and-guidance/guidance. 
In August 2017, FDA issued guidance extending premarket review compliance 
dates for deemed products on the market as of August 8, 2016, until August 8, 2021 
for combustible products and until August 8, 2022, for noncombustible products. 
On May 15, 2019, the U.S. District Court for the District of Maryland vacated the 
extended premarket review compliance dates in the guidance.20 On July 12, 2019, 
the court issued an order directing FDA to require that premarket authorization 
 
19 A new tobacco product is defined in section 910(a)(1) of the FD&C Act as: (A) any tobacco product (including 
those products in test markets) that was not commercially marketed in the United States as of February 15, 2007; or 
(B) 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. 
20 American Academy of Pediatrics, et al. v. Food and Drug Administration, et al., 379 F. Supp. 3d 461, 496 (D. 
Md. 2019). 
19  Contains Nonbinding Recommendations 
applications for all newi.e., not grandfathered21deemed tobacco products be 
submitted to the Agency within 10 months, by May 12, 2020, and providing for a 
one-year period during which products with timely filed applications might remain 
on the market pending FDA review.22 The court subsequently clarified that its order 
did not restrict FDAs authority to enforce the premarket review provisions against 
deemed products, or categories of deemed products, prior to the submission date or 
during the one-year review period.23 On April 22, 2020, the court, upon FDAs 
motion, extended the premarket application deadline set out in its order by 120 days 
(until September 9, 2020) in light of the global outbreak of respiratory illness 
caused by a new coronavirus.24 As required by the courts order, deemed new 
tobacco products on the market as of August 8, 2016, for which premarket 
authorization applications are not filed by September 9, 2020, are subject to FDA 
enforcement actions, in the Agencys discretion.25  
On August 19, 2020, the U.S. District Court for the District of Columbia remanded 
the Deeming Rule to FDA for the limited purpose of considering whether to 
develop a streamlined SE process for premium cigars.26 The courts order enjoins 
FDA from enforcing premarket review requirements against premium cigars until 
FDA completes that review. FDA has published a final guidance providing FDAs 
current thinking on enforcement of the FD&C Acts premarket review requirements 
for certain categories of newly deemed products. See the Guidance for Industry, 
Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and Other 
Deemed Products on the Market Without Premarket Authorization.27  
 
21 A grandfathered product is one that was on the market as of February 15, 2007. Guidance for Industry, 
Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007, 
dated September 2014, available at: https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/establishing-tobacco-product-was-commercially-marketed-united-states-february-15-2007. 
22 American Academy of Pediatrics, et al. v. Food and Drug Administration, et al., 399 F.Supp.3d 479 (D. Md. 
2019), affd in part, dismissed in part sub nom. In re Cigar Assn of Am., 812 Fed. Appx. 128 (4th Cir. May 4, 
2020). 
23 American Academy of Pediatrics, et al. v. Food and Drug Administration, et al., Case No. 8:18-cv-883 (PWG), 
(D. Md. Aug. 12, 2019), Dkt. No. 132. 
24 American Academy of Pediatrics, et al. v. Food and Drug Administration, et al., Case No. 8:18-cv-883 (PWG), 
(D. Md. Apr. 22, 2020), Dkt. No. 182. 
25 Id. 
26 Cigar Association of America, et al. v. Food and Drug Administration, Case No. 1:16-cv-01460 (APM), 2020 WL 
4816459, at *17 (D.D.C. Aug. 19, 2020) (Dkt. No. 214). For the purposes of the courts order, a premium cigar is 
a cigar that: (1) is wrapped in whole tobacco leaf; (2) contains a 100 percent leaf tobacco binder; (3) contains at least 
50 percent (of the filler by weight) long filler tobacco (i.e., whole tobacco leaves that run the length of the cigar); (4) 
is handmade or hand rolled (i.e., no machinery was used apart from simple tools, such as scissors to cut the tobacco 
prior to rolling); (5) has no filter, nontobacco tip, or nontobacco mouthpiece; (6) does not have a characterizing 
flavor other than tobacco; (7) contains only tobacco, water, and vegetable gum with no other ingredients or 
additives; and (8) weighs more than 6 pounds per 1,000 units. 
27 Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-priorities-
electronic-nicotine-delivery-system-ends-and-other-deemed-products-market. 
20  Contains Nonbinding Recommendations 
11. How does FDA intend to enforce the premarket requirements for newly 
deemed products that were not marketed on or before the effective date of 
the Deeming Rule? 
Newly deemed tobacco products that are grandfathered (on the market as of 
February 15, 2007) are not subject to premarket review. Newly deemed products 
that are not grandfathered and were not on the market as of the effective date of the 
Deeming Rule, are subject to the premarket review requirements and must obtain a 
marketing order from FDA specific to the product under the PMTA pathway, the 
SE application pathway, or the SE exemption request pathway. Any new tobacco 
product not on the market as of the effective date of the Deeming Rule is not 
covered by the court orders or guidance document described above and is subject to 
enforcement if it is marketed without premarket authorization. 
12. Will the newly deemed tobacco products be subject to good manufacturing 
practices (GMPs)? 
FDA must first promulgate through rulemaking good manufacturing practice 
requirements applicable to tobacco products (or Tobacco Product Manufacturing 
Practices). Once these requirements are in effect, they will apply to newly deemed 
tobacco products. However, manufacturers must comply with any applicable 
adulteration and misbranding provisions pertaining to tobacco products of chapter 
IX of the FD&C Act. 
13. Are the newly deemed tobacco products subject to user fees? 
Certain classes of tobacco products, including cigars and pipe tobacco, are subject 
to user fees. For additional information, please reference the User Fee Final Rule, 
codified at 21 CFR part 1150. 
14. When do the additional provisions (parts 1140 and 1143) become effective? 
  The additional provisions in part 1140 took effect on August 8, 2016, which 
was 90 days after the publication of the Deeming Rule. These provisions 
include the minimum age and identification provisions, the vending machine 
provision, and the prohibition on free sample distribution. 
  The health warning requirements in part 1143 took effect on May 10, 201828, 
which is 24 months after the publication of the Deeming Rule. On July 5, 2018, 
the United States District Court for the District of Columbia enjoined FDA 
from enforcing the warning requirements for cigars and pipe tobacco (21 CFR 
 1143.3 and 1143.5) until 60 days after the final disposition of the plaintiffs 
appeal in the case: Cigar Assn of America v. FDA, No. 1:16-cv-01460 
(D.D.C.) (order granting injunction pending appeal). On July 7, 2020, the D.C. 
 
28 The effective date is May 10, 2018. FDA issued a guidance on May 10, 2017, which, among other things, 
provided a compliance date of August 10, 2018. 
21  Contains Nonbinding Recommendations 
Circuit found that FDA needed to more closely consider whether the health 
warnings would likely affect the number of tobacco users for cigars and pipe 
tobacco, and remanded the case to the district court for further proceedings 
consistent with that decision. See Cigar Assn of America v. FDA, 964 F.3d 56, 
64-65 (D.C. Cir. 2020). The district court has vacated and remanded the health 
warnings for cigars and pipe tobacco. Cigar Assn of America v. FDA, No. 
1:16-cv-01460, ECF 228 (D.D.C. Sept. 11, 2020). Accordingly, FDA will not 
seek to enforce the warning requirements for cigars and pipe tobacco at this 
time.29  
  On February 3, 2020, the court in Cigar Assn of America v. FDA vacated the 
health warning requirements for premium cigars and remanded that portion 
of the deeming rule to the agency for further proceedings. See Cigar Assn of 
Am. v. FDA, Nos. 16-1460, 18-1797 (D.D.C. Feb. 3, 2020). 
  The requirement to submit a warning plan to FDA took effect on May 10, 
201730, which was 12 months after the publication of the Deeming Rule. 
15. Are there any additional extensions for small-scale tobacco product 
manufacturers? 
FDA is including targeted relief to small-scale tobacco product manufacturers.  
For purposes of such relief, 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. To help make FDAs 
individual enforcement decisions more efficient, a manufacturer may voluntarily 
submit information regarding employment and revenues. 
The additional time to comply afforded to the small-scale tobacco product 
manufacturer included: 
  SE Extension Request  For the first 30 months following the effective date 
of the Deeming Rule, FDA policy provided that the Agency intended to grant 
extensions on a case-by-case basis, for SE applicants that need additional time 
to respond to SE deficiency letters. 
  Tobacco Health Document Submission  FDA policy provided that the 
Agency did not intend to bring enforcement action against small-scale tobacco 
 
29 In addition, the agency does not intend to enforce the labeling requirements under sections 903(a)(2) and 920(a) 
for cigars and pipe tobacco at this time. See Compliance Policy for Certain Labeling and Warning Statement 
Requirements for Cigars and Pipe Tobacco (August 2018). 
30 The effective date for this requirement is May 10, 2017. FDA issued a guidance on May 10, 2017, which, among 
other things, provided a compliance date of August 10, 2017. 
22  Contains Nonbinding Recommendations 
product manufacturers who submit the required information within 12 months 
of the effective date of the Deeming Rule.31  
  Ingredient Listing Submission  FDA policy provided that the agency did not 
intend to bring enforcement action against those small-scale tobacco product 
manufacturers who submit the information required in section 904(a)(1) of the 
FD&C Act within 12 months of the effective date of the Deeming Rule.32  
Small-scale tobacco product manufacturers will also benefit from additional 
assistance, including: 
  Assistance with Marketing Applications  Like all manufacturers, small-
scale tobacco manufacturers will benefit from additional assistance with their 
marketing applications, including the designation of a Regulatory Health 
Project Manager, access to an appeals process in the event that FDA denies 
their marketing applications, and assistance from CTPs Office of Compliance 
and Enforcement (OCE) staff with identifying the types of documents that may 
be used to establish that their products were on the market on February 15, 
2007. 
  Assistance in Navigating Other Regulatory Requirements  Small-scale 
tobacco product manufacturers may obtain assistance from OCE staff with 
submission of rotational warning plans for FDA approval. CTP also has an 
extension system to assist small businesses in navigating the regulatory 
requirements of FDA. For example, the CTP Call Center receives calls 
received from regulated industry and sends them to the appropriate CTP office. 
  Office of Small Business Assistance (OSBA)- CTP has established the Office 
of Small Business Assistance (OSBA), which responds to hundreds of calls, 
emails, and correspondence from small businesses every year and assists in 
answering specific questions about the requirements that apply to small 
businesses and how to comply with the law. OSBA can be reached by email at 
SmallBiz.Tobacco@fda.hhs.gov or by phone at 1-877-CTP-1373 (1-877-287-
1373) Monday  Friday, 9:00 a.m.  4:00 p.m. EDT. 
 
31 FDA issued a guidance in October 2017, which, among other things, extended the compliance date to November 
8, 2017 for small-scale tobacco product manufacturers and to May 8, 2018 for small-scale tobacco product 
manufacturers in areas impacted by 2017 natural disasters or at least 90 days prior to the delivery for introduction 
into interstate commerce of the tobacco products to which the health documents relate, whichever is later. See, 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/tobacco-health-document-submission. 
32 FDA has previously extended the compliance date for small tobacco product manufacturers. Most recently, FDA 
issued a revised guidance on November 6, 2018, which extended the compliance date to May 8, 2019 for small-scale 
tobacco product manufacturers impacted by recent natural disasters. See, https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/listing-ingredients-tobacco-products. 
23  Contains Nonbinding Recommendations 
B.  Age and Identification Restrictions33 
1.  Where can I find the regulation containing age and identification 
restrictions and any explanation? 
The final regulation can be found in chapter 21 of the Code of Federal Regulations, 
part 1140. In addition, the full preamble to the Deeming Rule, which discusses 
these restrictions and comments received, can be found in the Federal Register. 
2.  What products are subject to the new age and identification restriction? 
Covered tobacco products are subject to the age and identification requirements that 
prohibit the sale of the products to people under the age of 18 and require 
verification of age with photo identification (except for any person over the age of 
26). Cigarettes and smokeless tobacco products remain subject to the age and 
identification requirements ( 1140.14(a)(1) and (a)(2)). 
3.  What is a covered tobacco product? 
Covered tobacco product means any tobacco product deemed to be subject to the 
FD&C Act pursuant to  1100.2 of this chapter (i.e., subchapter K), but excludes 
any component or part that is not made or derived from tobacco. Covered tobacco 
products include ENDS, cigars, pipe tobacco, waterpipe tobacco, dissolvable 
nicotine products, to name a few, as well as parts and components made or derived 
from tobacco, e.g., an e-cigarette cartridge containing e-liquid made or derived from 
tobacco. 
For example: 
  An e-liquid with nicotine made or derived from tobacco is a covered tobacco 
product. 
  A nicotine-free e-liquid that is not made or derived from tobacco is not a 
covered tobacco product (and not subject to the minimum age and 
identification requirements and the vending machine restrictions), but it is 
nevertheless subject to FDAs tobacco control authorities if it satisfies the 
definition of component or part. 
 
33 See supra footnote 3. The Further Consolidated Appropriations Act, 2020, instructs FDA to issue a final rule to 
update all references to persons younger than 18 years of age in subpart B of part 1140 of title 21, [C.F.R.], and to 
update the relevant age verification requirements under such part 1140 to require age verification for individuals 
under the age of 30. 
24  Contains Nonbinding Recommendations 
4.  How are cigars defined in this regulation? 
The Deeming Rule defines cigar as 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 
( 1143.1). 
5.  How are manufacturers and retailers defined in this regulation? 
Manufacturer34 means any person, including any repacker and/or relabeler, who 
manufactures, fabricates, assembles, processes, or labels a finished tobacco product 
( 1140.3). 
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 part 1140 ( 1140.3). 
6.  What are the requirements for retailers of newly deemed products? 
In addition to other requirements, retailers may not sell covered tobacco products to 
anyone under the age of 18. Except for those people over the age of 26, retailers 
must verify a purchasers age through photographic identification containing the 
bearers date of birth ( 1140.14(b)). 
7.  Am I required to verify a purchasers birth date if he or she is older than 
26 years of age? 
No, verification is not required for sale to a person over the age of 26 
( 1140.14(b)). 
8.  Does this regulation change the current age and identification requirements 
for the sale and distribution of cigarettes and smokeless tobacco? 
No, the current age and identification requirements for the sale and distribution of 
cigarettes and tobacco remain the same. As before, these products cannot be sold to 
anyone under the age of 1835 according to federal law, and verification is necessary 
for those people 26 years of age and under ( 1140.14(a)(1) and (a)(2)). 
9.  Can I sell covered tobacco products in vending machines? 
No, with one exception. Covered tobacco products must not be sold with the 
assistance of any electronic or mechanical device (such as a vending machine) 
 
34 For purposes of parts 1140 and 1143, the term manufacturer does not include importer. Importer is separately 
defined and means any person who imports any tobacco product that is intended for sale or distribution to 
consumers in the United States ( 1140.3). 
35 State laws may have a higher minimum age for sale. 
25  Contains Nonbinding Recommendations 
unless it is 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 ( 1140.14(b)(3)). 
10. When do the age and identification restrictions become effective? 
The age and identification requirements took effect on August 8, 2016, which was 
90 days after the publication of the Deeming rule. 
C.  Health Warning Requirements36 
1.  Where can I find information about the new health warning 
requirements? 
The health warning requirements are codified in Title 21 of the Code of Federal 
Regulations, part 1143. You can also find additional information about the required 
warnings in the preamble to the Deeming Rule. The preamble can be found in the 
Federal Register or at CTPs Deeming Rule webpage: 
https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/fdas-
deeming-regulations-e-cigarettes-cigars-and-all-other-tobacco-products. 
2.  What products are subject to the new health warning requirements? 
The new warning label requirements apply to all covered tobacco products37 as well 
as cigarette tobacco and RYO tobacco. The warning label requirements for all 
covered tobacco products (except cigars), cigarette tobacco, and RYO tobacco are 
codified in  1143.3 and the warning label requirements for cigars are codified in 
 1143.5. 
3.  Who must comply with the health warning requirements? 
Manufacturers, distributors, importers, and certain retailers of cigarette tobacco, 
RYO tobacco, or covered tobacco products must comply with the health warning 
requirements on packages and advertisements for sale or distribution of these 
 
36 See supra section II.D. On July 7, 2020, the D.C. Circuit found that FDA needed to more closely consider whether 
the health warnings would likely affect the number of tobacco users for cigars and pipe tobacco, and remanded the 
case to the district court for further proceedings consistent with that decision. See Cigar Assn of America v. FDA, 
964 F.3d 56, 64-65 (D.C. Cir. 2020). The district court has vacated and remanded the health warnings for cigars and 
pipe tobacco. Cigar Assn of America v. FDA, No. 1:16-cv-01460, ECF 228 (D.D.C. Sept. 11, 2020). Accordingly, 
FDA will not seek to enforce the warning requirements for cigars and pipe tobacco at this time. In addition, the 
agency does not intend to enforce the labeling requirements under sections 903(a)(2) and 920(a) for cigars and pipe 
tobacco at this time. See Compliance Policy for Certain Labeling and Warning Statement Requirements for Cigars 
and Pipe Tobacco (August 2018). 
37 As defined above, the term covered tobacco product means any tobacco product deemed to be subject to the 
FD&C Act pursuant to  1100.2, but excludes any component or part of a tobacco product that is not made or 
derived from tobacco. 
26  Contains Nonbinding Recommendations 
products in the United States. For purposes of the Deeming Rule, the terms 
manufacturer, distributor, importer, and retailer are defined as follows: 
  Manufacturer means any person, including any repacker or relabeler, who 
manufactures, fabricates, assembles, processes, or labels a finished tobacco 
product. 
  Distributor means any person who furthers the distribution of tobacco products 
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 part 1140. 
  Importer means any person who imports any tobacco product that is intended 
for sale or distribution to consumers in the United States. 
  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 part 1140. 
For example, if you make cigars, you are a manufacturer under these regulations. 
You are also a manufacturer, however, if you obtain cigars originally made by 
another manufacturer, remove them from the original manufacturers packaging (if 
any), and repackage or relabel them for sale under another name  even though 
you did not roll the cigars themselves. As a second example, if you own a trucking 
firm and are contracted to transport cigars from a warehouse to a retailer (only), you 
are a common carrier, not a distributor, for the purposes of the Deeming Rule 
( 1140.3). 
4.  Do the warning requirements apply to small businesses that meet the 
definition of manufacturer, distributor, importer, or retailer? 
The required warning statement(s) must be on all covered tobacco products, 
cigarette tobacco, and RYO tobacco packages and advertisements, regardless of 
who manufacturers, distributes, imports, sells, or offers to sell the product. 
5.  What are the consequences if a product is found to not be in compliance 
with the health warning requirements? 
Covered tobacco products, cigarette tobacco, and RYO tobacco packages that are 
not in compliance with the health warning provisions are misbranded under section 
903(a)(7)(B) of the FD&C Act (21 U.S.C. 387c(a)(7)(b)). Sale or distribution in 
interstate commerce of misbranded tobacco products may result in warning letters, 
criminal prosecution, civil money penalties, injunction, seizure, and/or no-tobacco-
sale orders. 
6.  Are retailers subject to enforcement if they sell a product in packaging that 
does not comply with the health warning requirements? 
A retailer will not be in violation of the Deeming Rule for the sale of covered 
tobacco products, cigarette tobacco, or RYO tobacco, where the packaging: 
27  Contains Nonbinding Recommendations 
(1)  Contains a health warning. 
(2)  Is supplied by a license- or permit-holding 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. 
(3)  Is not altered by the retailer in a way that is material to the requirements 
of these sections. 
 
( 1143.3(a)(3) and 1143.5(a)(4).)) 
7.  Are retailers subject to enforcement if they display an advertisement that 
does not comply with the health warning requirements? 
Requirements relating to health warnings on advertisements only apply to a retailer 
if the retailer is responsible for or directs the warning statement. However, this does 
not relieve the retailer of liability if the retailer publicly displays an advertisement 
for a covered tobacco product, cigarette tobacco, or RYO tobacco that does not 
contain a health warning, or if the retailer alters the warning on the advertisement in 
a manner that is material to the health warning requirements (for example, if the 
retailer tears the warning off a printed advertisement) ( 1143.3(b)(3) and 
1143.5(b)(3)). 
8.  Can FDA enforce the health warning requirements against other entities, 
aside from the retailer? 
Yes. Whether or not the above exceptions for retailers apply, FDA can enforce the 
health warning provisions against the manufacturer, importer, or distributor of the 
product, and, potentially, the product itself (e.g., through seizure). 
9.  When does this part of the Deeming Rule become effective? 
The health warning requirements will become effective 24 months after final 
publication of the Deeming Rule (the new warning date) ( 1143.13).38 As stated 
above, on July 5, 2018, the U.S. District Court for the District of Columbia enjoined 
FDA from enforcing the warning requirements for cigars and pipe tobacco (21 CFR 
 1143.3 and 1143.5) until 60 days after the final disposition of the plaintiffs 
appeal in the case: Cigar Assn of America v. FDA, No. 1:16- cv-01460 (D.D.C.) 
(order granting injunction pending appeal). On July 7, 2020, the D.C. Circuit found 
that FDA needed to more closely consider whether the health warnings would likely 
affect the number of tobacco users for cigars and pipe tobacco, and remanded the 
case to the district court for further proceedings consistent with that decision. See 
Cigar Assn of America v. FDA, 964 F.3d 56, 64-65 (D.C. Cir. 2020). The district 
court has vacated and remanded the health warnings for cigars and pipe tobacco. 
 
38 The effective date is May 10, 2018. FDA issued a guidance on May 10, 2017, which, among other things, 
provided a compliance date of August 10, 2018. 
28  Contains Nonbinding Recommendations 
Cigar Assn of America v. FDA, No. 1:16-cv-01460, ECF 228 (D.D.C. Sept. 11, 
2020). Accordingly, FDA will not seek to enforce the warning requirements for 
cigars and pipe tobacco at this time.39  
10. After the effective date for the health warnings, can manufacturers 
continue to sell and distribute their remaining stock of covered tobacco 
products, cigarette tobacco, and RYO tobacco if the packaging does not 
comply with the health warning requirements? 
Yes, for 30 days after the effective date only,40 manufacturers may continue to 
introduce into interstate commerce covered tobacco products, cigarette tobacco, and 
RYO tobacco manufactured before the effective date of the new warning 
requirements with packaging that do not comply with the new health warning 
requirements. This sell-off period only applies to products manufactured before the 
effective date of the new warning requirements ( 1143.13). As stated above, on 
July 5, 2018, the U.S. District Court for the District of Columbia enjoined FDA 
from enforcing the warning requirements for cigars and pipe tobacco (21 CFR  
1143.3 and 1143.5) until 60 days after the final disposition of the plaintiffs appeal 
in the case: Cigar Assn of America v. FDA, No. 1:16-cv-01460 (D.D.C.) (order 
granting injunction pending appeal). On July 7, 2020, the D.C. Circuit found that 
FDA needed to more closely consider whether the health warnings would likely 
affect the number of tobacco users for cigars and pipe tobacco, and remanded the 
case to the district court for further proceedings consistent with that decision. See 
Cigar Assn of America v. FDA, 964 F.3d 56, 64-65 (D.C. Cir. 2020). The district 
court has vacated and remanded the health warnings for cigars and pipe tobacco. 
Cigar Assn of America v. FDA, No. 1:16-cv-01460, ECF 228 (D.D.C. Sept. 11, 
2020). Accordingly, FDA will not seek to enforce the warning requirements for 
cigars and pipe tobacco at this time.41  
11. After the effective date for the health warnings, can distributors and 
retailers sell-off their remaining stock of covered tobacco products, 
cigarette tobacco, and RYO tobacco if the packaging does not comply with 
the new health warning requirements? 
Yes. Distributors and retailers may continue to sell and distribute the tobacco 
product packages after the effective date,42 but only if the products were 
manufactured before the effective date of the new required warning statement for 
 
39 In addition, the agency does not intend to enforce the labeling requirements under sections 903(a)(2) and 920(a) 
for cigars and pipe tobacco at this time. See Compliance Policy for Certain Labeling and Warning Statement 
Requirements for Cigars and Pipe Tobacco (August 2018). 
40 See note above. 
41 In addition, the agency does not intend to enforce the labeling requirements under sections 903(a)(2) and 920(a) 
for cigars and pipe tobacco at this time. See Compliance Policy for Certain Labeling and Warning Statement 
Requirements for Cigars and Pipe Tobacco (August 2018). 
42 See note above. 
29  Contains Nonbinding Recommendations 
covered tobacco products, cigarette tobacco, and RYO tobacco. As stated above, on 
July 5, 2018, the U.S. District Court for the District of Columbia enjoined FDA 
from enforcing the warning requirements for cigars and pipe tobacco (21 CFR 
 1143.3 and 1143.5) until 60 days after the final disposition of the plaintiffs 
appeal in the case: Cigar Assn of America v. FDA, No. 1:16-cv-01460 (D.D.C.) 
(order granting injunction pending appeal). On July 7, 2020, the D.C. Circuit found 
that FDA needed to more closely consider whether the health warnings would likely 
affect the number of tobacco users for cigars and pipe tobacco, and remanded the 
case to the district court for further proceedings consistent with that decision. See 
Cigar Assn of America v. FDA, 964 F.3d 56, 64-65 (D.C. Cir. 2020). The district 
court has vacated and remanded the health warnings for cigars and pipe tobacco. 
Cigar Assn of America v. FDA, No. 1:16-cv-01460, ECF 228 (D.D.C. Sept. 11, 
2020). Accordingly, FDA will not seek to enforce the warning requirements for 
cigars and pipe tobacco at this time.43  
12. When must I submit my cigar warning plan to FDA? 
Warning plans should be submitted 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 ( 1143.5(c)(3)). On 
May 10, 2017, FDA issued a guidance, which, among other things, provided a 
compliance date of August 10, 2017 for the warning plan requirement. Therefore, 
warning plans for tobacco products on the market as of August 8, 2016 that are 
subject to these requirements were expected to be submitted to FDA by August 10, 
2017. This will provide industry with sufficient time to submit proposed warning 
plans to FDA for review and approval. 
The warning plans should describe the random display of the warning statements 
required for packaging, the random distribution of the products in areas of the 
United States where the product is marketed, and the quarterly rotation of the 
warnings on advertisements for each brand of cigar ( 1143.5). FDA intends to 
work with the responsible manufacturer, importer, distributor, or retailer to ensure 
warning plans contain sufficient information required for approval. 
Cigar manufacturers, importers, distributors, and affected retailers may wish to 
contact FDA for assistance or questions regarding warning plan submission 
requirements. FDA may be contacted at 1-877-CTP-1373 or at the following address: 
Food and Drug Administration  
Center for Tobacco Products 
Office of Compliance and Enforcement  
Document Control Center 
 
43 In addition, the agency does not intend to enforce the labeling requirements under sections 903(a)(2) and 920(a) 
for cigars and pipe tobacco at this time. See Compliance Policy for Certain Labeling and Warning Statement 
Requirements for Cigars and Pipe Tobacco (August 2018). 
30  Contains Nonbinding Recommendations 
Building 71, Room G335  
10903 New Hampshire Avenue  
Silver Spring, MD 20993-0002 
13. What if my tobacco product does not contain nicotine? 
A tobacco product that does not contain nicotine44 is not required to bear the 
addictiveness warning if the manufacturer submits to FDA a statement certifying 
that the tobacco product does not contain nicotine and that the tobacco product 
manufacturer has data to support that assertion ( 1143.3(c)). These products are 
required to bear the alternative statement This product is made from tobacco on 
all packages and advertisements in place of the addictiveness warning ( 1143.3(c)). 
FDA may be contacted at 1-877-CTP-1373 or at the following address: 
Food and Drug Administration  
Center for Tobacco Products 
Office of Compliance and Enforcement  
Document Control Center 
Building 71, Room G335  
10903 New Hampshire Avenue  
Silver Spring, MD 20993-0002 
14. In what language must the required warnings appear on covered tobacco 
products (including cigars), cigarette tobacco, and RYO tobacco packages 
and advertisements? 
The required warning statement must be in the English language on all covered 
tobacco products, cigarette tobacco, and RYO tobacco packages. The required 
warning statement also must be in English in all covered tobacco product 
advertisements except in the following cases: 
(1)  If an advertisement appears in a foreign language publication (e.g., 
newspaper, magazine, periodical), the required warning statement must 
be in the predominant language of the publication, even if the 
advertisement is presented in a different language. The predominant 
language is the primary language used in the content in the publication 
(e.g., stories or articles featured in newspapers, magazines, periodicals). 
(2)  If an advertisement appears in an English language publication, but the 
advertisement is not presented in English, the textual portion of the 
required warning must be presented in the language principally used in 
the advertisement. 
   
 
44 As stated in footnote 5, components or parts that are not made or derived from tobacco do not meet the definition 
of covered tobacco product, and would not be required to carry an addiction warning or submit a self-certification. 
31  Contains Nonbinding Recommendations 
Table A. Compliance With Various Automatic Provisions 
FD&C Act  Compliance Upon 
Citation  Provision  Effective Date 
902(1)-(5), (8)  A tobacco product shall be deemed to be adulterated  Effective date of 
if--  part 1100 
(1) it consists in whole or in part of any filthy, putrid, 
or decomposed substance, or is otherwise 
contaminated by any added poisonous or added 
deleterious substance that may render the product 
injurious to health; 
(2) it has been prepared, packed, or held under 
insanitary conditions whereby it may have been 
contaminated with filth, or whereby it may have been 
rendered injurious to health; 
(3) its package is composed, in whole or in part, of 
any poisonous or deleterious substance which may 
render the contents injurious to health; 
(4) the manufacturer or importer of the tobacco 
product fails to pay a user fee assessed to such 
manufacturer or importer pursuant to section 919 by 
the date specified in section 919 or by the 30th day 
after final agency action on a resolution of any 
dispute as to the amount of such fee; 
(5) it is, or purports to be or is represented as, a 
tobacco product which is subject to a tobacco product 
standard established under section 907 unless such 
tobacco product is in all respects in conformity with 
such standard; 
* * * 
(8) it is in violation of section 911. 
903(a)(1)  (a) In General- A tobacco product shall be deemed to  Effective date of 
be misbranded--  part 1100 
(1) if its labeling is false or misleading in any 
particular; 
903(a)(6), (7)  (6) if it was manufactured, prepared, propagated,  Effective date of 
compounded, or processed in an establishment not  part 1100 
duly registered under section 905(b), 905(c), 905(d), 
or 905(h), if it was not included in a list required by 
section 905(i), if a notice or other information 
respecting it was not provided as required by such 
section or section 905(j), or if it does not bear such 
symbols from the uniform system for identification of 
tobacco products prescribed under section 905(e) 
32  Contains Nonbinding Recommendations 
FD&C Act  Compliance Upon 
Citation  Provision  Effective Date 
as the Secretary by regulation requires; 
(7) if, in the case of any tobacco product distributed 
or offered for sale in any State-- 
(A) its advertising is false or misleading in any 
particular; or 
(B) it is sold or distributed in violation of regulations 
prescribed under section 906(d); 
904(c)(2), (3)  (2) DISCLOSURE OF ADDITIVE- If at any time a  Effective date of 
tobacco product manufacturer adds to its tobacco  part 1100 
products a new tobacco additive or increases the 
quantity of an existing tobacco additive, the 
manufacturer shall, except as provided in paragraph 
(3), at least 90 days prior to such action so advise the 
Secretary in writing. 
(3) DISCLOSURE OF OTHER ACTIONS- If at any 
time a tobacco product manufacturer eliminates or 
decreases an existing additive, or adds or increases an 
additive that has by regulation been designated by the 
Secretary as an additive that is not a human or animal 
carcinogen, or otherwise harmful to health under 
intended conditions of use, the manufacturer shall 
within 60 days of such action so advise the Secretary 
in writing. 
905(i)(3)  (3) BIANNUAL REPORT OF ANY CHANGE IN  Effective date of 
PRODUCT LIST- Each person who registers with the  part 1100 
Secretary under this section shall report to the 
Secretary once during the month of June of each year 
and once during the month of December of each year 
the following: 
(A) A list of each tobacco product introduced by the 
registrant for commercial distribution which has not 
been included in any list previously filed by that 
person with the Secretary under this subparagraph or 
paragraph (1). A list under this subparagraph shall list 
a tobacco product by its established name and shall be 
accompanied by the other information required by 
paragraph (1). 
(B) If since the date the registrant last made a report 
under this paragraph that person has discontinued 
the manufacture, preparation, compounding, or 
processing for commercial distribution of a tobacco 
product included in a list filed under subparagraph 
33  Contains Nonbinding Recommendations 
FD&C Act  Compliance Upon 
Citation  Provision  Effective Date 
(A) or paragraph (1), notice of such discontinuance, 
the date of such discontinuance, and the identity of 
its established name. 
(C) If since the date the registrant reported under 
subparagraph (B) a notice of discontinuance that 
person has resumed the manufacture, preparation, 
compounding, or processing for commercial 
distribution of the tobacco product with respect to 
which such notice of discontinuance was reported, 
notice of such resumption, the date of such 
resumption, the identity of such tobacco product by 
established name, and other information required by 
paragraph (1), unless the registrant has previously 
reported such resumption to the Secretary under this 
subparagraph. 
(D) Any material change in any information 
previously submitted under this paragraph or 
paragraph (1). 
911(a), 911(b)  MODIFIED RISK TOBACCO PRODUCTS  Effective date of 
[with the  (a) In General- No person may introduce or deliver for  part 1100 
exception of  introduction into interstate commerce any modified 
products sold or  risk tobacco product unless an order issued pursuant 
distributed  to subsection (g) is effective with respect to such 
using the  product. 
descriptors set  (b) Definitions- In this section: 
forth in 
(1) MODIFIED RISK TOBACCO PRODUCT- The 
911(b)(2)(A)(ii)
term `modified risk tobacco product' means any 
] 
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. 
(2) SOLD OR DISTRIBUTED- 
(A) IN GENERAL- With respect to a tobacco 
product, the term `sold or distributed for use to 
reduce harm or the risk of tobacco-related disease 
associated with commercially marketed tobacco 
products' means a tobacco product-- 
(i) the label, labeling, or advertising of which 
represents explicitly or implicitly that-- 
(I) the tobacco product presents a lower risk of 
tobacco-related disease or is less harmful than one or 
more other commercially marketed tobacco products; 
34  Contains Nonbinding Recommendations 
FD&C Act  Compliance Upon 
Citation  Provision  Effective Date 
(II) the tobacco product or its smoke contains a 
reduced level of a substance or presents a reduced 
exposure to a substance; or 
(III) the tobacco product or its smoke does not 
contain or is free of a substance; 
*** 
(iii) the tobacco product manufacturer of which has 
taken any action directed to consumers through the 
media or otherwise, other than by means of the tobacco 
product's label, labeling, or advertising, after the date 
of enactment of the Family Smoking Prevention and 
Tobacco Control Act, respecting the product 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 exposure to, or does not contain 
or is free of, a substance or substances. 
919(a)  919(a) Establishment of Quarterly Fee- Beginning on  See FDAs final 
the date of enactment of the Family Smoking  rule revising the 
Prevention and Tobacco Control Act, the Secretary  current user fee 
shall in accordance with this section assess user fees  regulations 
on, and collect such fees from, each manufacturer and  published 
importer of tobacco products subject to this chapter.  concurrently with 
The fees shall be assessed and collected with respect to  the Deeming 
each quarter of each fiscal year, and the total amount  Rule. 
assessed and collected for a fiscal year shall be the 
amount specified in subsection (b)(1) for such year, 
subject to subsection (c). 
   
35  Contains Nonbinding Recommendations 
Table B. Compliance Periods for Other Provisions 
FD&C Act  Compliance 
Citation  Provision  Period 
903(a)(2)  A tobacco product shall be deemed misbranded if in   
package form unless it bears a label containing--  24 months after 
(A) the name and place of business of the tobacco  the publication of 
product manufacturer, packer, or distributor;  this final 
(B) an accurate statement of the quantity of the  regulation 
contents in terms of weight, measure, or numerical 
count; 
(C) an accurate statement of the percentage of the 
tobacco used in the product that is domestically 
grown tobacco and the percentage that is foreign 
grown tobacco; and 
(D) the statement required under section 920(a), 
except that under subparagraph (B) reasonable 
variations shall be permitted, and exemptions as to 
small packages shall be established, by regulations 
prescribed by the Secretary. 
903(a)(3)  A tobacco product is misbranded--if any word,  Effective date of 
statement, or other information required by or under  part 1100 PLUS 1 
authority of this chapter to appear on the label or  year 
labeling is not prominently placed thereon with such 
conspicuousness (as compared with other words, 
statements, or designs in the labeling) and in such 
terms as to render it likely to be read and understood 
by the ordinary individual under customary 
conditions of purchase and use. 
903(a)(4)  A tobacco product is misbranded--(4) if it has an  24 months after 
established name, unless its label bears, to the  the publication of 
exclusion of any other nonproprietary name, its  this final 
established name prominently printed in type as  regulation 
required by the Secretary by regulation. 
903(a)(8)  A tobacco product is misbranded--(8) unless, in the  24 months after 
case of any tobacco product distributed or offered for  the publication of 
sale in any State, the manufacturer, packer, or  this final 
distributor thereof includes in all advertisements and  regulation 
other descriptive printed matter issued or caused to be 
issued by the manufacturer, packer, or distributor 
with respect to that tobacco product--(A) a true 
statement of the tobacco product's established name 
as described in paragraph (4), printed prominently; 
and (B) a brief statement of--(i) the uses of the 
36  Contains Nonbinding Recommendations 
FD&C Act  Compliance 
Citation  Provision  Period 
tobacco product and relevant warnings, precautions, 
side effects, and contraindications; and (ii) in the case 
of specific tobacco products made subject to a finding 
by the Secretary after notice and opportunity for 
comment that such action is appropriate to protect the 
public health, a full description of the components of 
such tobacco product or the formula showing 
quantitatively each ingredient of such tobacco 
product to the extent required in regulations which 
shall be issued by the Secretary after an opportunity 
for a hearing. 
904(a)(1) and  (a)(1) REQUIREMENT.--Each tobacco product  Effective date of 
904(c)(1)  manufacturer or importer, or agents thereof, shall  part 1100 PLUS 6 
submit to the Secretary the following information:  months (products 
(1) Not later than 6 months after the date of  on the market as 
enactment of the Family Smoking Prevention and  of the effective 
Tobacco Control Act, a listing of all ingredients,  date) or 90 days 
including tobacco, substances, compounds, and  before delivery 
additives that are, as of such date, added by the  for introduction 
manufacturer to the tobacco, paper, filter, or other  into interstate 
part of each tobacco product by brand and by  commerce 
quantity in each brand and subbrand.  (products entering 
the market after 
 
the effective 
(c) TIME FOR SUBMISSION.-- 
date). 
(1) IN GENERAL.--At least 90 days prior to the 
delivery for introduction into interstate commerce of 
a tobacco product not on the market on the date of 
enactment of the Family Smoking Prevention and 
Tobacco Control Act, the manufacturer of such 
product shall provide the information required under 
subsection (a). 
904(a)(3)  REQUIREMENT.--Each tobacco product  6 months from the 
manufacturer or importer, or agents thereof, shall  publication date 
submit to the Secretary the following information:  of a final 
(3) Beginning 3 years after the date of enactment of  guidance 
the Family Smoking Prevention and Tobacco Control  regarding HPHC 
Act, a listing of all constituents, including smoke  reporting under 
constituents as applicable, identified by the Secretary  section 904(a)(3) 
as harmful or potentially harmful to health in each 
or 
tobacco product, and as applicable in the smoke of 
each tobacco product, by brand and by quantity in 
9 months from the 
each brand and subbrand. 
publication date 
37  Contains Nonbinding Recommendations 
FD&C Act  Compliance 
Citation  Provision  Period 
 
of a final 
(c) TIME FOR SUBMISSION.-- 
guidance 
(1) IN GENERAL.--At least 90 days prior to the 
regarding HPHC 
delivery for introduction into interstate commerce of 
reporting under 
a tobacco product not on the market on the date of 
section 904(a)(3), 
enactment of the Family Smoking Prevention and 
for small tobacco 
Tobacco Control Act, the manufacturer of such 
product 
product shall provide the information required under 
manufacturers.45  
subsection (a). 
or 
For products 
entering the 
market after the 
publication date 
of a final 
guidance 
regarding HPHC 
reporting under 
section 904(a)(3): 
90 days prior to 
marketing 
904(a)(4)  REQUIREMENT.--Each tobacco product  Effective date of 
manufacturer or importer, or agents thereof, shall  part 1100 PLUS 6 
submit to the Secretary the following information:  months 
(4) Beginning 6 months after the date of enactment of 
the Family Smoking Prevention and Tobacco Control 
Act, all documents developed after such date of 
enactment that relate to health, toxicological, 
behavioral, or physiologic effects of current or future 
tobacco products, their constituents (including smoke 
constituents), ingredients, components, and additives. 
905(b), (c), (d),  905(b)--REGISTRATION BY OWNERS AND  If the final rule 
and (h)  OPERATORS.--On or before December 31 of each  publishes in the 
year, every person who owns or operates any  second half of the 
establishment in any State engaged in the manufacture,  calendar year, FDA 
preparation, compounding, or processing of a tobacco  intends to issue a 
 
45 For this compliance policy, the term small tobacco product manufacturer has the meaning given that term under 
the statute, i.e., a tobacco product manufacturer that employs fewer than 350 employees. For purposes of 
determining the number of employees of a manufacturer under the preceding sentence, the employees of a 
manufacturer are deemed to include the employees of each entity that controls, is controlled by, or is under common 
control with such manufacturer. 
38  Contains Nonbinding Recommendations 
FD&C Act  Compliance 
Citation  Provision  Period 
product or tobacco products shall register with the  compliance policy 
Secretary the name, places of business, and all such  with a compliance 
establishments of that person. If enactment of the  period for 
Family Smoking Prevention and Tobacco Control Act  registration that is 
occurs in the second half of the calendar year, the  no later than 6 
Secretary shall designate a date no later than 6 months  months into the 
into the subsequent calendar year by which registration  subsequent 
under this subsection shall occur.  calendar year. 
905(c)--REGISTRATION BY NEW OWNERS 
AND OPERATORS.--Every person upon first 
engaging in the manufacture, preparation, 
compounding, or processing of a tobacco product or 
tobacco products in any establishment owned or 
operated in any State by that person shall 
immediately register with the Secretary that person's 
name, place of business, and such establishment. 
905(d)--REGISTRATION OF ADDED 
ESTABLISHMENTS.--Every person required to 
register under subsection (b) or (c) shall immediately 
register with the Secretary any additional 
establishment which that person owns or operates in 
any State and in which that person begins the 
manufacture, preparation, compounding, or 
processing of a tobacco product or tobacco. 
905(i)(1)  PRODUCT LIST.--Every person who registers with  Same compliance 
the Secretary under subsection (b), (c), (d), or (h)  period as that for 
shall, at the time of registration under any such  initial 
subsection, file with the Secretary a list of all tobacco  registration, see 
products which are being manufactured, prepared,  date specified for 
compounded, or processed by that person for  905(b). 
commercial distribution and which have not been 
included in any list of tobacco products filed by that 
person with the Secretary under this paragraph or 
paragraph (2) before such time of registration. Such 
list shall be prepared in such form and manner as the 
Secretary may prescribe and shall be accompanied 
by-- 
(A) in the case of a tobacco product contained in the 
applicable list with respect to which a tobacco 
product standard has been established under section 
907 or which is subject to section 910, a reference to 
the authority for the marketing of such tobacco 
39  Contains Nonbinding Recommendations 
FD&C Act  Compliance 
Citation  Provision  Period 
product and a copy of all labeling for such tobacco 
product; 
(B) in the case of any other tobacco product contained 
in an applicable list, a copy of all consumer 
information and other labeling for such tobacco 
product, a representative sampling of advertisements 
for such tobacco product, and, upon request made by 
the Secretary for good cause, a copy of all 
advertisements for a particular tobacco product; and 
(C) if the registrant filing a list has determined that a 
tobacco product contained in such list is not subject to 
a tobacco product standard established under section 
907, a brief statement of the basis upon which the 
registrant made such determination if the Secretary 
requests such a statement with respect to that 
particular tobacco product. 
907(a)(1)(B)  (B) ADDITIONAL SPECIAL RULE.--Beginning 2  Effective date of 
years after the date of enactment of the Family  part 1100 PLUS 2 
Smoking Prevention and Tobacco Control Act, a  years 
tobacco product manufacturer shall not use tobacco, 
including foreign grown tobacco, that contains a 
pesticide chemical residue that is at a level greater 
than is specified by any tolerance applicable under 
Federal law to domestically grown tobacco. 
911(b)(2)(A)(ii)  911(a)--IN GENERAL.--No person may introduce or  Use of light, 
deliver for introduction into interstate commerce any  low, and mild 
modified risk tobacco product unless an order issued  descriptors: 
under subsection (g) is effective with respect to such  Effective date of 
product.  part 1100 PLUS 1 
year (stop 
911(b)(1)--MODIFIED RISK TOBACCO  manufacture); 
PRODUCT.--The term 'modified risk tobacco  Effective date of 
product' means any tobacco product that is sold or  part 1100 PLUS 
distributed for use to reduce harm or the risk of  13 months (stop 
tobacco-related disease associated with commercially  distribution) 
marketed tobacco products. 
(2) SOLD OR DISTRIBUTED.-- 
(A) IN GENERAL.--With respect to a tobacco 
product, the term 'sold or distributed for use to 
reduce harm or the risk of tobacco-related disease 
associated with commercially marketed tobacco 
products' means a tobacco product-- 
40  Contains Nonbinding Recommendations 
FD&C Act  Compliance 
Citation  Provision  Period 
* * * 
(ii) the label, labeling, or advertising of which uses 
the descriptors light, mild, or low or similar 
descriptors; or 
* * * 
(3) EFFECTIVE DATE.--The provisions of 
paragraph (2)(A)(ii) shall take effect 12 months after 
the date of enactment of the Family Smoking 
Prevention and Tobacco Control Act for those 
products whose label, labeling, or advertising 
contains the terms described in such paragraph on 
such date of enactment. The effective date shall be 
with respect to the date of manufacture, provided that, 
in any case, beginning 30 days after such effective 
date, a manufacturer shall not introduce into the 
domestic commerce of the United States any product, 
irrespective of the date of manufacture, that is not in 
conformance with paragraph (2)(A)(ii). 
920(a)(1)  (1) REQUIREMENT.--Beginning 1 year after the  24 months after 
date of enactment of the Family Smoking Prevention  the publication of 
and Tobacco Control Act, the label, packaging, and  this final 
shipping containers of tobacco products other than  regulation 
cigarettes for introduction or delivery for 
introduction into interstate commerce in the United 
States shall bear the statement 'Sale only allowed in 
the United States.' 
   
41  Contains Nonbinding Recommendations 
DOCUMENT HISTORY 
May 2016  First edition of guidance issued. 
December 2016  Clarifying and corrective edits made throughout the document. Information 
regarding prohibition on free samples added. 
August 2018  Section III.A.10 and A.15 are revised to reflect changes to certain compliance 
dates, including the premarket review compliance policy for deemed products on the market as 
of August 8, 2016. Section III.A.14 and C.9-11 of guidance are revised to reflect a stay of 
enforcement of the warning requirements for cigars and pipe tobacco (21 CFR  1143.3 and 
1143.5) after the United States District Court for the District of Columbia granted plaintiffs 
motion for an injunction pending appeal. Cigar Assn of America v. FDA, No. 1:16-cv-01460 
(D.D.C.) (order granting injunction pending appeal) as well as FDAs intention to not enforce the 
requirements under sections 903(a)(2) and 920(a) of the FD&C Act for cigars and pipe tobacco 
while the injunction remains in effect. 
 Clarifying and corrective edits made throughout the document. 
November 2018  Revised compliance date for Ingredient listing to provide a six- month 
extension for small-scale tobacco product manufacturers and importers impacted by recent 
natural disasters. 
March 2019  Revised the HPHC reporting compliance date to six-months, and nine- months 
for small tobacco product manufacturers, from the publication date of a final guidance regarding 
HPHC reporting under section 904(a)(3). 
April 2020  Section III.A.10, 11, and 14, Section III.C.9, and Table B are revised to reflect the 
courts order in Am. Academy of Pediatrics, et al. v. FDA, No. PWG-18-883 (D.Md.) and in 
Cigar Assn of America v. FDA, Nos. 16-1460 and 18-1797 (D.D.C. Feb. 3, 2020), and FDAs 
issuance of the Guidance for Industry, Enforcement Priorities for Electronic Nicotine Delivery 
Systems (ENDS) and Other Deemed Products on the Market Without Premarket Authorization. 
 Section I, Section II.C, Section III.A.7 and Section III.B have been revised to reflect that the 
federal minimum age of sale has since been increased to 21, and FDA has been instructed to 
issue a final rule to, among other things, update all references to persons younger than 18 years 
of age in 21 C.F.R. part 1140 subpart B. See Further Consolidated Appropriations Act, 2020, 
Pub. L. No. 116-94,  603 (2019). 
 Clarifying and corrective edits made throughout the document. 
October 2020  Sections II.D, E, F, G, and H, III.A.10, 11, and 14, and III.C.9, 10, and 11 are 
revised to reflect the court decisions in Cigar Assn of Am., v. FDA, Case No. 1:16- cv-01460 
(APM), 2020 WL 4816459 (D.D.C. Aug. 19, 2020) (Dkt. No. 214); Cigar Assn of America v. 
FDA, 964 F.3d 56 (D.C. Cir. 2020); Cigar Assn of America v. FDA, No. 1:16-cv-01460, 
ECF 228 (D.D.C. Sept. 11, 2020); and In re Cigar Assn of Am., 812 Fed. Appx. 128 (4th Cir. 
May 4, 2020). 
42  Contains Nonbinding Recommendations 
March 2023Revised to note the amendments made by the Consolidated 
Appropriations Act (CAA) (Pub. L. 117-103). Among other things, the legislation 
amends the definition of tobacco product in section 201(rr) of the FD&C Act to 
include products containing nicotine from any source and makes tobacco 
products containing nicotine not made or derived from tobacco subject to Chapter 
IX of the FD&C Act without being deemed by regulation under section 901(b). 
The CAA further amends the definition of a tobacco product to exclude articles 
that are foods under section 201(f) of the FD&C Act if such articles contain no 
nicotine or no more than trace amounts of naturally occurring nicotine.  A new 
footnote added to Section I explains these amendments. 
43