Interpretation of and Compliance 
Policy for Certain Label 
Requirement; Applicability of 
Certain Federal Food, Drug, and 
Cosmetic Act Requirements to Vape 
Shops (Revised)* 
Guidance for Industry 
GUIDANCE 
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 
Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Room 1061, Rockville, MD 20852. All comments should be identified with Docket No. FDA- 
2017-D-0120. 
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/Labeling/RulesRegulationsGuidance/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 a revision to the first edition of this guidance, which issued in March 2019.  Revisions 
are noted by date at the end of the guidance. Contains Nonbinding Recommendations 
Table of Contents 
I.  INTRODUCTION ................................................................................................................. 2 
II.  BACKGROUND .................................................................................................................... 3 
A.  Section 904 of the FD&C Act ..................................................................................... 4 
B.  Section 910 of the FD&C Act ..................................................................................... 4 
C.  Section 905 of the FD&C Act ..................................................................................... 4 
III. DEFINITIONS ....................................................................................................................... 5 
IV.  DISCUSSION ......................................................................................................................... 7 
A.  FDAs Interpretation of and Compliance Policy for the Requirement Under 
Section 903(a)(2)(C) that the Label Include an Accurate Statement of the 
Percentage of Foreign and Domestic Grown Tobacco ............................................ 7 
B.  Vape Shop Activities and the Requirements of the FD&C Act .............................. 7 
1.  Activities That Modify a Product ............................................................................ 8 
2.  Activities That Do Not Modify the Product ........................................................... 10 
 
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Contains Nonbinding Recommendations 
Interpretation of and Compliance Policy for 
Certain Label Requirement; Applicability of 
Certain Federal Food, Drug, and Cosmetic 
Act Requirements to Vape Shops 
Guidance for Industry1 
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 guidance document is intended to assist retailers2 who sell newly deemed products3 by 
explaining whether engaging in certain activities subjects such establishments to additional 
requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and identifying the 
limited circumstances under which FDA does not intend to enforce compliance. This guidance 
document discusses, among other things: 
  Definitions 
  FDAs interpretation of and compliance policy for the label requirement in section 
903(a)(2)(C) of the FD&C Act 
  Which activities subject vape shops to certain requirements of the FD&C Act 
  Limited circumstances under which FDA does not intend to enforce compliance4 
 
1 This guidance was prepared by the Office of Regulations in the Center for Tobacco Products at FDA. 
2 While this guidance discuses vape shops, FDA considers it to apply to any establishment that performs the 
described activities for tobacco products, such as retail stores that sell waterpipes or pipes. 
3 See FDAs final rule, Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as 
Amended by the Family Smoking Prevention and Tobacco Control Act (81 FR 28973, May 10, 2016) (the deeming 
rule), available at https://www.gpo.gov/fdsys/pkg/FR-2016-05-10/pdf/2016-10685.pdf. 
4 The compliance policies described in this guidance are separate and apart from the compliance policies described 
in the preamble to the deeming rule. For more information on those policies, please refer to the preamble of the 
Deeming rule as well as to the guidances for industry on Extension of Certain Tobacco Product Compliance 
Deadlines Related to the Final Deeming Rule (Revised November 2017) (the compliance dates announced in that 
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Contains Nonbinding Recommendations 
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities. Instead, guidances 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 guidances means that something is suggested or 
recommended, but not required. 
II.  BACKGROUND 
On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act 
(Tobacco Control Act) (Public Law 111-31) into law. The Tobacco Control Act granted FDA 
authority to regulate the manufacture, marketing, and distribution of cigarettes, cigarette tobacco, 
roll-your-own tobacco (RYO), and smokeless tobacco products to protect the public health and 
to reduce tobacco use by minors. 
The Tobacco Control Act also gave FDA the authority to issue a regulation deeming other 
products that meet the statutory definition of tobacco product to be subject to FDAs tobacco 
product authority under chapter IX of the FD&C Act (section 901(b) of the FD&C Act). On May 
10, 2016, FDA issued the deeming rule extending FDAs tobacco product authority to all 
products, other than accessories of newly deemed products, that meet the statutory definition of 
tobacco product, including electronic nicotine delivery systems (ENDS) (81 FR 28973) (the 
deeming rule).5,6 The definition of tobacco product in Section 201 (rr) of the FD&C Act was 
amended on March 15, 2022, to include products containing nicotine from any source (Pub. L. 
117-103), and tobacco products containing nicotine that is not made or derived from tobacco 
became immediately subject to FDAs tobacco product authorities under Chapter IX of the 
FD&C Act without having to be deemed by regulation (see Pub. L. 117-103, section 111(b)). 
Retail establishments that engage in certain activities may also be subject to particular 
requirements of the FD&C Act that apply to tobacco product manufacturers and to 
establishments that engage in the manufacture, preparation, compounding, or processing of 
tobacco products. These activities may include modifying a product so that it is a new tobacco 
product subject to premarket review. As explained in the deeming rule, the FD&C Act 
authorizes FDA to regulate the manufacture of new tobacco products including those 
manufactured at the retail level. This is important to FDAs ability to protect the public health 
because products manufactured at the retail level pose many of the same risks as those 
manufactured upstream and possibly additional risks related to the lack of standard 
manufacturing practices and controls (81 FR 28973 at 29044). 
 
guidance supersede the compliance dates included in any other guidance issued prior to it), Registration and Product 
Listing for Owners and Operators of Domestic Tobacco Product Establishments (Revised December 2017), Listing 
of Ingredients for Tobacco Products (Revised April 2018), and Health Document Submission Requirements for 
Tobacco Products (Revised October 2017). 
5 Deeming rule (81 FR 28973). 
6 The requirements in section 904(a) of the FD&C Act also apply to importers. 
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Contains Nonbinding Recommendations 
A.  Section 904 of the FD&C Act 
Section 904(a) of the FD&C Act sets forth certain requirements for tobacco product 
manufacturers.6 These requirements include: 
  Ingredient listing (section 904(a)(1) of the FD&C Act); 
  Reporting of harmful or potentially harmful constituents (HPHCs) (section 
904(a)(3) of the FD&C Act); and 
  Tobacco health document submission (section 904(a)(4) of the FD&C Act). 
Section 904(c) of the FD&C Act requires the submission of information when 
changing any, or the quantity of any, additive in an existing tobacco product or 
introducing into interstate commerce a tobacco product that was not previously on 
the market.7  
As explained in the deeming rule, the requirements of section 904(a) and (c) of the 
FD&C Act apply to manufacturers of the newly deemed products, including ENDS 
retail establishments that mix or prepare e-liquids or create or modify aerosolizing 
apparatus, also referred to as e- cigarettes, for sale or distribution (81 FR 28973 at 
29046). 
B.  Section 910 of the FD&C Act 
Under section 910 of the FD&C Act, new tobacco products are subject to 
premarket review.8 As explained in the deeming rule, ENDS retailers engaged in 
mixing or preparing e-liquids or creating or modifying aerosolizing apparatus, also 
referred to as e-cigarettes, are required to obtain premarket authorization for each 
new tobacco product that they prepare for sale or distribution to consumers (81 FR 
28973 at 29044). If a tobacco product that is required to have marketing 
authorization is marketed without authorization, the product is adulterated under 
section 902(6)(A) of the FD&C Act. 
C.  Section 905 of the FD&C Act 
Additionally, section 905(b) of the FD&C Act requires that every person who 
owns or operates any establishment in any State engaged in the manufacture, 
preparation, compounding, or processing of a tobacco product or tobacco products 
register with FDA the name, places of business, and all establishments engaged in 
these activities owned or operated by that person. 
 
7 For more information, please see the guidances for industry Listing of Ingredients for Tobacco Products (Revised 
April 2018) and Health Document Submission Requirements for Tobacco Products (Revised October 2017). 
8 The term new tobacco product is defined in section 910(a)(1) of the FD&C Act and set out for convenience in 
section III of this guidance. 
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Contains Nonbinding Recommendations 
For purposes of section 905, manufacture, preparation, compounding, or 
processing includes repackaging, or otherwise changing the container, wrapper, 
or labeling of any tobacco product package in furtherance of the distribution of the 
tobacco product from the original place of manufacture to the person who makes 
the final delivery or sale to the ultimate consumer or user. Following the initial 
registration, every person must register annually by December 31 of each year. 
Section 905(i)(1) of the FD&C Act requires that all registrants shall, at the time of 
registration... file with [FDA] a list of all tobacco products which are being 
manufactured, prepared, compounded, or processed by that person for commercial 
distribution, along with certain accompanying information, including all labeling. 
In addition, section 905(i)(3) of the FD&C Act requires that certain changes in the 
product list be submitted biannually.9 As explained in the deeming rule, if an ENDS 
retail establishment engages in the manufacture, preparation, compounding, or 
processing of tobacco products, it is required to register and list its products with 
FDA in accordance with section 905 of the FD&C Act (81 FR 28973 at 29046). 
III.  DEFINITIONS 
For the purposes of this guidance, FDA intends to use the following definitions: 
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.  
(21 CFR 1100.3) 
Composition, as used in this definition, means the manner in which the materials, including, 
for example, ingredients, additives, and biological organisms (e.g., micro-organisms added for 
fermentation in smokeless products), are arranged and integrated. 
Examples of objects used with ENDS (including e-cigarettes) that would likely be considered 
accessories include screwdrivers and lanyards. 
 
9 For more information, please see Guidance for Industry: Registration and Product Listing for Owners and 
Operators of Domestic Tobacco Product Establishments (Revised December 2017). 
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Contains Nonbinding Recommendations 
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. (21 CFR 
1100.3) 
The following is a nonexhaustive list of examples of components or parts of 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; 
clearomizers (refillable e-liquid cartridges with built-in atomizer and wicking system), tank 
systems, flavors, bottles that contain e-liquids, and programmable software. 
For purposes of this guidance, FDA is using the terms component and part interchangeably and 
without emphasizing a distinction. FDA may clarify distinctions between component and part in 
the future. 
New tobacco product means: 
(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. 
(Section 910(a)(1) of the FD&C Act (21 U.S.C. 387j(a)(1))) 
Tobacco product is defined in section 201(rr) of the FD&C Act, which states in relevant part: 
(1) The term tobacco product means any product made or derived from tobacco, or 
containing nicotine from any source, 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).10  
(2) The term tobacco product does not mean an article that under the FD&C Act is a 
drug (section 201(g)(1)), a device (section 201(h)), or a combination product (section 
 
10 Note that this definition includes accessories and components and parts of tobacco products, whether they are 
made or derived from tobacco or contain nicotine from any source, and whether they are sold or distributed as 
finished tobacco products. However, as explained above, accessories of tobacco products subject to the deeming rule 
are explicitly excluded from the rules deeming provision. Thus, although they meet the definition of tobacco 
product, such accessories are not currently subject to regulation under chapter IX of the FD&C Act. 
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Contains Nonbinding Recommendations 
503(g)) (Section 201(rr)(2)). The term tobacco product does not mean an article 
that is a food under section 201(f) if such article contains no nicotine, or no more than 
trace amounts of naturally occurring nicotine (section 201(rr)(5)).  
IV.  DISCUSSION 
A.  FDAs Interpretation of and Compliance Policy for the Requirement Under 
Section 903(a)(2)(C) that the Label Include an Accurate Statement of the 
Percentage of Foreign and Domestic Grown Tobacco 
Under section 903(a)(2)(C) of the FD&C Act, a tobacco product in package form is 
misbranded if its label does not include an accurate statement of the percentage of 
tobacco used in the product that is foreign-grown and domestic-grown. FDA 
interprets this provision as applying only to tobacco products that are made or 
derived from tobacco. Therefore, tobacco products (including components, parts, 
and accessories) that are not made or derived from tobacco, such as cigarette filters, 
hookah pipes, and ENDS batteries, would not be required to bear an accurate 
statement of the percentage of foreign and domestic grown tobacco used in those 
products. Additionally, at this time, FDA does not intend to enforce the requirement 
in section 903(a)(2)(C) of the FD&C Act that tobacco products in package form 
bear a label with an accurate statement of the percentage of foreign- and domestic-
grown tobacco for those products that are made or derived from tobacco, including 
tobacco-derived liquid nicotine, e-liquid made or derived from tobacco, cigars, 
smokeless tobacco, and waterpipe tobacco. FDA is providing this compliance 
policy because it recognizes the current scientific and technical difficulties, in many 
circumstances, of quantifying the percentage of foreign and domestic tobacco used 
in these products. For example, these difficulties include lot-to-lot variation in 
tobacco, difficulties in discerning tobacco source percentages after mixing with 
other ingredients, and limitations on access to proprietary ingredient information 
from a supplier. To the extent that the circumstances relevant to compliance with 
this requirement change in the future, FDA intends to reassess this policy. 
B.  Vape Shop Activities and the Requirements of the FD&C Act 
Vape shops that are tobacco product manufacturers are subject to the requirements 
in section 904(a) and (c) the FD&C Act, including the requirements to provide 
ingredient listings, report HPHCs, and submit health documents. Vape shops that 
modify a product so that it is a new tobacco product as defined in section 910 are 
required to comply with the premarket authorization requirements. Finally, vape 
shops that are engaged in the manufacture, preparation, compounding, or processing 
of tobacco products are required to comply with establishment registration and 
product listing in accordance with section 905 of the FD&C Act. Below, we discuss 
whether vape shops engaged in certain activities are subject to the requirements 
described above and, if so, under what circumstances FDA generally does not 
intend to enforce compliance. 
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Contains Nonbinding Recommendations 
1.  Activities That Modify a Product 
a.  Modifications Outside the Marketing Authorization Order 
Generally, new tobacco products must obtain premarket authorization through the 
premarket tobacco application (PMTA), substantial equivalence (SE), or substantial 
equivalence exemption (SE exemption) pathway. Section 910(a)(2) of the FD&C 
Act. A vape shops modifying a product outside the marketing authorization order 
for that product would generally result in a new tobacco product for which the vape 
shop is required to seek premarket authorization (see section 910). Additionally, the 
vape shop generally would be required to comply with the ingredient listing, HPHC 
reporting, and health document submission requirements in section 904 of the 
FD&C Act as well as registration and listing in accordance with section 905 of the 
FD&C Act. 
b.  Modifications to Products on the Market as of August 8, 2016, that do not yet 
have a Marketing Authorization Order 
For products that do not yet have marketing authorization orders, a vape shops 
modifying a product would generally result in a new tobacco product for which the 
vape shop is required to seek premarket authorization (see section 910). 
Additionally, the vape shop generally would be required to comply with the 
ingredient listing, HPHC reporting, and health document submission requirements 
in section 904 of the FD&C Act as well as registration and listing in accordance 
with section 905 of the FD&C Act. However, if an original manufacturer has 
provided specifications11 for the tobacco product, FDA does not intend to enforce 
these requirements if the vape shop modifies a tobacco product consistent with the 
specifications provided by the original manufacturer. FDA is providing this 
compliance policy because FDA does not expect these modifications to alter the 
performance of the tobacco product as described or intended by original 
manufacturers. 
c.  Refilling Open ENDS 
If not already covered by a marketing authorization order, a vape shops refilling an 
open ENDS product12 would generally result in a new tobacco product for which 
the vape shop is required to seek premarket authorization. Additionally, the vape 
shop generally would be required to comply with the ingredient listing, HPHC 
reporting, and health document submission requirements in section 904 of the 
 
11 For the purposes of this guidance, a manufacturers specification includes instructions provided with the product, 
or other apparent markings or information on the product or its package noting specifications. For example, an 
original coil included in an ENDS apparatus may be marked with wattage compatibility or ohm resistance. 
Alternatively, an ENDS apparatus package may list ENDS components or parts, by model number or other criteria 
(e.g., wattage), that the original manufacturer represents would be compatible with the product. 
12 For the purposes of this guidance, the term open ENDS refers to those ENDS that include a refillable e-liquid 
reservoir (previously referred to as an open system ENDS). 
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Contains Nonbinding Recommendations 
FD&C Act as well as registration and listing in accordance with section 905 of the 
FD&C Act. However, if the vape shop does not make any further modifications to 
the product or any modifications to the e-liquid (e.g., mixing) before, during, or 
after the refill, that are either outside the marketing authorization order or, if there is 
no marketing authorization order, inconsistent with the original manufacturer 
specifications, then FDA does not intend to enforce these requirements. 
d.  Examples13 
If a vape shop performs the following activities in the examples below, the vape 
shop would be: modifying a product (and thus required to seek premarket 
authorization pursuant to section 910 of the FD&C Act); a tobacco product 
manufacturer (and thus required to submit ingredient lists, HPHC reports, and 
health documents pursuant to section 904 of the FD&C Act); and engaged in the 
manufacture, preparation, compounding, or processing of tobacco products (and 
thus required to register and list pursuant to section 905 of the FD&C Act): 
  A vape shop that modifies a closed ENDS14 to refill it for a customer. 
  A vape shop that repairs and modifies an atomizer head, and the modification is 
outside the marketing authorization order. 
  A vape shop that replaces the coils in an ENDS product that was on the market 
as of August 8, 2016 but that does not yet have a marketing authorization order 
with coils that have a different ohm15 and/or wattage rating.16 If there are no 
specifications from the original manufacturer, then the vape shop would not be 
subject to the compliance policy described above (in section IV.B.1.b). 
  A vape shop that assembles a custom final product17 from components or parts 
sold individually or from multiple pre-built kits, that were on the market as of 
August 8, 2016 but that do not yet have marketing authorization orders.18  
 
13 The examples provided are not intended to be an exhaustive list and any specific modifications will be considered 
on a case-by-case basis. 
14 For the purposes of this guidance, the term closed ENDS refers to those ENDS that include an e-liquid reservoir 
that is not refillable (previously referred to as a closed system ENDS). 
15 Ohms are the units used to measure and describe electrical resistance. 
16 Wattage rating is a rating expressing maximum power that a device can safely handle continuously. 
17 For the purposes of this guidance, a custom final product is one that is assembled from multiple off-the-shelf 
components or parts where the assembled product is not covered by a marketing authorization order, or if the 
components or parts do not yet have marketing authorization orders but were on the market as of August 8, 2016, 
the assembled product is inconsistent with the original manufacturers specifications. For example, if an ENDS 
retailer assembled a product from an off-the-shelf tank, battery, and atomizer, none of which have a marketing 
authorization order but all of which have been on the market as of August 8, 2016, if the assembled product is 
inconsistent with the original manufacturers specifications and is not covered by a marketing authorization order, it 
is a custom final product. A custom final product would not include a final product assembled from components and 
parts from multiple pre-built kits or sold individually if the final assembled product consists of components and parts 
that are also available packaged together in a single pre-built ENDS kit covered by a marketing authorization order 
or that was on the market as of August 8, 2016. 
18 If a vape shop assembled a product from multiple off-the-shelf components or parts that were on the market as of 
August 8, 2016 (but that do not yet have marketing authorization orders), consistent with the original manufacturers 
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Contains Nonbinding Recommendations 
2.  Activities That Do Not Modify the Product 
If a vape shop does not modify the tobacco product, the shop is not required to 
obtain premarket authorization. To the extent that the vape shop is required to 
comply with the ingredient listing, HPHC reporting, and health document 
submission requirements in section 904 of the FD&C Act as well as registration and 
listing in accordance with section 905 of the FD&C Act, FDA does not intend to 
enforce these requirements if the tobacco product is not modified. 
If a vape shop performs the following activities in the examples below, the vape 
shop would not be required to seek premarket authorization; submit ingredient lists, 
HPHC reports, and health documents in accordance with section 904 of the FD&C 
Act; or register and list in accordance with section 905 of the FD&C Act: 
  A vape shop that demonstrates the use of an ENDS product without assembling 
the product, including by providing instruction designed to assist users on the 
correct use of the product.19 
  A vape shop that explains how to charge the battery or fill the ENDS tank, or 
how to turn on the ENDS device 
If a vape shop performs the activities in the examples below, the vape shop would 
not be required to seek premarket authorization. To the extent that the vape shop 
would be a tobacco product manufacturer (and thus required to submit ingredient 
lists, HPHC reports, and health documents pursuant to section 904 of the FD&C 
Act) and engaged in the manufacture, preparation, compounding, or processing of 
tobacco products (and thus required to register and list pursuant to section 905 of 
the FD&C Act), FDA does not intend to enforce those requirements: 
  A vape shop that maintains an ENDS product by cleaning or tightening fixtures 
(e.g., screws) 
  A vape shop that replaces the coils in an ENDS product with identical coils 
from the same manufacturer (e.g., same ohm and wattage rating) 
  A vape shop that assembles a final product from the components or parts 
packaged together in a pre-built ENDS kit or from components and parts sold 
individually or from multiple kits if the final assembled product consists of 
components and parts that are also available packaged together in a single pre-
built ENDS kit. 
   
 
specifications, that assembled product would not be a custom final product. Additionally, the vape shop would be 
subject to the compliance policy described above (in section IV.B.1.b). 
19 Note, however, that permitting a potential purchaser to consume the product as part of a demonstration or 
explanation would be a violation of the ban on free samples under 1140(d)(1); it would not be a violation of the ban 
if the consumer has already purchased the product.: 
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Contains Nonbinding Recommendations 
DOCUMENT HISTORY  
June 2019  First edition of guidance issued.  
March 2023  Definition of tobacco product updated to reflect statutory amendments made by 
the Consolidated Appropriations Act, 2022 (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. 
  Section II.  Updated Background to include amendment to Section 201(rr) and 901(b) 
of the FD&C Act.  
  Section III.  Updated the definition of tobacco product.  
11