FDA Regulation of Tobacco Products
February 7, 2020
Cigarette use remains the leading cause of preventable death in the United States, claiming an
estimated 480,000 lives or more each year. Although cigarette use in the United States continues
Victoria R. Green
to decline, according to the Centers for Disease Control and Prevention (CDC), 34.2 million
Analyst in Health Policy
American adults smoked cigarettes every day or some days in 2018, and nearly 1.2 million

American middle and high school students smoked cigarettes in the past 30 days in 2019.

In recent years, electronic nicotine delivery systems (ENDS) have become increasingly popular.
ENDS is an umbrella term for various types of electronic tobacco products, including electronic cigarettes (e-cigarettes). An
e-cigarette is a battery-operated device typically containing nicotine, flavorings, and other chemicals that, when heated,
creates inhalable vapor. According to CDC analyses, 8.1 million American adults used e-cigarettes every day or some days in
2018, and about 5.4 million American middle and high school students used an e-cigarette in the past 30 days in 2019. There
has been debate in the public health community regarding the impact of ENDS on public health. Some view ENDS as a safer
alternative for adult cigarette smokers, while others are alarmed by increased use among youth. Further, the emergence of e-
cigarette, or vaping, product use-associated lung injury (EVALI), which has resulted in 60 deaths and the hospitalization of
2,711 individuals as of January 21, 2020, has raised further concern among public health stakeholders, Congress, and the
general public.
FDA Regulation of Tobacco Products
The Food and Drug Administration (FDA), an agency within the Department of Health and Human Services (HHS), is
responsible for regulating the manufacture, marketing, distribution, and sale of tobacco products. FDA’s Center for Tobacco
Products (CTP)—established in 2009 pursuant to the Family Smoking Prevention and Tobacco Control Act of 2009 (TCA;
P.L. 111-31)—is primarily responsible for tobacco product regulation. The TCA amended the Federal Food, Drug, and
Cosmetic Act (FFDCA) to establish a new chapter IX (“tobacco products”), which, as enacted, applied to cigarettes, cigarette
tobacco, roll-your-own tobacco, and smokeless tobacco. However, FDA has the broad authority to regulate any other tobacco
products deemed by the agency to meet the definition of a tobacco product and thus to be subject to chapter IX of the
FFDCA. In 2016, pursuant to this authority, FDA promulgated regulations (known as “the deeming rule”) that extended the
agency’s authority over all tobacco products that were not already subject to the FFDCA, including ENDS.
Because tobacco products have no reported health benefits, FDA’s regulation of these products differs in certain respects
from FDA’s regulation of medical products (e.g., prescription drugs, medical devices). Similar to medical product
manufacturers, tobacco product manufacturers are subject to manufacturer requirements, including payment of user fees and
premarket review, among other requirements. However, while medical product manufacturers are generally required to meet
a standard of safety and effectiveness to receive premarket approval from FDA, tobacco product manufacturers are instead
generally required to meet a standard “appropriate for the protection of public health” to receive marketing authorization.
Tobacco product manufacturers, importers, distributors, and retailers are also required to comply with tobacco-specific
requirements as a result of the harm that tobacco products pose to human health. Examples of such requirements include the
development of tobacco product standards, submission of health information to the agency, and distribution and promotion
restrictions, among others.
Policy Considerations
Both FDA and Congress have taken steps to address regulation of ENDS in light of EVALI and the youth ENDS epidemic.
FDA recently finalized a guidance document expressing its enforcement priorities pertaining to certain ENDS products.
Some public health stakeholders contend that the policy will not effectively address youth use of ENDS. In parallel,
legislation introduced in the 116th Congress includes more stringent proposals than those planned by FDA to address youth
ENDS use, such as banning all flavors in tobacco products (including ENDS). In FY2020 appropriations, Congress enacted
provisions raising the federal age of tobacco purchasing from 18 to 21. To apply certain existing FFDCA requirements to
tobacco product manufacturers and retailers, such as requiring ENDS manufacturers and importers to pay user fees,
congressional action would need to be taken.
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Introduction
Cigarette use remains the leading cause of preventable death in the United States, claiming an
estimated 480,000 lives or more each year.1 Further, between 2009 and 2012, cigarette smoking-
attributable economic costs totaled over $289 billion in the United States.2 Although cigarette use
in the United States continues to decline,3 according to Centers for Disease Control and
Prevention (CDC) analyses, 34.2 million American adults smoked cigarettes every day or some
days in 2018,4 and nearly 1.2 million American middle and high school students smoked
cigarettes in the past 30 days in 2019.5
Electronic nicotine delivery systems (ENDS) have become popular in recent years, particularly
among youth. ENDS is an umbrella term for various types of electronic tobacco products,
including electronic cigarettes (e-cigarettes). An e-cigarette is a battery-operated device typically
containing nicotine, flavorings, and other chemicals that, when heated, creates inhalable aerosol
(i.e., vapor).6 According to CDC analyses, 8.1 million American adults used e-cigarettes every
day or some days in 2018.7 About 5.4 million American middle and high school students used an
e-cigarette in the past 30 days in 2019.8
There has been debate in the public health community regarding the public health impact of
ENDS products. Some view them as a safer alternative for adults who smoke cigarettes because
the aerosol produced from e-cigarettes is considered less harmful in the short-term than
combusted smoke produced from cigarettes.9 However, others are alarmed by the marked increase
in ENDS use among youth, and are concerned that these products may undo the years of tobacco

1 U.S. Department of Health and Human Services, The Health Consequences of Smoking: 50 Years of Progress. A
Report of the Surgeon General, U.S. Department of Health and Human Services, Centers for Disease Control and
Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health,
Atlanta, GA, January 2014, https://www.surgeongeneral.gov/library/reports/50-years-of-progress/50-years-of-progress-
by-section.html.
2 Ibid.
3 See MeLisa R. Creamer, Teresa W. Wang, Stephen Babb, et al., “Tobacco Product Use and Cessation Indicators
Among Adults — United States, 2018,” Morbidity and Mortality Weekly Report (MMWR), vol. 68, no. 45 (November
15, 2019), pp. 1013-1019. See also Andrea S. Gentzke, MeLisa Creamer, Karen A. Cullen, et al., “Vital Signs: Tobacco
Product Use Among Middle and High School Students — United States, 2011–2018,” MMWR, vol. 68 (2019), pp. 157-
164.
4 Current smoking is defined as using every day or some days. See MeLisa R. Creamer, Teresa W. Wang, Stephen
Babb, et al., “Tobacco Product Use and Cessation Indicators Among Adults — United States, 2018,” Morbidity and
Mortality Weekly Report (MMWR), vol. 68, no. 45 (November 15, 2019), pp. 1013-1019.
5 Teresa W. Wang, Andrea S. Gentzke, MeLisa R. Creamer, et al., “Tobacco Product Use and Associated Factors
Among Middle and High School Students — United States, 2019,” Morbidity and Mortality Weekly Report (MMWR),
vol. 68, no. 12 (December 6, 2019), pp. 1-22.
6 National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH), Electronic Cigarettes (E-cigarettes),
Retrieved from https://www.drugabuse.gov/publications/drugfacts/electronic-cigarettes-e-cigarettes, on December 13,
2018.
7 See MeLisa R. Creamer, Teresa W. Wang, Stephen Babb, et al., “Tobacco Product Use and Cessation Indicators
Among Adults — United States, 2018,” Morbidity and Mortality Weekly Report (MMWR), vol. 68, no. 45 (November
15, 2019), pp. 1013-1019.
8 Teresa W. Wang, Andrea S. Gentzke, MeLisa R. Creamer, et al., “Tobacco Product Use and Associated Factors
Among Middle and High School Students — United States, 2019,” Morbidity and Mortality Weekly Report (MMWR),
vol. 68, no. 12 (December 6, 2019), pp. 1-22.
9 National Academies of Sciences, Engineering, and Medicine, Public Health Consequences of E-Cigarettes, The
National Academies Press, p. 18, Washington, DC, 2018, https://www.nap.edu/read/24952/chapter/3.
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control efforts that have successfully reduced cigarette smoking among both youth and adults.
Further, the emergence of e-cigarette, or vaping, product use-associated lung injury (EVALI),
which has resulted in 60 deaths and 2,711 hospitalizations as of January 21, 2020, has raised
concern among public health stakeholders, Congress, and the general public.10
The Food and Drug Administration (FDA), an agency within the Department of Health and
Human Services (HHS), is responsible for regulating the manufacture, marketing, distribution,
and sale of tobacco products. FDA’s Center for Tobacco Products (CTP)—established in 2009
pursuant to the Family Smoking Prevention and Tobacco Control Act of 2009 (TCA; P.L. 111-
31)—is primarily responsible for tobacco product regulation. The TCA established FFDCA
chapter IX, under which FDA is authorized to regulate tobacco products. Within CTP, the
Tobacco Products Scientific Advisory Committee (TPSAC) provides recommendations on
tobacco regulatory decisions or any other matter listed in chapter IX of the FFDCA. The TPSAC
includes 12 members with diversified experience and expertise.11
Because tobacco products have no added health benefits, FDA’s regulation of these products
differs in certain respects from FDA’s regulation of medical products under its jurisdiction (e.g.,
prescription drugs, biologics, and medical devices). Similar to medical product manufacturers,
tobacco product manufacturers are subject to manufacturer requirements, including payment of
user fees, registration establishment, and premarket review, among others. However, while
medical product manufacturers are generally required to meet a standard of safety and
effectiveness to receive premarket approval from FDA, tobacco product manufacturers are
instead generally required to meet a standard of “appropriate for the protection of public health”
to receive marketing authorization. In addition, tobacco product manufacturers, importers,
distributors, and retailers are required to comply with certain tobacco-specific requirements that
have been authorized under the TCA as a result of the unique harms that tobacco products pose to
human health. Examples of such requirements include the development of tobacco product
standards, testing and reporting of ingredients, submission of health information to the agency,
and distribution and promotion restrictions, among others.
This report describes (1) FDA’s authority to regulate tobacco products; (2) general requirements
for manufacturers of tobacco products, many of which are modeled after medical product
requirements; (3) requirements that are unique to tobacco product manufacturers, distributors,
importers, and retailers; and (4) compliance and enforcement. The report concludes with a
discussion of policy issues and considerations for Congress. Appendix A describes the IQOS
Tobacco Heating System, Appendix B briefly summarizes the Tobacco Master Settlement
Agreement of 1998, Appendix C provides definitions of terms used in this report, and Appendix
D provides acronyms used in this report.
FDA’s Authority to Regulate Tobacco Products
As amended by the TCA, Section 901 of the FFDCA gives FDA the authority to regulate the
manufacture, marketing, sale, and distribution of tobacco products. A tobacco product is defined
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

10 Centers for Disease Control and Prevention (CDC), “Outbreak of Lung Injury Associated with the Use of E-
Cigarette, or Vaping, Products,” https://www.cdc.gov/tobacco/basic_information/e-cigarettes/severe-lung-disease.html.
11 FFDCA §917; 21 U.S.C. §387q.
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tobacco used in manufacturing a component, part, or accessory of a tobacco product).”12 Any
article that is a drug, device, or combination product (a combination of a drug, device, or
biological product) is excluded from the definition of tobacco product. Drugs, devices, and
combination products are subject to chapter V authorities under the FFDCA.13 However, it is not
always clear whether a product that is derived from tobacco should be regulated as a drug, device,
combination product, or a tobacco product (e.g., an ENDS product that makes certain health
claims). As such, FDA has promulgated regulations to provide assistance to manufacturers
intending to market products that are made or derived from tobacco based on the products’
“intended uses.”14
Upon enactment, the TCA explicitly covered the following tobacco products: cigarettes and
cigarette tobacco, roll-your-own tobacco, and smokeless tobacco.15 However, the TCA gave FDA
the broad authority to regulate any other tobacco products deemed by the agency to meet the
definition of a tobacco product and thus subject to chapter IX of the FFDCA.16 In 2016, FDA
promulgated regulations (known as “the deeming rule”) that extended the agency’s authority over
all tobacco products that were not already subject to the FFDCA, including ENDS, cigars, pipe
tobacco, hookah tobacco, nicotine gels, dissolvable tobacco, and other tobacco products that may
be developed in the future.17 Figure 1 shows each of the tobacco products currently under FDA’s
authority.

12 FFDCA §201(rr); 21 U.S.C. §321(rr).
13 Ibid.
14 FDA, “Clarification of When Products Made or Derived from Tobacco Are Regulated as Drugs, Devices, or
Combination Products: Amendments to Regulations Regarding ‘Intended Uses,’” 82 Federal Register 2193, January 9,
2017.
15 FFDCA §901(b); 21 U.S.C. §387a(b).
16 Ibid.
17 21 C.F.R. §1100.
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Figure 1. Tobacco Products Currently Under FDA’s Authority, 2020

Source: Prepared by CRS with images of smokeless tobacco products, ENDS, cigars, nicotine gels, dissolvable
tobacco, and pipe tobacco from FDA’s website. Images of cigarettes, rol -your-own tobacco, and hookah
tobacco are from Shutterstock.
Notes: Some dissolvable tobacco products can be classified as smokeless tobacco products.
Tobacco Product Regulation:
Manufacturer Requirements
Tobacco product manufacturers are subject to certain requirements, including payment of user
fees, registration establishment, premarket review, and postmarket surveillance, among others. In
the sections below, manufacturer requirements are discussed for tobacco products overall, with
exceptions for issues unique to certain classes of tobacco products.
User Fees
Pursuant to its authorities in the FFDCA, FDA is required to assess and collect user fees from
domestic manufacturers and importers of tobacco products and use the funds to support CTP’s
activities.18 Similar to FDA’s other user fee programs, the agency assesses and collects fees from
industry sponsors of certain FDA-regulated products—in this case, tobacco manufacturers and
importers—and uses those funds to support statutorily defined activities.19 However, in contrast to
other FDA centers that are generally funded by a combination of discretionary appropriations
from the General Fund and user fees, CTP is funded solely by user fees. The tobacco product fee
authorities are also indefinite. Thus, unlike medical product fees that are authorized in legislation
on a five-year cycle, tobacco product fees do not require reauthorization. As with other FDA user

18 FFDCA §919; 21 U.S.C. §387s.
19 For more information, see CRS Report R44576, The Food and Drug Administration (FDA) Budget: Fact Sheet.
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fees, the tobacco fees are available only pursuant to an annual appropriation from Congress,
which provides FDA the authority to collect and spend fees.20
Tobacco user fees are assessed and collected quarterly, and the total user fee amount that can be
authorized and collected each year is specified in statute.21 For FY2019 and subsequent fiscal
years, this amount is $712 million. The total user fee amount is assessed among six tobacco
product classes specified in statute: (1) cigarettes, (2) cigars (including small cigars and cigars
other than small cigars), (3) snuff, (4) chewing tobacco, (5) pipe tobacco, and (6) roll-your-own
tobacco (see Table 1 for FY2020 data).22
The FFDCA requires that FDA use the Fair and Equitable Tobacco Reform Act of 2004
(FETRA)—enacted as Title VI of the American Jobs Creation Act of 2004 (P.L. 108-357)—
framework to assess user fees on six classes of tobacco products,23 and these are the same six
classes that are specified in the FETRA provisions.24 The FETRA provisions specify a two-step
formula.25 The first step determines the allocations for each of the six tobacco product classes,
and the second step determines the individual domestic manufacturer and importer allocations
within each respective tobacco product class. Because FETRA did not account for the differential
taxing of cigars compared to the other tobacco product classes, the FFDCA specifies how user
fees will be assessed for cigars.26
FDA has determined that it currently does not have the authority to assess user fees on ENDS
manufacturers and importers, or manufacturers or importers of certain other newly deemed
tobacco products (e.g., hookah tobacco).27 This determination was made by FDA because
Congress did not specify enumerated classes for these products and did not provide a framework
by which FDA could potentially assess user fees for such products.28
Table 1. Tobacco User Fee Assessment Formulation, by Product Class, FY2020
Percentage Share by
Tobacco Product Class
Class (%)a
Amount
Quarterly FY2020 User Fee Assessment
Cigarettes
86.0996%
$153,257,288
Cigars
11.6945%
$20,816,210
Snuff
1.2746%
$2,268,788
Pipe Tobacco
0.8218%
$1,462,804
Chewing Tobacco
0.0661%
$117,658

20 FFDCA §919(c); 21 U.S.C. §387s(c).
21 FFDCA §919(b)(1); 21 U.S.C. §387s(b)(1).
22 FFDCA §919(b)(2)(B(i); 21 U.S.C. §387s(b)(2)(B)(i).
23 FFDCA §919(b)(2)(B)(ii) & §919(b)(4); 21 U.S.C. §387s(b)(2)(B)(ii) & §387s(b)(4).
24 §625(c)(1) of P.L. 108-357; 7 U.S.C. §518d(c)(1).
25 USDA, “Determination of the Administrator of the Farm Service Agency and Executive Vice President of the
Commodity Credit Corporation Regarding the Current ‘Step A’ and ‘Step B’ Assessment Methods in the Tobacco
Transition Payment Program,” https://www.fsa.usda.gov/Internet/FSA_File/tobacco_determ_11162011.pdf.
26 FFDCA §919(b)(5); 21 U.S.C. §387s(b)(5).
27 FDA, “Requirements for the Submission of Data Needed To Calculate User Fees for Domestic Manufacturers and
Importers of Cigars and Pipe Tobacco,” 81 Federal Register 28709, May 10, 2016.
28 FDA, “Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and
Importers of Cigars and Pipe Tobacco,” 81 Federal Register 28707, May 10, 2016.
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Percentage Share by
Tobacco Product Class
Class (%)a
Amount
Rol -Your-Own Tobacco
0.0431%
$76,718
Total
99.9997%
$177,999,466
Total FY2020 User Fee Assessment

$711,997,864
Source: Prepared by CRS using FDA, “FY2020 Tobacco User Fee Assessment Formulation by Product Class,”
https://www.fda.gov/tobacco-products/manufacturing/tobacco-user-fee-assessment-formulation-product-class.
Notes: Percentages and user fees col ected may not add evenly due to rounding. Data were not available for all
four quarters of user fees col ected, and thus only anticipated fourth-quarter data are presented.
a. Percentages are based on volume of domestic sales by tobacco product class. These data are provided by
the Alcohol and Tobacco Tax and Trade Bureau, National Revenue Center, Report Symbol TTB S 5210-12-
2018 (March 12, 2019), http://www.ttb.gov/tobacco/tobacco-stats.shtml.
Establishment Registration and Product Listing
Owners and operators of domestic tobacco product manufacturers are required to immediately
register with FDA upon beginning operations and to subsequently register their establishments by
the end of each year.29 FDA is required to make this registration information public.30 As part of
the registration requirements, domestic tobacco product manufacturers must also submit product
listing information, which includes a list of all tobacco products manufactured for commercial
distribution.31 The listing for each tobacco product must be clearly identified by the product
category (e.g., smokeless tobacco) and unique name (i.e., brand/sub-brand). If the listed tobacco
products differ in any way, such as a difference in a component or part, manufacturers are
encouraged to list each tobacco product separately.32 In addition, the listing must include a
reference for the authority to market the tobacco product, and it must provide all consumer
information for each tobacco product, such as labeling and a “representative sampling of
advertisements.”33 However, given the potential administrative burden on the registrant, FDA
specifies in a guidance document that labeling for each individually listed tobacco product is not
necessary if information that represents the labeling for a selected set of related products is
provided.34 Registrants are encouraged to submit their materials online using FDA’s Unified
Registration and Listing System (FURLS) Tobacco Registration and Product Listing Module
(TRLM).35

29 FFDCA §905(b)-(c); 21 U.S.C. §387e(b)-(c).
30 FFDCA §905(f); 21 U.S.C. §387e(f).
31 Foreign manufacturers are not required to register until FDA issues regulations establishing requirements for such
manufacturers, per FDA, Guidance for Industry: Registration and Product Listing for Owners and Operators of
Domestic Tobacco Product Establishments, December 2017,
https://www.fda.gov/downloads/tobaccoproducts/labeling/rulesregulationsguidance/ucm191940.pdf.
32 Ibid.
33 FFDCA §905(i)(1)(B); 21 U.S.C. §387e(i)(1)(B).
34 FDA, Guidance for Industry: Registration and Product Listing for Owners and Operators of Domestic Tobacco
Product Establishments, December 2017,
https://www.fda.gov/downloads/tobaccoproducts/labeling/rulesregulationsguidance/ucm191940.pdf.
35 FDA, Tobacco Registration and Product Listing Module (TRLM) User Guide,
https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM456130.pdf.
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Tobacco Product Manufacturer Inspections
Every tobacco product manufacturer that registers with FDA is subject to biennial inspections.
This inspection requirement starts on the date the establishment registers, and FDA must conduct
an inspection at least once in every successive two-year period thereafter.36
The goal of such inspections is to review processes and procedures, observe and evaluate
operations, document and collect information, identify any violations, communicate those
violations to the manufacturer, and document any proposed corrective action plans.37 FDA
personnel—upon presenting appropriate credentials and a written notice to the owner, operator, or
agent in charge—are authorized to enter the tobacco product manufacturer to inspect the factory
and all pertinent equipment and materials “at reasonable times and within reasonable limits and in
a reasonable manner.”38 Upon completing the inspection and prior to leaving the premises, FDA
is required to produce a written report describing any observed conditions or practices indicating
that any tobacco product has been prepared in a way that is injurious to health.39
Good Manufacturing Practices (GMPs)
FDA is required to promulgate regulations that outline good manufacturing practices (GMPs) to
ensure that “the public health is protected and that the tobacco product is in compliance” with
chapter IX of the FFDCA.40 Specifically, statute specifies that the regulations should include the
methods, facilities, and controls involved in the manufacture, packing, and storage of a tobacco
product.41 Prior to promulgating the regulations, TPSAC and the public (through an oral hearing)
have an opportunity to recommend modifications to the proposed regulations. In addition, the
regulations are required to take into account different types of tobacco products, the financial
resources of different tobacco manufacturers, and reasonable time for manufacturers to comply
with GMPs.42 A manufacturer may petition to be exempt from such requirements and receive
approval from FDA if the agency determines that compliance with GMPs is not required to
ensure that the tobacco product would be in compliance with chapter IX of the FFDCA.43
To date, FDA has not promulgated GMP regulations. In 2012, 13 tobacco companies submitted
recommendations to be included in the GMP regulations and subsequently met with FDA to
review their recommendations and approach to developing them.44 FDA then established a public
docket for additional comments on the tobacco companies’ recommendations in 2013.45 However,
FDA did not take further action specific to promulgating GMP regulations after these actions.
FDA’s 2016 deeming rule stated that “FDA will have the authority to issue tobacco product

36 FFDCA §905(g); 21 U.S.C. §387e(g).
37 FDA, 2017, Compliance Training for Small Tobacco Product Manufacturers – Domestic Establishment Inspections,
https://www.fda.gov/media/83422/download.
38 FFDCA §704(a)(1); 21 U.S.C. §374(a)(1).
39 FFDCA §704(b); 21 U.S.C. §374(b).
40 FFDCA §906(e)(1)(A); 21 U.S.C. §387f(e)(1)(A).
41 Ibid.
42 Small tobacco product manufacturers would not be required to comply with a regulation until four years after it is
promulgated, per FFDCA §906(e)(1)(B)(v); 21 U.S.C. §387f(e)(1)(B)(v).
43 FFDCA §906(e)(2); 21 U.S.C. §387f(e)(2).
44 FDA, “Tobacco Product Manufacturing Practice; Establishment of a Public Docket,” 78 Federal Register 16824,
March 19, 2013.
45 Ibid.
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manufacturing practice regulations under section 906(e)” of the FFDCA for ENDS and other
newly deemed products.46 Following the issuance of this rule, numerous ENDS industry
stakeholders submitted recommendations to FDA highlighting differences between GMP
regulations for ENDS products and other tobacco products (cigarettes, cigarette tobacco, roll-
your-own tobacco, and smokeless tobacco).47 FDA then opened a public docket in November
2017 to allow for comment on these proposed ENDS GMPs,48 but the agency has not taken
further action since then.
Premarket Review Pathways
There are four different premarket review pathways for tobacco products: (1) premarket tobacco
application (PMTA), (2) substantial equivalence (SE), (3) substantial equivalence (SE)
exemption, and (4) modified risk tobacco product (MRTP). To legally market a new tobacco
product,49 a manufacturer must receive a PMTA marketing authorization order, unless FDA
determines that the new tobacco product is substantially equivalent to a predicate tobacco product
or is exempt from substantial equivalence.50 To legally market a new tobacco product with
reduced risk claims or modify a legally marked tobacco product to make reduced risk claims, a
manufacturer must receive an MRTP order.
All tobacco products originally covered by the TCA are required to undergo premarket review,
unless they are “grandfathered products.”51 Following the 2016 deeming rule, all newly deemed
tobacco products became subject to premarket review requirements as well. In July 2017, FDA
announced its Comprehensive Plan for Tobacco and Nicotine Regulation (Comprehensive Plan).
As part of its Comprehensive Plan, FDA issued guidance that pushed back premarket review
application deadlines to August 2021 for newly deemed combustible tobacco products (e.g.,
cigars) and August 2022 for newly deemed noncombustible tobacco products (e.g., ENDS) on the
market as of August 8, 2016.52 This administrative action was subject to legal challenge, after
several public health groups (e.g., American Academy of Pediatrics, Campaign for Tobacco-Free
Kids) filed a lawsuit against FDA.53 In May 2019, the U.S. District Court for Maryland ruled in

46 FDA, “Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the
Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products
and Required Warning Statements for Tobacco Products,” 81 Federal Register 28980, May 10, 2016.
47 RAI Services Company, “Proposed Good Manufacturing Practices Regulation To Account for FDA’s Deeming
Regulation” (Docket No. FDA-2013-N-022), June 7, 2017,
https://www.fda.gov/files/tobacco%20products/published/Proposed-Good-Manufacturing-Practices-Regulation-to-
Account-for-FDA%27s-Deeming-Regulation-%28Docket-No.-FDA-2013-N-022%29.pdf.
48 FDA, “Tobacco Product Manufacturing Practice; Request for Comments,” 82 Federal Register 55613, November 22,
2017.
49 FFDCA §910(a)(1) [21 U.S.C. §387j(a)(1)] defines a new tobacco product as any tobacco product (including those
products in test markets) that was not commercially marketed in the United States as of February 15, 2007, or any
modification (including a change in design, any component, any part, or any constituent, including a smoke constituent,
or in the content, delivery or form of nicotine, or any other additive or ingredient) of a tobacco product where the
modified product was commercially marketed in the United States after February 15, 2007.
50 FFDCA §910(a)(2); 21 U.S.C. §387j(a)(2).
51 Products that do not meet the statutory definition of a new tobacco product are referred to as “grandfathered
products” and do not require premarket review to be legally marketed.
52 FDA, Guidance for Industry: Extension of Certain Tobacco Product Compliance Deadlines Related to the Final
Deeming Rule, Sixth Revision, November 2018,
https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM557716.pdf.
53Am. Acad. of Pediatrics v. FDA, 2019 U.S. Dist. LEXIS 81652 (D. Md., Mar. 26, 2019) (No. 8:18-cv-00883-PWG).
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favor of the public health organizations,54 and in July 2019, imposed a 10 month deadline for
application submissions for all newly deemed tobacco products (i.e., May 2020) and a 1 year
deadline for reviewing the applications (i.e., May 2021).55
Table 2. Tobacco Product Marketing Orders Issued Between CY2015 and FY2020
FY2020

CY2015
CY2016
FY2017
FY2018
FY2019
as of 12/17/19
PMTA Marketing Orders
8
0
0
0
4
2
SE Orders
460
6a
79a
255
296
30
Exemption from SE Orders
1
0
26
58
244
41
MRTP Orders
0
0
0
0
0
8
Total
469
6
105
313
544
81
Source: Prepared by CRS using data from the FDA,
https://www.fda.gov/TobaccoProducts/Labeling/TobaccoProductReviewEvaluation/ucm339928.htm and
https://www.fda.gov/tobacco-products/premarket-tobacco-product-applications/premarket-tobacco-product-
marketing-orders, as of December 17, 2019.
Notes: CY=Calendar Year; FY=Fiscal Year; PMTA=Premarket Tobacco Application; SE=Substantial Equivalence;
MRTP=Modified Risk Tobacco Product. Applications were evaluated by year from 2014 to 2016, and by fiscal
year starting in FY2017. Data are presented starting in 2014, when PMTA Marketing Order data first became
available.
a. There were three SE marketing orders issued in December 2016, and those three SE orders are counted in
both CY2016 and FY2017.
As shown in Table 2, since 2014, most new tobacco products have been legally marketed through
the SE pathway. However, only requirements for the SE exemption pathway have been
promulgated in regulations.56 This has posed some challenges for manufacturers when preparing
application submissions for the PMTA, SE, and MRTP pathways. In April 2019, FDA issued a
proposed rule on the content and format of SE reports,57 with public comment open until June
2019. Also in June 2019, FDA finalized its guidance on PMTA submissions specific to ENDS.58
In September 2019, FDA issued a proposed rule on the content and format of PMTA applications,
with public comment open until November 2019.59 As of February 2020, FDA has not publicly
indicated a timeline for issuance of a final rule.
Premarket Tobacco Product Applications (PMTA) Pathway
A manufacturer must submit a PMTA and receive a PMTA marketing authorization order to
legally market a new tobacco product that is not substantially equivalent to a predicate tobacco

54 Am. Acad. of Pediatrics v. FDA, 379 F. Supp. 3d 461 (D. Md. 2019).
55 Am. Acad. of Pediatrics v. FDA, 2019 U.S. Dist LEXIS 00883 (D. MD. July 12, 2019).
56 21 C.F.R. §1107.1.
57 FDA, “Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on
Substantial Equivalence Reports,” 84 Federal Register 12740, April 2, 2019.
58 FDA, Guidance for Industry: Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems,
June 2019, https://www.fda.gov/media/127853/download.
59 FDA, “Premarket Tobacco Product Applications and Recordkeeping Requirements,” 84 Federal Register 50566,
September 25, 2019.
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product or exempt from substantial equivalence. To receive a PMTA order, the application must
demonstrate that the product is “appropriate for the protection of public health.”60 This
determination is made based on the risks and benefits to the whole population of users and
nonusers of the product, while taking into account
the increased or decreased likelihood that existing users of tobacco products will stop using
such products; and
the increased or decreased likelihood that those who do not use tobacco products will start
using such products.61
PMTA applications must include, among other things, full reports of health risk investigations; a
full statement of what is in the product (e.g., components, additives); a full description of
manufacturing and processing methods; compliance with tobacco product standards; samples and
components of the product; and proposed labeling of the product.62 FDA has 180 days after
receipt of the complete application to determine whether the product will receive a PMTA order.63
If marketing is authorized, FDA can require that the sale and distribution of the tobacco product is
restricted.64
FDA can deny a PMTA application for various reasons. These include if the agency determines
that marketing the new tobacco product would not be appropriate for the protection of public
health; the methods used for manufacturing, processing, or packing the tobacco product do not
align with good manufacturing practices; the proposed labeling of the tobacco product is false or
misleading; or the tobacco product does not conform with regulations specifying tobacco product
standards.65 FDA can withdraw or temporarily suspend a PMTA order if the agency finds that the
continued marketing of the tobacco product is no longer appropriate for the protection of public
health; the PMTA application contained false material; the applicant does not maintain records or
create reports about its tobacco product; the labeling of the tobacco product becomes false or
misleading; or the tobacco product does not conform to a tobacco product standard without
appropriate justification.66 To determine if there are grounds to withdraw or temporarily suspend a
PMTA order, FDA can require by regulation, or on an application-by-application basis, that
applicants establish and maintain records, and provide postmarket surveillance reports to FDA
following PMTA marketing authorization.67
Substantial Equivalence (SE) Pathway
A new tobacco product is considered to be substantially equivalent to a predicate tobacco product
if it has the same characteristics as the predicate tobacco product or if it has different

60 FFDCA §910(c)(4); 21 U.S.C. §387j(c)(4).
61 Ibid.
62 FFDCA §910(b)(1); 21 U.S.C. §387j(b)(1). See also FDA, Draft Guidance: Applications for Premarket Review of
New Tobacco Products, September 2011,
https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM273425.pdf.
63 FDA may refuse to file an application if the agency determines that the application is not complete (i.e., it does not
include all components required under FFDCA §910(b)(1) [21 U.S.C. §387j(b)(1)]). The 180 day clock does not start
until FDA receives the complete application.
64 FFDCA §910(c)(1)(B); 21 U.S.C. §387j(c)(1)(B). These restrictions are permissible to the extent that sale and
distribution is restricted under a regulation promulgated as part of FFDCA §906(d) [21 U.S.C. §387f(d)].
65 FFDCA §910(c)(2); 21 U.S.C. §387j(c)(2).
66 FFDCA §910(d)(1); 21 U.S.C. §387j(d)(1).
67 FFDCA §910(f)(1); 21 U.S.C. §387j(f)(1).
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characteristics that do not raise different questions of public health.68 A product may serve as a
predicate tobacco product if it was commercially marketed as of February 15, 2007, or if it has
previously been determined as substantially equivalent to another predicate tobacco product. A
tobacco product may not serve as a predicate product if it has been removed from the market or
has been determined to be adulterated or misbranded.
If a new tobacco product is considered substantially equivalent to the predicate tobacco product,
the manufacturer is required to submit an SE report to FDA justifying a substantial equivalence
claim at least 90 days prior to the introduction of the new tobacco product into the market.69 To
accommodate manufacturers following enactment of the TCA, a new tobacco product that was
introduced after February 15, 2007, but before March 22, 2011, could stay on the market while
FDA reviewed the manufacturer’s SE report, provided the report was submitted before March 23,
2011. However, if a manufacturer did not submit the SE report before March 23, 2011, or if the
new tobacco product has been on the market since March 22, 2011, the product is not permitted to
be marketed without an SE order from FDA, even if FDA takes longer than 90 days to approve
and issue the order.70
The contents of SE reports are not specified in statute or regulation,71 but FDA has provided
content recommendations for SE reports in guidance.72 Among other things, SE reports should
include a summary; a list of design features, ingredients and materials; a description of the
heating source and composition; and health information. Upon acceptance of the SE report
application and FDA’s evaluation that the predicate tobacco product selected is eligible, FDA
evaluates the scientific data and information in the SE report. FDA then issues an SE order letter
or not substantially equivalent order (NSE order) letter.73
Substantial Equivalence (SE) Exemption Pathway
A new tobacco product that has been modified from a legally marketed tobacco product by either
adding or removing a tobacco additive, or by increasing or decreasing the quantity of an existing
tobacco additive, may be exempt from demonstrating substantial equivalence.74 For such a
product to be exempt, FDA must determine that (1) the modification would be considered minor,
(2) an SE report that demonstrates substantial equivalence would not be necessary to ensure that
marketing the tobacco product would be appropriate for protection of public health, and (3) an

68 Characteristics are defined as “materials, ingredients, design, composition, heating source, or other features of a
tobacco product” in FFDCA §910(a)(3)(B) [21 U.S.C. §387j(a)(3)(B)].
69 FFDCA §905(j); 21 U.S.C. §387e(j).
70 FDA, Guidance for Industry and FDA Staff: Section 905(j) Reports: Demonstrating Substantial Equivalence for
Tobacco Products, January 2011,
https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM239021.pdf.
71 In April 2019, FDA issued a proposed rule on the content and format of SE reports. FDA, “Content and Format of
Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports,” 84
Federal Register 12740, April 2, 2019.
72 FDA, Guidance for Industry and FDA Staff: Section 905(j) Reports: Demonstrating Substantial Equivalence for
Tobacco Products, January 2011,
https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM239021.pdf.
73 FDA, “Substantial Equivalence,” https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-
product/substantial-equivalence#submit.
74 FDA, “Exemption from Substantial Equivalence,”
https://www.fda.gov/TobaccoProducts/Labeling/TobaccoProductReviewEvaluation/ExemptionfromSubstantialEquival
ence/default.htm.
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“exemption is otherwise appropriate.”75 Before the product can be legally marketed, FDA must
first grant the product an exemption from demonstrating substantial equivalence.76 Following this,
a manufacturer must submit an SE exemption report detailing the minor modification and
establishing that FDA has determined that the product is exempt from demonstrating substantial
equivalence to a predicate product.77
The content requirements for SE exemption reports are specified in regulation.78 Among other
things, SE exemption reports must contain a detailed explanation of the purpose of the
modification; a detailed description of the modification; a detailed explanation of why the
modification is minor; a detailed explanation of why an SE report is not necessary; and a
certification (i.e., signed statement by a responsible official of manufacturer) summarizing why
the modification does not increase the tobacco product’s appeal to or use by minors, toxicity,
addictiveness, or abuse liability.
Modified Risk Tobacco Products (MRTP) Pathway
A modified risk tobacco product (MRTP) is defined as “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.”79 For example, some ENDS manufacturers may
decide to submit an ENDS product through the MRTP pathway if the application can justify that
the product reduces the risk of tobacco-related disease compared with other tobacco products
(e.g., cigarettes). However, an MRTP may not be introduced or delivered into interstate
commerce until FDA has issued an MRTP order, regardless if it was already legally on the market
through another pathway (e.g., SE or SE exemption).80 Further, any manufacturer that has not
received an MRTP order for its tobacco product may not market the product with a label,
labeling, or advertising that implies the product has a reduced risk of harm or that uses the words
“light,” “mild,” “low,” or similar descriptions.81 Smokeless tobacco products that use certain
descriptors, such as “does not produce smoke” or “smoke-free,” are not automatically considered
MRTPs unless a manufacturer receives MRTP orders for those products.82 In addition, products
that are intended to treat tobacco dependence are not considered MRTPs if they have been
approved as a drug or device.83
Manufacturers must include certain information in a MRTP application, including
a description of the proposed product and any proposed advertising and labeling;
the conditions for using the product;
the formulation of the product;

75 FFDCA §905(j)(3); 21 U.S.C. §387e(j)(3).
76 21 C.F.R. §1107.1.
77 FFDCA §905(j)(1)(A)(ii); 21 U.S.C. §387e(j)(1)(A)(ii). See also FDA, “Exemption from Substantial Equivalence,”
https://www.fda.gov/TobaccoProducts/Labeling/TobaccoProductReviewEvaluation/ExemptionfromSubstantialEquival
ence/default.htm.
78 21 C.F.R. §1107.1.
79 FFDCA §911(b)(1); 21 U.S.C. §387k(b)(1).
80 FDA, Warning Letter, www.buyoneline-cigarettes.com, July 4, 2014, https://www.fda.gov/inspections-compliance-
enforcement-and-criminal-investigations/warning-letters/wwwbuyonline-cigarettescom-04072014.
81 FFDCA §911(b)(2)(B); 21 U.S.C. §387k(b)(2)(B).
82 FFDCA §911(b)(2)(C); 21 U.S.C. §387k(b)(2)(C).
83 FFDCA §911(c); 21 U.S.C. §387k(c).
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sample product labels and labeling;
all documents (including underlying scientific information) relating to research findings
conducted, supported, or possessed by the tobacco product manufacturer relating to the
effect of the product on tobacco-related diseases and health-related conditions, including
information both favorable and unfavorable to the ability of the product to reduce risk or
exposure and relating to human health;
data and information on how consumers actually use the tobacco product; and
such other information as the Secretary [FDA] may require.84
FDA must refer all complete MRTP applications to TPSAC given the health claims that need to
be evaluated and verified in applications for these products. TPSAC then has 60 days to provide
recommendations on the application to FDA. FDA can issue an MRTP order for a specified
period of time (but not more than five years at one time85) if, among other things, it determines
that the tobacco product will significantly reduce harm and the risk of tobacco-related disease to
individual tobacco users and benefit the health of the population as a whole by taking into
account users and nonusers of tobacco products.86 To continue to market a MRTP after the order’s
set term, a manufacturer would need to seek renewal of the MRTP order.
However, FDA may issue an order for certain tobacco products that may not meet the standard of
significantly reducing harm to individual users and benefiting population health as a whole. This
is possible if, among things, the manufacturer can demonstrate that the MRTP order for the
tobacco product would be appropriate to promote public health; the label, labeling, and
advertising for the tobacco product are limited to claims that the product presents less exposure to
a substance; scientific evidence is not available and cannot be made available without conducting
the long-term epidemiologic studies required to meet the MRTP standard; and the scientific
evidence that is available demonstrates if future studies are conducted, they would likely
demonstrate a measurable and substantial reduction in morbidity or mortality among users of the
tobacco product.87
MRTP Postmarket Requirements
To market a tobacco product that has received an MRTP order, the manufacturer must agree to
certain postmarket surveillance and studies that examine consumer perception, behavior, and
health pertaining to the product. Manufacturers required to conduct surveillance must submit the
surveillance protocol to FDA within 30 days of receiving notice from FDA that such studies are
required. Upon receipt of the protocol, FDA has 60 days to determine whether the protocol is
sufficient to collect data that will allow FDA to determine if the MRTP order is necessary to
protect public health.
FDA can also require that labeling and advertising of the product enable the public to understand
the significance of the presented information to the consumer’s health. Further, FDA can impose
conditions on the use of comparing claims between the tobacco product with an MRTP order and

84 FFDCA §911(d); 21 U.S.C. §387k(d).
85 FFDCA §911(g)(2)(C)(i); 21 U.S.C. §387k(g)(2)(C)(i).
86 FFDCA §911(g); 21 U.S.C. §387k(g).
87 FFDCA §911(g)(2); 21 U.S.C. §387k(g)(2).
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other tobacco products on the market, and require that the label of the product disclose substances
in the tobacco product that could affect health.88
FDA must withdraw the MRTP order, after the opportunity for an informal hearing, under
specified circumstances. Examples of such circumstances include if new information becomes
available that no longer make an MRTP order permissible, if the product no longer reduces risk or
exposure based on data from postmarket surveillance or studies, or if the applicant failed to
conduct or submit postmarket surveillance or studies.89
Investigational Tobacco Products
FFDCA Section 910(g) allows FDA to issue regulations exempting tobacco products from certain chapter IX
requirements. For example, manufacturers may need to use investigational tobacco products in studies to
generate evidence for submission as part of a premarket application. While FDA has not yet promulgated such
regulations, the agency issued draft guidance in February 2019 clarifying its enforcement policy regarding the use of
investigational tobacco products until regulations are issued and become effective.90
The guidance defines an investigational tobacco product as “a tobacco product that is intended for investigational use
and is:
(1) a new tobacco product; or
(2) a tobacco product that is required to comply with a tobacco product standard and that does not conform in
all respects to the applicable tobacco product standard.”91
Cessation Products
FDA’s Center for Drug Evaluation and Research (CDER) is generally responsible for regulating
tobacco-derived products that make health or cessation (i.e., quitting) claims, such as nicotine
replacement therapies (NRTs).92 NRTs contain nicotine as an active ingredient. Two types of
prescription NRT products (nasal spray and nicotine inhaler) and three types of over-the-counter
(OTC) NRT products have been approved by FDA through CDER, and most of these products
have been approved for over 20 years.93 The three types of OTC products include a nicotine gum,
a transdermal nicotine patch, and a nicotine lozenge. Prescription medications that do not have
nicotine as an active ingredient have also been approved by CDER for smoking cessation. These
medications include Chantix (varenicline tartrate) and Zyban (buproprion hydrochloride).94

88 FFDCA §911(h); 21 U.S.C. §387k(h).
89 FFDCA §911(j); 21 U.S.C. §387k(j).
90 FDA, Draft Guidance for Industry and Investigators: Use of Investigational Tobacco Products, February 2019,
https://www.fda.gov/media/94052/download.
91 Ibid.
92 Certain cessation products may be considered a combination product (composed of a drug and device). In such cases,
the product is regulated based on the primary mode of action. For example, if a cessation product is a combination of a
drug and a device, but its primary mode of action is dependent upon chemical action within the body or metabolizing
within the body to achieve its intended effects, it would be considered a drug and regulated through CDER. For a
general comparison of drug and device regulation, see CRS In Focus IF11083, Medical Product Regulation: Drugs,
Biologics, and Devices, by Agata Dabrowska and Victoria R. Green.
93 FDA, “Advancing Medicinal Nicotine Replacement Therapies as New Drugs – A new step in FDA’s comprehensive
approach to tobacco and nicotine,” https://www.fda.gov/news-events/fda-voices-perspectives-fda-leadership-and-
experts/advancing-medicinal-nicotine-replacement-therapies-new-drugs-new-step-fdas-comprehensive-approach.
94 FDA, “Want to Quit Smoking? FDA-Approved Products Can Help,” https://www.fda.gov/consumers/consumer-
updates/want-quit-smoking-fda-approved-products-can-help.
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In the future, ENDS manufacturers who make health or cessation claims for their products would
likely need to receive approval for marketing from CDER (rather than marketing authorization
from CTP).
Tobacco Product Regulation: Tobacco-Specific
Requirements
Tobacco product manufacturers, importers, distributors, and retailers are required to comply with
certain tobacco-specific requirements as a result of the unique harms that tobacco products pose
to human health. Each of these requirements is described below, and most requirements apply to
all tobacco products, with some specified exceptions.
Tobacco Product Standards
Prior to enactment of the TCA, Congress was concerned that the tobacco industry had the ability
to design new tobacco products or modify existing ones that might appeal to children or increase
exposure to harmful tobacco product constituents.95 The TCA gave FDA the authority to adopt
tobacco product standards that it deems necessary to protect the public’s health,96 but it explicitly
prohibited FDA from creating a standard that bans cigarettes, smokeless tobacco products, cigars,
pipe tobacco, or roll-your-own tobacco products.97 Congress could choose to amend this language
at any time.
A new tobacco product standard can set certain manufacturing, packaging, and distribution and
sale requirements for tobacco products. For example, FDA can set requirements for ingredients,
additives, components, or parts allowed in a tobacco product; testing of the tobacco product and
test results demonstrating compliance with the standard; measurement of characteristics of the
tobacco product; appropriate labeling of the tobacco product; and limited sale and distribution of
the tobacco product.98 To adopt a tobacco product standard, FDA is required to consider scientific
evidence on
the risks and benefits to the population as a whole, including users and nonusers of tobacco
products, of the proposed standard; the increased or decreased likelihood that existing users
of tobacco products will stop using such products; and the increased or decreased
likelihood that those who do not use tobacco products will start using such products.99
To propose a new tobacco product standard, FDA is required to publish a proposed rule in the
Federal Register and allow for a public comment period of no less than 60 days. If FDA
determines that the tobacco product standard is appropriate for the protection of public health
based on an evaluation of public comments, a report from TPSAC (if the standard was referred to
them), and other evidence, the agency must promulgate a final regulation to establish the
standard. This regulation cannot take effect until at least one year after its publication, unless
FDA determines that “an earlier effective date is necessary for the protection of public health.”100

95 U.S. Congress, House Committee on Energy and Commerce, Family Smoking Prevention and Tobacco Control Act,
Part 1, Report to accompany H.R. 1256, 111th Cong., 1st sess., March 26, 2009, H.Rept. 111-58, p. 4.
96 FFDCA §907(a)(3); 21 U.S.C. §387g(a)(3).
97 FFDCA §907(d)(3); 21 U.S.C. §387g(d)(3).
98 FFDCA §907(a)(4); 21 U.S.C. §387g(a)(4).
99 FFDCA §907(a)(3)(B)(i); 21 U.S.C. §387g(a)(3)(B)(i).
100 FFDCA §907(d)(2); 21 U.S.C. §387g(d)(2).
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FDA is required to periodically reevaluate tobacco product standards to determine if new data
need to be reflected. In addition, a tobacco product standard may be amended or revoked either
on the initiative of FDA or an interested party via petition (i.e., citizen petition). If FDA or a
citizen petition calls for an amendment to or revocation of an existing tobacco product standard, a
proposed rule would be issued in the Federal Register for public comment. As with a new
tobacco product standard, FDA would make a determination regarding the existing standard
based on review of the public comments, a TPSAC report (if relevant), and other evidence. For
FDA to revoke a standard, the agency must find that the standard is “no longer appropriate for the
protection of public health.”101
Flavors
When enacting the TCA, Congress recognized that flavors, specifically, can make tobacco
products more appealing to youth and expose tobacco users to additional carcinogens or other
toxic constituents.102 Although FDA has the authority to establish new tobacco product standards
(as previously described), Section 907 of the FFDCA establishes a tobacco product standard
explicitly banning characterizing artificial or natural flavors (other than tobacco or menthol),
herbs, or spices in any constituent, additive, and component or part of a cigarette.103 While
tobacco and menthol flavors are not included in the prohibition on characterizing flavors in
cigarettes, FDA may be able to establish a tobacco product standard addressing menthol in
cigarettes.104
Within one year of its establishment, TPSAC was required to submit a report and
recommendations to the Secretary of HHS regarding the impact of menthol cigarette use on
public health, specifically addressing use among youth and racial and ethnic minorities.105 In its
final report released in July 2011, TPSAC concluded that “removal of menthol cigarettes from the
marketplace would benefit public health in the United States.”106 In July 2013, FDA released an
advance notice of public rulemaking (ANPRM) on a tobacco product standard for menthol in
cigarettes, seeking comments, data, research, and any other relevant information.107 A final
regulation has not yet been promulgated; however, Former Commissioner Gottlieb expressed
interest in accelerating the promulgation of this tobacco product standard.108
FDA released an ANPRM in March 2018, “Regulation of Flavors in Tobacco Products,” that
requested public comments, data, research results, and other information related to the role of
flavors generally in tobacco products, among other things.109 After one extension, the comment
period closed in July 2018 and the agency had received over 500,000 comments. In January 2020,

101 FFDCA §907(c)(3); 21 U.S.C. §387g(c)(3).
102 U.S. Congress, House Committee on Energy and Commerce, Family Smoking Prevention and Tobacco Control Act,
Part 1, Report to accompany H.R. 1256, 111th Cong., 1st sess., March 26, 2009, H.Rept. 111-58, p. 4.
103 FFDCA §907(a); 21 U.S.C. §387g(a).
104 FFDCA §907(a)(1)(A); 21 U.S.C. §387g(a)(1)(A).
105 FFDCA §907(e); 21 U.S.C. §387g(e).
106 Tobacco Products Scientific Advisory Committee (TPSAC) and Center for Tobacco Products (CTP), Public Health
Impact of Menthol Cigarettes, FDA, Silver Spring, MD, July 2011, p. 208.
107 FDA, “Menthol in Cigarettes, Tobacco Products; Request for Comments,” 78 Federal Register 44485, July 24,
2013.
108 FDA Statement, “Statement from FDA Commissioner Scott Gottlieb, M.D., on proposed new steps to protect youth
by preventing access to flavored tobacco products and banning menthol in cigarettes,” November 15, 2018,
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm625884.htm.
109 FDA, “Regulation of Flavors in Tobacco Products,” 83 Federal Register 12299, March 21, 2018.
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FDA stated its intention to issue a proposed rule that would “ban the use of characterizing flavors
in cigars” but did not speak to characterizing flavors in other tobacco products.110
Nicotine
Nicotine is the naturally occurring drug in tobacco that can cause addiction to the product.111 The
FFDCA allows FDA to address nicotine yields of a tobacco product through development of a
tobacco product standard,112 but it prohibits the agency from establishing a tobacco product
standard that would require the reduction of nicotine yields to zero.113
A key feature of FDA’s Comprehensive Plan is to implement regulatory policies on addiction,
appeal, and cessation based on scientific evidence and public input. One stated goal was to lower
nicotine in cigarettes to a minimally or nonaddictive level to benefit the public’s health. In March
2018, FDA released an ANPRM for development of a tobacco product standard that would set a
maximum nicotine level for cigarettes.114 The ANPRM seeks public comment on whether a
tobacco product standard should apply to other combusted tobacco products (e.g., cigars, pipe
tobacco); what a nonaddictive level of nicotine would be; and other feasibility issues if such a
tobacco product standard is implemented. The comment period closed in July 2018, after an
extension, with nearly 8,000 comments received. As of February 2020, FDA has not taken further
regulatory action.
Testing and Reporting of Ingredients
FDA has the authority to conduct or to require testing, reporting, or disclosure of tobacco product
constituents, including smoke constituents.115 Pursuant to FFDCA Section 915, FDA is required
to promulgate regulations that require the testing and reporting of components or parts of a
tobacco product to protect the public health. Because FDA has not yet promulgated these testing
and reporting regulations, tobacco product manufacturers are not currently subject to these
requirements.116
As part of these regulations, once they are promulgated, FDA may require tobacco product
manufacturers to disclose the results of the testing of tar and nicotine through labels, advertising,
or other means to protect public health and not mislead consumers about harms associated with
use of the tobacco product. Small tobacco product manufacturers would be given additional time

110 FDA, Guidance for Industry: Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and Other
Deemed Products on the Market Without Premarket Authorization, January 2020, p. 31,
https://www.fda.gov/media/133880/download.
111 National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, Centers for
Disease Control and Prevention, The Health Consequences of Smoking – 50 Years of Progress, U.S. Department of
Health and Human Services, Atlanta, GA, 2014, https://www.surgeongeneral.gov/library/reports/50-years-of-
progress/full-report.pdf.
112 FFDCA §907(a)(4); 21 U.S.C. §387g(a)(4).
113 FFDCA §907(d)(3)(B); 21 U.S.C. §387g(d)(3)(B).
114 FDA, “Tobacco Product Standard for Nicotine Level of Combusted Cigarettes,” 83 Federal Register 11818, March
16, 2018.
115 FFDCA §915(c); 21 U.S.C. §387o(c).
116 FDA, “Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the
Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products
and Required Warning Statements for Tobacco Products,” 81 Federal Register 28980, May 10, 2016.
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to comply, and FDA could additionally delay compliance on a case-by-case basis for small
tobacco product manufacturers.117
Health Information
Tobacco product manufacturers are required to submit specified health information to FDA. This
health information includes a list of all ingredients, such as substances, compounds, and additives
that are added to the tobacco product by the manufacturer. Health information also includes “a
listing of all constituents, including smoke constituents as applicable, identified by the Secretary
as harmful or potentially harmful to health in each tobacco product.”118 Manufacturers must
provide this information within each brand of the tobacco product, and the quantity included in
each brand (e.g., Marlboro) and sub-brand (e.g., Marlboro Gold).119 FDA’s compliance policy for
ingredient listings, as specified in guidance, focuses on finished tobacco products (i.e., tobacco
products packaged and ready for consumption), including cigarettes, cigarette tobacco, roll-your-
own tobacco, smokeless tobacco, and newly deemed tobacco products (e.g., ENDS).120 Further,
FDA is focusing on components or parts of finished tobacco products that are made or derived
from tobacco or contain ingredients that are burned, aerosolized, or ingested while the tobacco
product is being used. As an example, e-liquids of ENDS are currently subject to this ingredient
listing requirement, while batteries of ENDS are not.
Harmful and Potentially Harmful Constituents
As interpreted by FDA in guidance, the phrase harmful and potentially harmful constituents
(HPHCs) refers to any chemical or chemical compound in a tobacco product or in tobacco smoke
that
is, or potentially is, inhaled, ingested, or absorbed into the body, including as an aerosol
(vapor) or any other emission; and
causes or has the potential to cause direct or indirect harm to users or non-users of tobacco
products.121
Examples of HPHCs include toxicants, carcinogens, and addictive chemicals and compounds. By
2012 (three years after enactment of the TCA), FDA was required to establish a list of HPHCs in
each tobacco product and, as applicable, to identify HPHCs by brand and sub-brand of tobacco
products.122 Based on TPSAC’s recommendations and after receiving multiple rounds of public
comment on these recommendations, FDA established a list of 93 HPHCs in tobacco products.
This list specifies whether the HPHC is a carcinogen, respiratory toxicant, cardiovascular
toxicant, reproductive or developmental toxicant, and/or addictive.123

117 FFDCA §915(d); 21 U.S.C. §387o(d).
118 FFDCA §904(a)(3); 21 U.S.C. §387d(a)(3).
119 FFDCA §904(a)(1); 21 U.S.C. §387d(a)(1).
120 FDA, Guidance for Industry: Listing of Ingredients in Tobacco Products, Revised November 2018,
https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM527044.pdf.
121 FDA, Guidance for Industry and FDA Staff: Harmful and Potentially Harmful Constituents in Tobacco Products as
Used in Section 904(e) of the Federal Food, Drug, and Cosmetic Act, Revised August 2016,
https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM241352.pdf.
122 FFDCA §904(a)(3); 21 U.S.C. §387d(a)(3).
123 FDA, “Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke; Established List,”
77 Federal Register 20034, April 3, 2012.
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Using FDA’s list, manufacturers are required to report HPHCs by brand and quantity of HPHCs
in each brand and sub-brand.124 Given potential monetary and feasibility challenges that were
associated with reporting all 93 HPHCs on FDA’s list, FDA released an accompanying 2012 draft
guidance that provided an abbreviated list of HPHCs that manufacturers of cigarettes, smokeless
tobacco, and roll-your-own tobacco would be required to report to FDA.125 FDA has not issued an
update to the 2012 draft guidance. As a result, FDA does not intend to enforce this requirement
for newly deemed tobacco products (e.g., ENDS) until after the publication date of the final
guidance.126 However, in August 2019, FDA announced that, for the first time, it is seeking public
comment on 19 additional HPHCs that can be found in ENDS products.127 The public comment
period closed in October 2019.128
Health Documents
Tobacco product manufacturers are required to submit to FDA all documents developed by the
manufacturer or any other party on health, toxicological, behavioral, or physiologic effects of
current or future tobacco products, including constituents, ingredients, components, and
additives.129 FDA interprets these documents to include “cell-based, tissue-based, animal, or
human studies, computational toxicology models, information on addiction, intentions to use,
cognition, emotion, motivation, and other behavioral effects at both the population-level
(epidemiology) as well as the individual level (such as abuse liability).”130
Records and Reports on Tobacco Products
FDA has the authority to require, by regulation, tobacco product manufacturers and importers to
establish and maintain records to ensure that tobacco products are not adulterated or misbranded
and to otherwise protect public health.131 Through such regulations, FDA can also require
manufacturers and importers to report if a tobacco product may have caused or contributed to a
“serious unexpected adverse experience or any significant increase in the frequency of a serious,

124 FFDCA §904(a)(3) [21 U.S.C. §387d(a)(3)]; FFDCA §915 [21 U.S.C. §387o].
125 FDA, Draft Guidance: Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco
Smoke Under Section 904(a)(3) of the Federal Food, Drug, and Cosmetic Act, March 2012,
https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM297828.pdf.
126 FDA, Guidance for Industry: Extension of Certain Tobacco Product Compliance Deadlines Related to the Final
Deeming Rule, Revised March 2019, https://www.fda.gov/media/105346/download.
127 FDA In Brief, “FDA seeks comment on proposed additions to list of harmful and potentially harmful constituents
found in tobacco products, including electronic nicotine delivery systems such as e-cigarettes and e-liquids,” August 2,
2019, https://www.fda.gov/news-events/fda-brief/fda-brief-fda-seeks-comment-proposed-additions-list-harmful-and-
potentially-harmful-
constituents?utm_campaign=080219_FIB_FDA%20seeks%20comment%20on%20proposed%20additions%20to%20to
bacco%20constituents%20list&utm_medium=email&utm_source=Eloqua.
128 FDA, “Harmful and Potentially Harmful Constituents in Tobacco Products; Established List; Proposed Additions;
Request for Comments,” 84 Federal Register 38032, August 5, 2019.
129 FFDCA §904(a)(4); 21 U.S.C. §387d(a)(4).
130 FDA, Guidance for Industry: Health Document Submission Requirements for Tobacco Products, Revised October
2017, https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM208916.pdf.
131 FFDCA §909(a); 21 U.S.C. §387i(a).
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expected adverse product experience.”132 Required reports cannot be overly burdensome and
cannot disclose the identity of a patient, except under certain circumstances.133
FDA has not yet promulgated regulations specifying these requirements. However, FDA issued a
proposed rule in April 2019 on the content of an SE report. The proposed rule would require
applicants submitting an SE report and receiving an SE order to maintain all records supporting
the SE report for at least four years.134 FDA also issued a proposed rule in September 2019 for
PMTAs that, among other things, would require manufacturers to “keep records regarding the
legal marketing of certain tobacco products without a PMTA.”135
Distribution and Promotion Requirements
Prior to 2009, restrictions on the distribution of tobacco products were largely enforced at the
state level, and promotion of cigarettes and smokeless tobacco was largely overseen by the
Federal Trade Commission (FTC).136 However, in 2009, the TCA explicitly gave FDA the
authority to require, by regulation, restrictions on the sale and distribution of a tobacco product if
such a regulation would be appropriate for the protection of public health.137 In addition, the
FFDCA specifies that FDA can impose restrictions, by regulation, on the advertising and
promotion of a tobacco product consistent with the First Amendment.138
In addition to authorizing FDA to regulate the sale and distribution of tobacco products, the TCA
also directed FDA to reissue its 1996 Tobacco Rule.139 Among other things, the 1996 Tobacco
Rule imposed requirements on the sale, labeling, and advertising of cigarettes and smokeless
tobacco.140 The TCA provided that the final rule must be identical to the 1996 rule, with specified
exceptions. FDA reissued the 1996 rule in March 2010,141 and the 2016 deeming rule extended
the applicability of sale and distribution restrictions, as well as certain labeling and advertising
requirements to newly deemed tobacco products (e.g., ENDS). In FY2020 appropriations,
Congress amended the federal minimum age of tobacco product purchasing from 18 to 21.142

132 FFDCA §909(a)(1); 21 U.S.C. §387i(a)(1).
133 FFDCA §909(a)(3)&(6); 21 U.S.C. §387i(a)(3)&(6).
134 FDA, “Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on
Substantial Equivalence Reports,” 84 Federal Register 12740, April 2, 2019.
135 FDA, “Premarket Tobacco Product Applications and Recordkeeping Requirements,” 84 Federal Register 50566,
September 25, 2019.
136 The Federal Cigarette Labeling and Advertising Act of 1965 (FCLAA; 15 U.S.C. §1331-1340) and the
Comprehensive Smokeless Tobacco Health Education Act of 1986 (CSTHEA; 15 U.S.C. §4401-4408) are overseen by
the Federal Trade Commission (FTC). For more information on the FCLAA, see FTC, “Federal Cigarette Labeling and
Advertising Act,” https://www.ftc.gov/enforcement/statutes/federal-cigarette-labeling-advertising-act. For more
information on the CHSTHEA, see https://www.ftc.gov/enforcement/statutes/comprehensive-smokeless-tobacco-
health-education-act-1986.
137 FFDCA §906(d)(1); 21 U.S.C. §387f(d)(1).
138 Ibid.
139 TCA §102(a). In 2000, the Supreme Court invalidated FDA’s 1996 tobacco rule. See FDA v. Brown & Williamson
Tobacco Corp., 529 U.S. 120 (2000). In this case, the Court concluded that under existing law, FDA lacked the
authority to regulate tobacco products. Id. at 160.
140 FDA, “Cigarettes and Smokeless Tobacco,” 61 Federal Register 44615, August 28, 1996.
141 FDA, “Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children
and Adolescents,” 75 Federal Register 13225, March 19, 2010.
142§603 of Division N of the Further Consolidated Appropriations Act, 2020 (P.L. 116-94).
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Current law and regulations restricting the sale and distribution of tobacco products will be
discussed first, followed by current law and regulations on the labeling and advertising of tobacco
products.
Restrictions on Sales and Distribution of Tobacco Products
The FFDCA—pursuant to changes made by the Further Consolidated Appropriations Act, 2020
(P.L. 116-94)—prohibits retailers from selling tobacco products to any person younger than 21
years of age143 and limits FDA’s ability to promulgate regulations that restrict the sale of tobacco
products to those over 21 years of age.144 FDA has stated that this new age sales restriction is
currently in effect.145
Prior to this statutory change, the minimum age of sale of tobacco products under federal
regulations was 18 years of age, and the FFDCA precluded FDA from promulgating regulations
restricting the sale of tobacco products to those over 18. As such, current federal regulations,
which were promulgated in 2016 prior to the enactment of P.L. 116-94, prohibit retailers from
selling cigarettes, smokeless tobacco products, and newly deemed tobacco products to anyone
younger than 18, and require retailers to verify the age of persons purchasing these products who
are younger than 27.146 To conform these regulations to changes made by P.L. 116-94, FDA is
required to update the regulations by June 20, 2020, to specify that retailers may not sell tobacco
products to those under 21 years of age and that retailers are required to verify the age of
individuals attempting to purchase tobacco products who are younger than 30. The final rule is to
take effect not later than September 20, 2020.147
Regulations also specify that manufacturers, distributors, or retailers may not distribute free
samples of cigarettes, smokeless tobacco products, and newly deemed tobacco products, with the
exception of smokeless tobacco in qualified adult-only facilities.148 Vending machine sales of
cigarettes, smokeless tobacco, and newly deemed tobacco products are prohibited, unless the
vending machine is located in a qualified adult-only facility.149 Consistent with the limitations
specified in statute, these regulations do not prohibit the sale of tobacco products in specific
categories of retail outlets (e.g., pharmacies, specialty stores).150

143 FFDCA §906(d)(5); 21 U.S.C. §387f(d)(5).
144 FFDCA §906(d)(3)(A)(ii); 21 U.S.C. §387f(d)(3)(A)(ii).
145 FDA, “Newly Signed Legislation Raises Federal Minimum Age of Sale of Tobacco Products to 21,” January 15,
2020, https://www.fda.gov/tobacco-products/ctp-newsroom/newly-signed-legislation-raises-federal-minimum-age-sale-
tobacco-products-21.
146 21 C.F.R. §1140.14.
147 Pursuant to §603(c) of Division N of the Further Consolidated Appropriations Act, 2020 (P.L. 116-94), FDA is
required to provide written notification to congressional committees of jurisdiction regarding the progress of
promulgating the final rule not later than 90 days after enactment of P.L. 116-94. If the final rule has not been
promulgated 180 days after enactment, FDA is required to provide a written notification and justification for the delay
in rulemaking to the committees of jurisdiction.
148 21 C.F.R. §1140.16(d). Regarding free samples, unlike other restrictions in the deeming rule that were applied to
newly deemed products made or derived from tobacco (“covered tobacco products”), the free sample ban applies to all
tobacco products subject to FDA’s authority, including components or parts not made or derived from tobacco (e.g.,
atomizers in ENDS products). See FDA, Guidance for Industry: The Prohibition of Distributing Free Samples of
Tobacco Products, October 2017, https://www.fda.gov/media/108259/download.
149 21 C.F.R. §1140.16(c).
150 FFDCA §906(d)(3)(A)(i); 21 U.S.C. §387f(d)(3)(A)(i).
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Synar Regulations
As mentioned above, prior to the enactment of the TCA, restrictions on the sale and distribution
of tobacco products were primarily enforced at the state level, and compliance with state laws
prohibiting tobacco sales to minors varied.151 Evidence emerged about health problems associated
with tobacco use by youth and about the ease with which youth could purchase tobacco products
through retail sources.152 In 1992, the Alcohol, Drug Abuse, and Mental Health Administration
(ADAHMA) Reorganization Act (P.L. 102-321) was signed into law, and it included an
amendment aimed at decreasing youth access to tobacco. More specifically, Section 1926 (known
as the Synar amendment) of the ADAHMA Reorganization Act required that the Substance Abuse
and Mental Health Services Administration (SAMHSA) make available the full Substance Abuse
Prevention and Treatment Block Grant (SABG) award funding to states and U.S. territories only
if they had laws in effect that prohibit the sale or distribution of tobacco products to individuals
younger than 18 years old.153 The SABG is a block grant program that distributes funds to 60
eligible states, U.S. territories, and freely associated states to plan, execute, and evaluate
substance use prevention, treatment, and recovery support services for affected individuals,
families, and communities.154 The SABG provides a consistent federal funding stream to states
through formula grants, and it is one of SAMHSA’s largest programs.155
The Synar regulations were promulgated by SAMHSA in 1996 to provide further guidance to
states on implementation of the Synar amendment. The regulation requires, among other things,
that states enact and enforce laws that prohibit the sale or distribution of tobacco products to
individuals younger than 18; conduct annual inspections of retailers that are representative of
retail outlets accessible to minors; and submit an annual report to SAMHSA on enforcement and
compliance actions in order to receive their full SABG funding.156 Because the term tobacco
product is not defined in the regulation, SAMHSA has indicated that each state may decide which
tobacco products should be included in tobacco retailer inspections, but encourages states to
include tobacco products being used most often by youth.157 In FY2020 appropriations, Congress
further amended the Synar amendment to require states, as a condition of receiving SABG
funding, to conduct annual, random inspections of retail outlets to ensure that such outlets are not
selling tobacco products to those under age 21 and comply with annual reporting requirements to

151 Thomas E Radecki and C Dianne Zdunich, “Tobacco sales to minors in 97 US and Canadian communities,”
Tobacco Control, vol. 2 (1993), pp. 300-305.
152 SAMHSA, “About the Synar Amendment and Program,” https://www.samhsa.gov/synar/about.
153 Public Health Service Act (PHSA) §1926 (42 U.S.C. §300x-26), as established by the Alcohol, Drug Abuse, and
Mental Health Administration (ADAHMA) Reorganization Act (P.L. 102-321).
154 SAMHSA, Justification of Estimates for Appropriations Committees for FY2020, p. 259,
https://www.samhsa.gov/sites/default/files/about_us/budget/samhsa_fy_2020_cj_submission_031919_508_final.pdf.
The ADAMHA Reorganization Act (P.L. 102-321) split the original 1981 Alcohol, Drug, and Mental Health Services
(ADMHS) block grant into the Mental Health Block Grant and the Substance Abuse Prevention and Treatment Block
Grant (SABG).
155 SAMHSA, Justification of Estimates for Appropriations Committees for FY2020, p. 259,
https://www.samhsa.gov/sites/default/files/about_us/budget/samhsa_fy_2020_cj_submission_031919_508_final.pdf;
SAMHSA, Operating Plan for FY2019,
https://www.samhsa.gov/sites/default/files/samhsa_fy2019_operating_plan_508.pdf.
156 SAMHSA, “Tobacco Regulation for Substance Abuse Prevention and Treatment Block Grants,” 61 Federal
Register 1492, January 19, 1996.
157 SAMHSA, “FFY 2014 Annual Synar Reports: Tobacco Sales to Youth,”
https://store.samhsa.gov/system/files/synar-15.pdf.
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SAMHSA on enforcement and compliance actions. SAMSHA will be required to update the
Synar regulations by June 20, 2020, to account for these changes.158
Tobacco Product Labeling and Advertisement Requirements
The Federal Cigarette Labeling and Advertising Act of 1965 (FCLAA)159 and the Comprehensive
Smokeless Tobacco Health Education Act of 1986 (CSTHEA) include certain labeling
requirements and advertising restrictions on cigarettes and smokeless tobacco, respectively.160
FTC generally oversees these two acts.161 For example, one advertising restriction within these
acts includes a ban on advertising cigarettes, little cigars, and smokeless tobacco products on
radio, television, or other media subject to the jurisdiction of the Federal Communications
Commission (FCC).162
In addition, manufacturers, distributors, and retailers may not sell or distribute tobacco products
with labels, labeling, or advertising that are not in compliance with the FFDCA and
accompanying FDA regulations.163 Certain labeling and advertising requirements specific to
cigarettes and smokeless tobacco include:
 Manufacturers, distributors, and retailers may not sponsor any athletic, musical,
or other social or cultural event with the brand name of a cigarette or smokeless
tobacco product.164
 Manufacturers and distributors of imported cigarettes and smokeless tobacco
may not market, license, distribute, or sell any product that bears the brand name,
logo, or any other identifying patterns associated with the brand name.165
 Labeling and advertising in audio and video formats are limited. For example,
audio formats cannot include music or sound effects.166
Tobacco product package labeling and advertisements must also include warning statements.
Table 3 lists the different health warning statements required to be displayed on tobacco product
package labeling and in tobacco product advertisements, by product. For example, all ENDS
package labeling and advertising is required to include “WARNING: This product contains
nicotine. Nicotine is an addictive chemical.”

158 PHSA §1926(c)(2); 42 U.S.C. §300x-26(c)(2).
159 The FCLAA was amended by the Public Health Cigarette Smoking Act of 1969.
160 The FCLAA and the CHSTHEA are overseen by the Federal Trade Commission (FTC). For more information on
the FCLAA, see FTC, “Federal Cigarette Labeling and Advertising Act,”
https://www.ftc.gov/enforcement/statutes/federal-cigarette-labeling-advertising-act. For more information on the
CHSTHEA, see https://www.ftc.gov/enforcement/statutes/comprehensive-smokeless-tobacco-health-education-act-
1986.
161 The FTC enforces unfair or deceptive marketing practices for tobacco products that may be in violation of Section 5
of the Federal Trade Commission Act (FTCA; 15 U.S.C. §41-58). For more information on the FTCA, see FTC,
“Federal Trade Commission Act,” https://www.ftc.gov/enforcement/statutes/federal-trade-commission-act.
162 15 U.S.C. §1335; 15 U.S.C. §4402(c).
163 FDA’s tobacco product regulations are included in 21 C.F.R. Part 1140.
164 21 C.F.R. §1140.34(c).
165 21 C.F.R. §1140.34(a).
166 21 C.F.R. §1140.32(b).
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Table 3. Required Warning Statements on Tobacco Product Packaging and
Advertising, by Tobacco Product
Tobacco Products
Required Warning Statements
Cigarettesa
SURGEON GENERAL’S WARNING: Smoking
Causes Lung Cancer, Heart Disease, Emphysema, And
May Complicate Pregnancy.

SURGEON GENERAL'S WARNING: Quitting
Smoking Now Greatly Reduces Serious Risks to Your
Health.

SURGEON GENERAL'S WARNING: Smoking By
Pregnant Women May Result in Fetal Injury, Premature
Birth, And Low Birth Weight.

SURGEON GENERAL'S WARNING: Cigarette
Smoke Contains Carbon Monoxide.
Cigarette Tobacco
WARNING: This product contains nicotine. Nicotine
is an addictive chemical.
Rol -Your-Own Tobacco (RYO)
WARNING: This product contains nicotine. Nicotine
is an addictive chemical.
Smokeless Tobaccob
WARNING: This product can cause mouth cancer.

WARNING: This product can cause gum disease and
tooth loss.

WARNING: This product is not a safe alternative to
cigarettes.

WARNING: Smokeless tobacco is addictive.
Newly Deemed Products (except cigars)c
WARNING: This product contains nicotine. Nicotine
is an addictive chemical.
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Tobacco Products
Required Warning Statements
Cigars
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, Stil birth and Low Birth Weight.

WARNING: This product contains nicotine. Nicotine
is an addictive chemical.
Tobacco products that do not contain or are not
These products are not subject to required warning
derived from tobacco or nicotine.
statements.
Source: Prepared by CRS, adapted from FDA, Retailers: Chart of Required Warning Statements on Tobacco Product
Packaging and Advertising, https://www.fda.gov/tobacco-products/retail-sales-tobacco-products/retailers-chart-
required-warning-statements-tobacco-product-packaging-and-advertising.
Notes: For all products, one of the warnings must be displayed on the two principal display panels. FDA is not
enforcing health warning statement requirements for cigar and pipe tobacco products, given pending litigation.
a. These cigarette health warning labels are required by the FCLAA (15 U.S.C. §§1331-1340) and are overseen
by FTC.
b. The first three listed warnings were originally authorized by the CSTHEA (15 U.S.C. §§4401-4408), The
TCA amended the CSTHEA to include the fourth listed warning. FTC oversees these warning label
requirements.
c. Newly deemed tobacco products include ENDS, cigars, pipe tobacco, hookah tobacco, nicotine gels,
dissolvable tobacco, and other tobacco products that may be developed in the future.
Cigarette Graphic Warning Labels
The TCA required FDA to promulgate regulations requiring color graphics depicting the negative
health consequences of cigarette smoking.167 In 2011, FDA published a final rule requiring
graphic warning labels on cigarette packaging—in addition to nine new warning statements
proposed in text—that would take effect 15 months after it was promulgated.168 The final rule was
challenged in court, and in 2012, an appeals court vacated the rule on First Amendment grounds
and remanded the issue to the agency. Ultimately, FDA did not seek further judicial review.169

167 15 U.S.C. §1333(d), as amended by TCA §201(a).
168 FDA, “Required Warnings for Cigarette Packages and Advertisements,” 76 Federal Register 36628, June 22, 2011.
169 FDA, Cigarette Graphic Health Warnings, https://www.fda.gov/tobacco-products/labeling-and-warning-statements-
tobacco-products/cigarette-graphic-health-warnings.
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FDA planned to develop and propose a new graphic warning rule and has continued to conduct
research for this rule since 2013.170 In 2016, multiple health organizations filed a suit against FDA
to compel the agency to promulgate a final rule more quickly.171 In March 2019, FDA was
ordered to issue a proposed rule by mid-August 2019 and a final rule by mid-March 2020.172 The
proposed rule, issued on August 16, 2019, specifies requirements for new cigarette health
warnings.173 Among other things, the warnings would occupy the top 50% of the front and rear
panels of cigarette packages, and at least 20% of the top area of cigarette advertisements.
However, it is to be determined whether this proposed rule will be subject to further litigation.
Compliance and Enforcement
If FDA finds that a retailer, manufacturer, importer, or distributor is not complying with FFDCA
chapter IX requirements or FDA regulations, the agency can take corrective action. Such
corrective actions include warning letters, civil money penalty (CMP) complaints, and no-
tobacco-sale order (NTSO) complaints, as well as seizures, injunctions, and criminal prosecution
(with the Department of Justice).174
Adulterated and Misbranded Tobacco Products
The FFDCA prohibits the adulteration and misbranding of tobacco products, as well as the
introduction, receipt, and delivery of adulterated or misbranded tobacco products into interstate
commerce.175
Adulterated Tobacco Products
In general, a tobacco product is deemed adulterated if
 it is contaminated by any substance that may render the product injurious to
health;
 it has been prepared in unsanitary conditions that may have contaminated the
product;
 its packaging is composed of any substance that could be harmful to health;
and/or
 if a manufacturer does not comply with user fee, tobacco product standard,
premarket review, and/or GMP requirements (when promulgated).176

170 Ibid.
171 American Academy of Pediatrics v. U.S. Food & Drug Admin, 330 F. Supp. 3d 657 (D. Mass. 2018);
https://www.tobaccofreekids.org/assets/content/press_office/2016/2016_10_04_fda_complaint.pdf.
172 American Academy of Pediatrics v. U.S. Food & Drug Admin, 2019 U.S. Dist. LEXIS 34946 (D. Mass. 2019);
https://www.tobaccocontrollaws.org/litigation/decisions/us-20190305-american-academy-of-pediatrics.
173 FDA, “Tobacco Products; Required Warnings for Cigarette Packages and Advertisements,” 84 Federal Register
42754, August 16, 2019.
174 For more general information about enforcement of the FFDCA, see CRS Report R43609, Enforcement of the Food,
Drug, and Cosmetic Act: Select Legal Issues.
175 FFDCA §301(a)-(c); 21 U.S.C. §331(a)-(c).
176 FFDCA §902; 21 U.S.C. §387b.
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Misbranded Tobacco Products
A tobacco product is deemed misbranded if
 the labeling is false or misleading in any way;177
 its package labeling does not include specified manufacturing information,
statements, or warnings required by regulation, or does not comply with an
established tobacco product standard;178
 the labeling, packaging, and shipping containers of tobacco products do not
contain the label “sale only allowed in the United States”;179
 it was manufactured, prepared, propagated, compounded, or processed in a
facility that was not registered with FDA;180
 its advertising is false or misleading in any way;181 and/or
 it is sold by a retailer to an individual under 21 years of age or is sold in violation
of regulations promulgated on the sale and distribution of tobacco products.182
FDA may, by regulation, require prior approval of statements made on labels of tobacco products
to ensure that the tobacco product is not misbranded. However, such a regulation cannot require
prior approval of an advertisement, except for MRTPs.183 To date, FDA has not issued such
regulations.
Tobacco Retailer Compliance Check Inspections
FDA is required to contract with states and territories to carry out compliance check inspections
of tobacco retailers.184 In some instances, FDA has awarded contracts to third-party entities that
hire commissionable inspectors to conduct compliance check inspections of tobacco retailers in
states and territories where FDA has not been able to contract with a state or territory agency.
FDA personnel may also conduct their own investigations.185
FDA ensures that tobacco retailers are in compliance with federal law and regulations through
undercover buy inspections. During these inspections, the retailer is unaware an inspection is
taking place. A trained minor, in consultation with a commissioned FDA inspector, attempts to
purchase a tobacco product.186 If a first-time violation is reported (e.g., sale to a minor, illegal
advertising), a warning letter is sent to the tobacco retailer, and the addressee has 15 working
days to respond to the letter, with no associated fines involved. When subsequent violations of
tobacco regulations or requirements are detected during these undercover buy inspections, FDA
files a CMP complaint. The associated fines vary based on the number of regulation violations

177 FFDCA §903(a)(1); 21 U.S.C. §387c(a)(1).
178 FFDCA §903(a)(2),(5), & (9); 21 U.S.C. §387c(a)(2),(5), & (9).
179 FFDCA §903(a)(2)(D); 21 U.S.C. §387c(a)(2)(D).
180 FFDCA §903(a)(6); 21 U.S.C. §387c(a)(6).
181 FFDCA §903(a)(7)(A) [21 U.S.C. §387c(a)(7)(A)]; 21 C.F.R. § 1141.14.
182 FFDCA §903(a)(7)(B); 21 U.S.C. §387c(a)(7)(B).
183 FFDCA §903(b); 21 U.S.C. §387c(b).
184 FFDCA §702(a)(1)(B)(i); 21 U.S.C. §372(a)(1)(B)(i).
185 FDA, “FDA Tobacco Retail Inspection Contracts,” https://www.fda.gov/tobacco-products/retail-sales-tobacco-
products/fda-tobacco-retail-inspection-contracts.
186 FDA, “Undercover Buy Inspections,” https://www.fda.gov/media/123583/download.
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and the time period in which the violations occurred.187 If retailers have repeated violations of the
restrictions on the sale and distribution of tobacco products, FDA may seek a NTSO, which
would prohibit sale of tobacco products at that retail outlet. A NTSO could be separate or
combined with CMPs.188 According to FDA, as of June 2019, the agency has “conducted more
than a million compliance check inspections and issued nearly 88,000 Warning Letters, 22,000
[CMPs], and 160 [NTSOs].”189
As mentioned above, in FY2020 appropriations, Congress amended the federal minimum age of
tobacco product purchasing from 18 to 21.190 FDA has stated that this new age sales restriction is
currently in effect, but also recognizes that the agency and retailers will need to update current
practices to account for these changes.191 As such, FDA has stated that “during this ramp-up
period, FDA will continue to only use minors under the age of 18 in its compliance check
program.”192
Notification and Recall
FDA has the authority to issue notifications and recalls of tobacco products once they are on the
market.193 FDA can issue a notification through a public service announcement if the tobacco
product “presents an unreasonable risk of substantial harm to the public health,”194 provided that
FDA determines there are no other practical means to eliminate such risk.
A tobacco product manufacturer can initiate or FDA can request a (voluntary) recall if the tobacco
product is thought to be in violation of the FFDCA.195 In addition, FDA has the authority to
mandate a tobacco product recall under specified circumstances. If FDA determines that a
tobacco product contains a manufacturing or other defect that would “cause serious, adverse
health consequences or death,” the agency can issue an order requiring the appropriate person
(e.g., the manufacturer, retailer, importer, or distributor) to immediately stop distribution of the
tobacco product.196 FDA is required to provide the person subject to the order an opportunity for
an informal hearing not later than 10 days after the order is issued. Following the hearing, FDA is
required to vacate the order if the agency determines that there is insufficient evidence to
maintain the order. If after the informal hearing FDA determines that the order should be

187 TCA §103(q)(2)(a).
188 FDA, Guidance for Tobacco Retailers: Determination of the Period Covered by a No-Tobacco-Sale-Order and
Compliance With an Order, August 2015,
https://www.fda.gov/downloads/tobaccoproducts/labeling/rulesregulationsguidance/ucm460155.pdf.
189 FDA, “Achievements in Tobacco Regulation Over the Past Decade and Beyond,” June 20, 2019,
https://www.fda.gov/news-events/fda-voices-perspectives-fda-leadership-and-experts/achievements-tobacco-
regulation-over-past-decade-and-beyond?utm_campaign=10-
year%20Anniversary%20Voice&utm_medium=email&utm_source=Eloqua.
190 §603 of Division N of the Further Consolidated Appropriations Act, 2020 (P.L. 116-94).
191 FDA, “Newly Signed Legislation Raises Federal Minimum Age of Sale of Tobacco Products to 21,” January 15,
2020, https://www.fda.gov/tobacco-products/ctp-newsroom/newly-signed-legislation-raises-federal-minimum-age-sale-
tobacco-products-21.
192 Ibid.
193 FFDCA §908(a); 21 U.S.C. §387h(a).
194 FFDCA §908(a)(1); 21 U.S.C. §387h(a)(1).
195 For more information on FDA’s general recall authority, see CRS Report R43609, Enforcement of the Food, Drug,
and Cosmetic Act: Select Legal Issues.
196 FFDCA §908(c)(1); 21 U.S.C. §387h(c)(1).
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amended to include a recall of the tobacco product, FDA must amend the order to require such
recall, specifying a timetable for and requiring periodic progress reports on the recall.
Issues for Congress and Policy Considerations
Although the TCA expanded FDA’s authority to regulate tobacco products in 2009, stakeholders
have recently identified several issues related to the regulation of these products that may be of
interest to Congress:
 FDA and public health stakeholders remain concerned about the marked increase
in use of ENDS among youth over the past few years, and many in the public
health community argue that this increase is largely driven by the availability of
youth-friendly flavors in these products. While the public health community
generally views ENDS as a safer alternative for adult cigarette smokers, there is
concern that increased use of ENDS among youth may undo the years of tobacco
control efforts that have successfully reduced cigarette smoking among both
youth and adults. The emergence of EVALI has further heightened concern
among public health stakeholders, Congress, and the general public.
 Public health stakeholders have been concerned about youth access to tobacco
products more broadly and expressed support for raising the minimum age of
access for tobacco products from 18 to 21 years of age. Congress recently made
this change legislatively, but some want Congress to take further action to
address tobacco use among youth.
 The remote sales of tobacco products—including ENDS—may be an opportunity
for youth to purchase tobacco products illegally, due to difficulties in enforcing
purchasing restrictions through this medium.
 Generally separate from the aforementioned public health issues, another issue
concerns FDA’s authority to collect tobacco user fees. More specifically, FDA
has determined that it currently does not have the authority to assess user fees
from ENDS manufacturers and importers, despite these products being deemed
subject to FDA regulation.
These four issues are discussed in detail below, along with potential considerations for
policymakers.197
ENDS: Harm Reduction Potential among Adults vs. Use among
Youth, Including Flavored ENDS Use
Since the emergence of ENDS in the tobacco marketplace, there has been ongoing debate
regarding their public health impact. The public health community generally views them as a
harm reduction tool for adults who specifically smoke cigarettes. Harm reduction refers to the
replacement of a more harmful activity with a less harmful one when elimination of the activity is
difficult or infeasible. ENDS have the potential to reduce harm among adult cigarette smokers

197 Currently, ENDS products are not subject to federal excise taxes, but discussion of this policy issue is outside the
scope of this report. For more information, see U.S. Government Accountability Office, Electronic Cigarettes: Effect
on Federal Excise Taxes Collected on Traditional Cigarettes is Not Currently Evident, GAO-15-771, September 2015,
https://www.gao.gov/assets/680/672467.pdf.
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who have experienced difficulty quitting, as the aerosol from ENDS “contains fewer numbers and
lower levels of most toxicants than does smoke from combustible tobacco cigarettes.”198
Yet the data are complex regarding the effectiveness of ENDS as a harm reduction or cessation
tool for adults who smoke cigarettes. As of early 2018, the National Academies of Sciences,
Engineering, and Medicine (NASEM) concluded that “there is general agreement that the
number, size, and quality of studies for judging the effectiveness of e-cigarettes as cessation aids
in comparison with cessation aids of proven efficacy are limited, and therefore there is
insufficient evidence to permit a definitive conclusion at this time.”199 Further, the long-term
health effects associated with use of ENDS are still largely unknown,200 and FDA has not yet
approved any ENDS products as cessation devices. In spite of these questions, many adult
cigarette smokers have expressed an interest in ENDS as a way to quit cigarette smoking.201
Some argue that having adults completely switch from cigarettes to ENDS can generally be
viewed as positive for the public’s health, given the morbidity and mortality associated with
cigarette smoking.202
However, many in the public health community are alarmed by the marked increase in use of
ENDS products among youth, which are now the most popular tobacco product used among this
age group.203 Research studies suggest that this change has occurred, in large part, as a result of
access to flavored ENDS products.204 The availability of flavored ENDS products has created
tension between industry and the public health community. Industry-funded research suggests that
availability of flavored ENDS may be more appealing to adult cigarette smokers (in comparison
to nonsmoking teens) and could help adult cigarette smokers quit cigarette smoking.205
Conversely, one systematic review of the literature found that both youth and adults enjoy flavors
in e-cigarettes. However, the authors of this review stated that “in terms of whether flavored e-
cigarettes assisted [adults] quitting smoking, we found inconclusive evidence.”206 In combination,
numerous studies have documented that flavors entice youth to initiate and continue using

198 National Academies of Sciences, Engineering, and Medicine, Public Health Consequences of E-Cigarettes, National
Academies Press, Washington, DC, 2018, p. 1, https://www.nap.edu/read/24952.
199 Ibid, p. 579.
200 Ibid, p. 483.
201 Matthew J. Carpenter, Bryan W. Heckman, Amy E. Wahlquist, et al., “A Naturalistic, Randomized Pilot Trial of E-
Cigarettes: Uptake, Exposure, and Behavioral Effects,” Cancer Epidemiology, Biomarkers & Prevention, vol. 26, no.
12 (December 2017).
202 U.S. Department of Health and Human Services, The Health Consequences of Smoking: 50 Years of Progress. A
Report of the Surgeon General, U.S. Department of Health and Human Services, Centers for Disease Control and
Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health,
Atlanta, GA, January 2014, https://www.surgeongeneral.gov/library/reports/50-years-of-progress/50-years-of-progress-
by-section.html.
203 Andrea S. Gentzke, MeLisa Creamer, Karen A. Cullen, et al., “Vital Signs: Tobacco Product Use Among Middle
and High School Students - United States, 2011-2018,” CDC Morbidity and Mortality Weekly Report (MMWR), vol.
68, no. 6 (February 2019).
204 FDA, Draft Guidance for Industry: Modifications to Compliance Policy for Certain Deemed Tobacco Products,
March 2019, https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM633281.pdf.
205 Saul Shiffman, Mark A. Sembower, Janine L. Pillitteri, et al., “The Impact of Flavor Descriptors on Nonsmoking
Teens’ and Adult Smokers’ Interest in Electronic Cigarettes,” Nicotine & Tobacco Research, January 7, 2015, pp.
1255-1262.
206 Samane Zare, Mehdi Nemati, and Yuqing Zheng, “A systematic review of consumer preference for e-cigarette
attributes: Flavor, nicotine strength, and type,” PLoS ONE, vol. 13, no. 3 (2018).
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tobacco products,207 including ENDS.208 Further, the NASEM concluded that there is substantial
evidence that ENDS use among youth increases the risk of such youth ever using cigarettes,209
leading to concern that tobacco control efforts that have successfully reduced cigarette smoking
among both youth and adults will be diminished. The culmination of these factors raises
questions about how to regulate ENDS products going forward and, specifically, how to address
flavors in tobacco products (including ENDS).
In March 2019, FDA released a draft guidance document specifying its intended enforcement
activities related to flavored ENDS.210 This guidance specified that FDA would prioritize
enforcement of premarket review, distribution, and sale requirements related to certain flavored
ENDS products that may be most accessible to youth. For example, FDA would prioritize
enforcement of distribution and sale requirements in retail locations where certain flavored ENDS
products may be most accessible to youth, such as in convenience stores and gas stations that do
not have adult-only sections. In September 2019, FDA announced that it would finalize this
guidance document “in the coming weeks,” with the intention of clearing “the market of flavored
e-cigarettes to reverse the deeply concerning epidemic of youth e-cigarette use.”211 Delays in
guidance finalization led to a congressional hearing on December 4, 2019, to investigate the cause
for delay.212 In January 2020, FDA released the final guidance document,213 with some changes
compared to the draft guidance. Specifically, the March 2019 draft guidance focused enforcement
of premarket authorization requirements based on how and where ENDS products are sold, while
the final guidance focuses enforcement of premarket authorization requirements based on ENDS
product characteristics (e.g., cartridge-based products). Some public health stakeholders
expressed concern that the final guidance does not go far enough to reduce ENDS use among
youth.214
In response to concerns regarding youth access to ENDS products, including flavored ENDS
products, Congress may consider further limiting when flavors can be used in ENDS. Congress

207 National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, Centers for
Disease Control and Prevention, Preventing Tobacco Use Among Youth and Young Adults: A Report of the Surgeon
General, U.S. Department of Health and Human Services, Atlanta, GA, 2012,
https://www.surgeongeneral.gov/library/reports/preventing-youth-tobacco-use/full-report.pdf.
208 National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, Centers for
Disease Control and Prevention, E-Cigarette Use Among Youth and Young Adults: A Report of the Surgeon General,
U.S. Department of Health and Human Services, Atlanta, GA, 2016, https://e-
cigarettes.surgeongeneral.gov/documents/2016_sgr_full_report_non-508.pdf.
209 National Academies of Sciences, Engineering, and Medicine, Public Health Consequences of E-Cigarettes, National
Academies Press, Washington, DC, 2018, p. 532, https://www.nap.edu/read/24952.
210 FDA, Draft Guidance for Industry: Modifications to Compliance Policy for Certain Deemed Tobacco Products,
March 2019, https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM633281.pdf.
211 FDA, “Trump Administration Combating Epidemic of Youth E-Cigarette Use with Plan to Clear Market of
Unauthorized, Non-Tobacco-Flavored E-Cigarette Products,” September 11, 2019, https://www.fda.gov/news-
events/press-announcements/trump-administration-combating-epidemic-youth-e-cigarette-use-plan-clear-market-
unauthorized-non.
212 U.S. Congress, House Committee on Oversight and Reform, Subcommittee on Economic and Consumer Policy, The
Federal Response to the Epidemic of E-Cigarette Use, Especially Among Children, and the Food and Drug
Administration’s Compliance Policy, 116th Cong., 1st sess., December 4, 2019.
213 FDA, Guidance for Industry: Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and Other
Deemed Products on the Market Without Premarket Authorization, January 2020,
https://www.fda.gov/media/133880/download.
214 Abby Goodnough, Maggie Haberman, and Sheila Kaplan, "With Partial Flavor Ban, Trump Splits the Difference on
Vaping," The New York Times, January 2, 2020.
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may also choose to outright ban all flavors (including menthol) in ENDS—as well as in other
tobacco products—as some legislation introduced in the 116th Congress has proposed.215
Congress may consider proposals that reduce any tobacco product use, including ENDS, among
youth while leaving the option of ENDS use open for adult cigarette smokers in order to benefit
the public’s health. Congress may also consider how availability of flavored tobacco products
would fit into those proposals.
E-cigarette, or Vaping, Product Use-Associated Lung Injury (EVALI)
Amidst a rise in ENDS use among youth, the emergence of EVALI has raised concern among
public health stakeholders, the general public, and Congress. According to CDC, data suggest that
the outbreak began in June 2019. Emergency department (ED) visits reached a peak in September
2019 but have since declined. As of January 21, 2020, 60 deaths had been confirmed in 27 states
and DC, and 2,711 hospitalized EVALI cases have been reported to CDC in all 50 states, DC,
Puerto Rico, and the U.S. Virgin Islands. Among hospitalized EVALI patients with available data,
66% were male and 76% were under 35 years old.216 Further, among a subset of hospitalized
EVALI patients,217 82% reported using tetrahydrocannabinol218 (THC)-containing products.
Although the causes of EVALI are still unknown, laboratory data suggest that vitamin E acetate—
an additive found in some THC-containing ENDS products—is closely associated with EVALI.219
Vitamin E acetate is commonly used as a dietary supplement and in skin creams. While the
ingestion and dermal use of vitamin E acetate are not generally associated with adverse health
effects, the safety of inhaling vitamin E acetate has not been closely examined.220
FDA and CDC, along with state and local health departments, have been working together closely
to investigate the issue. FDA, the Drug Enforcement Administration (DEA), and local and state
authorities have also been investigating the supply chain of ENDS associated with EVALI. FDA
and DEA announced that they have seized 44 websites that were advertising the sale of illicit
THC-containing vape cartridges, although none of the products advertised on the websites have
been linked to any cases of EVALI.221
Such THC-containing products may raise a larger question of federal oversight pertaining to these
products that are available in states permitting the sale of marijuana for recreational or medicinal
purposes. Marijuana—including marijuana-derived compounds such as THC—is an illicit
substance at the federal level subject to DEA enforcement and regulatory control.222 However,

215 H.R. 1498, 116th Congress; H.R. 2339, 116th Congress.
216 CDC, “Outbreak of Lung Injury Associated with the Use of E-Cigarette, or Vaping, Products,” January 14, 2020,
https://www.cdc.gov/tobacco/basic_information/e-cigarettes/severe-lung-disease.html.
217 The subset of patients included those with complete information on substances used in ENDS products three months
prior to symptom onset.
218 Tetrahydrocannabinol (THC) is the primary psychoactive compound, or cannabinioid, found in marijuana.
Marijuana is a variety or cultivar of the Cannabis sativa plant. See Figure 1 of CRS Report R46189, FDA Regulation of
Cannabidiol (CBD) Consumer Products: Overview and Considerations for Congress.
219 Benjamin C. Blount, Mateusz P. Karwowski, Peter G. Shields, et al., “Vitamin E Acetate in Bronchoalveolar-
Lavage Fluid Associated with EVALI,” The New England Journal of Medicine, December 20, 2019, DOI:
10.1056/NEJMoa1916433.
220 Ibid.
221 FDA, “FDA, DEA Seize 44 websites advertising sale of illicit THC vaping cartridges to US consumers as part of
Operation Vapor Lock,” December 20, 2019, https://www.fda.gov/news-events/press-announcements/fda-dea-seize-44-
websites-advertising-sale-illicit-thc-vaping-cartridges-us-consumers-part-operation.
222 Marijuana is currently listed as a Schedule I controlled substance under the Controlled Substances Act (CSA). For
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some states have implemented their own laws on marijuana pertaining to recreational and
medicinal use, and the DEA has largely focused resources on criminal networks involved in the
illicit marijuana trade.223 Therefore, THC-containing ENDS products available for sale in states
that are allowing recreational and medicinal marijuana may not be the focus of DEA’s current
enforcement efforts and regulation. Further, ENDS products that do not contain any components,
parts, or accessories that are derived from tobacco (e.g., do not contain nicotine) and are not
expected to be consumed like a tobacco product may not meet the definition of a tobacco product
under the FFDCA. Therefore, such products may not be subject to FDA regulatory requirements
pertaining to tobacco products. FDA has indicated that the agency would regulate such products
on a “case-by-case basis, based on the totality of the circumstances.”224
Tobacco to 21
Many public health stakeholders have been concerned about youth access to tobacco products
more broadly and expressed support for raising the minimum age of purchasing tobacco products
from 18 to 21. Numerous scientific studies and Surgeon General Reports have documented that
tobacco product use often begins before the age of 18.225 Nearly 90% of cigarette smokers have
tried their first cigarette by age 18, and 98% have tried their first cigarette by age 26.226
The TCA required FDA to commission a report on the public health impact of raising the
minimum age of tobacco product sales.227 FDA contracted with the Institute of Medicine (now
known as the National Academy of Medicine), and concluded in a 2015 report that “increasing
the minimum age of legal access to tobacco products will likely prevent or delay the initiation of
tobacco use by adolescents and young adults.”228 However, the report noted that “the impact on
initiation of tobacco use of raising the minimum age of legal access to tobacco products to 21 will

more information, see CRS Report R44782, The Marijuana Policy Gap and the Path Forward.
223 Deputy Attorney General David W. Ogden, Memorandum for Selected United States Attorneys, U.S. Department of
Justice, Investigations and Prosecutions in States Authorizing the Medical Use of Marijuana, Washington, DC, October
19, 2009, pp. 1-3.
224 See question 14 in FDA, “Commonly Asked Questions: About the Center for Tobacco Products,” June 11, 2019,
https://www.fda.gov/tobacco-products/about-center-tobacco-products-ctp/commonly-asked-questions-about-center-
tobacco-products#14.
225 U.S. Department of Health and Human Services, The Health Consequences of Smoking: 50 Years of Progress. A
Report of the Surgeon General, U.S. Department of Health and Human Services, Centers for Disease Control and
Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health,
Atlanta, GA, January 2014, https://www.surgeongeneral.gov/library/reports/50-years-of-progress/50-years-of-progress-
by-section.html.; National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and
Health, Centers for Disease Control and Prevention, Preventing Tobacco Use Among Youth and Young Adults: A
Report of the Surgeon General, U.S. Department of Health and Human Services, Atlanta, GA, 2012,
https://www.surgeongeneral.gov/library/reports/preventing-youth-tobacco-use/full-report.pdf.
226 U.S. Department of Health and Human Services, The Health Consequences of Smoking: 50 Years of Progress. A
Report of the Surgeon General, U.S. Department of Health and Human Services, Centers for Disease Control and
Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health,
Atlanta, GA, January 2014, https://www.surgeongeneral.gov/library/reports/50-years-of-progress/50-years-of-progress-
by-section.html.
227 TCA §104.
228 Institute of Medicine, Public Health Implications of Raising the Minimum Age of Legal Access to Tobacco
Products, The National Academies Press, p. 4-5, Washington, DC, 2015, https://www.nap.edu/read/18997/chapter/1.
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likely be substantially higher than raising it to 19, but the added effect of raising the minimum
age of legal access beyond age 21 to age 25 will likely be considerably smaller.”229
In FY2020 appropriations, Congress amended the FFDCA to raise the federal minimum age of
tobacco product sales to 21. FDA is also required to update its regulations by June 20, 2020 to
reflect the new federal minimum age of tobacco purchasing, as well as the federal minimum age
verification requirement (age verification required for individuals less than 30 years of age). The
final rule is required to take effect by September 20, 2020.230 While public health stakeholders
view this development in a positive light, some are concerned that the tobacco industry supported
this initiative to avoid other measures that could also curb tobacco use—including ENDS use—
among youth.231
Remote Sales
Related to the issue of youth access to tobacco products—including ENDS—some have identified
remote sales (i.e., non-face-to-face sales) as an opportunity for minors to illegally purchase
tobacco products, due to difficulties in enforcing purchasing restrictions through this medium.
While the Prevent All Cigarette Trafficking (PACT) Act of 2009 (P.L. 111-154) placed certain
restrictions on remote sales of cigarettes and smokeless tobacco, it did not outright prohibit them.
Further, the PACT Act limits the ability of states and local governments to regulate the delivery
carriers involved in remote sales—complicating enforcement efforts—and did not place such
restrictions on other tobacco products, such as ENDS.232
Section 906 of the FFDCA requires FDA to promulgate regulations on remote sales of tobacco
products, including age verification requirements. In 2011, FDA issued an ANPRM regarding
remote sales and distribution of tobacco products,233 but has not taken further regulatory action
since that time.
Legislation has been introduced in the 116th Congress that would ban all tobacco product remote
sales, including remote sales of ENDS.234 As has been proposed previously,235 Congress may also
consider amending the PACT Act to extend its provisions to other tobacco products beyond
cigarettes and smokeless tobacco, such as ENDS.

229 Ibid.
230 §603(b) of Division N of the Further Consolidated Appropriations Act, 2020 (P.L. 116-94). FDA has stated that the
new age sales restriction is currently in effect. See FDA, “Newly Signed Legislation Raises Federal Minimum Age of
Sale of Tobacco Products to 21,” January 15, 2020, https://www.fda.gov/tobacco-products/ctp-newsroom/newly-
signed-legislation-raises-federal-minimum-age-sale-tobacco-products-21.
231 Laurie McGinley and Yasmeen Abutaleb, “Congress set to prohibit sales of tobacco products to anyone under 21,”
Washington Post, December 16, 2019.
232 PACT Act §2A(e)(5)(A); Tobacco Legal Consortium, “E-Cigarettes and Other Tobacco Products Online:
Preventing Sales to Kids,” https://www.publichealthlawcenter.org/sites/default/files/resources/tclc-guide-online-
tobacco-products-kids-2016.pdf.
233 FDA, “Non-Face-to-Face Sale and Distribution of Tobacco Products and Advertising, Marketing, and Promotion of
Tobacco Products,” 76 Federal Register 55835, September 9, 2011.
234 H.R. 2339, 116th Congress.
235 S. 1253, 116th Congress; H.R. 3942, 116th Congress; H.R. 7337, 115th Congress.
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ENDS: User Fees
As mentioned above, FDA does not collect user fees from ENDS manufacturers and importers.
Given recent concerns around ENDS products, CTP has dedicated a portion of its user fees paid
by other tobacco product manufacturers and importers to address ENDS-specific issues.
Therefore, some stakeholders have suggested that manufacturers and importers of ENDS products
be subject to tobacco user fees to offset costs associated with FDA’s current and future ENDS-
specific activities. However, FDA has determined that it currently does not have the authority to
assess user fees from ENDS manufacturers and importers because Congress did not specify an
enumerated class for ENDS products and did not provide a framework by which FDA could
potentially assess user fees for ENDS products.236
Based on FDA’s interpretation, in order for ENDS manufacturers to be subject to the tobacco
product user fees, Congress would need to provide FDA with the statutory framework for doing
so. For example, Congress may consider amending both the FETRA formula and Section 919 of
the FFDCA. However, ENDS products are not currently subject to federal excise taxes,237 and
such taxes are a critical component of the FETRA formula (see “User Fees” section). Therefore, if
Congress were to amend FETRA and the FFDCA to explicitly provide FDA the authority to
assess user fees on ENDS manufacturers and importers, Congress would likely need to amend the
Internal Revenue Code (IRC) to make ENDS products subject to federal excise taxes.238 Another
option for Congress may be to create a new, separate ENDS user fee program.
There has been recent congressional and executive branch interest in requiring ENDS
manufacturers and importers to pay user fees. Legislation has been introduced in the 116th
Congress that would either amend the FFDCA’s current user fee structure by striking the FETRA
provisions to allow for assessment of ENDS user fees,239 or create a new, separate ENDS user fee
program.240 The FY2021 President’s budget request also proposed requiring ENDS manufacturers
and importers to pay $100 million in user fees starting in FY2021.241 However, based on FDA’s
current interpretation, user fees could not be collected from ENDS manufacturers and importers
without first enacting authorizing legislation.

236 FDA, “Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and
Importers of Cigars and Pipe Tobacco,” 81 Federal Register 28707, May 10, 2016.
237 For more information on why ENDS products are not currently subject to federal excise taxes, see U.S. Government
Accountability Office, Electronic Cigarettes: Effect on Federal Excise Taxes Collected on Traditional Cigarettes is
Not Currently Evident, GAO-15-771, September 2015, https://www.gao.gov/assets/680/672467.pdf, p. 16.
238 Relevant IRC provisions are found at 26 U.S.C. §§5701-02.
239 H.R. 2339, 116th Congress.
240 S. 616, 116th Congress.
241 FDA, Justification of Estimates for Appropriations Committee for FY2021, p. 268,
https://www.fda.gov/media/135078/download.
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Appendix A. The IQOS Tobacco Heating System
The IQOS Tobacco Heating System (IQOS) is commonly referred to as a “heat-not-burn” tobacco
product. This new technology differs from ENDS technology because it aerosolizes the tobacco
plant itself, rather than a tobacco-derived e-liquid. FDA has determined that the IQOS meets the
definition of a cigarette and, as such, is subject to additional FFDCA requirements and regulations
specific to cigarettes, such as advertising restrictions.
The IQOS is composed of three main components:
 The IQOS Heatstick is a filtered, noncombusted cigarette. A Heatstick is
designed to be electrically heated to release nicotine-containing aerosol. The
nicotine is derived from a reconstituted tobacco sheet made from ground tobacco
powder.
 The IQOS Holder is an electrically powered and rechargeable unit that holds and
warms the Heatstick. The Holder is used for a single Heatstick for about six to
seven minutes, after which the Holder needs to be charged and the used Heatstick
is discarded.
 The IQOS Charger recharges and cleans the Holder after each use.
Figure A-1. The IQOS Tobacco Heating System

Source: FDA, “Decision Summary: Phil ip Morris Products S.A. IQOS System Holder and Charger,” April 2019,
https://www.fda.gov/media/124247/download.
Notes: From left to right, pictured is the IQOS Tobacco Heating System Charger, Holder, and Heatstick,
respectively.
Given the novel technology of the IQOS, some industry stakeholders see this product as a
potential precedent for the premarket review process that ENDS products will eventually
undergo. On May 15, 2017, FDA received PMTAs from Phillip Morris International (PMI) for the
IQOS Tobacco Heating System (IQOS). PMI filed four PMTA applications for the IQOS. Three
PMTA applications were for the Heatstick—two of which were for menthol flavored heatsticks—
and one PMTA application was for the Holder and Charger.
Nearly two years later, on April 30, 2019, FDA authorized the IQOS Tobacco Heating System for
marketing through these PMTAs. Based on the substantial back and forth between PMI and FDA
to elicit the information needed for the complete PMTA applications, there is concern that small
ENDS manufacturers may not have the resources to engage in the PMTA process in the future.
There is also concern that FDA may need additional resources to accommodate the inevitable
influx of lengthy ENDS PMTA applications.
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Appendix B. Tobacco Master Settlement Agreement
of 1998242
On November 23, 1998, attorneys general from 46 states, the District of Columbia, and the U.S.
territories signed a contractual agreement (the Master Settlement Agreement, or MSA) with the
major cigarette companies to settle state lawsuits to recover the costs, borne by Medicaid and
other public programs, of treating smoking-related illnesses.243 The remaining four states—
Mississippi, Florida, Texas, and Minnesota—had settled individually with the companies prior to
the MSA. Under the terms of the MSA, the companies agreed to make annual payments in
perpetuity and accept certain restrictions on tobacco product advertising, marketing, and
promotion. Specifically, the MSA:
 prohibited cigarette companies from targeting youth in the advertising,
promotion, or marketing of their products;
 banned the use of cartoons in advertising;
 limited each company to brand-name sponsorship of one sporting or cultural
event a year, excluding concerts, team sports, events with a significant youth
audience, or events with underage contestants;
 banned public transit advertising;
 banned outdoor billboard advertising, excluding billboard advertising for brand-
name sponsored events;
 limited advertising outside retail stores to signs no bigger than 14 sq. ft;
 banned company payments to promote cigarettes in various media, including
movies and TV;
 banned noncigarette apparel with brand-name logos except at brand-name
sponsored events;
 banned gifts of noncigarette items to youth in exchange for cigarettes;
 restricted the use of nationally recognized nontobacco brand names for cigarettes;
and
 limited free samples of cigarettes to adult-only facilities.

242 This appendix summary was adapted from archived CRS Report R40475, FDA Tobacco Regulation: The Family
Smoking Prevention and Tobacco Control Act of 2009.
243 The full text of the MSA is available on the website of the National Association of Attorneys General, which is
responsible for enforcing it, at http://www.naag.org/backpages/naag/tobacco/msa.
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Appendix C. Definitions of Terms Used in
This Report
Example
Term
Definition
(if applicable)
Accessory
Any product that is intended or reasonably
Cigar clip
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 fol owing: (1) is
not intended or reasonably expected to affect or
alter the performance, composition, constituents,
or characteristics of a tobacco product or (2) is
intended or reasonably expected to affect or
maintain the performance, composition,
constituents, or characteristics of a tobacco
product but (i) solely controls moisture and/or
temperature of a stored product or (ii) solely
provides an external heat source to initiate but not
maintain combustion of a tobacco product.
Additive
Any substance the intended use of which results or
Menthol (flavor
may reasonably be expected to result, directly or
additive)
indirectly, in its becoming a component or
otherwise affecting the characteristic of any tobacco
product (including any substances intended for use
as a flavoring or coloring or in producing,
manufacturing, packing, processing, preparing,
treating, packaging, transporting, or holding), except
that such term does not include tobacco or a
pesticide chemical residue in or on raw tobacco or
a pesticide chemical.
Brand
A variety of tobacco products distinguished by the
Juul
tobacco used, tar content, nicotine content,
flavoring used, size, filtration, packaging, logo,
registered trademark, brand name, identifiable
pattern of colors, or any combination of such
attributes.
Cigarette
Any rol of tobacco wrapped in paper or in any

substance not containing tobacco and any rol of
tobacco wrapped in any substance containing
tobacco which, because of its appearance, the type
of tobacco used in the fil er, or its packaging or
labeling, is likely to be offered to or purchased by
consumers (15 U.S.C. §1332(1)).
Component or part
Any software or assembly of materials intended or
Pipe
reasonably expected: (1) To alter or affect the
tobacco product's performance, composition,
constituents or characteristics; or (2) to be used
with or for the human consumption of a tobacco
product.
Covered tobacco product
Any tobacco product, excluding any component or
E-liquid
part of a tobacco product that is not made or
derived from tobacco.
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Example
Term
Definition
(if applicable)
Electronic nicotine delivery systems
An umbrella term for noncombustible tobacco
E-cigarette
products containing an e-liquid that, when heated,
creates aerosol that a user inhales.
Finished tobacco product
A tobacco product, including all components and
E-liquid in final
parts, sealed in final packaging intended for
packaging to be
consumer use.
sold or
distributed to a
consumer for use
Grandfathered tobacco product
A tobacco product commercially marketed in the
Marlboro Box
United States as of February 15, 2007.
Cigarettes
Grandfathered tobacco products do not require
premarket review to be legally marketed.
Harmful and potentially harmful
Any chemicals or chemical compounds in a tobacco
Nitrobenzene
constituents
product or in tobacco smoke that is, or potentially
is, inhaled ingested, or absorbed into the body,
including as an aerosol (vapor) or any other
emission; and causes or has the potential to cause
direct or indirect harm to users or nonusers of
tobacco products.
Investigational tobacco product
A new or modified risk tobacco product that is not

legally marketed or a tobacco product that is
required to comply with a tobacco product
standard and that does not conform in all respects
to the applicable tobacco product standard, and is
intended for investigational use.
New tobacco product
Any tobacco product (including those products in

test markets) that was not commercially marketed
in the United States as of February 15, 2007 OR any
modification (including a change in design, any
component, any part, or any constituent, including a
smoke constituent, or in the content, delivery or
form of nicotine, or any other additive or
ingredient) of a tobacco product where the
modified product was commercially marketed in the
United States after February 15, 2007.
Package
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.
Qualified adult-only facility
A temporary facility or restricted area that requires

each person present to provide to a law
enforcement officer or to a security guard licensed
by a governmental entity government-issued
identification showing a photograph and at least the
minimum age established by applicable law for the
purchase of smokeless tobacco. The facility may not
sell, serve, or distribute alcohol (among other
requirements).
Rol -your-own tobacco
Any tobacco product, which, 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.
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Example
Term
Definition
(if applicable)
Small tobacco product manufacturer
A tobacco product manufacturer that employs

fewer than 350 employees. The employees of a
manufacturer are deemed to include the employees
of each entity that controls, is control ed by, or is
under common control of such manufacturer.
Small-scale tobacco product
A manufacturer of any regulated tobacco product

manufacturer
that employs 150 or fewer ful -time equivalent
employees and has annual total revenues of $5
mil ion or less.
Smokeless tobacco
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.
Smoke constituent
A chemical or chemical compound in mainstream
Carbon
or sidestream tobacco smoke that either transfers
monoxide
from any component of the combustible tobacco
product to the smoke that is formed by the
combustion or heating of tobacco, additives, or
other component of the tobacco product.
Tobacco product
Any product made or derived from tobacco that is
Cigarette
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 for a tobacco product).
Does not include an article that is a drug, device, or
combination product.
Tobacco product distributor
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.
Tobacco product importer
Any person who imports any tobacco product that

is intended for sale or distribution to consumers in
the United States.
Tobacco product manufacturer
Any person, including any repacker or relabeler,
Phil ip Morris
who manufactures, fabricates, assembles, processes,
International
or labels a tobacco product OR imports a finished
tobacco product for sale or distribution in the
United States.
Tobacco product retailer
Any person who sells tobacco products to
Walmart
individuals for personal consumption, or who
operates a facility where vending machines or self-
service displays are permitted.
Source: Prepared by CRS, but definitions (except for “Electronic Nicotine Delivery Systems”) are copied
directly from FFDCA chapter IX, Title 21 of the C.F.R., FDA guidance documents, and 15 U.S.C. §1332(1).
Notes: Definitions provided are relevant and applicable to chapter IX of the FFDCA.
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Appendix D. Acronyms Used in This Report
ANPRM
Advance Notice of Public Rulemaking
CDC
Centers for Disease Control and Prevention
CDER
Center for Drug Evaluation and Research
CMP
Civil Money Penalty
CSTHEA
Comprehensive Smokeless Tobacco Health Education Act of 1986
CTP
Center for Tobacco Products
DEA
Drug Enforcement Administration
ENDS
Electronic Nicotine Delivery Systems
EVALI
E-cigarette, or Vaping, Product Use-Associated Lung Injury
FCC
Federal Communications Commission
FCLAA
Federal Cigarette Labeling and Advertising Act of 1965
FDA
Food and Drug Administration
FETRA
Fair and Equitable Tobacco Reform Act of 2004
FFDCA
Federal Food, Drug, and Cosmetic Act
FTC
Federal Trade Commission
GMP
Good Manufacturing Practice
HHS
Department of Health and Human Services
HPHC
Harmful and Potentially Harmful Constituent
MRTP
Modified Risk Tobacco Product
MSA
Tobacco Master Settlement Agreement of 1998
NASEM
National Academies of Sciences, Engineering, and Medicine
NRT
Nicotine Replacement Therapy
NTSO
No-tobacco-sale-order
OTC
Over-the-counter
PACT
The Prevent All Cigarette Trafficking Act of 2009
PMTA
Premarket Tobacco Application
SABG
Substance Abuse Prevention and Treatment Block Grant
SAMHSA
Substance Abuse and Mental Health Services Administration
SE
Substantial Equivalence
TCA
Family Smoking Prevention and Tobacco Control Act of 2009
THC
Tetrahydrocannabinol
TPSAC
Tobacco Products Scientific Advisory Committee
TRLM
Tobacco Registration and Product Listing Module
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Author Information

Victoria R. Green

Analyst in Health Policy

Acknowledgments
C. Stephen Redhead, Deputy Assistant Director, and Vanessa K. Burrows, a former CRS Legislative
Attorney, wrote Appendix B of this report. The author also wishes to acknowledge Amber Wilhelm for her
assistance in formatting Figure 1 of the report.

Disclaimer
This document was prepared by the Congressional Research Service (CRS). CRS serves as nonpartisan
shared staff to congressional committees and Members of Congress. It operates solely at the behest of and
under the direction of Congress. Information in a CRS Report should not be relied upon for purposes other
than public understanding of information that has been provided by CRS to Members of Congress in
connection with CRS’s institutional role. CRS Reports, as a work of the United States Government, are not
subject to copyright protection in the United States. Any CRS Report may be reproduced and distributed in
its entirety without permission from CRS. However, as a CRS Report may include copyrighted images or
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copy or otherwise use copyrighted material.

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