FDA Regulation of Tobacco Products

August 13, 2019 – July 9, 2021 R45867

FDA Regulation of Tobacco Products
July 9, 2021
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
Hassan Z. Sheikh
to decline, according to the Centers for Disease Control and Prevention (CDC), an estimated 34.1
Analyst in Public Health
million American adults smoked cigarettes every day or some days in 2019, and nearly 910,000
Emergency Management
American middle and high school students had smoked cigarettes within a 30-day period in 2020.

Victoria R. Green
In recent years, electronic nicotine delivery systems (ENDS) have become increasingly popular.
Analyst in Health Policy
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, 10.9 million American adults used e-cigarettes every day or some days in 2019, and
about 3.58 million American middle and high school students had used an e-cigarette within a 30-day period in 2020.
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 (e.g., snuff, chewing 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.
FDA’s regulation of tobacco 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 in stead 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, amon g others.
This report provides a descriptive overview of FDA regulation of tobacco products. The report first discusses manufacturer
requirements, followed by tobacco-specific requirements and compliance and enforcement.

Congressional Research Service

FDA Regulation of Tobacco Products

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 bil ion 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, 34.1 mil ion American adults smoked cigarettes every day or some
days in 2019,4 and nearly 910,000 American middle and high school students had smoked
cigarettes within a 30-day period in 2020.5
Electronic nicotine delivery systems (ENDS) have become popular in recent years, particularly
among youth. ENDS is an umbrel a term for various types of electronic tobacco products,
including electronic cigarettes (e-cigarettes). An e-cigarette is a battery-operated device typical y
containing nicotine, flavorings, and other chemicals that, when heated, creates inhalable aerosol
(i.e., vapor).6 According to CDC analyses, 10.9 mil ion American adults used e-cigarettes every
day or some days in 2019.7 About 3.6 mil ion American middle and high school students had used
an e-cigarette within a 30-day period day in 2020.8
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

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 U.S. Department of Health and Human Services, The Health Consequences of Smoking: 50 Years of Progress. A
Report of the Surgeon General, Atlanta, GA, January 2014.
3 See Monica E. Cornelius, T eresa W. Wang, Ahmad Jamal, et al., “T obacco Product Use Among Adults—United
States, 2019,” Morbidity and Mortality Weekly Report (MMWR), vol. 69, no. 46 (November 20, 2020), pp. 1736 -1742.
See also Andrea S. Gentzke, MeLisa Creamer, Karen A. Cullen, et al., “Vital Signs: T obacco 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 of at least one tobacco product. See Monica E. Cornelius,
T eresa W. Wang, Ahmad Jamal, et al., “T obacco Product Use Among Adults—United States, 2019,” Morbidity and
Mortality Weekly Report (MMWR), vol. 69, no. 46 (November 20, 2020), pp. 1736 -1742.
5 Andrea S. Gentzke, T eresa W. Wang Ahmed Jamal, et al., “T obacco Product Use Among Middle and High School
Students—United States, 2020,” Morbidity and Mortality Weekly Report (MMWR), vol. 69, no. 50 (December 18,
2020), pp. 1881-88.
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 Monica E. Cornelius, T eresa W. Wang, Ahmad Jamal, et al., “T obacco Product Use Among Adults—United
States, 2019,” Morbidity and Mortality Weekly Report (MMWR), vol. 69, no. 46 (November 20, 2020), pp. 1736 -1742.
8 Andrea S. Gentzke, T eresa W. Wang Ahmed Jamal, et al., “T obacco Product Use Among Middle and High School
Students—United States, 2020,” Morbidity and Mortality Weekly Report (MMWR), vol. 69, no. 50 (December 18,
2020), pp. 1881-88.
Congressional Research Service
1

link to page 34 link to page 35 link to page 36 link to page 39 link to page 39 FDA Regulation of Tobacco Products

tobacco regulatory decisions or any other matter listed in chapter IX of the FFDCA. The TPSAC
includes 12 members with diversified experience and expertise.9
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 general y required to meet a
standard of safety and effectiveness to receive premarket approval from FDA, tobacco product
manufacturers are instead general y 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. 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
tobacco used in manufacturing a component, part, or accessory of a tobacco product).”10 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.11 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.”12

9 FFDCA §917; 21 U.S.C. §387q.
10 FFDCA §201(rr); 21 U.S.C. §321(rr).
11 FFDCA §201(rr); 21 U.S.C. §321(rr).
12 FDA, “Clarification of When Products Made or Derived from T obacco Are Regulated as Drugs, Devices, or
Combination Products: Amendments to Regulations Regarding ‘Intended Uses,’” 82 Federal Register 2193, January 9,
2017.
Congressional Research Service
2

link to page 7

FDA Regulation of Tobacco Products

Upon enactment, the TCA explicitly covered the following tobacco products: cigarettes and
cigarette tobacco, roll-your-own tobacco, and smokeless tobacco.13 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.14 In 2016, FDA
promulgated regulations (known as “the deeming rule”) that extended the agency’s authority over
al 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.15 Figure 1 shows each of the tobacco products currently under FDA’s
authority.
Figure 1. Tobacco Products Currently Under FDA’s Authority, 2021

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 surveil ance, among others. In
the sections below, manufacturer requirements are discussed for tobacco products overal , with
exceptions for issues unique to certain classes of tobacco products.

13 FFDCA §901(b); 21 U.S.C. §387a(b).
14 FFDCA §901(b); 21 U.S.C. §387a(b).
15 21 C.F.R. §1100.
Congressional Research Service
3

link to page 9 FDA Regulation 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.16 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.17 However, in contrast to
other FDA centers that are general y 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
fees, the tobacco fees are only available pursuant to an annual appropriation from Congress,
which provides FDA the authority to collect and spend fees.18
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.19 For fiscal year (FY) 2019 and
subsequent fiscal years, this amount is $712 mil ion. The total user fee amount is assessed among
six tobacco product classes specified in statute: (1) cigarettes, (2) cigars (including smal cigars
and cigars other than smal cigars), (3) snuff, (4) chewing tobacco, (5) pipe tobacco, and (6) roll-
your-own tobacco (see Table 1 for FY2021 data).20
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,21 and these are the same six
classes that are specified in the FETRA provisions.22 The FETRA provisions specify a two-step
formula.23 The first step determines the al ocations for each of the six tobacco product classes,
and the second step determines the individual domestic manufacturer and importer al ocations
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 wil be assessed for cigars.24
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).25 This determination was made by FDA because

16 FFDCA §919; 21 U.S.C. §387s.
17 For more information, see CRS Report R44576, The Food and Drug Administration (FDA) Budget: Fact Sheet.
18 FFDCA §919(c); 21 U.S.C. §387s(c).
19 FFDCA §919(b)(1); 21 U.S.C. §387s(b)(1).
20 FFDCA §919(b)(2)(B(i); 21 U.S.C. §387s(b)(2)(B)(i).
21 FFDCA §919(b)(2)(B)(ii) & §919(b)(4); 21 U.S.C. §387s(b)(2)(B)(ii) & §387s(b)(4).
22 §625(c)(1) of P.L. 108-357; 7 U.S.C. §518d(c)(1).
23 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 T obacco
T ransition Payment Program,” https://www.fsa.usda.gov/Internet/FSA_File/tobacco_determ_11162011.pdf.
24 FFDCA §919(b)(5); 21 U.S.C. §387s(b)(5).
25 FDA, “Requirements for the Submission of Data Needed T o Calculate User Fees for Domestic Manufacturers and
Importers of Cigars and Pipe T obacco,” 81 Federal Register 28709, May 10, 2016.
Congressional Research Service
4

link to page 9 FDA Regulation of Tobacco Products

Congress did not specify enumerated classes for these products and did not provide a framework
by which FDA could potential y assess user fees for such products.26
Table 1. Tobacco User Fee Assessment Formulation, by Product Class, FY2021
Percentage Share by
Tobacco Product Class
Class (%)a
Amount
Quarterly FY2021 User Fee Assessment
Cigarettes
85.23%
$151,711,002
Cigars
12.56%
$22,350,392
Snuff
1.31%
$2,329,308
Pipe Tobacco
0.80%
$1,424,356
Chewing Tobacco
0.06%
$108,224
Rol -Your-Own Tobacco
0.04%
$76,362
Total
100.00%
$177,999,644
Total FY2021 User Fee Assessment

$711,998,576
Source: Prepared by CRS using FDA, “FY2021 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 al
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-
2019 (May 28, 2020), 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.27 FDA is required to make this registration information public.28 As part of
the registration requirements, domestic tobacco product manufacturers must also submit product
listing information, which includes a list of al tobacco products manufactured for commercial
distribution.29 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.30 In addition, the listing must include a

26 FDA, “Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and
Importers of Cigars and Pipe T obacco,” 81 Federal Register 28707, May 10, 2016.
27 FFDCA §905(b)-(c); 21 U.S.C. §387e(b)-(c).
28 FFDCA §905(f); 21 U.S.C. §387e(f).
29 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
Dom estic Tobacco Product Establishm ents, December 2017, https://www.fda.gov/downloads/tobaccoproducts/
labeling/rulesregulationsguidance/ucm191940.pdf.
30 FDA, Guidance for Industry: Registration and Product Listing for Owners an d Operators of Domestic Tobacco
Product Establishm ents, December 2017, https://www.fda.gov/downloads/tobaccoproducts/labeling/
Congressional Research Service
5

FDA Regulation of Tobacco Products

reference for the authority to market the tobacco product, and it must provide al consumer
information for each tobacco product, such as labeling and a “representative sampling of
advertisements.”31 However, given the potential administrative burden on the registrant, FDA
specifies in a guidance document that labeling for each individual y listed tobacco product is not
necessary if information that represents the labeling for a selected set of related products is
provided.32 Registrants are encouraged to submit their materials online using FDA’s Unified
Registration and Listing System (FURLS) Tobacco Registration and Product Listing Module
(TRLM).33
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.34
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.35 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 al pertinent equipment and materials “at reasonable times and within reasonable limits and in
a reasonable manner.”36 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.37
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.38 Specifical y, statute specifies that the regulations should include the
methods, facilities, and controls involved in the manufacture, packing, and storage of a tobacco
product.39 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

rulesregulationsguidance/ucm191940.pdf.
31 FFDCA §905(i)(1)(B); 21 U.S.C. §387e(i)(1)(B).
32 FDA, Guidance for Industry: Registration and Product Listing for Owners and Operators of Domestic Tobacco
Product Establishm ents, December 2017, https://www.fda.gov/downloads/tobaccoproducts/labeling/
rulesregulationsguidance/ucm191940.pdf.
33 FDA, Tobacco Registration and Product Listing Module (TRLM) User Guide, https://www.fda.gov/downloads/
T obaccoProducts/Labeling/RulesRegulationsGuidance/UCM456130.pdf.
34 FFDCA §905(g); 21 U.S.C. §387e(g).
35 FDA, 2017, Compliance Training for Small Tobacco Product Manufacturers – Domestic Establishment Inspections,
https://www.fda.gov/media/83422/download.
36 FFDCA §704(a)(1); 21 U.S.C. §374(a)(1).
37 FFDCA §704(b); 21 U.S.C. §374(b).
38 FFDCA §906(e)(1)(A); 21 U.S.C. §387f(e)(1)(A).
39 FFDCA §906(e)(1)(A); 21 U.S.C. §387f(e)(1)(A).
Congressional Research Service
6

FDA Regulation of Tobacco Products

with GMPs.40 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.41
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.42 FDA then established a public
docket for additional comments on the tobacco companies’ recommendations in 2013.43 However,
FDA did not take further action specific to promulgating GMP regulations after these actions.
FDA’s 2016 deeming rule stated that “FDA wil have the authority to issue tobacco product
manufacturing practice regulations under section 906(e)” of the FFDCA for ENDS and other
newly deemed products.44 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).45 FDA then opened a public docket in November
2017 to al ow for comment on these proposed ENDS GMPs,46 but the agency has not taken
further action since then. The Spring 2021 White House Office of Management and Budget
(OMB) Unified Agenda indicates that a proposed rule wil be issued in October 2021.47
Premarket Review Pathways
There are four different premarket review pathways for tobacco products: (1) premarket tobacco
application (PMTA), (2) substantial equivalence (SE), (3) exemption from substantial equivalence
(EX REQ), and (4) modified risk tobacco product (MRTP). To legal y market a new tobacco
product,48 a manufacturer must receive a PMTA marketing authorization order. A PMTA is not
necessary if FDA determines that the new tobacco product is substantial y equivalent to a
predicate tobacco product—a product that was commercial y marketed as of February 15, 2007,

40 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).
41 FFDCA §906(e)(2); 21 U.S.C. §387f(e)(2).
42 FDA, “T obacco Product Manufacturing Practice; Establishment of a Public Docket,” 78 Federal Register 16824,
March 19, 2013.
43 FDA, “T obacco Product Manufacturing Practice; Establishment of a Public Docket,” 78 Federal Register 16824,
March 19, 2013.
44 FDA, “Deeming T obacco Product s T o Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the
Family Smoking Prevention and T obacco Control Act; Restrictions on the Sale and Distribution of T obacco Products
and Required Warning Statements for T obacco Products,” 81 Federal Register 28980, May 10, 2016.
45 RAI Services Company, “Proposed Good Manufacturing Practices Regulation T o 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.
46 FDA, “T obacco Product Manufacturing Practice; Request for Comments,” 82 Federal Register 55613, November 22,
2017.
47 OMB, “Agency Rule List – Spring 2021: Department of Health and Human Services, Requirements for T obacco
Product Manufacturing Practice,” https://www.reginfo.gov/public/do/eAgendaViewRule?p ubI d=202104&RIN=0910-
AH91.
48 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.
Congressional Research Service
7

FDA Regulation of Tobacco Products

or if it has previously been determined as substantial y equivalent to another predicate tobacco
product—or is exempt from substantial equivalence.49 To legal y market a new tobacco product
with reduced risk claims or modify a legal y marked tobacco product to make reduced risk claims,
a manufacturer must receive an MRTP order.
Al tobacco products original y covered by the TCA are required to undergo premarket review,
unless they are “grandfathered products.”50 Following the 2016 deeming rule, al newly deemed
tobacco products became subject to premarket review requirements as wel . 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, 2016.51 This administrative action was subject to legal chal enge, after
several public health groups (e.g., American Academy of Pediatrics, Campaign for Tobacco-Free
Kids) filed a lawsuit against FDA.52 In May 2019, the U.S. District Court for Maryland ruled in
favor of the public health organizations,53 and in July 2019, imposed a 10-month deadline for
application submissions for al newly deemed tobacco products (i.e., May 2020) and a one-year
deadline for reviewing the applications (i.e., May 2021).54 On April 22, 2020, the court extended
the premarket application deadline by 120 days to September 9, 2020, due to the Coronavirus
Disease 2019 (COVID-19) pandemic.55 FDA stated that it may continue to exercise enforcement
discretion for manufacturers that submitted applications by the aforementioned date. In other
words, barring a negative action on an application, FDA may effectively al ow such products to
be marketed for up to a year from the deadline (i.e., September 9, 2021) while applications are
being reviewed.56 As of mid-January 2021, FDA reported that it had processed SE requests for
6,800 products from 100 companies, EX REQ for 350 products from 15 companies, and PMTA
applications for 4.8 mil ion products from over 230 companies.57 As of June 2021, Acting FDA
Commissioner Janet Woodcock testified that the agency has completed initial processing of
PMTA applications for 6.5 mil ion products submitted by over 550 companies. The vast majority
of these submissions are for ENDS products.58

49 FFDCA §910(a)(2); 21 U.S.C. §387j(a)(2).
50 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. “Grandfathered products” have been
commercially marketed in the United States as of February 15, 2007.
51 FDA, Guidance for Industry: Extension of Certain Tobacco Product Compliance Deadlines Related to the Final
Deem ing Rule, Sixth Revision, November 2018, https://www.fda.gov/downloads/T obaccoProducts/Labeling/
RulesRegulationsGuidance/UCM557716.pdf.
52Am. Acad. of Pediatrics v. FDA, 2019 U.S. Dist. LEXIS 81652 (D. Md., Mar. 26, 2019) (No. 8:18 -cv-00883-PWG).
53 Am. Acad. of Pediatrics v. FDA, 379 F. Supp. 3d 461 (D. Md. 2019).
54 Am. Acad. of Pediatrics v. FDA, 2019 U.S. Dist. LEXIS 00883 (D. MD. July 12, 2019).
55 Am. Acad. of Pediatrics v. FDA, (D. Md. April 22, 2020) (No. 8:18–cv–
883-PWG).
56 FDA, “Coronavirus (COVID-19) Update: Court Grants FDA’s Request for Extension of Premarket Review
Submission Deadline for Certain T obacco Products Because of Impacts from COVID-19,” press release, April 23,
2020, https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-court-grants-fdas-request -
extension-premarket-review-submission-deadline.
57 FDA, Perspective: FDA’s Progress on Review of Tobacco Product Applications Submitted by the Sept. 9, 2020
Deadline, February 16, 2021, https://www.fda.gov/tobacco-products/ctp-newsroom/perspective-fdas-progress-review-
tobacco-product -applications-submitted-sept-9-2020-deadline.
58 FDA, T estimony of Dr. Janet Woodcock, Acting Commissioner, An Epidemic Continues: Youth Vaping in America,
before the U.S. Congress, House Committee on Oversight and Reform, Subcommittee on Economic and Consumer
Congressional Research Service
8

FDA Regulation of Tobacco Products

Since 2014, most new tobacco products have been legal y marketed through the SE pathway.59
However, only requirements for the SE exemption pathway have been promulgated in
regulations.60 This has posed some chal enges 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,61 with public comment open until June 2019. Also in
June 2019, FDA finalized its guidance on PMTA submissions specific to ENDS.62 In September
2019, FDA issued a proposed rule on the content and format of PMTA applications, with public
comment open until December 2019.63 On March 2020, FDA reopened the comment period on
only the aspect of the proposed rule dealing with agency collection activity.64 On January 19,
2021, the PMTA and SE final rules were displayed in the Federal Register but did not publish.65
A White House memorandum circulated the next day (i.e., January 20, 2021) ordered the
withdrawal of any rules that did not publish from the previous administration, including the
PMTA and SE rules.66 The Spring 2021 White House OMB Unified Agenda indicates that such
rules would be reissued in May 2021,67 but as of the date of this publication, this has not yet
occurred.
Premarket Tobacco Product Applications (PMTA) Pathway
A manufacturer must submit a PMTA and receive a PMTA marketing authorization order to
legal y market a new tobacco product that is not substantial y equivalent to a predicate tobacco
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.”68 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

Policy, 117th Cong., 1st sess., June 23, 2021, https://oversight.house.gov/sites/democrats.oversight.house.gov/files/
Woodcock%20T estimony.pdf, (hereinafter, FDA, T est imony of Dr. Janet Woodcock, “ An Epidemic Continues: Youth
Vaping in America”).
59 FDA, “Modified Risk T obacco Products,” last updated May 05, 2021, https://www.fda.gov/tobacco-products/market-
and-distribute-tobacco-product/substantial-equivalence#submit .
60 21 C.F.R. §1107.1.
61 FDA, “Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on
Substantial Equivalence Reports,” 84 Federal Register 12740, April 2, 2019.
62 FDA, Guidance for Industry: Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems,
June 2019, https://www.fda.gov/media/127853/download.
63 FDA, “Premarket T obacco Product Applications and Recordkeeping Requirements,” 84 Federal Register 50566,
September 25, 2019.
64 FDA, “Premarket T obacco Product Applications and Recordkeeping Requirements; Reop ening of the Comment
Period,” 85 Federal Register 13840-13841, 2020.
65 FDA, “Premarket T obacco Product Applications,” updated June 3, 2021, https://www.fda.gov/tobacco-products/
market -and-distribute-tobacco-product/premarket-tobacco-product-applications.
66 Ronald A. Klain, “Regulatory Freeze Pending Review: Memorandum for the Heads of Executive Departments and
Agencies,” Presidential Actions, January 20, 2021, https://www.whitehouse.gov/briefing-room/presidential-actions/
2021/01/20/regulatory-freeze-pending-review/.
67 OMB, “Agency Rule List – Spring 2021: Department of Health and Human Services, Premarket Tobacco Product
Applications and Recordkeeping Requirements,” https://www.reginfo.gov/public/do/eAgendaVie wRule?p ubI d=
202104&RIN=0910-AH44, and OMB, “ Agency Rule List – Spring 2021: Depart ment of Health and Human Services,
Format and Content of Reports Intended to Demonstrate Substantial Equivalence,” https://www.reginfo.gov/public/do/
eAgendaViewRule?pubI d=202104&RIN=0910-AH89.
68 FFDCA §910(c)(4); 21 U.S.C. §387j(c)(4).
Congressional Research Service
9

FDA Regulation of Tobacco Products

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.69
PMTA applications must include, among other things, full reports of health risk investigations; 70
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.71 FDA may “Refuse to Accept”
(RTA) a premarket application if it contains certain procedural errors such as a failure of the
application to pertain to a tobacco product, the application not being in English, not otherwise
being in an electronic format FDA can read, or not containing an environmental assessment or
valid claim of categorical exclusion. Once FDA has accepted a completed application, FDA has
180 days to determine whether the product wil receive a PMTA order.72 If marketing is
authorized, FDA can require that the sale and distribution of the tobacco product is restricted.73
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.74 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.75 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 surveil ance reports to FDA
following PMTA marketing authorization.76

69 FFDCA §910(c)(4); 21 U.S.C. §387j(c)(4).
70 FDA published draft guidance for tobacco product manufacturers on how to design tobacco product perception and
intention (TPPI) st udies that may be submitted as part of a PMT A, SE, or MRT P application. A T PPI study assesses an
individual tobacco user’s perception of, intent to use, and understanding of tobacco products. Ultimately, a T PPI study
can help a product manufacturer demonst rate that a new tobacco product meets the applicable premarket authorization
standard. For more information, see “T obacco Products: Principles for Designing and Conducting T obacco Product
Perception and Intention Studies; Draft Guidance for Industry; Availability,” 85 Federal Register 68341-68342,
October 28, 2020 and FDA, Tobacco Products: Principles for Designing and Conducting Tobacco Product Perception
and Intention Studies: Guidance for Industry, October 2020, https://www.fda.gov/media/143322/download.
71 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/T obaccoProducts/Labeling/
RulesRegulationsGuidance/UCM273425.pdf.
72 T he 180 day clock does not start until FDA receives the complete application.
73 FFDCA §910(c)(1)(B); 21 U.S.C. §387j(c)(1)(B). T hese 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)].
74 FFDCA §910(c)(2); 21 U.S.C. §387j(c)(2).
75 FFDCA §910(d)(1); 21 U.S.C. §387j(d)(1).
76 FFDCA §910(f)(1); 21 U.S.C. §387j(f)(1).
Congressional Research Service
10

FDA Regulation of Tobacco Products

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
characteristics that do not raise different questions of public health.77 A product may serve as a
predicate tobacco product if it was commercial y marketed as of February 15, 2007, or if it has
previously been determined as substantial y 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 substantial y 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.78 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.79
The contents of SE reports are not specified in statute or regulation,80 but FDA has provided
content recommendations for SE reports in guidance.81 Among other things, SE reports should
include a summary, listing 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 wil then issue a SE order
letter or not substantial y equivalent order (NSE order) letter.82
Exemption from Substantial Equivalence (EX REQ) Pathway
A new tobacco product that has been modified from a legal y 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.83 For such a
product to be exempt, FDA must determine that (1) the modification would be considered minor,

77 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)].
78 FFDCA §905(j); 21 U.S.C. §387e(j).
79 FDA, Guidance for Industry and FDA Staff: Section 905(j) Reports: Demonstrating Substantial Equivalence for
Tobacco Products, January 2011, https://www.fda.gov/downloads/T obaccoProducts/Labeling/
RulesRegulationsGuidance/UCM239021.pdf.
80 In April 2019, FDA issued a proposed rule on t he 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.
81 FDA, Guidance for Industry and FDA Staff: Section 905(j) Reports: Demonstrating Substantial Equivalence for
Tobacco Products, January 2011, https://www.fda.gov/downloads/T obaccoProduct s/Labeling/
RulesRegulationsGuidance/UCM239021.pdf.
82 FDA, “Substantial Equivalence,” https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/
substantial-equivalence#submit .
83 FDA, “Exemption from Substantial Equivalence,” https://www.fda.gov/T obaccoProducts/Labeling/
T obaccoProductReviewEvaluation/ExemptionfromSubstantialEquivalence/default.htm.
Congressional Research Service
11

FDA Regulation of Tobacco Products

(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
“exemption is otherwise appropriate.”84 Before the product can be legal y marketed, FDA must
first grant the product an exemption from demonstrating substantial equivalence.85 Following this,
a manufacturer must submit a 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.86
The content requirements for SE exemption reports are specified in regulation.87 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 a 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
commercial y marketed tobacco products.”88 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 legal y on the market
through another pathway (e.g., SE or SE exemption).89 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.90 Smokeless tobacco products that use certain
descriptors, such as “does not produce smoke” or “smoke-free,” are not automatical y considered
MRTPs unless a manufacturer receives MRTP orders for those products.91 In addition, products
that are intended to treat tobacco dependence are not considered MRTPs if they have been
approved as a drug or device.92
Manufacturers must include certain information in a MRTP application, including
a description of the proposed product and any proposed advertising and labeling;

84 FFDCA §905(j)(3); 21 U.S.C. §387e(j)(3).
85 21 C.F.R. §1107.1.
86 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/T obaccoProducts/Labeling/T obaccoProductReviewEvaluation/
ExemptionfromSubstantialEquivalence/default.htm.
87 21 C.F.R. §1107.1.
88 FFDCA §911(b)(1); 21 U.S.C. §387k(b)(1).
89 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.
90 FFDCA §911(b)(2)(B); 21 U.S.C. §387k(b)(2)(B).
91 FFDCA §911(b)(2)(C); 21 U.S.C. §387k(b)(2)(C).
92 FFDCA §911(c); 21 U.S.C. §387k(c).
Congressional Research Service
12

FDA Regulation of Tobacco Products

the conditions for using the product;
the formulation of the product;
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.93
FDA must refer al 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 time94) if, among other things, it determines
that the tobacco product wil 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.95 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.96
MRTP Postmarket Requirements
To market a tobacco product that has received an MRTP order, the manufacturer must agree to
certain postmarket surveil ance and studies that examine consumer perception, behavior, and
health pertaining to the product. Manufacturers required to conduct surveil ance must submit the
surveil ance 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 wil al ow 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

93 FFDCA §911(d); 21 U.S.C. §387k(d).
94 FFDCA §911(g)(2)(C)(i); 21 U.S.C. §387k(g)(2)(C)(i).
95 FFDCA §911(g); 21 U.S.C. §387k(g).
96 FFDCA §911(g)(2); 21 U.S.C. §387k(g)(2).
Congressional Research Service
13

FDA Regulation of Tobacco Products

other tobacco products on the market, and require that the label of the product disclose substances
in the tobacco product that could affect health.97
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 surveil ance or studies, or if the applicant failed to
conduct or submit postmarket surveil ance or studies.98
Investigational Tobacco Products
FFDCA Section 910(g) al ows 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.99
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
al respects to the applicable tobacco product standard.”100
Cessation Products
FDA’s Center for Drug Evaluation and Research (CDER) is general y responsible for regulating
over-the-counter and prescription drugs including tobacco-derived products that make health or
cessation (i.e., quitting) claims, such as nicotine replacement therapies (NRTs).101 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.102 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).103

97 FFDCA §911(h); 21 U.S.C. §387k(h).
98 FFDCA §911(j); 21 U.S.C. §387k(j).
99 FDA, Draft Guidance for Industry and Investigators: Use of Investigational Tobacco Products, February 2019,
https://www.fda.gov/media/94052/download.
100 FDA, Draft Guidance for Industry and Investigators: Use of Investigational Tobacco Products, February 2019.
101 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.
102 FDA, “Advancing Medicinal Nicotine Replacement T herapies 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.
103 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.
Congressional Research Service
14

FDA Regulation of Tobacco Products

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
al 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.104 The TCA gave FDA the authority to adopt
tobacco product standards that it deems necessary to protect the public’s health,105 but it explicitly
prohibited FDA from creating a standard that bans cigarettes, smokeless tobacco products, cigars,
pipe tobacco, or roll-your-own tobacco products.106 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 al owed 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.107 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.108
To propose a new tobacco product standard, FDA is required to publish a proposed rule in the
Federal Register and al ow 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.”109

104 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.
105 FFDCA §907(a)(3); 21 U.S.C. §387g(a)(3).
106 FFDCA §907(d)(3); 21 U.S.C. §387g(d)(3).
107 FFDCA §907(a)(4); 21 U.S.C. §387g(a)(4).
108 FFDCA §907(a)(3)(B)(i); 21 U.S.C. §387g(a)(3)(B)(i).
109 FFDCA §907(d)(2); 21 U.S.C. §387g(d)(2).
Congressional Research Service
15

FDA Regulation of Tobacco Products

FDA is required to periodical y 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 cal s 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.”110
Flavors
When enacting the TCA, Congress recognized that flavors, specifical y, can make tobacco
products more appealing to youth and expose tobacco users to additional carcinogens or other
toxic constituents.111 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.112 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.113
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, specifical y addressing use among youth and racial and ethnic minorities.114 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.”115 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.116 A final
regulation has not yet been promulgated; however, Former Commissioner Gottlieb expressed
interest in accelerating the promulgation of this tobacco product standard.117
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 general y in tobacco products, among other things.118 After one extension, the comment
period closed in July 2018 and the agency had received over 500,000 comments. In January 2020,

110 FFDCA §907(c)(3); 21 U.S.C. §387g(c)(3).
111 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.
112 FFDCA §907(a); 21 U.S.C. §387g(a).
113 FFDCA §907(a)(1)(A); 21 U.S.C. §387g(a)(1)(A).
114 FFDCA §907(e); 21 U.S.C. §387g(e).
115 T obacco Products Scientific Advisory Committee (T PSAC) and Center for T obacco Products (CT P), Public Health
Im pact of Menthol Cigarettes, FDA, Silver Spring, MD, July 2011, p. 208.
116 FDA, “Menthol in Cigarettes, T obacco Products; Request for Comments,” 78 Federal Register 44485, July 24,
2013.
117 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.
118 FDA, “Regulation of Flavors in T obacco Products,” 83 Federal Register 12299, March 21, 2018.
Congressional Research Service
16

FDA Regulation of Tobacco Products

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.119 In April 2021,
the agency released a statement outlining its intent to issue proposed product standards to ban
menthol in cigarettes, and al characterizing flavors in cigars.120 The Spring 2021 White House
OMB Unified Agenda indicates that FDA aims to release a proposed rule regarding cigars in
August 2021, and a proposed rule regarding cigarettes in April 2022.121
Nicotine
Nicotine is the natural y occurring drug in tobacco that can cause addiction to the product.122 The
FFDCA al ows FDA to address nicotine yields of a tobacco product through development of a
tobacco product standard,123 but it prohibits the agency from establishing a tobacco product
standard that would require the reduction of nicotine yields to zero.124
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 minimal y or non-addictive 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.125 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 non-addictive 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.126 Pursuant to FFDCA Section 915, FDA is required
to promulgate regulations that require the testing and reporting of components or parts of a

119 FDA, Guidance for Industry: Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and Other
Deem ed Products on the Market Without Prem arket Authorization , January 2020, p. 31, https://www.fda.gov/media/
133880/download.
120 FDA, “FDA Commits to Evidence-Based Actions Aimed at Saving Lives and Preventing Future Generations of
Smokers,” press release, April 29, 2021, https://www.fda.gov/news-events/press-announcements/fda-commits-
evidence-based-actions-aimed-saving-lives-and-preventing-future-generations-smokers.
121 OMB, “Agency Rule List – Spring 2021: Department of Health and Human Services, T obacco Product Standar d for
Characterizing Flavors in Cigars,” https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202104&RIN=0910-
AI28 and OMB, “ Agency Rule List – Spring 2021: Department of Health and Human Services, T obacco Product
Standard for Menthol in Cigarettes,” https://www.reginfo.gov/public/do/eAgendaViewRule?p ubI d=202104&RIN=
0910-AI60.
122 National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, Centers for
Disease Control and Prevention, The Health Consequences of Sm oking – 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.
123 FFDCA §907(a)(4); 21 U.S.C. §387g(a)(4).
124 FFDCA §907(d)(3)(B); 21 U.S.C. §387g(d)(3)(B).
125 FDA, “T obacco Product Standard for Nicotine Level of Combusted Cigarettes,” 83 Federal Register 11818, March
16, 2018.
126 FFDCA §915(c); 21 U.S.C. §387o(c).
Congressional Research Service
17

FDA Regulation of Tobacco Products

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.127
As part of these regulations, once they are promulgated, FDA may require tobacco product
manufacturers to disclose the results of the testing of tar (a chemical substance produced when
tobacco is burned) 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. Smal
tobacco product manufacturers would be given additional time to comply, and FDA could
additional y delay compliance on a case-by-case basis for smal tobacco product
manufacturers.128
Health Information
Tobacco product manufacturers are required to submit specified health information to FDA. This
health information includes a list of al ingredients, such as substances, compounds, and additives
that are added to the tobacco product by the manufacturer. Health information also includes “a
listing of al constituents, including smoke constituents as applicable, identified by the Secretary
as harmful or potential y harmful to health in each tobacco product.”129 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).130 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).131 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.132

127 FDA, “Deeming T obacco Products T o Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the
Family Smoking Prevention and T obacco Control Act; Restrictions on the Sale and Distribution of T obacco Products
and Required Warning Statements for T obacco Products,” 81 Federal Register 28980, May 10, 2016.
128 FFDCA §915(d); 21 U.S.C. §387o(d).
129 FFDCA §904(a)(3); 21 U.S.C. §387d(a)(3).
130 FFDCA §904(a)(1); 21 U.S.C. §387d(a)(1).
131 FDA, Guidance for Industry: Listing of Ingredients in Tobacco Products, Revised November 2018,
https://www.fda.gov/downloads/T obaccoProducts/Labeling/RulesRe gulationsGuidance/UCM527044.pdf.
132 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 Cosm etic Act, Revised August 2016, https://www.fda.gov/
Congressional Research Service
18

FDA Regulation of Tobacco Products

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.133 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.134
Using FDA’s list, manufacturers are required to report HPHCs by brand and quantity of HPHCs
in each brand and sub-brand.135 Given potential monetary and feasibility chal enges that were
associated with reporting al 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.136 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.137 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.138 The public comment
period closed in October 2019.139
Health Documents
Tobacco product manufacturers are required to submit to FDA al 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.140 FDA interprets these documents to include “cel -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 wel as the individual level (such as abuse liability).”141

downloads/T obaccoProducts/Labeling/RulesRegulationsGuidance/UCM241352.pdf.
133 FFDCA §904(a)(3); 21 U.S.C. §387d(a)(3).
134 FDA, “Harmful and Potentially Harmful Constituents in T obacco Products and T obacco Smoke; Established List,”
77 Federal Register 20034, April 3, 2012.
135 FFDCA §904(a)(3) [21 U.S.C. §387d(a)(3)]; FFDCA §915 [21 U.S.C. §387o].
136 FDA, Draft Guidance: Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco
Sm oke Under Section 904(a)(3) of the Federal Food, Drug, and Cosm etic Act, March 2012, https://www.fda.gov/
downloads/T obaccoProducts/Labeling/RulesRegulationsGuidance/UCM297828.pdf.
137 FDA, Guidance for Industry: Extension of Certain Tobacco Product Compliance Deadlines Related to the Final
Deem ing Rule, Revised March 2019, https://www.fda.gov/media/105346/download.
138 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%20tobacco%20constituents%20lis
t&utm_medium=email&utm_source=Eloqua.
139 FDA, “Harmful and Potentially Harmful Constituents in T obacco Products; Established List; Proposed Additions;
Request for Comments,” 84 Federal Register 38032, August 5, 2019.
140 FFDCA §904(a)(4); 21 U.S.C. §387d(a)(4).
141 FDA, Guidance for Industry: Health Document Submission Requirements for Tobacco Products, Revised October
2017, https://www.fda.gov/downloads/T obaccoProducts/Labeling/RulesRegulationsGuidance/UCM208916.pdf.
Congressional Research Service
19

FDA Regulation of Tobacco Products

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.142 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,
expected adverse product experience.”143 Required reports cannot be overly burdensome and
cannot disclose the identity of a patient, except under certain circumstances.144
FDA has not yet promulgated regulations specifying these requirements. However, FDA issued a
proposed rule in April 2019 on the content of a SE report. The proposed rule would require
applicants submitting an SE report and receiving an SE order to maintain al records supporting
the SE report for at least four years.145 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.”146 As mentioned, the Spring 2021
White House OMB Unified Agenda indicates that these final rules would be issued in May
2021,147 but as of the date of this publication, this has not yet occurred.
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).148 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.149 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.150

142 FFDCA §909(a); 21 U.S.C. §387i(a).
143 FFDCA §909(a)(1); 21 U.S.C. §387i(a)(1).
144 FFDCA §909(a)(3)&(6); 21 U.S.C. §387i(a)(3)&(6).
145 FDA, “Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on
Substantial Equivalence Reports,” 84 Federal Register 12740, April 2, 2019.
146 FDA, “Premarket T obacco Product Applications and Recordkeeping Requirements,” 84 Federal Register 50566,
September 25, 2019.
147 OMB, “Agency Rule List – Spring 2021: Department of Health and Human Services, Premarket Tobacco Product
Applications and Recordkeeping Requirements,” https://www.reginfo.gov/public/do/eAgendaViewRule?p ubI d=
202104&RIN=0910-AH44, and OMB, “ Agency Rule List – Spring 2021: Department of Health and Human Services,
Format and Content of Reports Intended to Demonstrate Substantial Equivalence,” https://www.reginfo.gov/public/do/
eAgendaViewRule?pubI d=202104&RIN=0910-AH89.
148 T he Federal Cigarette Labeling and Advertising Act of 1965 (FCLAA; 15 U.S.C. §1331-1340) and the
Comprehensive Smokeless T obacco Health Education Act of 1986 (CST HEA; 15 U.S.C. §4401 -4408) are overseen by
the Federal T rade Commission (FT C). For more information on the FCLAA, see FT C, “Federal Cigarette Labeling and
Advertising Act,” https://www.ftc.gov/enforcement/statutes/federal-cigarette-labeling-advertising-act. For more
information on the CHST HEA, see https://www.ftc.gov/enforcement/statutes/comprehensive-smokeless-tobacco-
health-education-act-1986.
149 FFDCA §906(d)(1); 21 U.S.C. §387f(d)(1).
150 FFDCA §906(d)(1); 21 U.S.C. §387f(d)(1).
Congressional Research Service
20

FDA Regulation of Tobacco Products

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.151 Among other things, the 1996 Tobacco
Rule imposed requirements on the sale, labeling, and advertising of cigarettes and smokeless
tobacco.152 The TCA provided that the final rule must be identical to the 1996 rule, with specified
exceptions. FDA reissued the 1996 rule in March 2010,153 and the 2016 deeming rule extended
the applicability of sale and distribution restrictions, as wel 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 21.154
Current law and regulations restricting the sale and distribution of tobacco products wil 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 sel ing tobacco products to any person younger than 21
years of age155 and limits FDA’s ability to promulgate regulations that restrict the sale of tobacco
products to those over 21 years of age.156 FDA has stated that this new age sales restriction is
currently in effect.157
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
sel ing 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 27.158 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 sel 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, 2020.159 Although the Spring 2021 White House OMB

151 T CA §102(a). In 2000, the Supreme Court invalidated FDA’s 1996 tobacco rule. See FDA v. Brown & Williamson
T obacco 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.
152 FDA, “Cigarettes and Smokeless T obacco,” 61 Federal Register 44615, August 28, 1996.
153 FDA, “Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless T obacco T o Protect Children
and Adolescents,” 75 Federal Register 13225, March 19, 2010.
154§603 of Division N of the Further Consolidated Appropriations Act, 2020 ( P.L. 116-94).
155 FFDCA §906(d)(5); 21 U.S.C. §387f(d)(5).
156 FFDCA §906(d)(3)(A)(ii); 21 U.S.C. §387f(d)(3)(A)(ii).
157 FDA, “Newly Signed Legislation Raises Federal Minimum Age of Sale of T obacco 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.
158 21 C.F.R. §1140.14.
159 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.
Congressional Research Service
21

FDA Regulation of Tobacco Products

Unified Agenda indicated that this rule would be published in May 2021,160 as of the date of this
publication, these rules have not been published.
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.161 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.162 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).163
Synar Regulations
As mentioned, 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.164 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.165 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 specifical y, 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.166 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.167 The SABG provides a consistent federal funding stream to states
through formula grants, and it is one of SAMHSA’s largest programs.168

160 OMB, “Agency Rule List – Spring 2021: Department of Health and Human Services, Prohibition of Sale of
T obacco Products to Persons Younger T han 21 Years of Age,” https://www.reginfo.gov/public/do/eAgendaViewRule?
pubId=202104&RIN=0910-AI51.
161 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 to bacco 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 Distribu ting Free Sam ples of
Tobacco Products, October 2017, https://www.fda.gov/media/108259/download.
162 21 C.F.R. §1140.16(c).
163 FFDCA §906(d)(3)(A)(i); 21 U.S.C. §387f(d)(3)(A)(i).
164 T homas E Radecki and C Dianne Zdunich, “T obacco sales to minors in 97 US and Canadian communities,”
Tobacco Control, vol. 2 (1993), pp. 300-305.
165 SAMHSA, “About the Synar Amendment and Program,” https://www.samhsa.gov/synar/about.
166 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).
167 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 . T he 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 T reatment Block Grant (SABG).
168 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
Congressional Research Service
22

FDA Regulation of Tobacco Products

The Synar regulations were promulgated by SAMHSA in 1996 to provide further guidance to
states on implementation of the Synar amendment.169 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.170 As 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.171 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 sel ing
tobacco products to those under age 21 and comply with annual reporting requirements to
SAMHSA on enforcement and compliance actions. SAMSHA was required to update the Synar
regulations by June 20, 2020 to account for these changes.172 However, as of the date of this
publication, the Synar regulations have not been updated to reflect the increased age stipulation.
Tobacco Product Labeling and Advertisement Requirements
The Federal Cigarette Labeling and Advertising Act of 1965 (FCLAA)173 and the Comprehensive
Smokeless Tobacco Health Education Act of 1986 (CSTHEA) include certain labeling
requirements and advertising restrictions on cigarettes and smokeless tobacco, respectively.174
FTC general y oversees these two acts.175 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).176
In addition, manufacturers, distributors, and retailers may not sel or distribute tobacco products
with labels, labeling, or advertising that are not in compliance with the FFDCA and
accompanying FDA regulations.177 Certain labeling and advertising requirements specific to
cigarettes and smokeless tobacco include the following:

for FY2019, https://www.samhsa.gov/sites/default/files/samhsa_fy2019_operating_plan_508.pdf.
169 45 C.F.R §96.130.
170 SAMHSA, “T obacco Regulation for Substance Abuse Prevention and T reatment Block Grants,” 61 Federal
Register 1492, January 19, 1996.
171 SAMHSA, “FFY 2014 Annual Synar Reports: T obacco Sales to Youth,” https://store.samhsa.gov/system/files/
synar-15.pdf.
172 PHSA §1926(c)(2); 42 U.S.C. §300x-26(c)(2).
173 T he FCLAA was amended by the Public Health Cigarette Smoking Act of 1969.
174 T he FCLAA and the CHST HEA are overseen by the Federal T rade Commission (FT C). For more information on
the FCLAA, see FT C, “Federal Cigarette Labeling and Advertising Act,” https://www.ftc.gov/enforcement/statutes/
federal-cigarette-labeling-advertising-act. For more information on the CHST HEA, see https://www.ftc.gov/
enforcement/statutes/comprehensive-smokeless-tobacco-health-education-act-1986.
175 T he FT C enforces unfair or deceptive marketing practices for tobacco products that may be in violation of Section 5
of the Federal T rade Commission Act (FT CA; 15 U.S.C. §41 -58). For more information on the FT CA, see FT C,
“Federal T rade Commission Act,” https://www.ftc.gov/enforcement/statutes/federal-trade-commission-act.
176 15 U.S.C. §1335; 15 U.S.C. §4402(c).
177 FDA’s tobacco product regulations are included in 21 C.F.R. Part 1140.
Congressional Research Service
23

link to page 28 link to page 29 link to page 29 FDA Regulation of Tobacco Products

 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.178
 Manufacturers and distributors of imported cigarettes and smokeless tobacco
may not market, license, distribute, or sel any product that bears the brand name,
logo, or any other identifying patterns associated with the brand name.179
 Labeling and advertising in audio and video formats are limited. For example,
audio formats cannot include music or sound effects.180
Tobacco product package labeling and advertisements must also include warning statements.
Table 2 lists the different health warning statements required to be displayed on tobacco product
package labeling and in tobacco product advertisements, by product. For example, al ENDS
package labeling and advertising is required to include “WARNING: This product contains
nicotine. Nicotine is an addictive chemical.”
Table 2. 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.

178 21 C.F.R. §1140.34(c).
179 21 C.F.R. §1140.34(a).
180 21 C.F.R. §1140.32(b).
Congressional Research Service
24

link to page 29 FDA Regulation of Tobacco Products

Tobacco Products
Required Warning Statements
Newly Deemed Products (except cigars)c
WARNING: This product contains nicotine. Nicotine
is an addictive chemical.
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 al 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 original y 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.181 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.182 The final rule was
chal enged 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.183

181 15 U.S.C. §1333(d), as amended by T CA §201(a).
182 FDA, “Required Warnings for Cigarette Packages and Advertisements,” 76 Federal Register 36628, June 22, 2011.
183 FDA, “Cigarette Graphic Health Warnings,” updated January 30, 2020, https://www.fda.gov/tobacco-products/
Congressional Research Service
25

FDA Regulation of Tobacco Products

FDA planned to develop and propose a new graphic warning rule and has continued to conduct
research for this rule since 2013.184 In 2016, multiple health organizations filed a suit against FDA
to compel the agency to promulgate a final rule more quickly.185 In March 2019, FDA was
ordered to issue a proposed rule by mid-August 2019 and a final rule by mid-March 2020.186 The
proposed rule, issued in August 2019, specifies requirements for new cigarette health warnings.187
In March 2020, FDA published the final rule establishing new cigarette health warnings for
cigarette packages and advertisements.188 Among other things, the rule specifies that 11 new
textual warning statements and accompanying color graphics are to be placed on cigarette
packages and advertisements. The rule further requires tobacco product manufacturers,
distributors, or retailers to submit for FDA approval a plan for the random and equal display and
distribution of the required warnings on packages, as wel as a quarterly rotation of those
warnings in advertisements. FDA issued guidance regarding the submission of these plans in May
2020.189 This final rule was chal enged by manufacturers, distributers, and retailers. While
litigation is currently pending, the effective date of the final rule has been postponed from June
18, 2021 to July 13, 2022.190
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 wel as seizures, injunctions, and criminal prosecution
(with the Department of Justice).191
Adulterated and Misbranded Tobacco Products
The FFDCA prohibits the adulteration and misbranding of tobacco products, as wel as the
introduction, receipt, and delivery of adulterated or misbranded tobacco products into interstate
commerce.192

labeling-and-warning-statements-tobacco-products/cigarette-graphic-health-warnings.
184 FDA, “Cigarette Graphic Health Warnings,” updated January 30, 2020, https://www.fda.gov/tobacco-products/
labeling-and-warning-statements-tobacco-products/cigarette-graphic-health-warnings.
185 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.
186 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.
187 FDA, “T obacco Products; Required Warnings for Cigarette Packages and Advertisements,” 84 Federal Register
42754, August 16, 2019.
188 FDA, “T obacco Products; Required Warnings for Cigarette Packages and Advertisements,” 85 Federal Register
15638-15710, March 18, 2020.
189 FDA, Guidance for Industry: Submission of Plans for Cigarette Packages and Cigarette Advertisements (Revised),
updated February 2021, https://www.fda.gov/media/133839/download.
190 For more information about the litigation and new requirements, see FDA, “Cigarette Labeling and Health Warning
Requirements,” updated June 4, 2021, https://www.fda.gov/tobacco-products/labeling-and-warning-statements-
tobacco-products/cigarette-labeling-and-health-warning-requirements.
191 For more general information about enforcement of the FFDCA, see CRS Report R43609, Enforcement of the Food,
Drug, and Cosm etic Act: Select Legal Issues.
192 FFDCA §301(a)-(c); 21 U.S.C. §331(a)-(c).
Congressional Research Service
26

FDA Regulation of Tobacco Products

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).193
Misbranded Tobacco Products
A tobacco product is deemed misbranded if
 the labeling is false or misleading in any way;194
 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;195
 the labeling, packaging, and shipping containers of tobacco products do not
contain the label “sale only al owed in the United States”;196
 it was manufactured, prepared, propagated, compounded, or processed in a
facility that was not registered with FDA;197
 its advertising is false or misleading in any way;198 and/or
 it is sold by a retailer to an individual under 21 years of age199 or is sold in
violation of regulations promulgated on the sale and distribution of tobacco
products.200
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.201 To date, FDA has not issued such
regulations.

193 FFDCA §902; 21 U.S.C. §387b.
194 FFDCA §903(a)(1); 21 U.S.C. §387c(a)(1).
195 FFDCA §903(a)(2),(5), & (9); 21 U.S.C. §387c(a)(2),(5), & (9).
196 FFDCA §903(a)(2)(D); 21 U.S.C. §387c(a)(2)(D).
197 FFDCA §903(a)(6); 21 U.S.C. §387c(a)(6).
198 FFDCA §903(a)(7)(A) [21 U.S.C. §387c(a)(7)(A)]; 21 C.F.R. §1141.14.
199 As noted earlier in this report, FDA regulations do not currently reflect the new minimum age limit for tobacco
retailers. FDA nonetheless is requiring tobacco retailers to continue ensuring that consumers meet the new age
threshold. For more information, see FDA, “ T obacco 21,” updated February 2, 2021, https://www.fda.gov/tobacco-
products/retail-sales-tobacco-products/tobacco-21.
200 FFDCA §903(a)(7)(B); 21 U.S.C. §387c(a)(7)(B).
201 FFDCA §903(b); 21 U.S.C. §387c(b).
Congressional Research Service
27

FDA Regulation of Tobacco Products

Tobacco Retailer Compliance Check Inspections
FDA is required to contract with states and territories to carry out compliance check inspections
of tobacco retailers.202 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.203
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.204 If a first-time violation is reported (e.g., sale to a minor, il egal
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
and the time period in which the violations occurred.205 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.206 According to FDA, as of February 28, 2021, the agency has “conducted
more than a mil ion compliance check inspections and issued over 98,000 Warning Letters,
25,000 [CMPs], and 200 [NTSOs].”207
As mentioned, in FY2020 appropriations, Congress amended the federal minimum age of tobacco
product purchasing from 18 to 21.208 FDA has stated that this new age sales restriction is currently
in effect, but also recognizes that the agency and retailers wil need to update current practices to
account for these changes.209 As such, FDA had stated that “during this ramp-up period, FDA wil
continue to only use minors under the age of 18 in its compliance check program.”210 As of
February 2021, FDA has started using individuals under the age of 21 to test nationwide retailer
compliance.211

202 FFDCA §702(a)(1)(B)(i); 21 U.S.C. §372(a)(1)(B)(i).
203 FDA, “FDA T obacco Retail Inspection Contracts,” https://www.fda.gov/tobacco-products/retail-sales-tobacco-
products/fda-tobacco-retail-inspection-contracts.
204 FDA, “Undercover Buy Inspections,” https://www.fda.gov/media/123583/download.
205 T CA §103(q)(2)(a).
206 FDA, Guidance for Tobacco Retailers: Determination of the Period Covered by a No -Tobacco-Sale-Order and
Com pliance With an Order, August 2015, https://www.fda.gov/downloads/tobaccoproducts/labeling/
rulesregulationsguidance/ucm460155.pdf.
207 FDA, “ FY 2022 Justification of Estimates for Appropriations Committees,” May 28, 2021, https://www.fda.gov/
media/149616/download#page=284.
208 §603 of Division N of the Further Consolidated Appropriations Act, 2020 ( P.L. 116-94).
209 FDA, “Newly Signed Legislation Raises Federal Minimum Age of Sale of T obacco 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.
210 FDA, “Newly Signed Legislation Raises Federal Minimum Age of Sale of T obacco Pro ducts to 21,” January 15,
2020.
211 FDA, “T obacco 21,” updated February 2, 2021 at https://www.fda.gov/tobacco-products/retail-sales-tobacco-
products/tobacco-21.
Congressional Research Service
28

FDA Regulation of Tobacco Products

Notification and Recall
FDA has the authority to issue notifications and recal s of tobacco products once they are on the
market.212 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,”213 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) recal if the tobacco
product is thought to be in violation of the FFDCA.214 In addition, FDA has the authority to
mandate a tobacco product recal 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.215 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
amended to include a recal of the tobacco product, FDA must amend the order to require such
recal , specifying a timetable for and requiring periodic progress reports on the recal .

212 FFDCA §908(a); 21 U.S.C. §387h(a).
213 FFDCA §908(a)(1); 21 U.S.C. §387h(a)(1).
214 For more information on FDA’s general recall authority, see CRS Report R43609, Enforcement of the Food, Drug,
and Cosm etic Act: Select Legal Issues.
215 FFDCA §908(c)(1); 21 U.S.C. §387h(c)(1).
Congressional Research Service
29

FDA Regulation of Tobacco Products

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 electrical y 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 electrical y 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 saw this product as a
potential precedent for the premarket review process that ENDS products wil eventual y
undergo. On May 15, 2017, FDA received PMTAs from Phil ip 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, some stakeholders raised
concerns that smal ENDS manufacturers may not have the resources to engage in the PMTA
process. In addition, there are concerns FDA may need additional resources to accommodate the
influx of lengthy ENDS PMTA applications.
Congressional Research Service
30

FDA Regulation of Tobacco Products

Appendix B. Tobacco Master Settlement Agreement
of 1998216
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 il nesses.217 The remaining four states—
Mississippi, Florida, Texas, and Minnesota—had settled individual y 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. Specifical y, 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 bil board advertising, excluding bil board 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 non-cigarette apparel with brand-name logos except at brand-name
sponsored events;
 banned gifts of non-cigarette items to youth in exchange for cigarettes;
 restricted the use of national y recognized non-tobacco brand names for
cigarettes; and
 limited free samples of cigarettes to adult-only facilities.

216 T his appendix summary was adapted from archived CRS Report R40475, FDA Tobacco Regulation: The Family
Sm oking Prevention and Tobacco Control Act of 2009.
217 T he full text of the MSA is available on the website of the National Association of Attorneys General, which is
responsible for enforcement, at http://www.naag.org/backpages/naag/tobacco/msa.
Congressional Research Service
31

FDA Regulation of Tobacco Products

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 (i ) 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.
Congressional Research Service
32

FDA Regulation of Tobacco Products

Example
Term
Definition
(if applicable)
Electronic nicotine delivery systems
An umbrel a 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 al 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 commercial y marketed in the
Marlboro Box
United States as of February 15, 2007.
Cigarettes
Grandfathered tobacco products do not require
premarket review to be legal y marketed.
Harmful and potential y harmful
Any chemicals or chemical compounds in a tobacco
Nitrobenzene
constituents
product or in tobacco smoke that is, or potential y
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

legal y marketed or a tobacco product that is
required to comply with a tobacco product
standard and that does not conform in al 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 commercial y 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 commercial y 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
cel ophane), 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
sel , 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.
Congressional Research Service
33

FDA Regulation of Tobacco Products

Example
Term
Definition
(if applicable)
Smal 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.
Smal -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 sel s 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 sel s 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.
Congressional Research Service
34

FDA Regulation of Tobacco Products

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 Potential y 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
OMB
White House Office of Management and Budget
OTC
Over-the-counter
PACT
The Prevent Al 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
Congressional Research Service
35

FDA Regulation of Tobacco Products

Author Information

Hassan Z. Sheikh
Victoria R. Green
Analyst in Public Health Emergency Management
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 authors also wish 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 n ot 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
material from a third party, you may need to obtain the permission of the copyright holder if you wish to
copy or otherwise use copyrighted material.

Congressional Research Service
R45867 · VERSION 11 · UPDATED
36

Download PDF

Download EPUB

Revision History

Jul. 9, 2021

HTML · PDF

30% changed

Feb. 10, 2020

HTML · PDF

33% changed

Feb. 7, 2020

HTML · PDF

29% changed