Regulation of Electronic Nicotine Delivery Systems (ENDS): Background and Select Policy Issues in the 117th Congress

September 10, 2021 – September 30, 2021 R46928




Regulation of Electronic Nicotine Delivery
Systems (ENDS): Background and Select
Policy Issues in the 117th Congress
September 30, 2021
Congressional Research Service
https://crsreports.congress.gov
R46928



Regulation of Electronic Nicotine Delivery Systems (ENDS)

R46928
Regulation of Electronic Nicotine Delivery
September 30, 2021
Systems (ENDS): Background and Select Policy Hassan Z. Sheikh
Issues in the 117th Congress
Analyst in Public Health
Emergency Management
In recent years, electronic nicotine delivery systems (ENDS) have become increasingly popular.

ENDS is an umbrella term for various types of electronic tobacco products, including electronic
cigarettes (e-cigarettes). An e-cigarette is a battery-operated device typically containing nicotine,

flavorings, and other chemicals that, when heated, creates inhalable vapor. According to Centers
for Disease Control and Prevention (CDC) analyses, 10.9 million American adults used e-cigarettes every day or some days
in 2019, and about 3.6 million American middle and high school students used an e-cigarette in the past 30 days in 2020.
Members of the public health community have debated the impact of ENDS on public health. Some view ENDS as a safer
alternative for adult cigarette smokers, while others are alarmed by its increased use among youth.
Regulation of ENDS 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. The Family Smoking
Prevention and Tobacco Control Act of 2009 (TCA; P.L. 111-31) 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. FDA has the broad authority to regulate any other tobacco products that it
determines meet the established definition and are thus 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 not already subject to the FFDCA, including ENDS. Some ENDS solutions contain tetrahydrocannabinol (THC), an
illicit substance at the federal level subject to various Drug Enforcement Agency (DEA) regulations. In addition, Congress
has directed the United States Postal Service to promulgate regulations clarifying how the prohibition on mailing cigarettes
applies to ENDS.
Policy Considerations
Both FDA and Congress have taken steps to address the regulation of ENDS in response to increased ENDS use among
youth. FDA has prioritized enforcement of ENDS products that are more likely to be used by minors, and the agency is
reviewing premarket applications for newly deemed products, including ENDS. Legislation introduced in the 116th and 117th
Congresses thus far includes various provisions addressing youth ENDS use, such as banning all flavors in tobacco products
(including ENDS) and setting a maximum nicotine concentration limit in e-liquids. In FY2020 appropriations, Congress
enacted provisions raising the federal minimum age of sale of tobacco products from 18 to 21. The application of certain
FFDCA requirements to tobacco product manufacturers and retailers, such as requiring ENDS manufacturers and importers
to pay user fees, would require congressional action.

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Contents
Introduction ................................................................................................................... 1
ENDS as a Harm-Reduction Tool ...................................................................................... 5
Flavored ENDS Regulation .............................................................................................. 6
ENDS Solutions Containing Additives ............................................................................... 8
Variable Concentration of Nicotine in E-Liquids .................................................................. 9
Remote Sales................................................................................................................ 11
ENDS User Fees ........................................................................................................... 12
Increasing Minimum Age for Purchasing ENDS Products ................................................... 13

Contacts
Author Information ....................................................................................................... 15


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Regulation of Electronic Nicotine Delivery Systems (ENDS)

Introduction
Nicotine is a natural y occurring chemical found in the tobacco plant. Repeated exposure to
nicotine can cause addiction.1 There is debate in the public health community regarding the
severity of harms of nicotine.2 A common misconception among the general public is that
nicotine is the primary cause of various harms associated with tobacco use, particularly cigarette
use. However, FDA has identified, including nicotine, 93 harmful or potential y harmful
constituents (HPHCs) in tobacco products and tobacco smoke.3 Some in the public health
community have advocated for a harm-reduction approach, emphasizing the use of
noncombustible electronic nicotine devices (ENDS) as an alternative to combustible tobacco
products that may contain more HPHCs. On the other hand, nicotine is not harmless. FDA has
acknowledged that higher concentrations of nicotine can lead to harmful effects, particularly in
youth.4 For example, nicotine may damage the developing adolescent brain, affecting parts of the
brain that control attention, learning, mood, and impulse control.5
ENDS use has proliferated in recent years, particularly among youth (anyone under the age of
18). ENDS is an umbrel a term for various types of electronic tobacco products, including
electronic cigarettes (e-cigarettes).6 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). ENDS products come in a variety of formats (such as e-hookahs, e-cigars, vape
pens). Whereas earlier generations of ENDS products were designed to be used only once, current
devices come with a prefil ed or refil able cartridge (“pod”) containing e-liquid, which is
converted to an aerosol by the ENDS product. This e-liquid can contain a number of ingredients
in addition to nicotine.7 According to Centers for Disease Control and Prevention (CDC)
analyses, 10.9 mil ion American adults used e-cigarettes every day or some days in 2019.8 About
3.6 mil ion American middle and high school students used an e-cigarette within a 30-day period
in 2020.9

1 National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, Centers for
Disease Control and Prevention, The Health Consequences of Smoking—50 Years of Progress, U.S. Department of
Health and Human Services, Atlanta, GA, 2014, https://www.surgeongeneral.gov/library/reports/50-years-of-progress/
full-report.pdf.
2 Scientific American, “Is Nicotine All Bad?” May 19, 2015, https://www.scientificamerican.com/article/is-nicotine-
all-bad/.
3 FDA, “Harmful and Potentially Harmful Constituents in T obacco Products and T obacco Smoke: Establish ed List,”
updated October 19, 2019, https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/harmful-and-
potentially-harmful-constituents-tobacco-products-and-tobacco-smoke-established-list.
4 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, pp. 41-42, https://www.fda.gov/
media/133880/download.
5 CDC, “Why Is Nicotine Unsafe for Kids, T eens, and Young Adults?” updated July 7, 2021, https://www.cdc.gov/
tobacco/basic_information/e-cigarettes/Quick-Facts-on-the-Risks-of-E-cigarettes-for-Kids-T eens-and-Young-
Adults.html?s_cid=OSH_emg_GL0004#why-is-nicotine-unsafe.
6 Other examples of ENDS products may include e-pipes, hookah pens, vape pens, vaporizers, or vapes, or electronic
cigars. See CDC, “E-Cigarette, or Vaping, Products Visual Dictionary,” https://www.cdc.gov/tobacco/
basic_information/e-cigarettes/pdfs/ecigarette-or-vaping-products-visual-dictionary-508.pdf.
7 CDC, “E-Cigarette, or Vaping, Products Visual Dictionary,” https://www.cdc.gov/tobacco/basic_information/e-
cigarettes/pdfs/ecigarette-or-vaping-products-visual-dictionary-508.pdf.
8 See Monica E. Cornelius, T eresa W. Wang, and 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.
9 Andrea S. Gentzke, T eresa W. Wang, Ahmed Jamal, et al., “T obacco Product Use Among Middle and High School
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The public health impact of ENDS products is a point of debate in the public health community.
Some view ENDS products as a safer alternative for adults who smoke cigarettes because the
aerosol produced from e-cigarettes is considered less harmful in the short-term than the
combusted smoke produced from cigarettes.10 Others are alarmed by the marked increase in
ENDS use among youth, and are concerned that these products, particularly those sold in flavors
appealing to children, may undo the years of tobacco control efforts that have successfully
reduced cigarette smoking among both youth and adults.11
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. Upon enactment, the
TCA explicitly covered the following tobacco products: cigarettes and cigarette tobacco, roll-
your-own tobacco, and smokeless tobacco. The TCA gave FDA broad authority to regulate any
other tobacco products that the agency determines meet the established definition and are thus
subject to Chapter IX of the FFDCA. In 2016, FDA promulgated regulations (known as “the
deeming rule”) that extended the agency’s authority over al tobacco products not already subject
to the FFDCA, including ENDS.12
Al tobacco products original y covered by the TCA are required to undergo premarket review,
unless they are “grandfathered products.”13 Following the 2016 deeming rule, al newly deemed
tobacco products became subject to premarket review requirements. Premarket applications for
ENDS products were due to the agency by September 9, 2020. In addition to the enforcement
priorities it expressed in April 2020 guidance, FDA stated that it may continue to exercise
enforcement discretion for manufacturers that submitted applications by the aforementioned
date.14 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 after the deadline (i.e., September 9, 2021) while
applications are being reviewed.15 As of June 2021, Acting Commissioner of Food and Drugs
Janet Woodcock testified that the agency has completed initial processing of Premarket Tobacco
Product Applications (PMTA) for 6.5 mil ion products submitted by over 550 companies. The
vast majority of these submissions are for ENDS products.16 On August 9, 2021, FDA issued a

Students—United States, 2020,” Morbidity and Mortality Weekly Report (MMWR), vol. 69, no. 50 (December 18,
2020), pp. 1881-88.
10 National Academies of Sciences, Engineering, and Medicine, Public Health Consequences of E-Cigarettes, T he
National Academies Press, p. 18, Washington, DC, 2018, https://www.nap.edu/read/24952/chapter/3.
11 See, for example, Laura Bach, JUUL and Youth: Rising E-Cigarette Popularity, Campaign for T obacco Free Kids,
June 8, 2021, pp. 3-5, https://www.tobaccofreekids.org/assets/factsheets/0394.pdf.
12 For more information about tobacco regulation, see CRS Report R45867, FDA Regulation of Tobacco Products.
13 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.
14 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, https://www.fda.gov/media/133880/
download.
15 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.
16 FDA, T estimony of Dr. Janet Woodcock, Acting Commissioner, An Epidemic Continues: Youth Vaping in America,
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Refuse to File (RTF)17 letter stating that an e-liquid company must remove approximately 4.5
mil ion products from the market because its PMTAs failed to meet the filing requirements.18 On
August 26, FDA issued market denial orders (MDOs) 19 for more than 50,000 ENDS products,
citing a lack of evidence that they were “a benefit to adult smokers sufficient to overcome the
public health threat posed by the wel -documented, alarming levels of youth use of such
products.”20
As of September 9, 2021, FDA stated that it had taken action on 93% of al applications to date.21
Many of the applications submitted to the FDA by the PMTA pathway were issued a RTF for
failure to include required information such as ingredient listings, or labels for marketed products.
FDA has further stated that it continues to work on the remaining applications, clarifying that in
addition to the remaining applications FDA is also reviewing a number of products submitted
under a substantial equivalence (SE) pathway.22 Some industry stakeholders have expressed
frustration at the FDA, claiming that FDA had failed to promptly review the applications of
companies who hold the largest market share of vape products.23 Other advocacy groups have
stated that the FDA’s decisions had not gone far enough to remove vape products from the
market.24 Ultimately, as FDA continues to process applications there may be significant upcoming
implications for the ENDs industry. While various stakeholders are demanding prompt FDA
action, Congress may consider whether or not to act before FDA has finished reviewing al
product applications.
Over the past few years, FDA and Congress have taken steps to regulate ENDS products.
Stakeholders have recently identified several issues regarding the regulation of ENDS that may
be of interest to Congress:

before the U.S. Congress, House Committee on Oversight and Reform, Subcommittee on Economic and Consumer
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 estimony of Dr. Janet Woodcock, “ An Epidemic Continues: Youth
Vaping in America”).
17 A “refuse-to-file” letter is generally issued for applications for which there is insufficient information available for
review.
18 FDA, “FDA Issues Refuse to File (RT F) Letter to JD Nova Group LLC,” August 09, 2021 at https://www.fda.gov/
tobacco-products/ctp-newsroom/fda-issues-refuse-file-rtf-letter-jd-nova-group-llc?utm_source=CT PTwitter&
utm_medium=social&utm_campaign=ctp-pmta.
19 A market-denial-order is issued after a determination that an application’s PMTA did not pass evaluation. PMT As
are evaluated on several factors, “ ... including whether permitting the marketing of a new tobacco product would be
appropriate for the protection of the public health, which is determined with respect to the risks and benefits of the
product to the population as a whole, including users and non-users.” See FDA, “ T obacco Products Marketing Orders,”
August 26, 2021, https://www.fda.gov/tobacco-products/market -and-distribute-tobacco-product/tobacco-products-
marketing-orders#Marketing%20Denial.
20 FDA, “FDA Denies Marketing Applications for About 55,000 Flavored E-Cigarette Products for Failing to Provide
Evidence T hey Appropriately P rotect Public Health,” press release, August 26, 2021, https://www.fda.gov/news-
events/press-announcements/fda-denies-marketing-applications-about-55000-flavored-e-cigarette-products-failing-
provide-evidence.
21 FDA, “FDA Makes Significant Progress in Science-Based Public Health Application Review, T aking Action on
Over 90% of More T han 6.5 Million ‘Deemed’ New T obacco Products Submitted,” press release, September 9, 2021,
https://www.fda.gov/news-events/press-announcements/fda-makes-significant -progress-science-based-public-health-
application-review-taking-action-over-90.
22 For a discussion on FDA premarket review pathways for tobacco products, see CRS Report R45867, FDA
Regulation of Tobacco Products.
23 Matt Richel, “F.D.A. Delays Decision on Juul’s E-Cigarettes but Orders Others Off the Market,” The New York
Tim es, September 9, 2021.
24 Ibid.
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“ENDS as a Harm-Reduction Tool.” The data regarding the effectiveness of
ENDS as a harm-reduction or cessation tool for adults who smoke cigarettes are
complex. FDA has not approved any ENDS products for smoking cessation,
although some stakeholders have stated that adults who switch from cigarettes to
ENDs may have better health outcomes.
“Flavored ENDS Regulation.” FDA and public health stakeholders remain
concerned about increased ENDS use among youth. Although data suggest that
both adults and youth enjoy flavored ENDS products, some in the public health
community argue that the increase in ENDS use among youth is largely driven by
the availability of youth-friendly flavors. FDA has issued policies prioritizing
enforcement against unauthorized flavored e-cigarette products; some public
health stakeholders have expressed concern that the policies do not go far enough
to reduce ENDS use among youth.
“ENDS Solutions Containing ” Along with the rise in ENDS use among youth,
the emergence of e-cigarette or vaping use-associated lung injury (“EVALI”) has
further heightened concern among public health stakeholders, Congress, and the
general public. Laboratory data suggest that in addition to tetrahydrocannabinol
(THC) containing ENDS products, vitamin E acetate—an additive sometimes
found in such products—is closely associated with EVALI. These THC-
containing products may raise a larger question of how they might be federal y
regulated in states that permit the sale of marijuana for recreational or medicinal
purposes.
“Variable Concentration of Nicotine in E-Liquids.” The nicotine
concentration in commercial y available solutions used in ENDS devices (“e-
liquids”) is variable and unregulated. As a result, users may have variable
concentrations of blood nicotine levels, which may contribute to increased side-
effect profiles such as nicotine dependence and addiction, particularly among
youth. However, variable nicotine levels may contribute to the utility of ENDS
products as possible harm-reduction tools. To address this concern, Congress has
previously introduced bil s setting a maximum concentration of nicotine in e-
liquids.
“Remote Sales.” The remote sales (i.e., non-face-to-face sales) of ENDS
products may enable youth to purchase tobacco products il egal y, due to
difficulties in enforcing purchasing restrictions.
“ENDS User Fees.” FDA has determined that it currently does not have the
authority to assess user fees from manufacturers and importers of ENDS, despite
these products being deemed subject to FDA regulation.25
“Increasing Minimum Age for Purchasing ENDS Products.” Many public
health stakeholders have been concerned about youth access to tobacco products
more broadly and expressed support for raising the minimum age of purchasing
tobacco products from 18 to 21. Although, FDA was required to publish the final

25 Currently, ENDS products are not subject to federal excise taxes; however, a discussion of this policy issue is outside
the scope of this report. For more information, see U.S. Government Accountability Office, Electronic Cigarettes:
Effect on Federal Excise Taxes Collected on Tra ditional Cigarettes is Not Currently Evident, GAO-15-771, September
2015, https://www.gao.gov/assets/680/672467.pdf.
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rule to reflect this change by May 2021, these rules have not been published as of
the date of this report.
These select issues are discussed in greater detail below, along with potential considerations for
policymakers.26
ENDS as a Harm-Reduction Tool
Since the emergence of ENDS products in the tobacco marketplace, there has been ongoing
debate regarding their public health impact. This debate has implications for how such products
should be regulated. Some data suggest that ENDS products may provide a harm-reduction tool
for some tobacco smokers.27 Harm reduction refers to the replacement of a more harmful activity
with a less harmful one when elimination of the original activity is difficult or infeasible. Some in
the public health community view ENDS as a harm-reduction tool for adults who smoke
cigarettes.28 Specifical y, ENDS products may be able to reduce harm among adult cigarette
smokers who have experienced difficulty quitting as the aerosol from ENDS “contains fewer
numbers and lower levels of most toxicants than does smoke from combustible tobacco
cigarettes.”29
Data regarding the effectiveness of ENDS as a harm-reduction or cessation tool are complex. As
of early 2018, the National Academies of Sciences, Engineering, and Medicine (NASEM)
concluded that “there is general agreement that the number, size, and quality of studies for
judging the effectiveness of e-cigarettes as cessation aids in comparison with cessation aids of
proven efficacy are limited, and therefore there is insufficient evidence to permit a definitive
conclusion at this time.”30 Further, the long-term health effects associated with use of ENDS are
stil largely unknown,31 and FDA has not yet approved any ENDS products as cessation devices.32
A 2018 CDC study, however, found that “15% of smokers who were current exclusive users of e-
cigarettes reported recent successful smoking cessation.”33 Despite these questions, some argue

26 Policy issues with respect to other tobacco products are outside the scope o f this report. For more information on
tobacco products, see CRS Report R45867, FDA Regulation of Tobacco Products.
27 Caitlin Notley, Emma Ward, Lynne Dawkins, et al., “T he unique contribution of e-cigarettes for tobacco harm
reduction in supporting smoking relapse prevention,” Harm Reduction Journal, vol. 15, no. 31 (June 20, 2018).
28 T homas J. Glynn, J. T aylor Hays, and Katherine Kemper, “E-Cigarettes, Harm Reduction, and T obacco Control,”
Mayo Clinic Proceedings, vol. 96, no. 4 (January 22, 2021), https://www.mayoclinicproceedings.org/article/S0025-
6196(20)31382-3/fulltext.
29 National Academies of Sciences, Engineering, and Medicine, Public Health Consequences of E-Cigarettes, National
Academies Press, Washington, DC, 2018, p. 1, https://www.nap.edu/read/24952.
30 National Academies of Sciences, Engineering, and Medicine, Public Health Consequences of E-Cigarettes, National
Academies Press, p. 579.
31 National Academies of Sciences, Engineering, and Medicine, Public Health Consequences of E-Cigarettes, National
Academies Press, p. 483.
32 FDA approval of ENDS devices as smoking cessation products would require regulatory approval not discussed at
length in this report. While e-cigarettes are regulated by the FDA’s Center for T obacco Products, ENDS devices
purporting a smoking cessation claim would likely be regulated similarly to other smoking cessation products and
would likely require that the FDA’s Center for Drug Evaluation and Research evaluate whether a specific ENDS
product is safe and effective for an end user. See Elizabeth Richardson, Meredith Freed, and Mark B. McClellan,
“Regulating Nicotine Replacement T herapies: Next Steps In A Comprehensive Strategy For T obacco Harm
Reduction,” Health Affairs, February 14, 2018, https://www.healthaffairs.org/do/10.1377/hblog20180212.333148/full/.
33 Kimp Walton, T eresa W. Wang, Yvonne Prutzman, et al., “Characteristics and Correlates of Recent Successful
Cessation Among Adult Cigarette Smokers, United States, 2018,” Preventing Chronic Disease, vol. 17 (December 10,
2020).
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that adults who completely switch from cigarettes to ENDS may have a positive effect on public
health, given the morbidity and mortality associated with cigarette smoking.34
Various stakeholders have concluded that additional information is needed to assess the harm-
reduction benefits, if any, of ENDS products. To help inform future regulatory standards for such
products, Congress may consider directing federal agencies such as the CDC and the National
Institutes of Health (NIH) to expand studies researching the potential of ENDS products as
cessation devices.
Flavored ENDS Regulation
The regulation of flavors in ENDS products is complicated by several factors. Some in the public
health community are alarmed by the marked increase among youth in the use of ENDS products,
which are now the most popular tobacco product for this age group.35 Research studies suggest
that this increase has occurred, in large part, as a result of access to flavored ENDS products.36
Numerous studies have documented that flavors entice youth to initiate and continue using
tobacco products,37 including ENDS.38 On the other hand, many adult cigarette smokers have
expressed an interest in ENDS as a way to quit cigarette smoking.39
The availability of flavored ENDS products has created tension between industry and some
members of the public health community. One systematic review of the literature found that both
youth and adults enjoy flavors in e-cigarettes. However, the authors of this review stated that “in
terms of whether flavored e-cigarettes assisted [adults] quitting smoking, we found inconclusive
evidence.”40 Industry-funded research suggested that flavored ENDS products may be more
appealing to adult cigarette smokers (compared with nonsmoking teens) and could help them quit
smoking.41

34 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.
35 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.
36 FDA, Draft Guidance for Industry: Modifications to Compliance Policy for Certain Deemed Tobacco Products,
March 2019, https://www.fda.gov/downloads/T obaccoProducts/Labeling/RulesRegulationsGuidance/UCM633281.pdf.
37 National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, Centers for
Disease Control and Prevention, Preventing Tobacco Use Am ong Youth and Young Adults: A Report of the Surgeon
General, U.S. Department of Health and Human Services, Atlanta, GA, 2012, https://www.surgeongeneral.gov/library/
reports/preventing-youth-tobacco-use/full-report.pdf.
38 National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, Centers for
Disease Control and Prevention, E-Cigarette Use Am ong Youth and Young Adults: A Report of the Surgeon General,
U.S. Department of Health and Human Services, Atlanta, GA, 2016, https://e-cigarettes.surgeongeneral.gov/
documents/2016_sgr_full_report_non-508.pdf.
39 Matthew J. Carpenter, Bryan W. Heckman, Amy E. Wahlquist, et al., “A Naturalistic, Randomized Pilot T rial of E -
Cigarettes: Uptake, Exposure, and Behavioral Effects,” Cancer Epidem iology, Biom arkers & Prevention , vol. 26, no.
12 (December 2017).
40 Samane Zare, Mehdi Nemati, and Yuqing Zheng, “A systematic review of consumer preference for e -cigarette
attributes: Flavor, nicotine strength, and type,” PLoS ONE, vol. 13, no. 3 (2018).
41 Saul Shiffman, Mark A. Sembower, Janine L. Pillitteri, et al., “T he Impact of Flavor Descriptors on Nonsmoking
T eens’ and Adult Smokers’ Interest in Electronic Cigarettes,” Nicotine & Tobacco Research, January 7, 2015, pp.
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In March 2019, FDA released a draft guidance document specifying its intended enforcement
activities related to flavored ENDS.42 This guidance specified that FDA would prioritize
enforcement of premarket review, distribution, and sale requirements related to certain flavored
ENDS products that may be most accessible to youth. For example, FDA would prioritize
enforcement of distribution and sale requirements in retail locations where certain flavored ENDS
products may be most accessible to youth, such as in convenience stores and gas stations that do
not have adult-only sections. In September 2019, FDA announced that it would finalize this
guidance document “in the coming weeks,” with the intention of clearing “the market of flavored
e-cigarettes to reverse the deeply concerning epidemic of youth e-cigarette use.”43 Delays in
guidance finalization led to a congressional hearing on December 4, 2019, to investigate the cause
for delay.44
In January 2020, with a subsequent update in April 2020, FDA released the final guidance
document,45 which included some changes to the draft guidance. Specifical y, the March 2019
draft guidance focused enforcement of premarket authorization requirements on how and where
ENDS products are sold, whereas the final guidance focuses such enforcement on
 any flavored, cartridge-based ENDS product (other than a tobacco- or menthol-
flavored ENDS product);
 al other ENDS products for which a manufacturer has failed to take (or is failing
to take) adequate measures to prevent minors’ access; and
 any ENDS product targeted to minors or whose marketing is likely to promote
the use of ENDS by minors.
Some public health stakeholders expressed concern that the final guidance does not go far enough
to reduce ENDS use among youth.46
In April 2021, FDA released a statement outlining its intent to issue proposed product standards
to ban menthol in cigarettes and al characterizing flavors47 in cigars. 48 The spring 2021 White

1255-1262.
42 FDA, Draft Guidance for Industry: Modifications to Compliance Policy for Certain Deemed Tobacco Products,
March 2019, https://www.fda.gov/downloads/T obaccoProducts/Labeling/RulesRegulationsGuidance/UCM633281.pdf.
43 FDA, “T rump Administration Combating Epidemic of Youth E-Cigarette Use with Plan to Clear Market of
Unauthorized, Non-T obacco-Flavored E-Cigarette Products,” September 11, 2019, https://www.fda.gov/news-events/
press-announcements/trump-administration-combating-epidemic-youth-e-cigarette-use-plan-clear-market-
unauthorized-non.
44 U.S. Congress, House Committee on Oversight and Reform, Subcommittee on Economic and Consumer Policy, The
Federal Response to the Epidem ic of E-Cigarette Use, Especially Am ong Children, and the Food and Drug
Administration’s Compliance Policy, 116th Cong., 1st sess., December 4, 2019.
45 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, https://www.fda.gov/media/133880/
download.
46 Abby Goodnough, Maggie Haberman, and Sheila Kaplan, “With Partial Flavor Ban, T rump Splits the Difference on
Vaping,” The New York Times, January 2, 2020.
47 Characterizing flavors are those that noticeably smell or taste differently than tobacco, such as ‘vanilla’, ‘candy’ or
‘fruit’. See T heresa Patten, Mariella De Biasi, “History Repeats itself: Role of Characterizing flavors on nicotine use
and abuse,” Neuropharmacology, vol. 177, no. 15 (October 2020), https://www.sciencedirect.com/science/article/abs/
pii/S0028390820302306.
48 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.
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House OMB Unified Agenda of Federal Regulatory and Deregulatory Actions indicates that FDA
aims to release a proposed rule regarding cigars in August 2021 and a proposed rule regarding
cigarettes in April 2022.49 However, these rules wil likely not address flavors in ENDS products.
In response to concerns regarding youth access to ENDS products, including flavored products,
Congress may consider further limiting the use of flavors in ENDS. In the 116th session, Congress
saw proposal of an outright ban on al flavors (including menthol) in ENDS, as wel as in other
tobacco products.50 Congress may consider proposals that reduce any tobacco product use,
including ENDS, among youth, while leaving open the option of ENDS use for adult cigarette
smokers, given the possible public health benefit. Congress may also consider how availability of
flavored tobacco products would fit into those proposals. Congress may choose to not act and rely
on the FDA to determine if the recent measures have had their intended effects.
ENDS Solutions Containing Additives
Some ENDS solutions contain tetrahydrocannabinol (THC), the primary psychoactive compound,
or cannabinoid, found in marijuana.51 Such THC-containing products, in particular those
available in states that permit the sale of the sale of marijuana for recreational or medicinal
purposes, may raise a question regarding federal oversight. Marijuana—including marijuana-
derived compounds such as THC—is an il icit substance at the federal level subject to Drug
Enforcement Administration (DEA) enforcement and regulatory control.52 However, some states
have implemented their own laws pertaining to recreational and medicinal marijuana use, and the
DEA has largely focused resources on criminal networks involved in the il icit marijuana trade.53
It is unclear how the DEA intends to prioritize enforcement efforts in states that al ow
recreational and medicinal marijuana versus those that do not.54 Further, ENDS products that do
not contain any components, parts, or accessories derived from tobacco (e.g., do not contain
nicotine) and are not expected to be consumed like a tobacco product may not meet the definition
of a tobacco product under the FFDCA. Therefore, such products may not be subject to FDA
regulatory requirements pertaining to tobacco products. FDA has indicated that the agency would
regulate such products on a “case-by-case basis, based on the totality of the circumstances.”55

49 OMB, “Agency Rule List – Spring 2021: Department of Health and Human Services, T obacco Product Standard for
Characterizing Flavors in Cigars,” https://www.reginfo.gov/public/do/eAgendaVie wRule?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.
50 H.R. 1498, 116th Congress; H.R. 2339, 116th Congress.
51 Marijuana is a variety or cultivar of the Cannabis sativa plant. See Figure 1 of CRS Report R46189, FDA Regulation
of Cannabidiol (CBD) Consum er Products: Overview and Considerations for Congress.
52 Marijuana is currently listed as a Schedule I controlled substance under the Controlled Substances Act (CSA). For
more information, see CRS Report R44782, The Marijuana Policy Gap and the Path Forward .
53 Deputy Attorney General David W. Ogden, Memorandum for Selected United States Attorneys, U.S. Department of
Justice, Investigations and Prosecutions in States Authorizing the Medical Use of Marijuana, Washington, DC, October
19, 2009, pp. 1-3.
54 In some reported instances, DEA has seized vape pens containing T HC in jurisdictions that allow purchasing of
medicinal marijuana. See for example, T racy Carloss, “ More than 15,000 T HC vaping cartridges seized by DEA agents
in Cleveland,” News 5: Cleveland, April 23, 2019, https://www.news5cleveland.com/news/local-news/cleveland-metro/
more-than-15-000-thc-vaping-cartridges-seized-by-dea-agents-in-cleveland.
55 See question 14 in FDA, “Commonly Asked Questions: About the Center for T obacco Products,” June 11, 2019,
https://www.fda.gov/tobacco-products/about-center-tobacco-products-ctp/commonly-asked-questions-about -center-
tobacco-products#14.
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The emergence of e-cigarette or vaping use-associated lung injury (“EVALI”) has highlighted the
potential dangers of ENDS solutions that contain additives. EVALI, which is characterized in
individuals by gastrointestinal and respiratory symptoms, has led to the deaths of 68 individuals
in 29 states and DC, and 2,807 hospitalized in al 50 states, DC, Puerto Rico, and the U.S. Virgin
Islands as of February 18, 2020.56 Among a subset of hospitalized EVALI patients,57 82%
reported using THC-containing products. Laboratory data suggest that in addition to THC-
containing ENDS products, vitamin E acetate is also closely associated with EVALI.58 Vitamin E
acetate is commonly used as a dietary supplement and in skin creams. Although the ingestion and
dermal use of vitamin E acetate is not general y associated with adverse health effects, research
suggests that vitamin E acetate may interfere with normal lung functioning when inhaled.59
FDA and CDC, along with state and local health departments, have worked together closely to
investigate the EVALI outbreak. FDA, DEA, and local and state authorities have also investigated
a possible connection between the ENDS supply chain and EVALI cases. FDA and DEA
announced in 2019 that they had seized 44 websites advertising the sale of il icit THC-containing
vape cartridges; however, none of the products advertised on the websites have been linked to any
cases of EVALI.60 In late 2019, FDA urged individuals who used THC-containing ENDS products
to stop.61 The CDC has reported that cases of EVALI spiked in September 2019 and have
gradual y declined due to various reasons, including increased law enforcement actions, removal
of vitamin E acetate from some products, and increased public awareness of the issue. Although
CDC stopped collecting data from states on EVALI cases in February 2020, it continues to
monitor EVALI-related trends and has not reported a resurgence of EVALI at this time.62
Variable Concentration of Nicotine in E-Liquids
ENDS products use nicotine solutions (“e-liquids”) containing various ingredients to deliver
nicotine to the user. The solution is heated to create an aerosol, which the user then inhales.63
From the lungs, the nicotine is rapidly absorbed into the bloodstream. Previous studies have
demonstrated that higher concentrations of nicotine can lead to systemic adverse effects,

56 CDC, “Outbreak of Lung Injury Associated with the Use of E-Cigarette, or Vaping, Products,” updated November
27, 2020, https://www.cdc.gov/tobacco/basic_information/e-cigarettes/severe-lung-disease.html.
57 T he subset of patients included those with complete information on substances used in ENDS products three months
prior to symptom onset.
58 Benjamin C. Blount, Mateusz P. Karwowski, Peter G. Shields, et al., “Vitamin E Acetate in Bronchoalveolar -Lavage
Fluid Associat ed with EVALI,” The New England Journal of Medicine, December 20, 2019, DOI:
10.1056/NEJMoa1916433.
59 CDC, “Outbreak of Lung Injury Associated with the Use of E-Cigarette, or Vaping, Products,” updated February 25,
2020, https://www.cdc.gov/tobacco/basic_information/e-cigarettes/severe-lung-disease.html.
60 FDA, “FDA, DEA Seize 44 websites advertising sale of illicit T HC vaping cartridges to US consumers as part of
Operation Vapor Lock,” December 20, 2019, https://www.fda.gov/news-events/press-announcements/fda-dea-seize-44-
websites-advertising-sale-illicit-thc-vaping-cartridges-us-consumers-part-operation.
61 FDA, “Vaping Illness Update: FDA Warns Public to Stop Using T etrahydrocannabinol (T HC) -Containing Vaping
Products and Any Vaping Products Obtained Off the Street,” press release, October 4, 2019, https://www.fda.gov/
consumers/consumer-updates/vaping-illness-update-fda-warns-public-stop-using-tetrahydrocannabinol-thc-containing-
vaping.
62 CDC, “Outbreak of Lung Injury Associated with the Use of E-Cigarette, or Vaping, Products,” updated February 25,
2020, https://www.cdc.gov/tobacco/basic_information/e-cigarettes/severe-lung-disease.html.
63 FDA, Vaporizers, E-Cigarettes, and other Electronic Nicotine Delivery Systems (ENDS), last updated September 17,
2020, available at https://www.fda.gov/tobacco-products/products-ingredients-components/vaporizers-e-cigarettes-and-
other-electronic-nicotine-delivery-systems-ends.
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including addiction.64 The concentration of nicotine in these e-liquids can vary, depending on the
manufacturer.65 As a result, the level of nicotine absorbed into the user’s blood stream can also
vary. Studies have demonstrated that in some instances variability may exist between the label ed
concentration of nicotine per solution and the actual measurement of nicotine in that solution.66 In
addition, several e-cigarette manufacturers have begun using nicotine salts67 in their formulations
of e-liquids, which are purported to provide a more pleasing sensory experience for the user by
masking the harshness of nicotine.68 These salts may increase the amount of nicotine the user
receives and may al ow manufactures to include additional nicotine in the solution.69
The deeming rule that extended the agency’s authority over ENDS products also extended to e-
liquids.70 While tobacco product manufacturers and importers are required to submit ingredient
information for finished tobacco products71 to the FDA, regulations do not currently specify a
concentration of nicotine in the e-liquid solution.72 FDA has previously discussed the
establishment of a potential nicotine product standard, which would lower nicotine levels in
combustible cigarettes to a minimal or non-addictive level.73 In March 2018, FDA issued an
advance notice of proposed rulemaking (ANPRM) to seek comments on setting such a potential
nicotine product standard, but the agency has not taken further regulatory action since that time.74
In addition, FDA has not publicly indicated that it wil pursue regulatory action regarding a
nicotine product standard for ENDS products.

64 Aseem Mishra, Pankaj Chaturvedi, Sourav Datta, et al., “Harmful effects of Nicotine,” Indian Journal of Medical
and Paediatric Oncology, vol. 36, no. 1 (January 2015), pp. 24-31.
65 National Academies of Sciences, Engineering, and Medicine, Public Health Consequences of E -Cigarettes, National
Academies Press, Washington, DC, 2018, p. 89, https://www.ncbi.nlm.nih.gov/books/NBK507171/pdf/
Bookshelf_NBK507171.pdf.
66 Jean-Francois Etter and Aurelie Bugey, “E-cigarette liquids: Constancy of content across batches and accuracy of
labeling,” Addictive Behaviors, vol. 73 (May 10, 2017), pp. 137-143.
67 Nicotine salts are a specific formulation of nicotine that combines a weak base with an acid. See Natalie Voos,
Maciej L. Goniewicz, and T homas Eissenberg, “ What is the nicotine delivery profile of electronic cigarettes?,” Expert
Opinion on Drug Delivery, vol. 16, no. 11 (September 13, 2019), pp. 1193 -1203.
68 Adam M. Leventhal, Danielle R. Madden, Natalia Pereza, et al., “Effect of Exposure to e-Cigarettes With Salt vs
Free-Base Nicotine on the Appeal,” JAMA Network, vol. 4, no. 1 (January 12, 2021).
69 Maciej L. Goniewicz, Rachel Boykan, Catherine R. Messina, et al., “High exposure to nicotine among adolescents
who use JUUL,” Tobacco Control, vol. 28, no. 6 (November 2019), pp. 676-677.
70 T erry McDonald, The “Deeming Rule”—New Requirement for Tobacco Retailers, FDA, 2016, https://www.fda.gov/
media/97860/download, and FDA, Guidance for Industry: Enforcem ent Priorities for Electronic Nicotine Delivery
System s (ENDS) and Other Deem ed Products on the Market Without Prem arket Authorization , January 2020. pp. 41-
42., https://www.fda.gov/media/133880/download.
71 A finished tobacco product is one in which all of the components and parts are sealed in a final package intended for
consumer use. A component and part sold separately from other tobacco products are considered finished products if
they are sold in final packaging. See FDA, Guidance for Industry: Listing of Ingredients in Tobacco Products,
November 2018, pp. 6, https://www.fda.gov/media/101162/download.
72 FDA, Guidance for Industry: Listing of Ingredients in Tobacco Products, November 2018, https://www.fda.gov/
media/101162/download.
73 FDA, “Statement from FDA Commissioner Scott Gottlieb, M.D., on pivotal public health step to dramatically reduce
smoking rates by lowering nicotine in combustible cigarettes to minimally or non-addictive levels,” press release,
March 14, 2018, https://www.fda.gov/news-events/press-announcements/statement -fda-commissioner-scott-gottlieb-
md-pivotal-public-health-step-dramatically-reduce-smoking.
74 FDA, “T obacco Product Standard for Nicotine Level of Combusted Cigarettes,” 83 Federal Register, March 16,
2018.
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Citing some of the health issues mentioned above, Congress held various hearings in the 116th
and 117th sessions.75 In the 117th Congress, H.R. 3051 would require FDA to regulate nicotine
levels in e-cigarettes to ‘‘(i) 20 mil igrams per mil iliter; or (i ) such lower nicotine concentration
as is determined by the Secretary to be minimal y addictive or non-addictive.” 76 Certain members
of the ENDS industry have proposed similar standards. For example, The American E-liquid
Manufacturing Standards Association (AEMSA)—a trade association composed of volunteer
American manufacturers of e-liquids—published recommended standards for manufacturers.
AEMSA has recommended, among other things, that the nicotine content in a final flavored
product have a set maximum level.77 At least one study, however, has suggested that low
concentrations of nicotine in e-liquid may lead users to overcompensate by increasing their use of
an ENDS product, thereby potential y negating any benefit of the initial lower nicotine
concentration and possibly exposing the user to additional harm from exposure to increased
aerosol or HPHCs.78
FDA has funded research to determine whether modest differences in nicotine concentration may
affect the abuse liability of an ENDS product.79 While this research is currently pending,
Congress may consider directing FDA or other federal research agencies to expand studies into
the potential effects (e.g., compensatory usage, harm due to increased exposure to aerosols,
reduction in addiction rates) of reducing nicotine concentration in ENDS products, as such
research may help inform future regulatory standards.
Remote Sales
Some have identified remote sales (i.e., non-face-to-face sales) as an opportunity for minors to
il egal y purchase tobacco products—including ENDS—due to difficulties in enforcing
purchasing restrictions. FDA is statutorily authorized to promulgate regulations on remote sales
of tobacco products, including age verification requirements.80 In 2011, FDA issued an ANPRM
regarding remote sales and distribution of tobacco products,81 but the agency has not taken further
regulatory action since that time.
The Prevent Al Cigarette Trafficking (PACT) Act of 2009 (P.L. 111-154) amended the Jenkins
Act of 194982 and placed certain restrictions on the remote sales of cigarettes and smokeless

75 For example, U.S. Congress, House Committee on Oversight and Reform, Subcommittee on Economic and
Consumer Policy, An Epidem ic Continues: Youth Vaping in Am erica , 117th Cong., 1st sess., June 23, 2021, and U.S.
Congress, House Committee on Oversight and Reform, Subcommittee on Economic and Consumer Policy, Exam ining
JUUL’s Role in the Youth Nicotine Epidemic: Part I, 116th Cong., 1st sess., July 24, 2019.
76 T his bill had been introduced in the 116th Congress as H.R. 4624 (2019).
77 AEMSA, E-Liquid Manufacturing Standards, January 14, 2014, https://www.aemsa.org/wp-content/uploads/2014/
02/AEMSA-Standards_Version-1-8.pdf.
78 Lynne Dawkins, Sharon Cox, and Maciej Goniewicz, “‘Real-world’ compensatory behaviour with low nicotine
concentration e-liquid: subjective effects and nicotine, acrolein and formaldehyde exposure,” Addiction, vol. 113, no.
10 (June 7, 2018), pp. 1874-1882.
79 FDA, “ The Effects of E-liquid Nicotine Concentration on the Abuse Liability of ENDS in Current Users,” October 3,
2019, https://www.fda.gov/tobacco-products/research/effects-e-liquid-nicotine-concentration-abuse-liability-ends-
current -users.
80 FFDCA §906.
81 FDA, “Non-Face-to-Face Sale and Distribution of T obacco Products and Advertising, Marketing, and Promotion of
T obacco Products,” 76 Federal Register 55835, September 9, 2011.
82 See U.S. Government Accountability Office, INTERNET CIGARETTE SALES: Limited Compliance and
Enforcem ent of the Jenkins Act Result in Loss of State Tax Revenue, GAO-03-714T , May 1, 2003,
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tobacco but stopped short of outright prohibiting them.83 Further, the PACT Act limited the ability
of states and local governments to regulate the delivery carriers involved in remote sales—
complicating enforcement efforts—and did not place such restrictions on other tobacco products,
such as ENDS.84
In FY2021, Congress enacted the Preventing Online Sales of E-Cigarettes to Children Act (Title
VI of Division FF, P.L. 116-260), which prohibited the remote sale of most ENDS by amending
the Jenkins Act to include a definition of ENDS in the definition of cigarettes.85 Congress further
directed the United States Postal Service (USPS) to promulgate regulations to clarify the
applicability of the prohibition on mailing cigarettes to ENDS. The prohibition on mailing
cigarettes is to be extended to ENDS immediately after said regulations have been promulgated.
On February 19, 2021, the USPS published a proposed rule that general y extended the
prohibition on mailing cigarettes and smokeless tobacco products86 to ENDS as defined in the
Preventing Online Sales of E-Cigarettes to Children Act.87 The proposed rule also included
provisions related to “any component, liquid, part, or accessory of an ENDS, regardless of
whether sold separately from the device.”88 Under this rule, ENDS products would be subject to
the same restrictions and exceptions as cigarettes. The comment period for the proposed rule
closed on March 22, 2021. In advance of the publication of the final rule, the USPS released a
guidance document on April 19, 2021, detailing how, once the final rule is published, mailers of
ENDS may prepare applications to apply for the same exceptions as cigarette manufacturers that
mail tobacco products.89
ENDS User Fees
FDA does not collect user fees from ENDS manufacturers and importers, because the agency is
not authorized to assess user fees from ENDS manufacturers and importers. FDA does not have
this authorization because Congress did not specify an enumerated class for ENDS products and
did not provide a framework by which FDA could potential y assess user fees for ENDS
products.90 Given recent concerns around ENDS products, the Center for Tobacco Products (CTP)
has dedicated a portion of its user fees paid by other tobacco product manufacturers and importers
to address ENDS-specific issues. Therefore, some stakeholders have suggested that
manufacturers and importers of ENDS products be subject to tobacco user fees to offset costs
associated with FDA’s current and future ENDS-specific activities.

https://www.gao.gov/assets/gao-03-714t.pdf.
83 See AT F, Prevent All Cigarette Trafficking (PACT) Act, June 28, 2021, https://www.atf.gov/alcohol-tobacco/
prevent -all-cigarette-trafficking-pact-act.
84 PACT Act §2A(e)(5)(A); T obacco Legal Consortium, “E-Cigarettes and Other T obacco Products Online: Preventing
Sales to Kids,” https://www.publichealthlawcenter.org/sites/default/files/resources/tclc-guide-online-tobacco-products-
kids-2016.pdf.
85 15 U.S.C. §375.
86 See generally 18 U.S.C. §1716E.
87 U.S. Postal Service, “T reatment of E-Cigarettes in the Mail,” 86 Federal Register 10218, February 19, 2021.
88 Ibid.
89 U.S. Postal Service, “T reatment of E-Cigarettes in the Mail,” 86 Federal Register 20287, April 19, 2021.
90 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.
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Based on FDA’s interpretation, for ENDS manufacturers to be subject to the tobacco product user
fees, Congress would need to provide FDA with the authority to do so. For example, Congress
may consider amending both Section 919 of the FFDCA91 and specific provisions of the Fair and
Equitable Tobacco Reform Act of 2004 (FETRA). Although cigarettes and other tobacco
products—including snuff, chewing tobacco, rol -your-own tobacco, cigars, and pipe tobacco—
are subject to federal excise taxes, 92 ENDS products are not subject to such taxes.93 These taxes
are a critical component of the FETRA formula;94 therefore, if Congress were to amend FETRA
and the FFDCA to explicitly provide FDA with the authority to assess user fees on ENDS
manufacturers and importers, Congress would likely need to amend the Internal Revenue Code
(IRC) to make ENDS products subject to federal excise taxes.95 Another option for Congress may
be to create a new, separate ENDS user fee program.
Some in Congress and the executive branch have recently expressed interest in requiring ENDS
manufacturers and importers to pay user fees. Legislation was introduced in the 116th Congress
that would have either amended the FFDCA’s current user fee structure (by striking the FETRA
provisions to al ow for assessment of ENDS user fees)96 or created a new, separate ENDS user fee
program.97 The FY2022 President’s budget request proposes requiring ENDS manufacturers and
importers (along with manufacturers and importers of certain other deemed products) to pay $100
mil ion annual y in user fees starting in FY2022.98 Based on FDA’s current interpretation, user
fees could not be collected from ENDS manufacturers and importers without first enacting
authorizing legislation.99
Increasing Minimum Age for Purchasing
ENDS Products
Some public health stakeholders have been concerned about youth access to tobacco products in
general and expressed support for raising the minimum age of purchasing tobacco products from
18 to 21.100 Numerous scientific studies and Surgeon General Reports have documented that

91 21 U.S.C. §387s.
92 See generally FDA, “T obacco Product User Fees: Reponses to Frequently Asked Questions”, May 2021,
https://www.fda.gov/media/149512/download.
93 For more information on why ENDS products are not currently subject to federal excise taxes, see U.S. Government
Accountability Office, Electronic Cigarettes: Effect on Federal Excise Taxes Collected on Traditional Cigarettes is
Not Currently Evident, GAO-15-771, September 2015, https://www.gao.gov/assets/680/672467.pdf, p. 16.
94 FET RA provisions specify a two-step formula. T he first step determines the allocations for each of the six tobacco
product classes, and the second step determines the individual domestic manufacturer and importer allocations within
each respective tobacco product class. See CRS Report R45867, FDA Regulation of Tobacco Products.
95 Relevant IRC provisions are found at 26 U.S.C. §§5701-02.
96 H.R. 2339, 116th Congress.
97 S. 616, 116th Congress.
98 FDA, Justification of Estimates for Appropriations Committee for FY2022, p. 288, https://www.fda.gov/media/
149616/download.
99 FDA’s interpretation also extends to other newly deemed products (e.g., hookah) not currently subject to user fee
assessment. See FDA, Tobacco Product User Fees: Reponses to Frequently Asked Questions, at https://www.fda.gov/
media/149512/download.
100 See, for example, T ruth Initiative, “Where we stand: Raising the tobacco age to 21,” October 23, 2017,
https://truthinitiative.org/research-resources/tobacco-prevention-efforts/where-we-stand-raising-tobacco-age-21.
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tobacco product use often begins before the age of 18.101 Nearly 90% of cigarette smokers have
tried their first cigarette by age 18, and 98% have tried their first cigarette by age 26.102
The Family Smoking Prevention and Tobacco Control Act of 2009 (TCA) required FDA to
commission a report on the public health impact of raising the minimum age of tobacco product
sales.103 FDA contracted with the Institute of Medicine (now known as the National Academy of
Medicine) and concluded in a 2015 report that “increasing the minimum age of legal access to
tobacco products wil likely prevent or delay the initiation of tobacco use by adolescents and
young adults.”104 However, the report noted that “the impact on initiation of tobacco use of
raising the minimum age of legal access to tobacco products to 21 wil likely be substantial y
higher than raising it to 19, but the added effect of raising the minimum age of legal access
beyond age 21 to age 25 wil likely be considerably smal er.”105
In FY2020 appropriations, Congress amended the FFDCA to raise the federal minimum age of
tobacco product sales to 21. FDA was also required to update its regulations by June 20, 2020, to
reflect the new federal minimum age of tobacco purchasing, as wel as the federal minimum age
verification requirement (the age verification required for individuals younger than 30 years of
age).106 The final rule was required to take effect by September 20, 2020.107 Although the spring
2021 White House OMB Unified Agenda of Federal Regulatory and Deregulatory Actions
indicated that this rule would be published in May 2021,108 the rule has not been published as of
the date of this report.

101 U.S. Department of Health and Human Services, The Health Consequences of Smoking: 50 Years of Progress. A
Report of the Surgeon General, U.S. Department of Health and Human Services, Centers for Disease Control and
Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health,
Atlanta, GA, January 2014, https://www.surgeongeneral.gov/library/reports/50-years-of-progress/50-years-of-progress-
by-section.html; National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and
Health, Centers for Disease Control and Prevention, Preventing Tobacco Use Am ong Youth and Young Adults: A
Report of the Surgeon General, U.S. Department of Health and Human Services, Atlanta, GA, 201 2,
https://www.surgeongeneral.gov/library/reports/preventing-youth-tobacco-use/full-report.pdf.
102 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.
103 T CA §104.
104 Institute of Medicine, Public Health Implications of Raising the Minimum Age of Legal Access to Tobacco
Products, T he National Academies Press, p. 4-5, Washington, DC, 2015, https://www.nap.edu/read/18997/chapter/1.
105 Institute of Medicine, Public Health Implications of Raising the Minimum Age of Legal Access to Tobacco
Products, T he National Academies Press, p. 4-5.
106 For more information, see CRS Report R45867, FDA Regulation of Tobacco Products.
107 §603(b) of Division N of the Further Consolidated Appropriations Act, 2020 ( P.L. 116-94). FDA has stated that the
new age sales restriction is currently in effect. See FDA, “Newly Signed Legislation Raises Federal Minimum Age of
Sale of 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. Congress directed FDA to provide a written
notification and justification for the delay in rulemaking to the committees of jurisdiction if the final rule was not
promulgated 180 days after enactment.
108 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.
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Author Information

Hassan Z. Sheikh

Analyst in Public Health Emergency Management


Acknowledgments
Victoria Green, former CRS Analyst in Health Policy, was the author of a prior report that introduced some
of the issues discussed here.


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
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Congressional Research Service
R46928 · VERSION 1 · NEW
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