Enforcement Priorities for Electronic Nicotine Delivery System (ENDS) and Other Deemed Products on the Market Without Premarket Authorization: Guidance for Industry

Administrative guidance, not enacted legislation. This captured publisher edition preserves the listed document and attachments; later developments are not independently consolidated.

Enforcement Priorities for
Electronic Nicotine Delivery
Systems (ENDS) and Other
Deemed Products on the Market
Without Premarket
Authorization (Revised)*
* This is a revision to the first edition of this guidance, which issued in January 2020.
Guidance for Industry
Comments may be submitted at any time for Agency consideration. Electronic comments may be
submitted to https://www.regulations.gov. Alternatively, submit written comments to the
Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Room 1061, Rockville, MD 20852. All comments should be identified with docket number
FDA-2019-D-0661.
For questions regarding this guidance, contact the Center for Tobacco Products at (Tel) 1-877-
CTP-1373 (1-877-287-1373) Monday-Friday, 9 a.m. – 4 p.m. ET.
Additional copies are available online at https://www.fda.gov/tobacco-products/products-
guidance-regulations/rules-regulations-and-guidance. You may send an e-mail request to
SmallBiz.Tobacco@fda.hhs.gov to receive an electronic copy of this guidance. You may send a
request for hard copies to U.S. Food and Drug Administration, Center for Tobacco Products,
Attn: Office of Small Business Assistance, Document Control Center, Bldg. 71, Rm. G335,
10903 New Hampshire Ave., Silver Spring, MD 20993-2000.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Tobacco Products
April 2020

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Table of Contents
I. 	INTRODUCTION............................................................................................................. 2
II. 	BACKGROUND ............................................................................................................... 3
A. Statutory and Regulatory History ................................................................................................ 3
B. 	FDA Response to Evidence of Increasing Youth Use of ENDS Products ................................. 6
III. 	DEFINITIONS .................................................................................................................. 9
IV. 	ENFORCEMENT PRIORITIES REGARDING CERTAIN ENDS PRODUCTS
ON THE MARKET WITHOUT PREMARKET AUTHORIZATION .................... 10
A. Overview........................................................................................................................................ 10
B. 	Data Show Substantial Increase in Youth Use of ENDS Products, Particularly Certain
Flavored, Cartridge-Based ENDS Products .............................................................................. 11
C. Additional Relevant Considerations .......................................................................................... 17
D. Enforcement Priorities for ENDS Products ............................................................................... 18
1. 	Any flavored, cartridge-based ENDS product (other than a tobacco- or menthol-
flavored product) ....................................................................................................... 19
2. 	All other ENDS products without adequate measures to prevent minors’ access .... 21
3. 	Any ENDS product that is targeted to minors or whose marketing is likely to
promote use of ENDS by minors .............................................................................. 24
4. 	Any ENDS product that is offered for sale in the United States after
September 9, 2020 ..................................................................................................... 27
E. 	Avoiding a “Black Market” ........................................................................................................ 28
V. 	PREMARKET REVIEW FOR OTHER DEEMED NEW TOBACCO
PRODUCTS .................................................................................................................... 29
APPENDIX A – SIGNIFICANT COMMENTS RECEIVED IN RESPONSE TO
MARCH 2019 DRAFT GUIDANCE AND FDA RESPONSES ..............................................30

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Enforcement Priorities for
Electronic Nicotine Delivery
Systems (ENDS) and Other
Deemed Products on the Market
Without Premarket
Authorization (Revised)
Guidance for Industry1
1 This guidance was prepared by the Office of Compliance and Enforcement, Office of Health Communication and
Education, Office of Regulations, and Office of Science in the Center for Tobacco Products at FDA.
This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on
this topic. It does not establish any rights for any person and is not binding on FDA or the public. You
can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the
title page.
I. 	INTRODUCTION
This guidance document describes how we intend to prioritize our enforcement resources with
regard to the marketing of certain deemed tobacco products that do not have premarket
authorization.2
2 As with FDA’s prior compliance policies on deemed new tobacco products that do not have premarket
authorization, this guidance document does not apply to any deemed product that was not on the market on August
8, 2016.

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For ENDS products marketed without FDA authorization, FDA intends to prioritize enforcement
against:
• 	Any flavored, cartridge-based ENDS product (other than a tobacco- or menthol-flavored
ENDS product);
• 	All other ENDS products for which the manufacturer has failed to take (or is failing to
take) adequate measures to prevent minors’ access; and
• 	Any ENDS product that is targeted to minors or whose marketing is likely to promote use
of ENDS by minors.3
3 For purposes of this Final Guidance, FDA’s use of the term “minor” refers to individuals under the age of 21. This
is consistent with the Further Consolidated Appropriations Act, 2020 (H.R. 1865), signed into law on December 20,
2019, which included a provision amending section 906(d) of the Federal Food, Drug, and Cosmetic Act to increase
the federal minimum age to purchase tobacco products from 18 to 21, and adding a provision that it is unlawful for
any retailer to sell a tobacco product to any person younger than 21 years of age. In addition, FDA is working to
update our regulations within 180 days, consistent with the timeline set forth in the law.
Further, FDA intends to prioritize enforcement of any ENDS product that is offered for sale after
September 9, 2020, and for which the manufacturer has not submitted a premarket application
(or after a negative action by FDA on a timely submitted application).
This guidance does not in any way alter the fact that it is illegal to market any new tobacco
product without premarket authorization. FDA is continuously evaluating new information and
adjusting its enforcement priorities in light of the best available data, and it will continue to do so
with respect to these products. FDA will take appropriate action regarding tobacco products that
are marketed without premarket authorization, including as warranted based on changed
circumstances, new information, or to better address minors’ use of those products.
FDA’s guidance documents, including this guidance, do not establish legally enforceable
responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should
be viewed only as recommendations, unless specific regulatory or statutory requirements are
cited. The use of the word should in Agency guidances means that something is suggested or
recommended, but not required.
II. 	BACKGROUND
A. Statutory and Regulatory History
The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Public
Law 111-31) granted FDA the authority to regulate the manufacture, marketing, and
distribution of cigarettes, cigarette tobacco, roll-your-own (RYO) tobacco, and smokeless
tobacco products to protect the public health and to reduce tobacco use by minors. The
Tobacco Control Act also gave FDA the authority to issue regulations deeming other
products that meet the statutory definition of a tobacco product4
4 21 U.S.C 321(rr) (section 201(rr) of the FD&C Act).
to be subject to chapter IX of
the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 387 through 387u)
(section 901(b) of the FD&C Act).

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In accordance with that authority, on May 10, 2016, FDA issued a final rule deeming all
products that meet the statutory definition of a tobacco product, except accessories of deemed
tobacco products, to be subject to FDA’s tobacco product authority. This included electronic
nicotine delivery systems (ENDS), cigars, waterpipe (hookah) tobacco, pipe tobacco,
nicotine gels, and dissolvables that were not already subject to the FD&C Act (81 FR 28974
at 28976 (May 10, 2016)).
The requirements in Chapter IX of the FD&C Act now apply to deemed products.
Particularly relevant to this guidance is section 910, which imposes certain premarket-review
requirements for “new tobacco products”—i.e., those that were not commercially marketed in
the United States as of February 15, 2007. Accordingly, after the rule’s effective date,
deemed new tobacco products were required to obtain premarket authorization under Section
910. Deemed new tobacco products that remain on the market without marketing
authorization are marketed unlawfully in contravention of the Tobacco Control Act. Through
the premarket review process, FDA conducts a science-based evaluation to determine
whether a new tobacco product meets the applicable statutory standard for marketing
authorization—for example, whether the product is appropriate for the protection of public
health with respect to the risks and benefits to the population as a whole, including users and
nonusers, and taking into account, among other things, the likelihood that those who do not
use tobacco products will start using them.
The preamble to the May 10, 2016, final deeming rule explained that FDA intended to defer
enforcement for failure to have premarket authorization during two compliance periods
related to premarket review: one for submission and FDA receipt of applications and one for
obtaining premarket authorization. The first compliance period depended on the type of
application. The compliance date was 12 months from the effective date of the rule for
substantial equivalence exemption requests (EX REQs), 18 months for substantial
equivalence reports (SE Reports), and 24 months for premarket tobacco applications
(PMTAs). In addition, the preamble explained that under the second compliance period:
Unless FDA has issued an order denying or refusing to accept the submission,
products for which timely premarket submissions have been submitted will be subject
to a continued compliance period for 12 months after the initial compliance period
described previously. For such products, FDA does not intend to initiate enforcement
for failure to have premarket authorization during this continued compliance period.5
5 81 FR at 29011.
The preamble further explained that this compliance policy did not apply to any new tobacco
product that was not on the market on August 8, 2016. Significantly, this policy did not
confer lawful marketing status on new tobacco products being marketed without the
necessary premarket authorization.
In May 2017, FDA published a guidance document, Three-Month Extension of Certain Tobacco
Product Compliance Deadlines Related to the Final Deeming Rule, under which the Agency, as

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a matter of enforcement discretion, stated its intention to defer enforcement for an additional
three months for all future compliance dates for requirements under the final deeming rule.
In July 2017, FDA announced a new comprehensive plan for tobacco and nicotine regulation that
would serve as a multi-year roadmap in an effort to significantly reduce tobacco-related disease
and death. Prior to this announcement, nationally representative data suggested that youth use of
e-cigarettes had declined beginning in 2016.6
6 Jamal, A., A. Gentzke, S.S. Hu, et al., “Tobacco Use Among Middle and High School Students — United States,
2011–2016,” Morbidity and Mortality Weekly Report, 66:597–603, 2017, available at:
https://www.cdc.gov/mmwr/volumes/66/wr/mm6623a1.htm.
The comprehensive plan was announced in part to
afford the Agency time to explore clear and meaningful measures to make combustible tobacco
products less toxic, less appealing, and less addictive. One aspect of the plan involved striking a
balance between regulation and encouraging development of innovative tobacco products that
may be less harmful than cigarettes. The Agency announced that it planned to issue an updated
compliance policy further deferring some enforcement timelines described in the final deeming
rule.
In accordance with this comprehensive plan, in August 2017, FDA announced an extension
of the period during which it did not intend to initiate enforcement action for premarket
review requirements under the final deeming rule (“August 2017 Compliance Policy”) for
deemed tobacco products that were on the market on August 8, 2016. This revised policy
stated that, for these products, FDA did not intend to initiate enforcement regarding
submitting EX REQs, SE Reports, and PMTAs for newly regulated combusted tobacco
products (such as most cigars) until August 8, 2021, and FDA did not intend to initiate
enforcement regarding EX REQs, SE Reports, and PMTAs for newly regulated
noncombusted tobacco products (such as most ENDS products) until August 8, 2022. In
addition, FDA revised the compliance policy relating to the period after FDA receipt of EX
REQs, SE Reports, and PMTAs for deemed tobacco products that were on the market on
August 8, 2016. FDA stated that, under this policy, it intended to continue deferring
enforcement until the Agency rendered a decision on an application (i.e., issuance of: a
Marketing Order; a No Marketing Order; a Refuse to File; or a Refuse to Accept) or the
application was withdrawn.
In March 2018, the August 2017 Compliance Policy was challenged in the U.S. District Court
for the District of Maryland, and on May 15, 2019, the court issued an order that vacated the
guidance.7
7 American Academy of Pediatrics, et al. v. Food and Drug Administration, et al., 379 F. Supp. 3d 461, 496 (D. Md.
2019).
On July 12, 2019, the court issued a further order directing FDA to require that
premarket authorization applications for all new—i.e., not “grandfathered”8
8 A “grandfathered” product is one that was on the market as of February 15, 2007. Guidance, Establishing That a
Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007, dated September 2014,
available at: https://www.fda.gov/media/123544/download.
—deemed tobacco
products be submitted to the Agency within 10 months, by May 12, 2020, and providing for a
one-year period during which products with timely filed applications might remain on the market

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pending FDA review.9
9 American Academy of Pediatrics, et al. v. Food and Drug Administration, et al., No. 8:18-cv-883 (PWG), 2019
WL 3067492, at *7 (D. Md. July 12, 2019) (Dkt. No. 127). The court has granted intervention to vapor industry
trade associations for purposes of appealing the court’s decision and remedies order. See American Academy of
Pediatrics, et al. v. Food and Drug Administration, et al., No. 8:18-cv-883 (PWG), Dkt. No. 154 (Oct. 2, 2019). An
appeal is pending. See American Academy of Pediatrics v. Cigar Ass’n of America, Nos. 19-2130, -2132, -2198, -
2242 (4th Cir.).
The court subsequently clarified that its order did not restrict FDA’s
authority to enforce the premarket review provisions against deemed products, or categories of
deemed products, prior to the submission date or during the one-year review period.10
10 American Academy of Pediatrics, et al. v. Food and Drug Administration, et al., Case No. 8:18-cv-883 (PWG),
(D. Md. Aug. 12, 2019), Dkt. No. 132.
On April
22, 2020, the court granted a motion for a 120-day extension (until September 9, 2020) in light of
the global outbreak of respiratory illness caused by a new coronavirus.11
11 American Academy of Pediatrics, et al. v. Food and Drug Administration, et al., Case No. 8:18-cv-883 (PWG),
(D. Md. Apr. 22, 2020), Dkt. No. 182.
As required by the
court’s order, deemed new tobacco products on the market as of August 8, 2016, for which
premarket authorization applications are not filed by September 9, 2020, are subject to FDA
enforcement actions, in the Agency’s discretion.12
12 American Academy of Pediatrics, et al. v. Food and Drug Administration, et al., No. 8:18-cv-883 (PWG), 2019
WL 3067492, at *7 (D. Md. July 12, 2019) (Dkt. No. 127).
B. FDA Response to Evidence of Increasing Youth Use of ENDS Products
In late 2017, FDA started to see a marked increase in complaints about ENDS products. FDA
initiated an investigation of these complaints, the majority of which pertained to minors’ access
to and use of these products. This new information indicated an alarming increase in the use of
ENDS products by middle and high school students. In April 2018, FDA conducted a
nationwide undercover enforcement effort that resulted in FDA issuing 56 warning letters to
online retailers and 6 civil money penalty (CMP) complaints to retail establishments related to
the illegal sales of certain ENDS products to minors. In addition, FDA sent an official request
for information to manufacturers of certain ENDS products commonly used by minors requiring
them to submit documents to facilitate the Agency’s understanding of the reported high rates of
youth use and the particular youth appeal of these products. FDA also took measures to address
the sale of ENDS products to minors online by contacting eBay to raise concerns over several
listings on its website. This resulted in listings for these ENDS products being removed from
eBay.
In May 2018, FDA issued 17 warning letters to manufacturers, distributors, and retailers for
selling e-liquids with labeling and/or advertising that resemble kid-friendly food products, such
as juice boxes, candy, or cookies. The warning letters stated that failure to correct violations
may result in FDA initiating further action such as seizure or injunctive relief. Of these warning
letters, 13 were issued as part of a joint action with the Federal Trade Commission (FTC).
On September 12, 2018, FDA announced a series of enforcement and other regulatory actions
related to the labeling and advertising of ENDS products, including that it had conducted

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nationwide, undercover investigations of brick-and-mortar and online stores over the summer of
2018 and issued more than 1,300 warning letters and CMP complaints to retailers who illegally
sold ENDS products to minors. FDA also issued 12 warning letters to online retailers that were
selling misleadingly labeled and/or advertised e-liquids resembling kid-friendly food products
such as candy and cookies.
In addition, on September 12, 2018, FDA issued letters to five ENDS product manufacturers,
requesting each company to submit a plan describing how it would address minors’ access to and
use of its products.
In response to the September 12 th letters to industry, manufacturers described safeguards that
they could implement to help to restrict minors’ access to ENDS products sold at brick and
mortar retailers and online. Examples of potential safeguards included:
• 	Establishing or enhancing programs, such as mystery shopper programs, to monitor
retailer compliance with age-verification and sales restrictions;
• 	Establishing and enforcing contractual penalties for contracted retailers that sell
tobacco products to youth;
• 	Using age-verification technology to better restrict access to the manufacturer’s
website, such as through independent, third-party age- and identity-verification
services that compare customer information against third-party data sources; and
• 	Limiting the quantity of ENDS products that a customer may purchase within a given
period of time.
In conjunction with issuing the September 2018 letters, FDA announced in September 2018 that
the Agency was considering whether, in light of current information, it would be appropriate to
revisit the August 2017 Compliance Policy, which could result in withdrawing or revising the
policy with respect to certain flavored products that may be contributing to the rise in youth use
and having firms “remove some or all of [these] products . . . until they receive premarket
authorization and otherwise meet all of their obligations under the law.”13
13 FDA takes new steps to address epidemic of youth e-cigarette use, including a historic action against more than
1,300 retailers and 5 major manufacturers for their roles perpetuating youth access (Sept. 11, 2018), available at:
https://www.fda.gov/news-events/press-announcements/fda-takes-new-steps-address-epidemic-youth-e-cigarette-
use-including-historic-action-against-more.
Following the
September 12th letters and announcement, FDA repeatedly publicly discussed14
14 See, e.g., 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, available at:
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm625884.htm; Scudder, L., “Vaping and E-
Cigarettes in Kids: An Unprecedented Epidemic,” Medscape, January 28, 2019, available at:
https://www.medscape.com/viewarticle/908077?faf=1.
the fact that these
compliance timelines were under reconsideration and solicited the view of stakeholders—
including manufacturers, retail associations, and public interest organizations.15
15 See, e.g., FDA Public Calendar – Meeting With FDA Officials, available at: https://www.fda.gov/news-
events/fda-meetings-conferences-and-workshops/public-calendar-meetings-fda-officials (noting meetings held on
October 11, 16, 18, 29 and 30 of 2018; November 13, 2018; and December 19, 2018); February 6, 2019 Letters sent

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Since the effective date of the Deeming Rule in August 2016, FDA has issued more than 10,000
warning letters and more than 1,400 CMP complaints to retailers for the sale of ENDS products
to minors. Specifically, from April 2018 through August 2019, FDA issued over 6,000 warning
letters and more than 1,000 CMP complaints to retailers for the sale of ENDS products to
minors. Since May 2018, FDA has also issued over 40 warning letters to manufacturers,
distributors, and retailers for selling e-liquids with false or misleading labeling and/or advertising
that resemble kid-friendly products. In June 2019, the Agency issued joint FDA/FTC warning
letters to four e-liquid manufacturers for violations related to online posts by social media
influencers on the companies’ behalf. In September 2019, FDA issued a warning letter to an
ENDS manufacturer for marketing unauthorized modified risk tobacco products, including in
outreach to youth.16
16 For more information, please see https://www.fda.gov/news-events/press-announcements/fda-warns-juul-labs-
marketing-unauthorized-modified-risk-tobacco-products-including-outreach-youth.
FDA will continue to use all available tools to prevent youth use of all
tobacco products, including ENDS products.
In 2018, FDA continued to receive information underscoring the problem of youth use of ENDS
products. Current e-cigarette use had increased considerably among U.S. middle and high school
students during 2017–2018, reversing a decline in e-cigarette use that had been observed in
recent years and increasing overall tobacco product use in 2018. Specifically, among high
school students, current e-cigarette use had increased by 78 percent in the past year (from 11.7
percent in 2017 to 20.8 percent in 2018, p<0.001), while among middle school students, current
e-cigarette use had increased by 48 percent (from 3.3 percent in 2017 to 4.9 percent in 2018, p =
0.001).17
17 Cullen, K.A., B.K. Ambrose, A.S. Gentzke, et al., “Notes from the Field: Increase in e-cigarette use and any
tobacco product use among middle and high school students – United States, 2011-2018,” Morbidity and Mortality
Weekly Report, 67(45);1276-1277, 2018.
Frequent use among high school students (defined as use on ≥ 20 of the past 30 days)
also had increased, from 20.0 percent in 2017 to 27.7 percent in 2018 (p = 0.008).18
18 Id.
Data from
this study, as well as the concerns described above, prompted FDA to issue a draft guidance,
“Modifications to Compliance Policy for Certain Deemed Tobacco Products” (“March 2019
Draft Guidance”), regarding the continued marketing of deemed tobacco products that have not
obtained premarket authorization, and to call on industry to do more to keep their products out of
the hands of minors.
In 2019, two of the largest surveys of tobacco use among youth found that e-cigarette use has hit
the highest levels ever recorded. As detailed in Section IV below, data from both the National
Youth Tobacco Survey (NYTS) and the Monitoring the Future (MTF) Study have documented a
continued increase in youth use of ENDS products and further underscored the magnitude of the
problem. These data, information conveyed to FDA in comments to the March 2019 Draft
Guidance, and concern about health and safety issues connected to these products—e.g., the
to JUUL Labs, Inc. and Altria Group Inc., requesting meetings to discuss concerns related youth addiction to
tobacco products, available at: https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/ctp-letters-
industry.

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harmful effects of nicotine on adolescent brain development, as well as battery explosions with
ENDS products—continue to inform FDA’s serious public health concerns regarding the sale of
these products without premarket authorization. Repeated exposure to nicotine during
adolescence induces long-lasting changes in brain regions involved in addiction, attention,
learning, and memory.
Furthermore, as of December 17, 2019, there have been approximately 2,506 reported cases of
hospitalizations for lung injuries associated with use of vaping products (“hospitalized EVALI
patients”), including 54 confirmed deaths.19
19 See Centers for Disease Control and Prevention, “Outbreak of Lung Injury Associated with E-cigarette Use, or
Vaping,” available at https://www.cdc.gov/tobacco/basic_information/e-cigarettes/severe-lung-disease.html#latest-
outbreak-information.
Working closely with other federal and state
agencies, FDA has not been able to determine the cause of this outbreak. It appears that most of
the patients impacted by these illnesses reported using THC-containing products, with evidence
suggesting that additive agents, specifically Vitamin E, may play a causative role. In many of
the cases, individuals reported using multiple products, including some with nicotine. Many
different substances and product sources are still under investigation.
Although this guidance does not address products that are not tobacco products, the outbreak of
lung injuries associated with use of vaping products illustrates public health and safety concerns
that may arise for products for which information related to product safety and health impact are
lacking and affirms the importance of the premarket review process, as contemplated by the
Tobacco Control Act, to scientifically evaluate products based on a public health standard.
Accordingly, FDA is issuing this Final Guidance to communicate its enforcement priorities with
respect to ENDS products. FDA’s decision to exercise its enforcement authorities with respect
to particular products will be determined on a case-by-case basis, informed by the enforcement
priorities described in this Final Guidance and any other relevant factors.20
20 See Heckler v. Chaney, 470 U.S. 821, 835 (1985) (providing that the FD&C Act’s enforcement provisions commit
broad discretion to the Secretary to decide how and when they should be exercised).
III. 	DEFINITIONS
For purposes of this guidance, FDA intends to use the following definitions:
Cartridge-based ENDS products are a type of ENDS product that consists of, includes, or
involves a cartridge or pod that holds liquid that is to be aerosolized through product use. For
purposes of this definition, a cartridge or pod is any small, enclosed unit (sealed or unsealed)
designed to fit within or operate as part of an electronic nicotine delivery system.21
21 An example of products that would not be captured by this definition include completely self-contained,
disposable products.
Electronic nicotine delivery systems (or ENDS) include devices, components, and/or parts that
deliver aerosolized e-liquid when inhaled. For example, FDA considers vapes or vape pens,
personal vaporizers, e-cigarettes, cigalikes, e-pens, e-hookahs, e-cigars, and e-pipes to be ENDS.

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E-liquids are a type of ENDS product and generally refer to liquid nicotine and nicotine-
containing e-liquids (i.e., liquid nicotine combined with colorings, flavorings, and/or other
ingredients). Liquids that do not contain nicotine or other material made or derived from tobacco,
but that are intended or reasonably expected to be used with or for the human consumption of a
tobacco product, may be components or parts and, therefore, subject to FDA’s tobacco control
authorities.
Label means a display of written, printed, or graphic matter upon the immediate container of any
article. Section 201(k) of the FD&C Act.
Labeling means all labels and other written, printed, or graphic matter (1) upon any article or any
of its containers or wrappers, or (2) accompanying such article. Section 201(m) of the FD&C
Act.
New tobacco product means (1) any tobacco product (including those products in test markets)
that was not commercially marketed in the United States as of February 15, 2007; or (2) any
modification (including a change in design, any component, any part, or any constituent,
including a smoke constituent, or in the content, delivery or form of nicotine, or any other
additive or ingredient) of a tobacco product where the modified product was commercially
marketed in the United States after February 15, 2007. Section 910(a) of the FD&C Act.
Tobacco product means any product made or derived from tobacco that is intended for human
consumption, including any component, part, or accessory of a tobacco product (except for raw
materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco
product). The term “tobacco product” does not mean an article that under the FD&C Act is a
drug (section 201(g)(1) (21 U.S.C 321(g)(1))), a device (section 201(h)), or a combination
product (section 503(g) (21 U.S.C 353(g))). Section 201(rr) of the FD&C Act.
IV. 	ENFORCEMENT PRIORITIES REGARDING CERTAIN ENDS PRODUCTS ON
THE MARKET WITHOUT PREMARKET AUTHORIZATION
A. Overview
The Tobacco Control Act provides that new tobacco products (i.e., non-grandfathered products)
may not legally be marketed without premarket authorization. Accordingly, all deemed new
tobacco products on the market without authorization are illegally marketed products.
Beginning February 6, 2020, FDA intends to prioritize enforcement of the premarket review
requirements for certain ENDS products, including against retailers selling such products.
Specifically, FDA intends to prioritize enforcement against:
(1) Flavored, cartridge-based ENDS products (except for tobacco- or menthol-flavored
products);
(2) All other ENDS products for which the manufacturer has failed to take (or is failing to
take) adequate measures to prevent minors’ access; and

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(3) Any ENDS products targeted to, or whose marketing is likely to promote use by,
minors.
In addition, FDA intends to prioritize enforcement of any ENDS product that is offered for sale
in the United States after September 9, 2020, and for which the manufacturer has not submitted a
premarket application (or after a negative action by FDA on a timely submitted application).22
22 We note that FDA would be enforcing the priorities discussed in Section IV of this guidance regardless of the
court’s decision in the AAP case. As discussed in this Final Guidance, FDA is implementing this policy to address
the alarming increase in youth use of ENDS products as well as other recent health and safety issues regarding such
products.
FDA will make enforcement decisions on a case-by-case basis, recognizing that it is unable, as a
practical matter, to take enforcement action against every illegally marketed tobacco product,
and that it needs to make the best use of Agency resources. This guidance does not in any way
alter the fact that it is illegal to market any new tobacco product without premarket authorization,
or to sell any tobacco product to minors. The Agency also retains discretion to pursue
enforcement action at any time against any deemed new tobacco product marketed without
premarket authorization, regardless of whether it falls within one of these categories of
enforcement priorities.
B. Data Show Substantial Increase in Youth Use of ENDS Products, Particularly Certain
Flavored, Cartridge-Based ENDS Products
At the time FDA issued the August 2017 Compliance Policy to announce changes in its approach
to enforcement regarding premarket authorization (as described in the preamble to the final
deeming rule), data from the 2016 NYTS showed a decrease in prevalence of current e-cigarette
use (i.e., past 30-day use) among high school students, from 16 percent in 2015 to 11.3 percent in
2016.23
23 Jamal, A., A. Gentzke, S.S. Hu, et al., “Tobacco Use Among Middle and High School Students — United States,
2011–2016,” Morbidity and Mortality Weekly Report, 66:597–603, 2017, available at:
https://www.cdc.gov/mmwr/volumes/66/wr/mm6623a1.htm.
Results from the 2017 NYTS later confirmed that in regards to youth use there was no
statistically significant rise at the time, with data suggesting that high school student use had
leveled off between 2016 (11.3 percent)24
24 Id.
and 2017 (11.7 percent).25
25 Wang, T.W., A. Gentzke, S. Sharapova, et al., “Tobacco Product Use Among Middle and High School Students –
United States, 2011-2017,” Morbidity and Mortality Weekly Report, 67:629-633, 2018, available at:
http://dx.doi.org/10.15585/mmwr.mm6722a3.
However, multiple survey results over the past several years demonstrate that there is significant
initiation by youth. The recent surge in youth use of ENDS products has caused us to reevaluate
our July 2017 assessment and to modify our enforcement priorities for ENDS products. Recent
data show an alarming increase in youth use of ENDS products in the past two years. They also
show youth are more likely to use certain flavored, cartridge-based ENDS products.

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Overall, data showed that ENDS product use more than doubled among middle school and high
school students from 2017 to 2019.26
26 Miech R, L. Johnston, P.M. O’Malley, et al., “Trends in adolescent vaping, 2017–2019,” New England Journal of
Medicine, 381:1490-1491, 2019; DOI:10.1056/NEJMc1910739.
Data from MTF showed that from 2017 to 2018, current
(past 30-day) e-cigarette use significantly increased from 6.6 percent to 10.4 percent among 8 th
graders (a 58 percent increase), 13.1 percent to 21.7 percent among 10 th graders (a 66 percent
increase), and 16.6 percent to 26.7 percent among 12th graders (a 61 percent increase).27
27 Miech, R. A., Johnston, L. D., O’Malley, P. M., et al., “Monitoring the Future national survey results on drug use,
1975–2018: Volume I, Secondary school students,” Ann Arbor: Institute for Social Research, The University of
Michigan (2019), available at http://monitoringthefuture.org/pubs.html#monographs. For each age group, the
increase from 2017 to 2018 was statistically significant (p<.001).
This
trend continued in the 2019 MTF data. The number of students who had used ENDS products
during the previous 12 months and those who had ever used ENDS products significantly
increased in 8th, 10th , and 12th grade from 2018 to 2019.28
28 Miech R, L. Johnston, P.M. O’Malley, et al., “Trends in adolescent vaping, 2017–2019,” New England Journal of
Medicine; 381:1490-1491, 2019; DOI:10.1056/NEJMc1910739.
Data from the NYTS for the same
time period show that, between 2017 and 2018, current e-cigarette use among high school
students increased from 11.7 percent to 20.8 percent (a 78 percent increase, p<0.001).29
29 Cullen, K.A., B.K. Ambrose, A.S. Gentzke, et al., “Notes from the Field: Increase in e-cigarette use and any
tobacco product use among middle and high school students – United States, 2011-2018,” Morbidity and Mortality
Weekly Report, 67(45);1276-1277, 2018. The NYTS defines e-cigarettes as “battery-powered devices that provide
nicotine and other additives to the user in the form of an aerosol.”
Current
e-cigarette use among middle school students also increased from 3.3 percent to 4.9 percent over
the same time period (a 48 percent increase, p=0.001), which we calculated as an increase of an
estimated 180,000 middle school students reporting past 30-day e-cigarette use in one year.30
30 Id.
The data from 2019 NYTS have also documented that this is the second year in a row where
current (past 30-day) e-cigarette use reached new highs among youth.31
31 Cullen, K.A., A.S. Gentzke, M.D. Sawdey, “E-cigarette use among youth in the United States, 2019,” JAMA,
322(21);2095-2103, 2019. Several improvements were made to the NYTS in 2019, including switching from paper-
and-pencil to electronic survey administration, adding skip patterns and example product images, and updating
brand examples to reflect the current tobacco marketplace (e.g., adding JUUL), which may affect the comparability
of tobacco product use behaviors, including e-cigarette use behaviors, with previous years. Although trend analyses,
which use more data points and are not solely dependent on changes during a single year, may be conducted without
major shifts in patterns or findings, the exact magnitude of the effect of these survey improvements in 2019 cannot
be fully quantified. Thus, direct statistical comparisons between estimates of tobacco product use between 2018 and
2019 were not conducted.
The prevalence of
current e-cigarette use among high school students was 27.5 percent and middle school students
was 10.5 percent.32
32 Cullen, K.A., A.S. Gentzke, M.D. Sawdey, “E-cigarette use among youth in the United States, 2019,” JAMA,
322(21);2095-2103, 2019.
Among high school students, 4.11 million reported having used an e-
cigarette in the past month in 2019 with 1.24 million middle school students reporting the same.
For the first time ever, the total number of middle and high school students reporting current use
of e-cigarettes surpassed 5 million in 2019.33
33 Id.

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Disturbingly, these data also indicate that a growing percentage of America’s youth who use e-
cigarettes have become frequent e-cigarette users (defined as reporting use on 20 days or more of
the prior 30-day period). An increasing number of youth are thus at greater risk of nicotine
addiction at a time when the developing brain is particularly susceptible to permanent changes
from nicotine use and when almost all nicotine addiction is established.34
34 Miech R., Johnston L, O’Malley PM, et al., “Adolescent vaping and nicotine use in 2017–2018 — U.S. National
Estimates,” New England Journal of Medicine; 380:192-3, 2019.
Data from the 2019
NYTS have documented continued frequent youth ENDS use.35
35 Cullen, K.A., A.S. Gentzke, M.D. Sawdey, “E-cigarette use among youth in the United States, 2019,” JAMA,
322(21);2095-2103, 2019.
The proportion of current high
school e-cigarette users who reported use on 20 days or more (of the prior 30-day period), and
thus were frequent users, was 34.2 percent in 2019.36
36 Id.
The proportion of current middle school e-
cigarette users who reported use on 20 days or more (of the prior 30-day period) was 18.0
percent in 2019.
This builds upon an increase in frequent ENDS use among youth who report using ENDS
products observed in 2018. For example, data from the 2018 NYTS showed that the proportion
of current high school e-cigarette users who reported use on 20 days or more (of the prior 30-day
period) increased by 38.5 percent, from 20.0 percent in 2017 to 27.7 percent in 2018.37
37 Cullen, K.A., B.K. Ambrose, A.S. Gentzke, et al., “Notes from the Field: Increase in e-cigarette use and any
tobacco product use among middle and high school students – United States, 2011-2018,” Morbidity and Mortality
Weekly Report, 67(45);1276-1277, 2018.
In a
study that collected data from February to May 2018 and focused specifically on 15-to-17-year-
old current users of JUUL products (the most commonly used brand, including among youth),
55.8 percent reported using such ENDS products on 3 or more of the previous 30 days, and over
a quarter (25.3 percent) reported use on 10 to 30 days of the prior month.38
38 Vallone, D.M., M. Bennett, H. Xiao, et al., “Prevalence and correlates of JUUL use among a national sample of
youth and young adults,” Tobacco Control,0:1-7, 2017, doi: 10.1136/tobaccocontrol-2018-05463.
The concerns caused by the sharp increase in the number of youth using ENDS products are
compounded by evidence indicating that youth whose first tobacco product is an ENDS product
are at an increased risk of becoming cigarette smokers as compared to non-ENDS users. A 2018
report by the National Academy of Sciences, Engineering, and Medicine entitled “Public Health
Consequences of E-Cigarettes,” which took into account multiple lines of evidence across
different studies and study designs, concluded that “there is substantial evidence that e-cigarette
use increases risk of ever using combustible tobacco cigarettes among youth and young adults.”39
39 National Academies of Sciences, Engineering, and Medicine, “Public health consequences of e-cigarette,”.
Washington, DC: The National Academies Press, 2018, doi: https://doi.org/10.17226/24952.
FDA is also concerned about the extraordinary popularity of flavored ENDS products with
youth. Research has long shown that flavors increase youth appeal of tobacco products,

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including ENDS.40
40 E.g., Carpenter, C.M., et al., “New Cigarette Brands with Flavors that Appeal to Youth: Tobacco Marketing
Strategies,” Health Affairs, 24(6):1601-1610, 2005; Pepper, J. K., K.M. Ribisl, N.T. Brewer, “Adolescents’ interest
in trying flavoured ecigarettes,” Tobacco Control, 25:ii62-ii66, 2016; Camenga, D. R., M. Morean, G. Kong, et al.,
“Appeal and use of customizable e-cigarette product features in adolescents,” Tobacco Regulatory Science, 4(2):51-
60, 2018; Harrell, M.B., S.R. Weaver, A. Loukas, et al., “Flavored e-cigarette use: characterizing youth, young
adult, and adult users,” Preventive Medicine Reports, 5:33-40, 2017.
Evidence continues to accumulate, further confirming that youth are
particularly attracted to flavored ENDS products. Data from the 2018 NYTS showed that past
30-day use of any flavored e-cigarette increased from 2017 among high school students who
reported current e-cigarette use (60.9 percent to 67.8 percent, p<0.05).41
41 Cullen, K.A., B.K. Ambrose, A.S. Gentzke, et al., “Notes from the Field: Increase in e-cigarette use and any
tobacco product use among middle and high school students – United States, 2011-2018,” Morbidity and Mortality
Weekly Report, 67(45);1276-1277, 2018.
In the 2016-2017
(Wave 4)42
42 Population Assessment of Tobacco and Health (PATH) Study [United States] Restricted Use Files (ICPSR
36231), available at: https://www.icpsr.umich.edu/icpsrweb/NAHDAP/studies/36231.
Population Assessment of Tobacco and Health (PATH) Study,43
43 The PATH study is a research study that assesses within-person changes and between-person differences in a
large national cohort of participants aged 12 years and older over time. Each wave is a follow-up where the PATH
study can examine its objectives, iteratively and cumulatively, to generate a broad body of knowledge about tobacco
product use in the USA. Data collection for each wave occurred during the following timeframes: Wave 1
(September 2013-December 2014), Wave 2 (October 2014-2015), Wave 3 (October 2015-2016), and Wave 4 (2016-
2017).
among youth age 12
to 17 who reported using an ENDS product, 93.2 percent reported that their first ENDS use was
with a flavored ENDS product.44
44 Rostron B et al. “Prevalence and Reasons for Use of Flavored Cigars and ENDS among US Youth and Adults:
Estimates from Wave 4 of the PATH Study, 2016-2017,” American Journal of Health Behavior, 44(1);76-81, 2020.
Data from Wave 4 also showed that 71 percent of current
youth ENDS users said they used ENDS products “because they come in flavors I like.”
45 Id.
45
The NYTS survey instrument groups mint- and menthol-flavored products together, so it is not
possible to differentiate youth use of mint and menthol flavors separately based on the NYTS
data. The 2018 NYTS data indicate that, among high school students whose only tobacco
product use is e-cigarettes, known as exclusive e-cigarette users, the proportion who reported
fruit-flavored ENDS use was 75.5 percent in 201846
46 Cullen, K.A., A.S. Gentzke, M.D. Sawdey, et al., “E-cigarette use among youth in the United States, 2019,”
JAMA, 322(21);2095-2103, 2019.
and the proportion who reported mint-and
menthol-flavored ENDS use was 38.1 percent.47
47 Cullen, K.A., B.K. Ambrose, A.S. Gentzke, et al., “Notes from the Field: Increase in e-cigarette use and any
tobacco product use among middle and high school students – United States, 2011-2018,” Morbidity and Mortality
Weekly Report, 67(45);1276-1277, 2018.
In 2019, in the same population, fruit-flavored
ENDS use was 66.1 percent and mint- and menthol-flavored ENDS use was 57.3 percent.48
48 Cullen, K.A., A.S. Gentzke, M.D. Sawdey, “E-cigarette use among youth in the United States, 2019,” JAMA,
322(21);2095-2103, 2019.
Among middle school exclusive e-cigarette users, the 2018 NYTS data indicate that use of fruit-
flavored ENDS use was 58.1 percent and mint-and menthol-flavored ENDS use was 20.6

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percent.49
49 Id.
In 2019, in the same population, fruit-flavored ENDS use was 67.7 percent and mint-
and menthol-flavored ENDS use was 31.1 percent.50
50 Id.
Between 2016 and 2019, high school
exclusive e-cigarette users who reported mint- and menthol-flavored ENDS use increased from
16.0 percent to 57.3 percent, p<0.05.51
51 Id.
Data for middle school e-cigarette users was inconclusive
on this point due to a limited number of middle-school students in the NYTS sample who not
only used e-cigarettes within the past 30 days, but whose exclusive tobacco product use in the
past 30 days was e-cigarettes.52
52 Id.
In 2019, the data indicate that more than one million middle and
high school exclusive e-cigarette users used mint- or menthol-flavored ENDS in the past 30
days.53
53 Id.
However, data from the MTF survey examine mint and menthol JUUL use separately and
indicate that youth use of menthol-flavored products is not as high as that for mint- and fruit-
flavored products. Specifically, a randomly-selected third of 2019 MTF respondents were asked
about their flavored JUUL use.54
54 Leventhal A., et al., “Flavors of e-Cigarettes Used by Youths in the United States,” JAMA, 322(21):2132-2134,
2019.
The analytic sample included past 30-day JUUL users who
answered the question, “Which JUUL flavor do you use most often?” with response options of
Classic Tobacco, Crème, Cucumber, Fruit, Mango, Menthol, Mint, Virginia Tobacco, and Other.
Among past 30-day JUUL users in each grade studied (8 th , 10th , and 12 th ), use of mango and mint
ranked highest, followed by fruit. Reported use of menthol and tobacco flavors were among the
lowest ranked options. Specifically, a number of 8th grade past 30-day JUUL users reported use
of mango (33.5 percent), while the others reported use of mint (29.3 percent), fruit (16.0
percent), and other (14.8 percent).55
55 The remaining flavors, including tobacco and menthol flavors, each had estimates of ≤ 2.3%.
A large percentage of 10th grade past 30-day JUUL users
reported use of mint (43.5 percent), while the others reported use of mango (27.3 percent), fruit
(10.8 percent), and other (8.4 percent).56
56 The remaining flavors, including tobacco and menthol flavors, each had estimates of ≤ 3.0%.
Close to half of 12th grade past 30-day JUUL users
reported use of mint (47.1 percent), while the others reported use of mango (23.8 percent), fruit
(8.6 percent), other (6.0 percent), menthol (5.9 percent), and cucumber (4.4 percent).57
57 The remaining flavors, including tobacco flavors, each had estimates of ≤ 1.5%.
Data from the 2019 NYTS also indicate that youth overwhelmingly prefer cartridge-based ENDS
products,58
58 Cullen, K.A., A.S. Gentzke, M.D. Sawdey, “E-cigarette use among youth in the United States, 2019,” JAMA,
322(21);2095-2103, 2019.
and we have found that these products are easy to conceal, can be used discreetly,
may have a high nicotine content, and are manufactured on a large scale. The 2019 survey
instrument included a measure for the “usual brand” of e-cigarette used in the past 30 days.

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Most youth who were current e-cigarette users reported a cartridge-based e-cigarette as their
usual brand.59
59 Id. Unpublished data from the 2019 survey list other brands that are used by youth, some of which are available
in both cartridge-based and non-cartridge-based forms.
In fact, the leading brand is a cartridge-based product that commands
approximately 70 percent of the market.60
60 Nielsen Total US xAOC/Convenience Database & Wells Fargo Securities, LLC, in Wells Fargo Securities,
Nielsen: Tobacco All Channel Data Thru 10/4 – Cig Vol Declines Moderate, October 15, 2019.
Of particular concern are the design features that appear to make the cartridge-based products so
popular with young people. Attributes typically present in cartridge-based products include a
relatively small size that allows for easy concealability, and intuitive and convenient features that
facilitate ease of use, including draw activation, prefilled cartridges or pods, and USB
rechargeability.
Small products may allow youth to use the product in circumstances where use of tobacco
products is prohibited, such as a school.61
61 See, e.g., Schillo B., et al., “JUUL in School: Teacher and Administrator Awareness and Policies of E-Cigarettes
and JUUL in U.S. Middle and High Schools,” Health Promot Pract., 21(1):20-24, 2020; “Why 'juuling' has become
a nightmare for school administrators,” Kaiser Health News (March 26, 2018), available at:
https://www.nbcnews.com/health/kids-health/why-juuling-has-become-nightmare-school-administrators-n860106/;
“Juul Is Sued by School Districts That Say Vaping Is a Dangerous Drain on Their Resources,” The New York Times
(October 7, 2019), available at: https://www.nytimes.com/2019/10/07/us/juul-vaping-schools.html.
Small size may also allow the user to quickly conceal
the product in the palm of one’s hand or in a pocket.62
62 http://pittsburgh.cbslocal.com/2017/12/13/new-ecigarette-popular-among-kids-easy-to-conceal-from-parents/
Small size may allow for product use in a
social setting without others’ awareness,63
63 https://www.npr.org/sections/health-shots/2017/12/04/568273801/teenagers-embrace-juul-saying-its-discreet-
enough-to-vape-in-class
particularly in conjunction with vaping techniques
that may be used to prevent or hide the vapor cloud. Additionally, depending on the size and
shape of the product, it may also blend in with other equipment that is expected in that setting
(e.g., if the ENDS is shaped like a flash drive, for example, next to a computer, where an actual
flash drive would be used), or it may otherwise go undetected because parents, teachers, or
coaches do not recognize the product as an ENDS.64
64 “New vaping devices may go undetected by parents,” The Excelsior Springs Standard, April 16, 2018, available
at: http://excelsior225.rssing.com/chan-47020297/all_p70.html#item1400.
Products ready for use immediately after purchase have characteristics that facilitate ease of use
among young people. With cartridge-based products, there are no settings to change and very
little assembly is required. Research on other tobacco products suggests that ease of use is
associated with susceptibility to tobacco product uptake among youth.65
65 Chaffee B.W., J. Urata, E.T. Couch, S. Gansky, “Perceived flavored smokeless tobacco ease-of-use and youth
susceptibility,” Tobacco Regulatory Science, 3(3):367-373, 2017.
Additional research
among youth suggests that younger adolescents are more likely to use more basic ENDS

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products than older adolescents.66
66 Pepper J.K., A.J. MacMonegle, J.M. Nonnemaker, “Adolescents’ use of basic, intermediate, and advanced device
types for vaping,” Nicotine & Tobacco Research, 21(1):55–62, 2019.
Thus, particularly easy-to-use products, such as cartridge-
based products, may have lower barriers to initiation.
Other product features that facilitate ease of use include pre-filled cartridges, which are
convenient because they do not require filling prior to use and are easy to dispose of and replace;
a draw-activated battery that makes the devices much easier to use than other devices; and
rechargeability, an important characteristic for use among youth who recharge via a USB port
when connected to a computer or charging adapter from other electronic devices, such as a
cellphone.
In the notice of proposed rulemaking for the Deeming Rule, FDA noted that the overall public-
health impact of ENDS products would depend crucially upon “who uses the products and how
they are used. If such products result in minimal initiation by children and adolescents while
significant numbers of smokers quit, then there is a potential for the net public health impact at
the population level to be positive. If, on the other hand, there is significant initiation by youth,
minimal quitting, or significant dual use of combust[ed] and non-combust[ed] products, then the
public health impact could be negative.”67
67 79 Fed. Reg. 23141, 23147 (2016).
The data discussed above demonstrate substantial and
increasing initiation of ENDS products by youth, particularly certain flavored, cartridge-based
products.
C. Additional Relevant Considerations
In issuing the March 2019 Draft Guidance, FDA solicited public comment generally on the
proposed approach and specifically sought information that could help inform its decision-
making for each key issue. In developing this Final Guidance, FDA considered information
provided in the public comments submitted on the March 2019 Draft Guidance. Overall, out of
the over 15,000 public comments FDA received in response to the Draft Guidance, many were
related to form letter campaigns, while approximately 294 public comments provided unique and
substantive information. In addition to the comments that provided unique and substantive
information, FDA received thousands of general comments expressing support or opposition to
the guidance and separate provisions within the guidance. These comments express broad policy
views and do not address specific points related to the March 2019 Draft Guidance. Additional
information regarding significant comments received in response to the March 2019 Draft
Guidance and FDA’s responses is described in Appendix A.68
68 FDA generally does not respond to comments in guidance documents and, as noted in the preamble to the
deeming rule, generally “[a]gency compliance/enforcement policies are not subject to the requirements that govern
notice-and-comment rulemaking.” 81 Fed. Reg. at 28,977, 29,010 (citing Prof’ls & Patients for Customized Care v.
Shalala, 56 F.3d 592 (5th Cir. 1995) (a compliance policy guide is not a substantive rule and not subject to APA’s
notice-and-comment rulemaking); Takhar v. Kessler, 76 F.3d 995, 1002 (9th Cir. 1996) (FDA compliance policy
guides were not required to go through notice-and-comment procedures)). Although FDA is addressing comments
here, it does so voluntarily and given the circumstances. By responding to comments here, FDA in no way

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FDA also remains concerned about health and safety issues connected to ENDS products—e.g.,
cases of lung injuries associated with use of vaping products69
69 See, e.g., Centers for Disease Control and Prevention, “Outbreak of Lung Injury Associated with E-cigarette Use,
or Vaping,” available at: https://www.cdc.gov/tobacco/basic_information/e-cigarettes/severe-lung-
disease.html#latest-outbreak-information; Layden, J. E., I. Ghinai, I. Pray, et al., “Pulmonary Illness Related to E-
Cigarette Use in Illinois and Wisconsin – Preliminary Report,” New England Journal of Medicine, Sept. 2019; DOI:
10.1056/NEJMoa1911614.
as well as battery explosions with
ENDS products70
70 See, e.g., Rossheim, M.E., M.D. Livingston, E.K. Soule, et al., “Electronic Cigarette Explosion and Burn Injuries,
US Emergency Departments 2015-2017,” Tobacco Control, 2019; 28:472-474, available at:
http://dx.doi.org/10.1136/tobaccocontrol-2018-054518.
—particularly given that these products have been marketed without premarket
evaluation. These current public health issues affirm the importance of the premarket review
process, as contemplated by the Tobacco Control Act, to scientifically evaluate products based
on a public health standard. For example, FDA review of premarket tobacco product
applications considers the risks and benefits of the product to the population as a whole,
including tobacco product users and non-users. In reviewing premarket tobacco product
applications, FDA will consider, among other things: the product’s components, ingredients,
additives, and properties; manufacturing practices; and any studies or investigations into the
health risks of the tobacco product.
D. Enforcement Priorities for ENDS Products
In the discussion that follows, we describe our current intent regarding prioritizing our
enforcement resources with respect to certain illegally marketed ENDS products.
FDA will prioritize enforcement of flavored, cartridge-based ENDS products (other than
tobacco- and menthol-flavored products), which are produced primarily by large manufacturers.
This policy should have minimal impact on small manufacturers (e.g., vape shops) that primarily
sell non-cartridge-based ENDS products, unless they market to youth or fail to take adequate
measures to prevent youth access. Specifically, FDA intends to prioritize enforcement regarding
the lack of marketing authorization against:
• 	Any flavored, cartridge-based ENDS product (other than a tobacco- or menthol-flavored
ENDS product);
• 	All other ENDS products for which the manufacturer has failed to take (or is failing to
take) adequate measures to prevent minors’ access; and
• 	Any ENDS product that is targeted to minors or whose marketing is likely to promote use
of ENDS by minors.
FDA intends to prioritize enforcement beginning February 6, 2020.
establishes a policy, practice, or precedent requiring the Agency to do so with respect to future iterations of this
document or any other guidance document.

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Further, FDA intends to prioritize enforcement of any ENDS product that is offered for sale after
September 9, 2020, and for which the manufacturer has not submitted a premarket application
(or after a negative action by FDA on a timely submitted application).
In addition to violations related to lack of marketing authorization, FDA will continue to take
legal action regarding sales of tobacco products to minors and other violations and will closely
monitor all sales of ENDS products.
1. 	Any flavored, cartridge-based ENDS product (other than a tobacco- or menthol-flavored
product)
FDA intends to prioritize enforcement for lack of marketing authorization against any flavored,
cartridge-based ENDS product (other than a tobacco- or menthol-flavored ENDS product) that is
offered for sale in the United States without regard to whether or when premarket application for
such product has been submitted.
In its balancing of the different public health considerations regarding ENDS products, the
March 2019 Draft Guidance did not include tobacco-, mint- and menthol-flavored ENDS
products in its proposed enforcement priorities, based on the data at that time indicating that
these flavors were preferred more by adults than youth. The intent was, to the extent possible
consistent with protecting population health, to avoid foreclosing one potential means by which
some adult smokers might seek to transition completely away from combusted tobacco products
to potentially less harmful tobacco products. Moreover, the March 2019 draft did not distinguish
between cartridge-based products and other products, and instead focused on how products are
sold rather than product characteristics.
As discussed above, evidence shows that youth are particularly attracted to flavored, cartridge-
based ENDS products. Data show that, among youth who reported ever using an ENDS product,
a large majority reported their first ENDS use was with a flavored ENDS product.71
71 Rostron B et al. “Prevalence and Reasons for Use of Flavored Cigars and ENDS among US Youth and Adults:
Estimates from Wave 4 of the PATH Study, 2016-2017,” American Journal of Health Behavior, 44(1);76-81, 2020.
Data also
show that among current youth ENDS users, a majority of youth respondents stated that they
used ENDS products “because they come in flavors I like.”72
72 Id.
In addition, recent data indicate
that flavors preferred by youth include mint. Data from the 2019 MTF survey indicate that youth
use of mint- and fruit-flavored JUUL products is higher than that of menthol- and tobacco-
flavored JUUL products.73
73 Leventhal A., et al., “Flavors of e-Cigarettes Used by Youths in the United States,” JAMA, 322(21):2132-2134,
2019.
Finally, data from the 2019 NYTS indicate that youth
overwhelmingly prefer cartridge-based ENDS products.74
74 Cullen, K.A., A.S. Gentzke, M.D. Sawdey, “E-cigarette use among youth in the United States, 2019,” JAMA,
322(21);2095-2103, 2019.
These products are easy to conceal,
can be used discreetly, may have a high nicotine content, and are manufactured on a large scale.

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FDA received a number of comments that focused on the popularity of mint- and menthol-
flavored ENDS among youth and adult populations. Some commenters suggested that such
products would become even more popular if others became less available. They argued that not
prioritizing enforcement against mint- and menthol-flavored ENDS products would risk the shift
of youth from one flavor of ENDS products to another based on a potential but indeterminate
impact on adult consumers. Several comments argued that data suggest that even if youth
currently prefer “fruit” and “sweets” to mint and menthol, this does not mean that youth do not
still find mint and menthol to be appealing flavors. FDA also received public comments
claiming that mint- and menthol-flavored ENDS products help smoking cessation. For example,
some commenters focused on the potential role that mint- and menthol-flavored ENDS products
could play in helping some adults cease the use of combusted tobacco products.
It is possible that prioritizing enforcement against mint-flavored ENDS products could at least in
the short term make fewer products available for some addicted adult smokers seeking to use
ENDS products to transition completely away from cigarettes. However, the comments, as well
as the recent surge in youth use of ENDS products, and especially the preferences indicated in
the 2019 NYTS and 2019 MTF data, have led FDA to reconsider its approach with regard to
prioritizing enforcement of mint-flavored ENDS products.
FDA also received multiple comments urging the Agency to further refine its enforcement
priorities in consideration of how the design features of certain ENDS products may make them
so popular among youth. Some commenters focused on the features of cartridge-based systems,
particularly that they may contain high nicotine content and that they are easy to conceal.
Similarly, some commenters focused on the potential impact of nicotine salts, which are used in
some brands of cartridge-based ENDS products. In contrast, FDA received a comment arguing
that the rise of youth use should not be attributed to all cartridge-based products but rather to a
single, uniquely prevalent cartridge-based product, and that FDA’s regulatory actions should be
tailored accordingly.
As discussed above, data show that flavors are a strong driver for youth use, and that youth
overwhelmingly use cartridge-based ENDS products. Moreover, preliminary research indicates
that certain effects of nicotine salts in ENDS products (e.g., higher nicotine exposure and faster
rate of absorption) may increase the abuse liability of ENDS with nicotine salts, which raises
concerns of addiction in youth, particularly due to the vulnerability of the developing adolescent
brain. However, for many individual addicted cigarette smokers, the potential for ENDS to act
as a substitute for cigarettes, thereby encouraging smokers to seek to switch completely away
from combustible cigarettes, may be dependent, in part, upon the product having acceptability
and abuse liability more comparable to a cigarette.
FDA has refined its enforcement priorities in the Final Guidance to focus on flavored, cartridge-
based ENDS products (other than tobacco- and menthol-flavored). This approach strikes an
appropriate balance between restricting youth access to such products, while maintaining
availability of potentially less harmful options for current and former adult smokers who have
transitioned or wish to transition completely away from combusted tobacco products. FDA will,
however, continue to evaluate new information and adjust these enforcement priorities, as
warranted, in light of the best available data about these products.

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We also note that the March 2019 Draft Guidance proposed to prioritize enforcement for
flavored ENDS products that are offered for sale in ways that pose a greater risk for minors to
access such products. Several comments discussed the wide availability of these products and
the means by which youth gain access. These included comments that expressed concern
regarding the availability of flavored ENDS products on the Internet and in vape shops. Other
commenters focused on how the enforcement priorities were unclear and difficult for retailers to
understand, and how that may negatively affect “potentially compliant” retail locations that
attempt to prevent minor access. Others expressed concern that the enforcement priorities were
altogether impractical and costly for retailers. While the March 2019 Draft Guidance proposed
to focus its enforcement priorities of flavored ENDS products on how the product was sold, after
considering the comments, the public health threats, and the new evidence described above, FDA
determined that focusing on how the product was sold would not appropriately address youth use
of the products that are the most popular among youth—i.e., flavored, cartridge-based products.
The reality is that youth have continued access to these products in the face of legal prohibitions
and even after voluntary actions by some manufacturers. Moreover, as discussed above, the data
show that youth overwhelmingly prefer certain flavors of cartridge-based ENDS products.75
75 Cullen, K.A., A.S. Gentzke, M.D. Sawdey, “E-cigarette use among youth in the United States, 2019,” JAMA,
322(21);2095-2103, 2019.
These products are produced on a large scale, are easy to conceal, can be used discreetly, and are
not the products typically produced in vape shops that mix nicotine with e-liquid flavors. Given
the urgent need to address the dramatic rise in youth use, this Final Guidance prioritizes
enforcement with respect to any flavored, cartridge-based ENDS products (other than a tobacco-
and menthol-flavored ENDS product) without regard to the location or method of sale. FDA
believes that focusing enforcement on these products is important in addressing the increasing
rates of youth use of these flavored, cartridge-based products because this is a primary driver in
youth experimentation with, and continued use of, ENDS products.
Accordingly, FDA has recalibrated its balancing of public health considerations in light of the
public health threats and the significant new evidence described above. This policy reflects
FDA’s balancing of concerns regarding the appeal of certain flavored, cartridge-based ENDS
products to youth; the potential public health benefit of noncombusted options by which some
adult smokers might seek to transition completely away from combusted tobacco products; and
the potential risks created by extended availability of these new tobacco products without
scientific review and evaluation under the applicable public health standard.
2. 	All other ENDS products without adequate measures to prevent minors’ access
FDA intends to prioritize enforcement for lack of a marketing authorization for any other ENDS
products (i.e., any tobacco-, menthol-, or non-flavored ENDS products and any non-cartridge-
based, flavored ENDS products) when the manufacturer has not taken or is not taking adequate
measures to prevent minors’ access to these products, without regard to whether or not, or when,
a premarket application for such product has been submitted.

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In assessing whether a manufacturer is taking (or has taken) adequate measures to prevent
minors’ access to these ENDS products, factors the Agency intends to consider include, but are
not limited to:
• 	Whether the manufacturer has implemented adequate programs to monitor retailer
compliance with age-verification and sales restrictions. Such programs might include,
for instance: screening retailers, in advance of establishing or renewing distribution
agreements, based on the strength of the retailers’ age verification policies; establishing
and publicizing a hotline for anonymous reporting of noncompliant sales; implementing a
mystery shopper program; requiring use of technology that tracks age-verification
practices; or other mechanisms.
• 	Whether the manufacturer has established and enforces penalties against retailers that fail
to comply with age-verification and sales restrictions. For instance, in response to the
September 12 th letters, respondent manufacturers stated that they had mechanisms, such
as through distribution agreements, to enforce financial penalties and stop sales to
retailers in response to noncompliance. In addition to such mechanisms, FDA may
consider whether a manufacturer has implemented a policy of notifying FDA of retailer
violations.
• 	If the manufacturer is also a retailer, factors to adequately prevent underage access might
include: whether the manufacturer/retailer has implemented programs to ensure
compliance with age-verification and sales restrictions; establishing and publicizing a
hotline for anonymous reporting of noncompliant sales; checking identification at the
door; or other mechanisms.
• 	If the manufacturer is also a retailer, whether the manufacturer uses adequate age-
verification technology (or requires that retailers who sell its products use such
technology) to prevent underage access to its website and to prevent underage sales
through the Internet. For instance, adequate age-verification could include use of an
independent, third-party age- and identity-verification service that compares customer
information against third-party data sources, such as public records; and
• 	Whether the manufacturer limits (or requires that retailers who sell its products to limit)
the quantity of ENDS products that a customer may purchase within a given period of
time.
FDA’s decision to exercise its enforcement authorities with respect to particular products will be
fact-specific and determined on a case-by-case basis.
This prioritization takes into account information that was provided by manufacturers in
response to the Agency’s September 2018 letters, including measures to address youth use that
manufacturers can or have already taken to address youth access to ENDS products, as well as
information provided in comments to the March 2019 Draft Guidance.

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As noted, FDA considered comments about the practical concerns of implementing an
enforcement policy based on how products are sold. The factors above reflect information FDA
received from industry, including information manufacturers shared during meetings with FDA
leadership, in response to the September 2018 letters, and public comments submitted in
response to the March 2019 Draft Guidance. From this information, FDA understands that
manufacturers have the means to monitor and/or control how their products are sold at retail by,
for example, including or requiring terms, conditions, or controls in their contracts with
downstream distributors (wholesalers, distributors, importers, and/or retailers) to prevent youth
access.
The March 2019 Draft Guidance did not propose to prioritize enforcement for tobacco- or
menthol-flavored ENDS products and did not propose to distinguish between cartridge-based
and other ENDS products. The continued significant increase in youth use of ENDS, as
demonstrated in the 2019 NYTS and MTF data, as well as the data showing that youth
overwhelmingly use flavored, cartridge-based ENDS products, support a reconsideration of the
Agency’s approach. As noted in the draft guidance, FDA is continuously evaluating new
information and adjusting its enforcement priorities in light of the best available data, and it will
continue to do so with respect to these unauthorized ENDS products.
As noted above, FDA received a number of comments arguing that the popularity of menthol-
flavored ENDS (as well as mint-flavored ENDS, which are discussed above) had increased
among youth and adult populations, and suggesting that such products would become even more
popular if other flavored ENDS products became less available. They argued that excluding
menthol-flavored ENDS products from prioritization would risk the shift of youth from one
flavor of ENDS products to another based on a potential but indeterminate impact on adult
consumers. FDA also received comments stating that it should immediately begin enforcing
premarket review of all ENDS products, including tobacco-flavored ENDS products.
Other commenters emphasized a need for ENDS products to remain available for former
smokers who have transitioned or current smokers who want to transition completely away from
combustible products. Menthol is unique compared to other available ENDS product flavors as
it is the only characterizing flavor available in cigarettes, and it may reduce the irritation and
harshness of smoking.76
76 See, e.g., Harris, B., “Menthol: A review of its thermoreceptor interactions and their therapeutic applications,”
International Journal of Aromatherapy, 16(3-4):117-131, 2006; Galeotti, N., L.D. Mannelli, G. Mazzanti, et al.,
“Menthol: a natural analgesic compound,” Neuroscience Letters, 322(3):145-148, 2002; Nishino, T., Y. Tagaito, Y.
Sakurai, “Nasal inhalation of l-menthol reduces respiratory discomfort associated with loaded breathing,” American
Journal of Respiratory and Critical Care Medicine, 156(1):309-313, 1997; Lawrence, D., B. Cadman, A.C. Hoffman,
“Sensory properties of menthol and smoking topography,” Tobacco Induced Diseases, 9 Suppl 1(Suppl 1):S3, 2011;
Garten, S. & R.V. Falkner, “Continual smoking of mentholated cigarettes may mask the early warning symptoms of
respiratory disease,” Preventive Medicine, 37(4):291-296, 2003.
Menthol cigarettes are also used by a substantial portion of the U.S.
population, who are addicted to nicotine and may be looking for an alternative product to seek to
transition completely away from combusted products.77
77 See, e.g., United States Department of Health and Human Services. Substance Abuse and Mental Health Services
Administration (SAMHSA). Center for Behavioral Health Statistics and Quality. National Survey on Drug Use and
FDA is compelled to act by data that

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show youth overwhelmingly prefer certain flavors of cartridge-based ENDS products such as
fruit, mint, and candy.78
78 Cullen, K.A., A.S. Gentzke, M.D. Sawdey, “E-cigarette use among youth in the United States, 2019,” JAMA,
322(21);2095-2103, 2019.
At the same time, FDA is aware that approximately 9 million adults
currently use e-cigarettes.79
79 Creamer, M.R., “Tobacco Product Use and Cessation Indicators Among Adults- United States 2018,” Morbidity
and Mortality Weekly Report, 68:1013-1019, 2019, available at:
https://www.cdc.gov/mmwr/volumes/68/wr/pdfs/mm6845a2-H.pdf.
Studies have shown that the majority of adult e-cigarette users use
flavored e-cigarettes and there is some evidence to suggest that flavored e-cigarettes may
improve switching from cigarette smoking to using e-cigarettes, compared to non-flavored e-
cigarettes.80
80 Russell, C. et al. “Changing Patterns of First E-Cigarette Flavor Used and Current Flavors Used by 20,836 Adult
Frequent E-Cigarette Users in the USA,” Harm Reduction Journal, 15(1):33-47, 2018; Bonhomme, M.G. et al.
“Flavoured Non-Cigarette Tobacco Product Use Among US Adults: 2013–2014,” Tobacco Control, 25(Suppl 2):4–
13, 2016.
FDA seeks both (1) to avoid foreclosing, even if temporarily, one potential means by which
some adult smokers might seek to transition completely away from combusted tobacco products
to potentially less harmful tobacco products; and (2) to prevent minors’ access to ENDS
products. FDA believes that this policy strikes an appropriate balance between restricting youth
access to ENDS products and maintaining availability of potentially less harmful options for
current and former adult smokers who have transitioned or wish to transition completely away
from combusted tobacco products.81
81 FDA notes that no ENDS product has been approved by FDA as a drug for smoking cessation. However, the
premarket review process for ENDS products will provide an opportunity for FDA to further examine the potential
of an ENDS product to meet the tobacco product premarket authorization standard of “appropriate for the protection
of public health,” including adult decisions to completely transition away from use of combustible products to
potentially less harmful ENDS products or other non-combustible forms of nicotine delivery.
Moreover, the prioritization of flavored, cartridge-based products articulated in Section D.1
above, and the prioritization of all other flavored ENDS product sold without adequate measures
to prevent youth access, should have minimal impact on those vape shops that primarily sell non-
cartridge-based ENDS products and that ensure purchasers are of the requisite age and not
purchasing for resale (e.g., are not purchasing in large quantities). Should evidence indicate to
the contrary, the Agency will take appropriate action.
3. 	Any ENDS product that is targeted to minors or whose marketing is likely to promote use
of ENDS by minors
Many ENDS products have been and continue to be marketed to minors through a wide variety
of media and technology, and their labels and labeling, print advertising, and/or online
advertising are appealing to minors. Unlike combusted cigarettes and smokeless tobacco
products, for which advertising through television and radio (and any other medium of electronic
Health, 2016. Analysis run on October 12, 2018. SAMHSA’s public online data analysis system (PDAS). (Original
Data Source: NSDUH 2016)

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communication subject to regulation by the Federal Communications Commission) has been
prohibited since 1971 and 1986 respectively,82
82 15 U.S.C. § 1335 (“It shall be unlawful to advertise cigarettes or little cigars on any medium of electronic
communication subject to the jurisdiction of the Federal Communications Commission”); 15 U.S.C. § 4402(c)
(same, for smokeless tobacco).
ENDS products are advertised through television,
radio, and online.83
83 U.S. Department of Health and Human Services, “E-Cigarette Use Among Youth and Young Adults. A Report of
the Surgeon General,” 2016.
Social media accounts are frequently used to electronically share tobacco-
product-related content with other minors.84
84 See Chu, K.-H., J.B. Colditz, B.A. Primack, et al., “JUUL: Spreading Online and Offline,” Journal of Adolescent
Health, 63(5), 582-586, 2018.
Sales of such products to minors are prohibited, and
FDA is concerned with actions likely to promote unlawful sales and maintain or increase youth
use. FDA has issued joint warning letters with the FTC to four firms that manufacture, advertise
and offer for sale or distribution several flavored e-liquid products for violations related to online
posts by social media influencers on each company’s behalf.85
85 FDA News Release, “FDA, FTC take action to protect kids by citing four firms that make, sell flavored e-liquids
for violations related to online posts by social media influencers on their behalf,” June 7, 2019, available at:
https://www.fda.gov/news-events/press-announcements/fda-ftc-take-action-protect-kids-citing-four-firms-make-sell-
flavored-e-liquids-violations-related.
This type of marketing is
especially concerning because longitudinal data from Waves 1 (2013-2014) and 2 (2014-2015)
of the PATH Study show that engagement with online tobacco marketing is a risk factor for
adolescent tobacco use, as adolescents who engaged with online tobacco marketing had greater
incidences of initiating tobacco use, increased frequency of use and progression to poly-product
use, and lower incidences of cessation compared to those who do not engage.86
86 Soneji, S., J. Yang, K.E. Knutzen, et al., “Online Tobacco Marketing and Subsequent Tobacco Use,” Pediatrics,
141(2):e20172927, 2018; doi:10.1542/peds.2017-2927.
Researchers have found that certain marketing strategies can increase youth appeal, both in
general and with respect to tobacco products in particular. FDA has previously issued warning
letters for products that resemble kid-friendly foods and drinks or that resemble other non-ENDS
products that are often consumed by youth.87
87 E.g., “E-Liquids Misleadingly Labeled or Advertised as Food Products,” available at:
https://www.fda.gov/tobaccoproducts/newsevents/ucm605729.htm; “FDA In Brief: FDA warns companies to stop
making, selling or distributing e-liquids marketed to resemble prescription cough syrups,” available at:
https://www.fda.gov/news-events/fda-brief/fda-brief-fda-warns-companies-stop-making-selling-or-distributing-e-
liquids-marketed-resemble.
This includes labeling and/or advertising that
results in the product resembling juice boxes, candy, or kid-friendly cereal. Actions by
manufacturers to present their ENDS products in this way are likely to promote youth use, and
also present a risk of confusion that could be harmful to children, including the risk of accidental
poisoning.88
88 See, e.g., Kamboj, A., H.A. Spiller, M.J. Casavant, et al., “Pediatric Exposure to E-Cigarettes, Nicotine, and
Tobacco Products in the United States,” Pediatrics, 2016;137(6):e2016004.
Other marketing conduct likely to promote youth use includes the use of cartoons
as part of e-cigarette manufacturers’ and retailers’ logos, marketing materials, promotions,89
89 Allem, J.-P., T. B. Cruz, J.B. Unger, et al., “Return of cartoon to market e-cigarette-related products,” Tobacco
Control, 0, 1-3, 2018; doi:10.1136/tobaccocontrol-2018-054437 (2018); Jackler, R. K., & Ramamurthi, D.,

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Instagram posts,90
90 Allem, J.-P., T.B. Cruz, J.B. Unger, et al., “Return of cartoon to market e-cigarette-related products,” Tobacco
Control, 0, 1-3, 2018; doi:10.1136/tobaccocontrol-2018-054437.
and video advertisements.91
91 Padon, A. A., Maloney, E. K., & Cappella, J. N., “Youth-targeted e-cigarette marketing in the US,” Tobacco
Regulatory Science, 3(1):95-101, 2017; doi:10.18001/TRS.3.1.9.
Cartoon figures are frequently used on product
packaging and in television advertising to promote youth consumption of consumer goods.92
92 Ethan, D., C.H. Basch, L. Samuel, et al., “An examination of product packaging marketing strategies used to
promote pediatric multivitamins,” Journal of Community Health, 40(3), 564-568, 2015; doi:10.1007/s10900-014-
9972-1; Kraak, V. I., & Story, M., “Influence of food companies' brand mascots and entertainment companies'
cartoon media characters on children's diet and health: a systematic review and research needs,” Obesity Reviews,
16(2), 107-126, 2015.
A
common theme discussed in food and beverage industry publications has been using cartoons in
marketing and packaging consumer products to target children and teenagers.93
93 Barrey, S., M. Baudrin, & F. Cochoy, “From fun foods to fun stores,” Young Consumers, 11(2);138-147, 2010;
Cioletti, J., “Cereal thrillers,” Supermarket Business Magazine, 56(10):30, 2001; Cioletti, J., “Future of... youth
marketing,” Beverage World, 122(8), 10 (2003); Cvetan, D., “Active market for active cultures,” Dairy Field,
183(4):18, 2000; Fry, J., “Moo kids on the block say they've got more than the white stuff,” Beverage World,
114(1596):1, 1995; Landi, H., “High Tea,” Beverage World, 130(7):18-22, 2011; Steinriede, K., “The year's best
packaging,” Beverage Industry, 91(12): 34, 2000; White, L., “A license for profits,” Professional Candy Buyer,
19(6):19-21, 2011.
Another
marketing strategy that has been recently employed by manufacturers is labeling, advertising,
and/or product design that results in the ENDS product resembling ordinary items that may not
draw the attention of adults.94
94 See, e.g., Ramamurthi, D., C. Chau,, R.K. Jackler, “JUUL and Other Stealth Vaporisers: Hiding the Habit From
Parents and Teachers,” Tobacco Control, Sept. 2018, doi: 10.1136/tobaccocontrol-2018-054455.
Similar marketing conduct likely to promote youth use includes
labeling and/or advertising highlighting how the product is ‘stealth’ or ‘secret’ and in the form of
ordinary objects that may not be readily recognized by parents or teachers.95
95 Id.
Any efforts to entice minors to use tobacco products are of concern to FDA. FDA intends to
prioritize its enforcement to focus on products that are targeted to minors or likely to promote
use of ENDS by minors. Some examples of such products include:
• 	Products marketed with labeling and/or advertising that resemble kid-friendly foods and
drinks or resemble other non-ENDS products that are often marketed and/or appealing to
youth. This includes, for example, labeling and/or advertising that results in the product
resembling juice boxes, candy, or kid-friendly cereal; and/or
• 	Products marketed directly to minors by promoting ease of concealing the product or the
nature of the product as a tobacco product from parents, teachers, or other adults; and/or
• 	Products marketed with youth-appealing cartoon or animated characters, such as those
that depict or resemble popular children’s characters; and/or
“Unicorns cartoons: marketing sweet and creamy e-juice to youth,” Tobacco Control, 26(4), 471-475, 2017;
doi:10.1136/tobaccocontrol-2016-053206; Kirkpatrick, M. G., T.B. Cruz, N.L. Goldenson, et al., “Electronic
cigarette retailers use Pokémon Go to market products,” Tobacco Control, 26(e2), e145, 2017;
doi:10.1136/tobaccocontrol-2016-053369 (2017); Padon, A. A., E.K. Maloney & J.N. Cappella, “Youth-targeted e-
cigarette marketing in the US,” Tobacco Regulatory Science, 3(1), 95-101, 2017; doi:10.18001/TRS.3.1.9.

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• 	Products marketed, including through paid social media influencers, with popular
children’s characters and titles (e.g., popular children’s YouTube channels, television
shows, or characters). This includes, for example, the use of minors or people who
portray minors on such shows and their associated show titles.
4. 	Any ENDS product that is offered for sale in the United States after September 9, 2020.
The U.S. District Court for the District of Maryland has ordered that premarket applications for
all deemed new tobacco products on the market as of August 8, 2016, be submitted by
September 9, 2020. Even in the absence of this court order, FDA would prioritize enforcement
of any ENDS product that lacks a premarket application after September 9, 2020, for the reasons
described in this guidance. For ENDS products other than those described in D.1 – D.3 above, if
premarket applications are submitted by September 9, 2020, FDA intends to continue to exercise
enforcement discretion for up to one year pending FDA review, unless there is a negative action
by FDA on such application. A negative action would consist of the issuance of a Refuse to
Accept (RTA), Refuse to File (RTF), and/or No Marketing Order (NMO); or of a letter
administratively closing the application, or cancelling the application if FDA finds that it
mistakenly accepted the application or that the application was submitted in error. In addition,
the other enforcement priorities discussed in this guidance would apply to such products,
regardless of whether or not a premarket application has been submitted for the product.
We note that the March 2019 Draft Guidance had included August 8, 2021, as the date for which
FDA would prioritize enforcement for flavored ENDS products that had not submitted premarket
applications. A number of comments expressed concern about the impact of the August 2021
date on businesses. For example, several commenters argued that any restriction on the sale or
distribution of ENDS products could result in companies going out of business. On the other
hand, FDA received many comments suggesting that in light of the problem of increasing youth
access and use of ENDS products, FDA should begin enforcing the premarket authorities as
applied to deemed new tobacco products earlier than August 8, 2021. Several comments
remarked that FDA should have begun enforcing the premarket review requirements against
ENDS products already, that FDA’s previous premarket review compliance date extensions
enabled some companies to “delay or circumvent areas of regulatory compliance,” and that
further delays were contrary to public health.
Although FDA considered the potential impact of the draft compliance policy on businesses
large and small, we note that, pursuant to the Tobacco Control Act, as of the effective date of the
final deeming rule, ENDS products were required to have premarket authorization prior to
marketing. While some deemed new tobacco products remained on the market in light of FDA’s
deferred enforcement policy, such policies are subject to change. Manufacturers cannot have
settled expectations to market unlawful products, especially in the face of evolving public health
concerns. Therefore, FDA believes that manufacturers should have begun contemplating and/or
preparing premarket applications no later than the time of the final deeming rule. As discussed
in Section II.B of this Final Guidance, FDA has repeatedly publicly discussed the fact that
enforcement discretion timelines for deemed tobacco products were under reconsideration and
solicited views from stakeholders. Manufacturers may obtain information about the application

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process from the statutory criteria, as well as published guidances, webinars, and marketing
orders and their accompanying documentation provided by FDA.96
96 For more information on premarket tobacco product applications please see Premarket Tobacco Product
Applications for [ENDS], Guidance for Industry (June 2019), available at https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/premarket-tobacco-product-applications-electronic-nicotine-delivery-
systems-ends; Applications for Premarket Review of New Tobacco Products (updated June 2019) available at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/applications-premarket-review-new-
tobacco-products. For more information on CTP’s other published regulations and guidances, please see
https://www.fda.gov/tobacco-products/products-guidance-regulations/rules-regulations-and-guidance; for more
information on FDA CTP webinars, please see https://www.fda.gov/tobacco-products/compliance-enforcement-
training/fda-tobacco-compliance-webinars; for information on marketing orders and accompanying documentation,
please see https://www.fda.gov/tobacco-products/compliance-enforcement-training.
Under the circumstances, FDA believes that earlier enforcement of the premarket review
provisions is appropriate for ENDS products. This policy should result in earlier submission of
applications and allow FDA to better evaluate whether these products meet the applicable
premarket standard, such as whether the products are appropriate for the protection of the public
health, considering the risks and benefits to the population as a whole, including users and
nonusers of the tobacco product. Because of FDA’s concerns regarding youth use of ENDS
products, as well as other ongoing health concerns regarding vaping more generally, all
described at length above, FDA is prioritizing enforcement of premarket review requirements for
ENDS products, as described in this section, and is doing so independently of the court order.
This will ensure that FDA has the necessary information to exercise adequate, timely oversight
over these relatively novel and potentially harmful products. Enforcing premarket authorization
requirements will, consistent with the process set forth in the Tobacco Control Act, ensure that
the burden falls on manufacturers of ENDS products to demonstrate that the manufacture and
sale of their products is appropriate for the protection of the public health.
E. Avoiding a “Black Market”
FDA is aware of concerns that, given the rise in popularity of ENDS, removal of some of the
most popular products from the market may be accompanied by an increase in black market
versions of these products that may pose additional health and safety risks to consumers beyond
those of the authentic products. Although all newly deemed products currently on the market
without premarket authorization are being sold in violation of the Tobacco Control Act, in this
section, we use the term “black market” to refer to, for example, products intended to look like
another ENDS products that is currently being marketed, products intended to take the place of
an ENDS product that a manufacturer has stopped distributing because the product lacks
premarket authorization, and ENDS products intended for another country’s market but diverted
to the U.S. market. Additional risks posed by these products include the potential that they
contain harmful chemicals or constituents that are not present in other products, that they are
manufactured using comparatively poor quality controls, and that they are designed in ways that
facilitate modifications by distributors or users—all of which increase the risk of adverse
events.97
97 E.g., “Amid Vaping Deaths, California Targets Counterfeit Products,” The New York Times (Sept. 17, 2019),
available at https://www.nytimes.com/2019/09/16/us/california-vaping.html; “‘Juul-alikes’ Are Filling Shelves With
Moreover, to the extent that such products are sold through nontraditional retail

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channels, such as social sources or online commercial marketplaces that do not include age-
verification requirements, they pose an increased risk of being accessed by minors.
FDA has regulatory tools and enforcement authorities to address ENDS and other tobacco
products that are marketed without authorization, that are counterfeit, and/or that are otherwise
involved in illicit trade.98
98 See, e.g., sections 301, 902, 903, 905, 910, and 920 of the FD&C Act.
FDA has previously issued letters to companies suspected of
marketing counterfeit or otherwise unauthorized products.99
99 E.g., “Statement from FDA Commissioner Scott Gottlieb, M.D., on forceful new actions focused on retailers,
manufacturers to combat youth access to e-cigarettes as part of FDA’s Youth Tobacco Prevention Plan,” available
at: https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-forceful-
new-actions-focused-retailers-manufacturers.
Additional potential actions against
adulterated or misbranded illicit tobacco could include: (1) issuing a Warning Letter; (2) issuing
an import alert and refusing admission of tobacco products imported or offered for import into
the United States; and (3) initiating seizure or injunction court actions. Persons engaging in
illicit trade in tobacco products may also be criminally prosecuted under the law.
As a result of this policy, FDA will be better situated to combat black market products, including
those that are particularly troubling from a public health or safety perspective, such as counterfeit
pods entering the country at the border or being sold through illicit, online channels. By
prioritizing our focus as outlined in Section IV.D, the Agency can target our supply chain
surveillance and investigation resources on the types of ENDS products that are likely to be
subject to counterfeiting and/or sale on the black market. As a result, we will be able to more
efficiently and effectively deploy our enforcement tools to get counterfeit and black market
products off the market. Moreover, FDA believes that there are significant public health benefits
of the policy set forth in this guidance, which is aimed at curbing the dramatic rise in youth use
of ENDS products and will help address safety issues connected to ENDS products that are not
fully understood—e.g., the development of acute or chronic lung injuries associated with use of
vaping products as well as battery explosions with ENDS products—particularly given that these
products have been marketed without premarket evaluation. These current public health issues
affirm the importance of the premarket review process, as contemplated by the Tobacco Control
Act, to scientifically evaluate products based on a public health standard.
V. 	PREMARKET REVIEW FOR OTHER DEEMED NEW TOBACCO PRODUCTS
FDA remains concerned with minors’ access to and use of all tobacco products, particularly
flavored tobacco products, which appeal to minors and promote initiation.100
100 U.S. Department of Health and Human Services, “E-cigarette Use Among Youth and Young Adults: A Report of
the Surgeon General,” 2016; Villanti, A.C., A.L. Johnson, B.K. Ambrose, et al., “Flavored Tobacco Product Use in
Youth and Adults: Findings From the First Wave of the PATH Study (2013-2014),” American Journal of
Preventive Medicine, 53(2); 139-151, 2017.
In addition to the
Sweet, Teen-Friendly Nicotine Flavors” The New York Times (Aug. 13, 2019), available at
https://www.nytimes.com/2019/08/13/health/juul-flavors-nicotine.html; Omaiye, E.E., I. Cordova, B. Davis, et. al.,
“Counterfeit Electronic Cigarette Products with Mislabeled Nicotine Concentrations,” Tobacco Regulatory Science,
3(3): 347–357, 2017.

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tobacco products covered earlier in this guidance document, FDA has considered revising its
enforcement priorities with respect to premarket authorization for other deemed new tobacco
products. We note that several comments on the March 2019 Draft Guidance suggested that
FDA begin immediately enforcing the premarket requirements for flavored deemed tobacco
products such as cigars and other deemed tobacco products.
FDA received numerous comments relating to the proposed policy for flavored cigars in the
March 2019 Draft Guidance. Some of the comments were supportive of that proposed policy,
although some wanted the Agency to take even more aggressive action. Other comments
opposed inclusion of flavored cigars as an enforcement priority and disagreed with the bases for
the proposed policy. For example, some commenters argued that flavored cigars are used most
commonly by adult users and that the inclusion of flavored cigars as an enforcement priority
limits adults’ freedom to choose their preferred product. Other commenters argued that FDA did
not have the data necessary to support the need for “a drastic and unprecedented change in
enforcement priorities.” Some commenters also stated that the evidence cited by FDA
discussing initiation of youth usage of flavored cigars was inconsistent and inconclusive. After
consideration of the data regarding youth use of cigars generally and comments received on this
issue, we have decided to not prioritize enforcement of flavored cigars before September 9,
2020. While there is no public health benefit associated with flavored cigars and FDA remains
concerned with youth use of flavored cigars, current data indicate that youth are using flavored
cigars at a lower rate than they are using flavored ENDS products.
Comments regarding deemed tobacco products other than ENDS products and cigars, such as
waterpipe tobacco (hookah) products, also provided data showing the use of such tobacco
products among high school students and stating that evidence reflects that flavors for these
tobacco products entice youth. However, such data do not appear to raise comparably urgent
public health concerns, as the lower prevalence of youth use of these products suggests that they
do not appear to be as appealing to youth at this time.
Accordingly, at this time, FDA has decided to prioritize use of its limited enforcement resources
to address the sudden and dramatic increase in youth use of ENDS products, as well as to focus
on health and safety concerns connected to ENDS products such as vaping-associated lung
injuries. While acknowledging that all new tobacco products on the market without the required
authorization are marketed unlawfully and are potentially subject to enforcement action, at any
time, in FDA’s discretion, FDA’s primary focus will be to address the sudden and dramatic
increase in youth use of ENDS products, and the products covered by this section of the
guidance will therefore be a lower priority.
We have decided not to prioritize enforcement of the tobacco products covered by this section
before September 9, 2020. Manufacturers of flavored cigars, however, just like manufacturers of
all other deemed new tobacco products, will be required to submit marketing applications for
those products by September 9, 2020, consistent with the U.S. District Court for the District of
Maryland’s order directing FDA to require that applications be submitted to the Agency by
September 9, 2020, for deemed new tobacco products on the market as of August 8, 2016, or be
subject to FDA enforcement actions, in FDA’s discretion. As part of the premarket review
process, FDA may evaluate, among other things, the product’s constituents, ingredients,

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additives, and properties; manufacturing practices; and any studies or investigations into the
health risks of the tobacco product. FDA also has stated its intention to issue a regulation that
would ban the use of characterizing flavors in cigars, and FDA is actively working towards that
proposed rule.
After September 9, 2020, FDA will make enforcement decisions on a case-by-case basis,
recognizing that it is unable, as a practical matter, to take enforcement action against every
illegally marketed tobacco product, and that it needs to make the best use of Agency
resources. FDA intends to prioritize enforcement based on the likelihood of youth use or
initiation to make the most efficient use of its resources. In assessing this, factors the Agency
intends to consider include, but are not limited to:
• 	What FDA understands about the number of youth currently using the product or
category of product;
• 	The trends in those numbers, particularly since 2016;
• 	Whether the product contains added flavors;
• 	What FDA understands about how the product or category of product is typically sold
and how that is likely to impact access and use by minors; and
• 	What FDA understands about the frequency and other demographics of use by minors.
To illustrate, based on these factors, FDA’s lowest priority among these products will include
relatively expensive, large hand-rolled cigars that do not have flavors (e.g., fruit, candy, or mint),
given what FDA understands to be their comparatively lower youth usage rates.
* 	* 	*
FDA is continuously evaluating new information and adjusting its enforcement priorities in light
of the best available data, and it will continue to do so with respect to these products. FDA will
take appropriate action regarding tobacco products that are marketed without premarket
authorization, including as warranted based on changed circumstances, new information, or to
better address minors’ use of those products.
VI. 	DOCUMENT HISTORY
January 2020 – First edition of guidance issued.
April 2020 – Guidance is revised to reflect the court’s order in American Academy of Pediatrics,
et al. v. Food and Drug Administration, et al., Case No. 8:18-cv-883 (PWG), (D. Md. Apr. 22,
2020), Dkt. No. 182, granting a motion for a 120-day extension (until September 9, 2020) in
light of the global outbreak of respiratory illness caused by a new coronavirus. Specific
revisions include the following:
• 	Section II.A – Added reference to order granting 120-day extension.
• 	Section IV.A (and throughout) – Changed language stating that FDA’s new enforcement
priorities would begin “30 days after issuance of this Final Guidance” to “February 6,

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2020,” which is 30 days after the Notice of Availability announcing the Final Guidance
was published.
• 	Section IV.A (and throughout document) – Changed “May 12, 2020” to “September 9,
2020.”

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APPENDIX A – SIGNIFICANT COMMENTS RECEIVED IN RESPONSE TO MARCH
2019 DRAFT GUIDANCE AND FDA RESPONSES
Legal and statutory framework issues
Comment 	Response
FDA should engage in legislative rulemaking
process
• 	The draft guidance constituted a major
rule and FDA has not followed procedures
established by the Administrative
Procedure Act (APA) governing the
promulgation of rules
• 	The Regulatory Flexibility Act requires an
analysis of a proposed rule’s impact on
small business and FDA has not conducted
such an analysis
• 	FDA is bypassing the requirement to
conduct a cost benefit analysis by issuing a
guidance instead of formal rule
• 	FDA has not considered regulatory
alternatives to the approach outlined in
the draft guidance
• 	This action would impose costs and
adverse effects on industry which
constitutes a major rule which should be
subject to the requirements under the
Congressional Review Act
• 	Though guidance documents are non-
binding, the way the guidance is written,
retail outlets would need to comply with
standards suggested by the draft guidance
as though they were law
• 	Engaging in rulemaking would offer more
substantial opportunity for stakeholders to
provide public comments and would
provide clarity on what stakeholders
(through the supply and retail chain)
needed to do to come into compliance
The Final Guidance is a statement of policy that
discusses the enforcement of premarket authorities
already existing in the statute. It does not establish
any rights for any person, is not binding on FDA or the
public, and is not subject to requirements of the
Regulatory Flexibility Act or the notice-and-comment
provisions of the APA. Historically, FDA has not
analyzed the economic effects of enforcement
guidance, including for reasons such as difficulty in
predicting such effects. Alternatives such as issuing
warning letters and other enforcement techniques
have been considered and used by the Agency.
Despite this, as shown by the data highlighted in the
Final Guidance, the rate of youth use of tobacco
products (particularly fruit- and candy-flavored and
mint-flavored ENDS products) has dramatically
increased. FDA retains discretion to enforce
premarket authorities.
The relevant substantive requirements are those
governing premarket authorization as set forth in
Section 910. The Final Guidance does not impose new
restrictions, for retailers or manufacturers, but rather
discusses FDA’s enforcement priorities for existing
statutory requirements. In Section 910, Congress
placed the onus on manufacturers to demonstrate
that the marketing of a tobacco product is appropriate
for the protection of the public health, taking into
account, among other things, the likelihood that those
who do not use tobacco products will start using
them.
FDA provided for a 45-day period for comment on the
draft guidance, and interested parties may continue to
submit comments after publication of the final
guidance, providing a substantial opportunity for
public input.
FDA is bypassing statutory restrictions on its
discretionary enforcement authority and
obligations related to rulemaking, by threatening
selective enforcement of its premarket
authorization authority.
FDA has discretion to decide how when to enforce its
premarket authorization authorities under the FD&C
Act. See Heckler v. Chaney, 470 U.S. 821, 835 (1985).
The Final Guidance is a statement of policy that

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outlines FDA’s enforcement priorities with respect to
such requirements.
Guidance should conform to Section 907.
• 	Actions in this guidance should conform to
Section 907, which obligates FDA to
consider factors not addressed by the
guidance, including technical achievability
and countervailing effects.
• 	FDA should not adopt modifications to
compliance policy but should instead
follow through with a rule that considers
the comments from FDA’s ANPRM on
Flavors in Tobacco Products.
Section 907 refers to tobacco product standards. This
Final Guidance is not setting tobacco product
standards, such as a tobacco product standard
restricting or eliminating the use of flavors in ENDS.
Instead, it is explaining FDA’s enforcement priorities
for premarket review requirements already included in
the Tobacco Control Act. A flavored product could be
marketed consistent with this guidance if it meets the
statutory standards for authorization. For example, in
April 2019, FDA authorized the marketing of a
menthol-flavored IQOS heat-not-burn cigarette
product through the PMTA pathway.101
101 For more information please see https://www.fda.gov/news-events/press-announcements/fda-permits-sale-iqos-
tobacco-heating-system-through-premarket-tobacco-product-application-pathway.
FDA is supposed to be an advisory agency, not a
regulatory agency, and its actions are an
overreach.
The Tobacco Control Act provides FDA with regulatory
authority over tobacco products.
FDA’s proposed actions are arbitrary and
capricious because it has failed to provide
adequate reasoning/scientific reasoning/used
incomplete or incorrect data.
The enforcement priorities explained in the Final
Guidance are based upon and supported by, among
other things, multiple high-quality scientific data
sources (e.g., NYTS, PATH, MTF).
FDA has failed to connect the proposed policy to
an official finding that the actions were
“appropriate for the protection of public health.”
The Final Guidance discusses the enforcement of
premarket authorities already existing in statute.
Section 910 places the onus on manufacturers to show
that the marketing of a tobacco product would be
appropriate for the protection of the public health, not
on the FDA to show otherwise. The Tobacco Control
Act uses the term “appropriate for the protection of
the public health,” in section 910 and several other
provisions. The considerations identified in the
statute typically include analysis of whether the action
would increase or decrease the likelihood that existing
users of tobacco products would stop using such
products, and whether it would increase or decrease
the likelihood that those who do not use tobacco
products will start using the products. The Guidance
reflects these considerations.
FDA has been unresponsive/lack of clarity.
• 	Manufacturers have been relying on
guidance and information since the
deeming rule; this is a drastic departure
FDA has communicated its concerns regarding the
increase in youth access in public statements, the
March 2019 draft guidance, and requests for
information to manufacturers. FDA has consistently

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from deeming and guidances issued since
deeming.
• 	Difficult to keep track of FDA’s policies and
compliance requirements.
informed industry that its compliance policies will be
responsive to changed circumstances. There could be
no reasonable reliance on a deferred enforcement
policy subject to change at any time. The guidance
explains why the changed circumstances warrant this
prioritization; i.e., the substantial increase in youth use
of ENDS in addition to other health and safety
considerations. FDA has always stated (and the
Tobacco Control Act itself is clear) that deemed new
tobacco products are required to obtain premarket
authorization and that such products that remain on
the market without marketing authorization are
marketed unlawfully.
FDA has stated it will provide further guidance and
issue rules to make the product review process
more transparent and predictable but has not
done so.
FDA has provided guidance and information to
industry on the premarket pathways through
publishing guidances and marketing orders, as well as
posting information via webinars and public
workshops.102
102 For more information on premarket tobacco product applications please see Premarket Tobacco Product
Applications for [ENDS], Guidance for Industry (June 2019), available at https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/premarket-tobacco-product-applications-electronic-nicotine-delivery-
systems-ends; Applications for Premarket Review of New Tobacco Products (updated June 2019) available at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/applications-premarket-review-new-
tobacco-products. For more information on CTP’s other published regulations and guidances, please see
https://www.fda.gov/tobacco-products/products-guidance-regulations/rules-regulations-and-guidance; for more
information on FDA CTP webinars, please see https://www.fda.gov/tobacco-products/compliance-enforcement-
training/fda-tobacco-compliance-webinars; for information on marketing orders and accompanying documentation,
please see https://www.fda.gov/tobacco-products/compliance-enforcement-training.
The statute also informs the public of
the information needed in a premarket tobacco
product application. Industry members have
successfully obtained marketing authorization orders
with information currently available.
Draft guidance would have unjustifiable
retroactive effects on industry actors who were “in
compliance” with FDA’s previous policy.
This Final Guidance would only affect those products
that are illegally on the market; none of the products
affected by the guidance were ever in compliance with
the premarket authorization requirements of the law.
FDA has consistently informed industry that its
compliance policies will be responsive to changed
circumstances. As discussed in the guidance, FDA
stated in the notice of proposed rulemaking for the
Deeming Rule, that the overall public health impact of
ENDS products would depend crucially upon “who
uses the products and how they are used. If such
products result in minimal initiation by children and
adolescents while significant numbers of smokers quit,
then there is a potential for the net impact at the

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36
population level to be positive. If, on the other hand,
there is significant initiation by youth, minimal
quitting, or significant dual use of combust[ed] and
non-combust[ed] products, then the public health
impact could be negative.” As such policies are
subject to change, manufacturers cannot have settled
expectations to market unlawful products, especially
in the face of evolving public health concerns.
Therefore, FDA believes that manufacturers should
have begun contemplating and/or preparing
premarket applications at no later than the time of the
final deeming rule.
Draft guidance will kill innovation and force
industry out of work.
FDA disagrees that the Final Guidance will cause these
results. The Final Guidance explains FDA’s
enforcement priorities for certain deemed new
products that are being marketed without required
premarket tobacco product authorization. The Final
Guidance would only affect those products that are
illegally on the market; none of the products affected
by the guidance were ever in compliance with the
premarket authorization requirements of the law. In
any event, FDA believes that the use of premarket
pathways will incentivize development of innovative
tobacco products that meet the applicable statutory
standards.
Draft guidance policy on marketing practices
would violate the First Amendment as it
represents an impermissibly broad commercial
speech restriction.
FDA disagrees that the Final Guidance violates the
First Amendment. Speech regarding an illegal activity
– including distribution of a product that requires
premarket review under the FDCA – is not protected
under the First Amendment. See United States v.
Caputo, 517 F.3d 935, 941 (7th Cir. 2008) (unapproved
device); United States v. LeBeau, 654 Fed. App’x 826,
831 (7th Cir. 2016) (unapproved drug); United States v.
Cole, 84 F. Supp. 3d 1159, 11-66-67 (D. Or. 2015)
(unapproved drug). Even if the First Amendment were
applicable, the government has a substantial interest
in protecting youth from tobacco products, and
prioritizing enforcement actions with respect to ENDS
products targeted to, or likely to promote use by,
minors is a reasonable measure to directly advance
that interest. See, e.g., Discount Tobacco City &
Lottery, Inc. v. United States, 674 F.3d 509, 536 (6th
Cir. 2012). We have provided additional examples for
clarity in the Final Guidance.
Modifications to ENDS Compliance Policy – Flavored ENDS except Tobacco, Mint, Menthol
Comment 	Response

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37
There is no evidence/limited evidence to connect
liquid nicotine use with harmful health effects in
youth.
As discussed in the Final Guidance the studies of the
effects of nicotine exposure in the naïve adolescent
brain find that the adolescent brain is uniquely
vulnerable to nicotine compared to the adult brain.
Repeated exposure to nicotine during adolescence
induces long-lasting structural and functional changes
in brain regions involved in addiction, attention,
learning, and memory.103
103 McDonald, C.G., A.K. Eppolito, J.M. Brielmaier, et. al., “Evidence for elevated nicotine-induced structural
plasticity in nucleus accumbens of adolescent rats,” Brain Research, 1151, 211-218, 2007; doi:
10.1016/j.brainres.2007.03.019; Bergstrom, H.C., R.F. Smith,, N.S. Mollinedo, et al., “Chronic nicotine exposure
produces lateralized, age-dependent dendritic remodeling in the rodent basolateral amygdala,” Synapse, 64(10), 754-
764, 2010; doi:10.1002/syn.20783; England, L.J., K. Aagaard, M. Bloch, et al., “Developmental toxicity of
nicotine: a transdisciplinary synthesis and implications for emerging tobacco products,” Neuroscience and
Biobehavioral Reviews, 72:176-189, 2017.
Studies further suggest that nicotine-induced changes
in the adolescent brain can lead to long-lasting effects
on cognitive function, such as cognitive deficits
following nicotine abstinence, and may contribute to
the risk for mood and anxiety disorders. Nicotine is the
primary addictive substance in tobacco products,
including e-cigarettes and combustible cigarettes. The
rate and extent of nicotine delivery significantly
impact product abuse liability. Higher nicotine content
and faster rates of nicotine delivery increase products’
abuse liability due to the rapid absorption of nicotine
into the brain. Some e-cigarettes are capable of
achieving similar or greater nicotine delivery as
cigarettes.104
104 Hiler, M., A. Breland, T. Spindle, et al., “Electronic cigarette user plasma nicotine concentration, puff
topography, heart rate, and subjective effects: Influence of liquid nicotine concentration and user experience,”
Experimental and Clinical Pharmacology, 25(5), 380-392, 2017; doi:10.1037/pha0000140; Lopez, A.A., M.M.
Hiler, E.K. Soule, et al., “Effects of Electronic Cigarette Liquid Nicotine Concentration on Plasma Nicotine and Puff
Topography in Tobacco Cigarette Smokers: A Preliminary Report,” Nicotine & Tobacco Research, 18(5):720-723,
2016; doi:10.1093/ntr/ntv182; Maloney, S. F., A. Breland, E.K. Soule, et al. “Abuse liability assessment of an
electronic cigarette in combustible cigarette smokers,” Experimental and Clinical Psychopharmacology, 27(5):443-
454, 2019; doi:10.1037/pha0000261; O’Connell, G., J.D. Pritchard, C. Prue, et al, “A randomised, open-label, cross-
over clinical study to evaluate the pharmacokinetic profiles of cigarettes and e-cigarettes with nicotine salt
formulations in US adult smokers,” Internal and Emergency Medicine, 14(6):853-861, 2019; doi:10.1007/s11739-
019-02025-3; Ramoa, C. P., M.M. Hiler, T.R. Spindle, et al. “Electronic cigarette nicotine delivery can exceed that
of combustible cigarettes: a preliminary report,” Tobacco Control, 25(e1): e6-9, 2016; doi:10.1136/tobaccocontrol-
2015-052447; Yan, X. S., & C. D’Ruiz, “Effects of using electronic cigarettes on nicotine delivery and
cardiovascular function in comparison with regular cigarettes,” Regulatory Toxicology and Pharmacology, 71(1):24-
34, 2015; doi:10.1016/j.yrtph.2014.11.004.
“Banning” flavors outside of tobacco, mint, and
menthol would deter cigarette smokers from
The Final Guidance does not ban any products but
rather identifies FDA’s priorities in connection with the
enforcement of the statutory premarket review

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38
quitting or force smokers to restart smoking if they
have already quit.
• 	Smokers trying to quit smoking avoid
tobacco-, mint-, and menthol-flavored
products because they are too similar to
flavors of a traditional cigarette.
• 	Stricter policies for ENDS products for
youth should not come at expense of adult
users.
requirements. Moreover, the policy announced in the
Final Guidance does not prioritize any menthol-
flavored, tobacco-flavored, or non-flavored ENDS
products or any non-cartridge-based flavored ENDS
products for enforcement where the manufacturer is
taking adequate measures to prevent minors’ access
to these products. Additionally, consumers will be
able to access ENDS products (including flavored ENDS
products) that receive market authorization. Nicotine
replacement therapy products also remain available
for tobacco product users who may need assistance
with withdrawal symptoms and are also available in
several flavors.
Available research does not support the argument that
smokers trying to quit smoking and transition to ENDS
products avoid tobacco and menthol-flavored ENDS
products because they are too similar to traditional
cigarette flavors.
FDA has repeatedly emphasized that the availability of
non-combustible options should not come at the
expense of addicting a generation of children to
nicotine through these same delivery vehicles. FDA
believes that this policy strikes an appropriate balance
between preventing youth access to ENDS products
and maintaining availability of potentially less harmful
options for current adult smokers who have
transitioned or wish to transition completely away
from combusted tobacco products.
No basis for prioritizing flavored ENDS products.
• 	The policy will not be successful at keeping
kids from using these products; kids use
anything that is taboo and illegal.
• 	Youth are more attracted to these
products due to peer use than flavors.
• 	Youth use ENDS products for nicotine
delivery not for flavors.
• 	Only a correlative, not causal, relationship
between youth preference for flavors and
increased ENDS usage.
As discussed in the Final Guidance, data from 2018
NYTS as well as from 2019 Monitoring the Future
study and 2019 NYTS show a significant increase in
youth use of these products. Data also clearly show
that flavors are a primary driver in youth
experimentation with, and continued use of, ENDS
products, and that the flavored ENDS products
overwhelmingly used by youth are cartridge-based
products. The policy outlined in the Final Guidance
prioritizes enforcement of ENDS products that are
targeted to minors or likely to promote use of ENDS by
minors. FDA expects that this policy and others stated
in the guidance will make fewer products available and
more difficult for youth to obtain.
No basis for excluding tobacco, mint, and menthol
from prioritization.
The Final Guidance explains that FDA intends to
prioritize mint-flavored, cartridge-based ENDS
products (and any other flavored, cartridge-based

Contains Nonbinding Recommendations
39
• 	General increasing popularity of mint and
menthol ENDS products amongst youth
populations.
• 	Mint- and menthol-flavored products drive
youth ENDS usage.
• 	Flavors clearly increase appeal of ENDS
products and some flavors have toxic
effects and documented respiratory
toxicity.
ENDS product, other than tobacco- or menthol-
flavored ENDS products) for enforcement for lack of a
marketing authorization. The guidance also explains
that FDA intends to prioritize enforcement for lack of a
marketing authorization for any tobacco- or menthol-
flavored ENDS products and non-cartridge-based
flavored ENDS products when the manufacturer is not
taking adequate measures to prevent minors’ access
to these products. Data shows that tobacco- and
menthol-flavored ENDS products are not as appealing
to minors as other flavored ENDS products. While the
NYTS groups mint- and menthol-flavored products
together, a randomly-selected third of respondents to
the Monitoring the Future (MTF) study were asked
specifically about their preferred flavors of JUUL and
reported use of menthol- and tobacco-flavored
products were among the lowest ranked options.
Based on the available data and FDA’s interest in
balancing between preventing youth usage and
preserving options for adults trying to transition away
from combustible products, FDA is not prioritizing
enforcement against tobacco-, menthol-, and non-
flavored ENDS products or non-cartridge-based
flavored ENDS products except when the
manufacturer is not taking adequate measures to
prevent minors’ access to these products.
Prioritizing flavors for enforcement will create a
significant black market for “banned” flavors
outside those that are exempted.
By black market flavored products, we assume this
could refer to, for example, flavored ENDS products,
including e-liquids, put on the market after the
guidance, flavored ENDS products diverted from
another country’s market to the U.S market, and/or
flavored ENDS products made to look like another
ENDS product that is currently being marketed. FDA
has regulatory tools and enforcement authorities to
address deemed tobacco products that are marketed
without authorization, counterfeit, and/or otherwise
involved in illicit trade. See, e.g., sections 301, 902,
903, 905, 910, and 920 of the FD&C Act.
This Final Guidance describes the Agency’s
enforcement priorities for products that are on the
market without the required premarket
authorization—it does not ban any tobacco product—
and illicit ENDS products are necessarily subject to the
enforcement priorities identified in the guidance as
they do not have premarket authorization. Thus, FDA
believes that this policy will not significantly increase

Contains Nonbinding Recommendations
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illicit practices or create new illicit markets, and it
could help FDA better address such practices. Once
products receive premarket authorization, they can
legally enter the market.
FDA believes that there are significant public health
benefits of the policy set forth in the guidance, which
is aimed at curbing the dramatic rise in youth use of
ENDS products and will help address safety issues
connected to ENDS products that are not fully
understood—e.g., lung injuries associated with use of
vaping products as well as battery explosions with
ENDS products—particularly given that these products
have been marketed without premarket evaluation.
These current public health issues affirm the
importance of the premarket review process, as
contemplated by the Tobacco Control Act, to
scientifically evaluate products based on a public
health standard. FDA believes that by pursuing this
policy the Agency will be better able to monitor and
identify illicit cartridge-based products that are threats
to public health and safety. As flavored, cartridge-
based products exit the market until they are able to
demonstrate that they meet the applicable public
health standard and receive authorization, the number
of potential flavored, cartridge-based products that
could cause these threats will shrink to a more
manageable number for FDA to monitor. Thus, FDA
expects that to the extent any illicit markets were to
develop with respect to cartridge-based products in an
attempt to evade premarket review requirements, this
guidance will help FDA better address the public
health threats caused by such markets and the overall
public health benefits that will likely accrue as a result
of the guidance will be greater than any negative
effects of increased illicit markets. Moreover, FDA
does not believe that the Agency should refrain from
enforcing existing statutory authorities merely
because regulated entities could find other ways to
violate such authorities. The Agency can, and will,
continue to monitor the marketing and use of ENDS
and other tobacco products, and adjust its policies and
approaches as warranted.
Many other harmful products (e.g., alcohol) are
available in various flavors attractive to youth; it is
inconsistent to only prioritize for enforcement
flavored ENDS products.
The policy expressed in this Final Guidance is limited
solely to tobacco products over which FDA has
statutory authority. The focus of this guidance and the
Agency’s enforcement priorities is tobacco products,

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specifically certain ENDS products. Moreover, this
comment is about flavored alcohol products that are
lawfully on the market, whereas this guidance
concerns products being sold in violation of the
requirement to have premarket authorization, where
the product’s ingredients and additives are among the
considerations in the premarket review.
FDA should focus its enforcement priorities on
products that contain nicotine salts and/or should
specify differences between nicotine and nicotine
salts.
FDA believes that ENDS products containing nicotine
salts will be adequately addressed by the enforcement
priorities set in this Final Guidance.
Research is ongoing to better understand the abuse
liability associated with nicotine-salt based e-liquids
and new cartridge-style ENDS products, the potential
for initiation in youth and nonusers, and the potential
for switching from combusted cigarettes in current
smokers from use of these products. Preliminary
research indicates that nicotine salts in ENDS products
can drive nicotine exposures in users higher than ENDS
containing freebase nicotine; these exposures can also
be comparable to or potentially higher than
cigarettes.105
105 Goniewicz, M. L., R. Boykan, C.R. Messina, et al., “High exposure to nicotine among adolescents who use Juul
and other vape pod systems (‘pods’),” Tobacco Control, 28(6), 2019; doi:10.1136/tobaccocontrol-2018-054565;
Talih, S., R. Salman, R. El-Hage, et al, “Characteristics and toxicant emissions of JUUL electronic cigarettes,”
Tobacco Control, 28(6):678-680, 2019; doi:10.1136/tobaccocontrol-2018-054616; Teichert, A., P. Brossard, L.F.
Medlin, et al, “Evaluation of Nicotine Pharmacokinetics and Subjective Effects following Use of a Novel Nicotine
Delivery System,” Nicotine Tobacco Research, 20(4):458-465, 458-465; doi:10.1093/ntr/ntx093.
In addition to greater nicotine
exposures, ENDS with nicotine salts can have faster
absorption106
106 O’Connell, G., J.D. Pritchard, C. Prue, et al., “A randomised, open-label, cross-over clinical study to evaluate the
pharmacokinetic profiles of cigarettes and e-cigarettes with nicotine salt formulations in US adult smokers,” Internal
and Emergency Medicine, 14:853-861, 2019; doi:10.1007/s11739-019-02025-3.
and potentially faster elimination from
the blood.107
107 Bowen, A., & C. Xing, “Nicotine Salt Formulations for Aerosol Devices and Methods Thereof,” United States
Patent, Pub. No. US 2015/0020824, 2015,
https://patentimages.storage.googleapis.com/57/f8/7e/2db69f396801d5/US20150020824A1.pdf (visited Oct 8
2019).
These factors can increase the abuse
liability of ENDS with nicotine salts compared to
freebase nicotine, and potentially cigarettes.
The higher abuse liability of ENDS with nicotine salts
compared to freebase nicotine raises concerns of
addiction in youth, particularly due to the vulnerability
of the developing adolescent brain. However, for
many individual addicted cigarette smokers, the
potential for ENDS to act as a substitute for cigarettes,

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thereby encouraging smokers to seek to switch
completely away from combustible cigarettes, may be
dependent, in part, upon the product having
acceptability and abuse liability more comparable to a
cigarette.
The Final Guidance focuses FDA’s priorities on
flavored, cartridge-based ENDS products because data
show that flavors are a strong driver for youth use,
and that youth overwhelmingly prefer cartridge-based
ENDS products. However, FDA is continuously
evaluating new information and adjusting its
enforcement priorities in light of the best available
data, including any data on ENDS products containing
nicotine salts, and it will continue to do so with
respect to these products.
FDA should focus its enforcement priorities on
cartridge-based ENDS products.
FDA is concerned about the rising youth appeal and
use of ENDS products. The data show that flavors are
a strong driver for youth use, and that youth
overwhelmingly use cartridge-based ENDS products.
Accordingly, such products are a key focus of the Final
Guidance. FDA will, however, take appropriate action
regarding ENDS that are marketed without premarket
authorization, including as warranted based on
changed circumstances, new information, or to better
address minors’ use of those products.
Modifications to ENDS Compliance Policy – Offered for sale in ways that pose a greater risk for minors to
access such products
Comment 	Response
The Tobacco Control Act prohibits FDA from
restricting tobacco sales to a specific category of
retail outlets.
FDA is not restricting or even prioritizing enforcement
against ENDS products sold in a specific category of
retail outlets. Although the March 2019 Draft
Guidance proposed to focus its enforcement priorities
for flavored ENDS products on how the product was
sold (regardless of the type of retail establishment),
after considering the comments, the public health
threats, and new evidence, FDA determined that
focusing on how the product was sold would not be
sufficient to address youth use of these products.
Given the urgent need to address the dramatic rise in
youth use, this Final Guidance prioritizes enforcement
with respect to any flavored, cartridge-based ENDS
products (other than a tobacco- and menthol-flavored
ENDS product) without regard to the location or
method of sale.

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With respect to tobacco-, menthol-, and non-flavored
ENDS products as well as flavored cartridge-based
ENDS products, the Final Guidance states that FDA
does not intend to prioritize enforcement where
manufacturers have taken adequate measures to
prevent youth access. These types of measures
generally are among those that manufacturers have
informed FDA that they are capable of implementing
for ENDS products and none involve a specific
category of retail outlet.
Lack of clarity for retail locations
• 	Should retail locations have age
verification at their door or a separate
room for the sale of any ENDS products?
• 	Can retail locations employ less
burdensome alternatives?
• 	Concern that the policy could make
traditional cigarette products more easily
accessible than ENDS products.
• 	Need clarity on how manufacturers or
wholesalers can document adequate
measures to prevent youth access.
• 	How are retail outlets supposed to balance
space constraints with youth access
concerns?
• 	FDA should give existing enforcement
mechanisms the chance to succeed or
focus on enforcing existing mechanisms
before instituting new policy.
FDA has provided additional details regarding factors
that it intends to consider in assessing whether a
manufacturer is taking adequate measures to prevent
youth access. For example, the Final Guidance lists
several different types of programs to monitor
compliance with age-verification and sales restrictions,
all of which are programs that some manufacturers
have stated they are capable of implementing for
ENDS products. Unlike the Draft Guidance, it does not
include, as a factor for prioritization, whether the
product is sold by retailers in a location where minors
are able to enter at any time.
The March 2019 Draft Guidance proposed to focus its
enforcement priorities of flavored ENDS products on
how the product was sold (regardless of the type of
retail establishment). After considering the
comments, the public health threats, and new
evidence, FDA determined that, to address youth use
of these products, this Final Guidance should prioritize
enforcement with respect to any flavored, cartridge-
based ENDS products (other than a tobacco- and
menthol-flavored ENDS product) without regard to the
location or method of sale. The alarming data on the
increase in youth use of ENDS products shows that the
FDA’s enforcement efforts to date did not adequately
address this problem.
Enforcement priorities would effectively ban many
retailers from selling ENDS products while allowing
sales from vape shops and online retailers.
• 	Concerns that many retailers will be forced
to close.
• 	Concerns that this will just cause retailers
to shift unauthorized products to vape
shops and other stores.
This Final Guidance prioritizes enforcement with
respect to any flavored, cartridge-based ENDS
products (other than a tobacco- and menthol-flavored
product) without regard to the location or method of
sale.
In addition, the Final Guidance explains that FDA
intends to prioritize enforcement for lack of a
marketing authorization for tobacco-, menthol-, and
non-flavored ENDS products and for non-cartridge-

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• 	Concerns about the rise in youth use of
open tank systems and sourcing of e-vapor
products at vape shops, as indicated by an
analysis of Wave 2 (2014-2015) to Wave 3
(2015-2016) of results from the PATH
study.
based flavored ENDS products where the
manufacturer is not taking adequate measures to
prevent youth access to ENDS products. For example,
the Final Guidance lists several different types of
programs to foster compliance with age-verification
and sales restrictions, all of which are programs that
some manufacturers have stated they are capable of
implementing for ENDS products.
Finally, FDA notes that there has been a dramatic rise
in youth use of cartridge-based ENDS products since
Wave 3 of the PATH study was completed in 2016, as
demonstrated by results from the NYTS in 2018 and
2019. These recent data inform FDA’s serious public
health concerns regarding the sale of certain flavored,
cartridge-based products without premarket
authorization. Moreover, although this Final Guidance
should have minimal impact on those vape shops that
primarily sell non-cartridge ENDS products and ensure
that purchasers are of the requisite age and are not
purchasing for resale (e.g., are not purchasing in large
quantities), should evidence indicate to the contrary,
the Agency will take appropriate action.
Stricter enforcement of current age verifications
rules would be an effective enforcement strategy.
• 	Lax enforcement is a primary driver of
youth ENDS use.
• 	FDA should increase penalties to retailers
who violate current regulations and sell to
minors.
• 	Age verification should be as strong as it is
for alcohol.
• 	There is a need for stricter age verification
for online sales of ENDS products.
As described in the Final Guidance, FDA vigorously
enforces the age verification requirements in its
compliance check program. FDA has been focusing
enforcement efforts on age verification as a strategy
to address youth use of tobacco products, and FDA
continues to enforce age restrictions. However, FDA
believes that age verification alone is not sufficient to
address this issue, given the most recent data that
youth use of ENDS products continues to increase.
FDA determined that focusing on how the product was
sold would not be sufficient to address youth use of
these products given the many sources of products
available for youth access. The reality is that youth
have continued access to ENDS products in the face of
legal prohibitions and even after voluntary actions by
some manufacturers. FDA believes that the policy
expressed in the Final Guidance is a more appropriate
means to combat youth use of, and access to, these
products.
Many companies already comply with age
verification requirements.
• 	Policies that encourage additional
measures would harm law-abiding
retailers.
The Final Guidance does not require additional age
verification measures. Instead, it states that FDA
intends to prioritize enforcement for lack of a
marketing authorization for tobacco-, menthol-, and
non-flavored ENDS products as well as non-cartridge-

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45
based flavored ENDS products where the
manufacturer is not taking adequate measures to
prevent youth access to ENDS products.
Online sales of ENDS products should be banned. 	This suggested sales restriction is outside of the scope
of this guidance, which concerns enforcement of the
premarket authorization requirements.
At this time, FDA is finalizing this Guidance to address
its concerns regarding youth use of ENDS products.
The guidance prioritizes enforcement with respect to
flavored, cartridge-based ENDS products because data
shows that flavors are the primary driver in youth
experimentation with, and continued use of, ENDS
products, and that youth overwhelmingly use
cartridge-based ENDS products. These priorities apply
whether the products are sold online or in brick-and-
mortar stores. However, the Agency will continue to
monitor this issue.
Lack of clarity on what quantity limits for online
sales would entail.
Given the data that many youth obtain their ENDS
products from friends or sources in their social
networks, FDA believes that quantity limits are one
measure that a manufacturer could adopt to prevent
individuals from purchasing large quantities of ENDS
products to then distribute to minors on a secondary
market. FDA’s enforcement decisions will be made on
a case-by-case basis and depend on many factors, but
FDA intends to consider whether a manufacturer limits
the quantity of ENDS products that a customer may
purchase within a given period of time as a factor in
assessing whether a manufacturer is taking adequate
measures to prevent youth access. There is wide
variation in these types of ENDS products and, based
on some of the comments FDA received and the
responses to the Agency’s September 12, 2018 letters,
FDA believes individual manufacturers are best
positioned to know how to set purchase limits for their
specific products. Therefore, FDA does not believe
that further detail is warranted regarding this issue.
Age to purchase ENDS products should be
increased to 21.
On December 20, 2019, the President signed into law
legislation that raised the federal minimum age of sale
of tobacco products from 18 to 21 years. FDA views
this as a major step in protecting the next generation
of youth from becoming addicted to ENDS and other
tobacco products. FDA believes, however, that this
change alone is not sufficient to address the epidemic
use of ENDS by youth, especially use of flavored,

Contains Nonbinding Recommendations
46
cartridge-based products (except for tobacco- or
menthol-flavored products) that are easily concealed,
produced on a large scale, and (in some cases) sold in
bulk quantities that has helped enable resale through
social or black market sources. As part of the
premarket review process for these products, FDA
intends to consider measures taken by manufacturers
to control youth access to these products.
Purchasing from other adolescents is a major
factor driving ENDS usage in youth populations.
• 	FDA should increase penalties for
individuals who provide products to youth.
• 	This type of behavior should be the
responsibility of parents, not the
government.
• 	Only specialty vape stores should be
permitted to sell ENDS.
• 	Data from CDC’s 2017 Youth Risk Behavior
Surveillance System (YRBSS) found that
86.4% of youth who used ENDS did not
purchase them at a retail store.
• 	Youth will find ways to purchase restricted
flavored products and increased
regulations will be ineffective.
FDA agrees that social sources remain a concern for
ENDS and other tobacco products. Given the
popularity of social sources, FDA believes that quantity
limits could be effective in preventing individuals from
purchasing large quantities of ENDS products to then
distribute to minors on a secondary market.
Accordingly, FDA intends to consider whether a
manufacturer limits the quantity of ENDS products
that a customer may purchase within a given period of
time as a factor in assessing whether a manufacturer is
taking adequate measures to prevent youth access.
Limits on retail or online sales would remove two
of the top purchase options for adult ENDS
product users.
The priorities in the Final Guidance are addressed to
particular products, not retailers. FDA believes that
the Final Guidance strikes an appropriate balance
between preventing youth access to ENDS products
and maintaining availability of potentially less harmful
options for current adult smokers who have
transitioned or wish to transition completely away
from combusted tobacco products. FDA would
consider measures taken by manufacturers to control
youth access, not adult access, when determining
whether to enforce the premarket authorities with
respect to these products.
Does not provide adequate reasoning or specificity
for manufacturers to understand what marketing
actions would prompt enforcement actions.
FDA’s decision to exercise its enforcement authorities
with respect to particular products will be determined
on a case-by-case basis, informed by the enforcement
priorities described in this Final Guidance and any
other relevant factors. The Final Guidance provides a
number of examples of measures manufactures can
take to help prevent youth access to their tobacco
products. Such examples reflect information provided
by manufacturers in response to the Agency’s
September 12, 2018 letters, including measures to

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address youth use that manufacturers can or have
already taken to address youth access to ENDS
products, as well as information provided in
comments to the March 2019 Draft Guidance.
Modifications to ENDS Compliance Policy – flavored ENDS offered for sale after August 8, 2021, without
the manufacturer submitting (and FDA receiving) a premarket application
Comment 	Response
Moving up the compliance review date would be
harmful.
• 	Has the potential to impact adults using
ENDS products for smoking cessation
purposes.
• 	Will harm businesses that have already
planned for the initial date.
• 	Will exacerbate an already burdensome
premarket review process.
• 	Will be difficult for small businesses to
submit complete applications by August 8,
2021.
The Tobacco Control Act provides that new tobacco
products may not be legally marketed without
premarket authorization. Accordingly, all deemed
new tobacco products on the market without
authorization are illegally marketed products. As
discussed in the Final Guidance, industry had notice
that FDA would revisit its compliance policy if
necessary. The Final Guidance announces that FDA
intends to prioritize for enforcement ENDS products
for which a premarket application has not been
submitted by September 9, 2020. FDA understands
the concerns expressed by these commenters but
believes that it is appropriate for ENDS products to
undergo premarket review on a shorter timeframe
given the rise in youth use, in addition to other new
and continuing public health and safety concerns, such
as the outbreak of pulmonary injuries and battery
hazards.
Leaving products on the market for this long is
problematic.
• 	Date is still too far away and will allow
harmful products to remain on the market.
• 	Deadline means longer time for products
on the market to continue to make
unsubstantiated claims without scientific
review.
• 	Leaving products on the market is
problematic due to lack of evidence
justifying later premarket review.
FDA agrees with these commenters that the proposed
August 8, 2021, date would allow products that may
be harmful to remain on the market too long, would
allow products to market unsubstantiated claims
without scientific review, and that the data before the
agency does not justify later premarket review. The
Final Guidance discusses the date for premarket
application submission and the importance of earlier
submission of applications to allow for FDA to better
evaluate whether these products meet applicable
premarket standards, such as whether the products
are appropriate for the protection of the public health,
considering the risks and benefits to the population as
a whole, including users and nonusers of the tobacco
product.
Lack of clarity around date for submission of
premarket review applications
• 	FDA should articulate the status of
submitted premarket applications and
provide manufacturers opportunity to
The Final Guidance discusses dates for submission of
applications for premarket review and provides links
to application submission information, including
where to view marketing orders and accompanying
documentation, available at FDA.gov. FDA has

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amend applications in light of changing
deadlines.
• 	Still unclear what information must be
included in a PMTA and/or SE report
provided guidance and information to industry on the
premarket pathways through publishing guidances
and marketing orders, as well as posting information
via webinars and public workshops.108
108 For more information on premarket tobacco product applications please see Premarket Tobacco Product
Applications for [ENDS], Guidance for Industry (June 2019), available at https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/premarket-tobacco-product-applications-electronic-nicotine-delivery-
systems-ends; Applications for Premarket Review of New Tobacco Products (updated June 2019) available at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/applications-premarket-review-new-
tobacco-products. For more information on CTP’s other published regulations and guidances, please see
https://www.fda.gov/tobacco-products/products-guidance-regulations/rules-regulations-and-guidance; for more
information on FDA CTP webinars, please see https://www.fda.gov/tobacco-products/compliance-enforcement-
training/fda-tobacco-compliance-webinars; for information on marketing orders and accompanying documentation,
please see https://www.fda.gov/tobacco-products/compliance-enforcement-training.
Modifications to ENDS Compliance Policy – targeted to minors or likely to promote use of ENDS product
by minors
Comment 	Response
FDA should use its authority to require ENDS
manufacturers to stop running ads with
unsubstantiated claims about smoking cessation
and modified risk claims.
This is outside of the scope of the Final ENDS
guidance, which addresses premarket review
requirements for ENDS products. FDA closely
monitors retailer, manufacturer, importer, and
distributor compliance with Federal tobacco laws and
regulations and takes corrective action when
violations occur. When enforcing FDA’s tobacco
product authorities, the Agency generally issues a
warning letter the first time a compliance check
reveals a violation of federal tobacco laws and
regulations, including when a manufacturer sells or
distributes a product as a modified risk tobacco
product without an FDA order in effect. Failure to
promptly and adequately correct all violations and
ensure compliance with all applicable laws and
regulations may lead to enforcement actions,
including civil money penalties, seizure, and/or
injunction. To the extent that manufacturers are
marketing their products for therapeutic purposes,
they are subject to FDA’s medical product authorities.
Lack of clarity – it is unclear what ENDS products
manufacturers (and other parties that engage in
ENDS marketing activities) and retailers can do to
avoid concerning marketing activities.
• 	Would like to know what specific steps
they can take to ensure their marketing
reaches adults rather than minors.
FDA believes the level of detail and examples in the
Final Guidance provide sufficient clarity.

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49
• 	Need clarity on what the agency considers
targeting or promoting to minors.
FDA should ensure social media platforms are not
used as advertising platforms for ENDS products,
including monitoring videos that promote ENDS
products and limiting the reach of social media
influencers who promote products.
To the extent this comment is about the advertising of
ENDS products generally, it is outside the scope of the
policy. To the extent this comment is about
advertising of ENDS products that are targeted to
minors or likely to promote use of ENDS by minors,
FDA believes the Final Guidance addresses this by
indicating that such products will be an enforcement
priority.
A number of ENDS products are designed to be
small and discreet, thus promoting ENDS use in
minors.
The Final Guidance discusses the Agency’s intent to
prioritize its enforcement for products that are
targeted to minors or likely to promote use of ENDS by
minors. One example of such products includes
products marketed directly to minors by promoting
ease of concealment.
FDA should support stakeholder partnerships to
develop common approach and standards in
preventing youth access.
FDA CTP’s Office of Stakeholder Relations regularly
connects with stakeholders. Stakeholders also have
access to the ombudsman as well.
Flavored Cigars
Comment 	Response
Enforcing the premarket requirements against
flavored cigars would limit adults’ freedom to
choose their preferred products.
The Final Guidance does not include a policy to
prioritize flavored cigars for enforcement. Instead, as
described in the Final Guidance, flavored cigars are
treated like all other deemed products that are not
ENDS. Flavored cigars may seek premarket
authorization from FDA. Manufacturers of flavored
cigars, and of other deemed new tobacco products,
will be required to submit marketing applications for
those products by September 9, 2020, consistent with
the U.S. District Court for the District of Maryland’s
order, as described in the Guidance.
Eliminating flavored cigars would result in the
creation of a black market.
The Final Guidance does not include a policy to
prioritize flavored cigars for enforcement. In addition,
we do not think development of a black market is
likely given that there are a number of
“grandfathered” flavored cigars that are lawfully
marketed and would remain available to consumers
regardless of FDA’s enforcement of premarket
authorities.
FDA’s assertion of product migration of youth is an
unfounded hypothesis.
• 	Concerns that FDA mischaracterizes
research and does not cite contrary
The Final Guidance does not include a policy to
prioritize flavored cigars for enforcement.

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government findings (citing to CDC reports
and PATH data)
• 	FDA’s data on this topic limited to two
studies that only recently became
available and has not been vetted
• 	There are limitations to the Wave 1-3
PATH data that FDA cites in support
• 	FDA relies on 2018 NYTS data and
incorrectly speculates that youth could
migrate to flavored cigars
• 	CDC MMWR data and PATH data
contradict suggestions that youth usage of
cigars is on the rise
• 	Data show decreasing importance of
flavors to first time cigar users
Only allowing 30 days after guidance is finalized
would result in a de facto ban on flavored cigars.
• 	Not enough time for manufacturers to
submit SE reports.
• 	May not be enough time for retailers to
sell off inventory/FDA should include an
additional sell off period of time to the
compliance guidance.
• 	Should be able to remain on the market
until FDA has reviewed and made a
determination on the premarket review
application.
The Final Guidance does not include a policy to
prioritize flavored cigars for enforcement. In addition,
we note that there are a number of “grandfathered”
flavored cigars that are lawfully marketed that would
remain available to consumers regardless of FDA’s
enforcement of premarket authorities.
Guidance should address grandfathered flavored
cigar products as well.
The Draft and Final Guidance are about enforcement
against products that lack required premarket
authorization. Grandfathered tobacco products,
which do not require premarket authorization, are
outside the scope of the policy.
Lack of clarity
• 	Lack of a definition of flavored cigars will
lead to confusion and leave retailers
misinformed about what constitutes a
flavored cigar.
• 	Lack of definition of characterizing flavor.
The Final Guidance no longer discusses prioritizing
enforcement for flavored cigars.
FDA should pursue the flavored cigar enforcement
policy addressed in the Draft Guidance.
At this time, FDA has decided to focus this Final
Guidance on ENDS products, given the recent surge in
youth use and additional considerations such as
battery explosions and vaping-related illnesses.
Nevertheless, FDA is continuously evaluating new
information and adjusting its enforcement priorities in
light of the best available data. FDA will take

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51
appropriate action regarding tobacco products that
are marketed without premarket authorization,
including cigars, in accordance with the court’s order
in American Academy of Pediatrics. FDA also has
stated its intention to issue a flavored cigar rule.
Compliance Policy for Other Deemed Products
Comment 	Response
FDA should modify compliance policy for other
deemed products.
• 	Data on waterpipe tobacco use
demonstrates increase in youth use.
As discussed in the Final Guidance, consistent with the
U.S. District Court for the District of Maryland’s order,
FDA intends to enforce premarket requirements for
these products after September 9, 2020.
FDA should not modify compliance policy for other
deemed products.
As discussed in the Final Guidance, consistent with the
U.S. District Court for the District of Maryland’s order,
FDA intends to enforce premarket requirements for
these products after September 9, 2020.
FDA should focus its efforts on menthol cigarettes. 	The Final Guidance describes FDA’s policy on enforcing
premarket requirements for products subject to the
deeming rule. Menthol cigarettes are outside the
scope of this policy.