Enforcement Priorities for 
Electronic Nicotine Delivery 
Systems (ENDS) and Other 
Deemed Products on the Market 
Without Premarket 
Authorization (Revised)* 
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 
*This is a revision to the first edition of this guidance, which issued in January 2020. Contains Nonbinding Recommendations 
 
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  
  i  Contains Nonbinding Recommendations 
 
Enforcement Priorities for 
Electronic Nicotine Delivery 
Systems (ENDS) and Other 
Deemed Products on the Market 
Without Premarket 
Authorization (Revised) 
 
 
1
Guidance for Industry  
 
 
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  
 
 
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. 
2 As with FDAs 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. 
  2  Contains Nonbinding Recommendations 
 
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 
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. 
 
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe the Agencys current thinking on a topic and should 
be viewed only as recommendations, unless specific regulatory or statutory requirements are 
cited.  The use of the word should in Agency guidances means that something is suggested or 
recommended, but not required.  
 
II.  BACKGROUND 
 
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 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). 
 
3 For purposes of this Final Guidance, FDAs 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.  
4 21 U.S.C 321(rr) (section 201(rr) of the FD&C Act). 
  3  Contains Nonbinding Recommendations 
 
 
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 FDAs 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 productsi.e., those that were not commercially marketed in 
the United States as of February 15, 2007.  Accordingly, after the rules 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 
authorizationfor 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  
 
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 
 
5 81 FR at 29011. 
  4  Contains Nonbinding Recommendations 
 
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  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  On July 12, 2019, the court issued a further order directing FDA to require that 
premarket authorization applications for all newi.e., not grandfathered8deemed 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 
 
6 Jamal, A., A. Gentzke, S.S. Hu, et al., Tobacco Use Among Middle and High School Students  United States, 
20112016, Morbidity and Mortality Weekly Report, 66:597603, 2017, available at:   
https://www.cdc.gov/mmwr/volumes/66/wr/mm6623a1.htm. 
7 American Academy of Pediatrics, et al. v. Food and Drug Administration, et al., 379 F. Supp. 3d 461, 496 (D. Md. 
2019).   
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.   
 
  5  Contains Nonbinding Recommendations 
 
pending FDA review.9  The court subsequently clarified that its order did not restrict FDAs 
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  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  As required by the 
courts 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 Agencys discretion.12   
 
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 Agencys 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 
 
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 courts 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 Assn of America, Nos. 19-2130, -2132, -2198, -
2242 (4th Cir.). 
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. 
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. 
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). 
  6  Contains Nonbinding Recommendations 
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 12th 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 manufacturers
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  Following the 
September 12th letters and announcement, FDA repeatedly publicly discussed14 the fact that these 
compliance timelines were under reconsideration and solicited the view of stakeholders
including manufacturers, retail associations, and public interest organizations.15    
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. 
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.  
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 
7  Contains Nonbinding Recommendations 
 
 
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  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 20172018, 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  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  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 productse.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.  
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. 
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. 
18 Id. 
 
  8  Contains Nonbinding Recommendations 
 
harmful effects of nicotine on adolescent brain development, as well as battery explosions with 
ENDS productscontinue to inform FDAs 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  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.  FDAs 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   
 
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   
 
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. 
 
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. 
20 See Heckler v. Chaney, 470 U.S. 821, 835 (1985) (providing that the FD&C Acts enforcement provisions commit 
broad discretion to the Secretary to decide how and when they should be exercised). 
21 An example of products that would not be captured by this definition include completely self-contained, 
disposable products. 
  9  Contains Nonbinding Recommendations 
 
 
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 FDAs 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 
  10  Contains Nonbinding Recommendations 
(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   
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  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 and 2017 (11.7 percent).25  
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.  
22 We note that FDA would be enforcing the priorities discussed in Section IV of this guidance regardless of the 
courts 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. 
23 Jamal, A., A. Gentzke, S.S. Hu, et al., Tobacco Use Among Middle and High School Students  United States, 
20112016, Morbidity and Mortality Weekly Report, 66:597603, 2017, available at:   
https://www.cdc.gov/mmwr/volumes/66/wr/mm6623a1.htm. 
24 Id. 
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.  
11  Contains Nonbinding Recommendations 
 
Overall, data showed that ENDS product use more than doubled among middle school and high 
school students from 2017 to 2019.26  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 8th 
graders (a 58 percent increase), 13.1 percent to 21.7 percent among 10th graders (a 66 percent 
increase), and 16.6 percent to 26.7 percent among 12th graders (a 61 percent increase).27  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  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  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  
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  The prevalence of 
current e-cigarette use among high school students was 27.5 percent and middle school students 
was 10.5 percent.32  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   
 
26 Miech R, L. Johnston, P.M. OMalley, et al., Trends in adolescent vaping, 20172019, New England Journal of 
Medicine, 381:1490-1491, 2019; DOI:10.1056/NEJMc1910739. 
27 Miech, R. A., Johnston, L. D., OMalley, P. M., et al., Monitoring the Future national survey results on drug use, 
19752018: 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).  
28 Miech R, L. Johnston, P.M. OMalley, et al., Trends in adolescent vaping, 20172019, New England Journal of 
Medicine; 381:1490-1491, 2019; DOI:10.1056/NEJMc1910739. 
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. 
30 Id. 
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. 
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.  
33 Id. 
 
  12  Contains Nonbinding Recommendations 
 
 
Disturbingly, these data also indicate that a growing percentage of Americas 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  Data from the 2019 
NYTS have documented continued frequent youth ENDS use.35  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  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  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  
 
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  
 
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, 
 
34 Miech R., Johnston L, OMalley PM, et al., Adolescent vaping and nicotine use in 20172018  U.S. National 
Estimates, New England Journal of Medicine; 380:192-3, 2019. 
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. 
36 Id.  
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.   
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.   
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. 
 
  13  Contains Nonbinding Recommendations 
 
including ENDS.40  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  In the 2016-2017 
(Wave 4)42 Population Assessment of Tobacco and Health (PATH) Study,43 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  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   
 
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 and the proportion who reported mint-and 
menthol-flavored ENDS use was 38.1 percent.47  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  
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 
 
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.  
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.    
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.   
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). 
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. 
45 Id. 
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. 
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.    
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. 
 
  14  Contains Nonbinding Recommendations 
percent.49  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  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  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  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   
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  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, Creme, Cucumber, Fruit, Mango, Menthol, Mint, Virginia Tobacco, and Other.  
Among past 30-day JUUL users in each grade studied (8th, 10th, and 12th), 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  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  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   
Data from the 2019 NYTS also indicate that youth overwhelmingly prefer cartridge-based ENDS 
products,58 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.  
49 Id. 
50 Id. 
51 Id. 
52 Id. 
53 Id. 
54 Leventhal A., et al., Flavors of e-Cigarettes Used by Youths in the United States, JAMA, 322(21):2132-2134, 
2019. 
55 The remaining flavors, including tobacco and menthol flavors, each had estimates of  2.3%. 
56 The remaining flavors, including tobacco and menthol flavors, each had estimates of  3.0%. 
57 The remaining flavors, including tobacco flavors, each had estimates of  1.5%. 
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. 
15  Contains Nonbinding Recommendations 
Most youth who were current e-cigarette users reported a cartridge-based e-cigarette as their 
usual brand.59  In fact, the leading brand is a cartridge-based product that commands 
approximately 70 percent of the market.60  
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  Small size may also allow the user to quickly conceal 
the product in the palm of ones hand or in a pocket.62  Small size may allow for product use in a 
social setting without others awareness,63 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  
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  Additional research 
among youth suggests that younger adolescents are more likely to use more basic ENDS 
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. 
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. 
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.  
62 http://pittsburgh.cbslocal.com/2017/12/13/new-ecigarette-popular-among-kids-easy-to-conceal-from-parents/ 
63 https://www.npr.org/sections/health-shots/2017/12/04/568273801/teenagers-embrace-juul-saying-its-discreet-
enough-to-vape-in-class 
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. 
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. 
16  Contains Nonbinding Recommendations 
 
products than older adolescents.66  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  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 FDAs responses is described in Appendix A.68  
 
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):5562, 2019.  
67 79 Fed. Reg. 23141, 23147 (2016). 
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 Profls & 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 APAs 
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 
 
  17  Contains Nonbinding Recommendations 
 
 
FDA also remains concerned about health and safety issues connected to ENDS productse.g., 
cases of lung injuries associated with use of vaping products69 as well as battery explosions with 
ENDS products70particularly 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 products 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. 
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.  
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.   
  18  Contains Nonbinding Recommendations 
 
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  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  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  Finally, data from the 2019 NYTS indicate that youth 
overwhelmingly prefer cartridge-based ENDS products.74  These products are easy to conceal, 
can be used discreetly, may have a high nicotine content, and are manufactured on a large scale.     
 
 
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. 
72 Id. 
73 Leventhal A., et al., Flavors of e-Cigarettes Used by Youths in the United States, JAMA, 322(21):2132-2134, 
2019.  
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. 
  19  Contains Nonbinding Recommendations 
 
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 FDAs 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.      
  20  Contains Nonbinding Recommendations 
 
 
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 youthi.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  
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 
FDAs 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.     
 
 
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. 
  21  Contains Nonbinding Recommendations 
 
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 12th 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. 
 
FDAs 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 Agencys 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. 
 
  22  Contains Nonbinding Recommendations 
 
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 
Agencys 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  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  FDA is compelled to act by data that 
 
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. 
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 
 
  23  Contains Nonbinding Recommendations 
 
show youth overwhelmingly prefer certain flavors of cartridge-based ENDS products such as 
fruit, mint, and candy.78  At the same time, FDA is aware that approximately 9 million adults 
currently use e-cigarettes.79  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 
 
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  
 
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. SAMHSAs public online data analysis system (PDAS). (Original 
Data Source: NSDUH 2016) 
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. 
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. 
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: 20132014, Tobacco Control, 25(Suppl 2):4
13, 2016.  
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. 
 
  24  Contains Nonbinding Recommendations 
 
communication subject to regulation by the Federal Communications Commission) has been 
prohibited since 1971 and 1986 respectively,82 ENDS products are advertised through television, 
radio, and online.83  Social media accounts are frequently used to electronically share tobacco-
product-related content with other minors.84  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 companys behalf.85  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 
 
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  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  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 
 
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).  
83 U.S. Department of Health and Human Services, E-Cigarette Use Among Youth and Young Adults. A Report of 
the Surgeon General, 2016. 
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. 
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.   
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. 
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.  
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.   
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., 
 
  25  Contains Nonbinding Recommendations 
 
Instagram posts,90 and video advertisements.91  Cartoon figures are frequently used on product 
packaging and in television advertising to promote youth consumption of consumer goods.92  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  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  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  
 
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 childrens 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 Pokemon 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. 
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. 
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. 
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. 
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. 
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. 
95 Id.  
  26  Contains Nonbinding Recommendations 
 
  Products marketed, including through paid social media influencers, with popular 
childrens characters and titles (e.g., popular childrens 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 FDAs 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 FDAs 
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 
  27  Contains Nonbinding Recommendations 
 
process from the statutory criteria, as well as published guidances, webinars, and marketing 
orders and their accompanying documentation provided by FDA.96   
 
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 FDAs 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 countrys 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 usersall of which increase the risk of adverse 
events.97  Moreover, to the extent that such products are sold through nontraditional retail 
 
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 CTPs 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.   
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 
 
  28  Contains Nonbinding Recommendations 
 
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  FDA has previously issued letters to companies suspected of 
marketing counterfeit or otherwise unauthorized products.99  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 understoode.g., the development of acute or chronic lung injuries associated with use of 
vaping products as well as battery explosions with ENDS productsparticularly 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  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): 347357, 2017.   
 
98 See, e.g., sections 301, 902, 903, 905, 910, and 920 of the FD&C Act. 
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 FDAs 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.  
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. 
  29  Contains Nonbinding Recommendations 
 
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 FDAs discretion, FDAs 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 
Marylands 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 FDAs discretion.  As part of the premarket review 
process, FDA may evaluate, among other things, the products constituents, ingredients, 
  30  Contains Nonbinding Recommendations 
 
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, FDAs 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 courts 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 FDAs new enforcement 
priorities would begin 30 days after issuance of this Final Guidance to February 6, 
  31  Contains Nonbinding Recommendations 
 
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. 
   
  32  Contains Nonbinding Recommendations 
 
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  The Final Guidance is a statement of policy that 
process  discusses the enforcement of premarket authorities 
  The draft guidance constituted a major  already existing in the statute.  It does not establish 
rule and FDA has not followed procedures  any rights for any person, is not binding on FDA or the 
established by the Administrative  public, and is not subject to requirements of the 
Procedure Act (APA) governing the  Regulatory Flexibility Act or the notice-and-comment 
promulgation of rules  provisions of the APA.  Historically, FDA has not 
  The Regulatory Flexibility Act requires an  analyzed the economic effects of enforcement 
analysis of a proposed rules impact on  guidance, including for reasons such as difficulty in 
small business and FDA has not conducted  predicting such effects.  Alternatives such as issuing 
such an analysis  warning letters and other enforcement techniques 
  FDA is bypassing the requirement to  have been considered and used by the Agency.  
conduct a cost benefit analysis by issuing a  Despite this, as shown by the data highlighted in the 
guidance instead of formal rule   Final Guidance, the rate of youth use of tobacco 
  FDA has not considered regulatory  products (particularly fruit- and candy-flavored and 
alternatives to the approach outlined in  mint-flavored ENDS products) has dramatically 
the draft guidance   increased.  FDA retains discretion to enforce 
  This action would impose costs and  premarket authorities. 
adverse effects on industry which 
The relevant substantive requirements are those 
constitutes a major rule which should be 
governing premarket authorization as set forth in 
subject to the requirements under the 
Section 910.  The Final Guidance does not impose new 
Congressional Review Act  
restrictions, for retailers or manufacturers, but rather 
  Though guidance documents are non-
discusses FDAs enforcement priorities for existing 
binding, the way the guidance is written, 
statutory requirements.  In Section 910, Congress 
retail outlets would need to comply with 
placed the onus on manufacturers to demonstrate 
standards suggested by the draft guidance 
that the marketing of a tobacco product is appropriate 
as though they were law  
for the protection of the public health, taking into 
  Engaging in rulemaking would offer more 
account, among other things, the likelihood that those 
substantial opportunity for stakeholders to 
who do not use tobacco products will start using 
provide public comments and would 
them.     
provide clarity on what stakeholders 
(through the supply and retail chain) 
FDA provided for a 45-day period for comment on the 
needed to do to come into compliance  
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  FDA has discretion to decide how when to enforce its 
discretionary enforcement authority and  premarket authorization authorities under the FD&C 
obligations related to rulemaking, by threatening  Act.  See Heckler v. Chaney, 470 U.S. 821, 835 (1985).  
selective enforcement of its premarket  The Final Guidance is a statement of policy that 
authorization authority.  
  33  Contains Nonbinding Recommendations 
 
  outlines FDAs enforcement priorities with respect to 
such requirements.    
Guidance should conform to Section 907.   Section 907 refers to tobacco product standards. This 
  Actions in this guidance should conform to  Final Guidance is not setting tobacco product 
Section 907, which obligates FDA to  standards, such as a tobacco product standard 
consider factors not addressed by the  restricting or eliminating the use of flavors in ENDS.  
guidance, including technical achievability  Instead, it is explaining FDAs enforcement priorities 
and countervailing effects.   for premarket review requirements already included in 
  FDA should not adopt modifications to  the Tobacco Control Act.  A flavored product could be 
compliance policy but should instead  marketed consistent with this guidance if it meets the 
follow through with a rule that considers  statutory standards for authorization.  For example, in 
the comments from FDAs ANPRM on  April 2019, FDA authorized the marketing of a 
Flavors in Tobacco Products.   menthol-flavored IQOS heat-not-burn cigarette 
product through the PMTA pathway.101       
FDA is supposed to be an advisory agency, not a  The Tobacco Control Act provides FDA with regulatory 
regulatory agency, and its actions are an  authority over tobacco products.  
overreach.  
FDAs proposed actions are arbitrary and  The enforcement priorities explained in the Final 
capricious because it has failed to provide  Guidance are based upon and supported by, among 
adequate reasoning/scientific reasoning/used  other things, multiple high-quality scientific data 
incomplete or incorrect data.  sources (e.g., NYTS, PATH, MTF).  
 
FDA has failed to connect the proposed policy to  The Final Guidance discusses the enforcement of 
an official finding that the actions were  premarket authorities already existing in statute. 
appropriate for the protection of public health.   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.  FDA has communicated its concerns regarding the 
  Manufacturers have been relying on  increase in youth access in public statements, the 
guidance and information since the  March 2019 draft guidance, and requests for 
deeming rule; this is a drastic departure  information to manufacturers.  FDA has consistently 
 
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.  
  34  Contains Nonbinding Recommendations 
 
from deeming and guidances issued since  informed industry that its compliance policies will be 
deeming.   responsive to changed circumstances. There could be 
  Difficult to keep track of FDAs policies and  no reasonable reliance on a deferred enforcement 
compliance requirements.  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  FDA has provided guidance and information to 
issue rules to make the product review process  industry on the premarket pathways through 
more transparent and predictable but has not  publishing guidances and marketing orders, as well as 
done so.  posting information via webinars and public 
  workshops.102  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  This Final Guidance would only affect those products 
retroactive effects on industry actors who were in  that are illegally on the market; none of the products 
compliance with FDAs previous policy.   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 
 
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 CTPs 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. 
  35  Contains Nonbinding Recommendations 
 
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  FDA disagrees that the Final Guidance will cause these 
industry out of work.  results.  The Final Guidance explains FDAs 
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  FDA disagrees that the Final Guidance violates the 
would violate the First Amendment as it  First Amendment.  Speech regarding an illegal activity 
represents an impermissibly broad commercial   including distribution of a product that requires 
speech restriction.  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. Appx 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 
  36  Contains Nonbinding Recommendations 
 
There is no evidence/limited evidence to connect  As discussed in the Final Guidance the studies of the 
liquid nicotine use with harmful health effects in  effects of nicotine exposure in the naive adolescent 
youth.  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 
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 
Banning flavors outside of tobacco, mint, and  The Final Guidance does not ban any products but 
menthol would deter cigarette smokers from  rather identifies FDAs priorities in connection with the 
enforcement of the statutory premarket review 
 
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. 
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; OConnell, 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. DRuiz, 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. 
  37  Contains Nonbinding Recommendations 
 
quitting or force smokers to restart smoking if they  requirements.  Moreover, the policy announced in the 
have already quit.  Final Guidance does not prioritize any menthol-
  Smokers trying to quit smoking avoid  flavored, tobacco-flavored, or non-flavored ENDS 
tobacco-, mint-, and menthol-flavored  products or any non-cartridge-based flavored ENDS 
products because they are too similar to  products for enforcement where the manufacturer is 
flavors of a traditional cigarette.  taking adequate measures to prevent minors access 
  Stricter policies for ENDS products for  to these products.  Additionally, consumers will be 
youth should not come at expense of adult  able to access ENDS products (including flavored ENDS 
users.  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.  As discussed in the Final Guidance, data from 2018 
  The policy will not be successful at keeping  NYTS as well as from 2019 Monitoring the Future 
kids from using these products; kids use  study and 2019 NYTS show a significant increase in 
anything that is taboo and illegal.  youth use of these products. Data also clearly show 
  Youth are more attracted to these  that flavors are a primary driver in youth 
products due to peer use than flavors.  experimentation with, and continued use of, ENDS 
  Youth use ENDS products for nicotine  products, and that the flavored ENDS products 
delivery not for flavors.  overwhelmingly used by youth are cartridge-based 
  Only a correlative, not causal, relationship  products.  The policy outlined in the Final Guidance 
between youth preference for flavors and  prioritizes enforcement of ENDS products that are 
increased ENDS usage.  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  The Final Guidance explains that FDA intends to 
from prioritization.  prioritize mint-flavored, cartridge-based ENDS 
products (and any other flavored, cartridge-based 
  38  Contains Nonbinding Recommendations 
 
  General increasing popularity of mint and  ENDS product, other than tobacco- or menthol-
menthol ENDS products amongst youth  flavored ENDS products) for enforcement for lack of a 
populations.  marketing authorization.  The guidance also explains 
  Mint- and menthol-flavored products drive  that FDA intends to prioritize enforcement for lack of a 
youth ENDS usage.  marketing authorization for any tobacco- or menthol-
  Flavors clearly increase appeal of ENDS  flavored ENDS products and non-cartridge-based 
products and some flavors have toxic  flavored ENDS products when the manufacturer is not 
effects and documented respiratory  taking adequate measures to prevent minors access 
toxicity.    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 FDAs 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  By black market flavored products, we assume this 
significant black market for banned flavors  could refer to, for example, flavored ENDS products, 
outside those that are exempted.   including e-liquids, put on the market after the 
guidance, flavored ENDS products diverted from 
another countrys 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 Agencys 
enforcement priorities for products that are on the 
market without the required premarket 
authorizationit 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 
  39  Contains Nonbinding Recommendations 
 
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 
understoode.g., lung injuries associated with use of 
vaping products as well as battery explosions with 
ENDS productsparticularly 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  The policy expressed in this Final Guidance is limited 
available in various flavors attractive to youth; it is  solely to tobacco products over which FDA has 
inconsistent to only prioritize for enforcement  statutory authority.  The focus of this guidance and the 
flavored ENDS products.  Agencys enforcement priorities is tobacco products, 
  40  Contains Nonbinding Recommendations 
 
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 products ingredients and additives are among the 
considerations in the premarket review. 
FDA should focus its enforcement priorities on  FDA believes that ENDS products containing nicotine 
products that contain nicotine salts and/or should  salts will be adequately addressed by the enforcement 
specify differences between nicotine and nicotine  priorities set in this Final Guidance.   
salts. 
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  In addition to greater nicotine 
exposures, ENDS with nicotine salts can have faster 
absorption106 and potentially faster elimination from 
the blood.107  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, 
 
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. 
106 OConnell, 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. 
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). 
  41  Contains Nonbinding Recommendations 
 
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 FDAs 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  FDA is concerned about the rising youth appeal and 
cartridge-based ENDS products.  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  FDA is not restricting or even prioritizing enforcement 
restricting tobacco sales to a specific category of  against ENDS products sold in a specific category of 
retail outlets.  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.  
  42  Contains Nonbinding Recommendations 
 
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  FDA has provided additional details regarding factors 
  Should retail locations have age  that it intends to consider in assessing whether a 
verification at their door or a separate  manufacturer is taking adequate measures to prevent 
room for the sale of any ENDS products?   youth access.  For example, the Final Guidance lists 
  Can retail locations employ less  several different types of programs to monitor 
burdensome alternatives?   compliance with age-verification and sales restrictions, 
  Concern that the policy could make  all of which are programs that some manufacturers 
traditional cigarette products more easily  have stated they are capable of implementing for 
accessible than ENDS products.   ENDS products.  Unlike the Draft Guidance, it does not 
  Need clarity on how manufacturers or  include, as a factor for prioritization, whether the 
wholesalers can document adequate  product is sold by retailers in a location where minors 
measures to prevent youth access.   are able to enter at any time. 
  How are retail outlets supposed to balance 
The March 2019 Draft Guidance proposed to focus its 
space constraints with youth access 
enforcement priorities of flavored ENDS products on 
concerns?  
how the product was sold (regardless of the type of 
  FDA should give existing enforcement 
retail establishment).  After considering the 
mechanisms the chance to succeed or 
comments, the public health threats, and new 
focus on enforcing existing mechanisms 
evidence, FDA determined that, to address youth use 
before instituting new policy.  
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 
FDAs enforcement efforts to date did not adequately 
address this problem. 
Enforcement priorities would effectively ban many  This Final Guidance prioritizes enforcement with 
retailers from selling ENDS products while allowing  respect to any flavored, cartridge-based ENDS 
sales from vape shops and online retailers.  products (other than a tobacco- and menthol-flavored 
product) without regard to the location or method of 
  Concerns that many retailers will be forced 
sale. 
to close.  
  Concerns that this will just cause retailers 
In addition, the Final Guidance explains that FDA 
to shift unauthorized products to vape 
intends to prioritize enforcement for lack of a 
shops and other stores.  
marketing authorization for tobacco-, menthol-, and 
non-flavored ENDS products and for non-cartridge-
  43  Contains Nonbinding Recommendations 
 
  Concerns about the rise in youth use of  based flavored ENDS products where the 
open tank systems and sourcing of e-vapor  manufacturer is not taking adequate measures to 
products at vape shops, as indicated by an  prevent youth access to ENDS products.  For example, 
analysis of Wave 2 (2014-2015) to Wave 3  the Final Guidance lists several different types of 
(2015-2016) of results from the PATH  programs to foster compliance with age-verification 
study.  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 FDAs 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  As described in the Final Guidance, FDA vigorously 
rules would be an effective enforcement strategy.  enforces the age verification requirements in its 
  Lax enforcement is a primary driver of  compliance check program.  FDA has been focusing 
youth ENDS use.   enforcement efforts on age verification as a strategy 
  FDA should increase penalties to retailers  to address youth use of tobacco products, and FDA 
who violate current regulations and sell to  continues to enforce age restrictions.  However, FDA 
minors.   believes that age verification alone is not sufficient to 
  Age verification should be as strong as it is  address this issue, given the most recent data that 
for alcohol.  youth use of ENDS products continues to increase.  
  There is a need for stricter age verification  FDA determined that focusing on how the product was 
for online sales of ENDS products.   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  The Final Guidance does not require additional age 
verification requirements.  verification measures.  Instead, it states that FDA 
  Policies that encourage additional  intends to prioritize enforcement for lack of a 
measures would harm law-abiding  marketing authorization for tobacco-, menthol-, and 
retailers.  non-flavored ENDS products as well as non-cartridge-
  44  Contains Nonbinding Recommendations 
 
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  Given the data that many youth obtain their ENDS 
sales would entail.   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.  FDAs 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 Agencys 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  On December 20, 2019, the President signed into law 
increased to 21.  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, 
  45  Contains Nonbinding Recommendations 
 
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  FDA agrees that social sources remain a concern for 
factor driving ENDS usage in youth populations.  ENDS and other tobacco products.  Given the 
  FDA should increase penalties for  popularity of social sources, FDA believes that quantity 
individuals who provide products to youth.  limits could be effective in preventing individuals from 
  This type of behavior should be the  purchasing large quantities of ENDS products to then 
responsibility of parents, not the  distribute to minors on a secondary market.  
government.  Accordingly, FDA intends to consider whether a 
  Only specialty vape stores should be  manufacturer limits the quantity of ENDS products 
permitted to sell ENDS.  that a customer may purchase within a given period of 
  Data from CDCs 2017 Youth Risk Behavior  time as a factor in assessing whether a manufacturer is 
Surveillance System (YRBSS) found that  taking adequate measures to prevent youth access. 
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.  
Limits on retail or online sales would remove two  The priorities in the Final Guidance are addressed to 
of the top purchase options for adult ENDS  particular products, not retailers.  FDA believes that 
product users.  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  FDAs decision to exercise its enforcement authorities 
for manufacturers to understand what marketing  with respect to particular products will be determined 
actions would prompt enforcement actions.  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 Agencys 
September 12, 2018 letters, including measures to 
  46  Contains Nonbinding Recommendations 
 
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  The Tobacco Control Act provides that new tobacco 
harmful.  products may not be legally marketed without 
  Has the potential to impact adults using  premarket authorization.  Accordingly, all deemed 
ENDS products for smoking cessation  new tobacco products on the market without 
purposes.  authorization are illegally marketed products.  As 
  Will harm businesses that have already  discussed in the Final Guidance, industry had notice 
planned for the initial date.  that FDA would revisit its compliance policy if 
  Will exacerbate an already burdensome  necessary.  The Final Guidance announces that FDA 
premarket review process.  intends to prioritize for enforcement ENDS products 
  Will be difficult for small businesses to  for which a premarket application has not been 
submit complete applications by August 8,  submitted by September 9, 2020.  FDA understands 
2021.  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  FDA agrees with these commenters that the proposed 
problematic.  August 8, 2021, date would allow products that may 
  Date is still too far away and will allow  be harmful to remain on the market too long, would 
harmful products to remain on the market.  allow products to market unsubstantiated claims 
  Deadline means longer time for products  without scientific review, and that the data before the 
on the market to continue to make  agency does not justify later premarket review.  The 
unsubstantiated claims without scientific  Final Guidance discusses the date for premarket 
review.  application submission and the importance of earlier 
  Leaving products on the market is  submission of applications to allow for FDA to better 
problematic due to lack of evidence  evaluate whether these products meet applicable 
justifying later premarket review.  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  The Final Guidance discusses dates for submission of 
premarket review applications  applications for premarket review and provides links 
  FDA should articulate the status of  to application submission information, including 
submitted premarket applications and  where to view marketing orders and accompanying 
provide manufacturers opportunity to  documentation, available at FDA.gov.  FDA has 
  47  Contains Nonbinding Recommendations 
 
amend applications in light of changing  provided guidance and information to industry on the 
deadlines.   premarket pathways through publishing guidances 
  Still unclear what information must be  and marketing orders, as well as posting information 
included in a PMTA and/or SE report  via webinars and public workshops.108 
 
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  This is outside of the scope of the Final ENDS 
manufacturers to stop running ads with  guidance, which addresses premarket review 
unsubstantiated claims about smoking cessation  requirements for ENDS products.  FDA closely 
and modified risk claims.  monitors retailer, manufacturer, importer, and 
distributor compliance with Federal tobacco laws and 
regulations and takes corrective action when 
violations occur.  When enforcing FDAs 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 FDAs medical product authorities.   
Lack of clarity  it is unclear what ENDS products  FDA believes the level of detail and examples in the 
manufacturers (and other parties that engage in  Final Guidance provide sufficient clarity. 
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. 
 
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 CTPs 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. 
  48  Contains Nonbinding Recommendations 
 
  Need clarity on what the agency considers 
targeting or promoting to minors.  
FDA should ensure social media platforms are not  To the extent this comment is about the advertising of 
used as advertising platforms for ENDS products,  ENDS products generally, it is outside the scope of the 
including monitoring videos that promote ENDS  policy.  To the extent this comment is about 
products and limiting the reach of social media  advertising of ENDS products that are targeted to 
influencers who promote products.   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  The Final Guidance discusses the Agencys intent to 
small and discreet, thus promoting ENDS use in  prioritize its enforcement for products that are 
minors.  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  FDA CTPs Office of Stakeholder Relations regularly 
develop common approach and standards in  connects with stakeholders. Stakeholders also have 
preventing youth access.   access to the ombudsman as well.  
Flavored Cigars 
Comment  Response 
Enforcing the premarket requirements against  The Final Guidance does not include a policy to 
flavored cigars would limit adults freedom to  prioritize flavored cigars for enforcement.  Instead, as 
choose their preferred products.   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 Marylands 
order, as described in the Guidance.  
Eliminating flavored cigars would result in the  The Final Guidance does not include a policy to 
creation of a black market.   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 FDAs enforcement of premarket 
authorities.  
FDAs assertion of product migration of youth is an  The Final Guidance does not include a policy to 
unfounded hypothesis.  prioritize flavored cigars for enforcement.   
  Concerns that FDA mischaracterizes 
research and does not cite contrary 
  49  Contains Nonbinding Recommendations 
 
government findings (citing to CDC reports 
and PATH data) 
  FDAs 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  The Final Guidance does not include a policy to 
would result in a de facto ban on flavored cigars.  prioritize flavored cigars for enforcement. In addition, 
  Not enough time for manufacturers to  we note that there are a number of grandfathered 
submit SE reports.  flavored cigars that are lawfully marketed that would 
  May not be enough time for retailers to  remain available to consumers regardless of FDAs 
sell off inventory/FDA should include an  enforcement of premarket authorities.  
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.  
Guidance should address grandfathered flavored  The Draft and Final Guidance are about enforcement 
cigar products as well.  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  The Final Guidance no longer discusses prioritizing 
  Lack of a definition of flavored cigars will  enforcement for flavored cigars.   
lead to confusion and leave retailers 
misinformed about what constitutes a 
flavored cigar.  
  Lack of definition of characterizing flavor.  
FDA should pursue the flavored cigar enforcement  At this time, FDA has decided to focus this Final 
policy addressed in the Draft Guidance.  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 
  50  Contains Nonbinding Recommendations 
 
appropriate action regarding tobacco products that 
are marketed without premarket authorization, 
including cigars, in accordance with the courts 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  As discussed in the Final Guidance, consistent with the 
deemed products.  U.S. District Court for the District of Marylands order, 
  Data on waterpipe tobacco use  FDA intends to enforce premarket requirements for 
demonstrates increase in youth use.  these products after September 9, 2020. 
FDA should not modify compliance policy for other  As discussed in the Final Guidance, consistent with the 
deemed products.  U.S. District Court for the District of Marylands 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 FDAs policy on enforcing 
premarket requirements for products subject to the 
deeming rule.  Menthol cigarettes are outside the 
scope of this policy.  
 
 
 
  51