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`EXHIBIT 7
`EXHIBIT 7
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`Enforcement Priorities for
`Electronic Nicotine Delivery
`Systems (ENDS) and Other
`Deemed Products on the Market
`Without Premarket
`Authorization (Revised)*
`
`Guidance for 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://wwwida.gov/tobacco-products/products-
`guidance-regulationskules-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, MID 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.
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`Contains Nonbinding Recommendations
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`Table of Contents
`
`I.
`
`INTRODUCTION
`
`II. BACKGROUND
`
`A. Statutory and Regulatory History
`
`B. FDA Response to Evidence of Increasing Youth Use of ENDS Products
`
`III. DEFINITIONS
`
`IV. ENFORCEMENT PRIORITIES REGARDING CERTAIN ENDS PRODUCTS
`ON THE MARKET WITHOUT PREMARKET AUTHORIZATION
`
`A. Overview
`
`B. Data Show Substantial Increase in Youth Use of ENDS Products, Particularly Certain
`Flavored, Cartridge-Based ENDS Products
`
`C. Additional Relevant Considerations
`
`D. Enforcement Priorities for ENDS Products
`
`2
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`3
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`3
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`6
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`9
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`10
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`10
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`11
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`17
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`18
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`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
`
`4. Any ENDS product that is offered for sale in the United States after
`September 9, 2020
`
`E. Avoiding a "Black Market"
`
`V. PREMARKET REVIEW FOR OTHER DEEMED NEW TOBACCO
`PRODUCTS
`
`APPENDIX A — SIGNIFICANT COMMENTS RECEIVED IN RESPONSE TO
`MARCH 2019 DRAFT GUIDANCE AND FDA RESPONSES
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`27
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`28
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`Contains Nonbinding Recommendations
`
`Enforcement Priorities for
`Electronic Nicotine Delivery
`Systems (ENDS) and Other
`Deemed Products on the Market
`Without Premarket
`Authorization (Revised)
`
`Guidance for Industryl
`
`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
`
`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 FDA's prior compliance policies on deemed new tobacco products that do not have premarket
`authorization, this guidance document does not apply to any deemed product that was not on the market on August
`8, 2016.
`
`2
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`Contains Nonbinding Recommendations
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`For ENDS products marketed without FDA authorization, FDA intends to prioritize enforcement
`against:
`
`• Any flavored, cartridge-based ENDS product (other than a tobacco- or menthol-flavored
`ENDS product);
`• All other ENDS products for which the manufacturer has failed to take (or is failing to
`take) adequate measures to prevent minors' access; and
`• Any ENDS product that is targeted to minors or whose marketing is likely to promote use
`of ENDS by minors.3
`
`Further, FDA intends to prioritize enforcement of any ENDS product that is offered for sale after
`September 9, 2020, and for which the manufacturer has not submitted a premarket application
`(or after a negative action by FDA on a timely submitted application).
`
`This guidance does not in any way alter the fact that it is illegal to market any new tobacco
`product without premarket authorization. FDA is continuously evaluating new information and
`adjusting its enforcement priorities in light of the best available data, and it will continue to do so
`with respect to these products. FDA will take appropriate action regarding tobacco products that
`are marketed without premarket authorization, including as warranted based on changed
`circumstances, new information, or to better address minors' use of those products.
`
`FDA's guidance documents, including this guidance, do not establish legally enforceable
`responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should
`be viewed only as recommendations, unless specific regulatory or statutory requirements are
`cited. The use of the word should in Agency guidances means that something is suggested or
`recommended, but not required.
`
`II. BACKGROUND
`
`A. Statutory and Regulatory History
`
`The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Public
`Law 111-31) granted FDA the authority to regulate the manufacture, marketing, and
`distribution of cigarettes, cigarette tobacco, roll-your-own (RYO) tobacco, and smokeless
`tobacco products to protect the public health and to reduce tobacco use by minors. The
`Tobacco Control Act also gave FDA the authority to issue regulations deeming other
`products that meet the statutory definition of a tobacco product4 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, FDA's use of the term "minor" refers to individuals under the age of 21. This
`is consistent with the Further Consolidated Appropriations Act, 2020 (H.R. 1865), signed into law on December 20,
`2019, which included a provision amending section 906(d) of the Federal Food, Drug, and Cosmetic Act to increase
`the federal minimum age to purchase tobacco products from 18 to 21, and adding a provision that it is unlawful for
`any retailer to sell a tobacco product to any person younger than 21 years of age. In addition, FDA is working to
`update our regulations within 180 days, consistent with the timeline set forth in the law.
`
`4 21 U.S.0 321(rr) (section 201(rr) of the FD&C Act).
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`In accordance with that authority, on May 10, 2016, FDA issued a final rule deeming all
`products that meet the statutory definition of a tobacco product, except accessories of deemed
`tobacco products, to be subject to FDA's tobacco product authority. This included electronic
`nicotine delivery systems (ENDS), cigars, waterpipe (hookah) tobacco, pipe tobacco,
`nicotine gels, and dissolvables that were not already subject to the FD&C Act (81 FR 28974
`at 28976 (May 10, 2016)).
`
`The requirements in Chapter IX of the FD&C Act now apply to deemed products.
`Particularly relevant to this guidance is section 910, which imposes certain premarket-review
`requirements for "new tobacco products"—i.e., those that were not commercially marketed in
`the United States as of February 15, 2007. Accordingly, after the rule's effective date,
`deemed new tobacco products were required to obtain premarket authorization under Section
`910. Deemed new tobacco products that remain on the market without marketing
`authorization are marketed unlawfully in contravention of the Tobacco Control Act. Through
`the premarket review process, FDA conducts a science-based evaluation to determine
`whether a new tobacco product meets the applicable statutory standard for marketing
`authorization—for example, whether the product is appropriate for the protection of public
`health with respect to the risks and benefits to the population as a whole, including users and
`nonusers, and taking into account, among other things, the likelihood that those who do not
`use tobacco products will start using them.
`
`The preamble to the May 10, 2016, final deeming rule explained that FDA intended to defer
`enforcement for failure to have premarket authorization during two compliance periods
`related to premarket review: one for submission and FDA receipt of applications and one for
`obtaining premarket authorization. The first compliance period depended on the type of
`application. The compliance date was 12 months from the effective date of the rule for
`substantial equivalence exemption requests (EX REQs), 18 months for substantial
`equivalence reports (SE Reports), and 24 months for premarket tobacco applications
`(PMTAs). In addition, the preamble explained that under the second compliance period:
`
`Unless FDA has issued an order denying or refusing to accept the submission,
`products for which timely premarket submissions have been submitted will be subject
`to a continued compliance period for 12 months after the initial compliance period
`described previously. For such products, FDA does not intend to initiate enforcement
`for failure to have premarket authorization during this continued compliance period.5
`
`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.
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`a matter of enforcement discretion, stated its intention to defer enforcement for an additional
`three months for all future compliance dates for requirements under the final deeming rule.
`
`In July 2017, FDA announced a new comprehensive plan for tobacco and nicotine regulation that
`would serve as a multi-year roadmap in an effort to significantly reduce tobacco-related disease
`and death. Prior to this announcement, nationally representative data suggested that youth use of
`e-cigarettes had declined beginning in 2016.6 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 new—i.e., not "grandfathered"8—deemed tobacco
`products be submitted to the Agency within 10 months, by May 12, 2020, and providing for a
`one-year period during which products with timely filed applications might remain on the market
`
`Jamal, A, A. Gentzke, S.S. Hu, et al., "Tobacco Use Among Middle and High School Students — United States,
`2011-2016," Morbidity and Mortality Weekly Report, 66:597-603, 2017, available at:
`https://www.cdc.gov/mnm th of unicsi6(0‘ Cmt11662 3 al .htm.
`
`American Academy of Pediafrics, et al. v. Food and Drug Administration, et al., 379 F. Supp. 3d 461, 496 (D. Md.
`2019).
`
`A "granclfathered" 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: hit ps:!Iwww. fda.gov/media/123544/dow nlo a d.
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`Contains Nonbinding Recommendations
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`pending FDA review.9 The court subsequently clarified that its order did not restrict FDA's
`authority to enforce the premarket review provisions against deemed products, or categories of
`deemed products, prior to the submission date or during the one-year review period.19 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
`court's order, deemed new tobacco products on the market as of August 8, 2016, for which
`premarket authorization applications are not filed by September 9, 2020, are subject to FDA
`enforcement actions, in the Agency's discretion.12
`
`B. FDA Response to Evidence of Increasing Youth Use of ENDS Products
`
`In late 2017, FDA started to see a marked increase in complaints about ENDS products. FDA
`initiated an investigation of these complaints, the majority of which pertained to minors' access
`to and use of these products. This new information indicated an alarming increase in the use of
`ENDS products by middle and high school students. In April 2018, FDA conducted a
`nationwide undercover enforcement effort that resulted in FDA issuing 56 warning letters to
`online retailers and 6 civil money penalty (CMP) complaints to retail establishments related to
`the illegal sales of certain ENDS products to minors. In addition, FDA sent an official request
`for information to manufacturers of certain ENDS products commonly used by minors requiring
`them to submit documents to facilitate the Agency's understanding of the reported high rates of
`youth use and the particular youth appeal of these products. FDA also took measures to address
`the sale of ENDS products to minors online by contacting eBay to raise concerns over several
`listings on its website. This resulted in listings for these ENDS products being removed from
`eBay.
`
`In May 2018, FDA issued 17 warning letters to manufacturers, distributors, and retailers for
`selling e-liquids with labeling and/or advertising that resemble kid-friendly food products, such
`as juice boxes, candy, or cookies. The warning letters stated that failure to correct violations
`may result in FDA initiating further action such as seizure or injunctive relief. Of these warning
`letters, 13 were issued as part of a joint action with the Federal Trade Commission (FTC).
`
`On September 12, 2018, FDA announced a series of enforcement and other regulatory actions
`related to the labeling and advertising of ENDS products, including that it had conducted
`
`9 American Academy of Pediafrics, et al. v. Food and Drug Administration, et al., No. 8:18-cv-883 (PWG), 2019
`WL 3067492, at *7 (D. Md. July 12, 2019) (Dkt. No. 127). The court has granted intervention to vapor industry
`trade associations for purposes of appealing the court's decision and remedies order. See American Academy of
`Pediatrics, et al. v. Food and Drug Administration, et al., No. 8:18-cv-883 (PWG), Dkt. No. 154 (Oct. 2, 2019). An
`appeal is pending. See American Academy of Pediatrics v. Cigar Ass 'n ofAmerica, Nos. 19-2130, -2132, -2198, -
`2242 (4th Cir.).
`
`1° 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).
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`E-liquids are a type of ENDS product and generally refer to liquid nicotine and nicotine-
`containing e-liquids (i.e., liquid nicotine combined with colorings, flavorings, and/or other
`ingredients). Liquids that do not contain nicotine or other material made or derived from tobacco,
`but that are intended or reasonably expected to be used with or for the human consumption of a
`tobacco product, may be components or parts and, therefore, subject to FDA's tobacco control
`authorities.
`
`Label means a display of written, printed, or graphic matter upon the immediate container of any
`article. Section 201(k) of the FD&C Act.
`
`Labeling means all labels and other written, printed, or graphic matter (1) upon any article or any
`of its containers or wrappers, or (2) accompanying such article. Section 201(m) of the FD&C
`Act.
`
`New tobacco product means (1) any tobacco product (including those products in test markets)
`that was not commercially marketed in the United States as of February 15, 2007; or (2) any
`modification (including a change in design, any component, any part, or any constituent,
`including a smoke constituent, or in the content, delivery or form of nicotine, or any other
`additive or ingredient) of a tobacco product where the modified product was commercially
`marketed in the United States after February 15, 2007. Section 910(a) of the FD&C Act.
`
`Tobacco product means any product made or derived from tobacco that is intended for human
`consumption, including any component, part, or accessory of a tobacco product (except for raw
`materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco
`product). The term "tobacco product" does not mean an article that under the FD&C Act is a
`drug (section 201(g)(1) (21 U.S.0 321(g)(1))), a device (section 201(h)), or a combination
`product (section 503(g) (21 U.S.0 353(g))). Section 201(rr) of the FD&C Act.
`
`IV. ENFORCEMENT PRIORITIES REGARDING CERTAIN ENDS PRODUCTS ON
`THE MARKET WITHOUT PREMARKET AUTHORIZATION
`
`A. Overview
`
`The Tobacco Control Act provides that new tobacco products (i.e., non-grandfathered products)
`may not legally be marketed without premarket authorization. Accordingly, all deemed new
`tobacco products on the market without authorization are illegally marketed products.
`
`Beginning February 6, 2020, FDA intends to prioritize enforcement of the premarket review
`requirements for certain ENDS products, including against retailers selling such products.
`Specifically, FDA intends to prioritize enforcement against:
`
`(1) Flavored, cartridge-based ENDS products (except for tobacco- or menthol-flavored
`products);
`(2) All other ENDS products for which the manufacturer has failed to take (or is failing to
`take) adequate measures to prevent minors' access; and
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`(3) Any ENDS products targeted to, or whose marketing is likely to promote use by,
`minors.
`
`In addition, FDA intends to prioritize enforcement of any ENDS product that is offered for sale
`in the United States after September 9, 2020, and for which the manufacturer has not submitted a
`premarket application (or after a negative action by FDA on a timely submitted application).22
`
`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
`court's decision in the AAP case. As discussed in this Final Guidance, FDA is implementing this policy to address
`the alarming increase in youth use of ENDS products as well as other recent health and safety issues regarding such
`products.
`
`23 Jamal, A, A. Gentzke, S.S. Hu, et al., "Tobacco Use Among Middle and High School Students — United States,
`2011-2016," Morbidity and Mortality Weekly Report, 66:597-603, 2017, available at:
`https://www.cdc.gov/mmwevolumes/66/wrimm6623a1 .htm.
`
`241d
`
`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:
`hitp://dx doi.org/ 1 0.15585/mmwtmm6722a3.
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`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-
`ci garette s. 89
`
`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. SAMHSA' s 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/mmwrivolumes/68/wripcIfs/mm6845a2-H.pclf.
`80 Russell, C. et al. "Changing Patterns of First E-Cigarette Flavor Used and Current Flavors Used by 20,836 Adult
`Frequent E-Cigarette Users in the USA," Harm Reduction Journal, 15(1):33-47, 2018; Bonhomme, M.G. et al.
`"Flavoured Non-Cigarette Tobacco Product Use Among US Adults: 2013-2014," Tobacco Control, 25(Suppl 2):4-
`13, 2016.
`
`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.
`
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`Case 1:20-cv-00393-LO-TCB Document 918-7 Filed 01/21/22 Page 12 of 12 PageID# 25932
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`Contains Nonbinding Recommendations
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`process from the statutory criteria, as well as published guidances, webinars, and marketing
`orders and their accompanying documentation provided by FDA.96
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`Under the circumstances, FDA believes that earlier enforcement of the premarket review
`provisions is appropriate for ENDS products. This policy should result in earlier submission of
`applications and allow FDA to better evaluate whether these products meet the applicable
`premarket standard, such as whether the products are appropriate for the protection of the public
`health, considering the risks and benefits to the population as a whole, including users and
`nonusers of the tobacco product. Because of FDA's concerns regarding youth use of ENDS
`products, as well as other ongoing health concerns regarding vaping more generally, all
`described at length above, FDA is prioritizing enforcement of premarket review requirements for
`ENDS products, as described in this section, and is doing so independently of the court order.
`This will ensure that FDA has the necessary information to exercise adequate, timely oversight
`over these relatively novel and potentially harmful products. Enforcing premarket authorization
`requirements will, consistent with the process set forth in the Tobacco Control Act, ensure that
`the burden falls on manufacturers of ENDS products to demonstrate that the manufacture and
`sale of their products is appropriate for the protection of the public health.
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`E. Avoiding a "Black Market"
`
`FDA is aware of concerns that, given the rise in popularity of ENDS, removal of some of the
`most popular products from the market may be accompanied by an increase in black market
`versions of these products that may pose additional health and safety risks to consumers beyond
`those of the authentic products. Although all newly deemed products currently on the market
`without premarket authorization are being sold in violation of the Tobacco Control Act, in this
`section, we use the term "black market" to refer to, for example, products intended to look like
`another ENDS products that is currently being marketed, products intended to take the place of
`an ENDS product that a manufacturer has stopped distributing because the product lacks
`premarket authorization, and ENDS products intended for another country's market but diverted
`to the U.S. market. Additional risks posed by these products include the potential that they
`contain harmful chemicals or constituents that are not present in other products, that they are
`manufactured using comparatively poor quality controls, and that they are designed in ways that
`facilitate modifications by distributors or users—all of which increase the risk of adverse
`events.97 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://wwwida.goviregulatorv-
`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/reg ula to n- -in fo rmati o n/sc a rc it-fda -g uida nc c-do cum en t s/appl ica t io ns-pre market-review-new-
`tobacco-products. For more information on CTP's other published regulations and guidances, please see
`litipS://WWW.fda.goy/tobacco-products/products-guidance-regulations/rules-rcgulations-and-guidance; for more
`information on FDA CTP \\ cbinars, please see hi ips : /11V\VW .fda go \ /t ob a c co-products/compliance-enforcement-
`training/fda-tobacco-comphancc-webinars; for information on marketing orders and accompanying documentation,
`c-c ro rcement-training.
`please see https://www.fdl. goiltobacco-product sic o ti tp
`97 E.g., "Amid Vaping Deaths, California Targets Counterfeit Products," The New York Times (Sept. 17, 2019),
`available at https://www.nvtimes.com/2019/09/16/us/california-vaping.html; —Juul-alikes' Are Filling Shelves With
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`1199_RESP00014146
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