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`EXHIBIT K
`EXHIBIT K
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`FDA NEWS RELEASE
`
`FDA finalizes enforcement policy on unauthorized
`flavored cartridge-based e-cigarettes that appeal to
`children, including fruit and mint
`
`Companies that do not cease manufacture, distribution and sale of unauthorized
`flavored cartridge-based e-cigarettes (other than tobacco or menthol) within 30 days
`risk FDA enforcement actions
`
`CO More Press AnnouncemeCiNP/Kligc[AfitickiNWRom/press-announcements)
`January 02, 2020
`
`Amid the epidemic levels of youth use of e-cigarettes and the popularity of certain
`products among children, the U.S. Food and Drug Administration today issued a policy
`prioritizing enforcement (/regulatory-information/search-fda-guidance-
`documents/enforcement-priorities-electronic-nicotine-delivery-system-ends-and-other-
`deemed-products-market) against certain unauthorized flavored e-cigarette products
`that appeal to kids, including fruit and mint flavors. Under this policy, companies that do
`not cease manufacture, distribution and sale of unauthorized flavored cartridge-based
`e-cigarettes (other than tobacco or menthol) within 30 days risk FDA enforcement
`actions.
`
`"The United States has never seen an epidemic of substance use arise as quickly as our
`current epidemic of youth use of e-cigarettes. HHS is taking a comprehensive, aggressive
`approach to enforcing the law passed by Congress, under which no e-cigarettes are
`currently on the market legally," said HHS Secretary Alex Azar. "By prioritizing
`enforcement against the products that are most widely used by children, our action today
`seeks to strike the right public health balance by maintaining e-cigarettes as a potential
`off-ramp for adults using combustible tobacco while ensuring these products don't
`provide an on-ramp to nicotine addiction for our youth. We will not stand idly by as this
`crisis among America's youth grows and evolves, and we will continue monitoring the
`situation and take further actions as necessary."
`
`"As we work to combat the troubling epidemic of youth e-cigarette use, the enforcement
`policy we're issuing today confirms our commitment to dramatically limit children's
`access to certain flavored e-cigarette products we know are so appealing to them — so-
`called cartridge-based products that are both easy to use and easily concealable. We will
`continue to use our full regulatory authority thoughtfully and thoroughly to tackle this
`alarming crisis that's affecting children, families, schools and communities," said FDA
`Commissioner Stephen M. Hahn, M.D. "Coupled with the recently signed legislation
`increasing the minimum age of sale of tobacco to 21, we believe this policy balances the
`urgency with which we must address the public health threat of youth use of e-cigarette
`products with the potential role that e-cigarettes may play in helping adult smokers
`transition completely away from combustible tobacco to a potentially less risky form of
`nicotine delivery. While we expect that responsible members of industry will comply
`with premarket requirements, we're ready to take action against any unauthorized
`e-cigarette products as outlined in our priorities. We'll also closely monitor the use rates
`of all e-cigarette products and take additional steps to address youth use as necessary."
`
`The final guidance outlining the agency's enforcement priorities for electronic nicotine
`delivery systems (ENDS), such as e-cigarettes and e-liquids, comes as the 2019 National
`Youth Tobacco Survey (NYTS) results
`(https://jamanetwork.com/journals/jama/fullarticle/to.toot/jama.2019.18387?
`guestAccessKey=54b2dc7d-3855-4728-a522-
`573083a5d2cd&utm_source=For_The_Media&utm_medium=referral&utm_campaign=ftm_links&utm_content=t1
`
`https://www.fda.gov/news-events/press-announcements/fda-finalizes-enforcement-policy-... 6/25/2020
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`(http://www.fda.gov/about-fda/website-policies/website-disclaimer) on e-cigarette
`use show that more than 5 million U.S. middle and high school students are current
`e-cigarette users (having used within the last 30 days) — with a majority reporting
`cartridge-based products as their usual brand.
`
`The NYTS survey, which is conducted annually by the FDA in conjunction with the
`Centers for Disease Control and Prevention, also shows that of current youth e-cigarette
`users in 2016, approximately 1.6 million were using the product frequently (use on 20
`days or more in a 30-day period), with nearly one million using e-cigarettes daily.
`Additional data from another federal survey
`(https://jamanetwork.com/journals/jama/fullarticle/to.toot/jama. 2019.17968?
`guestAccessKey=6cd13a73-46aa-460e-95c7-
`0cb2d6b66fdf&utm_source=For_The_Media&utm_medium=referral&utm_campaign=ftm_links&utm_content=tfl&utm_term=110516)
`(http://www.fda.gov/about-fda/website-policies/website-disclaimer) further
`underscore that youth are particularly attracted to e-cigarette flavors such as fruit and
`mint, much more so than tobacco or menthol flavored e-cigarettes. These overall levels
`of youth e-cigarette use are particularly concerning because using e-cigarettes puts them
`at risk for nicotine addiction and other health consequences. In particular, evidence
`shows that youth exposure to nicotine can adversely affect the developing adolescent
`brain and that, compared with non-users, youth who use e-cigarettes are more likely to
`try conventional cigarettes in the future.
`
`On Aug. 8, 2016, all e-cigarettes and other ENDS products became subject to the FDA's
`tobacco authorities, including the premarket authorization requirements in the Federal
`Food, Drug, and Cosmetic Act (FD&C Act). All e-cigarettes and other ENDS products on
`the market at that time needed to have authorization from the FDA to be legally
`marketed. However, as an exercise of its enforcement discretion, the agency had deferred
`enforcement of the premarket authorization requirements. To date, no ENDS products
`have been authorized by the FDA — meaning that all ENDS products currently on the
`market are considered illegally marketed and are subject to enforcement, at any time, in
`the FDA's discretion.
`
`Beginning 30 days from the publication of the notice of availability of this guidance in
`the Federal Register, the FDA intends to prioritize enforcement against these illegally
`marketed ENDS products by focusing on the following groups of products that do not
`have premarket authorization:
`
`• 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 likely to promote use of ENDS by
`minors.
`
`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 when the product is
`used. For purposes of this policy, a cartridge or pod is any small, enclosed unit (sealed or
`unsealed) designed to fit within or operate as part of an ENDS product.
`
`By not prioritizing enforcement against other flavored ENDS products in the same way
`as flavored cartridge-based ENDS products, the FDA has attempted to balance the public
`health concerns related to youth use of ENDS products with considerations regarding
`addicted adult cigarette smokers who may try to use ENDS products to transition away
`from combustible tobacco products. In addition to data showing that cartridge-based
`ENDS products are most commonly used among youth, important findings from the
`2016 Monitoring the Future survey
`(https://jamanetwork.com/journals/jama/fullarticle/to.toot/jama. 2019.17968?
`guestAccessKey=6cd13a73-46aa-460e-95c7-
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`0cb2cl9b66fdf&utm_source=For_The_Media&utm_medium=referral&utm_campaign=ftm_links&utm_content=tfl&utm_term=110519)
`(http://www.fda.gov/about-fda/website-policies/website-disclaimer) focusing on
`youth use of JUUL indicate that youth preference for menthol- and tobacco-flavored
`e-cigarettes is much lower than that for mint- and fruit-flavored e-cigarettes. Because of
`the relatively low numbers of youth using both menthol- and tobacco-flavored, cartridge-
`based ENDS products, these products are not among the current enforcement priorities.
`However, should the FDA become aware of an increase of youth using any other flavored
`products (both cartridge-based or otherwise), the agency will take additional steps to
`address youth use of those products if necessary.
`
`For all other products (cartridge-based or otherwise), including menthol-, tobacco-, and
`non-flavored ENDS products, the FDA will also prioritize enforcement where the
`manufacturer fails to take adequate measures to prevent youth access. For example, the
`FDA will consider whether the manufacturer has implemented adequate programs to
`monitor retailer compliance with age-verification and sales restrictions or if it has
`established and enforced penalties against retailers that fail to comply with those
`programs. The agency also will consider 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. In addition, consideration will be given to whether the
`manufacturer limits (or requires retailers who sell its products to limit) the quantity of
`ENDS products that a customer may purchase within a given period of time.
`
`The FDA also intends to prioritize enforcement with respect to any ENDS products that
`are targeted to youth or likely to promote use of ENDS by youth. Examples include:
`products marketed with labeling and/or advertising that resemble kid-friendly foods and
`drinks such as juice boxes or kid-friendly cereal; products marketed directly to minors by
`promoting ease of concealing the product or disguising it as another product; and
`products marketed with characters designed to appeal to youth.
`
`Importantly, the FDA's enforcement priorities are not a "ban" on flavored or cartridge-
`based ENDS. The FDA has already accepted and begun review of several premarket
`applications for flavored ENDS products through the pathway that Congress established
`in the Tobacco Control Act. Manufacturers that wish to market any ENDS product —
`including flavored e-cigarettes or e-liquids — are required by law to submit an application
`to the FDA that demonstrates that the product meets the applicable standard in the law,
`such as whether the product is appropriate for the protection of the public health. If a
`company can demonstrate to the FDA that a specific product meets the applicable
`standard set forth by Congress, including considering how the marketing of the product
`may affect youth initiation and use, then the FDA could authorize that product for sale.
`
`The guidance also states that, after May 12, 2020, the FDA intends to also prioritize
`enforcement against any ENDS products that continue to be sold and for which the
`manufacturers have not submitted a premarket application. For ENDS products other
`than those in the three groups described above, if premarket applications are submitted
`by that date, the FDA intends to continue to exercise enforcement discretion for up to
`one year pending FDA review of the applications, unless there is a negative action by the
`FDA on such application or the product is authorized to be marketed by the FDA.
`
`The FDA has demonstrated a deep commitment to taking steps to prevent youth from
`using and becoming addicted to any tobacco product, including e-cigarettes. This
`enforcement policy is an important step in the agency's ongoing work to ensure these
`products are not marketed to, sold to, or used by kids, as outlined in the agency's Youth
`Tobacco Prevention Plan (/tobacco-products/youth-and-tobacco/fdas-youth-tobacco-
`prevention-plan), including investing in public education campaigns (/tobacco-
`products/public-health-education/real-cost-campaign) to educate youth about the
`dangers of e-cigarette use, provide resources to educators, parents and community
`leaders to prevent youth use, as well as further explore how to help those kids who are
`already addicted to e-cigarettes quit.
`
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`The FDA, an agency within the U.S. Department of Health and Human Services, protects
`the public health by assuring the safety, effectiveness, and security of human and
`veterinary drugs, vaccines and other biological products for human use, and medical
`devices. The agency also is responsible for the safety and security of our nation's food
`supply, cosmetics, dietary supplements, products that give off electronic radiation, and
`for regulating tobacco products.
`
`###
`
`Consumer:
`
`888-INFO-FDA
`
`Inquiries
`Media:
`
`E Stephanie Caccomo
`(mailto:stephanie.caccomo@fda.hhs.gov)
`
`C 301-348-1956
`
`Related Information
`
`• FDA: Enforcement Priorities for Electronic Nicotine Delivery System (ENDS) and
`Other Deemed Products on the Market Without Premarket Authorization
`(/regulatory-information/search-fda-guidance-documents/enforcement-priorities-
`electronic-nicotine-delivery-system-ends-and-other-deemed-products-market)
`
`• Youth Tobacco Use: Results from the National Youth Tobacco Survey (/tobacco-
`products/youth-and-tobacco/youth-tobacco-use-results-national-youth-tobacco-
`survey)
`
`• FDA's Youth Tobacco Prevention Plan (/tobacco-products/youth-and-
`tobacco/fdas-youth-tobacco-prevention-plan)
`
`Retailers and manufacturers with questions about this policy can contact:
`Email: AskCTP@fda.hhs.gov (mailto:AskCTP@fda.hhs.gov)
`Phone: 1-877-287-1373
`
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