FDA Moves Forward with Proposal to Combat Teen E-Cigarette Use

On March 13th, the FDA issued a proposal to combat the rise in teen e-cigarette and cigar use.1  Data has shown that more than 3.6 million middle and high school students were e-cigarette users in 2018, an increase of 1.5 million students since 2017.2  Data also indicated that flavored cigarettes are becoming more popular among kids.3  According to the FDA statement, flavored e-cigarette advertising and packaging targeting children in addition to the illegal sale to minors in brick-and-mortar retailers and online has contributed to this crisis.4

The proposal addresses the necessary balance between preventing nicotine addiction in a new generation and providing adults “access to potentially less harmful forms of nicotine delivery.”5  Therefore, while almost all flavored nicotine products will be affected by these new guidelines, it will not affect mint, menthol, and tobacco flavored products since these are more likely to be used by adults.6  Manufacturers of the affected flavored nicotine products must submit premarket applications that show the products meet the public health standard by August 8, 2021, one year earlier than the FDA’s previous proposal.7  It will be difficult for products to meet this standard since manufacturers must show the products do not encourage vaping among minors.8

The FDA’s new rules are likely to increase the cost of selling flavored e-cigarette products that could lead to less retailers selling these products.  The proposal requires retailers to “sequester flavored e-cigarettes to areas off limits to anyone under age 18.”9  The agency also requires products sold online to have a quantity limit and verification service.10  Of note is that Juul, one of the largest sellers of e-cigarettes, has already agreed to stop selling flavored e-cigarette products in brick-and-mortar stores.  It now only sells them online where there is an age verification system.11

The FDA is also concerned about minors’ use of flavored cigars.12  If flavored cigars are considered a “new tobacco product” and were on the market on August 8, 2016, then they are subject to FDA enforcement.13  Manufacturers of flavored cigars (other than tobacco-flavored) would also be required to obtain premarket authorization for the cigars to be re-introduced to the market.14  The agency suggested that a ban on all flavored cigars may be possible in the future.15

The proposal simply states that the FDA is “putting all manufacturers and retailers on notice: you may be subject to FDA enforcement for selling certain flavored ENDS products without authorization.”16  While the FDA remains hopeful that manufacturers and retailers will voluntarily start taking the necessary steps to prevent minor’s access to these products, the guidelines will not be finalized until after the 30-day comment period.17

Some have criticized the proposal for still permitting the sale of mint and menthol flavors since these flavors are also popular among children18 or that the proposal is not aggressive enough to tackle this problem and that removing all flavored tobacco products from the market is necessary.19  On the other side, a spokeswoman for Vapers United stated that there was “insufficient clarity” concerning the measures the retailers needed to take and this might lead retailers to overcorrect and decrease access to these products for adult smokers.20  In addition, the National Association of Convenience Stores does not believe the FDA has the authority to enforce these requirements.21  The Association specifically points to the Tobacco Control Act, which they interpret as indicating the FDA cannot “discriminate against a specific channel of distribution.”22

This proposal comes after FDA Commissioner Scott Gottlieb announced his resignation. 23  But despite his resignation, it is expected that the FDA and the Trump administration will continue these efforts to decrease teen e-cigarette use.24  The FDA statement emphasized its support within the Trump Administration.25  One thing to note is that these guidelines are not legally binding; they are an exercise of the FDA’s discretionary enforcement authority.26 Therefore, flavored e-cigarette product manufacturers and retailers who sell these products may challenge this policy in court.27

  1. Press Release, FDA, Statement from FDA Commissioner Scott Gottlieb, M.D., on Advancing New Policies Aimed at Preventing Youth Access to, and Appeal of, Flavored Tobacco Products, Including E-Cigarettes and Cigars (Mar. 13, 2019), https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm633291.htm. 

  2. Id. 

  3. Id. 

  4. See id. 

  5. Id. 

  6. Id. 

  7. Id. 

  8. Laurie McGinley, FDA Rolls Out Vaping Policy to Make it Harder for Minors to Buy Flavored Products, Wash. Post(Mar. 13, 2019), https://www.washingtonpost.com/health/2019/03/13/fda-rolls-out-vaping-policy-make-it-harder-minors-buy-flavored-products/?utm_term=.c01feb1fba83. 

  9. Sheila Kaplan, F.D.A. Moves to Restrict Flavored E-Cigarette Sales to Teenagers, N.Y. Times (Mar. 13, 2019), https://www.nytimes.com/2019/03/13/health/e-cigarettes-teenage-vaping.html. 

  10. Press Release, supra note 1 

  11. Sheila Kaplan, F.D.A. Accuses Juul and Altria of Backing Off Plan to Stop Youth Vaping, N.Y. Times (Jan. 4, 2019), https://www.nytimes.com/2019/01/04/health/fda-juul-altria-youth-vaping.html. 

  12. Press Release, supra note 1 

  13. Id. 

  14. Id. 

  15. Id. 

  16. Id. 

  17. Id. 

  18. Kaplin, supra note 9. 

  19. McGinley, supra note 8. 

  20. Id. 

  21. Kaplin, supra note 9. 

  22. Id. 

  23. Margaret Talev & Anna Edney, No Letup Seen in Crackdown on Vaping by FDA After Gottlieb, Bloomberg (Mar. 8, 2019),https://www.bloomberg.com/news/articles/2019-03-07/white-house-says-no-dispute-with-fda-chief-gottlieb-before-exit. 

  24. McGinley, supra note 8. 

  25. Press Release, supra note 1 

  26. Id. 

  27. McGinley, supra note 8.