FDA Takes Sweeping Enforcement Action to Address “Epidemic” of Youth E-cigarette use, Could Move to Significantly Restrict Flavored Products
On Sept. 12, 2018, the U.S. Food and Drug Administration (FDA or the Agency) announced a series of significant enforcement actions related to the sale and marketing of e-cigarettes to minors. According to FDA, this was the largest coordinated enforcement effort in the Agency’s history, comprised of over 1,300 warning letters and civil money penalty complaints (i.e., fines) to retailers who illegally sold JUUL and other e-cigarette products to minors during a nationwide, undercover blitz of brick-and-mortar and online stores this summer.
Per FDA Commissioner Scott Gottlieb, M.D., the Agency sees “clear signs that youth use of electronic cigarettes has reached an epidemic proportion,” and as a result “must adjust certain aspects of our comprehensive strategy to stem this clear and present danger.”
In addition to announcing the warning letters and fines discussed above, FDA also yesterday made public its letters to the manufacturers of the five top-selling national e-cigarettes brands (i.e., JUUL, Vuse, MarkTen XL, blu e-cigs, and Logic). Significantly, in its letters to JUUL Labs, Reynolds American, Altria, Fontem Ventures, and Japan Tobacco International, USA, the Agency gave each firm 60 days within which to provide a written response to FDA that includes a detailed plan to address and mitigate widespread e-cigarette use by minors. Per the Agency’s letters, such a plan may include:
- Discontinuing sales to retail establishments that have been subject to an FDA civil monetary penalty for sale of tobacco products to minors within the prior 12 months;
- Developing or strengthening any internal program that exists to check on retailers and reporting to the Agency the name and address of retailers that have sold products to minors;
- Eliminating online sales, whether through Internet storefronts controlled by each firm company or other retailers, or providing evidence to demonstrate that the company’s online sales practices do not contribute to youth use of e-cigarette products;
- Revising current marketing practices to help prevent use by minors; and/or
- Removing flavored products from the market until those products can be reviewed by FDA as part of a premarket tobacco product application (PMTA).
Of these plan elements, discontinuing sales to non-compliant retailers, strengthening retailer compliance check programs and revising marketing practices are fairly straightforward and while they will not be easy lifts, are reasonable enough for e-cigarette firms. However, eliminating all online sales, whether or not the company controls the website and removing all flavored products from the market until FDA reviews PMTAs for the same would be highly burdensome on e-cigarette companies. Moreover, this would mean that e-cigarette firms would be removing from market products that are currently on the market legally.
As discussed previously, on Jul. 28, 2017, FDA announced a then-new, comprehensive plan for tobacco and nicotine regulation that would place nicotine and the issue of addiction, at the center of the Agency’s tobacco regulatory efforts. Part of that plan included delaying the deadline for marketing applications for non-combusted products such as electronic nicotine delivery systems (ENDS) or e-cigarettes until Aug. 8, 2022. Under this policy, as long as an e-cigarette was on the market as of Aug. 8, 2016 (i.e., the effective date of FDA’s Deeming Rule), the manufacturer could continue to market such product until a product application for the same is required to be submitted (i.e., Aug. 8, 2022) and while FDA reviews such product application. Accordingly, while FDA is suggesting that leading e-cigarette firms remove flavored products from the market, these companies are legally permitted to continue to market such products, as long as they were on the market as of Aug. 8, 2016 and unless and until FDA moves up its current marketing application deadline.
Per FDA, flavors may play a role in helping some adult cigarette smokers reduce combusted cigarette use and/or switch to potentially less harmful tobacco products (e.g., e-cigarettes). If manufacturers remove flavored e-cigarettes from the market, adult smokers might not transition away from combusted products (i.e., traditional cigarettes) as much as they have been. Recall that under the Family Smoking Prevention and Tobacco Control Act, all flavored combusted cigarettes are banned, so the only current flavored “cigarette” choice for adult smokers is flavored e-cigarettes. Despite the importance of flavors to adult smokers, Commissioner Gottlieb noted yesterday that “in enabling a path for e-cigarettes to offer a potentially lower risk alternative for adult smokers, we won’t allow the current trends in youth access and use to continue, even if it means putting limits in place that reduce adult uptake of these products.”
While FDA’s letters to leading e-cigarette firms are merely requests, Gottlieb said yesterday that the companies’ failure to respond within 60 days, or failure to “appropriately address the issue” in their responses, could result in the Agency revisiting its policy to allow e-cigarettes to remain on the market without a marketing order. More specifically, FDA could require these brands to remove some or all of their flavored products until they receive premarket authorization.
In the meantime, the Agency is currently investigating whether manufacturers introduced certain e-cigarette products to the market after Aug. 8, 2016 and may be subject to enforcement for marketing those products without premarket authorization. If, for example, a manufacturer introduced a new flavored product to the market on Aug. 9, 2016 or after, such product would not be able to take advantage of the Agency’s extended compliance date of Aug. 8, 2022 (i.e., it could not legally be on the market without approval from FDA).
Given FDA’s recent retailer enforcement sweep and its current focus on e-cigarette manufacturer practices:
- Retailers that sell e-cigarettes would be well advised to ensure strict compliance with tobacco product sales age verification requirements; and
- Manufacturers would be well advised to ensure they are not marketing any products introduced after Aug. 8, 2016 without a marketing order in effect.
If you have questions regarding an issue raised in this post, please contact the author or the attorney at the firm with whom you are regularly in contact.