Latest FDA Announcement on Actions to Address Youth Access to E-Cigarettes
By: Stacy L. Ehrlich and Will Woodlee
On September 12, 2018, FDA issued an announcement regarding e-cigarette actions that included the following information.
Over the summer, FDA issued more than 1,300 warning letters and civil money penalty complaints (fines) to retailers who allegedly sold JUUL and other e-cigarette products to minors during a nationwide, undercover blitz of brick-and-mortar and online stores.
On September 12, 2018, FDA issued 12 warning letters alleging that certain online retailers sell misleadingly labeled and/or advertised e-liquids that resemble kid-friendly food products such as candy and cookies. These products were the subject of agency action in May, and FDA indicates that the recipients of FDA’s May warning letters no longer sell the products with the labeling and advertising to which the Agency previously objected. However, FDA asserts that the retailers receiving the latest warning letters are still advertising and selling the allegedly violative products. Several of these retailers were also alleged to have illegally sold the products to minors.
On September 12, 2018, FDA also issued letters to the manufacturers of the five top-selling national e-cigarette brands – JUUL, Vuse, MarkTen XL, blu e-cigs, and Logic – which made up a vast majority of the products reportedly sold to minors as part of the blitz this summer. These letters request the following:
- Within 15 days an acknowledgement and a proposed timeline for meeting with FDA regarding youth use of the recipient’s products, and
- Within 60 days a written response that includes a detailed plan to address and mitigate widespread use by minors and to demonstrate that FDA should continue to defer enforcement of the premarket review provisions with respect to the company’s products, which 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 to check on retailers, and reporting to FDA the name and address of retailers that have sold products to minors;
- Eliminating online sales, whether through Internet storefronts controlled by the company or other retailers, or providing evidence to demonstrate that the company’s online sales practices do not contribute to youth use;
- Revising current marketing practices to help prevent use by minors;
- Removing flavored products from the market until those products can be reviewed by FDA as part of a PMTA.
FDA cautions that, if the companies that received these letters fail to respond, or if their plans do not appropriately address the issues, the Agency will consider whether it would be appropriate to revisit the current policy that results in these products’ at least temporarily remaining on the market without a marketing order from the Agency.
The announcement further stated:
- FDA will revisit its general compliance policy as applied to extend the dates for manufacturers of certain flavored e-cigarettes to submit applications seeking authorization to continue marketing products that were on the U.S. market on August 8, 2016, and remain sold pursuant to the Agency’s enforcement discretion policy.
- FDA will evaluate, and potentially change, its current compliance policy to determine whether it can better account for manufacturers that are not successfully preventing widespread youth use of their products. This means re-examining all aspects of the enforcement discretion that FDA exercised when it extended the compliance dates for premarket authorization for certain newly deemed tobacco products. This could also mean revising the general policy that applies to all manufacturers, and not just the firms receiving the above-discussed letters, and changing the policy as applied to the entire category of “cartridge based e-cigarettes.”
- FDA will closely evaluate manufacturers’ own internet storefronts and distribution practices and take appropriate enforcement actions if the Agency finds violations of the restrictions on sales to minors. FDA has at its disposal both civil and criminal remedies to address demonstrated violations of the law.
- FDA will investigate whether manufacturers of certain e-cigarette products may be marketing new products that were not on the market as of August 8, 2016, thus falling outside of the FDA’s compliance policy, and thus requiring actual premarket review.
The significance of this announcement remains to be seen. This action clearly reflects FDA’s intention to address concerns about youth access to and use of e-cigarette products, particularly “cartridge-based” products such as JUUL products, which have increasingly received press coverage. However, FDA Commissioner Dr. Scott Gottlieb also continues to emphasize that the Agency remains “fully committed to the concept that products that deliver nicotine exist on a continuum of risk, with combustible products representing the highest risk, and electronic nicotine delivery systems perhaps presenting an alternative for adult smokers who still seek access to satisfying levels of nicotine, but without all of the harmful effects that come from combustion.”