Outgoing Commissioner of the U.S. Food & Drug Administration (FDA) Scott Gottlieb, MD, has announced that the FDA is proposing new policies to restrict youth access to flavored electronic nicotine delivery system (ENDS) products (other than tobacco-, mint-, and/or menthol-flavored) and flavored cigars (other than tobacco-flavored). Commissioner Gottlieb issued the following statement:
- FDA is proposing to end current compliance policy as it applies to flavored electronic nicotine delivery system (ENDS) products such as electronic cigarettes (other than tobacco-, mint-, and menthol-flavored products), and prioritize enforcement of such products offered for sale in ways that pose a greater risk for minors to access these tobacco products.
- In addition, FDA expects manufacturers of all flavored ENDS products (other than tobacco-, mint-, and menthol-flavored) that remain on the market under these new conditions to submit premarket applications to the agency by Aug. 8, 2021. This application date is one year earlier than the agency previously proposed.
While any efforts to limit youth access to tobacco products is a positive step, the FDA’s announcement was criticized by some advocacy groups for not going far enough. Salynn Boyles, writing for the online publication MedPage Today notes that “the actions were widely criticized by health groups as insufficient to reverse the epidemic rise in e-cigarette use among teens and young adults.”
In her article, Boyles quotes Erika Sward of the American Lung Association (and a member of the U.S. COPD Coaition’s Public Policy Workgroup) as saying that the FDA’s latest action will have “little or no impact on the youth e-cigarette epidemic…They are nibbling around the edges of the problem, and failing to take meaningful action.” According to Boyles, Nancy Brown, CEO of the American Heart Association, agrees. “We appreciate that while [the] FDA has recognized the magnitude of the problem, frankly we are underwhelmed by today’s announcement…We don’t think the FDA has gone far enough to reverse the epidemic of youth addiction to e-cigarettes.”
Commissioner Gottlieb announced on March 5th that he will be stepping down as FDA Commissioner in April. Dr. Ned Sharpless, Director of the National Cancer Institute will become Acting Commissioner.