FDA's New Policies Aimed at Preventing Youth Access to Flavored Tobacco Products

On March 13, 2019, FDA Commissioner Scott Gottlieb, M.D. provided the following statement regarding additional guidelines for tobacco products.

The 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.

Additionally, the 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 August 8, 2021. This application date is one year earlier than the agency previously proposed.

There are many aspects of these policies outlined in a draft compliance policy published today, which we intend to review comments on and finalize as quickly as possible. We expect several things to happen because of these policy changes:

We expect that some flavored e-cigarette products will no longer be sold at all.
We expect that other flavored e-cigarette products that continue to be sold will be sold only in a manner that prevents youth access, while premarket authorization for these products is sought from the FDA by 2021.

We expect some flavored cigars will no longer be sold.

Specifically, today, with the strong support of the Secretary of Health and Human Services Alex M. Azar, and President Donald J. Trump, the FDA is proposing to end our current compliance policy as it applies to flavored electronic nicotine delivery system (ENDS) products (other than tobacco-, mint-, and menthol-flavored). Previously, for all ENDS products on the market as of August 8, 2016, the FDA had announced our intention not to enforce the premarket review requirements until August 2022, with the expectation that many such products would remain on the market. In addition, under this previous policy, we intended to continue deferring enforcement while an ENDS product’s application was pending review.

Even though these comments do not define the regulations that will be enforced it does shed light on radical changes that will be coming to flavored e-liquid products. We'd expect to hear in the months ahead what specific actions the FDA will be taking to regulate flavored e-liquid products. It will certainly limit the access of products to our customers and millions of customers in the United States.