FDA Issues Electronic Cigarette Guidance and Regulations

This week, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced the release of draft guidance entitled “Modifications to Compliance Policy for Certain Deemed Tobacco Products.” The draft guidance proposes to restrict flavored electronic cigarette sales and ban new flavored cigars from the market. FDA expects manufacturers of electronic nicotine delivery systems (ENDS) that remain on the market under new regulatory conditions set forth by the draft guidance to submit premarket applications to the agency by August 2021, which is one year earlier than previously proposed. FDA Commissioner Gottlieb also indicated the agency will prioritize enforcement efforts of products that pose a greater risk for access by minors.

Under the proposed guidance, the FDA expects that some flavored electronic cigarette and cigar products will no longer be sold and that other flavored electronic cigarette products that continue to be sold will be sold in a manner that prevents youth access. The FDA is soliciting comments on the draft guidance via the Federal Register by April 15, 2019. The full announcement from the FDA is available here.