FDA Outlines Flavored E-Cig Policy Changes

FDA Commissioner Gottlieb issued a statement on upcoming ENDS policy changes.

The U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, who recently resigned, issued a statement on advancing upcoming e-cigarette policy changes.

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)
  • to prioritize enforcement of such products offered for sale in ways that pose a greater risk for minors to access these tobacco products.
  • 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.
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“Today’s draft guidance states our expectation that manufacturers of all flavored ENDS products (other than tobacco-, mint- and menthol-flavored) that remain on the market under circumstances to limit youth access and appeal also submit their premarket applications by Aug. 8, 2021,” said Gottlieb. “This is an important change in our expectations and enforcement priorities. For all flavored ENDS products, including any that continue to be offered for sale under circumstances involving heightened age verification, the FDA expects manufacturers to prepare and submit applications that demonstrate these products meet the public health standard by Aug. 8, 2021.”

The FDA cited a recent increase in e-cigarette use among youth, which had appeared to be leveling off at the time the comprehensive plan was first announced in July 2017, as a threat to the progress made in reducing youth tobacco use.

This prompted the FDA to review its policies and regulatory priorities.

Because of these policy changes, the FDA expects:

  • Some flavored e-cigarette products to no longer be sold at all.
  • 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.
  • Some flavored cigars will no longer be sold.

“With the support of the Secretary of Health and Human Services Alex Azar, and President Donald 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),” said Gottlieb.

The agency will continue its efforts aimed at enforcement and education and will release a TV ad aimed at educating children about the risks of e-cigarettes.

The FDA will review comments and implement the policies 30 days after the guidance is finalized.

“However, we’re hopeful manufacturers and retailers will begin taking voluntary steps to further curb youth access to and appeal of these products,” said Gottlieb. “As we’ve said before, responsible manufacturers certainly don’t need to wait for the FDA to finalize policies to act. They can immediately stop certain marketing and sales practices—the ones we believe contribute to the problem of youth access and youth appeal. Likewise, manufacturers need not wait to submit premarket tobacco product applications for ENDS products, flavored or otherwise.”