Vape in FDA Crosshairs

Convenience store retailers await FDA final guidance on flavor restrictions and potential national age legislation to make 21 the minimum age for vape.

It’s been three months since outgoing U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced draft guidance for flavored tobacco products, noting, “We expect that some flavored e-cigarette products will no longer be sold at all.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.”

The guidance outlined FDA’s plans

  • 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;
  • to require 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.

Acting Commissioner Ned Sharpless, who replaced Gottlieb, is the director of the National Cancer Institute and supports restrictions on e-cigarettes.

In the National Association of Tobacco Outlets (NATO)’s review of the draft guidance, the association noted FDA could take enforcement action to prevent convenience stores, service stations, drug stores and grocery stores from selling these other flavored e-cigarette and vapor products. The guidance may also allow retailers to create an age-restricted area within the store to sell these products.

On the heels of flavor regulation, age restrictions are on the docket. At press time more than a dozen states had raised the purchase age for tobacco products to 21. U.S. Senator Mitch McConnell, R – Ky., also proposed a federal bill to raise the purchasing age for all tobacco products — including vape — to 21.

This April, the FDA began cracking down on manufacturers, selling and/or distributing nicotine-containing e-liquids with labeling that looks similar to that on prescription cough syrups.


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