Source: FDA, 3/12/19

Today, FDA announced publication of the draft guidance "Modifications to Compliance Policy for Certain Deemed Tobacco Products," as part of the agency’s commitment to limit youth access to, and appeal of, tobacco products. FDA is proposing to end theAugust 2017 compliance policy regarding premarket review requirements for certain deemed tobacco products – specifically for flavored electronic nicotine delivery system (ENDS) products (other than tobacco-, mint-, and/or menthol-flavored) and flavored cigars (other than tobacco-flavored).

Beginning 30 days after issuance of the final guidance, which will be released at a later date, all flavored ENDS products covered by the new policy would no longer be subject to FDA’s enforcement discretion outlined in the current compliance policy, which gives manufacturers of ENDS products on the market as of Aug. 8, 2016 until Aug. 8, 2022 to submit a premarket application. Also as of 30 days after the guidance is finalized, all manufacturers and retailers would be subject to FDA enforcement for selling flavored ENDS products that lack marketing authorization.

FDA is proposing to prioritize enforcement of the policy by focusing on flavored ENDS products (other than tobacco-, mint-, and/or menthol-flavored) that are offered for sale in ways that pose a greater risk for minors to access the products, and those that are targeted to minors or likely to promote use of ENDS by minors. Importantly, today’s draft guidance details FDA’s expectation that manufacturers of flavored ENDS products covered by the new policy – but that remain on the market – submit their premarket applications by Aug. 8, 2021.

In addition, 30 days after the guidance is finalized, any flavored cigars (other than tobacco-flavored) that were on the market as of Aug. 8, 2016, and that meet the definition of a new tobacco product, would be subject to enforcement action. As a result, flavored cigars that are not grandfathered tobacco products and lack marketing authorization would no longer be subject to FDA’s enforcement discretion outlined in the current compliance policy.

Starting tomorrow, March 14, comments on this draft guidance may be submitted to the open docket with the same title on Regulations.gov. Comments must be received by Apr. 15, 2019 to ensure that FDA considers them while working on the final guidance.

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