On March 13, the FDA proposed a new enforcement policy that could have a significant impact on sales of flavored electronic nicotine delivery systems (“ENDS”) and flavored cigars in the United States.

By way of background, in July 2017, the FDA announced a modification to its compliance policy for “new tobacco products” (defined as any product that was introduced to the US market after February 15, 2007, or changed in any way since then) subject to the Deeming Regulations. Under that policy, manufacturers and importers of combusted products such as cigars have until August 8, 2021 to submit requests to the FDA for marketing authorization, likely in the form of a substantial equivalence report. Manufacturers and importers of ENDS have until August 8, 2022 to submit such requests, likely in the form of a premarket tobacco application. Assuming the filing is made by those dates, the products could stay on the market unless the FDA ultimately denies marketing authorization.

Under the FDA’s proposed new policy, flavored ENDS and flavored cigars could immediately be subject to enforcement action unless: (1) they are “grandfathered” from premarket review requirements, or (2) have obtained FDA marketing authorization. Such a move would likely have a substantial impact on retail sales of these products, since there are no “grandfathered” ENDS, and it does not appear that any ENDS or cigars have thus far received FDA marketing authorization.

Under the enforcement policy, all non-grandfathered flavored cigars (note that the guidance does not define a “flavored cigar”) would be at risk of enforcement action. With ENDS, on the other hand, the FDA apparently plans to take enforcement action only under certain conditions:

  • The policy does not apply to ENDS with tobacco, mint and menthol flavors.
  • Flavored ENDS (other than tobacco, mint and menthol) that are sold in ways that involve greater risk for access to minors – According to the FDA, this includes retail sales in venues that are not age-restricted to prevent minors from entering, retail or internet sales by merchants that have sold ENDS to minors, sales on websites that have no restrictions on the quantity that can be sold in a given time period, and sales on websites that do not have adequate age verification through third-party data sources.
  • Flavored ENDS (other than tobacco, mint and menthol) for which a request for marketing authorization has not been submitted by August 8, 2021 – Thus, for flavored ENDS, the deadline for premarket review submissions has been moved up one year, to August 8, 2021.
  • All ENDS that are “targeted to minors” or “likely to promote use of ENDS by minors” – It appears that the FDA will take enforcement action against any ENDS (even with tobacco, mint and menthol flavors) that use cartoons, that resemble kid-friendly food or drinks, or that the FDA otherwise regards as appealing to minors.

The policy is slated to take effect 30 days after the FDA issues final guidance. The FDA has requested comments on this draft guidance, and comments are due by April 15. Given the impact, we encourage industry stakeholders to comment on the FDA’s proposal.