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Quick Hits: FDA Establishes Enforcement Policy on Unauthorized E-Cigs

The FDA has given companies 30 days to cease manufacture, distribution and sale of unauthorized flavored e-cigarette cartridges.

It’s been a long time coming, but the FDA has finalized its enforcement policy for unauthorized flavored vape cartridge that appeal to kids. The policy, outlined here, targets enforcement against certain flavored products that appeal to kids, including fruit and mint flavors. Companies that do not cease manufacture, distribution and sale of unauthorized cartridge-based e-cigarettes within 30 days will be subject to FDA enforcement actions. However, this does exclude tobacco and menthol flavors.

The final guidance on electronic nicotine delivery systems (ENDS) comes on the heels of the 2019 National Youth Tobacco Survey results, which showed that more than 5 million U.S. middle and high school students have used e-cigarettes within the last 30 days. The majority of users reported cartridge-based products as their usual brand. Beginning 30 days from the publication of the notice, the FDA will prioritize enforcement against:

  • Any flavored, cartridge-based ENDS product (other than a tobacco- or menthol-flavored ENDS product);
  • All other ENDS products for which the manufacturer has failed to take (or is failing to take) adequate measures to prevent minors’ access; and
  • Any ENDS product that is targeted to minors or likely to promote use of ENDS by minors.
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