The U.S. Food and Drug Administration (FDA) issued Thursday, Jan. 2, a policy prioritizing enforcement against certain unauthorized flavored e-cigarette products that appeal to kids, including fruit and mint flavors.

Under this policy, companies that do not stop manufacturing, distributing and selling unauthorized flavored cartridge-based e-cigarettes (other than tobacco or menthol) within 30 days, risk enforcement actions from the FDA.

The final guidance outlining the agency’s enforcement priorities for electronic nicotine delivery systems, such as e-cigarettes and e-liquids, comes as the 2019 National Youth Tobacco Survey results on e-cigarette use shows that more than five million U.S. middle and high school students are current e-cigarette users, with a majority of those reporting cartridge-based products, such as JUUL, as their usual brand.

Beginning in 30 days, the FDA intends to prioritize enforcement against these illegally marketed electronic nicotine delivery systems (ENDS) products by focusing on the following groups of products that do not have premarket authorization: any flavored, cartridge-based ENDS product (other than tobacco or menthol), all other ENDS products for which the manufacturer has failed to take adequate measures to prevent minors’ access, and any ENDS product that is targeted to minors or likely to promote use of ENDS to minors.

Oregon’s Senator Jeff Merkley, the top Democrat on the Appropriations Subcommittee that oversees the FDA, released a statement in response to the FDA announcement, stating that the health of millions of American children will continue to suffer.

“This announcement is simply stating that FDA will target its enforcement on flavors, and even then, it is carving out loopholes for tobacco and menthol flavors, and vape shops,” Merkley said in the statement. “FDA’s own announcement of preliminary data from the 2019 National Youth Tobacco Survey shows that youth use of menthol e-cigarettes soared in 2019 after JUUL stopped selling fruit flavors.”

A spokesperson for the FDA, Stephanie Caccomo, responded by email to the Headlight Herald’s request for a response to Merkley’s statement. Caccomo stated that the FDA believes that prioritizing enforcement with respect to flavored, cartridge-based ENDS products, other than tobacco or menthol-flavored ENDS products, achieves an appropriate balance between restricting youth access to kid-appealing flavored ENDS products and maintaining availability of potentially less harmful options for current adult smokers who have transitioned, or wish to transition, completely away from combusted tobacco products.

“A recently published study, focusing on youth use of JUUL – a cartridge-based ENDS product, shows that rates of use of tobacco and menthol-flavored JUUL products ranked among the lowest for respondents (i.e. eighth, 10th, and 12th graders), and were much lower than those for mint and fruit-flavored JUUL products,” Caccomo said. “Additionally, menthol, in particular, is unique compared to other available ENDS product flavors, as it is the only flavor available in cigarettes.”

Caccomo said menthol cigarettes are used by a substantial portion of adult smokers, so having a different policy for menthol ENDS may provide them with an alternative product to transition completely away from cigarettes. Because of these considerations, these products are not among the current enforcement policies. However, the FDA is prioritizing enforcement of premarket authorization requirement against all ENDS products (both cartridge-based or otherwise, and including menthol, tobacco and non-flavored) when the manufacturer has not taken or is not taking adequate measures to prevent minors’ access to these products.

“In addition, the FDA is prioritizing enforcement against all ENDS products that are targeted to minors or likely to promote use of ENDS by minors,” Caccomo said. “The FDA will continue to closely monitor the rates of all e-cigarette use among youth and, if needed, will take additional steps to address youth use of those products.”

Under the policy announced Jan. 2, tobacco and menthol-flavored cartridge-based e-cigarettes, are subject to the May 12, 2020 submission date for marketing applications, Caccomo said. The FDA intends to prioritize enforcement of an ENDS product offered for sale after May 12, and for which the manufacturer has not submitted a premarket application.


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