A newly released FDA memo is raising questions about the agency’s watershed authorization of fruit-flavored e-cigarettes after revealing that the products were not significantly more effective at helping smokers quit than tobacco-flavored alternatives, according to the Associated Press. The decision drew criticism from public health groups and Democratic lawmakers, who argue the authorization departs from the agency’s long-standing position that fruit and dessert flavors require a particularly high evidentiary standard because of their appeal to youth.
The six-page document, published weeks after the FDA approved mango- and blueberry-flavored vaping products from Glas Inc., acknowledged that study data showed no statistically significant difference in smoking cessation outcomes between users of the fruit-flavored products and those using tobacco-flavored e-cigarettes. The finding contrasts with previous FDA authorizations of flavored products, including menthol e-cigarettes from Juul Labs and NJOY, which demonstrated measurable benefits over tobacco-flavored products.
However, the AP said regulators explained that the Glas flavored vapes “did not have to demonstrate added adult benefit,” because young people were unlikely to use them. Glas requires users to unlock each e-cigarette with an age-verifying cellphone app. The memo indicates that FDA regulators instead relied heavily on the company’s age-verification technology, concluding that youth uptake was unlikely because users must unlock devices through a smartphone app. The approval was finalized shortly before the departure of former FDA Commissioner Marty Makary and comes amid broader scrutiny of the agency’s recent approach to vaping regulation.