FDA Memo Questions Flavored-Vape Reversal: AP - Tobacco Reporter
FDA memo shows fruit‑flavored vapes didn’t significantly help smokers quit more than tobacco flavors, yet were approved due to youth‑access limits.Summary
A newly released FDA memo is raising questions about the agency’s authorization of fruit‑flavored e‑cigarettes from Glas Inc., showing that study data found no statistically significant difference in smoking‑cessation outcomes between users of the mango‑ and blueberry‑flavored products and those using tobacco‑flavored e‑cigarettes. This contrasts with earlier FDA authorizations of menthol‑flavored vapes from Juul Labs and NJOY, which demonstrated measurable benefits over tobacco flavors. Agency officials said the Glas products did not need to prove added adult benefit because their age‑verification smartphone app makes youth uptake unlikely, and the approval was finalized shortly before former Commissioner Marty Makary’s departure amid broader scrutiny of the FDA’s vaping‑regulation approach.
(Source：Tobacco Reporter)
