FDA Memo: Fruit-Flavored Vapes No Better Than Tobacco for Quitting
TheĀ Food and Drug AdministrationĀ is facing intense scrutiny after a newly releasedĀ six-page FDA memoĀ revealed that recently authorizedĀ fruit-flavored e-cigarettesĀ are no more effective at helping smokers quit than tobacco-flavored alternatives. This revelation hasĀ stirred more questionsĀ regarding the agency’s sudden policy shift.
Historically, the FDA has maintained that sweet and fruity flavorsĀ appeal to children. To gain approval, manufacturers typically face a high evidentiary hurdle to prove theirĀ products benefit public healthĀ by helping adults switch while preventingĀ underage use by teens.
While the study showed Glas users were likely to switch from traditional cigarettes, it failed to show “statistically significant differences” between those using mango or blueberry flavors and those using tobacco-flavored vapes. This stands in stark contrast to previous authorizations for menthol products fromĀ JuulĀ andĀ NJOY, which successfully demonstrated that menthol helpedĀ vapes help adult smokers switch or quit cigarettesĀ more effectively than tobacco flavors.
To justify the approval, regulators argued that Glas’s products did not need to show added adult benefits because they require an age-verifying cellphone app to unlock, supposedly mitigating youth access.
The brief, six-page memo lacks the extensive scientific data typical of past FDA authorizations, sparking backlash from lawmakers. The decision was finalized during the final week ofĀ then-FDA Commissioner Marty Makary, who resigned following heavy industry lobbying for relaxed vaping regulations.
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