finance
FDA Issues Guidance Allowing Some Unauthorized Vapes and Nicotine Pouches
The Food and Drug Administration released a six-page memo that permits certain nicotine products to remain on the market while under review. Senior tobacco-center staff learned of the change the night before publication and were not consulted on its drafting.
May 23, 10:59 AM·2m read1 source
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The Food and Drug Administration posted a six-page memo earlier this month that directs staff to exercise enforcement discretion for certain unauthorized electronic cigarettes and nicotine pouches while they remain under scientific review. Senior officials in the FDA’s tobacco center were not consulted before the document appeared and learned of it only the night before publication, according to two staff members who spoke to The Associated Press on condition of anonymity.
The memo was issued days before former FDA Commissioner Marty Makary resigned and hours after media reports that President Donald Trump had approved a plan to remove him.
The guidance departs from prior FDA practice that required completed scientific verification of health benefits before new nicotine products could be introduced. Agency staff have since held extended meetings to determine how to apply the new instructions.
Mitch Zeller, who retired as the FDA’s tobacco director in 2022, said the process raises questions about whether subject-matter experts opposed the change. The memo bypassed the public-comment period normally required for new policy and was published as a final document.
The FDA has authorized vaping products from five companies and rejected millions of other applications, largely because of flavors that regulators determined appealed to minors. Unauthorized flavored disposable vapes remain widely available. Underage vaping rates have reached their lowest level in more than ten years, according to federal surveys.
The new enforcement priorities focus on products with youth-appealing features such as toy-like designs rather than on flavor alone.
King, former FDA tobacco director now at the Campaign for Tobacco-Free Kids, said the approach is expected to favor larger companies that have advanced applications under review. Robyn Gougelet, a Juul vice president, said the choice is between regulating products already on the market or leaving them illegal and untested.
