Key Points
- FDA Commissioner Marty Makary resigned on May 12.
- The New York Times reported that his opposition to fruit-flavored vape approvals was a key factor behind his departure.
- The White House had been pushing the FDA to expand flavored vape authorizations.
- The FDA recently approved two fruit-flavored vaping products and loosened marketing restrictions.
- Makary frequently clashed with tobacco, food, pharmaceutical, and anti-abortion groups during his tenure.
- FDA food chief Kyle Diamantas was named acting commissioner.
Flavored Vape Dispute Emerges as Key Trigger for Makary’s Exit
FDA Commissioner Marty Makary resigned on May 12 after weeks of speculation that the Trump administration planned to remove him, according to reporting by The New York Times.
The report, citing four people familiar with the matter, said Makary’s opposition to authorizing fruit-flavored vaping products became a key factor behind his departure.
According to the sources, Makary told associates he could not “in good conscience” approve flavored vapes because of concerns that fruity and candy flavors appeal to young people.
His resignation comes amid intensifying divisions within the U.S. government over tobacco harm reduction, youth vaping risks, and flavored vape regulation.
White House Had Pushed for Broader Flavored Vape Authorizations
The New York Times reported that the Trump administration had been pushing the FDA to expand authorizations for flavored vaping products.
Earlier this month, the FDA approved two fruit-flavored vaping products. Last Friday, the agency also issued a policy allowing broader marketing of such products.
Makary had resisted wider flavored vape approvals over concerns that fruit and candy flavors could attract younger users.
Earlier reporting by The Wall Street Journal indicated that the White House had pressured the FDA to approve more flavored vape products, with Makary emerging as a key internal obstacle.
The administration has framed expanded flavored vape access for adults as part of a broader tobacco harm reduction strategy.
Makary’s Tenure Marked by Multiple Controversies
Before joining the FDA, Makary was a cancer surgeon and health policy researcher at Johns Hopkins University.
As commissioner, he launched several reform initiatives, including efforts involving natural food dyes and hormone replacement therapy policies.
However, his tenure was also marked by controversy.
The New York Times reported that Makary drew criticism from public health leaders after releasing a memo alleging deaths linked to Covid vaccines without sufficient evidence.
He also faced scrutiny for allowing renewed access to certain peptide injection products with uncertain clinical effects, a policy supported by Health Secretary Robert F. Kennedy Jr.
At the same time, anti-abortion groups criticized Makary for delaying research related to the safety of the abortion drug mifepristone.
FDA Leadership and Staffing Turmoil Continued Under Makary
Makary’s tenure also coincided with major staffing disruptions at the FDA.
According to The New York Times, Health Secretary Robert F. Kennedy Jr. and Elon Musk’s Department of Government Efficiency (DOGE) pushed significant staff reductions affecting medical device reviews, food inspections, and drug safety monitoring.
Although some employees were later rehired, the FDA still lost more than 4,000 staff members — roughly one-fifth of its workforce.
Makary later advocated for rebuilding staffing levels and sought approval to hire about 3,000 employees, though progress remained slow.
The New York Times reported that FDA food chief Kyle Diamantas will serve as acting commissioner.
Diamantas previously worked at the law firm Jones Day, where he represented infant formula company Abbott Nutrition.
Future Direction of U.S. Vape Regulation Remains Uncertain
Industry observers say Makary’s departure could further reshape the direction of U.S. vape regulation.
The administration remains divided between two approaches: one emphasizing flavored vaping products as harm-reduction tools for adult smokers, and the other focused on preventing youth nicotine use.
Analysts say future FDA decisions involving flavored vapes, nicotine pouches, and other next-generation nicotine products will continue to be shaped by tensions among the White House, public health advocates, and industry stakeholders.
（Cover image: FDA Commissioner Marty Makary. | Image source: CNN）
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