By Ti0oy.jgtfhrmothy S. Donahue

Top Takeaways:

• Time to go: Marty Makary is resigning as FDA commissioner after roughly a year in the role.
• Tensions rising: Reports suggest tensions over flavored vape authorizations contributed to the split with President Trump.
• Acting the part: Kyle Diamantas is expected to serve as acting commissioner as the White House searches for a replacement.

President Donald Trump’s FDA commissioner has stepped down and the nicotine industry is once again left reading tea leaves in Washington.

Multiple reports Tuesday said Marty Makary plans to resign as commissioner of the U.S. Food and Drug Administration, ending a turbulent tenure marked by internal clashes, mounting political pressure and growing scrutiny of the agency’s handling of flavored nicotine products.

According to reports from Politico Pro and Endpoints News, Makary is expected to formally announce his resignation on Tuesday afternoon. Kyle Diamantas is expected to serve as acting commissioner while the White House searches for a permanent replacement.

Speaking to reporters before departing for China on Tuesday, Donald Trump declined to clarify whether Makary resigned voluntarily or was pushed out. “Well, I don’t want to say, but Marty’s a great guy, he’s a friend of mine, he’s a wonderful man and he’s going to be off,” Trump said. “Marty’s a terrific guy but he’s going to go on and he’s going to lead a good life. He was having some difficulty.”

The resignation comes just days after the FDA authorized four new tobacco products, amid growing reports that disagreements over flavored vaping products had strained Makary’s relationship with the White House.

The development comes at a particularly sensitive time for the nicotine industry, which has spent years navigating an increasingly unpredictable premarket tobacco application (PMTA) process at the FDA’s Center for Tobacco Products.

Laura Leigh Oyler, VP of Regulatory Affairs at Nicokick.com, said that the nicotine industry has been disappointed by the pace of nicotine product reviews at CTP. “If recent reporting is accurate, Commissioner Makary’s removal should be treated as an opportunity to refocus the FDA on timely, evidence-based decision-making,” said Oyler. “Adult consumers, responsible manufacturers, and retailers need a regulatory process that produces decisions, not indefinite uncertainty.

“CTP already has the scientific expertise needed to evaluate nicotine product applications and make appropriate determinations under the law. The next FDA commissioner should remove unnecessary bottlenecks and make clear that pending reviews will be decided by FDA scientists, not politicians.”

Makary’s tenure was also marked by broader turmoil inside FDA, including high-level staff departures, internal administrative disputes and criticism from both public health advocates and industry stakeholders. Anti-abortion groups and several Republican lawmakers had also criticized Makary over the agency’s handling of mifepristone, including approval of a second generic abortion pill and delays tied to a promised safety review.

Among Makary’s most vocal critics was Bill Cassidy, the Senate Health, Education, Labor and Pensions Committee chairman, who publicly expressed frustration with the agency’s direction under Makary.

For the nicotine industry, however, the resignation immediately raises fresh questions about the future direction of FDA tobacco regulation, particularly regarding flavored vaping products, menthol enforcement, PMTA reviews, and potential market authorizations for age-gated next-generation products.

Ross Marchand, executive director of the Taxpayers Protection Alliance, said millions of Americans have paid the price for “this soap opera of suddenly spurned approvals,” goalpost shifting, and even apparent violations of trade secret law.

“At long last, Makary is out. Since taking the helm of the agency last April, the Commissioner has made it far more difficult than it needs to be to bring new therapies to market,” said Marchand. “It’s time to finally turn the page on this sorry chapter at the FDA.

“The data is clear: the FDA is approving medications even more slowly now than it did before. As TPA noted in its recent report, the FDA has become far more likely to issue Complete Response Letters (CRLs)—or rejections—for new therapies. Agency rejections have soared as a share of agency approval decisions and are now near decade highs. Meanwhile, the FDA under Makary has continued de-facto prohibition on harm reduction products. It shouldn’t have to take the White House pressuring the FDA Commissioner to side with patients and consumers over bureaucrats.”

Makary had been scheduled to testify Wednesday before a Senate Appropriations subcommittee regarding FDA’s budget. It remains unclear whether that appearance will proceed following Tuesday’s announcement.

“Makary is finally gone, but the new Commissioner cannot be complacent. The FDA needs a leader who will stand up for patients and allow access to new and innovative therapies,” said Marchand. “Makary’s successor must embrace market innovation and break with the prohibitionary policies of the past.”