By Timothy S. Donahue

Top Takeaways:

• FDA pick: Trump has selected Heidi Overton to lead the agency.
• Confirmation next: The White House health aide must clear the Senate.
• Nicotine stakes: Overton would inherit major changes to FDA tobacco review and enforcement.

President Donald Trump has selected White House health policy adviser Heidi Overton to lead the U.S. Food and Drug Administration.

The choice places a physician with close ties to former Commissioner Marty Makary in line to oversee the agency as it reshapes its approach to nicotine regulation, including cigars, vapes, and nicotine pouches.

Overton is the deputy director of the White House Domestic Policy Council and previously worked at the America First Policy Institute. She would succeed Makary, who left the FDA in May after 13 months amid clashes with administration officials and controversy over several agency decisions, including the return of flavored vaping products to the U.S. market. Kyle Diamantas has led the FDA on an acting basis since Makary’s departure.

“Dr. Overton’s arrival at the FDA comes at a critical time for the agency’s policy priorities for nicotine pouches,” said Laura Leigh Oyler, VP of Regulatory Affairs for Nicokick.com. “With the Pouch Pilot Program still ongoing, and recent decisions facing legal challenges, the work happening at the FDA right now has major implications for American consumers. I hope that nicotine pouches receive the attention they deserve at this crucial moment.”

The White House had not formally announced the nomination when Bloomberg first reported on Trump’s decision. Reuters later confirmed the selection from a source familiar with the matter. The FDA commissioner requires Senate confirmation.

Overton’s selection drew mixed reactions early on.

Chris Meekins, a Raymond James analyst who served as a health official in Trump’s first administration, questioned her management experience and her close relationship with Makary.

“Overton has degrees but seemingly no real experience running anything,” Meekins told Axios, describing her as a Makary protégé and criticizing her association with elements of the administration’s health agenda.

Brian Blase, president of the Paragon Health Institute and a former Trump health policy adviser, offered a markedly different assessment, calling Overton a “great choice.”

Overton has longstanding ties to Makary. She trained at Johns Hopkins, where Makary served as a surgeon and professor, and the two co-authored work on health policy. The Wall Street Journal reported that Overton was a strong defender of Makary within the administration before his departure, which followed management problems and disagreements over vaping policy.

Her arrival would come at a critical time for the tobacco and nicotine industry.

In May, FDA’s Center for Tobacco Products announced changes to accelerate premarket tobacco product application reviews after reducing its backlog by roughly 70% in 2025. The agency then issued new guidance establishing enforcement priorities for certain unauthorized electronic nicotine delivery systems (ENDS) and nicotine pouch products with pending applications.

The policy allows certain unauthorized products that meet specified conditions to fall outside FDA’s current enforcement priorities while their PMTAs remain pending. These products remain unauthorized, and FDA has emphasized that the policy does not indicate whether they will ultimately receive marketing authorization.

FDA is also developing a public list of manufacturers and products that currently fall under the lower-priority enforcement policy, a move intended to provide retailers and others with greater visibility into the agency’s enforcement posture.

Overton has not publicly outlined a detailed tobacco or nicotine agenda, leaving it unclear whether she would maintain, expand, or alter the direction CTP has taken in recent months.

She earned her medical degree from the University of New Mexico, trained in general surgery at Johns Hopkins, and pursued clinical-investigation research training at the Johns Hopkins Bloomberg School of Public Health. She also served as a White House Fellow during Trump’s first administration.

If confirmed, Overton would take control of an FDA that has lost more than 3,000 employees, including senior officials and division heads, in the past year.