Trump Expected to Nominate Martin Makary as FDA Commissioner

President-elect Donald Trump is expected to nominate Johns Hopkins surgeon and professor Martin Makary to be commissioner of the Food and Drug Administration (FDA), according to reports from Trump transition insiders. 

The FDA regulates all consumer nicotine products, including vapes. 

Little is known about Makary’s positions on vaping and nicotine use, but vaping industry and consumer advocates are eager to replace Dr. Robert Califf, a staunch foe of vaping and tobacco harm reduction (THR). Califf said in a recent interview that the FDA—which many believe is dysfunctional—is currently operating at “peak performance.”

Makary doesn’t appear to have a history of actively opposing vaping and THR, but apparently made some negative comments about vaping around the time of the 2019 “EVALI” lung injury outbreak. 

Makary would be a fairly conventional FDA nominee

The British-born Makary is a pancreatic surgeon at Johns Hopkins Hospital, a professor at the Johns Hopkins School of Medicine, and an instructor at the Johns Hopkins Bloomberg School of Public Health. The Bloomberg School is named after billionaire Michael Bloomberg, who has donated large sums to Johns Hopkins, which has become a vector of anti-vaping and anti-nicotine activism.

Again, there is no evidence that Makary backs Bloomberg’s prohibitionist approach to nicotine regulation.

Makary is respected for surgical innovations, according to Reuters, and is also an author. He has written and spoken on a range of medical topics, including overtreatment in the U.S. medical system, overuse of antibiotics, and medical education reform. He was a critic of COVID-19 vaccine and mask mandates, and has acted as an adviser to conservative think tank the Paragon Health Institute.

The Trump health team so far

The Trump health team is beginning to come together. Trump has announced he will nominate Robert F. Kennedy Jr. as secretary of the Department of Health and Human Services (HHS), which oversees the FDA, the Centers for Disease Control and Prevention (CDC), the National Institutes for Health (NIH), and the Centers for Medicare and Medicaid Services (CMS). 

Kennedy’s positions on vaping, nicotine and tobacco harm reduction (THR) are unknown. A recent photo showed him holding a can of ZYN nicotine pouches, but it’s not certain he uses nicotine.

Trump has also named Dr. Mehmet Oz to run CMS. Oz actively opposes vaping, but will be unlikely to influence the other HHS agencies on policy. Nominees to the CDC and NIH posts have not been announced.

Unlike many other Trump cabinet and agency nominees—including Kennedy and Oz—Makary would be a fairly conventional choice, and appears unlikely to face determined opposition in the Senate confirmation process. Senate Democrats will have to carefully choose which nominees to spend their time and energy opposing, and Makary would probably be low on the list.

Will Trump “save vaping”?

Before the election, Trump promised he would “save vaping,” but that will require a strategic shift by the FDA and its Center for Tobacco Products (CTP). FDA Commissioner Califf appointed anti-vaping zealot Brian King to run the CTP, and the tobacco office—with Califf’s backing—has done its best to restrict access to popular vaping products.

In the three years since the agency began making decisions about premarket tobacco application (PMTA) submissions, millions of applications have been rejected or denied, and just a handful of products have been authorized—all of them manufactured by Big Tobacco-owned companies.

However, the FDA is facing a Supreme Court showdown soon (oral arguments scheduled for Dec. 2) with the independent vaping industry, which could determine whether the agency will be forced to abandon its “shadow ban” of flavored and open-system (refillable) vaping products. 

If the FDA wins the Supreme Court appeal of its Fifth Circuit loss against Triton Distribution, major changes at the CTP would be unlikely without deliberate and focused attention from HHS and FDA leadership. A Supreme Court victory for the FDA would essentially give the agency permission to continue on its current path. Changing that path would require CTP personnel changes and stern administration oversight, which would require active involvement by Trump's FDA commissioner. 

If the high court rules against the FDA, the Trump team could more easily chart a new regulatory course for vaping products. But at this point, we don’t know what the new administration’s goals or plans are regarding tobacco and nicotine regulation, or how much energy and time the policymakers intend to devote to vaping issues, which are a small part of the FDA’s overall portfolio.

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