Former FDA commissioner Marty Makary left the agency after clashes over flavored vape approvals and broader FDA priorities. Photo credit: US FDA
US Food and Drug Administration (FDA) commissioner Marty Makary resigned on May 12 following mounting political pressure, internal disputes, and controversy surrounding the agency’s recent shift on flavored vaping products.
Multiple media outlets reported that the White House had already decided to remove Makary before he formally stepped down, ending a turbulent 13-month tenure marked by clashes over regulatory priorities and public health policy.
The dispute over flavored e-cigarettes reportedly played a central role in his departure. Reuters and other outlets said senior administration officials became frustrated with Makary’s resistance to authorizing fruit-flavored vaping products, including devices equipped with Bluetooth-based age-verification technology.
Earlier this month, FDA authorized the marketing of four pod-based vaping products made by Los Angeles-based Glas Inc., including mango, blueberry and two menthol varieties marketed as Gold, Sapphire, Classic Menthol and Fresh Menthol. The decision marked the first time the agency authorized fruit-flavored e-cigarettes in the US after years of rejecting applications for sweet and fruit-flavored products over concerns about youth appeal.
FDA said the authorization applied only to adults aged 21 and older and relied heavily on the company’s age-restriction technology. Users must submit government-issued identification through a smartphone application, pair the device to the phone through Bluetooth and complete periodic biometric verification checks before the products will operate. The agency said the technology, along with marketing restrictions, reduced the likelihood of youth access.
The authorization also reflected a broader policy shift at the FDA. In March, the agency issued draft guidance stating that certain non-tobacco flavors, including mint, coffee, tea, spice and menthol, could help adult smokers transition away from cigarettes, although regulators continued to express concern about sweeter flavors such as fruit and candy.
Days after authorizing the Glas products, FDA also announced it would ease enforcement against some unauthorized vaping and nicotine pouch products with applications currently under agency review. Companies with pending submissions that meet FDA data requirements may avoid enforcement action while regulators continue reviewing applications.
The flavored vape decisions drew support from parts of the vaping sector while prompting criticism from health organizations and anti-vaping groups, which argued that fruit-flavored products could still appeal to underage users despite the technology safeguards.
Makary also faced criticism from several other sectors during his tenure. Reuters reported that lawmakers, pharmaceutical executives, anti-abortion groups, and vaping interests all challenged various FDA decisions over the past year. Disputes emerged over the agency’s handling of vaccines, abortion-pill reviews, and high-profile drug applications.
Despite the controversy, Makary pursued several modernization efforts at FDA. Associated Press reports said he promoted expanded use of artificial intelligence in drug reviews, faster approval pathways for treatments targeting rare diseases, and broader efforts to streamline regulatory procedures.
The administration named FDA deputy commissioner for food Kyle Diamantas as acting commissioner while officials search for a permanent replacement. Reuters reported that former FDA commissioners Stephen Hahn and Brett Giroir remain among the names under consideration.
The flavored vape debate also triggered fallout within the Department of Health and Human Services. Richard Danker, the former assistant secretary for public affairs at HHS, resigned over FDA’s authorization of fruit-flavored e-cigarettes, according to a resignation letter reviewed by ABC News. In the letter, Danker accused senior officials in health secretary Robert F. Kennedy Jr.’s immediate office of approving e-cigarette flavors that would allegedly expose children to “nicotine addiction, lung damage, and a higher risk of cancer.”
Before joining HHS, Danker worked primarily in economic and regulatory policy roles, including as a senior advisor at the Treasury Department during the previous administration. He did not have a healthcare background prior to joining HHS.
In a statement to ABC News, an HHS spokesperson said Kennedy is advancing the “MAHA” agenda to address chronic disease and said political appointees are expected to carry out that mission with “urgency, discipline, and focus.” The spokesperson added that individuals who “lose sight of the mission” are free to leave the agency and said HHS remains committed to delivering results for the American people.