The US Food and Drug Administration (FDA) recently carried out across-the-board layoffs, including the removal of tobacco regulatory chief Brian King, and several key experts in the field were affected. FDA leadership is in turmoil, new Commissioner Makary faces multiple challenges, and the future of tobacco policy is full of uncertainty.
Key points:
FDA Layoffs and Top Management Changes:
- The FDA cut staff across the board, with tobacco regulatory chief Brian King ousted and dozens of experts laid off.
- In recent months, there have been almost total changes at the top of the FDA, mostly through resignations and retirements.
Tobacco Regulation Controversy:
- Brian King was criticized for pulling fruit – and candy-flavored vapes from shelves, but teen vaping has fallen to a 10-year low.
- The FDA’s refusal to approve millions of flavored vape applications has led to multiple lawsuits, one of which has been heard before the Supreme Court.
New Director challenges:
- The new chief, Marty Makary, inherited a staff lacking top experts and faced the challenge of reviewing layoffs and tobacco policy.
Vape industry reaction:
- The vape Technology Association supports the removal of Brian King as a first step toward correcting the FDA’s operational errors.
- Tobacco and vape companies have criticized the FDA for being too slow to approve new products, especially low-risk ones.
Other senior departures:
- Several senior executives have recently left or retired, including Deputy Commissioner for Food Jim Jones and Dr. Patrizia Cavazzoni, director of the FDA’s Drug Center.
Trump administration layoffs hit FDA: tobacco center head Brian King removed from post
Brian King, the head of tobacco regulation at the U.S. Food and Drug Administration (FDA), was fired on Tuesday as part of a sweeping staff reduction. The move affected top experts in a range of fields, including food, drugs, vaccines and nicotine-containing products.
Brian King, head of the FDA’s Center for Tobacco Products (CTP), wrote in an email to his team,
- “It is with a heavy heart and deep disappointment that I inform you that I have been suspended from duty.”
Dozens of other employees at the FDA’s Center for Tobacco Products (CTP) also received layoff notices Tuesday morning, including two employees in the office responsible for drafting new tobacco regulations and developing policy.
Mitch Zeller, a former FDA tobacco chief, said in an interview,
- “If you make it almost impossible to develop and draft policy. You are undermining the role of the center.” From a public health perspective, it makes absolutely no sense.”
Other parts of the FDA were not spared, and the entire press office was notified. Senior FDA officials who oversaw the review of new drugs and vaccines were also fired, according to FDA staff. The staff members spoke on condition of anonymity because they were not authorized to speak publicly.
King, who joined the FDA in 2022, has come under intense criticism from vaping lobbyists for his mandate that thousands of companies remove fruit – and candy-flavored vapes from the market. During his tenure, the percentage of U.S. teens who use vapes has fallen to a 10-year low.
King’s ouster comes days after the forced departure of Dr. Peter Marks, the FDA’s vaccine chief, who referred in his resignation letter to Health Secretary Robert F. Kennedy Jr. for supporting vaccine “misinformation and falsehoods.”
Tobacco Regulation Controversy
The latest change means that in recent months almost all of the agency’s top leaders responsible for regulating drugs, foods, vaccines, medical devices and tobacco products have been changed, mostly through resignations and retirements.
“History will look back on this as a huge mistake,” Robert Califf. Former F.D.A. commissioner, wrote in an online post.
Califf noted when he resigned at the end of the Biden administration,
- “The FDA as we know it is finished, and most of the leaders with the institutional knowledge and in-depth understanding of product development and safety are no longer employed.”
As Kennedy prepares to lay off 3,500 FDA employees and move forward with a planned review of ultra-processed foods, children’s vaccines, antidepressants and other long-established products, the agency’s leadership is vacant.
The wave of departures means that the new FDA commissioner. Marty Makary, who was confirmed last week, will inherit an agency lacking many top experts and a beleaguered workforce that has endured weeks of layoffs and a chaotic reinstatement process. Only a handful of FDA employees are political appointees, and nearly all of the agency’s scientific reviews and decisions are overseen by career officials.
E-cigarette industry reaction
During his confirmation hearing. Makary told Senate lawmakers that he wanted to “take stock of the recent probationary layoffs.”
Neither Makary nor Kennedy said much about how tobacco policy would fit into their “Get America Healthy Again” plan. Despite historically low smoking rates, tobacco-related diseases remain the leading preventable cause of death in the United States, killing more than 490,000 people each year.
The FDA’s Center for Tobacco Products has been under pressure from critics in recent years. Politicians, parents and anti-tobacco groups want the FDA to further crack down on unlicensed vape products that may attract teenagers, many from China. Tobacco and vape companies say the FDA has been too slow to approve new products aimed at adult smokers, including vapes, which are often much less risky than traditional cigarettes.
Under King’s leadership, the FDA refused to approve applications for millions of flavored vapes, citing a lack of data proving the products would help adult smokers. These rejections led to multiple lawsuits by vape manufacturers against the FDA, one of which was heard in the Supreme Court in December 2024.
Dozens of experts fired
The Vapor Technology Association, which has been highly critical of King’s leadership, said in a statement that King’s removal “is the first step in correcting the faulty thinking that has hampered the operation of the FDA and the Center for Tobacco Products for nearly four years.”
Other recent departures at the FDA include:
- Jim Jones, the deputy food commissioner, resigned in February after dozens of employees were laid off.
- Dr. Patrizia Cavazzoni, director of the FDA’s drug Center, resigned just days before President Trump took office.
- The FDA’s principal deputy commissioner, Dr. Namandje Bumpus, resigned at the end of 2024.
- Dr. Jeffrey Shuren, the FDA’s longtime medical device chief, is retiring in the summer of 2024.
Many lieutenants and senior scientists have also retired or resigned in recent weeks.
