The Biden administration is vetting former FDA commissioner Robert Califf for a possible second appointment to the post. A final decision hasn’t been made, and the White House is still considering other names for the job, but the news, first reported yesterday by the Washington Post, has gotten a lot of attention in Washington.
President Joe Biden has been in office for nearly nine months, but has not nominated a candidate for FDA commissioner. FDA veteran Janet Woodcock has served as Acting Commissioner since Biden took over in January, but by law can’t remain in the job beyond mid-November.
The Biden transition team vetted several candidates for the FDA job, including former Obama FDA official Josh Sharfstein and former FDA commissioner David Kessler, both considered likely opponents of reasonable vaping regulations. Whoever is nominated and confirmed will serve as commissioner under Health and Human Services Secretary Xavier Becerra, himself an opponent of vaping and the vaping industry.
Califf served less than a year as commissioner during President Barack Obama’s final year in office, following Obama’s first commissioner Margaret Hamburg. He was nominated by Obama in September 2015 and confirmed by the Senate in February 2016. He left the office on Jan. 20, 2017—Obama’s final day in office—and was eventually succeeded by President Donald Trump’s nominee Scott Gottlieb. Califf, a Duke University cardiology professor, spent a year as FDA Deputy Commissioner of the FDA’s Office of Medical Products and Tobacco before taking over as commissioner.
Califf was FDA commissioner when the agency issued its final Deeming Rule, and was publicly supportive of the regulations, although he later lamented the White House Office of Management and Budget’s removal of the flavor ban that had been included in the original version. “With this rule, the FDA will be able to prevent misleading claims and provide consumers with information to help them better understand the risks,” Califf said when the rule was issued in May 2016.
Later, in a misguided 2019 article, Califf suggested a ban on flavored nicotine vaping products as a remedy for the “EVALI” outbreak (which was unrelated to nicotine vaping). He also supported moving nicotine vaping to a prescription-only model, as Australia has done.
“The regulatory trifecta,” Califf wrote, “would be to: 1) require the tobacco industry to lower the amount of nicotine in its products to subaddictive levels (if nicotine can be dialed up using irradiation and selective breeding, it can also be dialed down, even if the law forbids regulation that reduces the level to zero); 2) ban over-the-counter vaping products; and 3) support prescription vaping so that the 30 million current tobacco users do not go through acute withdrawal all at the same time.”
Needless to say, such an approach would be a very remote possibility at this point, requiring a radical overhaul of food and drug laws applying to consumer nicotine products. It would be opposed by both independent vaping interests and the tobacco industry, as well as trade groups representing related industries like convenience stores and gas stations.
Califf, like Scott Gottlieb, has suggested that perhaps open-system vaping products could be regulated differently than pod-based products that kids prefer. But in general his positions on vaping are informed by misunderstanding and ignorance, and a Califf-run FDA would be unlikely to authorize a useful variety of vaping products.
“Senators should be skeptical and prepared to vote no until we have an FDA commissioner who is willing to use vaping as a tool to promote public health and not continue the FDA’s regulatory arson that leaves former and current smokers without a safe and effective way to quit,” American Vapor Manufacturers Association (AVM) President Amanda Wheeler said in a statement about Califf’s possible nomination as FDA chief.
Although he was confirmed as commissioner by the Senate in 2016 by an 89-4 vote, he faced harsh criticism from several senators for his ties to the pharmaceutical industry.
That opposition—from Sens. Bernie Sanders and Joe Manchin, among other Democrats—may resurface if Califf is nominated again. Connecticut Sen. Richard Blumenthal has already said he would probably oppose Califf for a second time.
Featured image courtesy C-SPAN.