FDA commissioner Robert Califf ordered a review of the CTP following a series of events that brought the agency under scrutiny.
A lot seems to be going on at the US Food and Drug Administration (FDA), most recently the departure of senior officials and an impending review of its food and tobacco programs that came under scrutiny in a senate subcommittee hearing.
Compound these recent events with situations like FDA having to suspend its marketing denial order banning Juul sales, or coming under pressure from legislators for being seen as not doing enough to regulate synthetic nicotine, and one cannot help but wonder – what is going on with FDA?
Movers and shakers moving and shaking
In February, Robert Califf was sworn in as FDA commissioner. A familiar face, Califf served as FDA’s deputy commissioner for medical products and tobacco from February 2015 until his first appointment as commissioner in February 2016. Upon Califf’s second confirmation this year, Janet Woodcock, who was serving as interim FDA commissioner, transitioned to the position of principal deputy commissioner.
In a 2019 opinion piece for the Association of American Medical Colleges (AAMC), Califf urged strict enforcement of the premarket review requirements for electronic nicotine delivery systems (ENDS), as well as called for increased surveillance to curtail unlawful sales of such products to minors. He also demonstrated a firm stance against flavors, suggesting in the same article that FDA immediately ban all flavors in vape products. Did this influence FDA’s premarket authorization application (PMTA) reviews for ENDS? By mid-March FDA had ruled on 99% of the PMTAs it received with only one ENDS device and two tobacco-flavored cartridges receiving authorization. On the other hand, marketing denial orders for over 946,000 flavored ENDS products were issued. In April, Mitch Zeller retired and left his position as director of the Center for Tobacco Products (CTP). Michele Mital, CTP’s deputy director since 2018, became acting CTP director until Brian King was appointed CTP director in July. Critics pointed out that King, who served as deputy director for research translation at the Centers for Disease Control and Prevention’s (CDC) Office on Smoking and Health (OSH) within the National Center for Chronic Disease Prevention and Health Promotion, has little to no regulatory experience, having worked mostly for CDC. His primary research focus during this time was related to tobacco prevention and control. In addition, King also has a history of being a vocal opponent of vape products and had an instrumental role in CDC’s response to what the agency coined “e-cigarette, or vaping, product use-associated lung injury (EVALI)” in 2019.
The latest senior officer to leave FDA is Matt Holman, director of CTP’s Office of Science, who not only left the agency in late July but “crossed to the dark side”, joining Philip Morris International (PMI). Holman and FDA said Holman had recused himself from all tobacco-related regulatory decision making and was on leave prior to this. A respected scientist, Holman supports the idea that alternative products such as vapes, heated to-bacco, and oral tobacco are less harmful than combustible cigarettes and should be available to smokers who cannot or do not want to quit nicotine.
With Holman’s departure, it seems even more likely FDA’s stance on tobacco products and alternatives such as vape products will become even more antagonistic as two leadership positions are filled by individuals who appear to be anti-tobacco and anti-vape, while the person who has a more balanced approach and under-stands the science has left the agency.
Backtracking on Juul
FDA having to backtrack its marketing denial order (MDO) for Juul devices certainly did not help the agency’s credibility standing, either.
FDA issued its MDO to Juul in late June, claiming “there is insufficient evidence to assess the potential toxicological risks of using Juul products” and that the products are “not appropriate for the protection of public health.” This came after a two-year review and hundreds of millions of dollars spent by Juul to accumulate scientific data demonstrating its benefit to public health. Less than two weeks later, though, FDA issued an administrative stay on its own order, saying that there were “scientific issues unique to this application that warrant additional review.” Did Juul taking legal action and a stay ordered by a federal appeals court the very day after the MDO was issued help FDA see those “unique scientific issues”?
A victim of CTP’s EVALI misinformation (that Brian King, current CTP director, was involved in), Juul continued to be vilified by legislators and mainstream media outlets as the main villain getting young people addicted to vaping and nicotine. The fact that youth vaping in the US has declined and those who do vape tend to prefer disposable vapes like Puff Bar, which contains synthetic nicotine, was conveniently glossed over. All this seems to point to Juul being used in a politicized issue by FDA rather than defending public health like the agency purports to do.
Synthetic nicotine backlash
FDA also came under fire from legislators who said the agency was not doing enough to regulate synthetic nicotine despite being given authority in April. Companies had until July 13 to submit their premarket application to keep their products on the US market. On July 13, FDA reported that it had issued warning letters to two companies making synthetic nicotine vape products that had not submitted premarket applications as well as issued 107 warning letters to retailers in the two weeks prior for illegally selling nontobacco nicotine products.
“FDA has been fully committed to actively implementing this critical new law regulating non-tobacco nicotine products since its passage, and the warning letters announced today are just the beginning of our compliance and enforcement actions” said CTP director Brian King. However, FDA’s efforts were seen as too little, too late. In addition to the criticism from anti-tobacco groups, usually allies with FDA, US senators Susan Collins and Dick Durbin also sent a letter to FDA expressing their concern that FDA would not meet the July 13 deadline and called on commissioner Califf to pull all synthetic nicotine products without an authorization from the market. Collins and Durbin were instrumental in giving FDA authority of synthetic nicotine.
“The FDA is supposed to protect all Americans and particularly our children. I’m calling on FDA to finally come to its senses….This free fall in the legal department at the FDA is unimaginable. It’s not safe for America. And it’s not safe for our future,” Durbin said, criticizing the agency’s initiatives to control tobacco and vaping goods in a speech on the Senate floor.
CTP under review
In what is likely a damage-control attempt, commissioner Califf announced on July 19 that he had commissioned a review of CTP along with the agency’s Human Foods Program.
“In February 2022, I rejoined the US Food and Drug Administration as commissioner of food and drugs, having served in the role five years earlier,” said Califf in an announcement. “Since my return, the agency has taken many significant actions that benefit the public health. Yet at the same time, the agency has confronted a series of challenges that have tested our regulatory frameworks and stressed the agency’s operations, prompting me to take a closer look at how we do business. As a result, for two of the agency’s key programs, I have commissioned external agency experts to conduct a comprehensive evaluation.” The reviews will be conducted by an expert panel and the Reagan-Udall Foundation.
“Just over 13 years ago, Congress tasked the FDA with regulating tobacco products,” said Califf. “In the ensuing years, we have made important progress and reached regulatory decisions on a broad array of millions of products. But even greater challenges lie ahead as we determine how the agency will navigate complex policy issues and determine enforcement activities for an increasing number of novel products that could potentially have significant consequences for public health. CTP will continue its important work during the evaluation, including review pending applications and take enforcement actions as needed.” Review findings are to be reported within 60 days.