Just More Talking Points: FDA Commissioner Visits with the House Oversight Committee
On Thursday, April 11, Dr. Robert Califf, current commissioner of the U.S. Food and Drug Administration (FDA), met with the House Committee on Oversight and Accountability. It is clear that Califf leads a diverse and complex agency that, in most areas, functions well to protect Americans’ health; however, several comments related to tobacco harm reduction merit attention.
Delay, Excuse, Delay
Califf was questioned on the activities of the FDA’s Center for Tobacco Products (CTP). Several committee members voiced concerns about the availability of illegal electronic nicotine delivery systems (ENDS, also referred to as vapes or e-cigarettes), which are often imported from Chinese manufacturers. They felt that the CTP’s inability to process premarket tobacco product applications in a timely manner, along with its light-handed approach to enforcing regulatory statutes, led to these products infiltrating the United States. Califf’s response parroted what CTP leadership has said for several years now—that they were unprepared for the number of applications received, that 99 percent have already been reviewed, and that they are close to completing the remainder. While these statements are not inaccurate, Califf failed to articulate that the remaining applications represent products with the largest market share. His main excuse for the erratic state of regulatory control was the need for additional resources. He stated several times that a lack of user fees from the vaping industry would further hamper both review and enforcement processes.
The reality is that over the past 14 years, the CTP has failed to establish clear regulatory guidelines for manufacturers applying to develop ENDS products. The influx of millions of applications was a result of the CTP’s own folly: They require an application for each component of a device as opposed to one application per device. In the absence of clear standards and practices, manufacturers had to guess the information required to obtain marketing authorization. Currently, only the most prominent and well-resourced manufacturers can produce applications with a broad array of expensive studies, hoping that at least some of their data hits the CTP’s unobservable, internally established target. Measurable standards, testing regimens, and research requirements would establish process clarity and open the door to opportunities for small and mid-size companies to compete in the reduced-risk product marketplace.
Commissioner Califf made three comments during the hearing that were quite disturbing:
1. Nicotine Addiction Is the Problem
The first was a statement framing nicotine addiction as “a brutal, fierce addiction that is almost impossible to shake once you have it.” There is no question that nicotine dependence is a challenge for those who want to quit, but hyperbolic descriptors like “brutal” and “fierce” are simply unnecessary. Demonizing nicotine (and those who choose to use it) distracts from the actual public health problem— the use of combustible tobacco products. It also undermines FDA-approved nicotine cessation products that deliver nicotine without the combustion.
2. Smoking-Related Deaths Are Decreasing
Califf also stated that the number of deaths associated with smoking cigarettes has dropped due to CTP activities (estimating that 460,000 Americans will die from smoking-related disease this year). To characterize the number of tobacco-related deaths as declining is just not accurate—and neither is crediting the CTP for playing a role in the process. Between 2009 and 2023, the CTP collected and spent an estimated $8 billion in user fees directly from manufacturers and importers of tobacco and nicotine products; however, the impact of this fee collection and spending is unclear. The Centers for Disease Control and Prevention reported 480,000 tobacco-related deaths in 2022—a number that does not represent a significant reduction, as an estimated 437,400 Americans died due to smoking-related disease in 2009.
3. Tobacco Harm Reduction Is an Industry Construct
Finally, Califf stated that “tobacco harm reduction” is an industry term—an assertion challenged by Rep. James Comer (R-Ky.). In his response, Califf modified his phrasing to say he “accepts the idea” of a harm-reduction approach, though the best approach would be for people to avoid consuming nicotine in any form. This cognitive dissonance was again on display as he made positive comments about the approval of over-the-counter formulations of naloxone for opioid harm reduction. Nonetheless, the idea that the source somehow negates the outcomes of harm-reduction products is worrisome. Quite frankly, regardless of the source, if harm-reduction products reduce death and disease, then the government should promote them—or, at the very least, not block their entry into the market. Saving lives should be the priority of any regulatory agency, not employing punitive measures against industry.
Conclusion
In the past 14 years, the CTP’s activities have produced only two clear outcomes: the first, nearly unchanged tobacco-related mortality rates; the second, a dearth of reduced-risk tobacco and nicotine products on the consumer market. The CTP continues to ignore the need to establish new product development standards to reduce the health burdens associated with the use of traditional combustible tobacco products. Instead, they continue their cycle of requesting more science without articulating what standards need to be met. To truly function as a regulatory agency, the CTP must act transparently and work with manufacturers to produce attractive reduced-risk alternatives to combustible products. The CTP has a choice to make: Does it want to work with industry or continue to punish it? It cannot do both.