FDA Commissioner Robert Califf recently faced a grueling hearing before members of the House Oversight Committee. From contraceptives and baby formula to COVID-19 remedies and regulatory actions by the Center for Tobacco Products, the session covered a wide array of FDA actions — or mainly the lack thereof.
It may have been a long afternoon for the FDA commissioner, but for the tens of millions of American adults who smoke and are unable or unwilling to quit, it has been an even longer wait for the agency to acknowledge and approve the crucial role of “tobacco harm reduction,” or THR. The idea is to lower the health risks of smoking by cutting back or switching to nontobacco nicotine products, such as nicotine patches or e-cigarettes.
Since 2020, the FDA has asked to collect user fees on all tobacco products, estimating the agency could collect an additional $100 million a year. It’s a money grab.
The FDA’s missteps and inaction extends to providing poor regulatory oversight in a marketplace overwhelmed with products adults are seeking, as well as failing to inform adults who smoke about the “continuum of risk” among tobacco products.
During the hearing, lawmakers accused Califf and the FDA of allowing illegal e-cigarette products to spread while failing to approve others. The commissioner remained reluctant to endorse the harm reduction potential of e-cigarettes and other THR products.
For example, when questioned by Rep. Tim Burchett (R-Tenn.) about the relative harm of vaping compared to smoking traditional cigarettes, Califf wavered. While he acknowledged the lethality of combustible cigarettes, he remarked that if cigarettes didn’t exist, people would “be horrified by what is in the residue of vaping.” After repeating that the vape residue is horrifying, Califf conceded that vaping “is much less toxic … than combustible tobacco.”
Asked by Rep. Russell Fry (R-S.C.) about the FDA’s stance on the continuum of risk of nicotine products and the potential benefits to adults switching, Califf stressed the importance of quitting altogether while tentatively endorsing vaping as a secondary option.
Throughout the hearing, Califf emphasized the need for the benefits of THR products to outweigh the risks posed to youth — an argument the FDA has repeatedly invoked to reject over 25 million applications for vapor products in recent years, citing the “youth vaping epidemic.”
Rep. Rashida Tlaib (D-Mich.) asked Califf specifically whether he thought the United States was in the middle of such an epidemic. “To the extent that epidemic is defined as millions of people, yes,” he said.
In 2023, 7.7% of U.S. middle school and high school students reported using e-cigarettes. The FDA first began using the term “epidemic” in 2018 to describe the concerning increase in youth e-cigarette use. It was after declaring an epidemic that youth vaping peaked in 2019 and between then and 2023, youth vaping declined by 61.5%, including a 63.6% reduction among high schoolers and a 56.2% reduction among middle schoolers.
Official definitions of epidemic can be a problem affecting a disproportionately large number of persons within a population, “excessively prevalent,” or “very widespread growth.” Given the declines and the fact that fewer than 1 in 10 Americans under the age of 18 were vaping in 2023, epidemic is not the right word to describe youth vaping in America. In fact, Center for Tobacco Products Director Dr. Brian King last year announced the agency had quit using the term.
But perhaps more alarming is that Califf kept insisting the FDA needs user fees on newly approved products to handle the declining youth use, address the growing demand and supply of unauthorized vape products, and inform adults of the continuum of risk among tobacco products.
FDA’s Center for Tobacco Products is completely funded by user fees, which currently apply to only six categories of tobacco products and does not include e-cigarettes or other THR goods. Since FY 2020’s budget request, the FDA has asked for authority to collect user fees on all tobacco products, estimating the agency could collect an additional $100 million a year.
It’s a money grab. The FDA can’t get its story straight about reducing tobacco-related harms.
For the 2017 fiscal year budget request, the agency conceded “a continuum of risk for user[s] of tobacco products” does, in fact, exist. This sentiment was echoed in all subsequent budget requests, except the most recent for fiscal year 2025. Now, the agency has changed its tune. The agency seems to no longer recognize the risk continuum and instead seeks funding to research projects to “better understand the impact that messaging about the continuum of risk for tobacco products.”
The inconsistency is troubling. In its FY 2023 budget request, the agency claimed it was “pursuing an integrated agency-wide policy on nicotine-containing products that is public health based and recognizes the continuum of risk among such products.” Yet, between January 2023 and April 1 of this year, the agency has authorized no e-cigarette products for retail sale, while authorizing 945 other tobacco products — including 662 combustible cigarette products.
It is clear that the FDA’s stance on the risk continuum is evolving to the detriment of millions of American adults who could benefit from tobacco harm reduction. Congressional intervention may be necessary to realign the agency with its stated goal of reducing tobacco-related harm.