FDA Commissioner Robert Califf faced a tough situation recently. hearing Before members of the House Oversight Committee. From contraceptives and infant formula to COVID-19 treatments and regulatory actions by the Center for Tobacco Products, the session covered a wide range of FDA actions, or primarily 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 can’t or don’t want to quit, it’s even more important for the FDA to recognize and approve the important role of It was a long wait. Tobacco Harm Reduction” or THR. The idea is to reduce the health risks of smoking by cutting down on smoking or switching to non-tobacco nicotine products such as nicotine patches or e-cigarettes.
Since 2020, the FDA has required a user fee on all tobacco products, and the agency estimates it could collect an additional $100 million annually. It’s a money grab.
The FDA’s failures and inactions extend beyond providing inadequate regulatory oversight in a market full of products adults seek, as well as failing to inform adults who smoke about the “continuum of risks” of tobacco products. I’m reading.
During the hearing, lawmakers accused Khalif and the FDA of allowing illegal vaping products to proliferate while failing to approve other vaping products. The Commissioner was reluctant to support the harm reduction potential of e-cigarettes and other THR products.
For example, Khalif became upset when asked by Rep. Tim Burchett (R-Tenn.) about the relative harms of e-cigarettes compared to smoking traditional cigarettes. While acknowledging the lethality of combustible cigarettes, he said that if cigarettes didn’t exist, people “would be horrified by the components in e-cigarette residue.” After repeating that e-cigarette residue is scary, Khalif acknowledged that e-cigarettes are “much less toxic than combustible cigarettes.”
Asked by Congressman Russell Frye (R.S.C.) about the FDA’s position on the continued risks of nicotine products and the potential benefits of adults switching from nicotine, Mr. Khalif said that vaping is a secondary While tentatively supporting this as an option, he emphasized the importance of quitting smoking completely.
Throughout the hearing, Mr. Khalif emphasized the need for the benefits of THR products to outweigh the risks posed to young people. This is an argument the FDA has made repeatedly in recent years to deny more than 25 million applications for vaping products, citing the “youth e-cigarette epidemic.”
Rep. Rashida Tlaib (D-Mich.) specifically asked Khalif whether he believed the United States was in the midst of such an epidemic. “As long as an epidemic is defined as millions of people, that’s true,” he said.
In 2023, 7.7% of middle school and high school students in the United States reported using e-cigarettes. The FDA first began using the term “epidemic” in 2018 to describe the alarming increase in youth e-cigarette use. The youth e-cigarette epidemic peaked in 2019, after it was declared an epidemic, and into 2023. Decline of e-cigarette use among young people The number of students decreased by 61.5%, including 63.6% for high school students and 56.2% for junior high school students.
The official definition of an epidemic can be a problem that affects a disproportionately large number of people in a population, is “disproportionately prevalent,” or is “an extremely widespread increase.” Given this decline and the fact that fewer than 1 in 10 Americans under the age of 18 will vape by 2023, epidemic is not the appropriate word to describe vaping among American youth. In fact, Dr. Brian King, director of the Center for Tobacco Products, announced the agency’s creation last year. I had stopped using it term.
But perhaps more worryingly, new efforts are underway to address declining use among youth, address the growing supply and demand for unapproved e-cigarette products, and inform adults of the continued risks of tobacco products. Khalif continued to insist to the FDA that approved products require user fees.
FDA’s Center for Tobacco Products is fully funded by user fees, which currently apply only to six categories of tobacco products and do not include e-cigarettes or other THR products.Since then 2020 budget requestthe FDA is seeking authority to collect user fees on all tobacco products, and the agency estimates it could collect an additional $100 million annually.
It’s a money grab. The FDA has not been able to properly talk about reducing tobacco-related harm.
for Estimate request for fiscal year 2017authorities acknowledged that “risks to users continue.”[s] Tobacco product regulations do exist. This opinion was reflected in all subsequent budget requests except the most recent one for fiscal year 2025. Now, government agencies are changing their tune.What about the agency? no longer recognized Instead, it seeks funding for research projects to “better understand the impact of messages on the tobacco product risk continuum.”
That contradiction is troubling.among them Budget request for fiscal year 2023, the agency asserted that it is “pursuing an integrated agency-wide policy on nicotine-containing products that is based on public health and recognizes the continuum of risk among nicotine-containing products.” However, from January 2023 to April 1 this year, the authorities have not approved retail sales of e-cigarette products, while approving 945 other tobacco products, including 662 combustible tobacco products. ing.
It is clear that the FDA’s stance on a range of risks is evolving to the detriment of millions of American adults who could benefit from tobacco harm reduction. Congressional intervention may be needed to realign government agencies toward the stated goal of reducing tobacco-related harm.
