Baby steps, but 2025 might have been the year the United States Food and Drug Administration started changing course on tobacco harm reduction.
To THR advocates, it’s too little and long overdue. The FDA has been guilty of spreading misinformation about safer nicotine products that can help people quit smoking. It has been notorious for a sluggish, punishing and politicized vape authorization process that obstructs regulated access—sending applicants for flavored vapes, in particular, on a “wild goose chase,” according to one appeals court, and moving the goalposts to “arbitrarily and capriciously” deny them (even if the Supreme Court didn’t see it that way in April).
The agency has been blamed for making a “gigantic, chaotic mess” of the US vapes market, ceding the space to the unregulated products that now dominate, and generally dissuading people who smoke from switching with a relentless, grossly exaggerated emphasis on youth vaping harms.
In January, however, the FDA authorized some nicotine pouches for the first time under its Premarket Tobacco Products Applications (PMTA) process—acknowledging that they “offer greater benefits to population health than risks.”
April saw the removal of the director of the FDA’s Center for Tobacco Products (CTP), Dr. Brian King, who’d unapologetically prioritized youth prevention more than the needs of adults who smoke (he soon found a new job at the Bloomberg-funded, anti-THR Campaign for Tobacco-Free Kids). And in July, the FDA authorized Juul vapes after a years-long legal battle—a move heavy with symbolism, when the company once served as chief scapegoat for youth use.
“This pilot will potentially result in a wider variety of authorized nicotine pouches from which to choose,” the FDA stated.
Then in September, the FDA launched a pilot program to streamline its PMTA review process for nicotine pouches. Its announcement acknowledged—as the agency has done previously, if not very loudly, using “continuum of risk” language—that non-combustible nicotine products are safer than cigarettes. It also pointed to evidence that nicotine pouches can be valuable smoking-cessation aids.
The FDA said that to increase efficiency in its case-by-case reviews of pouches, it will focus “on the most critical elements for this product category,” in assessing “appropriate for the protection of public health”—aiming for better communication with applicants and “shorter review timeframes.”
“For adults who smoke and want to switch to a nicotine pouch product, this pilot will potentially result in a wider variety of authorized nicotine pouches from which to choose,” the agency stated.
Whether the promise is kept remains to be seen. If it is, it could be a huge win for US public health. Uptake of low-risk oral nicotine products has reduced Sweden’s smoking rate to 5.3 percent—verging on world-first “smoke-free” status.
Experts have long called for the FDA to start authorizing a much wider range of safer nicotine products. People have individual preferences, and often find completely different products helpful or unhelpful. So offering them lots of options, with the confidence of knowing they’re authorized, would give the US the best chance to accelerate smoking cessation like Sweden or New Zealand.
The promised streamlining of pouch authorizations sounds like a start. It also suggests that the FDA has the ability to make changes swiftly—particularly if pushed. But the agency could be using many other tools, too, if it really wants THR to take off.
The paper sets out 15 practical recommendations that the FDA has the power to adopt.
In September, just days after the FDA pilot announcement, a group of researchers in the field published a paper with the American Enterprise Institute (AEI)—“Regulating the Tobacco and Nicotine Market in the American Public Interest: A Reform Agenda for the FDA.” It sets out 15 practical recommendations that the FDA has the power to adopt.
When pressed by THR proponents, FDA officials such as King have pleaded that they’re merely implementing the law under the Tobacco Control Act, and that their hands are therefore tied. But as the paper states, “These reforms do not require a change in the law but rather a pragmatic interpretation of the process governing the PMTA and the ‘appropriate for the protection of public health’ test.”
The recommendations include: applying the “least-burdensome principle” to regulation; establishing “soft standards” to speed up authorizations in a given product category, using “category-wide findings” rather than endlessly demanding individual findings for every single product; not always requiring manufacturers to produce human studies, when studying a product’s emissions is a “reasonable proxy;” and using “real-world outcomes” of products already on the market to evaluate public health impacts.
The authors also want authorized manufacturers to be allowed to communicate more clearly to the public about the reduced-risk nature of their products. And they call on the FDA to “Educate health professionals and the public” about the “differential risks between smoking and smoke-free products.”
“These reforms are necessary and urgent,” Dr. Brad Rodu, professor of medicine at the University of Louisville and one of the authors of the paper, told Filter. When around 480,000 people die of smoking-related illnesses each year in the US, guaranteeing access to more non-combustible alternatives is paramount.
“Crowd out the illicit market by authorizing at least 4,000 products that smokers desire, reduce review time to the statutory maximum 180 days and lower application costs.”
To date, Rodu pointed out, the FDA has authorized just 39 mostly unpopular vaping products, with a handful of menthol options the only non-tobacco flavors. This just isn’t enough to outcompete the vast array of cigarettes and other combustible tobacco products available. But even partial prohibition is enough to boost unregulated markets.
“The demand for safer cigarette substitutes is now being met by illegal vaping products,” Rodu said. People who use these products instead of smoking are still practicing harm reduction, but without the safeguards of product standards and consumer protections. This, Rodu said, could be solved by the paper’s recommendations.
“Crowd out the illicit market by authorizing at least 4,000 products that smokers desire,” he urged, “reduce agency review time from several years to the statutory maximum 180 days, and lower product application costs from tens of millions, to tens of thousands of dollars.”
And if the full benefit of authorizing far more safer nicotine products is to be realized, the FDA has a responsibility to make sure people who smoke know about them.
“The FDA must invest heavily in honest consumer education on the differential risks of combustible and smoke-free tobacco,” Rodu said.
“The FDA and HHS leaders can correct course, but doing so will require genuine leadership.”
“Currently, the general public and health professionals are grossly misinformed about the significant risk-benefit ratio of nicotine itself, and the large difference in health risks between smoked tobacco and use of smoke-free delivery systems,” he pointed out. “[Health and Human Services] Secretary Kennedy knows these basic facts: So should all Americans.”
Gregory Conley, a longtime THR advocate and former legislative director of the American Vapor Manufacturers Association, sees the AEI paper as a “major opportunity” for the FDA to reset, by building an authorization pathway to a functioning regulated market.
“Despite a campaign trail commitment from President Trump to ‘save’ flavored vaping, companies still face an opaque and impractical process,” Conley told Filter. “The FDA and HHS leaders can correct course, but doing so will require genuine leadership and a break from the missteps of prior administrations.”
There have been signals that new FDA leadership might be more receptive to these signals than their predecessors were. In October, acting CTP Director Dr. Bret Koplow voiced support for THR, including potentially increasing the range of authorized flavored vapes, as a way to reduce use of lethal cigarettes.
“I agree with the proposals. Millions of lives are waiting for the CTP, and all of us, to get this right.”
“After hearing Bret Koplow speak at the FDLI Tobacco and Nicotine Conference, I feel more hopeful than I have in a long time,” Skip Murray, a THR advocate who herself quit smoking with vapes, told Filter.
Murray strongly agrees with the paper’s authors that the PMTA process “needs a do-over.” For her, the long-term obstruction has been personal. Murray’s husband has COPD after years of smoking, as she recently wrote for Filter, and she has lost many loved ones from smoking-related illnesses.
“Streamlining the PMTA process would free up funds available to the CTP to put towards educating the public on the continuum of risk,” Murray pointed out. “I agree with the proposals in the AEI. Millions of lives are waiting for the CTP, and all of us, to get this right.”
Photograph via Freerange Stock/Public Domain
The Influence Foundation, which operates Filter, formerly received donations from Juul Labs, Inc. Filter‘s Editorial Independence Policy applies.