FDA Set to Relax Nicotine Pouch Regulations in a Shift Under Trump Administration

Internal meeting transcripts reveal that the U.S. Food and Drug Administration (FDA) will loosen its requirements for nicotine pouch manufacturers under a new pilot program. This marks the first clear indication of a more relaxed approach to smoking alternatives under the Trump White House. The FDA has historically subjected all new nicotine products to rigorous pre-market tests before granting licenses for sale in the United States, including requiring costly studies from manufacturers to detail the population-wide effects of their products. The agency has sought to ensure that products offer a net benefit to public health by helping smokers transition away from cigarettes without creating new problems, such as a spike in youth usage. However, according to transcripts of an internal meeting held earlier this month and reviewed by Reuters, the FDA will drop the requirement for manufacturers to submit product-specific studies in several areas under the new pilot. A shifting Trump administration stance: Among the changes, manufacturers will no longer need to provide a study on the product’s effectiveness in helping smokers reduce their cigarette use. The transcripts show that the FDA will instead rely on existing general research on nicotine pouches, which are placed under the lip to deliver a nicotine dose, to address such questions. Reuters had previously reported that the FDA was preparing to fast-track its reviews of nicotine pouches through this pilot. On Thursday, the FDA confirmed certain program details, such as more frequent communication with applicants and faster review timelines. However, it did not specify the shift from product-specific to more general evidence in key areas. While still just a test program, the move signals a potential change by the FDA toward easing a stringent review process, which has been considered a major hurdle for companies operating in the world’s largest market for smoking alternatives. Tobacco giants like Philip Morris International, Altria, and British American Tobacco have often waited for years for the FDA to review their applications, or in some cases, have had them rejected. The pilot program will benefit these companies’ pouch brands, including Zyn, On!, and Velo. PMI and Altria declined to comment before the full details of the pilot were made public. BAT stated that it has long advocated for improvements to the review process and that sensible regulation is crucial for public health in America. FDA maintains scientific standards: During the meeting, Bret Koplow, acting director of the FDA’s Center for Tobacco Products (CTP), said the pilot program might inform updates to the FDA’s review process for other product categories, the transcript showed. These categories include vapes, where the agency has so far remained more cautious. Koplow did not respond to a request for comment sent via LinkedIn. In response to Reuters’ questions, the Department of Health and Human Services, which oversees the FDA and handles its media requests, referred to Koplow’s previous comments about the pilot program. In that prior statement, Koplow said the CTP was not under pressure from the Trump administration or agency leadership to lower its scientific standards. The Trump administration has removed key officials at the center and cracked down on the widespread sale of unregulated vapes. However, before the pouch pilot, it was unclear if it would respond to calls for a simplified review process. Nicotine pouches: risks vs. benefits: During the meeting this month, FDA officials stated that nicotine pouches were generally lower risk, exposing users to fewer toxic chemicals than other nicotine product categories, and had not yet led to significant youth use. Reuters briefed Mary Hrywna, an associate professor at Rutgers University who has studied nicotine pouches, on the contents of the FDA discussions. She said that clearing new nicotine products for a faster market launch could increase the availability of less harmful options for smokers. However, she noted that whether this encourages them to switch is another matter. Meanwhile, two former directors of the Center for Tobacco Products maintained that product-specific studies are essential to properly understand whether companies’ products deliver on expected public health benefits. Brian King, CTP director until April, said that even in relatively uniform categories like nicotine pouches, differences between products—such as nicotine content or flavor—can affect how they are used by smokers or adopted by new users. King, now executive vice president for U.S. programs at the Campaign for Tobacco-Free Kids, declined to comment directly on Reuters’ reporting until the details of the pilot program were confirmed by the FDA. Mitch Zeller, CTP director until 2022, agreed that specific studies are needed to determine if a product encourages smokers to reduce their cigarette intake to a level low enough to yield health benefits. Based on the limited information Reuters was able to provide, he said the program appeared to show a “cavalier” approach to youth use, given that pouches can be easily and discreetly used by young people. Zeller pointed to the case of vapes, which saw a sudden surge in youth use in the past. Two tobacco industry analysts said an easier FDA process would boost sales in the already fast-growing pouch category. However, Jessica Zdinak, CEO at consultancy ARAC, said that based on details in the transcript, clinical studies would still be necessary even under the streamlined pilot process. This included what she called “one of the most time and resource intensive” studies currently required, meaning that applications would still be challenging for manufacturers.