The Food and Drug Administration on Tuesday authorized Philip MorrisZyn's proprietary Zyn nicotine pouches will be marketed as less harmful than cigarettes, giving the tobacco giant a major regulatory victory as the Trump administration loosens restrictions on nicotine products.
The decision, first reported by Axios, allows 20 Zyn products to carry a modified risk statement saying that switching from cigarettes to Zyn reduces the risk of oral cancer, heart disease, lung cancer, stroke, emphysema and chronic bronchitis.
Zyn pouches contain nicotine but not tobacco. They sit between the user's gum and lip and have gained popularity among conservatives, tech workers and others who promote them as a cleaner alternative to cigarettes and chewing tobacco or as a productivity aid.
The FDA's decision does not mean that Zyn is safe. The agency has said that there is no safe tobacco product, that youth should not use tobacco products, and that adults who do not use tobacco products should not start using tobacco products.
Still, the order gives Philip Morris a powerful health-related claim for one of the fastest-growing products in the nicotine market, as cigarette sales continue to decline in the U.S. and major tobacco companies invest more in smoke-free products.
President Donald Trump, who backed restrictions on flavored e-cigarettes during his first term, changed course during the 2024 campaign and vowed to “save vaping.” Since returning to office, his administration has taken a more industry-friendly approach, including creating a path for some flavored e-cigarettes and nicotine pouches to remain on the market while they undergo FDA review.
The change came after heavy pressure from the tobacco and vaping industries, which have argued that adult smokers need greater access to less harmful alternatives to cigarettes.
“President Trump consistently pledged throughout the election campaign to expand access to vapes, pouches and other nicotine products that evidence shows help adults quit smoking,” White House spokesman Kush Desai told CNBC. “The only guiding factor behind the Trump administration's decision-making is Gold Standard science.”
Zyn has also become a cultural marker in conservative politics. Former Fox News host Tucker Carlson helped popularize the brand on the right before souring on Zyn and launching his own nicotine pouch brand, Alp.
Nicotine pouches have also gained followers within Trump's orbit. The Wall Street Journal reported that Health and Human Services Secretary Robert F. Kennedy Jr. uses nicotine pouches and that Trump recently asked Kennedy which pouches he used after a lunch with tobacco executives.
The FDA had already authorized the sale of the same 20 Zyn products in January 2025, but that earlier decision did not allow Swedish Match, the Philip Morris subsidiary that makes Zyns, to market them to reduce the risk of disease. Tuesday's order goes further by allowing the company to make a specific lower risk claim related to several major smoking-related diseases.
“FDA's review of modified risk products is intended to ensure that adult users have clear, science-based information about the relative harms of tobacco products so they can make informed decisions,” Bret Koplow, acting director of the FDA's Center for Tobacco Products, said in a statement. “Today's decision allows these products to be marketed with a modified risk statement that informs adult smokers of the lower risks associated with these products.”
The products covered by the order include Zyn Chill, Cinnamon, Citrus, Coffee, Cool Mint, Menthol, Peppermint, Smooth, Spearmint and Wintergreen, each in nicotine strengths of 3 and 6 milligrams.
“The FDA's decision is an important moment for the more than 45 million legal-age nicotine users in the United States,” Philip Morris US CEO Stacey Kennedy said in a statement. “Today's news ensures these adults have access to accurate, science-based information, including FDA-cleared evidence that switching from cigarettes to ZYN reduces the risk of smoking-related diseases such as heart disease and lung cancer.”
