FDA Clears Zyn Nicotine Pouches as Less Harmful Than Cigarettes

The Food and Drug Administration on Tuesday cleared Philip Morris -owned Zyn nicotine pouches to be marketed as less harmful than cigarettes, giving the tobacco giant a major regulatory win as the Trump administration loosens restrictions on nicotine products.

The decision, first reported by Axios, allows 20 Zyn products to carry a modified-risk claim saying that switching from cigarettes to Zyn lowers the risk of mouth cancer, heart disease, lung cancer, stroke, emphysema and chronic bronchitis.

Zyn pouches contain nicotine but not tobacco. They are placed between a user's gum and lip and have surged in popularity among conservatives, tech workers and others who promote them as a cleaner alternative to cigarettes and chewing tobacco or a productivity aid.

The FDA decision does not mean Zyn is safe. The agency has said 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.

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 heavily in smoke-free products.

President Donald Trump, who backed restrictions on flavored e-cigarettes during his first term, reversed course during the 2024 campaign and promised to "save vaping." Since returning to office, his administration has taken a more industry-friendly approach, including by creating a pathway for some flavored e-cigarettes and nicotine pouches to remain on the market while they undergo FDA review.

The shift has followed heavy lobbying from the tobacco and vaping industries, which have argued that adult smokers need more access to less harmful alternatives to cigarettes.

"President Trump consistently pledged on the campaign trail to expand access to nicotine vapes, pouches, and other products that evidence shows help adults quit smoking," White House spokesperson 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 later souring on Zyn and launching his own nicotine pouch brand, Alp.

Nicotine pouches have also gained fans inside 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 same 20 Zyn products for sale in January 2025, but that earlier decision did not allow Swedish Match, the subsidiary of Philip Morris that makes Zyns, to market them as reducing disease risk. Tuesday's order goes further by allowing the company to make a specific lower-risk claim tied 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 choices," 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 claim that informs adults who smoke about 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 3-milligram and 6-milligram nicotine strengths.

"FDA's decision is an important moment for the more than 45 million legal-age nicotine consumers in America," Philip Morris U.S. CEO Stacey Kennedy said in a statement. "Today's news ensures these adults have access to accurate, science-based information, including FDA-authorized evidence that switching from cigarettes to ZYN reduces the risk of smoking-related diseases like heart disease and lung cancer."