FDA lets 20 ZYN nicotine pouches claim lower risk than cigarettes; critics warn of danger
· Medical Xpressby Ellyn Vohnoutka
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The U.S. Food and Drug Administration (FDA) has authorized marketing of 20 ZYN nicotine pouch products as a lower-risk option than cigarettes, a decision that drew immediate criticism from anti-cancer advocates worried about youth use.
Nicotine pouches are placed in the mouth between the lip and gums. They are made of nicotine powder, flavorings and other ingredients.
The agency issued the orders to Swedish Match U.S., Inc. after what it called an extensive scientific review. The company is a subsidiary of Philip Morris International, based in Stamford, Connecticut.
The products—sold in the United States since January 2025—may now carry a claim telling cigarette smokers that switching to ZYN "puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema and chronic bronchitis."
A modified risk order applies to specific products, not to nicotine pouches as a category, the FDA noted.
"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," said Bret Koplow, acting director of the FDA's Center for Tobacco Products.
He said the decision lets the products be marketed with a claim that "informs adults who smoke about the lower risks associated with these products."
The authorization covers 10 ZYN varieties—including Chill, Cinnamon, Citrus, Coffee, Cool Mint, Menthol, Peppermint, Smooth, Spearmint and Wintergreen—each in 3-milligram and 6-milligram strengths.
The FDA stressed that no tobacco product is safe and that people who do not use tobacco should not start. But for adults who smoke, the agency said, switching completely from cigarettes to authorized pouches may reduce exposure to many harmful chemicals.
To date, the FDA has authorized 26 nicotine pouch products, all manufactured by Swedish Match U.S., Inc. and Helix Innovations LLC.
The five-year orders require Swedish Match to conduct postmarket surveillance, including tracking whether more young people take up the products.
That youth risk is central to the pushback. Lisa Lacasse, president of the American Cancer Society Cancer Action Network, said the move undercuts the agency's core mission.
"The FDA's job is to protect public health, not expand the profit margins of Big Tobacco," she said in a statement, warning that the tobacco industry uses flavored products to draw in a new generation. Lacasse urged the FDA to strengthen oversight rather than open the door to more marketing of addictive products.
Her concern is grounded in recent federal data. The FDA's 2025 National Youth Tobacco Survey, released June 23, found that 1.7% of middle and high school students (about 460,000) now use nicotine pouches.
More than 1 in 6 of those users reported using them daily, and more than 9 in 10 chose flavored versions, with mint the most popular—a flavor included in the new marketing orders.
ZYN was the most commonly reported brand, named by 69% of young users.
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Visit the U.S. Food and Drug Administration for more information on the relative risks of tobacco products.
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