The FDA granted orders for 20 Zyn products, allowing the company to claim reduced risk for certain respiratory and cardiovascular diseases compared to cigarettes.
RT’s Three Key Takeaways:
- Risk Modification Claims: The FDA authorized 20 Zyn nicotine pouch products to be marketed with claims that they pose a lower risk for conditions like emphysema and lung cancer compared to cigarettes.
- Adult Tobacco Transition: The authorization is designed to provide adult smokers with science-based information about relative harms to encourage switching from combustible cigarettes to authorized nicotine pouches.
- Youth Usage Warnings: Health advocacy groups like the American Lung Association are opposing the move, citing data that shows nicotine pouches are the most popular tobacco product among youth.
The USFDA issued modified risk granted orders today to Swedish Match USA Inc for 20 Zyn nicotine pouch products, according to the agency.
The decision allows these products, which have been available in the US since January 2025, to be marketed with a claim stating that using Zyn instead of cigarettes puts users at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.
“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, PhD, JD, acting director of the FDA’s Center for Tobacco Products. “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 FDA says it based its decision on a scientific review of the manufacturer’s applications, consumer perception data, and the potential impact on the general population. While the products are not approved to help people quit smoking, the agency concluded that the specific modified risk claim is scientifically accurate for these products and would benefit the health of the population as a whole.
However, the American Lung Association (ALA) expressed concern regarding the authorization of flavored products.
“The American Lung Association is deeply concerned that the FDA would authorize 20 nicotine pouch products in 10 flavors as modified risk tobacco products,” said Mike Seilback, avp of nationwide advocacy and state public policy at the American Lung Association, in a news release.
Seilback pointed to data from the National Youth Tobacco Survey indicating an increase in youth usage of nicotine pouches, noting that Zyn is currently the most popular brand for that demographic. He called on the agency to reverse the action to protect children from nicotine addiction.
The modified risk orders require Swedish Match USA, Inc. to conduct postmarket surveillance and behavior studies. These orders will expire in five years, and the FDA may withdraw them if there is a significant increase in youth uptake or if the marketing no longer benefits public healthcare.
The FDA previously authorized these products through the premarket tobacco product application pathway in January 2025. The agency maintained that while switching completely to nicotine pouches may reduce exposure to harmful chemicals, the most significant health benefit for adult smokers comes from fully quitting all tobacco products.
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