The Food and Drug Administration on Tuesday issued modified risk granted orders to Swedish Match USA Inc. for 20 Zyn nicotine pouch products.
Stamford, Connecticut-based Philip Morris International Inc. (PMI), which owns Swedish Match, said these are the first modified risk tobacco product (MRTP) orders granted for nicotine pouches.
The products, each with two nicotine strengths (3 milligrams and 6 milligrams), include Zyn Chill, Zyn Cinnamon, Zyn Citrus, Zyn Coffee, Zyn Cool Mint, Zyn Menthol, Zyn Peppermint, Zyn Smooth, Zyn Spearmint and Zyn Wintergreen.
With this issuance, these Zyn nicotine pouch products have been authorized for sale in the United States since January 2025, the FDA said.
The agency said the products may now be marketed with the following risk modification claim: “Using Zyn instead of cigarettes puts you 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, 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 said scientific evidence supports the reduced-risk claim for these Zyn nicotine pouches and that consumers understand what the claim means. The agency also determined that allowing Swedish Match to market the products with the claim would benefit public health overall. The FDA said it also considered the recommendations from the Jan. 22 Tobacco Products Scientific Advisory Committee meeting, public comments, data, information submitted to the agency, as well as other scientific information the FDA identified from other sources.
The FDA said the authorization requires Swedish Match USA Inc. to conduct postmarket surveillance and studies that include an assessment of the MRTP users’ behaviors and their understanding of the risk-related information. The authorization is valid for five years, after which the company must seek FDA approval to continue marketing the products with those claims.
The FDA said it can revoke the authorization if the products no longer benefit public health, including if youth use increases significantly.
Stacey Kennedy, PMI U.S. CEO, said the FDA’s decision is an important moment for the more than 45 million legal-age nicotine consumers in America.
“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,” Kennedy said. “More broadly, it reinforces the agency’s science-based approach to evaluating products across the continuum of risk and communicating those findings transparently.”
To date, FDA has authorized 26 nicotine pouch products.
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