Philip Morris International (PMI) presented evidence Thursday to the Food and Drug Administration recommending authorizing Zyn nicotine pouch products as a modified risk tobacco product.
PMI scientists presented data to the FDA’s Tobacco Products Scientific Advisory Committee (TPSAC) as part of the FDA’s process for a Modified Risk Tobacco Product (MRTP) designation for the company’s Zyn nicotine pouch products.
The Zyn nicotine pouch products submitted for the MRTP designation are the same products that received premarket tobacco product application (PMTA) authorization in January 2025.
The products, each with two nicotine strengths (3 milligram and 6 milligram), include Zyn Chill, Zyn Cinnamon, Zyn Citrus, Zyn Coffee, Zyn Cool Mint, Zyn Menthol, Zyn Peppermint, Zyn Smooth, Zyn Spearmint and Zyn Wintergreen.
This designation would allow PMI’s U.S. family of businesses to communicate to adult cigarette smokers that switching completely to Zyn lowers the risk of many smoking-related diseases, the Stamford, Connecticut-based tobacco company said.
"The FDA’s Center for Tobacco Product’s (CTP) mission is to make smoking-related disease and death a part of America’s past,” said Keagan Lenihan, chief external affairs officer for PMI U.S. “Smoke-free products, like Zyn, play a critical role in helping CTP achieve this mission and provide adults who smoke with important information to guide their choices and a real opportunity to change.”
In its presentation to the committee, the FDA stated: "The evidence suggests the proposed modified risk claim is scientifically accurate."
Tobacco company Philip Morris International (PMI) bought Zyn maker Swedish Match North America (SMNA) in 2022.
In December the FDA issued marketing granted orders to six On Plus nicotine pouch products. The products are made by Helix Innovations LLC, a subsidiary of Altria, Richmond, Virginia. They are available in two nicotine strengths (6 milligrams and 9 milligrams). They include On Plus Mint, On Plus Wintergreen and On Plus Tobacco, with each flavor offered in both strengths.
A full list of the 26 nicotine pouch products authorized by the FDA is available on the agency’s website.
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