Philip Morris International Seeks FDA Authorization for Zyn as Modified Risk Tobacco Product
Key Insights
Philip Morris International (search) presented evidence to the FDA's Tobacco Products Scientific Advisory Committee seeking Modified Risk Tobacco Product designation for Zyn (search) nicotine pouches.
The FDA stated that "the evidence suggests the proposed modified risk claim is scientifically accurate" during the committee presentation.
The designation would allow PMI to communicate to adult cigarette smokers that switching completely to Zyn (search) lowers the risk of many smoking-related diseases.
Philip Morris International (search) (PMI) presented evidence Thursday to the Food and Drug Administration recommending authorization of Zyn (search) nicotine pouch products as a modified risk tobacco product, marking a significant step in the company's efforts to position smoke-free alternatives in the U.S. market.
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 (search) 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.
Product Portfolio and Market Impact
The products under review include ten Zyn (search) varieties, each available in two nicotine strengths (3 milligram and 6 milligram): Zyn Chill, Zyn Cinnamon, Zyn Citrus, Zyn Coffee, Zyn Cool Mint, Zyn Menthol, Zyn Peppermint, Zyn Smooth, Zyn Spearmint and Zyn Wintergreen. The popular pouch generated $3.24 billion in sales last year and has gained widespread attention on social media, with videos of "Zynfluencers" using the pouches accumulating tens of millions of views.
The tiny pouches are about the same size as a piece of gum, and when placed between the gums and teeth, they deliver nicotine directly to the bloodstream as they dissolve. Unlike cigarettes, Zyn (search) doesn't contain tobacco, but serves as a catalyst for nicotine delivery.
FDA Assessment and Regulatory Pathway
In its presentation to the committee, the FDA stated: "The evidence suggests the proposed modified risk claim is scientifically accurate." This designation would allow PMI's U.S. family of businesses to communicate to adult cigarette smokers that switching completely to Zyn (search) lowers the risk of many smoking-related diseases.
"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 (search), 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."
Health Considerations and Risks
The American Cancer Society notes that Zyn (search) can harm dental health and might put users at risk for increased heart rate, greater risk of heart disease and stroke, damage to blood vessels, nausea, headaches, dizziness, and upset stomach. Philip Morris is asking to claim that using Zyn reduces "mouth cancer, heart disease, lung cancer, and stroke" compared to cigarettes.
Whether using Zyn (search) reduces risk for lung cancer remains to be seen without clinical trials. The FDA is reviewing the request to use the wording "reduced risk" when comparing Zyn to cigarettes, although Philip Morris hasn't conducted long-term studies of Zyn users or whether this product will encourage smokers to make the switch to the nicotine pouch.
Industry Context
Tobacco company Philip Morris International (search) bought Zyn (search) maker Swedish Match North America (search) (SMNA) in 2022. In December, the FDA issued marketing granted orders to six On Plus nicotine pouch products made by Helix Innovations LLC, a subsidiary of Altria (search). These products are available in two nicotine strengths (6 milligrams and 9 milligrams) and include On Plus Mint, On Plus Wintergreen and On Plus Tobacco flavors.
A full list of the 26 nicotine pouch products authorized by the FDA is available on the agency's website. The FDA has yet to make a decision on whether Zyn (search) will receive approval for its claims about being a healthier alternative to smoking.