FDA Authorizes ZYN Nicotine Pouches With Modified Risk Claims
- Food and Drug Administration issued modified risk granted orders to Swedish Match USA, Inc.
- The regulatory action follows an extensive scientific review by the FDA, which evaluated relative health risks, consumer understanding, youth risk data, and potential population impact.
- “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...
The U.S. Food and Drug Administration issued modified risk granted orders to Swedish Match USA, Inc. on June 30, 2026, authorizing 20 ZYN nicotine pouch products to be marketed with specific risk modification claims. According to the agency, the decision allows these products to inform adult smokers that using ZYN instead of cigarettes puts them at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.
FDA Authorizes Lower-Risk Claims for 20 ZYN Products
The regulatory action follows an extensive scientific review by the FDA, which evaluated relative health risks, consumer understanding, youth risk data, and potential population impact. Bret Koplow, acting director of the FDA’s Center for Tobacco Products, stated that the review ensures adult users receive clear, science-based information about relative tobacco harms.
“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, Ph.D., J.D., 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.”
U.S. Food and Drug Administration
Flavors, Strengths, and Lower Constituent Levels
The authorized lineup includes multiple flavors available in 3-milligram and 6-milligram nicotine strengths. The approved products comprise ZYN Chill, ZYN Cinnamon, ZYN Citrus, ZYN Coffee, ZYN Cool Mint, ZYN Menthol, ZYN Peppermint, ZYN Smooth, ZYN Spearmint, and ZYN Wintergreen. Additionally, separate authorizations cover 11 Zyn Ultra nicotine pouch products containing lower levels of most harmful and potentially harmful constituents compared with other oral and smokeless tobacco products.
Strict Oversight and Five-Year Expiration Terms
While the products were originally authorized for sale through the premarket tobacco product application pathway on January 16, 2025, seeking the optional modified risk tobacco product pathway requires stringent ongoing oversight. The current orders require Swedish Match USA, Inc. to conduct postmarket surveillance and studies. These studies must assess user behaviors and consumer understanding of the risk-related information.
The granted orders will expire in five years. Before that expiration date, the manufacturer may request continued authorization. The FDA retains the authority to withdraw the orders if data indicates that continued marketing no longer benefits population health, such as in the event of a significant increase in youth uptake.
Public Health Context and Total Authorized Count
Federal health authorities maintain that no tobacco product is safe, and individuals who do not use tobacco should not start. Complete cessation of all tobacco products remains the most beneficial path for adult cigarette smokers. However, the agency notes that switching completely from cigarettes to FDA-authorized nicotine pouches can reduce exposure to many harmful chemicals found in combustible cigarettes. To date, the FDA has authorized a total of 26 nicotine pouch products after determining they meet statutory public health standards.
