The U.S. Food and Drug Administration (FDA) has authorized the marketing of 20 ZYN nicotine pouch products through the premarket tobacco product application pathway, marking the first-ever authorization for nicotine pouches in the U.S. The authorization covers products containing either 3-mg or 6-mg nicotine strengths across 10 flavors.

The FDA's scientific review demonstrated that these synthetic fiber pouches, designed for placement between the gum and lip, contain substantially lower levels of harmful constituents compared with cigarettes and most smokeless tobacco products, including moist snuff and snus. Clinical evidence indicated a lower risk of cancer and other serious health conditions associated with the pouches compared with traditional tobacco products.

"To receive marketing authorizations, the FDA must have sufficient evidence that the new products offer greater benefits to population health than risks. In this case, the data show that these nicotine pouch products meet that bar by benefiting adults who use cigarettes and/or smokeless tobacco products and completely switch to these products," stated Matthew Farrelly, PhD, director of the Office of Science in the FDA's Center for Tobacco Products.

The authorization decision considered population-wide health implications, as mandated by the 2009 Family Smoking Prevention and Tobacco Control Act. Notably, study data demonstrated that a substantial proportion of adults who previously used cigarettes or smokeless tobacco products completely switched to using these nicotine pouches.

Youth usage data played a crucial role in the authorization process. The 2024 National Youth Tobacco Survey revealed that only 1.8% of U.S. middle and high school students reported current nicotine pouch use, despite increasing market sales.

The authorization includes strict marketing restrictions targeting adults aged 21 and older, including:

• Prohibition of mass-market radio and television advertising
• Required use of models aged 35 years or older, or styled to appear over 35
• Elimination of youth-targeted content, including characters, images, or themes
• Implementation of demographic tracking for advertising audiences.

"While current data show that youth use remains low, the FDA is closely monitoring the marketplace and is committed to taking action, as appropriate, to best protect public health," emphasized Brian King, PhD, MPH, director of the FDA's Center for Tobacco Products.

The authorization specifically covers ZYN products in chill, cinnamon, citrus, coffee, cool mint, menthol, peppermint, smooth, spearmint, and wintergreen flavors. Importantly, this authorization does not constitute FDA approval or safety certification, nor does it permit reduced-risk claims, which would require a separate modified risk tobacco product application.

The FDA retains the authority to suspend or withdraw marketing authorization if continued marketing fails to meet public health standards, particularly in the event of increased youth initiation. This authorization represents part of the FDA's broader tobacco product review process, which has evaluated applications for nearly 27 million products to date.

Reference:

FDA Authorizes Marketing of 20 ZYN Nicotine Pouch Products After Extensive Scientific Review. U.S. Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-20-zyn-nicotine-pouch-products-after-extensive-scientific-review