Zyn Nicotine Pouches Get FDA Nod But Not Without Warnings

The FDA announced on January 16, 2025, the marketing authorization of 20 ZYN nicotine pouch products under the Premarket Tobacco Product Application pathway, citing fewer negative health benefits compared with cigarettes and other tobacco products.¹

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The action marks the first authorization for the sale of nicotine pouches, products designed to be placed between the gum and lip. However, it does not mean “these tobacco products are safe, nor are they ‘FDA approved,’” the agency stated in a press release.

“To receive marketing authorizations, the FDA must have sufficient evidence that the new products offer greater benefits to population health than risks,” Matthew Farrelly, PhD, director of the Office of Science at the FDA’s Center for Tobacco Products, said in the release. Farrelly noted that data reviewed by the agency “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.”¹

Among the considerations that led to the decision, the FDA cited its review of evidence showing that the substantially lower levels of harmful ingredients in the pouches compared with combustible cigarettes and most smokeless tobacco products reduce the risk of cancer and other known serious health conditions. However, the FDA reiterated that these products are not risk-free and cautioned adults who do not use tobacco products against starting with the synthetic nicotine tranches.¹

Youth use of nicotine pouches remains a critical concern. The FDA reviewed data from the 2024 National Youth Tobacco Survey, which indicated that only 1.8% of US middle and high school students reported current use of these products last year.² Regardless of these findings, the agency has imposed tight marketing restrictions to prevent youth exposure, including limiting advertising to audiences aged 21 and older, avoiding mass-market TV and radio advertising, and ensuring that marketing materials do not feature actors styled under the age of 35 or use characters and themes appealing to youth.¹

“While current data show that youth use remains low, the FDA is closely monitoring the marketplace and remains committed to taking action to protect public health,” Brian King, PhD, MPH, director of the FDA’s Center for Tobacco Products. There is no safe tobacco product; youth should not use tobacco products and adults who do not use tobacco products should not start, the agency reiterated in the press statement. 

The marketing authorization is conditional and subject to ongoing oversight. The FDA retains the right to suspend or withdraw the marketing orders if the products no longer meet public health standards, including in cases of increased youth initiation. The products authorized come in 3 mg and 6 mg nicotine strengths and in 10 flavors that include Cool Mint, Cinnamon, and Citrus. The authorization also restricts the applicant, Phillip Morris International, from making claims of the products’ reduced risk.

While this decision represents progress in harm reduction for adult tobacco users, it underscores the FDA’s dual commitment to reducing youth exposure and safeguarding public health.¹

References
1. FDA authorizes marketing of 20 ZYN nicotine pouch products after extensive scientific review. News release. FDA. January 16, 2025. Accessed January 20, 2025. https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-20-zyn-nicotine-pouch-products-after-extensive-scientific-review
2. Results from the Annual National Youth Tobacco Survey. US Food and Drug Administration. https://www.fda.gov/tobacco-products/youth-and-tobacco/results-annual-national-youth-tobacco-survey