FDA announcements or reports on compliance violations

FDA Authorizes Marketing of 20 ZYN Nicotine Pouch Products by Philip Morris International for First Time, Citing Lower Health Risks

Jan 16, 2025, 09:32 PM

The U.S. Food and Drug Administration (FDA) has authorized the marketing of 20 ZYN nicotine pouch products, manufactured by Philip Morris International, following an extensive scientific review. This marks the first time the agency has approved products known as nicotine pouches, which are small synthetic fiber pouches containing nicotine designed for placement between the gum and lip. The FDA determined that these products meet the public health standard required by the 2009 Family Smoking Prevention and Tobacco Control Act, citing their lower risk of cancer and other serious health conditions compared to cigarettes and most smokeless tobacco products. The authorized products include 10 flavors available in two nicotine strengths, 3 mg and 6 mg. The agency found that a substantial proportion of adults who use cigarettes or smokeless tobacco have completely switched to ZYN. While the FDA has authorized their marketing, it does not mean these products are 'FDA approved' or safe, as there is no safe tobacco product. The FDA will closely monitor youth use, which remains low at 1.8% among U.S. middle and high school students, and the company's compliance with stringent marketing restrictions to ensure these products are marketed responsibly to adults aged 21 and older.