(WDNews) The U.S. Food and Drug Administration (FDA) has authorized the marketing of 20 ZYN nicotine pouch products following an extensive scientific review. This marks the first time the FDA has approved the sale of nicotine pouches, which are designed to be placed between the gum and lip, through the premarket tobacco product application (PMTA) pathway.
The FDA determined that these products meet public health standards established by the 2009 Family Smoking Prevention and Tobacco Control Act. The review found that the products contain significantly lower levels of harmful substances compared to cigarettes and most smokeless tobacco products, such as moist snuff and snus. Evidence also showed that some adult tobacco users transitioned completely to nicotine pouches, reducing their exposure to more harmful tobacco products.
“These nicotine pouches meet the necessary standards by benefiting adult smokers and smokeless tobacco users who completely switch, while posing a lower risk to public health,” said Matthew Farrelly, Ph.D., director of the FDA’s Office of Science in the Center for Tobacco Products.
The FDA highlighted that youth use of nicotine pouches remains low. According to the 2024 National Youth Tobacco Survey, only 1.8% of middle and high school students reported using these products. To further protect youth, the FDA has imposed strict marketing restrictions, including targeting advertisements to adults 21 and older and limiting youth exposure through responsible advertising practices. The manufacturer has committed to additional measures, such as avoiding TV and radio mass-market ads and not using models under 35 in promotional materials.
While the authorization allows these products to be legally marketed in the U.S., the FDA emphasizes that they are not “FDA approved” and do not carry a claim of reduced risk. The agency will continue to monitor the marketing and use of these products, and can withdraw authorization if they no longer meet public health standards.
The approved ZYN products, each available in 3mg and 6mg strengths, include flavors such as Chill, Citrus, Coffee, Cool Mint, and Wintergreen. The authorization applies only to these specific products, and no reduced-risk claims are permitted without additional applications.
This decision follows the FDA’s broader efforts to regulate new tobacco products, which include science-based reviews of nearly 27 million applications to date. For more information, visit the FDA’s searchable database of authorized tobacco products.
