Approval marks first time the agency has approved sale of a nicotine pouch
By Stephanie Brown HealthDay Reporter
FRIDAY, Jan. 17, 2025 (HealthDay News) — Following an extensive scientific review, the U.S. Food and Drug Administration has authorized the marketing of 20 ZYN nicotine pouch products. Nicotine pouches — small synthetic fiber pouches containing nicotine — are designed to be placed between a person’s gum and lip.
Referencing the public health standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act, the FDA determined that due to substantially lower amounts of harmful constituents than cigarettes and most smokeless tobacco products, the authorized nicotine pouches pose a lower risk for cancer and other serious health conditions. In addition, there is evidence that these nicotine pouches can help current users of cigarettes and other tobacco products successfully quit these more harmful products.
“To receive marketing authorizations, the FDA must have sufficient evidence that the new products offer greater benefits to population health than risks,” Matthew Farrelly, Ph.D., director of the Office of Science in the FDA Center for Tobacco Products, said in an agency news release. “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.”
The FDA emphasized this authorization does not mean the nicotine products are completely safe but that they meet the requirements for providing more benefit than harm. The agency added it will follow the marketing of these products closely to guard against marketing to youth and will enforce “stringent restrictions” on digital, television, and radio advertising.
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