FDA Authorizes 20 ZYN Nicotine Pouch Products by Philip Morris International in 10 Flavors

Jan 16, 2025, 04:42 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 a person's 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, considering the risks and benefits to the population as a whole. The authorized products, available in 10 flavors with nicotine strengths of 3 mg and 6 mg, pose a lower risk of cancer and other serious health conditions compared to cigarettes and most smokeless tobacco products due to significantly lower levels of harmful constituents. Evidence also suggests that a substantial portion of adults who use cigarettes or smokeless tobacco products have completely switched to these nicotine pouches. The FDA emphasized that while these products are authorized for sale to adults aged 21 and older, they are not considered safe, and youth should not use any tobacco products. The agency will continue to monitor the marketing and use of these products, imposing stringent marketing restrictions to prevent youth exposure.