The U.S. Food and Drug Administration has authorized Philip Morris International (PMI) to market ZYN nicotine pouches in the United States for adults 21 and older, following an extensive scientific review through the premarket tobacco product application (PMTA) pathway.

In its decision, the FDA said the authorized nicotine pouch products meet the public health standard required under the 2009 Family Smoking Prevention and Tobacco Control Act. The agency concluded that, compared with cigarettes and most smokeless tobacco products such as moist snuff and snus, the nicotine pouches contain substantially lower amounts of harmful constituents and therefore pose lower risk of cancer and other serious health conditions.

FDA approval also hinged on evidence that a substantial proportion of adult users of cigarettes and/or other smokeless tobacco products switch completely to the nicotine pouches. The FDA further reviewed youth-related data and said that youth use remains low despite growth in sales in recent years. It cited the 2024 National Youth Tobacco Survey, which reported that 1.8% of U.S. middle and high school students said they currently use nicotine pouches.

The FDA emphasized that the authorization does not mean nicotine pouches are “safe,” and it noted it is not an “FDA approved” status in the sense of safety. The agency said there is no safe tobacco product, and young people should not use tobacco products.

As part of the approval, the FDA said it will closely monitor both youth use and the company’s compliance with marketing restrictions, and that authorizations can be suspended or withdrawn if the products no longer meet the necessary public health standard.

The authorization applies to specific ZYN nicotine pouch products approved under PMTA—distinct products within the ZYN line—rather than extending automatically to all versions or future products without review.