US Food and Drug Administration approves ZYN nicotine pouch risk modification claim

The U.S. Food and Drug Administration (FDA) has issued modified risk granted orders to Swedish Match USA, Inc. for 20 ZYN nicotine pouch products following extensive scientific review.

With this issuance, these ZYN nicotine pouch product, which are authorized for sale in the United States since January 2025, may now be marketed with the following risk modification claim, “Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”

A risk modification claim is a modified risk claim, which is a statement asserting that a specific product, most commonly a regulated consumer or tobacco product, carries a lower health risk or is less harmful than a conventional alternative

“FDA’s review of modified risk products is intended to ensure that adult users have clear, science-based information about the relative harms of tobacco products, so they can make informed choices,” said Bret Koplow, Ph.D., J.D., acting director of the FDA’s Center for Tobacco Products.

“Today’s decision allows these products to be marketed with a modified risk claim that informs adults who smoke about the lower risks associated with these products,” he further added.

An order permitting the sale of a modified risk tobacco product (MRTP) refers to specific products, not an entire class of tobacco products.

The products receiving modified risk granted orders include the following, each with two nicotine strengths (3 milligram and 6 milligram):

ZYN Chill, ZYN Cinnamon, ZYN Citrus, ZYN Coffee, ZYN Cool Mint, ZYN Menthol, ZYN Peppermint, ZYN Smooth, ZYN Spearmint and ZYN Wintergreen.

The FDA concluded that Swedish Match had demonstrated that the specific modified risk claim is scientifically accurate with respect to the aforementioned ZYN products, that consumers understand the claim, and that marketing the products with the claim would benefit the population as a whole.

However, this authorization requires Swedish Match USA, Inc. to conduct post-market surveillance and studies that include an assessment of the MRTP users’ behaviors and their understanding of the risk-related information that has been provided.

There is no safe tobacco product for human consumption, and those who do not use tobacco products should not start.

For adults who currently smoke cigarettes, fully quitting the use of all forms of tobacco products would most benefit their health but they can opt for switching completely from cigarettes to FDA-authorized nicotine pouches, which may reduce exposure to many harmful chemicals found in cigarettes.

To date, FDA has authorized 26 nicotine pouch products and these products have undergone rigorous scientific review and have been found by FDA to meet the statutory public health standard.