FDA Authorizes 20 ZYN Nicotine Pouches to Be Marketed with Specific Modified Risk Claim
June 30, 2026
Today, the U.S. Food and Drug Administration (FDA) 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 products—which have been 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.”
“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.”
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
- ZYN Wintergreen
Based on FDA’s scientific review of Swedish Match USA, Inc.’s MRTP applications, including the relative health risks of the products to individuals who use tobacco, consumer understanding and perception of the products marketed with the modified risk claim, data regarding youth risk, and the potential impact to the population, FDA concluded that Swedish Match had demonstrated that the specific modified risk claim is scientifically accurate with respect to these ZYN products, that consumers understand the claim, and that marketing the products with the claim would benefit the population as a whole. FDA also considered the recommendations from the January 22, 2026, Tobacco Products Scientific Advisory Committee meeting, public comments, data, information submitted to FDA, and other scientific information the FDA identified from other sources.
While a new tobacco product can be legally sold if FDA authorizes it through the premarket tobacco product application (PMTA) pathway, seeking FDA authorization of the product through the optional MRTP pathway presents a meaningful harm reduction opportunity for manufacturers to communicate that certain products present a lower risk of tobacco-related disease, providing adults who smoke with the ability to make more informed decisions.
Today’s authorization requires Swedish Match USA, Inc. to conduct postmarket surveillance and studies that include an assessment of the MRTP users’ behaviors and their understanding of the risk-related information. These orders will expire in five years, before which time the company may request and receive FDA authorization to continue marketing the products as MRTPs. If at any point the agency determines that, among other things, the continued marketing of the products as MRTPs no longer benefits the health of the population as a whole, such as if there is a significant increase in youth uptake, the agency may withdraw the orders.
Following a thorough review, FDA originally authorized the marketing of these products through the PMTA pathway on January 16, 2025. There is no safe tobacco product, 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. However, switching completely from cigarettes to FDA-authorized nicotine pouches may reduce exposure to many harmful chemicals found in cigarettes.
To date, FDA has authorized 26 nicotine pouch products. These products have undergone rigorous scientific review and have been found by FDA to meet the statutory public health standard.
More information about these modified risk granted orders are available on the FDA website.