Key Takeaways
- The U.S. FDA has authorized 20 ZYN nicotine pouch products with a specific modified risk claim.
- This approval is limited to the USA and applies only to the reviewed products.
- The authorization allows marketing of these products with claims about lower risks compared to cigarettes.
On June 30th, the U.S. Food and Drug Administration (FDA) issued Modified Risk Tobacco Product (MRTP) orders for 20 ZYN nicotine pouches, allowing Philip Morris International U.S. (PMI U.S.) to market these products in the United States with a specific modified risk claim.
According to FDA regulations, such authorization is limited to the USA and applies only to the products reviewed and authorized by the agency under relevant orders. This means that the approval does not extend to an entire category or class of tobacco or nicotine products.
The decision was based on extensive scientific review conducted by the FDA, including evidence relating to the relative health risks of the product for individuals who use tobacco, consumer understanding and perception of the authorized modified risk claim, data regarding youth risk, and the potential impact on the population.
Based on this review, the FDA concluded that Swedish Match had demonstrated that the specific modified risk claim is scientifically accurate with respect to these 20 ZYN products. The agency also confirmed that consumers understand the claim, and marketing the products with the authorized claim would benefit the population.
With this issuance, these ZYN nicotine pouches, which were previously authorized for sale in the USA through the Premarket Tobacco Product Application (PMTA) pathway in January 2025, may now be marketed in the USA. The FDA authorized marketing of these products with a modified risk claim stating: 'Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.'
In an FDA press release announcing the orders, Bret Koplow, Ph.D., J.D., acting director of the U.S. FDA’s Centre for Tobacco Products stated: '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.' He further added that the 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.
This approval marks the first time the FDA has granted MRTP orders for nicotine pouches. More information on these modified risk granted orders is available on the FDA website.
'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.'
Bret Koplow, Ph.D., J.D., Acting director of the U.S. FDA’s Centre for Tobacco Products
