FDA Grants Modified Risk Claim to Zyn

Tobacco harm reduction (THR) products have been proven to be a safer alternative to cigarettes and an effective way to help smokers quit.  On June 30, 2026, the Food and Drug Administration (FDA) took a significant step to increase the availability and use of THR products by announcing the approval of 20 Zyn nicotine pouch products to be marketed with a modified risk claim.

The products, including flavors like peppermint, citrus, and cinnamon, will have labels that inform smokers that using them “instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”  Acting Director of the FDA’s Center for Tobacco Products Bret Koplow said, “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.  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.”

Citizens Against Government Waste has been following and promoting the benefits of THR products in reducing smoking since 2016.  The issuance of a modified risk claim is another welcome development after the FDA issued its first marketing authorization of fruit flavored e-cigarette products on May 5, 2026.

The FDA should be applauded for issuing a modified risk claim for Zyn products and should continue to enact policies that promote THR products.  If smokers are better informed about their benefits and the products are more widely available, more smokers will be likely to permanently give up smoking.