The US Food and Drug Administration (FDA) has granted Modified Risk Tobacco Product orders to 20 ZYN nicotine pouch products after concluding that a specific lower-risk claim relative to cigarettes is scientifically accurate.
The authorization allows PMI US to market the 20 products with the claim: “Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”
Issued on June 30, the decision represents the first modified-risk authorization granted by the US FDA to nicotine pouch products.
The products, manufactured by Swedish Match USA, a subsidiary of Philip Morris International, had earlier secured US FDA marketing authorization in January 2025.
Modified-risk authorization is separate from general marketing authorization. The latest orders apply specifically to the 20 evaluated ZYN products and the exact modified-risk claim approved by the agency, rather than to nicotine pouches as a category.
The FDA said the decision followed an extensive scientific review that considered the products’ relative risks compared with cigarettes, whether consumers understood the proposed claim, potential youth use and the likely effects on the population as a whole.
The agency concluded 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.”
Bret Koplow, Ph.D., J.D., acting director of the FDA’s Center for Tobacco Products, said the modified-risk review process is intended to provide adult consumers with scientifically supported information.
“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 added.
PMI US CEO Stacey Kennedy also welcomed the decision.
“FDA’s decision is an important moment for the more than 45 million legal-age nicotine consumers in America,” said Kennedy. “Today’s news ensures these adults have access to accurate, science-based information, including FDA-authorized evidence that switching from cigarettes to ZYN reduces the risk of smoking-related diseases like heart disease and lung cancer.”
The modified-risk orders are valid for five years and require continued monitoring of the products in the market.
The FDA said it can withdraw the authorization if monitoring indicates increased youth use or if the products’ continued marketing under the authorized claim no longer benefits public health.
The regulator also said non-tobacco users should not begin using the products and reiterated that quitting all tobacco and nicotine products remains the best option for adult smokers.
