FDA Allows 20 ZYN Pouches to Carry Lower-Risk Claim

The FDA has issued modified risk granted orders for 20 ZYN nicotine pouch products. The decision allows Swedish Match USA to tell adult smokers that using pouches instead of cigarettes lowers the risk of six smoking-related diseases.

This authorization matters because it is a rare federal permission slip for a nicotine company to say the obvious out loud: not all nicotine products carry the same risk. For adult smokers, that kind of information is not a loophole; it is the entire point of tobacco harm reduction.

The authorized modified risk tobacco product (MRTP) claim says: “Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.” The orders apply only to ten ZYN varieties: Chill, Cinnamon, Citrus, Coffee, Cool Mint, Menthol, Peppermint, Smooth, Spearmint and Wintergreen, each in 3 mg and 6 mg nicotine strengths, according to the FDA’s ZYN MRTP application page.

An MRTP order is not a blanket endorsement of ZYN, nicotine pouches, or nicotine use. FDA says an MRTP order applies to specific products, not an entire class. The agency’s rules stipulate that an application generally must demonstrate that the product will significantly reduce the risk of harm and disease for individual tobacco users. They must also benefit the population as a whole, including people who do not use tobacco products.

The 20 ZYN products were already legal to sell. FDA authorized them through the premarket tobacco application (PMTA) pathway on Jan. 16, 2025. However, at the time, Swedish Match could not make reduced-risk claims without a separate MRTP authorization. In the agency’s technical review for that PMTA decision, FDA described the products as “oral tobacco products that do not contain cut, ground, powdered, or leaf tobacco.”

The agency said it considered consumer understanding, youth risk, public comments, and the Jan. 22, 2026 Tobacco Products Scientific Advisory Committee meeting before granting the orders. Bret Koplow, Ph.D., J.D., acting director of the FDA Center for Tobacco Products, said the decision allows the company to give adults who smoke “clear, science-based information” about the lower risks associated with switching.

Philip Morris International (PMI), which owns Swedish Match, noted that the decision was the first MRTP authorization for nicotine pouches. The company may use the claim immediately, but the orders require postmarket surveillance and expire in five years unless the FDA authorizes continued MRTP marketing.

For a regulator that has spent years burying low-risk nicotine products under paperwork, denial orders and youth-panic politics, this is a useful crack in the wall. FDA still will not say nicotine pouches are “safe”, and nobody serious needs it to, but the agency has now formally recognized that switching from cigarettes to a noncombustible nicotine product can reduce disease risk.