FDA Issues Modified Risk Orders for 20 ZYN Pouches After Review of Swedish Match Data

The agency granted five-year modified risk orders to Swedish Match U.S. after reviewing chemical, biomarker and behavioral data submitted by the Philip Morris subsidiary. The claims apply only to the listed Chill, Cinnamon, Citrus, Coffee, Cool Mint, Menthol, Peppermint, Smooth, Spearmint and Wintergreen varieties in 3 mg and 6 mg strengths. No broader category authorization was issued and all products remain subject to the same manufacturing and labeling rules as other authorized tobacco products.

The 2025 National Youth Tobacco Survey recorded 1.7 percent current use among middle and high school students, with ZYN named by 69 percent of users and flavors chosen by more than 90 percent. Daily use was reported by more than one in six pouch users. Postmarket surveillance plans require the company to track initiation, dual use with cigarettes, and cessation patterns among adults and adolescents through 2031.

This decision continues the FDA's product-by-product approach previously applied to certain snus and heated tobacco products. Long-term population surveillance of oral nicotine pouches remains limited compared with cigarettes, leaving open questions about sustained switching rates, gateway effects, and cardiovascular outcomes at population scale. The orders explicitly prohibit marketing to non-users and require prominent statements that no tobacco product is safe.

Next steps include FDA review of the first annual surveillance reports and potential adjustment of marketing restrictions if youth uptake thresholds are crossed. Ongoing monitoring will determine whether the authorized claims alter adult switching behavior enough to offset any increase in overall nicotine exposure.