U.S. — The Food and Drug Administration authorized Swedish Match USA, Inc. on June 30, 2026, to market 20 ZYN nicotine pouch products with modified risk claims compared to cigarettes. The authorization allows these products to be presented as posing a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.

Swedish Match USA, Inc. is a subsidiary of Philip Morris International. The authorized ZYN products include flavors such as Chill, Cinnamon, Citrus, Coffee, Cool Mint, Menthol, Peppermint, Smooth, Spearmint, and Wintergreen, available in 3-milligram and 6-milligram nicotine strengths. Flavors Black Cherry and Peach are not included in this authorization.

Nicotine pouches contain nicotine but do not contain tobacco. They are not approved by the FDA as nicotine replacement products to help users quit smoking. Users place these pouches between their lip and gum and remove them after use; they can contain up to 6 milligrams of nicotine.

The FDA mandated that Swedish Match USA study customer risk perception of its products for five years as part of the authorization. The agency also stipulated that it could reverse the decision if evidence indicates a rise in youth use of the products. The FDA had previously authorized the sale of these 20 ZYN products in January 2025, but without the modified risk claims.

Mike Seilback, assistant vice president of nationwide advocacy and state public policy at the American Lung Association, called the FDA's authorization of ZYN modified risk claims "appalling." Seilback also stated, "The Lung Association calls on the FDA to reverse this action." He added, "We must protect our children from a lifelong addition to nicotine." The FDA's National Youth Tobacco Survey 2025 found that 1.7% of middle and high school students reported using nicotine pouches, with ZYN being the most popular brand among these students. More than 1 in 6 middle and high school students who reported using nicotine pouches in 2025 indicated daily use. The FDA has stated that there is no safe tobacco product and that youth should not use tobacco products. The agency also advises that adults who do not use tobacco products should not start.

Why It Matters

The FDA's decision to permit modified risk claims for ZYN nicotine pouches marks a regulatory development for tobacco-free nicotine products. This authorization allows the manufacturer to market the products with specific health claims relative to traditional cigarettes, potentially influencing consumer perceptions and product choices. The FDA's mandate for post-market studies on customer risk perception and the condition for potential reversal reflects ongoing agency concern about public health impacts, particularly regarding youth.

Concerns from public health organizations, such as the American Lung Association, indicate a differing perspective on the authorization, particularly in light of existing youth usage data. The 2025 National Youth Tobacco Survey identified ZYN as the most popular nicotine pouch brand among middle and high school students, with many reporting daily use. This context highlights the contrasting views on the potential effects of altered marketing on youth nicotine use, despite the FDA's general stance against tobacco product initiation by youth and non-users.