The Food and Drug Administration has updated its regulations for Swedish Match USA Inc.’s ZYN nicotine pouches, enabling the product to be marketed with language suggesting that switching from cigarettes reduces the risk of several serious health conditions.
In a move described by the agency as critical for adult nicotine users, the FDA now permits labels on the 10-flavor original line (at two strengths: three milligrams and six milligrams) to state: “Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”
The updated regulations apply to the flavors chill, cinnamon, citrus, coffee, cool mint, menthol, peppermint, smooth, spearmint, and wintergreen. However, the change does not extend to ZYN’s new flavors—peach, black cherry, and dragonberry—which were recently introduced on the brand’s social media channels.
Bret Koplow, acting director of the FDA’s Center for Tobacco Products, stated in a statement that the agency’s review of modified risk products aims to ensure adult users have “clear, science-based information about the relative harms of tobacco products.” He noted that the decision allows these products to be marketed with claims of reduced risks.
Philip Morris U.S. CEO Stacey Kennedy said the update ensures “over 45 million legal-age nicotine consumers” have access to “accurate, science-based information.”
The FDA emphasized that this regulatory change is a marketing authorization, not an approval. The agency maintains that “no tobacco product is safe,” and its evaluation focuses on relative risk reduction for individual users and public health benefits.
