PM · 10-Q · 2026Q3 · Full report

FDA ZYN Modified Risk Authorization

Philip Morris International Inc. · 2026-10-23 · Importance 47 · Surprise 60

In June 2026, the FDA found the modified-risk claim for all 20 ZYN nicotine pouch varieties scientifically accurate, understandable to consumers and beneficial to public health overall. The FDA authorized these products to carry a claim that using ZYN instead of cigarettes puts users at lower risk of specified serious diseases. PMI states these are the only nicotine pouch products on the U.S. market authorized as modified-risk tobacco products.

Key facts

• In June 2026, the FDA authorized the modified-risk claim for all 20 ZYN products, finding it scientifically accurate, understood by consumers and beneficial to the population as a whole. source
• The FDA authorized 20 ZYN nicotine-pouch varieties for U.S. sale on January 16, 2025, finding them appropriate for the protection of public health. source
• The 20 ZYN products authorized for the modified-risk claim are the only nicotine pouch products on the U.S. market authorized as modified-risk tobacco products. source
• PMI's July 17, 2023 FDA application requested re-authorization to market eight General snus products with a modified-risk claim; the FDA renewed the orders on November 7, 2024, with expiration in November 2032. source
• The FDA renewed the General snus modified-risk orders on November 7, 2024, with a stated expiration date in November 2032. source
• PMI's FDA-authorized IQOS and ZYN products are not guaranteed to remain authorized for sale in the United States, and new IQOS versions or other ZYN products are not guaranteed to receive authorization, particularly if underage or non-nicotine-user initiation rises significantly. source
• FDA premarket tobacco product and modified-risk authorizations for certain PMI IQOS and ZYN products are subject to strict marketing, reporting, and other requirements. source