FDA Clears 11 Higher-Nicotine ZYN Ultra Products for Philip Morris International

The U.S. Food and Drug Administration authorized 11 ZYN Ultra nicotine pouch products for Philip Morris International on August 21, 2026, clearing a new line of pouches with higher nicotine content for sale in the United States. The agency simultaneously published an updated list of nicotine pouches authorized for the U.S. market.

The ZYN Ultra authorization extends PMI's regulatory wins for the ZYN brand, which had previously secured premarket authorization for 20 standard-strength products and, in June 2026, became the first nicotine pouch to receive modified-risk status allowing it to be marketed as posing lower risks than cigarettes for conditions including mouth cancer, heart disease and lung cancer.