FDA authorizes 11 higher-strength ZYN nicotine pouches

The U.S. Food and Drug Administration (FDA) has authorized 11 new nicotine pouch products from Swedish Match USA, specifically within the ZYN ULTRA line. These new authorizations bring the total number of FDA-cleared nicotine pouch products to 43.

The newly authorized products feature higher nicotine strengths than previously cleared versions. Ten of the products contain 9 milligrams of nicotine per pouch, while one product, ZYN ULTRA Smooth, contains 11 milligrams. The FDA noted that these products contain lower levels of most harmful and potentially harmful constituents compared to other oral and smokeless tobacco products.

This move comes as Philip Morris, the parent company, seeks to expand its presence in the rapidly growing nicotine pouch market to compete with rivals like British American Tobacco’s Velo. The authorizations were processed through a pilot program designed to expedite applications for these products.