On Oct. 30, the U.S. Food and Drug Administration issued Marketing Granted Orders to Modoral Brands Inc., a Reynolds American subsidiary, for 24 VELO nicotine pouch products, marking the first FDA marketing authorizations for British American Tobacco’s VELO brand in the United States. The orders cover eight product varieties across three packaging configurations, all containing 4 mg of nicotine. VELO Mini Pouch flavors include Crema, Lime, Orange Crema and Passion Fruit, while VELO Mini Pouch 2 comes in Crema, Lime, Orange Crema and Cinnamon. Each pouch weighs 400 mg.
The FDA said its scientific review found that the authorized products contain lower levels of harmful and potentially harmful constituents than cigarettes and smokeless tobacco products, with several carcinogenic constituents, including those associated with oral cancer, below measurable levels. The agency evaluated whether the products could benefit adults who switch completely from other tobacco products while considering potential risks to youth and nonusers. The FDA emphasized that marketing authorization does not mean the products are safe and that adults who use tobacco must switch completely to potentially lower-risk alternatives to realize the full health benefits.
The decision brings the total number of FDA-authorized nicotine pouch products to 67, including products marketed by Swedish Match USA’s ZYN and Altria’s Helix Innovations. The authorizations also give BAT a place alongside its two major competitors in the FDA-authorized U.S. nicotine pouch market. Only nicotine pouch products listed on the FDA’s authorized products list may legally be sold in the United States.
