Despite a fast-track Food and Drug Administration scheme, popular nicotine pouch products have yet to be approved for sale in the US. The FDA is concerned about potential risks to new users, including children, as new tobacco products like pouches must be authorised by the FDA in order to be legally sold in the U.S. The world's largest market for smoking alternatives is worth $22 billion. However, applications for three other pouch brands are still pending due to a cautious approach by agency reviewers. Pouches are the fastest-growing nicotine product in the country with millions of users and PMI alone sold 794 million cans of its current version of Zyn in 2025.