FDA planned to fast-track applications for authorization, but agency reviewers raise alarm over addiction risk

Popular nicotine pouch products have yet to be cleared for sale in the United States despite a fast-track Food and Drug Administration scheme, as agency scientists hesitate to authorize them due to potential risks to new users, including children, three sources told Reuters.

New tobacco products like pouches, which users insert under their lip to get a nicotine buzz, must be authorised by the FDA in order to be legally sold in the US, the world’s largest market for smoking alternatives worth some $22bn.

When granting licenses, the agency weighs whether a product can help smokers switch to a less harmful form of nicotine use while not driving risks too high for non-tobacco users and children.