FDA's Cautious Stance Puts Brakes on Nicotine Pouch Approval

U.S. sales of nicotine pouches face uncertainty as the Food and Drug Administration hesitates on approvals, concerned about their appeal to underage users and non-smokers. Despite a fast-track scheme, FDA scientists remain cautious about the potential risks, sources reveal.

The delay is a setback for companies like Philip Morris International and British American Tobacco, who await authorisation for newer, competitive versions of their brands. Stocks have fluctuated as a result, with PMI shares falling over 6% and BAT stocks down by 2.5%.

While pouches represent a less harmful nicotine option compared to cigarettes, youth addiction fears persist. The FDA stresses its decisions will be governed by science and law, despite industry pressure to expedite authorisations for this burgeoning $22 billion market.