FDA staff blindsided by move allowing more e-cigarettes and nicotine pouches onto US market

The Food and Drug Administration (FDA) quietly introduced new guidelines in late May that permit certain nicotine-based products, including e-cigarettes and pouches, to be marketed without full regulatory approval. The six-page memo, posted online without prior consultation with enforcement staff, reverses decades of FDA policy requiring scientific validation of health benefits for smokers before new products are introduced. Two anonymous FDA staffers told The Associated Press they learned of the policy changes the night before publication, raising concerns about transparency and internal dissent. The document’s sudden release also bypassed a federally mandated public comment period, a process typically used to refine regulations before finalization. Mitch Zeller, the retired FDA tobacco director, questioned whether experts opposed the policy but were overruled, undermining public trust in the agency. The policy shift follows months of complaints from industry lobbyists close to the White House about former Commissioner Marty Makary, who resigned last week. The FDA’s statement defended the change, claiming it strengthens protections against youth nicotine addiction while supporting evidence-based alternatives for adult smokers. However, critics argue the move prioritizes industry interests over rigorous oversight. Underage vaping in the US has dropped to its lowest level in over a decade, partly due to pandemic disruptions and stricter regulations. Yet the FDA has struggled to regulate the market, approving only five companies’ vaping products while rejecting millions of others—particularly those with sweet flavors deemed appealing to children. Unauthorized vapes remain widely available despite these restrictions. The policy change also reflects broader political influences. President Trump has historically supported the vaping industry, and major tobacco companies like Reynolds American and Altria have contributed millions to political campaigns. Makary’s tenure at the FDA saw limited focus on vaping issues, with internal memos revealing his deputies blocking flavor authorizations even when FDA reviewers deemed them unlikely to target minors.