The US Food and Drug Administration (FDA) will ease requirements on nicotine pouch manufacturers under a new pilot program, internal meeting transcripts show, in the first clear sign of a softer stance on smoking alternatives under Trump’s White House.
The FDA has long applied rigorous tests to all new nicotine products before licensing them for sale in the United States, including requiring costly studies by manufacturers to detail the population-level effects of their products.
The FDA has wanted to ensure products offer a net benefit to public health by helping smokers switch away from cigarettes without creating new issues, such as a surge in youth use.
Under the pilot, however, the FDA will drop a requirement that manufacturers submit product-specific studies in several areas, according to transcripts of an internal meeting held earlier this month that were seen by Reuters.
Among the changes, manufacturers will no longer need to submit a previously required study of a product’s effectiveness in helping smokers cut back.
The FDA will instead rely on existing general research on nicotine pouches, which users insert under the lip to get a nicotine kick, to answer such questions, the transcripts show.
Reuters previously reported that the FDA was set to fast-track nicotine pouch reviews under the pilot.
On Thursday, the FDA confirmed some details of the program, such as more frequent communication with applicants and shorter review time frames.
But it did not outline the switch from product-specific to more general evidence in key areas.
While still only a test program, the move indicates a potential shift by the FDA towards relaxing aspects of a stringent review process considered to be among the primary barriers to doing business in the world’s largest market for smoking alternatives.
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