The U.S. Food and Drug Administration (FDA) is set to ease research requirements for manufacturers of nicotine pouches under a new pilot scheme, according to internal meeting transcripts. This marks the clearest indication yet of a more relaxed approach to smoking alternatives.

Previously, the FDA required extensive testing for all new nicotine products seeking approval in the United States, including costly studies to assess their impact at a population level. These rules were designed to ensure that such products deliver a net public health benefit—such as helping smokers quit—without creating new risks, particularly among young people.

Under the pilot scheme, however, manufacturers will no longer be required to conduct product-specific studies in several areas. For example, they will not need to provide data on how effectively their products help reduce cigarette consumption. Instead, the FDA will rely on broader research on nicotine pouches, which are placed under the lip to deliver nicotine.

The program will also introduce more frequent communication with applicants and shorter review timelines. Although still in the testing phase, the scheme suggests the FDA may relax elements of its strict review process, which has often been cited as a major barrier for companies entering the U.S. market for smoking alternatives.

Major tobacco companies such as Philip Morris International, Altria and British American Tobacco—whose pouch brands include Zyn, On!, and Velo—stand to benefit from the pilot.

Despite the easing of certain requirements, the FDA has stressed it will continue to uphold rigorous scientific standards. Acting director of the FDA’s Center for Tobacco Products, Bret Koplow, noted that the pilot could also inform future updates to the agency’s review process for other product categories, including vaping devices, where regulatory caution has been greater.

Critics, including two former directors of the Center for Tobacco Products, argue that product-specific studies remain vital. They emphasize that variations in nicotine strength or flavor can influence smoking behaviors and uptake by non-smokers, potentially undermining claims of public health benefit.

Concerns have also been raised about the appeal of pouches to young people, given their discreet usage. While the pilot may ease the regulatory burden on manufacturers, some resource-intensive clinical trials will still be required even under the revised process.