The U.S. Food and Drug Administration has launched a pilot program aimed at streamlining reviews of premarket tobacco product applications (PMTAs) for nicotine pouches.

The new initiative comes as nicotine pouches continue to gain market share in the United States, driven by rising adult demand for non-combusted alternatives to cigarettes, according to an agency press release.

FDA officials said the pilot reflects the agency’s recognition of the “continuum of risk” across tobacco products, where combustibles such as cigarettes are typically the most harmful while oral, smoke-free products such as nicotine pouches present comparatively lower risks.

Under the pilot, FDA reviewers will concentrate on the most critical scientific elements needed to determine whether marketing a product is “appropriate for the protection of public health.”

The agency stated that the process will include greater real-time interaction with applicants, including early requests for clarification and opportunities to address deficiencies before the review closes. The goal is to shorten timelines and reduce the number and severity of formal deficiency letters.

FDA said this “case-by-case” approach is designed to increase transparency for manufacturers while preserving the rigorous science-based evaluation that underpins the PMTA process.

The FDA noted evidence that nicotine pouches can help some adults switch away from more harmful tobacco products, with complete switching or significant reduction in cigarette use potentially reducing exposure to toxicants. Still, the agency said each product must be assessed not only for its potential benefit to smokers but also for risks to non-users and the population as a whole.

The move comes amid growing attention to unintentional nicotine pouch exposures among children. FDA recently urged manufacturers to incorporate child-resistant packaging and other safeguards, citing reported cases of accidental ingestion requiring hospitalization.

To date, FDA has authorized 20 nicotine pouch products for sale in the U.S., including several under the market-leading Zyn brand, while hundreds of other products remain under review or on the market without authorization.