September 18, 2025

This month, FDA launched a pilot program that aims to increase efficiency and streamline the review process for premarket tobacco product applications (PMTAs) for nicotine pouch products. This initiative represents a significant step forward in FDA's commitment to improving regulatory efficiency while upholding the agency’s rigorous scientific standards for tobacco product review.

The pilot program is based on the understanding that the health risks for different tobacco products exist on a spectrum – sometimes referred to as a “continuum of risk.” For example, existing data indicate that products that are combusted (such as cigarettes) are typically the most harmful to health, while non-combusted tobacco products (such as FDA authorized nicotine pouches) can generally pose lower health risks. There is evidence that nicotine pouches can help some adults switch away from more harmful tobacco products, and adults who significantly reduce their cigarette use or fully switch from smoking cigarettes to using a lower-risk alternative tobacco product could generally reduce their health risks and exposure to toxic and cancer-causing chemicals. FDA will ultimately consider available evidence to assess impact of the applicant products to users, non-users and the population as a whole.

FDA’s case-by-case review of individual applications will increase efficiency by focusing review on the most critical elements for this product category to determine whether permitting the marketing of a product is appropriate for the protection of the public health. The pilot will feature increased real-time communication between FDA and applicants with the goal of providing more frequent feedback and shorter review timeframes. As part of the pilot, FDA intends to have ongoing conversations with applicants to discuss missing information or request clarification with the hope to address issues sooner or at least limit the number and severity of issues included in a deficiency letter at the conclusion of the evaluation.

In light of a steady rise in the reported cases of accidental nicotine pouch exposures in young children that has led to hospitalization, FDA recently urged manufacturers to incorporate child-resistant packaging or other measures to mitigate the risk of accidental exposure to children.

The pilot program is an example of FDA’s ongoing commitment to ensuring all new tobacco products marketed in the United States undergo science-based review. For adults who smoke and want to switch to a nicotine pouch product, this pilot will potentially result in a wider variety of authorized nicotine pouches from which to choose.