The FDA recently launched a pilot program which aims to “increase efficiency and streamline the review process for premarket tobacco product applications (PMTAs) for nicotine pouch products,” the agency said.
FDA said its 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.”
“We hope this creates urgency within FDA to expedite all outstanding PMTAs and inform retailers which products can and cannot be sold,” said Anna Ready Blom, strategic advisor to NACS.
The FDA said 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.”
“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,” the agency said.
Tobacco companies have previously had to wait years for their products to be cleared. In January 2025, FDA authorized the marketing of 20 Zyn nicotine pouch products through the PMTA pathway after an extensive scientific review—“the first time the agency has authorized products commonly referred to as nicotine pouches.”
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