The Food and Drug Administration plans to start a pilot program to fast-track nicotine pouch authorizations, according to Reuters, citing meeting transcripts seen by the news outlet.
The program aims to finish the review of nicotine pouches from Philip Morris International (PMI), Stamford, Connecticut; Altria, Richmond, Virginia; Reynolds American, Winston-Salem, North Carolina; and Turning Point Brands, Louisville, Kentucky, by December, Reuters reported. The program launched Monday amid pressure from the Trump administration, Reuters reported, citing a transcript from a Friday FDA meeting.
When CSP Daily News reached out for FDA comment, the Department of Health and Human Services (HHS) issued the following statement from Bret Koplow, acting director of the FDA’s Center for Tobacco Products:
“The FDA has long stated that the health risks of tobacco products differ by product type, with some products posing greater health risks than others. We’ve also stated that for adults who smoke, switching completely from cigarettes to nicotine pouch products authorized by FDA may reduce exposure to many harmful chemicals found in cigarettes. FDA is under no pressure—from the administration or agency leadership—to lower its scientific standard or compromise its commitment to protecting public health from the risks posed by tobacco products.”
Reuters said products selected for the pilot include Zyn Ultra, an updated version of PMI’s pouches. Also included are Altria’s On Plus, Reynolds’ Velo mini and Turning Point Brands’ Fre and Alp, Reuters reported.
According to the transcript from Friday’s meeting, Reuters reported that reviewers will focus “only on information essential to start the scientific review of nicotine pouches, core product characterization, manufacturing consistency and stability, and abuse-liability data.”
With cigarettes on the decline, Sam Dashiell, manager, U.S. press office, PMI U.S., told CSP Daily News that “a project of this nature could be a step in the right direction.”
He said that the FDA’s review process for smoke-free products requires “urgent reform, as we have conveyed to administration officials. We encourage efforts toward a workable and timely review for products that are a better choice for legal-age adults that would otherwise use traditional tobacco products, including combustible cigarettes."
New tobacco products must submit a premarket tobacco product application (PMTA) and receive authorization, or a marketing granted order (MGO), from the FDA in order to be legally sold in the United States. In January, the FDA issued MGOs to 20 Zyn nicotine pouch products. PMI bought Zyn maker Swedish Match North America in 2022.
A spokesperson for Turning Point Brands told CSP Daily News, “we have long been supportive of an expedited path to market for reduced risk nicotine products like Fre and Alp nicotine pouches. The FDA’s embrace of a streamlined path to market demonstrates the administration’s continued commitment to efficiency, effectiveness and transparency.”
On the FDA’s decision to fast-track nicotine pouches, a spokesperson for Altria told CSP Daily News that “this approach by the FDA is encouraging and would be a positive development for harm reduction.”
Reynolds declined to comment.
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