Zyn is currently the dominant pouch brand in the US. Photo credit: Aphis Marta, CC4.0.
The US Food and Drug Administration (FDA) has launched a high-stakes pilot program to fast-track nicotine pouch premarket tobacco product applications (PMTA) from some of the industry’s most influential players, a move that could shift the balance in the fastest-growing segment of the next generation nicotine market.
According to internal transcripts reviewed by Reuters, FDA plans to decide by December on submissions from Philip Morris International, Altria, Reynolds American (a unit of British American Tobacco), and Turning Point Brands. The expedited timeline marks a significant change from years-long delays that have frustrated manufacturers and slowed product launches.
PMI’s Zyn, now the dominant pouch brand in the US, was authorized only this January after a 5-year process. Products chosen for the pilot include PMI’s upcoming Zyn Ultra, which, according to rivals, has been delayed to their benefit while PMI has been awaiting FDA authorization, and Alp, a pouch line backed by media personality Tucker Carlson and manufactured by Turning Point Brands.
Agency officials acknowledged “pressure from leadership, including at the White House,” to speed up the review process. Still, Bret Koplow, acting director of FDA’s Center for Tobacco Products, emphasized that the agency would not cut corners on scientific evaluation.
Public health advocates remain skeptical. “There should be no shortcuts when it comes to our kids’ health,” said Yolonda Richardson, c.e.o. of the Campaign for Tobacco-Free Kids, warning of potential youth appeal.
For manufacturers, expedited decisions could mean quicker legal launches and relief from uncertainty over the status of popular pouches already on the market without FDA authorization. That would reduce enforcement risks and provide distributors and retailers with a clearer understanding of the compliance landscape.
The White House has not issued any public comment. Campaign finance records indicate that Reynolds American recently contributed US$10 million to the Trump-aligned super PAC Make America Great Again Inc. Industry lobbying in Washington has increased, with companies pushing for a faster and more predictable regulatory pathway for entering the U.S. market.
Nicotine pouches are growing faster than any other tobacco product category in the US, the world’s largest reduced risk nicotine market. While seen as one of the lowest risk options because they avoid combustion and tobacco, critics still raise concerns about their appeal to new users. FDA officials noted at a meeting on September 5 that current data does not indicate significant youth uptake.
Unfortunately, smaller pouch producers that have PMTA under review – many of which were accepted before the brands being fast-tracked - may now be forced to wait even longer to receive a decision on their applications.
Austin, Texas-based Sesh, for example, prioritized regulatory compliance early on. FDA accepted its PMTA covering 72 stock-keeping units (SKU) in October 2023, and they are still under review. Sesh also recently secured more than US$40 million in funding to support its US expansion. Now, the company has been moved further down the line.