By Timothy S. Donahue
Key Takeaways:
- FDA to pilot faster nicotine pouch reviews: Four major tobacco firms will have products assessed under an expedited program aiming for decisions by December.
- White House pressure cited: Officials acknowledged pressure from Trump administration leadership to accelerate reviews, though FDA says scientific standards remain intact.
- Industry stakes high: Authorization could clear legal uncertainty for market leaders and speed new launches such as PMI’s Zyn Ultra.
The U.S. Food and Drug Administration launched a pilot program Monday to fast-track reviews of nicotine pouches from three of the world’s largest tobacco companies and another independent major player. Industry insiders are calling the action an unprecedented move that could reshape the fast-growing market for oral nicotine products.
According to transcripts of internal meetings reviewed by Reuters, the agency intends to complete its review of submissions from Philip Morris International, Altria, British American Tobacco (BAT)owned Reynolds American, and Turning Point Brands by December.
Tobacco companies have long criticized the FDA’s slow pace in authorizing next-generation nicotine products, with some waiting years for decisions. PMI’s Zyn pouches, now the category leader, only received marketing authorization in January after a five-year review.
The products set to be fast-tracked include: Swedish Match/PMI (ZYN Ultra), Helix Innovations/Altria Group (on! and on! PLUS), R.J. Reynolds) (Velo mini), and Turning Point Brands (Fre and media personality Tucker Carlson’s pouch brand, Alp).
The FDA informed staff that it was facing “pressure from leadership, including at the White House” to expedite pouch applications, according to media reports. Bret Koplow, acting director of the Center for Tobacco Products, stated during an August staff meeting that the program would not compromise the agency’s scientific standards.
“There should be no shortcuts when it comes to our kids’ health,” countered Yolonda Richardson, CEO of the Campaign for Tobacco-Free Kids, underscoring concerns about potential youth uptake.
Industry interest in the pilot is high. Authorization would not only allow faster legal launches for new products but also clear up doubts about the legality of popular pouches already on sale without FDA approval. This could lower enforcement risks and give retailers and distributors more certainty.
The White House hasn’t commented on the transcripts, but filings show BAT’s Reynolds American recently contributed $10 million to Trump-aligned super PAC Make America Great Again Inc. Industry lobbying has increased in recent months, with companies advocating for a faster and more predictable FDA process.
Nicotine pouches continue to be the fastest-growing tobacco product in the U.S., the world’s largest reduced-risk market. They are generally seen as safer alternatives to smoking because they contain nicotine but not tobacco leaf, and are used without inhalation. FDA officials mentioned during Friday’s meeting that current evidence does not suggest significant youth adoption.
For the industry, the stakes are clear: a faster regulatory process could solidify market positions before a wave of new entrants arrives, while giving the FDA a chance to see if streamlined reviews can maintain public health standards while increasing speed.
Unfortunately, smaller pouch producers that have PMTAs 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, moved early on regulatory compliance. The FDA accepted its PMTAs covering 72 stock-keeping units (SKUs) in October 2023, and those remain under review. Sesh also recently secured more than $40 million in funding to fuel its U.S. Expansion. Now, the company has been pushed further back in the line.
