By Timothy S. Donahue
Top Takeaways:
- Regulatory update: FDA accepted Sesh’s 64-SKU nicotine pouch PMTA for thorough review.
- Independent push: Sesh is an independent U.S.-based company seeking full authorization.
- Next phase: Applications now proceed to scientific review, the final step before a decision.
Sesh Products US has cleared a key regulatory hurdle in the FDA’s premarket process, with its nicotine pouch application moving to the final review stage.
The company said the U.S. Food and Drug Administration determined its bundled premarket tobacco product application (PMTA), covering 64 SKUs, meets filing requirements, allowing the submission to move forward to scientific review.
The filing determination confirms that FDA’s Center for Tobacco Products found the application “sufficiently complete to proceed to substantive review”—the final step before the agency decides whether to issue marketing orders.
The PMTA covers Sesh’s Sesh+ line of nicotine pouches, including various flavors, nicotine strengths, and packaging options intended for adult consumers.
“Clearing filing review is a meaningful step in a rigorous regulatory process,” said Max Cunningham, CEO of Sesh. “It reflects years of scientific work and our ongoing collaboration with FDA.”
Cunningham stated that the company aims to join a select group of authorized products in the category.
“We’re committed to seeing this through to a marketing order and to being one of the few independent, U.S.-based brands that has built a genuine regulatory foundation in this category,” he said.
The company stated it will keep working with regulators during the review. “Sesh looks forward to addressing any questions the agency may have during the substantive review process to come,” Cunningham said.
The company has been granted a United States Patent and Trademark Office patent for its Sesh+ pouch technology and maintains an active presence across major U.S. convenience retail chains.
