Sesh Products US Inc.'s Nicotine Pouch Bundled PMTA Advances to FDA Substantive Scientific Review Phase

Application Covering 64 SKUs Clears FDA Filing Review, Poised to Enter the Final Regulatory Phase Prior to a Marketing Order Decision

AUSTIN, Texas--(BUSINESS WIRE)--Sesh Products US, Inc. (Sesh) today announced that the U.S. Food and Drug Administration (FDA) has determined that its bundled Premarket Tobacco Product Application (PMTA) submission, covering 64 SKUs, meets the filing requirements for new tobacco products seeking a marketing order under section 910(c)(1)(A)(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The bundled PMTA for Sesh Products US Inc. is now filed, and, effective as of the date of the FDA's filing letter, poised for entry into the substantive scientific review phase of the PMTA process.

This filing determination means that the FDA's Center for Tobacco Products (CTP) has determined the application is sufficiently complete to proceed to substantive review — the final stage of the PMTA process before a marketing order decision is issued. Sesh's bundled PMTA covers its Sesh+ line of nicotine pouches across a range of varieties, nicotine strengths, and packaging configurations designed for adult (21+) nicotine 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. 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. Sesh looks forward to addressing any questions the agency may have during the substantive review process to come."

About the PMTA Process

Established under the Family Smoking Prevention and Tobacco Control Act, the PMTA process requires manufacturers to demonstrate that permitting the marketing of a new tobacco product is appropriate for the protection of public health. A filing decision is a threshold determination that an application is complete enough for substantive review; it does not reflect an FDA evaluation of the adequacy of the data contained in the PMTA and does not constitute a marketing order.

About Sesh

Sesh Products US, Inc., a wholly owned subsidiary of Sesh Products Inc., develops modern oral nicotine products for adult consumers. The company holds a granted USPTO patent on its Sesh+ pouch technology and has an active presence across major U.S. convenience retail chains. For more information, visit www.seshproducts.com.