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