Sesh+ Patented Nicotine Pouches' Premarket Tobacco Product Application (PMTA) Accepted for Review by FDA
DOVER, Del., Oct. 4, 2023 /CNW/ - Sesh Products US, Inc. (Sesh) is pleased to announce that its Premarket Tobacco Product Applications (PMTAs) have been accepted for review by the U.S. Food and Drug Administration (FDA). In compliance with the May 14, 2022, deadline for then-marketed synthetic nicotine products, Sesh submitted a bundled PMTA covering 72 SKUs, all under the brand "Sesh+" brand. These applications have now progressed to the next phase of the PMTA review process.
This significant milestone reflects Sesh's commitment to ensuring product consistency, meeting quality standards, and adherence to federal regulations.
Sesh+ nicotine pouches are designed for adult (21+) users of nicotine products, especially for those who either cannot or opt not to quit nicotine. Sesh has a goal of aiding those adults (21+) who wish to transition from traditional combustible products to potentially less harmful alternatives.
Max Cunningham, CEO of Sesh, on the achievement: "This acceptance is a testament to our dedication in working collaboratively with the FDA throughout the PMTA process. We're committed to providing high-quality, innovative alternatives to adult nicotine consumers. We recognize the need for potentially less harmful alternatives, especially for those adults who cannot or choose not to quit nicotine. Working closely with the FDA is a critical part of our promise to ensure we meet this need responsibly."
Sesh's collaboration with Chemular Inc. ? a renowned scientific and regulatory consulting firm ? has been instrumental in achieving this acceptance.
"Our partnership with Sesh has always been founded on mutual trust and a shared vision of bringing compliant, quality, and innovative products to market," commented Chief Operating Officer of Chemular, Inc., Bryan Burd. "This FDA acceptance only strengthens our commitment to supporting the Sesh team throughout the rest of the PMTA review process."
As the company marks this significant achievement for Sesh, the core mission remains clear: eliminating tobacco-related harm entirely..
About Sesh
Sesh Products US, Inc., a wholly owned subsidiary of Sesh Products Inc., is a leading company in modern oral nicotine products. The Sesh companies strive to offer innovative proprietary alternatives that align with stringent regulatory standards. The company is a proud holder of a granted USPTO patent for its innovative Sesh+ pouch product.
For more information about the companies and Sesh+ range of products, visit www.seshproducts.com
Media Contact
Savannah Burron - savannah@seshproducts.com
SOURCE Sesh Products
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