2ONE Labs Receives Second FDA PMTA 'Acceptance' Notification for Additionally Submitted 2ONE® Branded Nicotine Pouch Products

LAKE TAHOE, Nev., Dec. 03, 2024 (GLOBE NEWSWIRE) -- 2ONE Labs Inc., is pleased to have received 'Acceptance' of a second Premarket Tobacco Product Application (PMTA) for additional flavored 2ONE^® nicotine product styles submitted to the U.S. Food and Drug Administration (FDA).

Welcoming receipt of this additional FDA ‘Acceptance’ notification, Vincent Schuman, CEO of 2ONE Labs, said: “Our strategy has always been to maintain a steady flow of supportable and responsible PMTA submissions for the 2ONE^® nicotine pouch brand that reflect current adult consumer product demands. Our timely PMTA filings with the FDA reflect our company's commitment to remaining at the forefront of product innovation in the nicotine pouch marketplace.

As with our previously 'Accepted' 2ONE^® PMTA submission, this application will move forward to the next stage of FDA review. 2ONE Labs aims to fund these submissions to a successful 'Authorization' by FDA. Our wholesale, retail and sponsorship partners should take confidence in this additional ‘Acceptance’ as a reflection of our ability to manage and navigate the complex PMTA process, and of our commitment to supporting the 2ONE^® brand in the US market.”

Schuman added: “2ONE^® Tobacco-Free nicotine pouches are for adult users (21+), who want to switch from cigarettes, cigars or traditional oral tobacco chewing products. The 2ONE^® brand has been in the market since early 2020 and has helped many thousands of adults move towards a better nicotine offering. We believe adults will continue to seek out 2ONE^® as the best-in-class pouch product it has become. We remain encouraged by FDA’s acceptance of the 2ONE^® PMTA submission, and we look forward to continuing to support the needs of adult consumers making their journey away from tobacco."

2ONE^® nicotine pouch products are offered in a variety of nicotine levels and satisfying flavors at over 20,000+ retail outlets nationwide, including Circle K locations, and can be purchased online by adult consumers at: www.21Pouches.com.

About 2ONE^® Nicotine Pouches

2ONE Labs Inc.: Founded by pioneers in synthetic nicotine production, 2ONE Labs specializes in providing the most innovative tobacco-free nicotine products to adult consumers seeking an alternative to other tobacco products. For more information, contact 21Pouches.com.

2ONE^® is a registered trademark of 2ONE Labs Inc., Lake Tahoe, NV. All Rights Reserved.

Source: 2ONE LABS INC.

Contact: Press@21pouches.com