2ONE Labs Receives PMTA ‘Acceptance’ for 2ONE® Nicotine Pouch brand from FDA Center for Tobacco Products
LAKE TAHOE, Nev., Oct. 29, 2024 (GLOBE NEWSWIRE) — 2ONE Labs Inc., is pleased to announce the ‘Acceptance’ of its Premarket Tobacco Product Application (PMTA) submission by the U.S. Food and Drug Administration for its 2ONE® branded nicotine pouches.
Acknowledging receipt of the FDA ‘Acceptance’ notification, Vincent Schuman, CEO of 2ONE Labs, said: “This means the 2ONE® PMTA application will now move forward to the next important stage of FDA review. Our company will continue to fully fund this submission to a successful conclusion, and our wholesale, retail and sponsorship partners should take confidence in this ‘Acceptance’ as a sign of our ability to navigate this complex PMTA process, and of our unwavering commitment to support the long-term availability of the 2ONE® brand in the US market.”
Schuman added: “We created 2ONE® nicotine pouches for adult users (21+), who find it challenging to switch from combustible or traditional oral tobacco-leaf products. The availability of the 2ONE® brand in the market over the past 5 years, and the interest and growth our brand has achieved through strong retail partnerships, such as with CircleK®, has shown it is possible – even for innovative companies – to identify and introduce unique brands that truly offer adults the perfect switching product. We are encouraged by FDA’s acceptance of the 2ONE® PMTA submission and we look forward to continuing to support the needs of adult consumers switching from tobacco.”
2ONE® nicotine pouch products are offered in a variety of nicotine levels and satisfying flavors at over 18,000 retail outlets nationwide, and can be purchased online by adult consumers at: 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:
Vincent@21pouches.com
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