2ONE Labs Announces PMTA Submission Update, Nicotine Pouch Products Receive FDA 'Acceptance' Again

Dec.05.2024
2ONE Labs Announces PMTA Submission Update, Nicotine Pouch Products Receive FDA 'Acceptance' Again
Nicotine pouch brand 2ONE Labs Inc. has announced that it has received an 'Acceptance' notification from FDA for its second Pre-market Tobacco Application (PMTA) submission for the 2ONE® nicotine-flavored products.

LAKE TAHOE, Nev., Dec. 03, 2024-- 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."

 

Source: GLOBE NEWSWIRE

We welcome news tips, article submissions, interview requests, or comments on this piece.

Please contact us at info@2firsts.com, or reach out to Alan Zhao, CEO of 2Firsts, on LinkedIn


Notice

1.  This article is intended solely for professional research purposes related to industry, technology, and policy. Any references to brands or products are made purely for objective description and do not constitute any form of endorsement, recommendation, or promotion by 2Firsts.

2.  The use of nicotine-containing products — including, but not limited to, cigarettes, e-cigarettes, nicotine pouchand heated tobacco products — carries significant health risks. Users are responsible for complying with all applicable laws and regulations in their respective jurisdictions.

3.  This article is not intended to serve as the basis for any investment decisions or financial advice. 2Firsts assumes no direct or indirect liability for any inaccuracies or errors in the content.

4.  Access to this article is strictly prohibited for individuals below the legal age in their jurisdiction.

 

Copyright

 

This article is either an original work created by 2Firsts or a reproduction from third-party sources with proper attribution. All copyrights and usage rights belong to 2Firsts or the original content provider. Unauthorized reproduction, distribution, or any other form of unauthorized use by any individual or organization is strictly prohibited. Violators will be held legally accountable.

For copyright-related inquiries, please contact: info@2firsts.com

 

AI Assistance Disclaimer

 

This article may have been enhanced using AI tools to improve translation and editorial efficiency. However, due to technical limitations, inaccuracies may occur. Readers are encouraged to refer to the cited sources for the most accurate information.

We welcome any corrections or feedback. Please contact us at: info@2firsts.com

Imperial Brands to Close Langenhagen Cigarette Factory by 2027
Imperial Brands to Close Langenhagen Cigarette Factory by 2027
Imperial Brands said it will gradually close the Reemtsma factory in Langenhagen near Hanover by 2027 after efforts to find a buyer failed to produce a sustainable agreement. The factory has produced cigarettes since 1971 and currently affects around 600 employees. The company said it had examined all realistic options over recent months but did not receive a binding offer from a potential buyer.
Mar.27 by 2FIRSTS.ai
Illegal Trade in Tobacco and E-Cigarettes Continues to Rise in Germany, BVTE and BDZ Call for Enforceable Regulation
Illegal Trade in Tobacco and E-Cigarettes Continues to Rise in Germany, BVTE and BDZ Call for Enforceable Regulation
BVTE and BDZ said at a joint press conference in Berlin on March 10 that illegal trade in tobacco products, e-cigarettes and other nicotine products continues to grow in Germany, posing challenges to the rule of law, youth protection, consumer protection and state fiscal authority. The groups said there is still no reliable overall statistic for the illegal trade in tobacco products, e-cigarettes, nicotine pouches and oral nicotine products.
Mar.12 by 2FIRSTS.ai
Belgium Calls for EU-Wide Limits on Vape Ingredients and Ban on Disposable E-Cigarettes
Belgium Calls for EU-Wide Limits on Vape Ingredients and Ban on Disposable E-Cigarettes
Belgian Health Minister Frank Vandenbroucke has called on the European Union to take stronger action on vaping, saying it is becoming an “epidemic” and accusing the industry of targeting young people.
Mar.26 by 2FIRSTS.ai
Korean Vape Retailers Warn of Possible Store Closures After New Tobacco Rules Take Effect
Korean Vape Retailers Warn of Possible Store Closures After New Tobacco Rules Take Effect
South Korea’s revised Tobacco Business Act will take effect on April 24, bringing synthetic nicotine liquid vapes into the legal definition of tobacco and subjecting both retailers and manufacturers to formal regulation.
Apr.13 by 2FIRSTS.ai
Russian Vape GOST Revision Would Limit Capacity, Packaging Design and Warning Labels
Russian Vape GOST Revision Would Limit Capacity, Packaging Design and Warning Labels
Russia is preparing changes to its e-cigarette state standard GOST R 58109–2018. Under a draft order submitted to Rosstandart, the shelf life of vape devices and liquids would be limited to no more than two years, and capacity would be strictly capped at 2 mL for replaceable capsules, 10 mL for disposable systems and 30 mL for refill containers.
Apr.27 by 2FIRSTS.ai
Exclusive|Logistics Operators Warn of Possible New U.S. Border Crackdown on Illicit Vapes
Exclusive|Logistics Operators Warn of Possible New U.S. Border Crackdown on Illicit Vapes
Recent inspections and cargo disruption have led some logistics operators in the China-U.S. vape trade to see early signs of another U.S. border crackdown on illicit e-cigarettes. With late April to early May viewed as a key risk window, the market is watching closely. The bigger question is not only whether enforcement will tighten, but whether it can be sustained.
Special Report
Apr.09