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

Product | Labeled “Built in the USA” Up to 60,000 Puffs: DOJO PUREX 60K Launches on U.S. Sales Channels
Product | Labeled “Built in the USA” Up to 60,000 Puffs: DOJO PUREX 60K Launches on U.S. Sales Channels
DOJO unveiled the PUREX 60K e-cigarette at TPE 2026 held in Las Vegas, United States. The product is labeled “Built in the USA,” supports up to 60,000 puffs, and features 16ml e-liquid capacity, a 1000mAh battery, and ECO and SMART output modes. It has gone live on DOJO’s official website and select U.S. online sales channels at a price of $18.99.
Apr.07 by 2FIRSTS.ai
Seoul to Fine Use of Liquid E-Cigarettes in No-Smoking Areas From April 24
Seoul to Fine Use of Liquid E-Cigarettes in No-Smoking Areas From April 24
Seoul will begin fining the use of all tobacco products, including liquid e-cigarettes, in no-smoking areas from April 24, when the revised Tobacco Business Act takes effect.
Apr.09 by 2FIRSTS.ai
Poland Seizes 223,688 Disposable Vapes Without Required Excise Marks
Poland Seizes 223,688 Disposable Vapes Without Required Excise Marks
Poland’s Customs and Tax Service in Łódź carried out an inspection at a property near Zgierz and seized 223,688 disposable e-cigarettes without the required excise markings.
Apr.07 by 2FIRSTS.ai
Special Report| War continues to shape the Ukrainian tobacco market
Special Report| War continues to shape the Ukrainian tobacco market
Four years into the war, Ukraine’s tobacco market is being reshaped by stress-driven consumption, tax pressure, youth e-cigarette use and a growing illicit segment. Surveys point to rising tobacco and nicotine product use, while higher excise duties and shadow trade are adding new complexity to the market.
Apr.17
Virginia Restricts Vape Sales to Products Listed in State Directory From April 1
Virginia Restricts Vape Sales to Products Listed in State Directory From April 1
From April 1, vape shops in Virginia may sell only liquid nicotine and vapor products listed in the state directory. The Office of the Attorney General has recommended that commonwealth attorneys begin enforcing the 2024 law.
Apr.02 by 2FIRSTS.ai
AIR Romania Manufacturing Facility Expected to Begin Operations in Q1 2027
AIR Romania Manufacturing Facility Expected to Begin Operations in Q1 2027
AIR Limited announced on May 7, 2026, that it plans to open a new manufacturing facility of approximately 70,000 square feet in Stefanesti, Bucharest North, Romania. The facility is expected to begin operations by the first quarter of 2027. AIR said that once fully operational, the facility is expected to support more than 150 jobs and be capable of producing more than 4,000 tons of flavored shisha molasses each year.
May.08 by 2FIRSTS.ai