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

BAT Japan Announces McLaren Collaboration “glo Hilo Plus” Limited-Edition Set, Priced at About USD 200
BAT Japan Announces McLaren Collaboration “glo Hilo Plus” Limited-Edition Set, Priced at About USD 200
British American Tobacco Japan (BAT Japan) announced a collaboration with McLaren Racing to launch the “glo Hilo Plus・McLaren Racing Inspired Limited-Edition Set.” Sales begin on March 3 via the glo Store Ginza and the official glo online store. Based on the “glo Hilo Plus,” the set includes a limited-edition device and dedicated accessories, priced at JPY 30,000 (about USD 200).
Mar.03 by 2FIRSTS.ai
FDA Commissioner Stresses “Predictability” as Science Chief Addresses Industry Uncertainty
FDA Commissioner Stresses “Predictability” as Science Chief Addresses Industry Uncertainty
FDA Commissioner Marty Makary briefly appeared at the February 10 PMTA roundtable, underscoring the importance of regulatory predictability. At the close of the session, Office of Science Director Matthew Farrelly responded to industry concerns over review uncertainty, stating the agency will issue a written summary of feedback, while reiterating that no fixed quantitative risk benchmark governs authorization decisions.
Feb.11
Liverpool City Region Considers Healthier Advertising Rules for Trains, Ferries and Buses — Vapes Included
Liverpool City Region Considers Healthier Advertising Rules for Trains, Ferries and Buses — Vapes Included
The Liverpool City Region is considering a region-wide clampdown on advertising for junk food, sugary drinks and vapes on publicly owned infrastructure. The move is framed as part of a broader push to promote healthier lifestyles and tackle deep-rooted health inequalities, with a particular focus on reducing children’s exposure to harmful marketing in public spaces. The plan is set to go before the Combined Authority on Friday.
Jan.23 by 2FIRSTS.ai
Myanmar announces ban on e-cigarettes, covering imports/exports, sales, possession and use
Myanmar announces ban on e-cigarettes, covering imports/exports, sales, possession and use
Myanmar’s Ministry of Health said it has received cabinet authorization to enforce an e-cigarette ban under the Essential Supplies and Services Law, listing prohibited acts including the import, export, sale, possession, storage, carrying, distribution and use of vaping products.
Feb.26 by 2FIRSTS.ai
PMTA Roundtable Opens with Industry Questioning Product Characterization Standards, FDA Defends Regulatory Boundaries
PMTA Roundtable Opens with Industry Questioning Product Characterization Standards, FDA Defends Regulatory Boundaries
At the opening of FDA’s PMTA roundtable, small ENDS manufacturers warned that unclear product characterization standards are limiting their ability to invest and raise capital. FDA officials acknowledged industry concerns but said regulatory flexibility is constrained by statutory and procedural boundaries.
Feb.11
Alabama Senate Passes SB9 to Ban Vaping in Indoor Public Places
Alabama Senate Passes SB9 to Ban Vaping in Indoor Public Places
Alabama’s Senate approved SB9 by a 31–1 vote, expanding existing indoor smoking restrictions to include vaping in a wide range of public places. The bill keeps the current $25 fine, renames the state’s Clean Indoor Air Act, and now heads to the House. If enacted, it would take effect on Oct. 1, 2026.
Feb.02 by 2FIRSTS.ai