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 | Full-screen display and 10K puffs: IVG launches new Pro-series pod vape in the UK
Product | Full-screen display and 10K puffs: IVG launches new Pro-series pod vape in the UK
E-cigarette brand IVG has recently rolled out the IVG Pro 2 across several UK online retailers. The device is compatible with IVG Pro pods and comes in 33 flavours with nicotine strengths of 0mg, 10mg and 20mg. Channel listings show a 2ml prefilled pod paired with a 10ml refill container, with pricing around £9.99.
Feb.02 by 2FIRSTS.ai
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
Nicotine pouch brand SNÜ launches three fruit flavours, keeps “rub-and-smell” label to reduce retail shrink
Nicotine pouch brand SNÜ launches three fruit flavours, keeps “rub-and-smell” label to reduce retail shrink
UK nicotine pouch brand SNÜ has added three new flavours—Wild Cherry, Cherry Cola and Tropical Punch—spanning multiple nicotine strengths from 9mg to 60mg. The new products also retain the brand’s “rub-and-smell” packaging feature, designed to let shoppers preview the aroma without opening the can and help lower in-store product loss.
Feb.02 by 2FIRSTS.ai
Philippine FDA Requires Licenses for Vape Products with Medical Claims
Philippine FDA Requires Licenses for Vape Products with Medical Claims
The Philippine Food and Drug Administration has announced that establishments selling vaporized nicotine and non-nicotine products and novel tobacco products with medicinal or therapeutic claims must secure Licenses to Operate. Such products are also required to be registered as pharmaceutical products through the Center for Drug Regulation and Research. The FDA urged stakeholders to comply with the new requirements to ensure product safety, efficacy and quality.
Dec.22 by 2FIRSTS.ai
Korea’s MFDS sets 2026 plan to manage and disclose harmful constituents in tobacco products
Korea’s MFDS sets 2026 plan to manage and disclose harmful constituents in tobacco products
South Korea’s Ministry of Food and Drug Safety (MFDS) said it has established its 2026 work plan to systematically manage harmful constituents in tobacco products and disclose related information under the Tobacco Harmfulness Management Act, which took effect in November 2025.
Jan.16 by 2FIRSTS.ai
BAT Expects Around 2% Revenue and Operating Profit Growth in FY25
BAT Expects Around 2% Revenue and Operating Profit Growth in FY25
British American Tobacco (BAT) reaffirmed its 2026 guidance while announcing a £1.3 billion (approximately USD 1.65 billion) share buyback for FY26. The company expects around 2% growth in revenue and adjusted profit from operations for FY25. Accelerating New Category growth, driven by Velo Plus and improving U.S. Vuse performance, is expected to deliver double-digit H2 revenue growth.
Dec.09 by 2FIRSTS.ai