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

Dec.05.2024

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

References:

[1] 2ONE Labs Receives Second FDA PMTA 'Acceptance' Notification for Additionally Submitted 2ONE® Branded Nicotine Pouch Products

Also Read:

[1] U.S. nicotine pouch brand 2ONE Labs says 2ONE® gains FDA “approval”

#North America #United States #Nicotine-free e-cigarettes #Major companies

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

British Museum Ends Long-Running Sponsorship with Japan Tobacco International

According to The Guardian, the British Museum has ended its 15-year sponsorship with Japan Tobacco International after government inquiries into whether the deal breached WHO tobacco-control rules. Critics had long opposed the partnership, while the museum said sponsorship remains essential for its financial stability and public access.

Nov.20

Trump Signs H.R.5371: FDA to Deploy $200 Million for ENDS Enforcement

President Donald Trump signed the Continuing Appropriations Act, 2026 (H.R.5371) on November 12, Section 772 of Part B—the Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act (S.2256)—requires the FDA to allocate no less than $200 million in tobacco user fees to enforce regulations against illegal e-cigarettes, vapes, and other ENDS products. At least $2 million of this funding supports a federal multi-agency task force targeting products originating from the China.

Nov.14 by 2FIRSTS.ai

R.J. Reynolds Seeks Dismissal of “Carbon Neutral” Lawsuit over Vuse E-Cigarette Claims

R.J. Reynolds Vapor Co. has moved to dismiss a class-action lawsuit alleging false “carbon neutral” claims for its Vuse e-cigarettes, arguing its statements were based on independent certifications from Verra and Vertis, not misleading consumers.

Oct.23 by 2FIRSTS.ai

Product | Airis, Kangvape and HAYATI Launch Christmas-Themed E-cigarettes in UK and US Online Markets

As the Christmas holiday season approaches in Europe and North America, e-cigarette brands such as Airis, Kangvape and HAYATI have successively launched Christmas special editions featuring festive-themed designs and selected limited-time flavors, which are now available through online channels in both the United States and the United Kingdom.