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

Imperial Brands launches ZONE nicotine pouches in the UK, covering the core 9–12 mg strength segment

Imperial Brands has launched its ZONE nicotine pouches in the UK, targeting the mainstream 9–12 mg nicotine strength segment. The brand debuts with five flavours at a recommended retail price of £6.50 per can. Mint variants currently account for around 70% of UK nicotine pouch sales, while fruit flavours are growing rapidly. ZONE will be distributed primarily through independent retail channels.

Nov.18 by 2FIRSTS.ai

Arizona e-cigarette shops ordered to pay $460,000 for selling tobacco and nicotine products to minors

Arizona Attorney General Kris Mayes announced Pro Source Supply LLC, Pro Source Vapes LLC, Pro Source CBD LLC, and owner Timothy Kell must pay $460,000 in restitution tied to a lawsuit filed last year alleging illegal sales of tobacco and nicotine products to underage buyers.

Jan.07 by 2FIRSTS.ai

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

Lao Shuts Down Nearly 300 Online Vape Stores in Joint Crackdown with WHO and Meta

In a coordinated effort with the World Health Organization (WHO) and Meta, the Lao Ministry of Health has taken 288 online e-cigarette stores with more than 759,599 members offline, reinforcing the country’s total ban on e-cigarettes under the National Tobacco Control Law.