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

FDA Grants MRTP Orders for 20 ZYN Nicotine Pouches
FDA Grants MRTP Orders for 20 ZYN Nicotine Pouches
The U.S. Food and Drug Administration (FDA) has issued modified risk granted orders to Swedish Match USA for 20 ZYN nicotine pouch products, allowing the already-authorized products to be marketed with a specific claim that using ZYN instead of cigarettes lowers the risk of mouth cancer, heart disease, lung cancer, stroke, emphysema and chronic bronchitis.
Jul.01
Global Tobacco Control Faces Regional Adaptation Test as Nicotine Markets Evolve, Asian Specialist Says
Global Tobacco Control Faces Regional Adaptation Test as Nicotine Markets Evolve, Asian Specialist Says
As e-cigarettes, heated tobacco products and nicotine pouches expand across global markets, a central question is gaining urgency: can tobacco control rely on a universal policy model? In an interview with 2Firsts, Asian public health and addiction medicine specialist Dr. Rashidi Mohamed bin Pakri Mohamed says Western experience remains relevant, but policies must be adapted to local culture, healthcare systems, enforcement capacity, illicit markets and clinical evidence.
Jul.08
Chinese Disposable Brands OXBAR, LYCO Challenge Vuse and JUUL: Pennsylvania’s Pending List Offers a Glimpse of the Future Legal Vape Market
Chinese Disposable Brands OXBAR, LYCO Challenge Vuse and JUUL: Pennsylvania’s Pending List Offers a Glimpse of the Future Legal Vape Market
Pennsylvania’s June 26 ENDS Pending Certifications list previews the state’s future legal vape market, placing Vuse, JUUL and Logic alongside Chinese-linked disposable brands OXBAR and LYCO. Shaped by PMTA eligibility and state rules, the list shows competition shifting from market share to market access.
Special Report
Jul.06
FDA Proposes Foreign Tobacco Factory Registration Rule to Tighten Import Oversight
FDA Proposes Foreign Tobacco Factory Registration Rule to Tighten Import Oversight
The FDA has proposed a rule requiring foreign tobacco manufacturers to register facilities and list products before exporting to the U.S. If finalized, the rule could affect overseas OEM/ODM factories, contract manufacturers, specification developers, bulk product makers, and repackaging or relabeling firms. FDA says the proposal would help identify unauthorized imported tobacco products, including e-cigarettes.
Special Report
Jun.26
Oral Thin-Film Technology Firm CTT Pharma Eyes U.S. Nicotine Product Trials
Oral Thin-Film Technology Firm CTT Pharma Eyes U.S. Nicotine Product Trials
CTT Pharmaceutical Holdings said it has signed a letter of intent with a U.S. company to conduct clinical trials and testing for several potential nicotine products using its patented oral thin-film technology.
Jun.18
Product | BAT Japan Launches virto Bright Peach Click in Japan, Expanding glo Hilo’s Capsule-Based Flavor Portfolio
Product | BAT Japan Launches virto Bright Peach Click in Japan, Expanding glo Hilo’s Capsule-Based Flavor Portfolio
British American Tobacco Japan (BAT Japan) has introduced virto Bright Peach Click, a new heated tobacco stick designed for the glo Hilo system. The product expands the existing virto consumable lineup with a combination of tobacco, menthol and ripe peach flavors, featuring a capsule mechanism that releases additional fruit flavor when activated. The product launched in Japan on July 27, 2026, through glo official online channels, convenience stores and tobacco retailers.
Aug.03