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

Kantar Study Finds More Than 93% of Vape Products in Ukraine Fail Regulatory Requirements
Kantar Study Finds More Than 93% of Vape Products in Ukraine Fail Regulatory Requirements
According to Interfax-Ukraine, a study conducted by market research firm Kantar Ukraine at the request of major tobacco companies found that more than 93% of vape products in Ukraine did not fully comply with regulatory requirements. The research examined product categories, brand distribution and consumer purchasing channels, showing that pod systems and disposable vapes represent major segments of the market, while offline retail remains the dominant purchasing channel. The findings highlight ongoing compliance challenges in Ukraine’s vape market.
Aug.26
2Firsts Data | China’s U.S. Vape Exports Have Yet to Regain Previous Growth Momentum in H1 2026, but Hardware Grew 15.2% and 6-Methyl Nicotine-Related Products Rose 234.7%
2Firsts Data | China’s U.S. Vape Exports Have Yet to Regain Previous Growth Momentum in H1 2026, but Hardware Grew 15.2% and 6-Methyl Nicotine-Related Products Rose 234.7%
China’s vape exports to the U.S. reached approximately $1.58 billion in the first half of 2026, remaining broadly stable from a year earlier but still below previous growth momentum. 2Firsts’ analysis of China Customs data shows that the U.S. market has not simply returned to its previous trajectory after the enforcement shock and inventory-driven swings of 2025. Instead, export momentum is shifting across product categories. Vaping devices and atomization hardware increased 15.2% year over year, while 6-methyl nicotine-related and other nicotine substitute products surged 234.7%. Meanwhile, traditional nicotine-containing vaping products continued to face pressure.
Jul.22
JT Plans ¥800 Billion Investment in Heated Tobacco Over Three Years, Betting on Ploom as Second Growth Engine
JT Plans ¥800 Billion Investment in Heated Tobacco Over Three Years, Betting on Ploom as Second Growth Engine
Japan Tobacco Inc. (JT) CEO Takehiko Tsutsui said the company plans to invest about ¥800 billion (approximately US$5.4 billion) in heated tobacco products over three years through 2028, aiming to establish Ploom as a second growth engine after combustible cigarettes. Tsutsui said Ploom AURA helped JT increase its share of Japan’s heated tobacco market to 15.8% in the first quarter of 2026. Ploom products are now available in 29 markets, with Ploom AURA sold in 25 markets including Japan. JT also plans to continue its cigarette business while positioning its food operations, particularly frozen noodle products in North America, as another growth opportunity.
Jul.23
Product | Vapsolo Launches Sixer 180K, Introducing a 6-in-1 Architecture for Disposable Vapes
Product | Vapsolo Launches Sixer 180K, Introducing a 6-in-1 Architecture for Disposable Vapes
Vapsolo has launched the Sixer 180K, a flagship disposable vape built around a 6-in-1 architecture featuring six independent e-liquid tanks and six dedicated mesh coils. Alongside a claimed up to 180,000 puffs, the new device reflects a broader shift in disposable vape development from increasing puff counts toward modular hardware design and multi-flavor user experience.
Jul.03
Canadian Court Allows Juul and Altria Vape Class Action to Move Forward Over Youth Marketing Claims
Canadian Court Allows Juul and Altria Vape Class Action to Move Forward Over Youth Marketing Claims
A Quebec Superior Court has allowed a class action lawsuit against Juul Labs and Altria Group related to vaping products to proceed, involving allegations concerning marketing practices, youth exposure and corporate responsibility. The ruling only allows the case to move forward and does not represent a finding that Juul or Altria are legally liable. The case highlights continued legal risks facing vape companies regarding product marketing, youth protection and corporate accountability.
Jul.28
Vietnam’s Vape Crackdown Expands From Ban Proposal to Grassroots Enforcement
Vietnam’s Vape Crackdown Expands From Ban Proposal to Grassroots Enforcement
Vietnam tightens e-cigarette rules. Health Ministry proposes banning production, trade, transport, storage, ads, promotion, sponsorship, and use of e-cigarettes, heated tobacco, and new products. Hanoi also urges residents to report illegal activities, showing enforcement moves from lawmaking to local action.
Jul.08