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

Oct.30.2024

U.S. nicotine pouch brand 2ONE Labs announces its product 2ONE® has received Premarket Tobacco Product Application (PMTA) “approval” from the FDA, marking its progression to the next stage in the FDA review process.

2ONE Labs announced on October 29 that its 2ONE® brand of nicotine pouches has received approval from FDA for its Pre-Market Tobacco Product Application (PMTA), according to Globe Newswire.

Translation into English: Nicotine pouch brand "2ONE" from 2ONE Labs | Image source: 2ONE Labs official website

After receiving the “approval” notification from the FDA, 2ONE Labs CEO Vincent Schuman stated:

“This signifies that the PMTA application for 2ONE® has advanced to the next critical phase of the FDA review process. Our company will continue to provide financial backing to ensure the successful completion of this submission. Our wholesale, retail, and sponsorship partners should view this ‘approval’ as a testament to our ability to navigate the complex PMTA process and our firm commitment to supporting the long-term availability of the 2ONE® brand in the U.S. market.”

“The 2ONE® nicotine pouches were developed for adult users (21+) who face challenges transitioning from combustible tobacco or traditional oral tobacco products to alternative options. Over the past five years, the 2ONE® brand has garnered market attention and growth, thanks to strong distribution partnerships like those with CircleK®. FDA’s approval of 2ONE®’s PMTA application is exciting, and we look forward to continuing to support adult consumers seeking alternatives to traditional tobacco products.”

References:

[1] 2ONE Labs, 미 식품의약국 (FDA)담배 제품 센터로부터 2ONE® 니코틴 파우치 브랜드에 대한 PMTA '승인' 획득

Also Read:

[1] Lawsuit Filed Against Imperial Brands Over Trademark Infringement

[2] NFL player Baker Mayfield caught using nicotine pouches on the field

[3] The Rise of Nicotine Pouches Among Young Adults

[4] San Francisco Prosecutor David Chiu Sues Four Online Tobacco Retailers

#North America #United States #Market #Nicotine-free e-cigarettes

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

PMI Launches VEEV E-Cigarette in South Africa, Expanding Access to Smoke-Free Alternatives

Philip Morris International's South Africa branch launches e-cigarette product Veev, making South Africa one of 20 countries with PMI's smoke-free products.

Oct.13 by 2FIRSTS.ai

WHO Chief Warns of E-Cigarette Threat to Youth as COP11 Opens in Geneva

More than 1,400 delegates from 162 Parties convened in Geneva on November 17 for the Eleventh Session of the Conference of the Parties (COP11) to the WHO Framework Convention on Tobacco Control (WHO FCTC). WHO Director-General Tedros Adhanom Ghebreyesus opened the session with a stark warning: tobacco and nicotine companies are targeting schools as the “new front line” to recruit a generation of addicts through e-cigarettes and nicotine pouches.

Nov.18 by 2FIRSTS.ai

U.S. FDA Includes Cytisinicline for Vaping Addiction in National Priority Voucher Program, Shortens Review to 1–2 Months

The U.S. Food and Drug Administration (FDA) has added Cytisinicline, a plant-based therapy developed by Achieve Life Sciences for nicotine vaping addiction, to its new National Priority Voucher (CNPV) program. The initiative shortens drug review timelines from 10–12 months to just 1–2 months, expediting approval for treatments that address major public health needs.

Oct.20 by 2FIRSTS.ai

KT&G Unveils lil hybrid 3.0 Misty Rose Limited Edition, Limited to 20,000 Devices

KT&G has launched the limited-edition “lil hybrid 3.0 Misty Rose Edition” heated tobacco device in South Korea, betting on year-end consumer demand with a gradient rose-colored design. The release is capped at 20,000 units and is available through both online and offline channels, with an official retail price of 78,000 won (approximately USD 53).