Home
Company
Product
Regulation
China
Data
Exhibition
Interview
中文版
Home
Company
Product
Regulation
China
Data
Exhibition
Interview
中文版
Search

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

Oct.30.2024
U.S. nicotine pouch brand 2ONE Labs says 2ONE® gains FDA “approval”
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.

 

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

China Tobacco Regulation Shift：Policy Updates and Market Impact
China Tobacco Regulation Shift：Policy Updates and Market Impact
R.J. Reynolds Vapor Company Launches Flavored Vuse Pro Pods in U.S. Without FDA Marketing Authorization
R.J. Reynolds Vapor Company Launches Flavored Vuse Pro Pods in U.S. Without FDA Marketing Authorization
R.J. Reynolds Vapor Company has begun selling four flavored Vuse Pro pods — Peach, Berry, Watermelon and Fresh Mint — in Ohio and selected other U.S. markets. According to the Vuse U.S. FAQ, Vuse Pro contains approximately 5.0% nicotine by weight, and Vuse Pro pre-filled pods are intended for use with Vuse Alto devices. Reynolds told 2Firsts that product labeling lists an e-liquid capacity of 2.0 mL per pod. The Vuse Alto Power Unit received FDA marketing authorization in 2024, while the new Vuse Pro pods themselves have not received marketing granted orders. The rollout follows the FDA’s May 2026 revision of enforcement priorities for certain unauthorized vaping products with qualifying pending applications.
BAT
Sep.10
UK Vape Tax Countdown: Retailer Vape HQ Estimates 100ml E-liquid Prices Could Rise From £12.99 to £39.39, While Pod Kits Increase Less Than 10%
UK Vape Tax Countdown: Retailer Vape HQ Estimates 100ml E-liquid Prices Could Rise From £12.99 to £39.39, While Pod Kits Increase Less Than 10%
The UK’s Vaping Products Duty (VPD), scheduled to take effect in October 2026, is prompting retailers to assess how different vape categories may be affected. UK retailer Vape HQ has estimated potential price changes under the new volume-based tax system, showing that 100ml shortfill e-liquids could see prices rise from around £12.99 to £39.39, a 203% increase, while 2ml prefilled pod vape kits could rise from £5.99 to £6.52, an increase of about 9%. The estimates highlight how a volume-based tax structure creates uneven cost impacts across product categories.
Aug.19
Product | Philip Morris Japan Launches Ginza-Exclusive IQOS ILUMA i PRIME, Limited to 1,814 Units at First Global Flagship
Product | Philip Morris Japan Launches Ginza-Exclusive IQOS ILUMA i PRIME, Limited to 1,814 Units at First Global Flagship
Philip Morris Japan (PMJ) launched the IQOS ILUMA i PRIME Ginza Limited Model Set in Tokyo on September 4, 2026, alongside the opening of IQOS Flagship Ginza, the brand’s first global flagship store. The Oasis Blue edition is limited to 1,814 individually numbered units, with the figure derived from the store’s address at Ginza 1-8-14. The set also includes two Yamanaka-nuri glasses and special packaging, priced at JPY 11,980 and sold exclusively at the Ginza flagship.
Sep.07
U.S. Ninth Circuit Upholds FDA Denial of MH Global’s Flavored Vape PMTA Applications
U.S. Ninth Circuit Upholds FDA Denial of MH Global’s Flavored Vape PMTA Applications
The U.S. Court of Appeals for the Ninth Circuit upheld the FDA’s denial of MH Global LLC’s applications to market flavored electronic nicotine delivery systems (ENDS). The court ruled that FDA’s comparative-efficacy framework, which requires applicants to show that flavored products provide greater cessation or switching benefits than tobacco-flavored alternatives, is consistent with the Tobacco Control Act’s “appropriate for the protection of the public health” standard. The court also found that FDA was not required to establish the framework through notice-and-comment rulemaking.
Aug.26
Huabao International Buys Indonesian HNB Manufacturer for RMB 90 Million, Adding OEM/ODM Capacity
Huabao International Buys Indonesian HNB Manufacturer for RMB 90 Million, Adding OEM/ODM Capacity
Huabao International Holdings Limited will acquire 100% of PT Broad Far Indonesia through two wholly owned subsidiaries for approximately RMB 90 million. The Indonesian company manufactures and sells heat-not-burn tobacco sticks and provides OEM/ODM services. The sellers are part of a related-party group controlled by Huabao International Chair and controlling shareholder Zhu Linyao. PT Broad Far Indonesia generated $4.37 million in revenue and $177,000 in profit after tax in the first half of 2026, while net assets stood at about $326,000 at June-end. An independent valuer assessed the company’s equity at approximately RMB 93.06 million. Following completion, the HNB manufacturing operation will be consolidated into Huabao International.
News
Sep.29 by 2Firsts Perspectives
Japan Survey Finds 49.5% Would Cut Tobacco Use if Prices Rise, 64.6% Show Interest in Nicotine-Free Alternatives
Japan Survey Finds 49.5% Would Cut Tobacco Use if Prices Rise, 64.6% Show Interest in Nicotine-Free Alternatives
A September online survey commissioned by Japanese smoking-accessories company Lightec found that 49.5% of respondents would consider reducing tobacco use if prices rose further, while 25.1% would consider switching to cheaper brands and 14.5% would consider using or combining alternatives such as vapes and nicotine-free herbal sticks. Another 64.6% expressed some level of interest in such alternatives. The survey covered 1,088 respondents aged 20 to 70 and was conducted by a company that sells NICOLESS nicotine-free vaping and herbal-stick products, meaning its findings should not be treated as representative of Japan's smoking population.
DATA
Oct.12
Related Topics
News
Related Read
R.J. Reynolds Vapor Company Launches Flavored Vuse Pro Pods in U.S. Without FDA Marketing Authorization
R.J. Reynolds Vapor Company Launches Flavored Vuse Pro Pods in U.S. Without FDA Marketing Authorization
UK Vape Tax Countdown: Retailer Vape HQ Estimates 100ml E-liquid Prices Could Rise From £12.99 to £39.39, While Pod Kits Increase Less Than 10%
UK Vape Tax Countdown: Retailer Vape HQ Estimates 100ml E-liquid Prices Could Rise From £12.99 to £39.39, While Pod Kits Increase Less Than 10%
Product | Philip Morris Japan Launches Ginza-Exclusive IQOS ILUMA i PRIME, Limited to 1,814 Units at First Global Flagship
Product | Philip Morris Japan Launches Ginza-Exclusive IQOS ILUMA i PRIME, Limited to 1,814 Units at First Global Flagship
U.S. Ninth Circuit Upholds FDA Denial of MH Global’s Flavored Vape PMTA Applications
U.S. Ninth Circuit Upholds FDA Denial of MH Global’s Flavored Vape PMTA Applications
Huabao International Buys Indonesian HNB Manufacturer for RMB 90 Million, Adding OEM/ODM Capacity
Huabao International Buys Indonesian HNB Manufacturer for RMB 90 Million, Adding OEM/ODM Capacity
2Firsts Perspectives
Japan Survey Finds 49.5% Would Cut Tobacco Use if Prices Rise, 64.6% Show Interest in Nicotine-Free Alternatives
Japan Survey Finds 49.5% Would Cut Tobacco Use if Prices Rise, 64.6% Show Interest in Nicotine-Free Alternatives
FOLLOW US ON SOCIAL MEDIA
Contact: info@2firsts.com
Stay up to date.
Submit your email to receive weekly newsletter on the most relevant news of the e-cigarette industry.
© 2026 2FIRSTS. All Right Reserved.
2FIRSTS is only accessible to industry practitioners, researchers, media and other professionals. Access by minors is prohibited.
This website provides services to users outside the Chinese mainland.
English
English
中文