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
Pennsylvania Lists 163 Vape Products Eligible for Sale, Including Vuse and JUUL; Previously Pending Chinese Brands Such as OXBAR Remain Absent, While Unlisted Products Including Geek Bar Face Enforcement From October 19
Pennsylvania Lists 163 Vape Products Eligible for Sale, Including Vuse and JUUL; Previously Pending Chinese Brands Such as OXBAR Remain Absent, While Unlisted Products Including Geek Bar Face Enforcement From October 19
Pennsylvania begins enforcing its electronic nicotine delivery system (ENDS) directory restrictions on October 19, 2026. The October 18 directory contained 163 product records from seven manufacturers, including Vuse, JUUL, NJOY, Logic and Naked 100. Geek Bar, RAZ and Lost Mary were absent. BAT, Altria, Japan Tobacco and JUUL collectively accounted for 112 records, or 68.7%, while Imperial Brands' blu had no listings. The directory included 15 disposable vape records, 40 bottled e-liquids and 10 products labeled 0mg, but no open-system refillable devices. Twenty-two manufacturer certifications remained under review. Four Logic models corresponding to Smoore's pending records were listed under the brand owner, while LYCO, OXBAR and Boulder/Rock had no approved directory entries.
Regulations
Oct.19
Special Report | How Capital Is Reassessing the Global Tobacco and Modern Nicotine Industry: Lessons from a New York Forum
Special Report | How Capital Is Reassessing the Global Tobacco and Modern Nicotine Industry: Lessons from a New York Forum
Capital is reassessing the global tobacco and modern nicotine industry as heated tobacco, vaping and nicotine pouches reshape demand, profitability and regulation. At the 2026 New Approaches Summit in New York, investors and analysts examined whether smoke-free growth can sustain earnings, how regulation shapes startup value, and whether shareholder engagement can be more effective than divestment. The debate points to a broader shift: tobacco transition is increasingly becoming a capital-allocation, governance and valuation question.
Capital Markets
Oct.05
South Korea Constitutional Court Upholds Volume-Based E-Liquid Tax, With Challenged Rates at KRW 370 and KRW 628 per Milliliter
South Korea Constitutional Court Upholds Volume-Based E-Liquid Tax, With Challenged Rates at KRW 370 and KRW 628 per Milliliter
South Korea's Constitutional Court has upheld fixed taxes on nicotine-containing e-cigarette liquids based on solution volume, ruling that challenged provisions imposing KRW 370 per milliliter in individual consumption tax and KRW 628 per milliliter in tobacco consumption tax do not violate the Constitution. The cases stemmed from historical disputes involving importers that reported nicotine as being extracted from tobacco stems rather than leaves. South Korea has since broadened its tobacco definition to include synthetic nicotine, while current tax laws provide reduced rates for certain products not derived from tobacco.
Sep.18
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
Sweden Finds ZYN Ingredient Labels Noncompliant Over Generic Flavoring Disclosure, Swedish Match Faces SEK 2 Million Monthly Penalty
Sweden Finds ZYN Ingredient Labels Noncompliant Over Generic Flavoring Disclosure, Swedish Match Faces SEK 2 Million Monthly Penalty
Sweden's Public Health Agency has found ingredient labels on ZYN nicotine pouches sold by Philip Morris International subsidiary Swedish Match to be noncompliant, according to Dagens industri. The products' packaging listed 10 to 13 ingredients, compared with 11 to 42 in regulatory submissions, with multiple flavoring ingredients grouped under the generic term "aromer." The agency ordered corrective action, warning of a conditional penalty of SEK 2 million per month for noncompliance. The order applies only to products manufactured after the decision becomes legally effective and does not require recalls. Swedish Match disputes the agency's interpretation and plans to appeal.
PMI
Oct.22
Reynolds Showcases Vuse Pro Flavors and VELO Nicotine Pouches at NACS Show 2026
Reynolds Showcases Vuse Pro Flavors and VELO Nicotine Pouches at NACS Show 2026
Reynolds American, a BAT subsidiary, showcased four Vuse Pro flavored e-cigarette pods and its VELO nicotine pouch portfolio at NACS Show 2026. Booth staff confirmed to 2Firsts that the Vuse Pro flavors are sold in the U.S., although they have not received FDA marketing authorization. BAT outlined plans to expand Vuse retail distribution and reported that VELO held a 30.5% year-to-date volume share of the U.S. modern oral nicotine category through August 2026. The booth also featured the newly launched VELO MAX range and merchandising displays combining cigarettes, vaping products and oral nicotine brands.
EXPO
Oct.09
Related Topics
News
Related Read
Pennsylvania Lists 163 Vape Products Eligible for Sale, Including Vuse and JUUL; Previously Pending Chinese Brands Such as OXBAR Remain Absent, While Unlisted Products Including Geek Bar Face Enforcement From October 19
Pennsylvania Lists 163 Vape Products Eligible for Sale, Including Vuse and JUUL; Previously Pending Chinese Brands Such as OXBAR Remain Absent, While Unlisted Products Including Geek Bar Face Enforcement From October 19
Special Report | How Capital Is Reassessing the Global Tobacco and Modern Nicotine Industry: Lessons from a New York Forum
Special Report | How Capital Is Reassessing the Global Tobacco and Modern Nicotine Industry: Lessons from a New York Forum
South Korea Constitutional Court Upholds Volume-Based E-Liquid Tax, With Challenged Rates at KRW 370 and KRW 628 per Milliliter
South Korea Constitutional Court Upholds Volume-Based E-Liquid Tax, With Challenged Rates at KRW 370 and KRW 628 per Milliliter
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
Sweden Finds ZYN Ingredient Labels Noncompliant Over Generic Flavoring Disclosure, Swedish Match Faces SEK 2 Million Monthly Penalty
Sweden Finds ZYN Ingredient Labels Noncompliant Over Generic Flavoring Disclosure, Swedish Match Faces SEK 2 Million Monthly Penalty
Reynolds Showcases Vuse Pro Flavors and VELO Nicotine Pouches at NACS Show 2026
Reynolds Showcases Vuse Pro Flavors and VELO Nicotine Pouches at NACS Show 2026
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