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
F1 Faces Renewed Pressure Over Tobacco and Nicotine Sponsorships as 67 Groups Target ZYN and VELO Ahead of Madrid Race
F1 Faces Renewed Pressure Over Tobacco and Nicotine Sponsorships as 67 Groups Target ZYN and VELO Ahead of Madrid Race
Ahead of the Formula 1 race in Madrid, 67 Spanish and international public-health, medical and consumer organizations have sent an open letter to F1 President and CEO Stefano Domenicali calling for an end to sponsorships linked to the tobacco and nicotine industry, including nicotine pouches, vaping products and heated tobacco. The letter focuses on Philip Morris International’s ZYN partnership with Ferrari and British American Tobacco’s long-running partnership with McLaren and exposure for VELO. The campaign follows a March letter in which more than 160 organizations worldwide made a similar request to Formula 1.
Sep.10
Arizona Turns to a 50% Retail Vape Tax as Tobacco Tax Revenue Falls 47% From 2008
Arizona Turns to a 50% Retail Vape Tax as Tobacco Tax Revenue Falls 47% From 2008
Arizona's First Things First is pushing for an excise tax equal to 50% of the retail price of vaping products, estimating that the measure could generate about $100 million annually. The agency says its tobacco-tax revenue has fallen 47% from 2008 levels. Arizona has attempted to broaden its nicotine tax base in each of the past two years: a 2025 bill proposed a 50% wholesale-price tax, while a 2026 measure shifted to a 50% retail-price tax covering alternative nicotine products and vapor products. Separately, the state enacted HB 4001 this year to establish a new licensing and sales framework for alternative nicotine products.
Sep.21
JTI Liggett Puts U.S. Value Cigarette Brands in Spotlight at 2026 NACS Show
JTI Liggett Puts U.S. Value Cigarette Brands in Spotlight at 2026 NACS Show
At the 2026 NACS Show in Las Vegas, JTI Liggett highlighted its value-priced cigarette portfolio, including LD and Montego, following JT Group's acquisition of Vector Group. The company's U.S. business reported market share gains, with LD sales volume rising 32.6% in the first half of 2026. Meanwhile, Ploom was displayed separately at Altria's booth under an existing partnership. JTI Liggett booth staff told 2Firsts that the company had not yet launched nicotine pouch products in the United States.
EXPO
Oct.09
Wisconsin Vape Directory One Year On: Retailer Reports Four Store Closures and 70% Staff Cuts
Wisconsin Vape Directory One Year On: Retailer Reports Four Store Closures and 70% Staff Cuts
Wisconsin's electronic vaping device directory has been fully enforced for more than a year, and local vape retailers say the reduced range of eligible products has contributed to declining sales, store closures and layoffs. Johnny Vapes owner Ben Hall said he has closed four of seven locations and cut about 70% of his staff. State law bars the sale of vaping devices not listed on the Wisconsin Department of Revenue directory and allows penalties of $1,000 per day for each unlisted device sold or offered for sale. In April 2026, the U.S. Court of Appeals for the Seventh Circuit allowed enforcement of the law to continue.
Regulations
Oct.10
RLX Technology Dropped From FTSE All-World as International Business Reaches 68.5% of Q2 Revenue
RLX Technology Dropped From FTSE All-World as International Business Reaches 68.5% of Q2 Revenue
RLX Technology (NYSE: RLX) has been removed from the FTSE All-World Index, effective September 21. FTSE Russell records show RLX was already part of its global equity index universe by 2022, when its American depositary receipts were classified as China Large Cap securities. Trading volume rose to about 44.77 million shares on September 18, roughly 23 times the previous session's volume. RLX reported RMB1.0105 billion in second-quarter revenue, up 14.8% year over year, with international operations contributing 68.5%. The company also acquired a 51% stake in one of Western Europe's largest distributors of next-generation smoke-free and FMCG products in July.
Sep.22
FDA Unifies Tobacco Registration and Product Listing Form Across Product Categories
FDA Unifies Tobacco Registration and Product Listing Form Across Product Categories
The U.S. FDA has consolidated two tobacco establishment registration and product listing forms into a redesigned Form FDA 3741 covering all regulated product categories, including e-cigarettes, heated tobacco products and nicotine pouches. The current requirements remain limited to domestic establishments. Separately, the FDA has proposed extending registration and product listing requirements to foreign manufacturers, signaling greater regulatory attention to manufacturing entities and product-level information across the tobacco and nicotine supply chain.
FDA
Sep.30
Related Topics
News
Related Read
F1 Faces Renewed Pressure Over Tobacco and Nicotine Sponsorships as 67 Groups Target ZYN and VELO Ahead of Madrid Race
F1 Faces Renewed Pressure Over Tobacco and Nicotine Sponsorships as 67 Groups Target ZYN and VELO Ahead of Madrid Race
Arizona Turns to a 50% Retail Vape Tax as Tobacco Tax Revenue Falls 47% From 2008
Arizona Turns to a 50% Retail Vape Tax as Tobacco Tax Revenue Falls 47% From 2008
JTI Liggett Puts U.S. Value Cigarette Brands in Spotlight at 2026 NACS Show
JTI Liggett Puts U.S. Value Cigarette Brands in Spotlight at 2026 NACS Show
Wisconsin Vape Directory One Year On: Retailer Reports Four Store Closures and 70% Staff Cuts
Wisconsin Vape Directory One Year On: Retailer Reports Four Store Closures and 70% Staff Cuts
RLX Technology Dropped From FTSE All-World as International Business Reaches 68.5% of Q2 Revenue
RLX Technology Dropped From FTSE All-World as International Business Reaches 68.5% of Q2 Revenue
FDA Unifies Tobacco Registration and Product Listing Form Across Product Categories
FDA Unifies Tobacco Registration and Product Listing Form Across Product Categories
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