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

KT&G Approves Plan to Establish Guatemala Branch as First Local Base in Central and South America
KT&G Approves Plan to Establish Guatemala Branch as First Local Base in Central and South America
KT&G has approved a plan to establish a branch in Guatemala, which will serve as its first local base in Central and South America. The company is currently preparing office space, staffing, and operating systems. KT&G said the branch is intended to secure a regional distribution base and will focus on local channel management and new sales channel expansion. Meanwhile, overseas cigarette revenue in 2025 exceeded the domestic share for the first time.
Mar.09 by 2FIRSTS.ai
Special Report|FDA Revises Device Name in Glas Vape Authorization; Company Signals Optimism on Menthol, Flavored Pods
Special Report|FDA Revises Device Name in Glas Vape Authorization; Company Signals Optimism on Menthol, Flavored Pods
The FDA updated public records on the PMTA authorization of a Glas vape product, renaming “Glas G Device” to “Glas G² Device” and releasing the order letter detailing scientific review and marketing restrictions. Company disclosures suggest the platform may include age-verification technology. If confirmed, Glas G² could be the first vape with device-level age verification to receive an FDA MGO. Glas executives also said menthol and other flavored pods could gain authorization in the future.
Special Report
Mar.14
South Dakota Legislature Approves Two Nicotine Licensing Bills Pending Governor’s Decision
South Dakota Legislature Approves Two Nicotine Licensing Bills Pending Governor’s Decision
The South Dakota Legislature gave final approval on Tuesday to two proposals requiring state licenses for businesses that sell nicotine products. Under the bills, wholesalers, distributors and retailers of nicotine products in the state would need to be licensed by the government.
Mar.12 by 2FIRSTS.ai
Belarus Official Says Full Vape Ban Is Not Advisable Due to Supply Risks From Russia
Belarus Official Says Full Vape Ban Is Not Advisable Due to Supply Risks From Russia
A Belarusian Interior Ministry official said on March 18 at a press conference on preventing dependence on electronic smoking systems that a full ban on vapes is not appropriate in Belarus at this stage.
Mar.19 by 2FIRSTS.ai
Thailand police seize 17,320 disposable vapes valued at over USD 22,330 in Nonthaburi
Thailand police seize 17,320 disposable vapes valued at over USD 22,330 in Nonthaburi
Thai authorities arrested a 31-year-old man in Bang Bua Thong, Nonthaburi, on January 20, 2026, and seized 17,320 disposable e-cigarettes and a pickup truck. The seized goods were valued at more than THB 7 million (about USD 223,349.62).
Jan.21 by 2FIRSTS.ai
2Firsts Interview with Glas |Why a California ENDS Company Believes Its Age-gated Flavored Vape Could Be Next in Line for FDA Authorization
2Firsts Interview with Glas |Why a California ENDS Company Believes Its Age-gated Flavored Vape Could Be Next in Line for FDA Authorization
As the FDA advances efforts to streamline its PMTA review process, including support for small businesses, expectations are rising that additional product authorizations may follow. Age-verification technology is emerging as a key consideration in future approvals.In this interview, California-based Glas discusses its G2 platform, integrating smartphone-based identity verification, proximity controls and anti-counterfeit systems, and outlines its positioning under the FDA’s PMTA framework.
Mar.02