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

California: Stiiizy hit with another lawsuit alleging high-THC vapes marketed to teens
California: Stiiizy hit with another lawsuit alleging high-THC vapes marketed to teens
A new lawsuit in California state court accuses Stiiizy Inc. of steering high-THC vape products toward teens through youth-appealing branding and weak age verification, alleging the plaintiff’s underage use was followed by cannabis-induced psychosis-related symptoms and significant personal harm.
Feb.06 by 2FIRSTS.ai
Myanmar announces ban on e-cigarettes, covering imports/exports, sales, possession and use
Myanmar announces ban on e-cigarettes, covering imports/exports, sales, possession and use
Myanmar’s Ministry of Health said it has received cabinet authorization to enforce an e-cigarette ban under the Essential Supplies and Services Law, listing prohibited acts including the import, export, sale, possession, storage, carrying, distribution and use of vaping products.
Feb.26 by 2FIRSTS.ai
Kazakhstan Investigates Social-Media Vape Sales Linked to a Banking “Drop” Arrangement
Kazakhstan Investigates Social-Media Vape Sales Linked to a Banking “Drop” Arrangement
Kazakhstan’s Financial Monitoring Agency (AFM) in Ulytau Region is conducting a pre-trial investigation into alleged illegal vape sales and the unlawful acquisition of access to a bank account. Authorities say a Satpayev resident has sold banned devices via social media since 2024 and used a “dropper” arrangement to disguise proceeds.
Jan.27 by 2FIRSTS.ai
Vietnam’s Health Ministry consults on tobacco-control law amendments, proposing an e-cigarette ban
Vietnam’s Health Ministry consults on tobacco-control law amendments, proposing an e-cigarette ban
VTV.vn reports that Vietnam’s Ministry of Health is collecting feedback on a draft amendment to the Law on Prevention and Control of Tobacco Harms, proposing an e-cigarette ban and broader public health protections.
Jan.13 by 2FIRSTS.ai
Product | VOZOL’s New E-Cigarette Appears on Middle East Social Media, Touted at 40,000 Puffs with Dual Mesh Coils and Dual Modes
Product | VOZOL’s New E-Cigarette Appears on Middle East Social Media, Touted at 40,000 Puffs with Dual Mesh Coils and Dual Modes
VOZOL has recently promoted its MAGIC FLEX 40000 e-cigarette on its official Iraq social media account, using mainly Arabic-language posts and listing Baghdad as the account location. The campaign highlights a detachable/separate battery, the ability to switch flavors at will, ECO/POWER dual-mode operation, and a display-based user interface.
Jan.27 by 2FIRSTS.ai
Cyprus customs seizes 269 packs containing cannabis and THC; Pharmacy Department flags unauthorized CBD products
Cyprus customs seizes 269 packs containing cannabis and THC; Pharmacy Department flags unauthorized CBD products
The report says an international operation across EU countries aimed at detecting illicit substances in e-cigarettes also took place in South Cyprus, where multiple e-liquid items and products containing cannabis and THC were seized. It states the operation, titled “eVAPER8,” was conducted by the International Narcotics Control Board (INCB) in November and December to identify e-cigarette liquids that may contain synthetic drugs.
Feb.09 by 2FIRSTS.ai