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

Vietnam Drafts Administrative Penalties for E-Cigarette Use, Setting Fines up to USD 380
Vietnam Drafts Administrative Penalties for E-Cigarette Use, Setting Fines up to USD 380
Vietnam plans to formalise penalties for e-cigarette and heated tobacco use under a draft decree. Individual users could be fined VND 3–5 million (USD 114–190), while premises allowing use face fines up to VND 10 million (USD 380). Higher penalties apply to business violations.
Dec.25 by 2FIRSTS.ai
RJ Reynolds asks ITC to investigate alleged vape restriction violations by Heaven Gifts network
RJ Reynolds asks ITC to investigate alleged vape restriction violations by Heaven Gifts network
R.J. Reynolds Tobacco Co. has asked the U.S. International Trade Commission to open a Section 337 investigation into Heaven Gifts International — the umbrella company behind Elf Bars and Geek Bars — its subsidiaries and nine U.S. distributors.
Jan.16 by 2FIRSTS.ai
Hungary’s Continental Tobacco Launches New Slay Nicotine Pouch Brand in UK Targeting Female Consumers
Hungary’s Continental Tobacco Launches New Slay Nicotine Pouch Brand in UK Targeting Female Consumers
Hungary’s Continental Tobacco Group has launched its Slay nicotine pouch brand in the UK, featuring compact, pastel-toned packaging and backed by a multi-million-pound investment and retail pilot programme to build its presence in the local market.
Dec.03 by 2FIRSTS.ai
Kentucky to issue provisional state licenses to tobacco, nicotine and vapor retailers who applied before Jan. 1, 2026
Kentucky to issue provisional state licenses to tobacco, nicotine and vapor retailers who applied before Jan. 1, 2026
Kentucky will issue provisional state licenses to tobacco, nicotine and vapor product retailers that applied for a license with the Department of Alcoholic Beverage Control (ABC) before Jan. 1, 2026.
Dec.31 by 2FIRSTS.ai
BAT Japan rolls out limited-edition “Rose Quartz” colourway for glo Hilo, launches new virto click-capsule flavour
BAT Japan rolls out limited-edition “Rose Quartz” colourway for glo Hilo, launches new virto click-capsule flavour
British American Tobacco (BAT) Japan will introduce its first Valentine’s-season limited-edition colourway, “Rose Quartz,” for the glo Hilo heated tobacco device lineup, covering both the glo Hilo and glo Hilo Plus. The devices are priced at JPY 3,980 (about $25.2) and JPY 6,980 (about $44.1), respectively, and will go on sale via official channels from Feb. 9. BAT Japan will also launch a new glo Hilo-compatible virto tobacco stick variant, “virto Bright Cherry Click,” on Feb. 2.
Jan.20 by 2FIRSTS.ai
Polish Government Plans Ban on Flavoured Nicotine Pouches and Disposable E-Cigarettes
Polish Government Plans Ban on Flavoured Nicotine Pouches and Disposable E-Cigarettes
Poland’s government is preparing to amend the Act on Protection of Health from the Consequences of Tobacco Use to ban the sale of flavoured nicotine pouches and disposable e-cigarettes. The Health Ministry says the goal is to protect youth from nicotine addiction, citing World Health Organization data on the risks of such products. However, industry representatives and legal experts argue the proposal is abrupt and could expand the illicit market.
Dec.05 by 2FIRSTS.ai