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

UK PM Andy Burnham Shifts Business Rates Policy, Supporting Hospitality While Raising Pressure on Vape Shops
UK PM Andy Burnham Shifts Business Rates Policy, Supporting Hospitality While Raising Pressure on Vape Shops
UK Prime Minister Andy Burnham’s government is adjusting business rates policy to support hospitality businesses while some other sectors, including vape retailers, face higher operating cost pressures. According to Streamline Feed, AJ Bell and other reports, the policy shift reflects a redistribution of business rate burdens as the government seeks to support sectors facing economic pressure. For UK vape shops, the change comes amid a broader regulatory environment shaped by the disposable vape ban, the upcoming Vaping Products Duty and increased compliance requirements.
News
Jul.24
Nicotine Pouches Gain Ground in U.S. Convenience Stores as Vape Unit Sales Fall 14%
Nicotine Pouches Gain Ground in U.S. Convenience Stores as Vape Unit Sales Fall 14%
According to convenience retail publication CStore Decisions, U.S. convenience store tobacco categories are undergoing a structural shift. Based on Circana OmniMarket Total U.S. Convenience data for the 52 weeks ending June 14, 2026, cigarettes remained the largest category with $50.8 billion in sales, but unit sales declined 5.3%. Electronic smoking devices and vaping products also declined, while modern oral nicotine products continued to grow, with nicotine pouch sales rising 29% in dollars and 17% in units. Retailers said changing consumer preferences are reshaping tobacco product assortments at convenience stores.
Regulations
Aug.07
JUUL2 Sued Within a Week of FDA Authorization as AJ Marketing Alleges Infringement of Programmable Vape Patent
JUUL2 Sued Within a Week of FDA Authorization as AJ Marketing Alleges Infringement of Programmable Vape Patent
Less than a week after JUUL2 received U.S. FDA marketing authorization on August 28, 2026, JUUL Labs was sued for patent infringement in federal court in Delaware. AJ Marketing LLC filed the complaint on September 3, alleging that both JUUL 1 and JUUL2 infringe U.S. Patent No. 8,851,068 B2. The patent covers aspects of programmable electronic vaporization devices, including controls over dose delivery, usage frequency and operating parameters. The plaintiff is seeking reasonable royalties and ongoing royalties tied to the remaining life of the patent. JUUL has not yet publicly responded to the case.
Sep.10
PMI CEO Attends Opening of IQOS Global Flagship in Tokyo’s Ginza as 1,814 Limited ILUMA i PRIME Sets Launch
PMI CEO Attends Opening of IQOS Global Flagship in Tokyo’s Ginza as 1,814 Limited ILUMA i PRIME Sets Launch
IQOS opened its first global flagship, IQOS Flagship Ginza, in Tokyo on September 4, 2026, replacing the former IQOS Store Ginza after nearly a decade of operation. The new location expands conventional product retail into member lounges, digital experiences, art installations and brand programming. IQOS also launched a Ginza-exclusive IQOS ILUMA i PRIME set limited to 1,814 individually numbered units, priced at JPY11,980, or about US$77. PMI Sales Strategy Consultant Yuji M. later said on LinkedIn that more than 500 people had lined up from the night before the opening.
Sep.07
Major U.S.  Vape Distributor Demand Vape Pays at Least $300,000 for White House Lobbying Amid Enforcement Pressure
Major U.S. Vape Distributor Demand Vape Pays at Least $300,000 for White House Lobbying Amid Enforcement Pressure
New York vape distributor Ecto World, which operates as Demand Vape, hired political consultant Roger Stone to lobby the Executive Office of the President on regulation of vaping and related products while facing state enforcement and multiple lawsuits. Public lobbying disclosures show that Ecto World paid at least $300,000 for the work through June 30, 2026. Separately, New York State announced in March that more than 28,500 pounds of vaping products tied to the company had been seized, while New York City and the state have pursued legal or enforcement actions. Public records do not show that the lobbying directly changed any specific regulatory or enforcement outcome.
Sep.08
Charlie’s Says 30 PACHA Vape SKUs Tentatively Identified for FDA’s Non-Priority Enforcement Public List
Charlie’s Says 30 PACHA Vape SKUs Tentatively Identified for FDA’s Non-Priority Enforcement Public List
Charlie’s Holdings said the U.S. Food and Drug Administration notified the company on June 23, 2026, that 30 PACHA vape SKUs with submitted PMTAs had been tentatively identified for inclusion on a planned public-facing FDA webpage. Under enforcement guidance issued by FDA in May, the webpage is intended to identify certain unauthorized products for which the agency generally does not intend to prioritize enforcement of premarket authorization requirements. Charlie’s disclosed the development alongside second-quarter revenue of $3.8 million, up 116% year over year.
Aug.25