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

U.S. Expands Illicit Vape Enforcement as ATF Brings PACT Act Powers Into Trade Fraud Task Force
U.S. Expands Illicit Vape Enforcement as ATF Brings PACT Act Powers Into Trade Fraud Task Force
The U.S. Bureau of Alcohol, Tobacco, Firearms and Explosives said on September 23 that it has joined the interagency Trade Fraud Task Force to strengthen enforcement against illegal, misdeclared and smuggled vape and tobacco products. ATF will bring its authority under the Prevent All Cigarette Trafficking Act into the task force, including registration, reporting, shipping and record-inspection requirements covering interstate sales of electronic nicotine delivery systems. ATF said the move will strengthen its ability to trace illicit products from U.S. points of entry through domestic trafficking and distribution networks.
News
Sep.28 by 2Firsts Perspectives
Sweden Threatens EU Tobacco Tax Deal as Nicotine Pouch Duty Dispute Looms Over November 9 Meeting
Sweden Threatens EU Tobacco Tax Deal as Nicotine Pouch Duty Dispute Looms Over November 9 Meeting
Sweden is expected to oppose a European Union proposal to raise minimum tobacco excise duties, Law360 reported on October 26, 2026, citing an EU official. A provisional Council agenda dated October 23 confirms that the tobacco taxation package is scheduled for discussion at the November 9 finance ministers' meeting, where member states will seek a general approach. The proposed reforms would raise minimum taxes on conventional tobacco products and establish EU-wide excise rules for vaping liquids, heated tobacco and nicotine pouches. Sweden supports harmonising tobacco taxation rules but objects to requiring nicotine pouches to bear the same minimum tax burden as certain smoking tobacco products. As EU indirect tax legislation requires unanimous Council approval, Swedish opposition could block the proposal in its current form.
Regulations
Oct.29
Los Angeles Cracks Down on Illicit Flavored Vapes and Counterfeit Goods: 12 Businesses Searched, 24 Arrested, Eight Truckloads Seized
Los Angeles Cracks Down on Illicit Flavored Vapes and Counterfeit Goods: 12 Businesses Searched, 24 Arrested, Eight Truckloads Seized
Los Angeles authorities searched 12 businesses and arrested 24 people during a multi-agency operation targeting illicit flavored vaping products, flavored cigarettes and counterfeit merchandise on October 22, 2026. The Los Angeles County Sheriff's Department said approximately eight tractor-trailer loads of merchandise were seized. Alleged violations involved flavored tobacco sales restrictions, tobacco licensing requirements and counterfeit trademark laws. Local, state and federal agencies participated. Authorities have not disclosed the number, brands or value of vaping products seized. Investigations remain ongoing.
Enforcement
Oct.28
Germany Probes 7.6 Million Illegal Vape Case With Estimated €33.3 Million Tax Loss; Four Chinese Manufacturer Employees Under Investigation, Some Packaging in Enforcement Images Resembles FUMOT Products
Germany Probes 7.6 Million Illegal Vape Case With Estimated €33.3 Million Tax Loss; Four Chinese Manufacturer Employees Under Investigation, Some Packaging in Enforcement Images Resembles FUMOT Products
German prosecutors and customs authorities are conducting a criminal investigation into an alleged cross-border organised vape network. Authorities say that between January 2024 and March 2025, four employees of an unnamed Chinese e-cigarette manufacturer allegedly built a network of sales agents and wholesalers that brought more than 7.6 million nicotine disposable vapes into Germany, causing an estimated €33.3 million in excise-tax losses. The manufacturer has not been named. Some products visible in enforcement images have packaging resembling products from FUMOT’s portfolio. European regulatory records from 2024, FUMOT’s public overseas-sales materials and records involving German vape importer and distribution company Zamu-Pro GmbH also show FUMOT/RandM products and German distribution activity during the period covered by the investigation.
Sep.21
PMI Pushes Smoke-Free Business in Latin America as Argentina Lifts Heated Tobacco Ban, Mexico City Share Tops 7%
PMI Pushes Smoke-Free Business in Latin America as Argentina Lifts Heated Tobacco Ban, Mexico City Share Tops 7%
Philip Morris International (PMI) showcased IQOS heated tobacco systems and nicotine pouch products at Technovation 2026 in Buenos Aires on October 7–8, presenting research on consumer attitudes, regulatory developments and illicit cigarette trade across Latin America. PMI Chief Global Growth Officer Stefano Volpetti said smoke-free products accounted for more than 7% of the Mexico City market. Argentina repealed its heated tobacco ban in May 2026 and introduced registration requirements for tobacco and nicotine products, while local media reported nicotine pouch sales in Mendoza. A PMI-commissioned survey found that only 8% of respondents across four Latin American countries were familiar with nicotine pouches. A separate KPMG study estimated illicit cigarette consumption at 77 billion sticks across 11 markets in Latin America and Canada in 2025.
PMI
Oct.13
U.S. Military Could Test Nicotine Pouches and Vapes for Smoking Cessation as Washington Examiner Cites ZYN and Potential $4 Billion Reduction in Related Defense Costs
U.S. Military Could Test Nicotine Pouches and Vapes for Smoking Cessation as Washington Examiner Cites ZYN and Potential $4 Billion Reduction in Related Defense Costs
The House-passed FY2027 National Defense Authorization Act includes a provision authorizing the defense secretary to conduct a one-year smoking-cessation pilot for active-duty service members. Section 707 lists counseling, nicotine gum and patches alongside what the bill calls "electric nicotine delivery systems," nicotine pouches and heat-not-burn products. A recent Washington Examiner op-ed cited ZYN as an example in arguing for the provision, but the legislation does not name any commercial brand or supplier. ZYN is made by PMI-owned Swedish Match USA, with specified products holding FDA marketing authorizations and modified risk orders.
Sep.20