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

Product | Philip Morris Korea Launches TEREA Limona Pearl, Expanding Fresh Blend Capsule Lineup to Five
Product | Philip Morris Korea Launches TEREA Limona Pearl, Expanding Fresh Blend Capsule Lineup to Five
Philip Morris Korea launched TEREA Limona Pearl in South Korea on August 31, 2026, expanding the TEREA Fresh Blend capsule tobacco stick lineup from four variants to five. Designed for the IQOS ILUMA series, the new stick combines a capsule with what the company calls a Fresh Filter. Philip Morris Korea describes the product as offering an aromatic, refreshing flavor profile with a cooling sensation, with an additional fresh note released when the capsule is crushed. The recommended retail price is KRW 4,800 per pack, with sales through IQOS stores and convenience stores nationwide. No reliable evidence has been found that the same Limona Pearl SKU was previously officially launched in another major IQOS market.
Sep.01
KT&G’s Lil Strengthens Market Lead in Korea as Heated Tobacco Share Reaches 47.4%
KT&G’s Lil Strengthens Market Lead in Korea as Heated Tobacco Share Reaches 47.4%
According to South Korea’s UpKorea, KT&G’s heated tobacco brand Lil reached a 47.4% share of Korea’s heated tobacco stick market in the first quarter of 2026. The company is expanding its next-generation products (NGP) business through product development, technology investment and overseas growth. KT&G reported NGP sales of 890.1 billion won (approximately US$650 million) in 2025, up significantly from 279.3 billion won in 2020. Lil products are now available in 34 markets, while KT&G continues building its technology portfolio through patents and multiple product platforms.
Jul.23
As Regulators Focus on Nicotine Pouch Child Safety, Safeguard Pursues an External Packaging Route
As Regulators Focus on Nicotine Pouch Child Safety, Safeguard Pursues an External Packaging Route
As regulators pay closer attention to child safety in nicotine pouches, manufacturers face a practical challenge: how to strengthen child-resistant packaging without unnecessarily reworking products, production lines and regulatory submissions already in place. In a written interview with 2Firsts, Chemular detailed Safeguard’s external packaging approach, its customer-specific testing requirements and possible PMTA pathways. The model remains early-stage, but it offers a new way to think about an increasingly important regulatory and manufacturing issue.
Industry Insight
Sep.19
Product | PMI Japan Launches SENTIA Passion Fruit Capsule, Expanding the IQOS ILUMA Flavor Portfolio
Product | PMI Japan Launches SENTIA Passion Fruit Capsule, Expanding the IQOS ILUMA Flavor Portfolio
Philip Morris Japan (PM Japan) has introduced SENTIA Passion Fruit Capsule, a new tobacco stick designed for the IQOS ILUMA heated tobacco platform. Featuring a crush-activated capsule, the product combines menthol with passion fruit flavor to provide an additional flavor experience. The product launched in Japan from August 3, 2026, through IQOS official channels, convenience stores and tobacco retailers.
Aug.04
FDA Authorizes Four More Nicotine Pouches as Review Pilot Expands Beyond Initial Decisions
FDA Authorizes Four More Nicotine Pouches as Review Pilot Expands Beyond Initial Decisions
The FDA has authorized four additional on! nicotine pouches, bringing the U.S. total to 30. The decision marks another outcome of the agency’s nicotine pouch review pilot, whose communication and review practices are now being applied more broadly across the category. It also extends Helix’s authorized portfolio from on! PLUS to the earlier on! line. Yet all FDA-authorized nicotine pouches still come from subsidiaries of PMI or Altria, underscoring how concentrated U.S. regulatory access remains.
Aug.05
From Border-Logistics Insiders to Retail Service Stations, Australia Mounts a Sweeping Crackdown on the Illicit Nicotine Trade as iGET Vapes Surface in A$80 Million Crime Networks
From Border-Logistics Insiders to Retail Service Stations, Australia Mounts a Sweeping Crackdown on the Illicit Nicotine Trade as iGET Vapes Surface in A$80 Million Crime Networks
Australian authorities have disclosed two major enforcement actions that go beyond product seizures and retail closures to examine how illicit tobacco and vape networks operate. On Aug. 14, the Multi Agency Strike Team said seven people had been charged and two criminal networks were valued by authorities at a combined A$80 million, or about US$56.8 million. Investigators allege the groups used bonded warehouses, freight businesses and “trusted insiders” in legitimate industries to circumvent border controls. In a separate operation on Aug. 11, more than 100 service stations were targeted as authorities sought information on illicit tobacco importation, distribution networks and the movement of sales proceeds.
Aug.17