Bantam E-Cigarettes Receives FDA PMTA Approval

Dec.27.2022
Bantam E-Cigarettes Receives FDA PMTA Approval
Bantam receives FDA approval for its PMTA application, allowing its nicotine oil products to proceed to scientific review.

Bantam e-cigarettes have received permission from the US FDA for their pre-market tobacco product application (PMTA). The application for Bantam's non-tobacco nicotine e-liquids will now move to the next stage of the PMTA process, undergoing initial scientific review to confirm that all necessary items are included in the application for the FDA's substantive review.


On May 13th, 2022, Bantam submitted an application to the FDA for non-tobacco nicotine e-liquid and is seeking approval for market release from the organization.


Anthony Dillon, spokesperson for Bantam, stated that receiving this acceptance letter reflects Bantam's efforts to provide high-quality, science-based e-liquids for adult consumers while also maintaining our responsibility to restrict access and usage of these products by young people. Bantam continues to support the necessary regulation of e-liquids based on scientific evidence and is proud of our various PMTA advancements. We remain confident in the quality, consistency, and scientific foundation of our products.


Prior to the submission focused on non-tobacco nicotine, Bantam submitted a PMTA for tobacco-derived e-liquids to the FDA in September 2020. The application underwent scientific review in August 2021 and is currently still under FDA consideration.


Earlier this year, this e-liquid manufacturer received an exemption from the United States Postal Service (USPS), allowing the company to ship its e-liquid products to specific e-cigarette retailers and distributors across the United States.



Disclaimer

This article is provided solely for professional research, industry discussion, and informational purposes. Any references to brands, companies, products, technologies, or policies are made for factual reporting and analytical purposes only, and do not constitute endorsement, recommendation, promotion, or advertising by 2Firsts.

Nicotine-containing products, including but not limited to cigarettes, e-cigarettes, heated tobacco products, and nicotine pouches, carry significant health risks. Readers are responsible for complying with all applicable laws and regulations in their respective jurisdictions, including age restrictions and access limitations.

The information contained in this article should not be regarded as investment, legal, medical, regulatory, or commercial advice. While 2Firsts strives to ensure the accuracy and reliability of its content, it does not assume liability for any direct or indirect loss arising from errors, omissions, inaccuracies, or reliance on the information contained herein.

This article is not intended for individuals below the legal age for accessing tobacco or nicotine-related information in their jurisdiction.

 

Copyright Notice

This article is either original content produced by 2Firsts or content reproduced, translated, summarized, or adapted from third-party sources with attribution where applicable. The intellectual property rights of the original content remain with 2Firsts or the respective original rights holders.

No individual or organization may copy, reproduce, distribute, republish, modify, translate, or otherwise use this content without prior authorization. Any unauthorized use may result in legal action.

For copyright-related inquiries, corrections, or removal requests, please contact: info@2firsts.com.

 

AI-Assisted Translation and Editing Notice

Portions of this article may have been translated, edited, or reviewed with the assistance of artificial intelligence tools to improve efficiency and readability. Due to the limitations of AI-assisted translation and editing, discrepancies, omissions, or inaccuracies may exist when compared with the original source.

Where applicable, readers are advised to refer to the original source for the most complete and accurate information. If you identify any errors or believe that any content infringes upon your rights, please contact us at info@2firsts.com, and we will review and address the matter promptly.

India Steps Up Nicotine Pouch Enforcement as ZYN, White Fox Circulate and Drug Panel Urges Halt to New Nicotine Formulations
India Steps Up Nicotine Pouch Enforcement as ZYN, White Fox Circulate and Drug Panel Urges Halt to New Nicotine Formulations
India's Ministry of Health and Family Welfare has directed states to step up enforcement against nicotine pouch sales, citing increased availability through online and offline channels and concern about nicotine exposure among children. Reuters reported that international brands including ZYN and White Fox are being sold in India. A study led by ICMR-NICPR found pouches in seven of 10 surveyed locations and identified 68 brands and 445 flavors online. Separately, India's Drugs Technical Advisory Board recommended in August that no new nicotine formulation be approved.
Regulations
Sep.28 by 2Firsts Perspectives
IVG Parent Secures HMRC Excise Warehouse and Duty Stamp Approvals Ahead of UK Vape Tax
IVG Parent Secures HMRC Excise Warehouse and Duty Stamp Approvals Ahead of UK Vape Tax
Acme Vape Ltd, the company behind UK vaping brand IVG, has received HM Revenue & Customs approval to operate an excise warehouse for vaping products and participate in the Vaping Duty Stamps Scheme. The UK's Vaping Products Duty will take effect on October 1, 2026, at a flat rate of £2.20 per 10ml of vaping liquid. Acme Vape Ltd says its approved warehouse in Preston will become operational under the new regime on the same date.
Regulations
Sep.18 by 2Firsts Perspectives
Product | JTI Introduces Fully Dissolvable PERLZ Nicotine Pearls in UK, Expands Range From 30-Pearl Dispensers to 10-Pearl Sachets
Product | JTI Introduces Fully Dissolvable PERLZ Nicotine Pearls in UK, Expands Range From 30-Pearl Dispensers to 10-Pearl Sachets
Japan Tobacco International (JTI) has introduced PERLZ nicotine pearls in the UK, expanding its oral nicotine portfolio beyond conventional nicotine pouches. The fully dissolvable, multi-layer pearls are placed under the tongue and come in Mint and Berry flavors at concentrations of 1mg/g and 2mg/g, equivalent to approximately 0.3mg and 0.5mg of nicotine per pearl. UK retailer Haypp published four 30-pearl dispenser listings on July 31, 2026, followed by three 10-pearl sachet products on August 17. The dispensers retail for £6.50, while the sachets cost £2.50.
product
Oct.12
On-Site Report | After FDA Announces Review of PMTA Framework, CTP Director Details Reform Priorities
On-Site Report | After FDA Announces Review of PMTA Framework, CTP Director Details Reform Priorities
FDA CTP Director Bret Koplow used his FDLI keynote in Washington to outline how the agency is rethinking the PMTA framework. He discussed category-specific review, nicotine pouch and sPMTA pilots, AI-assisted review, a 70% reduction in pending applications, and a major staffing constraint: CTP currently has only nine scientific review teams. He also reaffirmed tobacco harm reduction while stressing youth protection, flavored products, risk communication, and the challenge of unauthorized e-cigarettes.
Regulations
Oct.06
Special Report | Can Nicotine Be Replaced? 6-MN Is Already on the Market While Key Human Evidence Is Still Missing
Special Report | Can Nicotine Be Replaced? 6-MN Is Already on the Market While Key Human Evidence Is Still Missing
Nicotine analogues such as 6-methylnicotine are already appearing in e-cigarettes and oral pouches, even as key human evidence remains limited. A new Nixodine-S study adds nonclinical data showing differences from nicotine in cytotoxicity and receptor activity, while independent studies point to a more complex toxicological picture. With supply-chain activity growing and FDA seeking clearer authority over nicotine analogues, the industry now faces a larger question: what evidence is needed before these substances can credibly replace nicotine?
SCIENCE
Sep.23
US ITC Judge Finds Glas Infringed Two JUUL Vape Patents, Recommends Restrictions on Related Imports——Glas Received FDA Marketing Authorization for Four Vape Pods in May 2026; Proposed Restrictions Remain Under Commission Review
US ITC Judge Finds Glas Infringed Two JUUL Vape Patents, Recommends Restrictions on Related Imports——Glas Received FDA Marketing Authorization for Four Vape Pods in May 2026; Proposed Restrictions Remain Under Commission Review
A U.S. International Trade Commission (USITC) administrative law judge issued an initial determination on October 20, 2026, finding that certain Glas vaping devices, cartridges and components infringed 12 claims across two patents asserted by JUUL, constituting a violation of Section 337 of the Tariff Act of 1930. The judge recommended a limited exclusion order and a cease and desist order against the Glas respondents. Five months earlier, the FDA authorized four Glas e-cigarette pods, including mango, blueberry and two menthol variants. The patent investigation concerns device and cartridge structures and is separate from FDA premarket review. The proposed import restrictions have not become final, and their product-level scope remains unresolved.
company
Nov.05