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.

Ispire Reports Fiscal Q3 2026 Revenue of $18.7 Million and Net Loss of $9.5 Million
Ispire Reports Fiscal Q3 2026 Revenue of $18.7 Million and Net Loss of $9.5 Million
Ispire Technology reported financial results on May 7, 2026, for the third quarter of fiscal 2026, covering the three months ended March 31, 2026. Revenue was $18.7 million, compared with $26.2 million in the third quarter of fiscal 2025 and $20.3 million in the prior quarter. Gross profit was $2.0 million, with gross margin of 10.7%. Net loss was $9.5 million, or $0.17 per share. The company said it held $18.0 million in cash as of March 31, 2026, up $468,000 sequentially.
May.08 by 2FIRSTS.ai
FDA Foreign Tobacco Registration Proposal Could Strengthen ENDS Import Oversight, Azim Chowdhury Says
FDA Foreign Tobacco Registration Proposal Could Strengthen ENDS Import Oversight, Azim Chowdhury Says
FDA’s proposed rule requiring foreign tobacco manufacturers to register establishments and list products is more than routine paperwork, Keller and Heckman LLP partner Azim Chowdhury told 2Firsts. He said it could strengthen FDA’s import enforcement, inspections and market surveillance. Chinese e-cigarette OEM/ODM manufacturers, specification developers, brand owners and component suppliers may need to review their roles, product data and U.S. market authorization status.
Special Report
Jun.29
U.S. Senator Durbin Criticizes FDA’s First Flavored Vape Authorization, Says Trump Administration Conceded to Big Tobacco
U.S. Senator Durbin Criticizes FDA’s First Flavored Vape Authorization, Says Trump Administration Conceded to Big Tobacco
U.S. Senator Dick Durbin on May 13 criticized the Trump Administration’s Food and Drug Administration for approving the sale and marketing of fruit-flavored e-cigarettes for the first time, while also allowing some illegal vaping products to remain on the market. He also linked the regulatory shift to the departure of FDA Commissioner Marty Makary, saying White House pressure on regulators to approve tobacco product applications could create serious public-health consequences.
Regulations
May.15
Product|PMI Expands High-Strength Nicotine Pouch Portfolio With Zyn 16.5mg
Product|PMI Expands High-Strength Nicotine Pouch Portfolio With Zyn 16.5mg
According to Better Retailing, Philip Morris International (PMI) has launched Zyn Menthol Ice 16.5mg in the UK, marking the highest-strength nicotine pouch in the Zyn range to date. The eucalyptus- and menthol-flavored product is now available through PMI Open and will begin rolling out to wholesale channels from the end of May.
PMI
May.28
Argentina’s New Nicotine Rules Draw Cautious Optimism and Market Concerns, Local Tobacco Harm Reduction Advocate Says
Argentina’s New Nicotine Rules Draw Cautious Optimism and Market Concerns, Local Tobacco Harm Reduction Advocate Says
Argentina’s new tobacco and nicotine framework marks a shift from prohibition toward registration, traceability and health surveillance. Argentine THR advocate Juan Facundo Teme told 2Firsts that adult consumers and parts of the local commercial sector are cautiously optimistic, but concerns remain over flavor limits, registration costs and market access. The policy’s implementation may determine whether Argentina can move informal sales into regulated channels.
May.11
 NYT: Reynolds American Donated $5 Million Before FDA Vape Policy Shift
NYT: Reynolds American Donated $5 Million Before FDA Vape Policy Shift
According to The New York Times, Reynolds American donated $5 million to a Trump-backed super PAC shortly before the FDA introduced a new policy that could benefit major tobacco companies seeking to sell flavored vaping products.
News
May.21