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.

Former ATF Official’s Claims on Chinese Vape Companies and 6-Methyl Nicotine Fuel US Regulatory Debate
Former ATF Official’s Claims on Chinese Vape Companies and 6-Methyl Nicotine Fuel US Regulatory Debate
Former ATF Deputy Director Edgar Domenech has warned that some Chinese vape companies may be using 6-methyl nicotine, a nicotine analogue, raising new questions over how US regulators should classify emerging nicotine compounds.
Jul.13
Exclusive: China Tobacco Launches Locally Made MODEN FREE Nicotine Pouches in Indonesia
Exclusive: China Tobacco Launches Locally Made MODEN FREE Nicotine Pouches in Indonesia
2Firsts exclusively reports that China Tobacco Zhejiang Industrial has launched MODEN FREE nicotine pouches in Indonesia. The locally manufactured product is sold through Sixhill, a next-generation tobacco channel under CFU Group, at about $1.80 per 18-pouch can. The launch moves China Tobacco’s nicotine pouch activity beyond trade-show displays and testing into local production and public retail.
Jul.16
BP, Marathon and Valero Warn U.S. Gas-Station Stores: Illegal Vape Sales Could Bring Heavy Fines and Card-Processing Limits
BP, Marathon and Valero Warn U.S. Gas-Station Stores: Illegal Vape Sales Could Bring Heavy Fines and Card-Processing Limits
Fiserv and service station operators including BP, Marathon Petroleum and Valero have warned U.S. partners and gas-station convenience-store owners that selling illegal vapes could lead to heavy fines, breach brand agreements and even put stores’ card-processing access at risk, according to Reuters.
Regulations
Jul.07 by 2Firsts Perspectives
Dutch NVWA Seizes Record 277,000 Illegal Vapes; Video Shows “AL FAKHER” Cartons
Dutch NVWA Seizes Record 277,000 Illegal Vapes; Video Shows “AL FAKHER” Cartons
The Dutch Food and Consumer Product Safety Authority, known as the NVWA, seized more than 277,000 illegal vapes near Rotterdam and nearly 150,000 boxes of nicotine pouches in Utrecht and Rotterdam, calling them the largest batches of such products it has found to date. Video footage released by the NVWA shows some cartons in the warehouse bearing the “AL FAKHER / الفاخر” name, though the agency did not identify brands.
Jul.10
BAT Restructuring to Affect 9,000 Roles as Tobacco Group Pushes Cost Cuts and AI
BAT Restructuring to Affect 9,000 Roles as Tobacco Group Pushes Cost Cuts and AI
British American Tobacco (BAT) plans to cut about 5,500 jobs globally and shift around 3,500 roles to strategic partners by the end of 2026, affecting about 9,000 roles in total, as the company seeks to simplify operations, strengthen technology capabilities and deliver £600 million in annual savings by 2028.
BAT
Jun.29
Research | Swedish Study Finds Oral Lesions in 79% of Examined Nicotine Pouch Users, With Distinct Tissue Responses
Research | Swedish Study Finds Oral Lesions in 79% of Examined Nicotine Pouch Users, With Distinct Tissue Responses
A new Swedish study found oral mucosal lesions in 79% of examined nicotine pouch users and 89% of tobacco-derived snus users, with different tissue-response patterns between the two categories. For manufacturers and regulators, the findings shift attention toward product formulation, flavouring, pouch materials and local oral exposure, not only whether a product contains tobacco. The study found no higher prevalence of caries or periodontal disease, but it could not establish causality, long-term outcomes or differences between individual products or designs.
Special Report
Jul.27