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.

South Korea Imports 12,126 Kg of Nicotine Analogues From April to August After Bringing Synthetic Nicotine Under Tobacco Law
South Korea Imports 12,126 Kg of Nicotine Analogues From April to August After Bringing Synthetic Nicotine Under Tobacco Law
South Korea's liquid-vape market is showing changes across raw-material imports, product types and sales channels after synthetic nicotine came under the Tobacco Business Act on April 24. Customs data show nicotine-analogue imports totaled 12,126 kilograms from April through August, while synthetic-nicotine imports over the same five months totaled 231,663 kilograms, just 39.3% of the amount imported in March alone. Physical liquid-vape stores tracked in Seoul and Gyeonggi Province fell 9.9%, unmanned outlets edged higher and online sales listings increased from 27,774 to 42,437. Government testing of 105 liquid inhalation products promoted as nicotine-free separately found nicotine in 13 and 6-methylnicotine in 12.
Sep.22
Pennsylvania Vape Directory Enforcement Starts Oct. 19, Barring Retail Sales of Unlisted Products
Pennsylvania Vape Directory Enforcement Starts Oct. 19, Barring Retail Sales of Unlisted Products
Pennsylvania's Act 57 vape directory regime will reach the end of its 120-day inventory transition period on Oct. 19. Nicotine-containing e-cigarettes intended for retail sale in the state that are not listed on the Attorney General's ENDS directory will then be barred from retail sale and treated as contraband subject to seizure, forfeiture and destruction. Manufacturers face annual product certification, brand- and style-based fees and a minimum $50,000 surety bond, while retailers and wholesalers must source through licensed channels and monitor the directory.
Regulations
Oct.08
Kelly White Bets on Female Consumers as Nicotine Pouch Competition Intensifies | 2Firsts Interview
Kelly White Bets on Female Consumers as Nicotine Pouch Competition Intensifies | 2Firsts Interview
Swedish nicotine pouch brand Kelly White is building its strategy around adult female consumers. Founder and CEO Sophia Wilsby told 2Firsts that women accounted for around 70% of the brand’s repeat customers on HAYPP in Sweden in 2025. The interview explores female consumer segmentation, product and design differentiation, gender stereotypes, packaging regulation, and how independent brands can compete with global players such as ZYN and VELO while considering funding, partnerships and future ownership options.
Business
Sep.24
AIR Global Starts Debt Refinancing Four Months After Nasdaq Listing With About $400 Million Notes Expected
AIR Global Starts Debt Refinancing Four Months After Nasdaq Listing With About $400 Million Notes Expected
AIR Limited, a wholly owned subsidiary of AIR Global, has launched an offering of U.S. dollar-denominated senior unsecured notes, with proceeds primarily intended to repay its existing term loan and revolving credit facility. AIR has not disclosed the final size, maturity or coupon; Refinitiv, citing Moody's, reported an expected issuance of approximately $400 million and a Ba3 rating. AIR had about $412.4 million outstanding under the two bank facilities at June 30 and net debt of $344.8 million. In the first half of 2026, AIR's Al Fakher-led flavored shisha molasses business generated about 99% of company revenue, while New Growth Categories including Crown Switch produced $2.2 million in revenue and remained loss-making on an adjusted EBITDA basis.
Sep.23
New York City Opens Lottery for 55 Vape Retail License Slots Across 23 Community Districts, Including 28 in Brooklyn
New York City Opens Lottery for 55 Vape Retail License Slots Across 23 Community Districts, Including 28 in Brooklyn
New York City's Department of Consumer and Worker Protection (DCWP) opened applications on November 2, 2026, for a lottery covering tobacco and electronic cigarette retail dealer licenses, with a deadline of 5 p.m. New York local time on November 30. According to the city's October 1 notice, 55 electronic cigarette retail license slots are available across 23 community districts, including 28 in Brooklyn, alongside 322 tobacco retail license slots across 41 districts. Businesses must enter the lottery and, if invited, complete licensing requirements within 65 days. New York City continues to restrict e-cigarette retail sales to tobacco-flavored or unflavored products, while city retail licenses do not replace FDA product marketing authorization.
Market
Nov.04
Spain Cigarette Volumes Fall 5.2% in August, BAT Drops 14.5%, JTI Gains Share; France Down 8.3% on Adjusted Basis
Spain Cigarette Volumes Fall 5.2% in August, BAT Drops 14.5%, JTI Gains Share; France Down 8.3% on Adjusted Basis
Spain's cigarette volumes declined 5.2% year over year in August 2026, according to government data cited by UBS and reported by Investing.com on October 7. British American Tobacco's volumes fell 14.5%, followed by Imperial Brands at 8.8%, Philip Morris International at 6.6% and Japan Tobacco at 4.6%. JTI was the only one of the four companies to gain cigarette market share, rising six basis points to 26.7%. In France, official customs data showed an unadjusted 3.7% decline in cigarette deliveries. Adjusting for the difference in delivery days produces a decline of approximately 8.3%, consistent with the UBS figure. The bank also estimated the earnings exposure of major tobacco companies to both markets.
Market
Oct.13