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
North Carolina Tightens Vape Product Directory Enforcement, Expands State and Local Powers as Violators Face Fines, Product Seizures and License Suspension or Revocation
North Carolina Tightens Vape Product Directory Enforcement, Expands State and Local Powers as Violators Face Fines, Product Seizures and License Suspension or Revocation
North Carolina has expanded enforcement of its vapor product directory rules, authorizing more state and local law enforcement participation and establishing a task force led by the State Bureau of Investigation. The legislation requires at least one unannounced compliance inspection annually for retailers, distributors and wholesalers handling covered products. Penalties effective October 1, 2026, include civil fines of $500–$750 for a first violation and $1,000–$1,500 for repeated violations within 12 months, along with potential license suspension or revocation. Manufacturers may face penalties of $10,000 per unlisted product. The measures strengthen the product directory system established in 2024.
Regulations
Oct.28
Special Report|From CrossBar 20K to 6-Methyl Nicotine KUMI: Two Routes Into U.S. State Vape Directories?
Special Report|From CrossBar 20K to 6-Methyl Nicotine KUMI: Two Routes Into U.S. State Vape Directories?
Several U.S. states have incorporated the September 9, 2020 PMTA filing deadline into eligibility rules for certain vaping products. CrossBar 20K drew attention after appearing on Pennsylvania's 163-entry directory. A broader 2Firsts investigation found that related registration businesses also listed KUMI and CROSSBAR SIX products, with 171 KUMI-related entries across Louisiana, Nebraska and Wisconsin. Corporate records link Scott Silverman to Blue Nine LLC and VR Products I LLC. PMTA compliance expert Mr. K said historical applications and nicotine-analogue products may offer two different approaches to state-directory access.
Regulations
Oct.26
FDA Revises Import Alert 98-07 Rules, Bringing May Enforcement Priorities Into Unauthorized ENDS Detentions
FDA Revises Import Alert 98-07 Rules, Bringing May Enforcement Priorities Into Unauthorized ENDS Detentions
The U.S. Food and Drug Administration has revised the rules under Import Alert 98-07 to incorporate its May 2026 enforcement-priority policy for certain electronic nicotine delivery systems marketed without premarket authorization. The alert continues to allow detention without physical examination, or DWPE, for ENDS lacking required marketing authorization, while directing field divisions to apply the May risk-based framework. When necessary, detention or refusal decisions must also undergo review by the FDA's Center for Tobacco Products. Products including PACHA and Vuse Pro have already emerged as industry examples of the May policy, although enforcement discretion does not constitute FDA marketing authorization.
News
Sep.28 by 2Firsts Perspectives
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
UK HMRC Launches Vape Duty Stamps on October 1, Ushering in Supply-Chain Traceability as Chinese Exporters Face New Compliance Hurdles
UK HMRC Launches Vape Duty Stamps on October 1, Ushering in Supply-Chain Traceability as Chinese Exporters Face New Compliance Hurdles
HM Revenue & Customs put the UK's Vaping Products Duty and Vaping Duty Stamps Scheme into effect on October 1. All vaping liquids manufactured in or imported into the UK are now subject to duty at £2.20 per 10ml, regardless of nicotine content. The stamp regime will introduce digital functionality designed to provide traceability throughout the supply chain, with approved manufacturers, importers and warehousekeepers required to report product movements and retailers and consumers eventually able to scan stamps to verify authenticity. China exported $177 million of vape-related products to the UK in August, up 51.4% year over year, increasing the significance of the new compliance regime for China's Shenzhen-centered vape supply chain.
Regulations
Oct.04