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.


This document has been generated through artificial intelligence translation and is provided solely for the purposes of industry discourse and learning. Please note that the intellectual property rights of the content belong to the original media source or author. Owing to certain limitations in the translation process, there may be discrepancies between the translated text and the original content. We recommend referring to the original source for complete accuracy. In case of any inaccuracies, we invite you to reach out to us with corrections. If you believe any content has infringed upon your rights, please contact us immediately for its removal.

Canadian Border Officers Seize Contraband Worth CAD 4.5 Million at Point Edward Crossing
Canadian Border Officers Seize Contraband Worth CAD 4.5 Million at Point Edward Crossing
The Canada Border Services Agency said border officers at the Point Edward port of entry in Sarnia, Ontario, seized more than CAD 4.5 million worth of illegal tobacco and nicotine vapes over a seven-day period. The agency said the contraband was entering Canada from the United States and described the seizure as part of ongoing efforts to prevent illegal products from entering the country and disrupt organized crime.
Mar.26 by 2FIRSTS.ai
BAT Shares Surge Nearly 6% as FDA Policy Shift Eases Pressure on Vuse and Velo
BAT Shares Surge Nearly 6% as FDA Policy Shift Eases Pressure on Vuse and Velo
British American Tobacco (BAT) shares rose sharply on May 12 after the U.S. Food and Drug Administration signaled it would deprioritize enforcement against certain unauthorized e-cigarette and nicotine pouch products with accepted premarket applications. Investors viewed the move as favoring established players such as BAT’s Vuse and Velo brands.
BAT
May.13
Fontem Drops Texas Lawsuit and Plans to Refile in D.C. Over FDA Handling of Zone Application
Fontem Drops Texas Lawsuit and Plans to Refile in D.C. Over FDA Handling of Zone Application
Fontem US, the maker and seller of Zone nicotine pouches, has voluntarily dismissed its lawsuit against the U.S. Food and Drug Administration, which it had accused of unfairly delaying its market application.
Mar.25 by 2FIRSTS.ai
 Bangladesh Approves Amended Tobacco Control Law Expanding Ad Bans and Smoke-Free Areas
Bangladesh Approves Amended Tobacco Control Law Expanding Ad Bans and Smoke-Free Areas
Bangladesh’s new government has approved a broad tobacco control amendment that bans tobacco advertising, promotion and display across print, electronic, digital and social media, entertainment platforms and points of sale. The law does not cover newer products such as vapes, heated tobacco products, electronic nicotine delivery systems or nicotine pouches.
Apr.22 by 2FIRSTS.ai
STMA Issues Trial Credit Management Rules for E-Cigarette Manufacturers and Wholesalers
STMA Issues Trial Credit Management Rules for E-Cigarette Manufacturers and Wholesalers
Mar.26 by 2FIRSTS.ai
FDA Tobacco Center Pushes Review-Efficiency Statement After Commissioner’s Exit
FDA Tobacco Center Pushes Review-Efficiency Statement After Commissioner’s Exit
FDA CTP issued a May 7 statement on accelerating product review and improving PMTA efficiency, but did not push it via official X and newsletter until May 13, one day after FDA Commissioner Marty Makary’s resignation was confirmed. FDA has not explained the delay, and no public evidence links it directly to the leadership change. The timing is notable given CTP’s usual 24-hour distribution practice.
Special Report
May.14