Bantam is a manufacturer of artisanal flavours which are built from scratch using only high-quality ingredients. The brand is adamant about their quality and transparency standards, in fact they have employed the SENTRI℠ track and trace system, with which one can simply enter the batch number of an e-liquid bottle to check the content quality.
A preliminary review of Bantam’s PMTAs was completed by the FDA in November 2020, making its applications eligible for formal substantive review. “Following the receipt of Bantam’s filing letter, it has waited in anticipation for FDA to begin the next step in the PMTA process – formal scientific review,” said Bantam spokesperson Anthony Dillon. “As we approach the one-year anniversary of the filing deadline, this action represents a critical stage in FDA’s consideration of Bantam’s request for a marketing order.”
Meanwhile Bantam has submitted a formal extension request to FDA, in the hope that the agency will grant this extra time to review Bantam’s complete applications and hopefully ensure that the brand’s products remain on the market while the applications are under review.
“Entering the coveted scientific review phase is a significant development. This is especially true given FDA’s growing enforcement actions against non-compliant brands,” said Dillon. “Bantam remains confident in its PMTA submissions and will continue to engage with FDA in order to obtain the marketing orders needed to stay on the market moving forward,” explained Bantam in a press release.
4.5 million PMTAs denied from the same brand
Meanwhile last month, the FDA denied PMTA licences for 4.5 million vaping products by JD Nova LLC, on grounds that they lack an “adequate Environmental Assessment.”
A recent press release by the FDA, stated that the vape brand JD Nova LLC, which owns Vapolocity was issued with a Refuse to File (RTF) letter. “Under FDA’s regulations implementing the National Environmental Policy Act (NEPA) an EA must be prepared for each proposed authorization, and an EA adequate for filing addresses the relevant environmental issues,” stated the letter.
A recent article on Filter highlighted that this first action related to the PMTA licencing for JD Nova LLC is concerning. “While the agency did appear to just eliminate 75 percent of the total PMTAs, they are all from one relatively small company that apparently did not fulfill the requirements of the process, or could not afford to do so. The FDA has another 2 million to go, and many of them are from major, well-financed companies with the means to submit robust, scientifically thorough applications.”