The U.S. Food and Drug Administration has informed e-liquid manufacturer Bantam Vape that its non-tobacco flavored electronic nicotine delivery system (ENDS) products are now in the agency’s formal scientific review stage of the premarket tobacco product application (PMTA) process, according to a press release. Scientific review is the final step in the PMTA process prior to FDA’s decision to grant a marketing order.Bantam is seeking marketing orders from FDA for its suite of e-liquid products. Credit: Bantam Vape
“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.”
The FDA completed a preliminary review of Bantam’s PMTAs in November 2020, making its applications eligible for formal substantive review. During the substantive review phase, FDA will conduct an in-depth evaluation of Bantam’s scientific studies and other materials it submitted in conjunction with the brand’s applications.
This includes FDA’s consideration of Bantam’s product testing for harmful and potentially harmful constituents (HPHCs) and physical characteristics of the e-liquids and aerosol at multiple time points; an analysis of leachable chemicals and stability testing of its e-liquids at multiple time points; microbial testing of the final e-liquids at multiple time points; in vitro toxicity testing including Ames, micronucleus and neutral red uptake (NRU) studies; four pharmacokinetic and topography studies for multiple flavors at various nicotine concentrations; and consumer surveys to understand the demographic and usage patterns of its e-liquids. Multiple comprehensive, quantitative risk assessments across many areas of potential risk for the Bantam products were also provided to FDA, demonstrating that Bantam products are appropriate for the protection of public health.
Additionally, to ensure Bantam’s ongoing ability to provide consumers with “high-quality, science-based e-liquid products” following the Sept. 9, 2021 deadline, the brand submitted a formal extension request to FDA. Bantam is hopeful that FDA will grant the extension, which would provide the regulatory agency with additional time to review Bantam’s complete applications and allow the brand’s products to 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.”
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