Tuesday, April 16, 2024

Bantam Vape Moves to FDA’s Substantive Review Phase


Bantam Vape has received a filing letter for its premarket tobacco product application (PMTA). The filing letter signifies completion of FDA’s preliminary review of Bantam’s PMTA and the progression of its application into the formal substantive review phase. Bantam is seeking marketing orders from FDA for its suite of e-liquid products.

During this phase, the U.S. Food and Drug Administration (FDA) will conduct an in-depth evaluation of the scientific studies and other materials submitted in conjunction with Bantam’s application. Bantam, a provider of high-quality, science-based e-liquid products submitted its PMTA to FDA on Sept. 2 and received its initial acceptance notification from the agency the following month.

“Bantam is pleased its PMTA has been formally filed and will be entering the scientific review phase of this process. Bantam looks forward to engaging with FDA as it reviews the submission and scientific research provided in support of the filing,” said Bantam spokesperson Anthony Dillon. “Bantam’s goal has always been to provide consumers with high-quality, science-based e-liquid products that can be enjoyed for years to come. News of the filing brings Bantam one step closer to reaching that goal.”

Bantam has invested significant resources into the PMTA process and remains confident that the content and quality of materials in its submission will result in the receipt of the necessary marketing orders from FDA, according to a press release.

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