MORRISVILLE, N.C. — Bantam Vape LLC, an e-liquid manufacturer, said the U.S. Food and Drug Administration (FDA) filed its premarket tobacco application (PMTA).
The company submitted its PMTA on Sept. 2 and received its initial acceptance notification the following month. This means the FDA completed a preliminary review of Bantam’s PMTA and it will move on to the substantive review phase, during which the FDA will conduct an in-depth evaluation of the scientific studies and other materials submitted with Bantam’s application, the company said.
"Bantam is pleased its PMTA has been formally filed and will be entering the scientific review phase of this process,” the Morrisville, N.C.-based company’s spokesperson Anthony Dillon said. “Bantam looks forward to engaging with FDA as it reviews the submission and scientific research provided in support of the filing. 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."
Companies had until Sept. 9 to submit deemed products to the FDA for authorization. The administration has one year to review products filed on time and plans to eventually make public a list of all companies that have submitted PMTAs.