• February 21, 2024

FDA Accepts PMTA from AMV Holdings

 FDA Accepts PMTA from AMV Holdings

Madvapes, Columbia, SC (PRNewsFoto/Madvapes)

Photo: Tobacco Reporter archive

The U.S. Food and Drug Administration (FDA) has accepted a premarket tobacco product application (PMTA) from AMV Holdings.

Since receiving the notification, AMV has filed an additional 104 PMTA submissions accounting for more than 5,000 stock keeping units.  All these submissions reflect the same file and information structure as the PMTA for which AMV has already received its acceptance for review notification.

Mark Kehaya

“We are proud of our team and their achievement in completing a significant step in a rigorous regulatory process and look forward to the FDA’s review of all our products,” said Mark Kehaya, chairman of AMV Holdings, in a statement.

“We view this multi-year effort as another milestone in leading with science and quality in the vapor industry. We hope that the FDA’s PMTA process will increase consumers’ trust in the industry and the products we offer give combustible tobacco users a reliable alternative.”

AMV Holdings, which includes the brands Alohma, Kure, Madvapes, ELB Labs, and Wholesale Vaping Supply, is a leading manufacturer and retailer of electronic nicotine delivery systems in the United States and Europe.

AMV currently operates 113 retail locations in the United States through a combination of corporately owned, franchised and licensed stores and a further seven stores in Germany and Ireland. AMV manufactures e-liquids through ELB Labs, to distribute to their brick and mortar vape stores, online (B2C) e-commerce platforms, and third-party vape stores for consumers who want to switch from smoking cigarettes to vaping/e-cigarettes.

“It’s exciting to know that we will be able to continue to offer our guests Prime e-liquids in all our retail locations,” said Sam Salaymeh, president of AMV Holdings. “The process with the FDA has enabled us to document our philosophy of providing high-quality standards and superior chemistry of our Prime e-liquid line, that is something we are all proud of. We look forward to providing our guests with the best service and products in the industry for many years to come.”