AMV Holdings Receives First PMTA Acceptance Letter

AMV Holdings has received its first premarket tobacco product application (PMTA) from the U.S. Food and Drug Administration (FDA). AMV has filed an additional 104 PMTA submissions accounting for over 5,000 SKUs. All of these submissions reflect the same file and information structure as the PMTA for which AMV received the acceptance letter, according to a press release.

Acceptance of a PMTA is the first step in a long approval process that, if positive, will end in a marketing order. AMV’s first PMTA will now be on to the substantive review phase to determine if the product is beneficial to public health.

“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. “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 manufacturer and retailer of electronic nicotine delivery systems (ENDS) products in the U.S. and Europe. AMV currently operates 113 retail locations in the U.S. through a combination of corporate-owned, franchised and licensed stores. The company also has seven stores in Germany and Ireland.

“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.”

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