AMV Holdings Receives First FDA Premarket Tobacco Product Application Acceptance

MOORESVILLE, NC / ACCESSWIRE / September 9, 2020 / AMV Holdings, LLC (AMV) is pleased to announce that it has been notified by the FDA that its first Premarket Tobacco Product Application (PMTA) filed on 8/25/2020 has been accepted for review. Since receiving the notification, 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 has already received its acceptance for review notification.

The FDA's PMTA process requires an applicant to show that the product is appropriate for the protection of public health and is a regulatory requirement for vapor products to remain on the market. The deadline for PMTA submissions is September 9, 2020. Acceptance of a PMTA is the first step in a long approval process that, if positive, will cumulate in a marketing order.

"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. 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." said Mark Kehaya, Chairman of AMV Holdings.

AMV Holdings, which includes the brands Alohma, Kure, Madvapes, ELB Labs, and Wholesale Vaping Supply, is a leading manufacturer and retailer of ENDS products 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 7 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. 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." Sam Salaymeh, President of AMV Holdings.


AMV Holdings is the largest operator of specialty brick and mortar vape stores in the USA and the manufacturer of multiple e-liquid brands, including the exclusive PRIME line of nicotine e-liquids. AMV Holdings operates 120+ retail locations under the Alohma, Kure, Madvapes and MAXX brands in the US and Europe.


Nicole Brewer


← Older Post Newer Post →