Saturday, July 13, 2024

Air Factory, Charlie’s Chalk Dust Get PMTA Filing Letters


My Vape Order, Inc. (MVO) announced that on October 9, 2020, the U.S. Food and Drug Administration (FDA) issued a Filing Letter notifying MVO that the Air Factory’s premarket tobacco product application (PMTA) met the FDA’s requirements and was moving forward into the regulatory agency’s substantive scientific review phase.

Charlie’s Chalk Dust e-liquids have also received a filing letter and moved on to substantive review. “It is with great pleasure that we can announce to our customers that the FDA’s Center for Tobacco Products has informed us that our PMTA is sufficiently complete to enter the Substantive Review phase of the process,” wrote Brandon Stump, CEO of Charlie’s Chalk Dust. “This news is worthy of celebration as it highlights our progress towards achieving full regulatory compliance and providing our customers with a trusted product portfolio. It is a reflection of our relentless hard work and meticulousness in the pursuit of precision. We are confident that during the Substantive Review process the FDA will recognize that our submission is both distinguished and suitable for approval.”

Kyle Godfrey, MVO’s CEO, said the FDA will review the extensive scientific data and research submitted with the PMTA to determine whether the Air Factory products are appropriate for the protection of public health. “The Air Factory PMTA was the culmination of years of planning and extensive toxicological testing and scientific research,” he said. “We look forward to working with FDA on its review of the Air Factory products, with the ultimate goal of obtaining FDA marketing orders for the products.”

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