Tag: Air Factory

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

    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.”

  • Air Factory Receives PMTA Acceptance for 72 Flavors

    Air Factory Receives PMTA Acceptance for 72 Flavors

    Credit: MVS

    My Vape Order (MVO) received its premarket tobacco product application acceptance letter, yesterday, Oct. 2. The company announced that the letter from the U.S. Food and Drug Administration (FDA) for its 72 bundled Air Factory e-liquids meets the statutory and regulatory requirements for a PMTA submission.

    MVO submitted its Air Factory PMTA on Sept. 3.

    “MVO looks forward to working with FDA on its review of the … PMTA, which covers a suite of 72 Air Factory products, including both freebase and salt nicotine formulations in a variety of nicotine strengths tailored to meet the needs of our Air Factory consumers,” wrote MVO CEO Kyle Godfrey on the Air Factory website. “The PMTA is supported by robust scientific data, including independently-conducted toxicological risk assessment data for the submitted products, and thorough research establishing the products to be appropriate for the protection of public health. MVO is committed to working with FDA through the entire PMTA review process as expeditiously as possible.”

    The company will continue to provide PMTA and product updates at www.airfactoryeliquid.com.

  • Air Factory Submits PMTA for 72 Flavors to FDA

    Air Factory Submits PMTA for 72 Flavors to FDA

    Credit: MVS

    My Vape Order, parent to the Air Factory e-liquid brand, has announced its submission of a bundled premarket tobacco product application (PMTA) to the U.S. Food and Drug Administration (FDA). The PMTA was for the company’s suite of 72 Air Factory flavors. The products include both freebase and salt nicotine formulations in a variety of nicotine strengths.

    “Submission of the Air Factory PMTA marked the culmination of years of planning and hard work for the MVO team and our valued partners,” said MVO’s CEO Kyle Godfrey. “MVO is honored to be a leader in the vape industry, and is proud to provide consumers of tobacco and nicotine products a quality line of e-liquids that consumers can trust and enjoy.”

    The PMTA submission was electronically filed with FDA on September 3, 2020. Included with the application were robust scientific data including independently-conducted toxicological risk assessments for the submitted products, as well as thorough research findings intended to establish the AIR FACTORY® products as appropriate for the protection of public health, according to a press release. T

    The company’s PMTA filing coincides with the launch of redesigned product packaging for the Air Factory brand and the implementation of additional safeguards through the company’s B2B and B2C websites to further the company’s commitment to preventing youth exposure to tobacco and nicotine products.