FDA Sends its 69th PMTA Warning Letter

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    The U.S. Food and Drug Administration (FDA) issued three more warning letters to vapor companies on March 19. The latest announcement brings the count to 69 letters this year for companies selling vapor products without gaining regulatory approval through the agency’s premarket tobacco product application (PMTA) process.

    The latest letters were issued to Arizona-based Vapor Outlet, Vapor Tech Hawaii and the Vaporium in Illinois. In its letter to Vaporium, the FDA stated that the company continues to “manufacture, sell and/or distribute to customers in the United States The Vaporium 6 mg Red White and Blue 70/30 30 mL e-liquid product” without a marketing authorization order.

    “Your firm is a registered manufacturer with 19,860 products listed with FDA. It is your responsibility to ensure that your tobacco products comply with each applicable provision of the FD&C Act and FDA’s implementing regulations,” the letter states. “Failure to adequately address this matter may lead to regulatory action, including, but not limited to, civil money penalties, seizure and/or injunction.”

    Companies that receive warning letters from the FDA have to submit a written response to the letter within 15 working days from the date of receipt describing the company’s corrective actions, including the dates on which it discontinued the violative sale and/or distribution of the products. They also require the company’s plan for maintaining compliance with the FD&C Act in the future.

    Many of the FDA’s letters so far have gone to local vape shops that manufacture their own e-liquids in the store. For example, Vapor Tech Hawaii’s letter states that the FDA has determined that it “manufacture[s], sell[s] and/or distribute[s] to customers its Vapor Tech Hawaii Waikikiwi 100 mL 3 mg e-liquid product” without a marketing authorization order.

    On March 12, the U.S. FDA sent warning letters to 13 firms that manufacture and sell unauthorized e-liquids.