SILVER SPRING, Md. — E-liquid company JD Nova Group LLC must remove about 4.5 million products from the market because the company’s premarket tobacco product applications (PMTAs) associated with those products do not meet filing requirements.
The U.S. Food and Drug Administration (FDA) said it issued a refuse-to-file letter (RTF) to JD Nova Group on Aug. 9. The RTF letter does not apply to all product applications submitted by JD Nova Group, as some applications submitted by the Sept. 9 deadline are still moving through the review process. A list of products that JD Nova Group must pull, or risk FDA enforcement, can be found on the agency’s website.
JD Nova Group was issued the RTF letter because its application for the 4.5 million products lacked an adequate environmental assessment, the FDA said.
The company can resubmit a complete application for these products at any time; however, the products may not be marketed unless they receive a marketing granted order. Retailers should contact JD Nova Group with questions about products in their inventory, the agency said.
“This is a significant step in taking action on the unprecedented number of applications received by the Sept. 9, 2020, deadline,” the FDA said. “In accordance with that deadline, FDA received applications for over 6.5 million products from over 500 companies. The agency is committed to working as quickly as possible to transition the current marketplace for deemed new tobacco products to one in which all products available for sale have undergone a careful, science-based review by the FDA.”
The FDA issued a total of nine warning letters to firms that manufacture and sell unauthorized e-liquids in July, advising them that selling products without premarket authorization is illegal. One of those warning letters, issued on July 28, was to a single company with more than 15 million tobacco products listed with the FDA.
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