SILVER SPRING, Maryland – E-liquids company JD Nova Group LLC to withdraw approximately 4.5 million products from the market because the company’s pre-market tobacco product (PMTA) applications associated with these products do not meet filing requirements .
The United States Food and Drug Administration (FDA) said it sent a refusal to file letter (RTF) to JD Nova Group on August 9. The RTF letter does not apply to all product requests submitted by JD Nova Group, as some requests submitted before the September 9 deadline are still under review. A list of products that JD Nova Group must withdraw, or risk FDA enforcement, can be found on the agency’s website. website.
JD Nova Group received the RTF letter because its application for the 4.5 million products lacked adequate environmental assessment, the FDA said.
The company can resubmit a complete request for these products at any time; however, the products can only be marketed if they are the subject of a marketing order. Retailers should contact JD Nova Group with any questions about products in their inventory, the agency said.
“This is an important step in taking action on the unprecedented number of applications received by the September 9, 2020 deadline,” the FDA said. “In accordance with this deadline, the FDA has received submissions for more than 6.5 million products from more than 500 companies. The agency is committed to working as quickly as possible to shift the current market for reputable new tobacco products to a market in which all products available for sale have undergone careful and scientific scrutiny by the FDA. “
The FDA issued a total of nine warning letters to companies that manufacture and sell unauthorized e-liquids in July, warning them that selling products without prior marketing authorization is illegal. One of those warning letters, issued on July 28, was addressed to a single company with more than 15 million tobacco products listed with the FDA.
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