The U.S. Food and Drug Administration has issued a “refuse to file” (RTF) letter to JD Nova Group. The letter notifies the company that the premarket tobacco product applications (PMTAs) it submitted for approximately 4.5 million of its products do not meet the filing requirements for a new tobacco product seeking a marketing order.
As a result of this RTF action, JD Nova Group must remove approximately 4.5 million products from the market or risk enforcement action by the FDA. The company may resubmit a complete application for these products at any time. However, the products may not be marketed unless they receive a marketing granted order.
The FDA’s action affects a significant share of PMTAs under review. The agency has received applications for more than 6.5 million products from over 500 companies.
According to the FDA, JD Nova was issued the RTF letter because the company’s applications for these products lacked an adequate environmental assessment. Under the FDA’s regulations implementing the National Environmental Policy Act, an environmental assessment must be prepared for each proposed authorization.
This RTF does not apply to all product applications submitted by JD Nova. The remaining product applications the company submitted by the Sept. 9, 2020, deadline are still moving through the review process, according to the FDA.
The list of affected products is available here.