FDA: ‘Refuse to File’ Letter for JD Nova, 4.5 Million PMTAs

The JD Nova Group submitted premarket tobacco product applications (PMTAs) for an estimated 4.5 million products, approximately two-thirds of the total number of PMTA submissions. Today, the U.S. Food and Drug Administration issued a Refuse to File (RTF) letter to the company. The letter notified JD Nova that the majority of their PMTAs did not meet the filing requirements for a new tobacco product seeking a marketing order.

Credit: Tashatuvango

“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,” the FDA stated in a press release. “As a result of this RTF action, the company must remove approximately 4.5 million products from the market or risk enforcement action by 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.”

During the filing stages of application review, the FDA reviews for basic information to ensure applications contain the required material for scientific review, according to the release. If required contents for filing are missing, the FDA refuses to file the application.

“JD Nova was issued the RTF letter because the company’s applications for these products lacked an adequate Environmental Assessment (EA),” the release states. “Under FDA’s regulations implementing the National Environmental Policy Act (NEPA), an EA must be prepared for each proposed authorization, and an EA adequate for filing addresses the relevant environmental issues.”

JD Nova was one of more than 360 companies included on a recent list of products that had submitted a timely PMTA to the FDA and was allowed to market products for up to one year, until Sept. 9 2021, or until the FDA makes a regulatory decision such as refusing to file a PMTA.

From January through July 2021, the FDA has issued more than 135 warning letters to firms selling or distributing more than 1,470,000 unauthorized ENDS and that did not submit premarket applications by the Sept. 9 deadline. One company, Visible Vapors, had more than 15 million products registered with the FDA. On FDA’s Warning Letters page, you can find these warning letters by searching “Center for Tobacco Products” under “Issuing Office.” The regulatory agency has issued at least two warning letters in August so far.