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On Aug. 9, FDA issued a Refuse to File (RTF) letter to JD Nova Group LLC. The letter notified the company that their Premarket Tobacco Product Applications (PMTAs) that are associated with approximately 4.5 million of their products do not meet the filing requirements for a new tobacco product seeking a marketing order. 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.
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.
This is a significant step in taking action on the unprecedented number of applications received by the Sept. 9, 2020 deadline. 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.
During the filing stages of application review, FDA reviews for basic information to ensure applications contain the required material for scientific review. If required contents for filing are missing, 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). 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.
As a result of this RTF action, effective immediately, JD Nova may not introduce or deliver for introduction these products into the interstate commerce in the United States. Retailers also may not introduce or deliver for introduction these products into interstate commerce in the United States. Retailers should contact JD Nova with any questions about products in their inventory.
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