FDA issues refuse to file letter to JD Nova Group
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.
Hannah Prokop – CSP Daily – 2021-08-10.