CRN Denounces FDA Rejection of New Dietary Ingredient Notifications for Hemp Extract Containing CBD, Urges Congress to Act

CANNANNEW REPORT

WASHINGTON–(BUSINESS WIRE)–The Council for Responsible Nutrition (CRN), the leading trade association for the dietary supplement and functional food industry, today denounced FDA’s rejection of two new dietary ingredient (NDI) notifications for full-spectrum hemp extract containing cannabidiol (CBD)—and urged Congress to act on pending legislative proposals that require the agency to address the lack of regulation of hemp-derived products. The following is a statement from CRN President & CEO Steve Mister: “CRN is extremely disappointed to learn that FDA rejected NDI notifications for full-spectrum hemp extract containing CBD submitted earlier this year by supplement manufacturers Charlotte’s Web and Irwin Naturals. Ultimately, it seems that the agency engaged these supplement companies in a months-long process unnecessarily. “FDA has wrongly mischaracterized these products as the same article as a prescription drug and has ignored, dismissed, and downplayed ample evidence that these full-spectrum hemp products can be marketed in a manner that is reasonably expected to be safe. Meanwhile, the agency has done little to protect consumers from the unregulated marketplace it has created from more than two years of inaction. “FDA continually asked the companies for meetings and safety data about their products containing full-spectrum hemp extract. After complying with FDA’s requests, these companies saw FDA reject their NDI notifications—disregarding published peer-reviewed toxicology studies and years’ worth of real-world safety evidence. “FDA also claimed the full-spectrum ingredients containing CBD and Epidiolex should be considered the same ‘article,’ a term used for purposes of determining what substances are eligible to be dietary supplements under the Federal Food, Drug and Cosmetic Act. However, Epidiolex, manufactured by GW Pharma, is a highly concentrated CBD isolate that contains 10 times more CBD than either of the full-spectrum hemp ingredients and plainly is not the same article supplement companies are producing, as CRN has argued for several years.…

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Source : CRN Denounces FDA Rejection of New Dietary Ingredient Notifications for Hemp Extract Containing CBD, Urges Congress to Act

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