FDA Status for Hemp-Derived CBD in Dietary Supplements

June 24, 2020

Volume X, Number 176

June 23, 2020

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June 22, 2020

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New Citizens Petition Requests FDA Status for Hemp-Derived CBD in Dietary Supplements

We reported on a November 14, 2019 citizen petition submitted to FDA by the Consumer Healthcare Products Associated (CHPA) requesting that the agency issue regulations to establish a clear pathway for the use of cannabidiol (CBD) in dietary supplements.  After public hearings and the first of two Congressionally mandated reports from FDA, discussed here, however, the market for FDA-regulated food and dietary supplement products that contain CBD continues to grow rapidly while a regulatory pathway for lawfully marketing such products still is not in place in the U.S.

Undeterred by FDA’s inaction on the CHPA petition, the Council for Responsible Nutrition (CRN) filed a similar citizen petition on June 16, 2020 urging FDA to regulate hemp-derived CBD as a dietary ingredient.  The petition distinguishes “full spectrum” hemp extracts from CBD isolates, which CRN argues is the substance that has been approved for use in a drug and is therefore prohibited from use in a food or a dietary supplement.  Regarding the petition’s focus only on dietary supplements, a CRN spokesperson told Food Navigator that FDA’s report to Congress indicates that FDA’s safety concerns may be limited to food uses of CBD, although CBD-infused beverage brands maintain that both categories can be safely accommodated under the current regulatory framework.  CRN recognizes that its petition could languish with FDA and told Food Navigator that the organization is focusing mainly on legislative initiatives to bypass FDA altogether.

A June 17, 2020 letter from the consumer organizations, Consumer Federation of America (CFA), Center for Science in the Public Interest (CSPI), Consumer Reports, and Public Health institute, urged lawmakers not to push FDA to act on CBD before it has adequate data or to by-pass FDA.

© 2020 Keller and Heckman LLPNational Law Review, Volume X, Number 174

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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States ities in the European Union (EU) and similar ities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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