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Congress Continues to Seek Regulatory Clarity on CBD from FDA

A bipartisan group of members of Congress sent a letter to FDA on September 19 urging the Agency to quickly provide legal clarity and establish a regulatory pathway for food products containing hemp-derived cannabidiol (CBD). “We appreciate FDA’s proactive approach towards pursuing a legal pathway for the production of hemp-derived products containing CBD … However, FDA’s current regulatory posture on CBD has created significant regulatory and legal uncertainty for participants in this quickly evolving industry,” wrote the lawmakers.

Expressing concern about FDA’s estimate that a rulemaking process could span 3 to 5 years, the lawmakers stated, “We believe there are more expeditious measures that FDA could take that would establish regulatory clarity while pursuing enforcement actions against bad actors.” These include: first, announce a policy of enforcement discretion and, second, consider issuing an interim final rule to establish a clear regulatory framework for CBD as a dietary supplement and food additive.

This is not the first request from Congress to FDA to provide legal clarity on the use of CBD in foods and dietary supplements.

As previously reported on this blog, in a January 12, 2019 letter to FDA Commissioner Scott Gottlieb, Senators Ron Wyden (D-OR) and Jeff Merkely (D-OR) urged the Commissioner to update federal regulations governing the use of certain hemp-derived ingredients in food, beverages, and dietary supplements.

Congresswomen Chellie Pingree (D-Maine), who was the lead author on the September 19 letter, points out in a press release that she first wrote to FDA in February 2019 requesting guidance on legal pathways for food products containing CBD.

Last week, we reported on an amendment to the Senate appropriations bill that would require FDA to issue temporary guidance on enforcement related to products containing cannabidiol (CBD).

We will continue to report on developments in the regulation of CBD by FDA.

© 2021 Keller and Heckman LLPNational Law Review, Volume IX, Number 267
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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 authorities in the European Union (EU) and similar authorities 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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