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Cannabidiol: (Clinical) Trials and Tribulations

FDA issues Warning Letters to eight companies marketing cannabidiol products.

  • As previously covered on this blog, FDA released a 2015 Q&A document stating its views that cannabidiol (CBD) products are excluded from the dietary supplement definition due to the existence of known substantial clinical investigations on this substance.  This is the so-called “drug exclusion” from the dietary supplement category.  Although FDA previously issued several Warning Letters to companies marketing CBD products as unapproved new drugs, we wondered whether future Warning Letters would target CBD supplements for running afoul of the “drug exclusion.”

  • On February 4, FDA sent Warning Letters to 8 companies marketing CBD products — some positioned as foods and others positioned as supplements — alleging that the products are unapproved new drugs.  In the Warning Letters targeting the supplements, FDA also alleged that the products run afoul of the “drug exclusion” due to the known existence of at least two investigational new drug applications (INDs) filed by companies studying the therapeutic effects of CBD.

  • As was the case in the 2015 FAQ document, FDA has invited parties to submit evidence that would call into question the Agency’s view that CBD products run afoul of the “drug exclusion.”  CBD marketers could challenge FDA’s conclusion by providing proof that dietary supplements containing CBD were lawfully on the market before the two known INDs for CBD were filed.  FDA’s reissuance of the “call for data” as part of the recent spate of Warning Letters suggests that the Agency has not yet reviewed any credible evidence on this point.  We anticipate that the regulatory battle over CBD and other hemp-based products will not conclude any time soon.

© 2019 Keller and Heckman LLP


About this Author

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...