CBD Format – Spectrum Or Isolate? – Likely To Be Differentiator Tried In FDA Forum, Courts
Companies choosing between CBD options – namely broad- or full-spectrum hemp extracts or CBD isolate – need to appreciate the differences and potential legal implications, attorneys say.
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Plaintiffs against Florida-based Green Roads used certificates of analysis the company makes freely available to consumers to determine that batches of two of the company’s products contained “significantly” less cannabidiol versus labeled amounts. A Florida federal court rejected the firm’s motion to dismiss, but it is interested in seeing how FDA rulemaking develops.
California federal courts have shown themselves receptive to proposed class actions alleging that purported cosmetics carrying unapproved drug claims violate the state’s Unfair Competition Law. Plaintiffs now are testing similar theories in suits against marketers of CBD-infused topical products.
The agency announces that it cannot conclude cannabidiol is GRAS, potentially heading off GRAS notifications and making NDI notifications a likelier future for CBD use in the supplement sector if any “lawful pathway” is to be found. In addition to a barrage of warning letters to marketers of CBD products, the FDA issued a stark warning to consumers about potential hazards.