FDA Rejects Dietary Supplement Applications
The most recent move by the FDA in CBD regulation is a major setback to cannabinoid companies eager to gain approval for their products as a ‘new dietary ingredient’ (NDI). Colorado based Charlotte’s Web and California based Irwin Naturals both failed to advance their applications, because CBD was previously approved as an investigational new drug (IND), in the form of GW Pharmaceutical’s Epidiolex.
For hemp policy wonks, this is nothing new. The IND preclusion has been the FDA’s perennial position on CBD in dietary supplements. However, these two companies were seeking to separate full-spectrum hemp extract from the CBD isolate that is the active ingredient in Epidiolex.
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