Red Yeast Rice History Offers Blueprint For Clearing CBD As Dietary Ingredient
Legal dispute between FDA and Pharmanex decided in 1999 could be precedent for using hemp-derived ingredients including CBD in supplements, even though CBD already has been authorized for clinical drug evaluation and for use in a drug, says attorney Miriam Guggenheim.
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FDA drug center could hold more sway over which ingredients are allowed for use in supplements than center regulating supplement industry, suggests CRN CEO Steve Mister at a recent regulatory conference. ODSP second-in-command Gregory Noonan allows that agency has “vague” rule for “article” used in a supplement or a drug.
Restrictions on daily doses and mandatory label warnings now apply to dietary supplements containing monacolins from red yeast rice sold in the EU following long-running safety concerns about the substance.
FDA, along with supplement and food industries, have looked to Congress to authorizing agency to waive exclusion rule for hemp ingredients. Instead, Michael McGuffin recommends amending DSHEA to clarify that the same ingredients at different concentrations can be allowed in supplements and drugs.