Ovos' Former IND Homotaurine Strikes Out As Dietary Ingredient
This article was originally published in The Tan Sheet
FDA rejects Ovos Natural Health's citizen petition to classify homotaurine as a dietary ingredient, but leaves the door open for future attempts on the pathway Ovos tried to navigate – moving a substance from failed investigational new drug to dietary supplement.
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The exemption Congress gave dietary supplement manufacturers from the hazard analysis and critical control points regulations for food products does not extend to ingredient suppliers, experts say.
Ovos Natural Health plans a 2010 U.S. launch of its Vivimind cognitive health supplement, contingent upon FDA's go-ahead