A US Food and Drug Administration proposed rule could provide incentive for studies of health benefits from dietary supplements or further limit health claims firms attempt to provide for dietary ingredients.
Dietary Ingredient Studies For Health Benefits Could Be Fenced In By US FDA IND Proposal
Proposed rule introduces two exemptions agency would allow from needing IND clearance for clinical investigations to evaluate food, supplements or cosmetics. Both begin with basic requirement of trial not intended to support drug development plan or labeling change that would make a food, dietary ingredient or cosmetic an unlawfully marketed drug.
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