New England Journal of Medicine · 2012 · 79 citations · 0 references
PharmacyNutritionPharmaceutical PolicyDrug Approval ProcessesLabeling RegulationPharmaceutical RegulationDietary Supplement RegulationPost-authorization Safety StudiesProduct SafetySafety EvaluationSupplement RegulationDemonstration LawDietary Supplement Quality ControlGuidanceHerbal SupplementsIngredient Safety AssessmentNutritional Supplement LabelingProduct Safety ProfileSupplement Dosage
By law, dietary supplements whose ingredients were not sold in the United States before 1994 require demonstration of a “reasonable expectation of safety” — a currently unenforced requirement. Will the FDA's proposed new guidance in this area be adequate?