Clarification of   “FDA approved!” claim

DOES approve:

  • New Drugs and Biologics – by determining e benefits of the product outweigh the known risks for the intended use
  • Medical Devices – use risk-based, tiered approach
  • Human Cells and Tissues – use risk-based approach
  • Food and Color additives – for safety

DOES NOT approve :

  • Companies – health care facilities, laboratories, or manufacturers; can inspect
  • Compounded drugs
  • Tobacco products – regulated based on public health standard
  • Cosmetics – except color additives
  • Medical foods – for dietary management
  • Infant formula
  • Dietary Supplements
  • Food Label, including the Nutrition Facts panel
  • Structure-Function claims on dietary supplements and other foods

Misuse of FDA’s logo may violate federal law


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