Is It Really ‘FDA Approved?’
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