In the United States, dietary supplements are regulated differently from drugs. FDA does not approve supplements for safety and effectiveness before they are marketed.
Overview
In the United States, dietary supplements are regulated differently from drugs. FDA does not approve supplements for safety and effectiveness before they are marketed.
Why this matters
Manufacturers and distributors are responsible for ensuring their products meet applicable requirements. FDA can act against unsafe or unlawful products after they reach the market.
How this applies to supplement research
Separate three layers of evidence: normal physiology, research on an individual ingredient, and evidence on the exact finished product. These layers are related but not interchangeable.
When a product uses broad phrases such as “detox,” “metabolic support” or “fat burning,” look for the precise outcome being claimed and the quality of evidence supporting it.
Consumer checklist
- Read the full label, not only the front-of-bottle claims.
- Check serving size and exact ingredient amounts when available.
- Look for independent sources rather than only promotional references.
- Discuss interactions with a healthcare professional if you use medicines or have a health condition.
- Report serious adverse reactions to appropriate medical and regulatory channels.