DSHEA is the foundation of every supplement brand operating in the United States. It defines what a "dietary supplement" is, what claims you can and cannot make, what ingredients qualify, and where the legal line sits between a supplement and an unapproved drug.
What DSHEA establishes:
- Definition of a dietary supplement: A product intended to supplement the diet, containing one or more dietary ingredients (vitamins, minerals, herbs, amino acids, or other dietary substances), intended for ingestion in tablet, capsule, powder, softgel, gelcap, or liquid form, labeled as a dietary supplement.
- Manufacturer responsibility: The manufacturer is responsible for ensuring the product is safe before marketing it. No pre-market FDA approval is required for supplements built from ingredients in commerce before October 15, 1994.
- New Dietary Ingredients (NDI): Any dietary ingredient not in commerce in the U.S. before October 15, 1994 requires an NDI notification to FDA at least 75 days before marketing.
- Structure/function claims: Supplements can claim to "support immune health" or "promote restful sleep" — descriptions of how the product affects the body's structure or function. These claims must be truthful, not misleading, and accompanied by the FDA disclaimer ("This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.").
- Disease claims are prohibited: Saying a supplement "treats arthritis" or "cures insomnia" makes it an unapproved drug. The line is enforced through FDA Warning Letters.
cGMP for dietary supplements (21 CFR 111) was established later, in 2007, to give DSHEA operational teeth on the manufacturing side.