What Is DSHEA?
The Dietary Supplement Health and Education Act (DSHEA) of 1994 is the federal law that governs dietary supplements in the United States. Unlike drugs, dietary supplements do not require FDA pre-approval before going to market — but they are still subject to strict labeling, manufacturing, and claims requirements.
Under DSHEA, a dietary supplement is defined as a product intended to supplement the diet that contains one or more of the following: vitamins, minerals, herbs or botanicals, amino acids, or other dietary substances.
Structure/Function Claims vs. Disease Claims
This is the most critical distinction in dietary supplement marketing. Getting it wrong can result in your product being classified as an unapproved drug — with serious regulatory consequences.
Permitted Structure/Function Claims (Examples)
- ✅ "Calcium builds strong bones"
- ✅ "Antioxidants maintain cell integrity"
- ✅ "Fiber maintains bowel regularity"
- ✅ "Supports immune function"
- ✅ "Helps maintain healthy cholesterol levels already within the normal range"
✗ "Prevents heart disease"
✗ "Treats diabetes"
✗ "Cures cancer"
✗ "Reduces the risk of Alzheimer's disease"
Any claim that suggests the product diagnoses, cures, mitigates, treats, or prevents disease makes the product an unapproved drug.
Required FDA Notification for Structure/Function Claims
If you use a structure/function claim, you must notify the FDA within 30 days of first marketing the product with that claim. The notification must include:
- The text of the claim
- The name and address of the manufacturer or distributor
- A statement that the notification is being provided
Mandatory Disclaimer
Every structure/function claim must be accompanied by the following disclaimer, displayed prominently on the label:
Required FDA Disclaimer (Exact Language)
"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."
The disclaimer must appear on the same panel as the claim and must be separated from the claim by adequate space or a symbol.
Required Label Elements for Dietary Supplements
- Statement of identity: "Dietary Supplement" must appear on the principal display panel
- Net quantity of contents
- Supplement Facts panel (not Nutrition Facts)
- Complete ingredient list
- Name and place of business of manufacturer/distributor
- Directions for use
- Any required warnings (e.g., "KEEP OUT OF REACH OF CHILDREN")
Supplement Facts Panel Requirements
Dietary supplements use a Supplement Facts panel rather than a Nutrition Facts panel. It must list:
- Serving size and servings per container
- Each dietary ingredient and its amount per serving
- The % Daily Value for each ingredient where one is established
- The part of the plant for botanical ingredients (e.g., "leaf," "root," "seed")
cGMP Requirements for Supplement Manufacturers
All dietary supplement manufacturers (including foreign facilities exporting to the U.S.) must comply with FDA's Current Good Manufacturing Practices (cGMP) for dietary supplements under 21 CFR Part 111. This includes identity testing, purity testing, composition testing, and strength verification.