What is DSHEA?
The Dietary Supplement Health and Education Act (DSHEA) of 1994 is the primary federal law governing dietary supplements in the United States. Unlike drugs, dietary supplements do not require FDA approval before reaching the market — but that does not mean they are unregulated.
Under DSHEA, the burden of ensuring a supplement is safe and lawfully marketed falls on the manufacturer or distributor, not the FDA.
Who Qualifies as a "Dietary Supplement"?
A product qualifies as a dietary supplement if it:
- Is intended to supplement the diet
- Contains one or more dietary ingredients (vitamins, minerals, herbs, amino acids, enzymes, etc.)
- Is intended to be taken orally (capsules, tablets, powders, liquids, etc.)
- Is labeled as a dietary supplement
Key FDA Requirements Under DSHEA
1. Facility Registration
All domestic and foreign facilities that manufacture, process, pack, or hold dietary supplements for U.S. sale must register with FDA. Registration must be renewed every two years between October 1 and December 31.
2. Current Good Manufacturing Practices (cGMP) — 21 CFR Part 111
All supplement manufacturers must comply with FDA's Dietary Supplement cGMP regulations. These require:
- A master manufacturing record for each product
- Batch production records
- Component and finished product testing
- Personnel training programs
- Calibrated equipment and validated processes
- Complaint handling and recall procedures
FDA inspects supplement facilities and issues 483 observations for cGMP deviations.
3. New Dietary Ingredient (NDI) Notifications
If your supplement contains a dietary ingredient that was not marketed in the U.S. before October 15, 1994, it is considered a New Dietary Ingredient (NDI). Before marketing such a product, you must submit an NDI notification to FDA at least 75 days before introduction.
The notification must include:
- Identity of the NDI
- Conditions of use (dosage, duration, population)
- Safety evidence (history of use, clinical data, toxicological studies)
4. Supplement Facts Labeling — 21 CFR 101.36
All dietary supplements must have a Supplement Facts panel that includes:
- Serving size and servings per container
- Calories and nutrient information
- List of dietary ingredients and their amounts
- Percent Daily Value (%DV) where established
- A "Daily value not established" footnote for other ingredients
5. Structure/Function Claims
DSHEA allows supplement labels to carry structure/function claims — statements describing how a nutrient affects the body (e.g., "Vitamin C supports immune health"). These are distinct from drug claims.
To use a structure/function claim, you must:
- Have competent and reliable scientific evidence supporting the claim
- Submit a notification to FDA within 30 days of first marketing the product
- Include the mandatory 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."
6. Adverse Event Reporting
Under the Dietary Supplement and Nonprescription Drug Consumer Protection Act, manufacturers, packers, and distributors must:
- Submit reports of serious adverse events to FDA within 15 business days
- Maintain records of all adverse events (serious and non-serious) for 6 years
Common DSHEA Compliance Mistakes to Avoid
- Marketing a supplement with disease claims (e.g., "cures diabetes") — this turns it into an unapproved drug
- Failing to notify FDA about structure/function claims within the 30-day window
- Using an NDI without submitting the required notification
- Inadequate Supplement Facts labeling or missing required disclaimers
- Failing to conduct identity testing on incoming ingredients
How United Regulatory Can Help
Our team specializes in DSHEA compliance strategy, NDI notification preparation, cGMP gap assessments, label reviews, and structure/function claim substantiation. Contact us for a free consultation to evaluate your supplement's compliance posture.