DSHEA Compliance for Supplement Affiliates: An Overview
The Dietary Supplement Health and Education Act of 1994 (DSHEA) defines how supplements are regulated. What it established, the FDA/FTC split, and why affiliates must understand it.
The Dietary Supplement Health and Education Act of 1994 — DSHEA — is the federal law that defines how dietary supplements are regulated in the United States. For any affiliate who promotes supplements, DSHEA is essential background: it determines what can and cannot be said about a supplement, and repeating a non-compliant claim can make you part of the problem in the eyes of regulators.
What DSHEA established
DSHEA amended the Federal Food, Drug, and Cosmetic Act and created a distinct regulatory category for dietary supplements, treating them as a subcategory of food rather than as drugs. The practical consequences shape the entire industry:
- Supplements do not require FDA pre-market approval the way drugs do.
- Manufacturers are responsible for ensuring their products are safe and their labels are truthful and not misleading.
- The FDA generally acts post-market — the burden is on the agency to show that a marketed supplement is unsafe or misbranded.
- Supplements may make certain claims, but disease claims are prohibited — only drugs may claim to diagnose, treat, cure, or prevent disease.
Two agencies regulate supplements
The FDA governs supplement labeling, manufacturing, and claim notifications under DSHEA. The FTC governs supplement advertising, requiring that claims be truthful and substantiated. Both apply at once, and an affiliate’s content is advertising.
Why DSHEA matters to affiliates
If you run a supplement affiliate site, you are promoting products whose claims are tightly regulated. When you repeat a manufacturer’s structure/function claim, imply a health benefit, or feature testimonials, you step into the same rules the seller faces. The FTC is explicit that everyone who participates in marketing shares responsibility for truthful, substantiated claims — which includes affiliates. On top of that, you owe your ordinary affiliate disclosure.
This section
- The three types of supplement claims — health, nutrient content, and structure/function, plus the disease-claim line.
- Structure/function claims and the DSHEA disclaimer — the required wording, notification, and a copyable disclaimer.
- Supplement advertising and FTC substantiation — the “competent and reliable scientific evidence” standard.
- New dietary ingredients and cGMP — NDI notifications and manufacturing standards that define a compliant product.
For the affiliate-disclosure angle specifically, see supplement affiliate disclosures in the Industries section.
Authoritative sources
Last reviewed July 2026. This page is general educational information, not legal or tax advice.