Regulation of Dietary Supplements

A dietary supplement is defined as a product taken by mouth containing a dietary ingredient intended to supplement the diet. Dietary ingredients include vitamins, minerals, herbs or other botanicals, and amino acids. In 1994, Congress passed the Dietary Supplements Health and Education Act (DSHEA), an important piece of legislation which provided a regulatory framework for assuring the safety of dietary supplements. DSHEA also granted the U.S. Food and Drug Administration (FDA) authority to establish regulations regarding dietary supplement manufacturing, regulating health claims and labeling.

Dietary supplements are regulated products. Dietary supplement marketing, manufacturing, labeling, and advertising are all covered by regulations enforced by FDA and the Federal Trade Commission.

Further Reading

• Dietary Supplements, FDA
• A Summary of the Key Differences Between the FDA’s Drug and Dietary Supplement GMPs
• Side-by-Side Comparison: 21 CFR, Parts 110, 111, 211 and 820
• FDA Recalls, Market Withdrawals, & Safety Alerts
• National Center for Complementary and Integrative Health