HealthMap

Federal Regulation of Dietary Supplements

Based on the information from Acu-Cell Nutrition, the sale and regulation of dietary supplements in the United States are primarily governed by the Dietary Supplement Health and Education Act (DSHEA) of 1994, which is an amendment to the Federal Food, Drug, and Cosmetic Act.

Key Aspects of the Governing Law

• Definition: Under DSHEA, dietary supplements are defined as products intended to supplement the diet that contain one or more dietary ingredients, such as vitamins, minerals, herbs, amino acids, and metabolites.
• Pre-Market Approval: Unlike pharmaceutical drugs, manufacturers do not need FDA approval before marketing dietary supplements, placing the responsibility on the manufacturer to ensure safety and truthful labeling.
• FDA Oversight: The Food and Drug Administration (FDA) is responsible for regulating dietary supplements after they reach the marketplace, meaning they must prove a product is unsafe or misbranded to take regulatory action.
• Labeling Requirements: Products must include a "Supplement Facts" panel and are prohibited from making disease-treatment claims (such as claiming to cure, treat, or prevent a specific disease).