FAQs | American Dietary Supplements (3) - How Are Dietary Supplements Regulated in the U.S.?

We have collected frequently asked questions on the dietary supplement in the United States for your reference.

1. What are the FDA’s regulatory responsibilities for dietary supplements?

The FDA’s regulatory responsibilities for dietary supplements include:

• Inspecting dietary supplement manufacturing facilities;
• Reviewing new dietary ingredient notifications and other regulatory submissions related to dietary supplements;
• Investigating complaints;
• Monitoring the dietary supplement market;
• Inspecting imported dietary supplements and dietary ingredients to ensure they meet U.S. requirements; and
• Reviewing adverse event reports submitted by companies, consumers, and healthcare professionals to identify products that may pose safety concerns.

2. Who is responsible for ensuring that dietary supplement products meet appropriate safety standards?

Manufacturers and distributors are responsible for ensuring that dietary supplement products meet safety standards. If they fail to fulfill this responsibility and counterfeit supplements enter the market, the FDA has the authority to take enforcement actions to protect consumers. The FDA generally only enforces regulations after a product is on the market. Manufacturers and distributors must record, investigate, and report serious adverse events related to their products to the FDA. The FDA assesses these reports, as well as any other adverse events submitted by healthcare professionals or consumers, to identify early signals of potential safety risks posed by the products.

3. Who regulates dietary supplement advertising?

The FDA and the Federal Trade Commission (FTC) share responsibility for regulating dietary supplements and related promotions. The FDA typically oversees safety, quality, and labeling of dietary supplements. The FTC primarily regulates advertising.

If violations are found, both agencies have the authority to take enforcement actions against dietary supplements and companies. When evaluating the intended use of a product labeled as a dietary supplement, the FDA takes into account the advertising content. Advertisements and other promotional materials sent via mail are also regulated by the U.S. Postal Inspection Service.

4. Who regulates the use of the term "organic" on dietary supplements under the National Organic Program? 

The U.S. Department of Agriculture (USDA) regulates the use of the term "organic" under the National Organic Program (NOP). The NOP is a federal regulatory program designed to establish and enforce consistent national standards for organic agricultural products sold in the U.S.

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Further Information

FAQs| American Dietary Supplement (1) – How Do You Label A Dietary Supplement?

FAQs| American Dietary Supplements (2) – Do Dietary Supplements Require FDA Approval Before Marketing?