Guide to Understanding Dietary Supplement Regulations

With so many dietary supplements on the market today, many people wonder if these products are truly regulated and if so, what the regulations cover.

Does the U.S. federal government regulate dietary supplements?

Yes. Congress established the Dietary Supplement Health and Education Act (DSHEA) in 1994 to create a regulatory framework to address the safety and labeling of dietary supplements. More recent regulations require manufacturers to observe good manufacturing practices (GMPs) established for this industry, including ingredient testing.

In contrast to prescription and over-the-counter drugs, dietary supplements covered by this act do not normally need approval from the U.S. Food and Drug Administration (FDA) prior to being marketed. The main exception is for products introducing a new dietary ingredient, where pre-market review for safety data and other information is required.

Does the U.S. federal government regulate the advertising of dietary supplements?

Yes. The Federal Trade Commission (FTC) regulates advertising for supplements and most other products sold to consumers.

Advertising and promotional materials received in the mail are subject to U.S. Postal Inspection Service regulations.

How do regulations for supplements differ from those that cover prescription or over-the-counter drugs?

Dietary supplements are classified under the general category of food products, not drugs.

Before marketing, drugs must undergo clinical studies to determine their effectiveness, safety, possible interactions with other substances and appropriate dosages. The U.S. FDA then reviews the data and determines whether to authorize use of the drugs.

In most cases, the FDA does not test dietary supplements or authorize their use prior to their being marketed. The FDA can order the removal of a dietary supplement from the marketplace, however, if they feel it is unsafe for consumers.

Is there an American National Standard for dietary supplements?

Yes. NSF/ANSI Standard 173: Dietary Supplements is an American National Standard that helps confirm that what's on the label matches what's in the bottle. In addition, testing is conducted to confirm that there are no unsafe levels of contaminants such as heavy metals, pesticides and herbicides in the product.