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With so many dietary supplements on the market today, many people wonder if they are truly regulated and if so, what the regulations cover.
Here are answers to some of the more frequently asked questions received by the NSF Consumer Affairs Office.
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 have been adopted that 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 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.
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.
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 FDA will then review the data and determine 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.
Yes. NSF/ANSI Standard 173 is an American National Standard that helps assure consumers that what's on the label matches what's in the bottle. The NSF Certification Program, which is based on that American National Standard, protects consumers by testing for contaminants and verifying that NSF Certified supplements contain the ingredients stated on the label and that there are no unlisted ingredients or unsafe levels of contaminants present in the product.
For additional information about supplements, visit the NSF Dietary Supplement Web page or contact the NSF Consumer Affairs Office at info@nsf.org.
