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Overview
About the Office of Nutritional Products, Labeling, and Dietary Supplements
FDA-DSFL Electronic Newsletter | Recent Announcements | Frequently Requested Information
FDA regulates dietary supplements under a different set of regulations than those covering “conventional” foods and drug products (prescription and Over-the-Counter). Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. Generally, manufacturers do not need to register their products with FDA nor get FDA approval before producing or selling dietary supplements.* Manufacturers must make sure that product label information is truthful and not misleading.
FDA’s post-marketing responsibilities include monitoring safety, e.g. voluntary dietary supplement adverse event reporting, and product information, such as labeling, claims, package inserts, and accompanying literature. The Federal Trade Commission regulates dietary supplement advertising.
*Domestic and foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States are required to register their facility with the FDA. For more information, see Registration of Food Facilities.
About the Office of Nutritional Products, Labeling, and Dietary Supplements
- Office of Nutritional Products, Labeling, and Dietary Supplements November 2004; Updated January 2006
FDA-DSFL Electronic Newsletter
Recent Announcements
- Buying Fake ED Products Online January 4, 2008; Updated: March 27, 2008 (Consumer Update)
- Fortify Your Knowledge About Vitamins November 2007 (Consumer Update)
- Satellite Broadcast: Overview of the Implementation of the Current Good Manufacturing Practices for Dietary Supplements Guidance for Industry October 5, 2007
Frequently Requested Information
- What is a dietary supplement?
- What is FDA’s role in regulating dietary supplements versus the manufacturer’s responsibility for marketing them?
- Where can I get information about a specific dietary supplement?
- Who has the responsibility for ensuring that a dietary supplement is safe?
- Dietary Supplement Health and Education Act of 1994
- Consolidated Information on Dietary Supplement Labeling
- Consolidated Information on Ephedrine Alkaloids
- Responses to Questions about Codex and Dietary Supplements August 2005
