FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA):
The manufacturer of a dietary supplement or dietary ingredient is responsible for ensuring that the product is safe before it is marketed.
- FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market.
This section provides detailed information about:
Q&A on Dietary Supplements
Frequently asked questions about dietary supplements, including definitions, labeling requirements, and regulatory roles and responsibilities.
Using Dietary Supplements
Tips for dietary supplement users, including older supplement users.
Report an Adverse Event
Learn how consumers, health care providers, and others can report a complaint, concern, or problem related to dietary supplements. Includes links to guidance for dietary supplement manufacturers, packers, and distributors.
New Dietary Ingredients Notification Process
Background information for industry, instructions for submitting premarket notifications, and links to relevant guidance and Federal Register documents.
Ensuring the Safety of Dietary Supplements
Generally, manufacturers do not need to register their products with FDA or get FDA approval before producing or selling dietary supplements.* Manufacturers must make sure that product label information is truthful and not misleading.
Under FDA regulations at 21 CFR part 111, all domestic and foreign companies that manufacture, package, label or hold dietary supplement, including those involved with testing, quality control, and dietary supplement distribution in the U.S., must comply with the Dietary Supplement Current Good Manufacturing Practices (CGMPs) for quality control.
In addition, the manufacturer, packer, or distributor whose name appears on the label of a dietary supplement marketed in the United States is required to submit to FDA all serious adverse event reports associated with use of the dietary supplement in the United States.
FDA's responsibilities include product information, such as labeling, claims, package inserts, and accompanying literature. The Federal Trade Commission (FTC) 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 FDA. For more information, see Registration of Food Facilities.
Alerts & Safety Information
Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues Guidance for Industry: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements; Small Entity Compliance Guide Guidance for Industry: Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act FDA Letter to Industry Concerning Liquid Vitamin D Dietary Supplements[ARCHIVED]
- All Dietary Supplements Guidance
- Consumer Update: Fabricant: Supplement Safety is Priority
- For Industry: Dietary Supplements - Reporting an Adverse Event
Energy "Drinks" and Supplements: Investigations of Adverse Event Reports
- Consumer Update: Tainted Products Marketed as Dietary Supplements [ARCHIVED]
- Information on Imports, Exports, and Other International Activities