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Dietary Supplements

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:

• How FDA regulates dietary supplement products and dietary ingredients
• Responsibilities of foreign and domestic companies that produce or sell dietary supplements
• Consumer information about the potential benefits and risks of using dietary supplements

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.

View Frequently Asked Questions on dietary supplements. 

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