Food
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.
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Recently Issued Warning Letters
Warning letters to ten manufacturers and distributors of dietary supplements containing dimethylamylamine, more popularly known as DMAA, for marketing products for which evidence of the safety of the product had not been submitted to FDA.
- Press Release: FDA challenges marketing of DMAA products for lack of safety evidence
April 27, 2012 - Warning Letter to iSatori Global Technologies, LLC 4/24/12
- Warning Letter to Exclusive Supplements, Inc. 4/24/12
- Warning Letter to USP Labs, LLC 4/24/12
- Warning Letter to Fahrenheit Nutrition 4/24/12
- Warning Letter to Nutrex Research, Inc. 4/24/12
- Warning Letter to Gaspari Nutrition, Inc. 4/24/12
- Warning Letter to SNI LLC 4/24/12
- Warning Letter to SEI Pharmaceuticals, Inc 4/24/12
- Warning Letter to Muscle Warfare Inc 4/24/12
- Warning Letter to MuscleMeds Performance Technologies 4/24/12
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Energy "Drinks" and Supplements: Investigations of Adverse Event Reports - Consumer Update: Tainted Products Marketed as Dietary Supplements
- Information on Imports, Exports, and Other International Activities