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Federal Regulation of Dietary Supplements
The Federal Government regulates dietary supplements through the U.S. Food and Drug Administration (FDA). The regulations for dietary supplements are not the same as those for prescription or over-the-counter drugs. In general, the regulations for dietary supplements are less strict.
- A manufacturer does not have to prove the safety and effectiveness of a dietary supplement before it is marketed. A manufacturer is permitted to say that a dietary supplement addresses a nutrient deficiency, supports health, or is linked to a particular body function (e.g., immunity), if there is research to support the claim. Such a claim must be followed by the words "This statement has not been evaluated by the U.S. Food and Drug Administration (FDA). This product is not intended to diagnose, treat, cure, or prevent any disease."
- Manufacturers are expected to follow certain "good manufacturing practices" (GMPs) to ensure that dietary supplements are processed consistently and meet quality standards. Requirements for GMPs went into effect in 2008 for large manufacturers and are being phased in for small manufacturers through 2010.
- Once a dietary supplement is on the market, the FDA monitors safety. If it finds a product to be unsafe, it can take action against the manufacturer and/or distributor, and may issue a warning or require that the product be removed from the marketplace.
Also, once a dietary supplement is on the market, the FDA monitors product information, such as label claims and package inserts. The Federal Trade Commission (FTC) is responsible for regulating product advertising; it requires that all information be truthful and not misleading.
The Federal Government has taken legal action against a number of dietary supplement promoters or Web sites that promote or sell dietary supplements because they have made false or deceptive statements about their products or because marketed products have proven to be unsafe.
Sources of Science-Based Information for Dietary Supplements
It's important to look for reliable sources of information on dietary supplements so you can evaluate the claims that are made about them. The most reliable information on dietary supplements is based on the results of rigorous scientific testing.
To get reliable information on a particular dietary supplement:
- Ask your health care providers. Even if they do not know about a specific dietary supplement, they may be able to access the latest medical guidance about its uses and risks.
- Look for scientific research findings on the dietary supplement. The National Center for Complementary and Alternative Medicine (NCCAM) and the National Institutes of Health (NIH) Office of Dietary Supplements (ODS), as well as other Federal agencies, have free publications, clearinghouses, and information on their Web sites.