Dietary supplements refer to vitamins, minerals and other substances available in the form of a pill, gum, lozenge, drops or injections and intended for human consumption. Dietary supplements are available at health food stores, vitamin shops and even in doctor's offices. While their purpose is to provide health benefits, supplements should never be used as a substitute for nutrients found in foods or medication prescribed by your doctor.
About Supplement Regulation
The U.S. Food and Drug Administration was created to regulate all food and drugs in the United States -- this agency does not monitor dietary supplements. The Center for Food Safety and Applied Nutrition, or CFSAN, is a scientific regulatory organization responsible for cosmetics, drugs, medical devices and dietary supplements produced in and imported into the United States. As part of a 1994 act that helped to form this agency, the FDA created the United States Pharmacopeia and National Formulary, which provides dietary supplement guidelines and specifications. Manufactures of dietary supplements are not legally obligated to follow these guidelines.
Regulations
Dietary supplements are treated similarly to food products with some exceptions. Supplement manufacturers are not required to register with the FDA and do not need approval from the FDA to produce or sell a product. Manufacturers are responsible for ensuring that their product is safe and are obligated to print non-misleading labels that are truthful.
Monitoring
Supplement manufacturers operate under very loose guidelines. They're encouraged to report adverse events, such as injuries or illness, caused by or related to their product. Manufacturers, however, are not legally required to report to the FDA. The FDA monitors the safety of supplements through this voluntary process. Information on supplement labels and advertising fall under a completely different agency. The Federal Trade Commission, or FTC, is responsible for regulating false and misleading health claims from dietary supplement manufacturers and distributors.
Good Manufacturing Practices
One way to ensure that a dietary supplement is safe is by purchasing products acknowledged under a program known as good manufacturing practices, or GMPs. This program provides strict, detailed guidelines for manufacturing products meant for human consumption, including food, drugs and dietary supplements. This is a voluntary verification program developed so that consumers can identify products that are made following specific guidelines developed by the FDA.
References
- U.S. Pharmacopeia: The Regulation of Dietary Supplements; October 2006
- Food and Drug Administration: About the Center for Food Safety and Applied Nutrition; April 2010
- Food and Drug Administration: Current Good Manufacturing Practices; December 2010
- Office of Dietary Supplements: Frequently Asked Questions
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