Table of Contents
Regulating Quality
Regulation of dietary supplements by the U.S. Food and Drug Administration (FDA) is a complex issue.
Labels on vitamins and other dietary supplements now include nutrient information and list all ingredients, including identifying parts of plants from which ingredients may be taken. Unlike the labels for drugs, however, labels for vitamins and supplements may not claim to prevent or treat any specific disease. Labels for vitamins and supplements include one of the following:
- Health claim -- description of how the substance may reduce the risk of a health-related condition
- Nutrient claim -- description of the amount of the nutrient in the product
- Structure or function claim -- description of how the product may affect organs or systems of the body, without claiming to prevent or treat specific diseases
The quality of dietary supplements depends on the manufacturer and is not regulated by the FDA. The U.S. government does not require that supplements be standardized, meaning that the amounts or quality of nutrients may vary depending on the batch. So, more expensive supplements are not necessarily better than less expensive ones. Government regulations are in the process of catching up to the boom in the supplement industry. In the meantime, some companies voluntarily adhere to rigorous quality controls, while others do not.
The U.S. Pharmacopeia (USP), an independent organization that sets quality standards for drugs, has also implemented standards for vitamins. Consumers may look for the USP label on products of companies that adhere to these standards. USP verification means the following:
- What is in the bottle matches what is listed on the label.
- There are no harmful levels of contaminants.
- The supplement will be absorbed properly into the body.
- It has been produced according to good manufacturing standards.
The FDA does not require manufacturers to provide any scientific evidence that dietary supplements are safe and effective before a product is sold (unlike drugs, which must be proven both safe and effective through clinical trials). If a supplement causes side effects in people once it is for sale, the government may place restrictions on the supplement or withdraw it from the market. The FDA may also withdraw products from the market if their labels are misleading or false.
People Who Should Take Vitamin Supplements
About 30% of Americans take at least one vitamin or mineral supplement daily. However, studies evaluating the population as a whole found no difference in mortality rates between people who took vitamin supplements and those who didn't. Most people who eat a healthy diet do not need vitamins, but there are some exceptions.
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Review Date: 10/08/2010
Reviewed By: Harvey Simon, MD, Editor-in-Chief, Associate Professor of Medicine,
Harvard Medical School; Physician, Massachusetts General Hospital.
Also reviewed by David Zieve, MD, MHA, Medical Director, A.D.A.M.,
Inc.
A.D.A.M., Inc. is accredited by URAC, also known as the American Accreditation HealthCare Commission (www.urac.org)
