WASHINGTON -- To bolster the U.S. Food and Drug Administration's ability to evaluate the safety of dietary supplements, a new report from the Institute of Medicine and the National Research Council of the National Academies outlines a science-based process for assessing supplement ingredients, even when data about a substance's safety in humans is scarce. This approach to safety evaluation works within the regulatory parameters set by the Dietary Supplement Health and Education Act (DSHEA), which does not require manufacturers to provide safety data on their products. However, supplement makers, the public, and others need to increase their reporting of health problems related to supplement use in order to further improve the agency's ability to protect consumers, the report says.

"Approximately 29,000 dietary supplements are currently available to the American consumer, and while most are safe, questions have been raised about FDA's resources to identify and address the occasional problem products," said Barbara Schneeman, chair of the committee that wrote the report and professor of nutrition, food science, and internal medicine, University of California, Davis. DSHEA established in 1994 that dietary supplements are to be regulated like foods instead of drugs, meaning that they are considered safe unless proved otherwise and are not required to be clinically tested before they reach the market. It is therefore up to FDA to determine whether a particular substance on the market is harmful based upon information available in the public domain. "In some cases, data on an ingredient's safety in humans are scant or nonexistent," Schneeman said. "Our report describes how other types of data -- such as the results of tests in animals, or information on similar substances -- can be used in a science-based approach to determine whether a supplement poses a significant risk to human health."

The process provides a way to identify supplement ingred
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Contact: Christine Stencel
news@nas.edu
202-334-2138
The National Academies
1-Apr-2004

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