IOM Releases Report on Supplement Safety

WASHINGTON--The Institute of Medicine (IOM) and the National Research Council of the National Academies outlined a science-based process for assessing supplement ingredients in Dietary Supplements: A Framework for Evaluating Safety, which was sponsored by the Food and Drug Administration (FDA). According to IOM, this approach to safety evaluations works within the regulatory parameters set by the Dietary Supplement Health and Education Act (DSHEA).

"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, chairwoman of the committee that wrote the report and a professor of nutrition, food science and internal medicine at the University of California, Davis.

IOM stated DSHEA gives FDA the ability to regulate dietary supplements as foods instead of drugs--which allows supplements to bypass the premarket approval process. "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 report states FDA does not need to wait to take action until a product is seen to directly harm humans; rather, the agency must show a product poses an unreasonable risk to users. The IOM report states data from animal studies and validated in vitro tests may provide enough information to warrant FDA action, even without direct evidence of harmful effects in people. In addition, historical use is not always enough by itself to prove the safety of a supplement, even if it has been consumed for centuries or used in folk medicine, the committee determined.

IOM advises manufacturers report adverse events to FDA in a timely fashion to facilitate safety evaluations. According to the report, lack of reporting significantly hampers the agency's ability to actively monitor supplement safety. The report also suggests supplements should include a toll-free number for health problems or concerns related to the product, as well as include the name and place of business of both the distributor and the manufacturer.

For more on the report, visit www.iom.edu/report.asp?id=19578.