Annual sales of dietary supplements in the United States are approaching $16 billion.  An average of 1,000 new products are developed each year.  Although manufacturers are restricted from claiming that using their products leads to therapeutic benefits, surveys show that many people take supplements for purposes such as treating colds or alleviating depression.  According to other survey data, the majority of consumers believe these products to be either reasonably or completely safe.

The Dietary Supplement Health and Education Act (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 the U.S. Food and Drug Administration (FDA) to determine whether a particular substance on the market is harmful based upon information available in the public domain.

To bolster the FDA's ability to evaluate the safety of dietary supplements, the Institute of Medicine report, titled Dietary Supplements: A Framework for Evaluating Safety, 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 DSHEA, which does not require manufacturers to provide safety data on their products.  However, the report states that 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.

Dietary Supplements: A Framework for Evaluating Safety

• Press Release
• Report
• Prototype Monographs