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Food Safety Works Colorado State University Extension
SafeFood Rapid Response Network

SAFEFOOD NEWS - Spring 1998 - Vol 2 / No. 3

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Special Nutritionals Adverse Event Monitoring System (SN/AEMS)

The passage of DSHEA (Dietary Supplements Health and Education Act) in 1994, resulted in dietary supplements no longer being subject to pre-market safety evaluations. This has made it easier for more dietary supplements to enter the market. Trying to keep up to date with the multitude of herbs and supplements available to consumers is a daunting task. It is estimated that Americans spent 3.2 billion dollars on dietary supplements last year.

Since pre-market safety evaluations are no longer required, an adverse event monitoring system has been designed to identify unanticipated or unintended safety problems with the use of marketed products. The Special Nutritionals Adverse Event Monitoring System (SN/AEMS) is used by FDA to identify patterns of adverse events which may require further investigation to determine whether public health actions are needed.

It is now possible to search the SN/AEMS database if you have a question about a specific herb or supplement and whether an adverse event has occurred with its use. The SN/AEMS contains adverse events dating back to approximately 1993. As of May 14, 1998, the report contained at least 2,450 adverse event reports and information on at least 3,183 products. It is important to remember that the absence of a report does not necessarily mean a particular product or ingredient has not been or is not likely to be associated with an adverse event. Rather, it may have not been reported to the FDA at this time.

Encouraging consumers and/or clients to report adverse events with the use of dietary supplements to the MedWatch reporting program will enhance SN/AEMS. To access MedWatch, either call the FDA Office of Consumer Affairs at (301) 443- 5006, or access the URL at http://www.fda.gov/medwatch/

For more information on SN/AEMS and how to search the database, use the following URL address http://vm.cfsan.fda.gov/~dms/aems.ht ml. Other web sites to consider include

Sources: 1) U.S. FDA Center for Food Safety and Appled Nutriton, Dietary Supplement Health and Education Act of 1994, December 1, 1995. 2) U.S. FDA Center for Food Safety and Applied Nutrition, the Special Nutritionals Adverse Event Monitoring System.

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