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Panel offers recommendations for monitoring adverse events from dietary supplements

(November 15, 2004) Bethesda, MD The General Accounting Office estimates that there are some 1500 manufacturing and repacking facilities for dietary supplements in the US. These facilities produce approximately 29,000 unique formulations that are packed into more than 75,000 distinctly labeled products and made readily available to the public through supermarkets, retail outlets, the Internet and television infomercials.

Protecting the health of those that consume dietary supplements is of great importance to public health agencies like the Food and Drug Administration (FDA) and the product manufacturers. A newly released report may further help consumers, regulators and manufacturers learn more about the safety of dietary supplements.

The report, entitled "Recommendations for Adverse Event Monitoring Programs for Dietary Supplements" is the latest scientific review to be released by the Life Sciences Research Office (LSRO), WWW.LSRO.ORG. The LSRO is an internationally renowned, non-profit organization located in suburban Washington, DC that provides independent expert evaluation of issues, opportunities, data, programs, and proposals in the food, health and bioscience sectors.

Background
Since l994, the FDA has regulated dietary supplements under a different set of regulations than 'conventional' foods or drug products. No federal mandate for collecting, documenting or evaluating health-related consumer complaints associated with the use of dietary supplements now exists. Rather, adverse event reporting (an undesirable health-related sign or symptom that is detected in an exposed individual after using the product) is based on the concept of postmarket (after product introduction) surveillance. Postmarket surveillance programs are similar across a variety of product categories since they follow similar information processing principles. However, in the dietary supplements sector
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Contact: Donna Krupa
djkrupa1@aol.com
703-527-7357
Life Sciences Research Office
15-Nov-2004


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