The Life Sciences Research Office undertook a study to review adverse event monitoring systems for dietary supplements, identify procedural problems with these systems, and make recommendations about establishing a useful system to monitor and respond to adverse event reports.

Sponsor

Metabolife International, Inc. (San Diego, CA), through its counsel, Patton Boggs, L.L.P. sought improvements in the process of monitoring product safety. They were concerned that the current system of documenting consumer complaints may not support recognition of product-related events and they sought scientific advice on how to establish a system tailored to the task of monitoring the safety of dietary supplements.

Goals and Process

In Phase I of the project, LSRO reviewed and analyzed 200 data records from the Sponsor, collected for a particular brand of dietary supplements and compared them to data accumulated by the U.S. Food and Drug Administration about similar products. The goal of the review was not to evaluate whether the existing data would support causal relationships between use of the product and identifiable adverse health outcomes, but rather to compare the data sets qualitatively and to make conclusions about the usefulness of the data as signals for product safety. The review took place in context of the applicable regulatory standards for dietary supplements and focused on products containing controversial ingredients.

In Phase II of the project the Committee outlined how adverse event reports might be collected and evaluated in the future by the dietary supplement industry to provide more useful and reliable signals of potential problems with product.

LSRO Report

The report, "Recommendations for Adverse Event Monitoring Programs for Dietary Supplements," was completed and delivered to the Sponsor on June 7, 2004. This report is available to the public for purchase.