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). 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.
Since 1994, 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 voluntary postmarket surveillance is uncommon and no accepted surveillance standards exist.
Proposed changes in federal regulation of the dietary supplement industry have spurred some manufacturers to consider their monitoring systems. Taking this first step was Metabolife International Inc. (MET), which retained LSRO. LSRO was asked to determine how a system for handling consumer inquiries could be tailored to the task of monitoring the safety of dietary supplements.
The LSRO in conjunction with an Expert Committee of scientists completed this study in two phases:
Phase I examined 200 postmarket surveillance Individual Data Records (IDRs) collected by the FDA and 200 IDRs reports collected by MET relating to Metabolife 356® and other ephedrine alkaloid-containing supplements. The goal of Phase I was to determine how useful these data were as signals in detecting product problems.
Phase II examined noteworthy postmarket surveillance programs currently in use for other products regulated by FDA with an eye to making recommendations for the design and implementation of an effective monitoring system for adverse events relating to dietary supplements.
In their Phase I review, the Committee found that the records collected by MET were qualitatively less informative than those collected by the FDA and posed a greater challenge for application in public health-related analyses. As the MET IDRs were not intended to support an adverse event reporting system, consumer complaints were collected in most cases during a single telephone contact at a customer service center. The researchers found that while both the FDA and the MET IDRs had sufficient information to permit the preliminary step in detection of potential product problems (signal detection), a substantially greater number of FDA IDRs had sufficient information to permit prioritizing the signals, because (1) a relatively high percentage of FDA reports were from health care professionals and (2) most MET IDRs lacked follow up and physician evaluation.