(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), http://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.
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 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.
In Phase II, LSRO’s Expert Committee concluded that if a voluntary surveillance program were to be adopted by dietary supplement companies, it would be inappropriate to use the methods being used for mandatory surveillance programs for prescription medications. The study authors noted that surveillance systems for dietary supplements had to be tailored to accommodate the voluntary and consumer-driven (as opposed to health care professional-driven) nature of supplement-associated adverse event reporting.
Conclusions and Recommendations
Analyses of MET IDRs and a review of existing surveillance programs led the LSRO experts to make several recommendations, which they noted, should be broadly applicable to dietary supplements and not to any one particular type of supplement or manufacturer. The LSRO Committee concluded that an effective postmarket surveillance program can enhance the likelihood that true adverse effects, unknown at the time of marketing, are identified. The recommendations include specific, detailed advice concerning the required components of such a system, as well as recommended enhancements to improve the effectiveness of the system including: (1) a proposal of a surveillance program for the dietary supplements sector that would make such a system practical and auditable; (2) a user-friendly approach for consumers that was simple and concise, and available 24-hours a day, 365 days per year; (3) creation of a standardized questionnaire that would facilitate the collection of data that are useful for detecting, prioritizing and evaluating adverse event signals in order to establish and maintain the integrity of the process; and (4) ways in which issues regarding signaling, issues resolution and risk management, and quality assurance could be addressed.
The LSRO report provides a framework for building a postmarket surveillance system for dietary supplements that can be implemented by individual manufacturers or by the industry as a whole. Building on this framework could be a significant step in helping to assure consumer safety for the one in three adult Americans who routinely use dietary supplements, accounting for a cumulative $18 billion per year in sales.
For nearly half a century, the Life Sciences Research Office (LSRO) has provided expert objective scientific opinions and evaluations to governmental agencies and leading corporations in the food, health and bioscience sectors. A non-profit organization originally established in 1962 by the Federation of American Societies for Experimental Biology, LSRO provides independent science-based analysis and advice.
Donna Krupa: 703.527.7357