For Dietary Supplements Press Release The Life Sciences Research Office Announces Completion of New Report:
Recommendations for Adverse Event Monitoring Programs
for Dietary Supplements Today, August 4, 2004, the Life Sciences Research Office (LSRO) announced completion of a new report, Recommendations for Adverse Event Monitoring Programs for Dietary Supplements. Currently, there is no federal guidance or mandate for the collection, documentation, or evaluation of consumer health complaints associated with the use of dietary supplements. Metabolife International, Inc. (San Diego, CA), through its counsel, Patton Boggs, L.L.P. (Washington, DC), tasked LSRO, a 501(c)3 nonprofit scientific research organization, to make recommendations for the design and development of adverse event monitoring programs specifically tailored for dietary supplements. LSRO convened an ad-hoc independent, expert advisory panel and divided this overall project into two phases:
(1) The review and comparison of individual data records associated with the use of dietary supplements and evaluation of their usefulness for generating signals of potential product problems.
(2) The review of postmarketing surveillance programs described in the scientific literature and recommendations for the design and implementation of an effective system for monitoring and responding to health complaints associated with the use of dietary supplements.
The members of the ad-hoc expert panel are:
Catherine St. Hilaire, Ph.D. (Chair)
Alexandria, VA John A. Clark, M.D., MSPH
Blue Bell, PA Barbara Insley Crouch, Pharm.D., MSPH
Salt Lake City, UT Janet Greger, Ph.D.
Storrs, CT Robert Hoerr, M.D., Ph.D.
St. Paul, MN Valen Johnson, Ph.D.
Ann Arbor, MN D. Warner North, Ph.D.
Belmont, CA
Adverse event monitoring programs identify potential product-related health problems or signals, which are further quantified and evaluated to determine whether they represent coincidence, artifact, or a genuine problem in toxicity that might lead to changes in labeling and/or restrictions in use. The new LSRO report provides scientific advice on how adverse event surveillance programs can be tailored to monitoring the safety of dietary supplements. The report is intended to be useful in the modern dietary supplement industry and in the future.
To determine the requirements of an effective adverse event monitoring program, LSRO staff and their advisors reviewed approximately 500 published scientific papers, books, and guidance documents. In its report, LSRO explains how adverse events are collected, documented, organized, and analyzed during postmarketing surveillance and outlines the minimal requirements to develop a program specifically for dietary supplements. The text is supplemented with several figures and tables, and in-depth materials are included in the appendices for reference, with emphasis on example surveillance programs.
LSRO reports provide information, analysis, and advice about fundamental issues in areas such as medicine, health care, nutrition, food safety, and the environment. Copies of this and other LSRO publications may be obtained from LSRO at 9650 Rockville Pike, Bethesda, MD 20814-3998, 301-634-7030, or from the LSRO Publication Bookstore at the LSRO website (www.LSRO.org).
