USP Urges Quality, Safety in Dietary Supplements
Lee, Shirley, Drug Topics
Are you among the 50% of all adult Americans shown by a recent survey to use dietary supplements on a regular basis? If so, do you believe they are as beneficial as their manufacturers claim? These and other pertinent questions were put to attendees of a three-day conference sponsored by the U.S. Pharmacopeia (USP) at the University of California Los Angeles campus last month. The focus of the conference was on ensuring the quality and appropriate use of dietary supplements, nutritionals, herbals, and botanicals.
Nearly 200 participants heard Jerome A. Halperin, executive v.p., USP, explain that among USP's goals is establishing standards and providing information to help pharmacists and others understand the quality of botanicalbased products and the validity of their claims. Halperin further emphasized that USP is focusing only on those botanicals that, combined, account for approximately 90% of retail sales.
Robert E. Vestal, M.D., chief of the clinical pharmacology and gerontology research unit at the Department of Veterans Affairs Medical Center, Boise, Idaho, and an elected member of the USP committee of revision, addressed concerns about claims based on trials that are not up to the usual standards for clinical drug trials. He discussed consumer self-diagnosis as well as the lack of public information regarding the use of botanical products in specific circumstances, such as during pregnancy, while breast-feeding, and by children. Two other issues the industry should concern itself with, he said, are the scarcity of adverse-reaction and druginteraction reports and the dearth of information on studies showing no significant benefits.
Finally, he emphasized, "the manufacturing of many dietary supplements is not standardized within the industry, and the active ingredients may vary from batch to batch. Since these products are classified as dietary supplements or foods, there is minimal regulation by the Food & Drug Administration."
Paul L. Schiff Jr., Ph.D., professor of pharmaceutical sciences at the University of Pittsburgh School of Pharmacy and a member of the USP subcommittee on natural products, pointed out that USP's efforts to standardize botanical substances dates back to 1820 and to the first published edition of the United States Pharmacopeia. While the number of USP monographs have decreased significantly over the years with the pharmaceutical industry's focus on synthetic medicines, the trend has begun to reverse itself, he said. Schiff credited the 1994 Dietary Supplement Health & Education Act (DSHEA) and a 1995 USP Convention resolution as an impetus behind his committee's decision to refocus on standards for dietary supplements, including botanicals. …