Report condemns FDA over supplements
regulation of dietary supplements, stating that current standards
and their enforcement...
US federal investigators this week called for much more stringent regulation of dietary supplements, stating that current standards and their enforcement were grossly inadequate and allowed safety problems to go unchecked, the New York Times reports. In the final draft of a new report, the acting inspector general of the Health and Human Services Department said manufacturers of dietary supplements, the supplements themselves and their ingredients should be registered with thegovernment. The investigators said the Food and Drug Administration lacked the most basic information needed to analyse reports of illness and injury associated with dietary supplements, which include vitamins and minerals, herbal products, amino acids and some sports nutrition products. Manufacturers of supplements are not required to report such "adverse events" to thegovernment, as makers of prescription drugs must do. In many cases, the investigators said, federal officials could not determine the ingredients and could not identify or locate the maker of products suspected of harming users. The study, to be issued later this month, said: "F.D.A. was unable to determine the ingredients for 32 per cent (1,153 of 3,574) of the products mentioned in adverse event reports. F.D.A. does not have the product labels for 77 per cent of theproducts mentioned in reports. FDA. was unable to determine the manufacturer for 32 per cent of the products involved in reports." The acting inspector general, Michael F. Mangano, said more than 100 million Americans were taking dietary supplements. The industry estimates that retail sales total nearly $15 billion a year. The Council for Responsible Nutrition, a trade organisation of dietarysupplement manufacturers, said the report was seriously flawed and demanded extensive revision of the draft before the report is made public.