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Post Washington, DC • • FDASets Labeling Rules For Dietary Supplements Nutritional Data, Support for Health G7aims Required -By-3ohn Schwartz er,Lkm"eou sne et. The Food and Drug Administration yes- terday announced new rules governing la- beling and health claims for vitamins, min- erals, herbs and other dietary supplements. The rules would prohibit supplement la- bels from making anyhe3lth claims not sup- ported by "significant agreement" within the scientific community. They also would require manufacturers of dietary supple- ments to rewrite their labels to include de- tailed nutritional information, including the FDA-recommended daily intake of the sub- stance. The FDA will accept public comment on the rules for 60 days; barring changes by the agency, the regulations will become law on Dec. 15. The regulations have been harshly crit- icized by supplement manufacturers, who contend that the rules will unduly restrict information available to consumers. "FDA's goal is simple," FDA Commis- sioner David A. Kessler said in a statement. "We want people to have access to products that are safe, and claims made about the health and nutritional benefits should be useful." In an interview, Kessler said he consid- ered the new regulations part of the agen- cy's central mission. "Fifty years ago our food and drug laws were designed to sep- arate products made by snake oil salesmen from drugs that really worked," he said. "For every product and diet supplement today that may be helpful to reduce disease, there are hundreds of products marketed to cure diseases like AIDS and cancer that are unsubstantiated " The FDA statement said that at least one supplement claim already had been proven sufficiently-manufacturers will be allowed to print claims that folic acid might prevent neural tube birth defects, as when babies are bom with open spinal columns. The agency said it also is looking at evidence that antioxidants such as vitamin E might have a role in preventing cancer and other diseases. At the same time, the agency pointed to risks in supplements that still merit further study, especially the popular use of amino acids. A bad batch of the amino acid L-tryp- tophan was linked to 1,500 illnesses and 38 deaths last year. The agency asked manu- facturers of amino acids to submit infomia- tion substantiating the safety of their prod- ucts. Manufacturers claim that FDA attempts to regulate the supplements industry are in fact an attempt to ban-and, by extension, to restrict the consumers' right to buy-vi- tamins and supplements. Gerald Kessler, president of the industry group Nutritional Health Alliance, linked vitamin-taking to "our spiritual heritage," because medicinal herbs are mentioned in the Bible, and to the right to make informed choices. "You're treading on the essence of democracy and the essence of a spiritual legacy," he said. J.B. Cordaro, president of the Council for Responsible Nutrition, a manufacturers trade association, said his group supports federal regulation concerning quality stan- dards and truthful labeling, but he added that the FDA is too restrictive about the health claims it allows manufacturers to make. The new requirements are designed to , bring supplements under the 1990 Nutn- tional Labeling and Education Act, which sets standards for labels on virtually all processed foods. Congress temporarily ex- cluded dietary supplements from the law last year. But manufacturers say the FDA is treat- ing their products more like drugs, which must go through rigorous and costly ap- proval processes, than like food. An industry-favored bill, proposed in March by Sen. Orrin G. Hatch (R-Utah), would allow broader product claims. Utah is home to a $700 million supplements indus- try. Kessler said the agency is not out to ban vitamins. "There is a lot of misinformation out there," he said. "For the vast majority of vitamins and minerals we have no problem." But many supplements that are derived from foods still might hurt consumers if ingested in high concentrations, said Mike Taylor, FDA deputy commissioner for pol- icy. "Just because a substance exists in na- ture does not make it safe." Some consumer advocates applauded the FDA's move. Bruce Silverglade, director of legal affairs for the nonprofit Center for Science in the Public Interest, said, "As con- sumers increasingly turn toward supple- ments to protect their health, it's all the more important that the FDA rid the shelves of health food stores.of products that make shaky and downright dishonest health claims." 0