State Journal-Register 10/9/94 Law will ban unproven diet supplement claims THE ASSOCIATED

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State Journal-Register 10/9/94 Law will ban unproven diet supplement claims THE ASSOCIATED PRESS WASHINGTON--Congress decided a bitter fight between dietary supplement makers and their critics Friday, passing legislation that allows any supplement to be sold once it has been shown to be safe, but banning most claims to cure or prevent illness. The Senate passed the bill early Saturday and sent it to President Clinton for his expected signature. The House passed the bill Friday. "This bill resolves an extremely contentious issue," Rep. Henry Waxman, D-Calif., said before the House passed the bill by voice vote at 3 a.m. Saturday and sent it to the Senate. The measure would require manufacturers of vitamins, minerals, herbal products and amino acids to follow for four years very strict government rules on product health claims --rules companies say constitute a ban. The bill would set the first safety standard for dietary supplements: They must not pose a "significant or unreasonable risk" of injury if used as directed. And makers of new products would have to show the Food and Drug Administration proof that they are safe 75 days before they go on the market, so FDA has a chance to fight any sup plements it fears are dangerous. Those provisions were the most fiercely fought in the two-year battle over the $4 billion industry. Companies contended FDA unfairly treated their mostly natural products as drugs, and spent S2.5 million lobbying Congress to change that. Critics charged the industry with selling snake-oil therapy. Half of all Americans are estimated to consume dietary supplements, and about 2 million wrote Congress asking for legislation ensuring their access to the products. But Friday, both sides were happy. The bill "will help to keep our industry alive," said Gerald Kessler of the Nutritional Health Alliance. "Now dietary supplements will be regulated within a rational framework," said Michael Ford of the National Nutritional Foods Association. "We are delighted," said Bruce Silverglade of the consumer group Center for Science in the Public Interest. "The bill preserves access to supplement ingredients while protecting consumers from misleading health claims and unsafe products." The bill amends a Senate version, adding the safety provisions to beef up FDA oversight. The new version is expected to easily pass the Senate before Congress adjourns this weekend. The other major change is that supplements comply with strict health-claim rules for four years, instead of the two years the Senate had mandated. At issue are FDA standards that require significant scientific agreement on the disease benefits of supplements before a product can make a claim. Only calcium to prevent osteoporosis and folic acid to fight birth defects have passed FDA muster. Manufacturers say significant agreement is almost never found in science, and that FDA-rejected claims such as "anti-oxidant vitamins prevent cancer" should be allowed. Under the compromise bill, a presidential commission composed of supplement experts would study the issue for two years and decide how health claims should be treated. Then, the secretary of health and human services would have two adjust FDA rules. If the secretary did not, Congress could reopen the issue. But manufacturers did win some leeway--the right to label how a substance affects bodily function. They could say, for example, that Vitamin A is necessary for good vision. That does not mean people need extra supplements of Vitamin A, which is easily found in the U.S. diet, to maintain normal vision, Silverglade said. "Consumers will have to . . . be on guard against such dubious promotional tactics," he said. FDA will be looking carefully at such claims to ensure they're not deceptive, said spokesman Jim O'Hara.


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