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House OKs Bill on Vitamin Benefit Claims : Health: Measure gives consumers continued access to products but affords government right to oversee nutritional and dietary supplement industry.

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TIMES STAFF WRITER

The House ended an intensely fought battle between the dietary supplement industry and its critics Friday by approving a measure that guarantees consumers’ continued access to the products but also preserves the government’s right to regulate claims used to sell them.

Passage of the House bill is regarded as a victory for the Food and Drug Administration and members of the public health community, who wanted undisputed scientific evidence of a supplement’s health benefits before claims of such benefits can be used to promote or sell it.

The House bill differs from a more restrictive version passed earlier by the Senate but the Senate is expected to approve the House bill before Congress adjourns.

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The issue was one of the most hotly debated in Congress this session, prompting a multimillion-dollar campaign by the $4-billion industry and a widespread grass-roots letter-writing campaign by consumers who feared that they would lose access to their vitamins.

“This bill resolves an extremely contentious issue,” said Rep. Henry A. Waxman (D-Los Angeles), who was instrumental in drafting the House compromise.

The House legislation, which passed on a voice vote, would prohibit the makers of supplements from making health claims for their products for four years while the issue is under study by a special commission. After two years, the commission would make recommendations, which would be reviewed by the secretary of health and human services and possibly by Congress.

During this time, manufacturers would have to comply with existing law, which requires “significant scientific agreement” before a vitamin or supplement maker can claim on a product’s label that it prevents a certain disease or condition.

Also, the measure would set the first specific safety standards for dietary supplements, requiring that they not pose a “significant or unreasonable risk” of harm if used as directed.

But the bill slightly weakens current rules. Now, manufacturers have to provide the FDA with safety evidence 75 days before a product is introduced into the market and the FDA must approve the product before it can be sold. The bill changes that slightly, saying that if the FDA does not specifically disapprove the supplement within the 75-day period, the product can go onto the market. But the FDA could still later try to remove the product.

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In another concession to the supplement industry, manufacturers gained permission to make certain nutritional claims, such as “Vitamin A is necessary for good vision.” While such statements are medically accurate, industry critics fear that they would be used in a way that would imply nutritional supplements are necessary.

Also, the House bill would allow supplement makers to distribute reprints of preliminary scientific studies that describe potential health benefits of supplements.

All sides seemed pleased with the outcome.

The legislation “will help to keep our industry alive,” said Gerald Kessler of the Nutritional Health Alliance, which represents the dietary supplement industry. “We have made great progress. . . . Many compromises were made to achieve a workable bill.”

FDA spokesman Jim O’Hara said that the agency “will work hard to protect consumers from unsafe or deceptively labeled products.” But he cautioned: “We are concerned, though, that some dietary supplement manufacturers might try to interpret this legislation in a way that would let them make deceptive claims. Consumers need to exercise vigilance in judging the validity of many of the claims.”

Bruce Silverglade of the Center for Science in the Public Interest, a consumer advocacy group, called the compromise a “win-win” for consumers.

“The bill preserves access to supplement ingredients while protecting consumers from misleading health claims and unsafe products.”

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But “consumers should remain wary of other dubious marketing practices,” he added.

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