Vitamin makers required to back up health claims


WASHINGTON -- In a controversial rule opposed by some nutritionists and consumers, the Food and Drug Administration announced yesterday that it will require makers of vitamins, minerals and herbs to substantiate their health claims.

The FDA did not go as far as restricting vitamin potencies or limiting consumer access to herbs and amino acids, as the agency had indicated it might do last summer.

But the new standards require that any health claim -- such as preventing cancer or promoting virility -- "must be supported by significant scientific agreement among qualified experts."

Vitamin makers, nutritionists and some consumer groups fear that although the new standard sounds reasonable, the FDA's strict interpretation of it could block truthful information from reaching the public.

FDA commissioner David Kessler said the agency is simply extending the rules for conventional foods to vitamins and other supplements.

The agency contends that the regulations will prevent "snake oil" claims that supplements cure everything from baldness to AIDS.

"It's a flexible standard that will keep unsubstantiated claims out of the marketplace," Mr. Kessler said.

Michael Onstott -- of ACT UP San Francisco Alternative Treatments, an AIDS group -- said: "My concern is that the FDA's definition of valid is so stringent that they will continue to act as censors of health information."

But some organizations praised the FDA rules as setting a reliable standard.

Bruce Silverglade, director of the consumer group Center for Science in the Public Interest, said the current labels are a "hodgepodge of fact and fiction."

The new standards for health claims are to take effect July. In 1995, makers of dietary supplements would be required to carry the identical nutritional information on their labels as do most other foods.

The new FDA rules are expected to face plenty of battles next year on Capitol Hill, where the issue of vitamin regulation has led to an intense lobbying campaign.

A bill by Sens. Orrin Hatch, R-Utah, and Bill Richardson, D-N.M., would reverse the FDA rules and substitute a separate regulatory apparatus for supplements that would establish less stringent standards for health claims.

Mr. Richardson, who said the bill will be his "top legislative priority" next year, called the FDA position "nonsensical."

The national debate on health care reform will focus on disease prevention, he said, but the FDA is curbing the "dissemination of information about products that could end up saving this nation billions of dollars in health care costs."

Critics argue that the FDA restrictions on information will cost lives.

"I honestly believe, on the basis of a very careful analysis of the scientific literature, that literally thousands of cancer deaths per year might be prevented or delayed if the U.S. population had a higher intake" of these nutrients, said Gladys Block, a professor HTC of nutrition and epidemiology at the University of California at Berkeley.

The FDA currently permits only two health claims. One, linking folic acid with prevention of neural tube birth defects, was approved in yesterday's rules.

Critics blasted the FDA's folic acid approval as flawed, however, because it favors food sources over supplements when evidence indicates the reverse.

The other FDA-approved claim, linking calcium with reduced risk of osteoporosis, came nearly a decade after the National Institutes for Health affirmed the connection.

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