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Health Claims on Foods May Not Be Well-Grounded
Date:5/12/2010

od supplements, the standard is even lower," Ball said. "There is a presumption in favor of the supplement, and the FDA has to show that it's got a negative effect in order to be able to do anything about it."

"We are saying, 'You ought to have the same basic scientific standard for all the products,' " Ball said of the committee's report.

In addition, the FDA needs to do a better job tracking products once they are on the market, he said. "One of the things we did find [was that] even in post-marketing surveillance, where companies agreed to come forward with information, only about 10 percent of those agreements have been fully followed up," he said.

The bottom line for Ball is that the FDA needs more authority to regulate health claims being made -- a change that would require Congress to change the laws under which the agency operates.

As Sprinkle said: "A lot of what you see driving this report is revealed where the IOM says that Congress should give the FDA more authority and more money. But that recommendation is sure to be opposed vigorously, but, of course, quietly."

"So is this all about biomarkers?" he asked. "Well, yes and no."

More information

The U.S. Food and Drug Administration has more on nutrition labeling on foods.



SOURCES: John Ball, M.D., executive vice president, American Society for Clinical Pathology, Chicago; Robert H. Sprinkle, M.D., Ph.D., associate professor, School of Public Policy, University of Maryland, College Park; May 12, 2010, report, Institute of Medicine, Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease


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