F.D.A. plans to reevaluate soy health claim

by Jeff Gelski
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WASHINGTON — The Food and Drug Administration is seeking public comment on its intent to reevaluate the scientific evidence for its authorized health claim for soy protein and the risk of coronary heart disease, according to a Dec. 21 Federal Register notice. The F.D.A. will accept comments until Feb. 19, 2008.

In the health claim issued on Oct. 26, 1999, the F.D.A. said soy protein included in a diet low in saturated fat and cholesterol may reduce the risk of coronary heart disease by lowering blood cholesterol levels.

"Since authorizing this health claim, numerous studies have evaluated the relationship between soy protein and coronary heart disease, and the findings of these studies are inconsistent," the F.D.A. said in its Dec. 21 notice.

The F.D.A. pointed to research at the Tufts-New England Medical Center Evidence-based Practice Center, Boston, that was reported on in an Agency for Healthcare Research and Quality publication in July 2005. The study concluded soy products appear to exert a small benefit on low-density lipoprotein (L.D.L.) cholesterol.

"However, it is not clear whether soy protein (versus other types of soy products) was responsible for such a benefit," the F.D.A. said. "The AHRQ report included studies that evaluated substances in addition to soy protein (e.g., isoflavones).

"In addition, the AHRQ report used markers of cardiac functions (e.g., triglycerides, endothelial functions, oxidized L.D.L.) that are not validated surrogate endpoints recognized by the agency for heart disease risk."

The F.D.A. said it will evaluate scientific evidence to determine if it meets the significant scientific agreement standard needed for a health claim.

The F.D.A. in the Dec. 21 Federal Register notice also said it plans to reevaluate a health claim for dietary lipids (fat) and cancer along with two qualified health claims, one involving antioxidant vitamins and risk of certain cancers and the other involving selenium and certain cancers.

"The agency is undertaking a reevaluation of the scientific basis for these authorized health claims and qualified health claims because of new scientific evidence that has emerged for these substance-disease relationships," the F.D.A. said of all four claims, including the soy claim. "The new scientific evidence may have the effect of weakening the substance-disease relationship for these authorized health claims and either strengthening or weakening the scientific support for the substance-disease relationship for these qualified health claims."

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