The U.S. Food and Drug Administration recently proposed a rule revoking the right of companies to say soy protein protects the heart, while potentially allowing a more circumspect health claim.
The agency, which to date has never revoked a health claim, said studies published since it authorized the soy protein claim in 1999 had shown inconsistent results.
A review of that evidence has led the agency to conclude that the relationship between soy protein and heart disease does not meet the rigorous standard for an FDA-authorized health claim.
The FDA said that if its proposed rule is finalized, it would consider allowing the use of a qualified health claim, which requires a lower scientific standard of evidence than an authorized claim.
The move comes nearly a decade after the FDA announced its intent to reevaluate the scientific evidence for certain health claims, including the one that soy protein may lower the risk of heart disease.
The American Heart Association has long advocated revoking the soy health claim. In a 2008 comment on the FDA’s intent to reevaluate the evidence, the association said: “Direct cardiovascular health benefit of soy protein or isoflavone supplements is minimal at best.”
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