(Reuters) – The U.S. Food and Drug Administration on Monday proposed a rule revoking the right of companies to claim soy protein protects the heart, while potentially allowing a more circumspect health claim.
The agency said studies published since the FDA authorized the claim in 1999 have shown inconsistent results. This is the first time the FDA has revoked a health claim.
“Our review of that evidence has led us to conclude that the relationship between soy protein and heart disease does not meet the rigorous standard for an FDA-authorized health claim,” the agency said in a statement.
The FDA said that if its proposed rule is finalized the agency would consider allowing the use of a qualified health claim, which requires a lower scientific standard of evidence than an authorized health claim.
Reporting by Toni Clarke in Washington; Editing by Chizu Nomiyama
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