Daniel Acker | Bloomberg | Getty Images
A Monsanto soybean production facility in Manlius, Illinois.
The U.S. Food along with Drug Administration on Monday 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 the idea authorized the soy protein claim in 1999 had shown inconsistent results.
“Our review of that will evidence has led us to conclude that will the relationship between soy protein along with heart disease does not meet the rigorous standard for an FDA-authorized health claim,” the agency said in a statement.
The FDA said that will if its proposed rule will be finalized, the idea might 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 will 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 will be minimal at best.”
inside same comment, the association urged the FDA not to allow the use of a qualified health claim.
“Consumer research conducted by AHA, the FDA along with others has repeatedly shown that will despite the presence of qualifying language, consumers do not understand qualified health claims along with do not understand that will they are based on limited along with varying degrees of evidence,” the organization said.
American Heart Association officials were not immediately available to comment on the FDA’s most recent announcement.