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The U.S. Food and Drug Administration [FDA] has released a proposal calling for the revocation of a claim that soy protein reduces the risk of heart disease.
The statement, which was penned by FDA Center for Food Safety and Applied Nutrition director Susan Mayne, is proposing a revocation of an authorized health claim for the first time ever.
According to Mayne, Ph.D., studies show ‘inconsistent findings’ regarding the soy protein’s ability to lower heart-damaging LDL cholesterol.
The FDA has been responsible for evaluating health claims on packaged foods for 27 years, authorizing only 12 such claims (e.g. the effect of calcium and vitamin D in lowering the risk of osteoporosis).
Proposal
Mayne writes: “While some evidence continues to suggest a relationship between soy protein and a reduced risk of heart disease—including evidence reviewed by the FDA when the claim was authorized—the totality of currently available scientific evidence calls into question the certainty of this relationship.
“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,” said Mayne of the health claim that was authorized in 1999.
And while the FDA intends on revoking soy’s ‘authorized health claim’, it still has the opportunity to remain a ‘qualified health claim’ – which requires a lower standard of evidence.
Manufacturers will be allowed to keep the current authorized claim on their products until the agency makes a final decision, states the proposal.
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