FDA To Revoke Authorized Health Claim That Soy Protein Can Reduce Heart Disease Risk


The U.S. Food and Drug Administration (FDA) has proposed a rule to revoke the right of companies to say that soy protein protect the heart. The move is the first time the FDA has attempted to revoke a previously authorized health claim.

New Scientific Evidence Clouds Link Between Soy Protein And Reduced Heart Disease Risk

In a statement released Monday, Oct. 30, the agency said that studies published since it green-lighted health claims for soy protein in 1999 had shown inconsistent findings.

FDA said that review of evidence has led to conclusion that the link between soy protein and heart disease does not meet the rigorous standard set for an FDA-authorized health claim.

"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," the FDA said in a statement.

Qualified Health Claim May Be Allowed

Authorized health claims are grounded on well-established relationships that the agency said are based on the most robust level of scientific evidence. Qualified health claim would allow the industry to use qualifying languages that would offer explanations on the limited evidence that link consumption of soy protein and reduction of heart disease risk.

The agency said that if the proposed rule is finalized, it would consider allowing use of qualified health claim that requires lower scientific standard of evidence compared with an authorized claim.

AHA's Take On Soy Protein And Cardiovascular Heart Disease

The American Heart Association (AHA), the oldest and largest voluntary organization in the United States dedicated to fighting heart disease and stroke, has recommended that FDA revoke the soy protein and cardiovascular health claim as early as about 10 years ago.

AHA said that the direct health benefits of soy protein or isoflavone supplements are minimal. The organization, for instance, cited that while majority of research showed that very large amount of soy protein intake may lower bad cholesterol level by a few percentage points, the reduction is very small relative to the amount of soy protein that was tested in the studies and the data and primarily from hypercholesterolemic individuals.

"There are no evident benefits of soy protein consumption on HDL cholesterol, triglycerides, lipoprotein(a), or blood pressure," AHA said in 2008. "The totality of evidence linking soy protein consumption with reduced risk of coronary heart disease is not sufficient to meet the standards of significant scientific agreement (SSA)."

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