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FDA proposes to revoke soy health claim

The US FDA has proposed to revoke a health claim for soy protein and heart disease.

“FOR THE first time, we have considered it necessary to propose a rule to revoke a health claim because numerous studies published since the claim was authorized in 1999 have presented inconsistent findings on the relationship between soy protein and heart disease,” said Susan Mayne, PhD, director for the FDA’s Center for Food Safety and Applied Nutrition, in an Oct 30 statement.

In its re-evaluation, the FDA identified 709 publications, which were drawn from studies included in the 1999 final rule, comments submitted to a 2007 FDA notice of re-evaluation, a 2008 citizen petition and searches of the more recent literature.

The FDA tentatively concluded the evidence does not support its previous determination that there is significant scientific agreement among qualified experts for a health claim regarding the relationship between soy protein and reduced risk of coronary heart disease.

“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 authorised, the totality of currently available scientific evidence calls into question the certainty of this relationship,” Dr Mayne said.

“For example, some studies, published after the FDA authorised the health claim, show inconsistent findings concerning the ability of soy protein to lower heart-damaging low-density lipoprotein (LDL) cholesterol.

“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-authorised health claim.”

Should the FDA finalise the proposed rule to revoke the health claim, the agency intends to allow the use of a qualified health claim as long as sufficient evidence supports a link between eating soy protein and a reduced risk of heart disease, she said.

“A qualified health claim, which requires a lower scientific standard of evidence than an authorised health claim, would allow industry to use qualifying language that explains the limited evidence linking consumption of soy protein with heart disease risk reduction,” Dr Mayne said.

The FDA will accept public comments on its proposed action for 75 days. The proposal was scheduled to be published in the Federal Register on Oct 31.

Manufacturers will be allowed to keep the current authorized claim on their products until the FDA makes a final decision.

“In a time when heart disease is the No. 1 cause of death both in the United States and the world, we can’t afford to discourage people from taking steps to improve their diets with heart-healthy ingredients,” said Ron Moore, president of the American Soybean Association and Illinois farmer.

“There is still evidence that shows eating soy protein can help reduce the risk of heart disease, and while we are of course disappointed that FDA is looking at moving the health claim for these products from ‘unqualified’ to ‘qualified,’ it’s important for consumers to remember that soy protein can be an important part of a heart-healthy diet.”

The FDA authorised a health claim for soy protein and the reduced risk of coronary heart disease in the Oct 26, 1999, issue of the Federal Register. It said soy protein included in a diet low in saturated fat and cholesterol may reduce the risk of coronary heart disease by lowering blood cholesterol levels. 


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