WASHINGTON – The Food and Drug Administration 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, Ph.D., director for the F.D.A.’s Center for Food Safety and Applied Nutrition, in an Oct. 30 statement.
In its re-evaluation, the F.D.A. identified 709 publications, which were drawn from studies included in the 1999 final rule, comments submitted to a 2007 F.D.A. notice of re-evaluation, a 2008 citizen petition and searches of the more recent literature. The F.D.A. 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 F.D.A. when the claim was authorized, 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 F.D.A. authorized 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 F.D.A.-authorized health claim.”
Should the F.D.A. finalize 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 authorized 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 F.D.A. 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 F.D.A. makes a final decision.The F.D.A. authorized 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.