FDA considers revoking claim soy reduces heart disease risk

The totality of current scientific research calls into question the claim that soy protein can reduce the risk of heart disease.
By Amy Wallace  |  Oct. 31, 2017 at 10:57 AM
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Oct. 31 (UPI) -- The U.S. Food and Drug Administration announced it is reversing its authorized health claim that soy protein can reduce the risk of heart disease.

According to Susan Mayne, director of the FDA's Center for Food Safety and Applied Nutrition, this is the first time the FDA has proposed a rule to revoke a health claim due to numerous studies published since the claim was made. The FDA made the claim that soy protein could reduce the risk of heart disease in 1999.

In 2008, The Weston Price Foundation submitted a petition to the FDA to drop its claim that soy protein reduces heart disease risk.

"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," Mayne said in a news release.

"For example, some studies, published after the FDA 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 FDA-authorized health claim."

Mayne said that if new evidence is presented supporting a link between eating soy protein and a reduced risk of heart disease then the FDA could allow a qualified health claim, which requires a lower scientific standard compared to an authorized health claim.

"We look forward to working with stakeholders and others interested in this topic throughout the rulemaking process and invite them to submit comments on the proposed rule," Mayne said.

The agency will accept comments on the proposed change through Jan. 16, 2018.

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