FDA May Revoke Heart-Healthy Claim for Soy Protein

Megan Brooks

November 01, 2017

SILVER SPRING, MD — The US Food and Drug Administration (FDA) has proposed revoking the health claim that soy protein reduces the risk of heart disease[1].

"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," Dr Susan Mayne, director of FDA's Center for Food Safety and Applied Nutrition, said in a statement[2].

"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," said Mayne.

Some studies published after the FDA authorized the health claim for soy protein show "inconsistent findings" on the ability of soy protein to lower LDL cholesterol, she noted. That evidence led the FDA 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.

If the FDA decides to finalize this rule, the agency would still allow the use of a qualified health claim on soy protein products, "as long as there is sufficient evidence to support a link between eating soy protein and a reduced risk of heart disease," Mayne said.

A qualified health claim requires a lower scientific standard of evidence than an authorized health claim and would allow industry to use qualifying language that explains the limited evidence linking consumption of soy protein with heart-disease risk reduction, Mayne explained.

The FDA will accept comments on the proposed rule change on soy protein and heart disease for 75 days. The agency will consider the comments as well as existing information to decide whether to proceed with final rule making. In the meantime, manufacturers will be allowed to keep the current authorized claim on their products until the agency makes a final decision.

"This proposed action, which has undergone a thorough FDA review, underscores our commitment to providing consumers with information they can trust to make informed dietary choices," Mayne said.

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