FDA moves to revoke soy health benefit claim


The FDA is proposing a rule to revoke a health claim that soy protein reduces the risk of heart disease.

The government agency first approved the language about the benefits of soy protein in reducing the risk of heart disease in 1999, but numerous studies since then have presented inconsistent findings.

Soy and heart disease: What you need to know 

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In a news release, the FDA said this is the first time it has proposed a rule to revoke a health claim since it began approving such statements in 1990:

“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. 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.”

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The claim that soy protein can reduce heart disease appears on about 200 to 300 products in the United States, according to the Associated Press.

There will be a comment period for 75 days before the FDA decides whether to proceed.

In the meantime, manufacturers will be able to keep the current authorized claim on their products until the agency makes a final decision.

Read more about the FDA’s proposal on its website.

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