FDA To Remove Soy Heart Benefit Labels

U.S. moves to revoke claim that soy protein protects the heart

This statement revokes that claim as it is deemed that the health claim is not based upon robust scientific evidence.

Yesterday, the U.S. Food and Drug Administration (FDA) issued a press release announcing plans to revoke an existing health claim that soy protein can help to reduce the 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 authorized - the totality of now available scientific evidence calls into question the certainty of this relationship". Before a manufacturer can make such a claim, the FDA has to approve it, based on scientific evidence. This health claim was authorized by the same organization in 1999 she said.

After all, he said, the FDA has been "under tremendous pressure" from anti-soy groups like the Weston A. Price Foundation to revoke the claim, despite some studies suggesting that soy has health benefits.

The move comes almost a decade after the FDA announced its intent to reevaluate the scientific evidence for certain health claims, including the one that soy protein may lower the risk of heart disease. The objective of these authorizations is for the public to make informed dietary choices she said. These were present when FDA had authorized the claim the soy proteins are protective.

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Authorized health claims are reviewed by the FDA and typically allowed on food labeling to show that a food or food component may reduce the risk of a disease or a health-related condition. However several studies published after the claim was authorized show inconsistent results.

"Vegetarian diets can be nutritious and offer a way to lower LDL-cholesterol when saturated fat intake from meats or other animal sources are substituted with vegetable protein and especially when accompanied by poly-unsaturated fat sources", Van Horn said. Taking into consideration all of these studies and evidence the panel of experts believe that soy protein does not meet the standards for FDA to continue to endorse it as protective against heart disease.

What is a health claim? This is a special kind of approval, Mayne explained, where lower standards of evidence of the protective nature of a food are acceptable. And the consumer will have to be told that there's a difference.

Mayne went on to say that the FDA would work closely with the stakeholders and other interested parties. Later though, some research studies depicted that there was no evidence between soy protein consumption and health benefits. But the FDA on Monday moved to revoke that soy heart benefit claim-the first time ever that the agency has attempted to nix a previously authorized health claim.

For consumers who have questions about eating soy products, we recommend they continue to follow advice from the 2015-2020 Dietary Guidelines, which state that a healthy eating pattern can include soy beverages and a variety of protein foods, including soy products.

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