Friday, 24 November 2017


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The US Food and Drug Administration (FDA) published in the Federal Register a proposed rule to revoke the authorized health claim linking soy protein to the reduced risk of coronary heart disease.

On October 30, the FDA stated they are proposing to revoke the authorized health claim based on their review of scientific evidence and the tentative conclusion that available evidence does not support their previous determination that there is significant scientific agreement among qualified experts for the health claim.

In 1999, the FDA authorized a health claim about the relationship between soy protein and a reduced risk of coronary heart disease. The FDA announced their intention to reevaluate the scientific evidence for the health claim in 2007, because new studies yielded varied and inconsistent findings from one trial to another. A discussion of the new studies is in the proposed regulation. If finalized, the proposed rule will revoke the soy protein and coronary heart disease health claim in 21 CFR 101.82.

This proposed rule is open to comments from October 31, 2017 to January 16, 2018 and the proposed rule states that if the final rule is published before December 31, 2018, the compliance date will be January 1, 2020.

Even though the FDA is considering revoking the authorized health claim, Dr. Susan Mayne, director of the FDA’s Center for Food Safety and Applied Nutrition stated in her press announcement on October 30, 2017 that “should the FDA finalize this rule, the agency intends to allow the use of a qualified health claim as long as there is sufficient evidence to support a link between eating soy protein and a reduced risk of heart disease”.

This would allow a claim to be made as long as the statement uses approved wording that qualifies the claim. The proposed rule states the FDA will consider whether there is credible evidence to support the qualified health claim and what qualifying statements or other information should accompany the claim. 

Related articles: 

FDA Talks Extension for Nutrition Labeling Compliance 

US FDA to Issue Guidance on Menu Labeling Requirements 

American Bakers Association Asks FDA to Reconsider Dietary Fiber Definition

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