FDA proposes revoking the health claim that soy protein reduces the risk of heart disease

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In Washington D.C., the U.S. Food and Drug Administration proposed a rule to revoke a health claim for soy protein relating to heart disease. For the first time, the FDA 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.

Health claims authorized by the FDA reflect well-established relationships based on the most robust level of scientific evidence. This proposed action, which has undergone a thorough FDA review, underscores a commitment to providing consumers with information they can trust to make informed dietary choices.

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.