FDA Considers Revoking Soy-Heart Health Claim

By Dave Fusaro, Editor in Chief

Oct 31, 2017

The FDA on Oct. 30 announced it was considering revoking the health claim that soy protein can prevent heart disease.

"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," said Susan Mayne, director of the FDA’s Center for Food Safety and Applied Nutrition. "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."

The announcement went on to explain:

"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.

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

"We look forward to working with stakeholders and others interested in this topic throughout the rulemaking process and invite them to submit comments on the proposed rule. The comment period will be open for 75 days, at which time we will consider the comments received along with the existing information we have to determine whether to proceed with final rulemaking. In the meantime, manufacturers will be allowed to keep the current authorized claim on their products until the agency makes a final decision.

"We note that the authorized health claim at issue addresses only soy protein and reduced risk of coronary heart disease. Other purported health benefits of soy or soy-derived food ingredients (such as soybean oil) are not addressed as part of this proposed rule."

Since 1990, FDA has authorized 12 such health claims, such as the effect of calcium and vitamin D in helping to lower the risk of osteoporosis or certain fruits and vegetables to lower the risk of cancer.

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