FDA to Revoke Claim that Soy Lowers Heart Disease Risk

Significant efforts have been devoted to investigate which foods are beneficial to heart health and which may increase the risk of cardiovascular disease and related health events. Since 1990, the FDA has evaluated claims on food deemed to be healthy to ensure that Americans are receiving the correct information to make healthy choices.

Thus far, there have been 12 claims authorized by the FDA, including that calcium and vitamin D reduce the risk of osteoporosis, and certain fruits and vegetables protect against cancer, according to a press release. These claims have been established on the grounds of significant scientific evidence.

However, the FDA announced that they are proposing a rule to revoke a claim regarding soy and heart disease. Since it was authorized in 1999, there has been inconsistent evidence that soy protein lowers the risk of cardiovascular disease, according to the release.

This action has undergone agency review and aims to help consumers make more informed food choices that benefit their health.

Although certain evidence suggests a positive relationship between soy intake and reduced heart disease risk, the sum of the information calls the link into question, according to the FDA. Newer studies have also found inconsistent results regarding the ability of soy protein to lower low-density lipoprotein 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,” said Susan Mayne, PhD, director of the Center for Food Safety and Applied Nutrition at the FDA.

If the rule is finalized, the FDA will lower the relationship to a qualified health claim if there is enough evidence. A qualified health claim requires less evidence than an authorized health claim and would allow companies to use language that indicates there is limited evidence that shows the risk of heart disease can be lowered through soy protein intake, according to the release.

The FDA invites stakeholders to submit comments on the proposed rule to determine their final ruling.

“In the meantime, manufacturers will be allowed to keep the current authorized claim on their products until the agency makes a final decision,” Dr Mayne concluded.