FDA has issued a proposed rule to revoke its regulation authorizing the use of health claims on the relationship between soy protein and coronary heart disease on the label or in the labeling of foods. The agency is taking this action based on its review of the totality of publicly available scientific evidence currently available and its tentative conclusion that such evidence does not support its previous determination that there is significant scientific agreement among qualified experts for a health claim regarding the relationship between soy protein and reduced risk of coronary heart disease.
The thinking behind the proposed rule was presented in a statement from FDA CFSAN Director Susan Mayne:
“We’ve long recognized that some foods and nutrients can help reduce the risk of certain diseases or conditions. Since 1990, the FDA has been responsible for evaluating health claims on packaged foods to ensure that they are rooted in strong science. To date, we have 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.
“FDA-authorized health claims reflect well-established relationships based on the most robust level of scientific evidence. Today, we are proposing a rule to revoke a health claim for soy protein and 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. 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.
“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.”
Instructions for submitting comments are available in the Federal Register. The comment period will be open for 75 days, at which time FDA will consider the comments received along with the existing information to determine whether to proceed with final rulemaking. In the meantime, manufacturers may keep the current authorized claim on their products until the agency makes a final decision.