FDA Considers Revoking Soy Protein Health Claim

FDA has concluded the relationship between soy protein and heart disease does not meet the rigorous standard for an FDA-authorized health claim, said Dr. Susan Mayne, director of FDA's Center for Food Safety and Applied Nutrition.

The U.S. Food and Drug Administration has proposed for the first time to revoke one of the 12 health claims it has authorized so far -- a health claim that soy protein reduces the risk of heart disease. "We've long recognized that some foods and nutrients can help reduce the risk of certain diseases or conditions," Dr. Susan Mayne, director of FDA's Center for Food Safety and Applied Nutrition, wrote in an Oct. 30 statement on the FDA website. "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."

She explained that comments on the proposed rule will be accepted for 75 days. If FDA does finalize the rule, it plans 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, she wrote, adding that a qualified health claim requires a lower scientific standard of evidence than an authorized health claim. Manufacturers could use qualifying language that explains the limited evidence linking consumption of soy protein with heart disease risk reduction.

Mayne recommended that consumers who have questions about eating soy products continue to follow advice from the 2015-2020 Dietary Guidelines, which state that a healthy eating pattern can include soy beverages and a variety of protein foods, including soy products. "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," Mayne noted.

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