On Oct. 30, FDA proposed a rule to revoke an authorized health claim for soy protein and its relationship between soy protein and reduced risk of coronary heart disease CHD).  Based on its re-evaluation of the totality of the publicly available scientific evidence now available, FDA said evidence does not support its previous determination that there is [significant scientific agreement] SSA to support the authorized health claim.

In 1999, FDA approved the health claim that “25 grams of soy protein a day, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease."

The agency, responsible for evaluating health claims on packaged foods since 1990, has never revoked a health claim and only authorized 11 other health claims. Once the proposed rule is finalized, FDA said it may consider allowing the use of a qualified health claim, which are somewhat weaker and based on limited evidence.

“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, FDA’s Center for Food Safety and Applied Nutrition (CFSAN). “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 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," Mayne said.

The proposed rule is open for comment for 75 days, at which time the FDA will consider the comments received along with the existing information 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.

According to FDA, between 200 to 300 food products, including soy milk, supplements, snack foods, soups, tofu etc., bear this health claim.  FDA estimates total annualized costs of $35,000 to $81,000, when the relabeling costs are annualized over 20 years at a 7 percent discount rate. The initial one-time costs are $370,000 to $860,000.

Swift Industry Reaction

Industry stakeholders were quick to respond to FDA’s announcement. In a statement, American Soybean Association (ASA) President and Illinois farmer Ron Moore, said: “In a time when heart disease is the number one cause of death both in the United States and the world, we can’t afford to discourage people from taking steps to improve their diets with heart-healthy ingredients. There is still evidence that shows eating soy protein can help reduce the risk of heart disease, and while we are of course disappointed that FDA is looking at moving the health claim for these products from ‘unqualified’ to ‘qualified,’ it’s important for consumers to remember that soy protein can be an important part of a heart-healthy diet. Even in today’s announcement, FDA still refers customers to the agency’s 2015-2020 Dietary Guidelines, which state that healthy eating patterns include soy beverages and a variety of protein foods, including soy products. Moving forward, we hope that in its upcoming re-evaluation of the available data, FDA will focus on the many studies that show the heart-healthy benefits of a diet that includes soy protein."

The Soyfoods Association of North America (SANA) issued a statement voicing its concern over the proposal to modify the claim from unqualified to qualified. “Numerous scientific studies published before and since the soy protein health claim was approved in 1999 consistently show that soy protein lowers LDL-cholesterol and that the totality of the evidence supports continued approval of an unqualified claim. FDA’s decision is inconsistent with 12 other countries that have authorized health claims on soy protein and heart disease, including Health Canada’s most recent approval of such a claim in 2015," the association said.