Soy Protein and the Heart Health Claim

The FDA's recent proposal to revoke its heart health claim for soy protein marks the first time the agency has moved to revoke a claim since it started approving such statements.

By Lauren R. Hartman, Product Development Editor

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For years, manufacturers of soy protein foods have been allowed to claim their products help reduce the risk of heart disease. But that came into question on Oct. 30, 2017, when the FDA proposed to revoke the claim, saying that the science doesn't appear to back it up.

Soy protein is easy to include as an added ingredient in processed foods for its clean, bland flavor and smooth texture. It provides amino acids and phytochemicals needed to help lower dietary cholesterol and has been shown to have a favorable impact. Yet some animal studies indicate soy isoflavones might increase the recurrence of breast cancer by promoting the growth of estrogen-sensitive cells.

In early January, the FDA stated it was completing its evaluation of the scientific evidence between soy protein and coronary heart disease and was developing the final proposal – although the agency did extend the public comment period to March 19, in response to requests. According to industry figures FDA cited, the claim that soy protein can reduce heart disease appears on about 200-300 products in the U.S., including popular brands of soy milk.

While admitting there is some evidence soy protein can have a heart benefit, "the totality of current scientific evidence calls into question the certainty of the relationship," says Susan Mayne, director of the FDA's Center for Food Safety and Applied Nutrition. "Our review of that evidence has led us to conclude the relationship between soy protein and heart disease does not meet the rigorous standard for an FDA-authorized health claim."

Issued in 1999, the claim said soy protein included in a low saturated fat and low cholesterol diet may reduce the risk of coronary heart disease by lowering blood cholesterol levels. Soybean use soon rose, reports the USDA, in products like soy milk, tofu, edamame products and soybean oil.

According to the Hartman Group, heart health is the top health feature U.S. consumers look for when grocery shopping. In addition, 55 percent of consumers are trying to avoid or reduce saturated fat in their diet, and nearly 40 percent are trying to incorporate healthier fats such as polyunsaturated and monounsatured fats.

No scientific consensus

If the agency does rescind the soy-heart health claim, food and beverage companies would be allowed to use a less rigorous qualified health claim, as long as they have sufficient evidence to support a link between eating soy protein and a reduced risk of heart disease. A "lower scientific standard of evidence" than the authorized health claim would let producers use language that explains that the evidence on the link is limited.

To use the qualified health claim on a product, manufacturers are asked to petition the FDA about the phrasing they want to use. There are no specific phrases that meet the FDA's criteria for a qualified health claim. Rather, they will be determined on a case-by-case basis, and the agency will decide what language is in line with available evidence.

The qualified claim for soy doesn't mean the FDA wants people to stop consuming soy, elaborated Douglas Balantine, director of the Office of Nutrition and Food Labeling. "The Dietary Guidelines clearly continue to advise the use of plant-based foods like soy as a replacement for foods higher in saturated fat, [and that is] one technique that would reduce the risk of heart disease."

Only a dozen such health claims to date have received the FDA's blessing. One example is the effect of calcium and vitamin D in lowering the risk of osteoporosis.

Costs associated with relabeling the 200-300 products currently making the health claim are estimated at between $370,000 and $860,000 upfront, according to a federal filing.

The American Heart Assn. (, which submitted a comment letter with the agency in 2007 to get soy's authorized claim revoked, says its position hasn't changed since then.

"We are on board with the FDA’s proposal to revoke the soy protein and coronary heart disease health claim," says the AHA's Retha Sherrod, director of media advocacy. "Back in 2007, we urged them to take this action. One of the key reasons this is necessary is because we concur with the FDA’s stance that the scientific evidence no longer supports a significant scientific agreement level health claim."

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