Nearly two decades after it agreed that consumption of soy protein reduced the risk of heart disease, the FDA proposed revocation of the so-called health claim because of new research that questions the relationship. It would be the first time the agency revoked any of the 12 health claims authorized since 1990.
In a statement, the FDA said it would allow a “qualified health claim” for soy protein if it revokes the current language. Recent studies have returned inconsistent results on the ability of soy protein to reduce the presence of heart-damaging LDL cholesterol, according to FDA.
“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, director of the Center for Food Safety and Applied Nutrition. ” 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.”
After a 75-day comment period, the FDA will decide whether to proceed with the revocation.
“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,” said the American Soybean Association.
After the soy health claim was first approved by the FDA in 1999, sales of soy-based foods such as soy milk and soy nutrition bars rose dramatically.