WASHINGTON, Oct. 30 (Xinhua) -- The U.S. Food and Drug Administration (FDA) on Monday proposed a rule to revoke a health claim that soy proteins can help reduce the risk of heart disease.
The FDA said it's the first time it has proposed 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."
"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 cholesterol," the U.S. regulator said in a statement.
"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."
The FDA said if this rule is finalized, 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," it explained.
The comment period for the proposal will be open for 75 days.
Manufacturers will be allowed to keep the current authorized claim on their products until the agency makes a final decision, the U.S. agency added.
To date, the FDA has authorized 12 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.
