FDA Makes Decision to Revoke Soy Health Claims of Reduced Heart Disease Risk

WASHINGTON, DC — The United States Food and Drug Administration (FDA) announced that it has decided to revoke an official authorized health claim that consuming soy protein can reduce the risk of heart disease. The agency wants to propose a new rule to allow the use of a qualified health claim provided there is enough evidence to support a link between eating soy protein and reducing the risk of heart disease, according to a statement.

Officials from the FDA said that since 1999 when the claim was authorized by the FDA, the agency and scientific community that has studied this particular area of research has learned new information that is inconsistent with the earlier research. Soy protein is derived from soy bean plants and previous research suggested that daily consumption of soy protein could slightly decrease harmful LDL cholesterol, which was thought to produce benefits for the human heart, according to reports. This assumption has now come into question and now scientists believe lowered cholesterol can actually produce harm to the body. Also, there have never been any clinical trials that have shown that eating more of the soy protein will result in improved heart health, Dr. Karol Watson, a cardiologist and director of the UCLA Women’s Cardiovascular Health Center told CNN News.

According to a statement from the FDA by Susan Mayne, director of the FDA Center for Food Safety and Applied Nutrition, there have been 12 previous authorized health claims. Those include claims such as the effect of calcium and vitamin D to help lower risk of osteoporosis. It also includes the claim that eating certain fruits and vegetables can lower the risk of cancer.

“Should the FDA finalize this rule, 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,” Mayne said. “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.”

As other reports suggest, this announcement doesn’t necessarily mean that soy is not good for your heart, but rather that more information is needed to back up specific claims. The FDA said it may allow the soy claim to be designated as a qualified health claim, which is a designation that does not require as much scrutiny or standard of evidence.

The FDA is asking for the public and stakeholders to submit comments on the proposed rule, according to the statement from Mayne. The comment period will be open for 75 days. The FDA said they will will consider comments received combined with existing data to make their final determination on the rule. Meanwhile, manufacturers can keep current authorized claims on their products while they await the final FDA decision.

The FDA recommends that consumers eating soy products continue to follow advice from the 2015-2020 Dietary Guidelines. Those guidelines state that soy beverages and foods can be part of a healthy eating pattern still. Other benefits of soy are not addressed in this specific claim and subsequent proposed rule. Also, health professionals warn against the risk of obesity for keeping the heart healthy.