FDA Reverses Stance on Soy and Heart Health

The FDA recently announced they intend to revoke authorization for claims that soy protein reduces the risk of heart disease. The claim currently appears on about 300 products in the US including soy milk, and tofu, and many other foods. The FDA first began issuing and approving health statements in 1990. Up until now they have authorized 12 other claims on food. This will be the first time they have revoked previously authorized health claims. However, they feel that the evidence of heart health previously submitted is now insufficient. In 2005 and again in 2007, research by the Agency for Healthcare Research and Quality and others revealed that soy did not have much effect on 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,” said Susan Mayne, director of the Center for Food Safety and Applied Nutrition at the FDA. As per current guidelines, the FDA must allow a minimum of 75 days for concerned people, agencies, and businesses to respond to this suggested new ruling. Until then the old ruling stands, and producers may continue to print their claims.

If the new ruling prevails, the FDA says it would allow “qualified health claims” (a lower level of scientific standard) providing manufactures explain the limited evidence supporting heart health on the labels. Product manufacturers would have to petition the FDA on an individual basis as to the language they intend to use regarding health claims so as to not mis-lead consumers. They will be approved or disapproved on an individual basis.

Bonnie Liebman, a nutritionist at the Center for Science in the Public Interest commented that soy replacement for red meat would only be of benefit due to the elimination of the meat, not from the heart benefits of the soy alone.

Industry proponents have disputed the FDA’s findings and have referenced a dozen or more countries including Canada that have not disapproved soy labeling as the FDA proposes. It is expected the industry will oppose the new ruling proposal. As an industry, the soy products world accounted for $4.5 billion; it is a world-wide staple for vegetarians and health conscious people everywhere. The FDA has suggested that this labeling change-over may cost the industry $370-860,000.

Despite the proposed ruling above, Soy still has many benefits. As stated, substituting soy for red meat has the advantage of suppling plenty of protein as a meat substitute, thereby reducing the disadvantages of red meat. Note that although soy may not lower cholesterol is remains a very viable and health meat substitute.

There has been controversy regarding Soy products linking it to breast cancer. The previous studies indicated this were done with rats and not people, whose physiology and immune systems are different. An extensive review of over 35 studies around the world revealed that not only does soy not cause cancer, Soy may actually reduce it, says one study from the UK. The same researchers from the UK do caution that patients with thyroid problems should avoid soy as much as possible as it can cause hypothyroidism. Soy contains phytoestrogens which affects the thyroid negatively.