FDA proposed rule would revoke health claims for soy protein and heart disease, the first time the agency has backtracked on an authorized claim. NPA CEO Dan Fabricant says the proposal could sway food and supplement firms to seek qualified health claims rather than invest in research to support authorized health claims.

The European Food Safety Authority concludes that a cause and effect relationship is not established between the consumption of soy protein and lower levels of low-density lipoprotein cholesterol, which lowers the risk of coronary heart disease. Though petitioners submitted 40 studies, the regulatory authority rejected most because they did not test soy protein but soy protein isolate or soy foods containing other substances that have a proven effect on heart health. The petitioners submitted four additional meta-analyses, all of which EFSA said failed to show a relationship between the consumption of soy protein and lower levels of LDL. The soy heart health claim also is under fire in the U.S., where nutrition groups submitted a 2008 citizen petition to FDA to have the health claim overturned and the American Heart Association recommended the claim be revoked (1"The Tan Sheet" Sept. 1, 2008)

The European Food Safety Authority concludes that a cause and effect relationship is not established between the consumption of soy protein and lower levels of low-density lipoprotein cholesterol, which lowers the risk of coronary heart disease. Though petitioners submitted 40 studies, the regulatory authority rejected most because they did not test soy protein but soy protein isolate or soy foods containing other substances that have a proven effect on heart health. The petitioners submitted four additional meta-analyses, all of which EFSA said failed to show a relationship between the consumption of soy protein and lower levels of LDL. The soy heart health claim also is under fire in the U.S., where nutrition groups submitted a 2008 citizen petition to FDA to have the health claim overturned and the American Heart Association recommended the claim be revoked (1"The Tan Sheet" Sept. 1, 2008)