Soy Protein and Coronary Heart Disease Health Claim Review

June 30, 2016

Food and Drug Administration

The FDA is completing its evaluation of the totality of the current scientific evidence regarding the relationship between soy protein and coronary heart disease and is developing a proposed rule with respect to a health claim authorized in 1999. The agency has reviewed more than 700 publications identified through literature searches, comments and other information, including information solicited by the FDA in 2007. The FDA plans to publish a proposed rule in the Federal Register and solicit public comments and scientific information concerning the proposal. During the rulemaking process, food manufacturers may continue to use the authorized health claim.

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