Information provided by the Soyfoods Association of North America

As part of the ongoing litigation between the Food and Drug Administration (FDA) and the Weston A. Price Foundation related to the FDA-approved soy protein and coronary heart disease health claim, the parties filed a joint status report and motion requesting a stay of all proceedings until June 30, 2017.

The FDA stated in the filing that it was “now completing its internal review of the totality of the publicly available scientific evidence for the health claim at issue and is preparing to initiate regulatory action, i.e. to issue a proposed rule that FDA expects will require at least an additional year.”

While it is unclear what the nature of the proposed rule will be, it would appear, based on the decision to take regulatory action, that FDA may issue a proposal to change the current soy protein and coronary heart disease health claim or deny it.

According to the FDA website, “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.”