Soy Nutrition Institute
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Jan 22, 2016

FDA Rejects Attempt to Revoke Soy Health Claim

This month the FDA responded to the Weston A. Price Foundation (WAPF) in its petition to the FDA for the revocation of the soy health claim approved by FDA in 1999. The response, regarding Docket Number: FDA-2008-P-0452-0001, states the following:

1. FDA is denying your petition in accordance with 21 Code of Federal Regulations ("CFR") 10.30(e)(3), because the limited relevant evidence submitted in the petition and the petition supplement does not provide sufficient grounds for the Agency to revoke the soy protein and coronary heart disease ("CHD") health claim at this time.  Contrary to your representations, you have not presented sufficient data to FDA to demonstrate that the significant scientific agreement standard has not been met for this health claim.

2. FDA does not consider any procedures, including a hearing, to be warranted at this time because we first must complete our review of the totality of the publicly available scientific evidence for the health claim before we consider what, if any, action may be needed with respect to the 1999 Final Rule.

3. FDA is actively reviewing the entire body of scientific evidence to allow the agency to make a more informed decision on the next steps for this health claim. Once the agency has evaluated the information before it, FDA will reach a conclusion about next steps, including whether there may be grounds to initiative rulemaking process for amending or revoking the health claim.