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  • Debra Topham

FDA Extends comment period for Soy Protein and Coronary Heart Disease Health Claims


Background “In the Federal Register of October 31, 2017, FDA published a proposed rule to revoke our regulation authorizing the use of health claims on the relationship between soy protein and coronary heart disease on the label or in the labeling of foods. We proposed this action based on our review of the totality of publicly available scientific evidence currently available and our tentative conclusion that such evidence does not support our previous determination that there is significant scientific agreement among qualified experts for a health claim regarding the relationship between soy protein and reduced risk of coronary heart disease. We provided a 75-day comment period for the proposed rule.

We have received requests for a 60- day extension of the comment period for the proposed rule. Each request conveyed concern that the current comment period does not allow sufficient time to develop a meaningful or thoughtful response to the proposed rule.

FDA has considered the requests and is extending the comment period for the proposed rule until March 19, 2018. We believe that this extension allows adequate time for interested persons to submit comments without significantly delaying rulemaking on these important issues.” source

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