Vitamin E Health Claim Falls Short Of Significant Scientific Agreement - FDA
This article was originally published in The Tan Sheet
Executive Summary
FDA has determined a health claim relating vitamin E to a reduced risk of heart disease does not meet the "significant scientific agreement" standard. The agency's decision is articulated in a Jan. 11 letter to the Washington, D.C. firm Emord & Associates, which submitted the claim petition on behalf of Julian Whitaker, MD, Durk Pearson, Sandy Shaw and others.
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Dietary supplement companies would have to spend between $58 mil. and $348 mil. for NDA-type approval for each of six health claims they seek to make under FDA's significant scientific agreement standard, an Emory University economist maintains.
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