Supplement Health Claim Approval Costs Unaffordable, Economist Says
This article was originally published in The Tan Sheet
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.
You may also be interested in...
Dietary supplement manufacturers will be able to market products with health claims supported by indefinite scientific evidence under an interim procedure set forth in the Oct. 6 Federal Register.
A preliminary injunction against FDA requested by the Pearson v. Shalala plaintiffs was denied May 24 by D.C. federal court judge Gladys Kessler. An appeal was filed May 26 by Emord & Associates (Washington, D.C.).
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.