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Emord sues FDA; selenium claim suppression violates First Amendment.

On August 8, 2009, Emord & Associates, PC, filed suit in the US District Court for the District of Columbia against the Food and Drug Administration on behalf of the Alliance for Natural Health US, dietary supplement formulators Durk Pearson and Sandy Shaw, and the Coalition to End FDA and FTC Censorship. The suit seeks declaratory and injunctive relief, asking the Court to hold FDA's decision on June 19, 2009, to suppress selenium/cancer risk reduction claims unconstitutional under the First Amendment, and to enjoin FDA from censoring the claims.

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In Whitaker v. Thompson 1, 284 F.Supp.2d 1, 13 (D.D.C. 2002), US District Court Judge Gladys Kessler gave FDA the First Amendment standard it was to apply in health claim cases. FDA has not once cited, let alone applied, that standard in the review of any health claims, including the selenium/cancer risk reduction claim. In its review of qualified health claims, FDA has often not permitted accurate representations of emerging science to reach the public. Instead, it has created a rigid construct that categorically rejects review of science that the scientific community considers persuasive, including animal studies, in vitro studies, and clinical trials (if they involve treatment of diseased populations or are deemed methodologically deficient for one reason or another). FDA thus does not in fact review the totality of scientific evidence but only a small fraction of it, thus erecting a straw man to either deny or saddle claims with misleadingly negative disclaimers.

Upon filing the suit, lead counsel Jonathan W. Emord stated, "FDA has reinstated a regime of censorship, demanding near conclusive proof before it allows any nutrition science to enter the market. That move violates four First Amendment cases that have repeatedly demanded that FDA favor disclosure of nutrition science over its suppression as the operative rule. Rather than permit public access to accurate representations of science, FDA refuses to allow any science to reach the market unless it thinks scientific proof established to a near conclusive degree, an extremely rare happenstance.

"It was this same paternalistic censorship that kept from the public the folic acid/neural tube defect claim for four years, resulting in an estimated 2,500 preventable neural tube defect births each year," Emord said. "FDA still does not understand that the First Amendment protects freedom to receive accurate information, even if scientifically inconclusive. FDA has no constitutional authority to serve as the nation's food nanny, banning from the market nutrition science on the offensive assumption that FDA knows better than consumers what is in their own best interests."

Emord & Associates has defeated FDA in five prior First Amendment cases, including the landmark Pearson v. Shalala, 172 F.3d 72 (D.C.Cir. 1999). The firm has also filed, and obtained approval, for most of the qualified health claims now permitted by the agency.

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Author:Emord, Jonathan W.
Publication:Townsend Letter
Article Type:Report
Geographic Code:1USA
Date:Oct 1, 2009
Words:476
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