EMORD SUES FDA: ANTIOXIDANT VITAMIN CLAIM SUPPRESSION VIOLATES FIRST AMENDMENT
Today Emord & Associates, P.C. filed a third suit in as many weeks against the Food and Drug Administration in the U.S. District Court for the District of Columbia against the FDA. The firm did so 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 June 19, 2009 decision censoring antioxidant vitamin/cancer risk reduction claims unconstitutional under the First Amendment and to enjoin FDA from preventing entry of the claims into the market.
In Whitaker v. Thompson I, 284 F.Supp.2d 1, 13 (D.D.C. 2002), U.S. District Court Judge Gladys Kessler gave FDA the First Amendment standard it was to apply in health claim cases. FDA has not cited, let alone applied, that standard in the review of any health claims, including the antioxidant vitamin/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, erecting a straw man to either deny or saddle claims with misleadingly negative disclaimers.
Upon filing the suit, lead counsel Jonathan W. Emord stated, "This is the third time we have gone to Court against FDA for its suppression of an antioxidant vitamin/cancer risk reduction claim. The U.S. Court of Appeals in Pearson v. Shalala ordered FDA to allow the claim with reasonable disclaimers. FDA refused, and we sued the agency again. The U.S. District Court in Whitaker v. Thompson I ordered FDA to allow the claims a second time, condemning FDA's refusal to abide by Pearson v. Shalala. We are now back a third time, demanding that FDA abide by the same constitutional law and precedent it has refused to accept for more than a decade. It is clear that FDA thinks itself unanswerable to the federal courts and above the supreme law of the land, the Constitution. We hope in this case the district court will make clear that FDA is neither."
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.
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.