Suit claims FDA "censorship" on QHCs
This article was originally published in The Tan Sheet
Executive Summary
FDA's rejection of certain qualified health claims linking selenium to cancer prevention violates a federal court ruling that mandates a First Amendment standard for reviewing QHCs, Jonathan Emord asserts. The Clifton, Va.-based attorney filed a 1complaint July 30 in the U.S. District Court for the District of Columbia on behalf of the Alliance for Natural Health U.S., the Coalition to End FDA and FTC Censorship, which Emord founded, and supplement businesspersons Durk Pearson and Sandy Shaw. FDA recently approved a number of narrowly qualified, essentially unusable QHCs for selenium in response to an Emord citizen petition (2"The Tan Sheet" June 29, 2009). "FDA has denied consumers accurate representations of nutrition science," the complaint states
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Court rules for Emord in health claims case
A federal court rules FDA must adhere to the First Amendment standard established in Pearson v. Shalala and allow certain qualified anti-carcinogenic claims for selenium, as sought by attorney Jonathan Emord. Clifton, Va.-based Emord & Associates sued FDA in 2009 on behalf of the Alliance for Natural Health U.S., the Coalition to End FDA and FTC Censorship and supplement businesspersons Durk Pearson and Sandy Shaw, alleging FDA's approval of narrowly qualified health claims denied consumers accurate information (1"The Tan Sheet" Aug. 3, 2009, In Brief). In a May 27 2decision, the U.S. District Court for the District of Columbia calls FDA's position on QHCs "troubling" and says the agency "is obligated to at least consider the possibility of approving plaintiffs' proposed language with the addition of 'short, succinct, and accurate disclaimers.'
Litigation In Brief
Antioxidant claims basis for FDA suit: In his third lawsuit filed against FDA in less than a month, attorney Jonathan Emord alleges FDA "created a rigid construct that categorically rejects a large quantum of peer-reviewed science," namely qualified health claims linking antioxidant vitamins C and E with reduced risk of site-specific cancers. Emord's 1complaint, filed Aug. 14 in the U.S. District Court for the District of Columbia, says FDA violated First Amendment-based precedent in denying the claims for which he petitioned in 2008. As with the similar recent suit Emord filed against FDA for rejecting selenium QHCs, the Clifton, Va.-based attorney represents the Alliance for Natural Health U.S., the Coalition to End FDA and FTC Censorship, and businesspeople Durk Pearson and Sandy Shaw (2"The Tan Sheet" Aug. 3, 2009, In Brief)
Emord takes on FDA over supplement GMPs
The final rule for dietary supplement good manufacturing practices is "poorly written and unnecessarily a trap for the unwary," asserts attorney Jonathan Emord in a 1complaint filed Aug. 7 against FDA. The GMPs violate the Dietary Supplement Health and Education Act by allowing the agency to hold products as adulterated without proving they present a public health risk, he says. Emord also claims that because firms are not given proper guidance for complying with GMPs, the rule violates the constitutional prohibition against vague laws. Like his July 30 suit regarding FDA's rejection of health claims, the Aug. 7 suit also was filed in the U.S. District Court for the District of Columbia and on behalf of the Alliance for Natural Health U.S., the Coalition to End FDA and FTC Censorship and supplement businesspersons Durk Pearson and Sandy Shaw (2"The Tan Sheet" Aug. 3, 2009, In Brief)