FDA told to amend selenium health claims (again)

01-Jun-2010 - Last updated on 28-Jul-2010 at 14:42 GMT

The Food and Drug Administration has been ordered to amend qualified selenium health claims by a Washington DC district court that found FDA’s addition of lengthy disclaimers to the claims to be in breach of Constitutional, First Amendment, free speech principles.

The court backed the plaintiffs – the Alliance for Natural Health USA, Durk Pearson and Sandy Shaw, and the Coalition Against FDA and FTC Censorship – in ordering the FDA to redraft disclaimers for selenium claims in relation to certain cancers and respiratory and digestive health benefits.

However Justice Ellen Segal Huvelle’s judgment denied the plaintiff’s request to prevent the FDA from acting against proposed selenium messaging on all supplement products.

Conclusivity

Virginia-based food attorney, Jonathan W Emord from the firm Emord and Associates, who acted as counsel to the plaintiffs, and whose firm has brought six similar successful actions dating back to 1999 (Pearson versus Shalala), called the decision a, “momentous victory over FDA censorship.”

"It reestablishes the supremacy of the First Amendment over FDA, confirming that this agency may not escape the strictures of the Constitution to achieve health claim suppression," he said

"The court held that FDA may not demand conclusive proof as a condition precedent for health claim allowance but must permit claims that accurately represent the state of credible scientific evidence linking nutrients to disease, so long as the inconclusiveness of the evidence is revealed to the public.

"We are comforted and reassured by the decision; our federal district court has once again defended the First Amendment against a full frontal assault by the FDA. We wish only that FDA would finally get the message, this being the sixth time the courts have upheld the plaintiffs' First Amendment claims against the agency."

He said the plaintiffs would seek contempt of court measures if the FDA failed to identify, “accurate and succinct disclaimers” within “reasonable speed” as the ruling requests. He said three months was a reasonable time frame.

The FDA said it would determine its course of action, if any, after completing a review of the decision.

Well-designed studies

Colorado-based food attorney, James Prochnow said the ruling was “comprehensive” and would benefit not only the plaintiffs, but the FDA and the dietary supplements industry.

“The FDA will not, in my judgment, appeal this decision, but will get to work on proposed disclaimers to be used by the plaintiffs and others in this industry who wish to make these particular selenium claims.”

“This careful analysis and conclusions of this trial court demonstrate the need for well-designed and carried-out studies when a company wishes to sell a high-profile product that is accompanied by aggressive structure-function or qualified health claims.”

He said the verdict would resonate beyond the health claims area.

Dan Fabricant, PhD, the Natural Products Association’s vice president of scientific and global government affairs, said the verdict was significant because it upheld Pearson and the cases that had followed it, but questioned whether it would prompt the FDA to alter the claims.

He said the agency would identify the studies that had sparked the lengthy disclaimers in the first place, and “re-rate the strength of the body of evidence based on the quality of the studies”.

“I would be surprised if any new disclaimers are substantially different from FDA’s prior position on the matter.”

One of the FDA’s disputed selenium claims read: “Two weak studies suggest that selenium intake may reduce the risk of prostate cancer. However, four stronger studies and three weak studies showed no reduction in risk. Based on these studies, FDA concludes that it is highly unlikely that selenium supplements reduce the risk of prostate cancer.”