SUBSCRIBE

Breaking News on Supplements, Health & Nutrition - North America EU edition | APAC edition

News > Regulation

Read more breaking news

 

 

Court asked to rule on selenium claims

By Shane Starling , 19-Oct-2009

The legal firm behind two actions that challenge the US qualified health claims system has asked a District of Columbia District Court to issue a summary judgment against the FDA over its selenium claims.

The selenium complaint, along with a similar action regarding antioxidants, accuses the Food and Drug Administration of mal-administration of qualified health claims, principally by endowing them with disclaimers that limit their commercial value.

Virginia-based Emord & Associates in July lodged the selenium suit on behalf of the Alliance for Natural Health US; Durk Pearson and Sandy Shaw; and the Coalition to End FDA and FTC Censorship.

It lodged the antioxidant suit soon after and is also suing the FDA over its approach to Good manufacturing Practices (GMPs).

The current action asks the District Court to deem the FDA’s selenium claims approach unconstitutional for breaching First Amendment freedom of speech rights.

“The action asks the court to issue an order holding FDA’s censorship unconstitutional and enjoining FDA from taking any action to censor the plaintiffs’ claims,” Emord said.

“The present motion follows the original complaint and is the formal request that the Court act on the causes of action in the complaint.”

The actions also accuse the FDA of failing to follow case law precedents such as Pearson versus Shalala that found the FDA should not discriminate against science just because it is not conclusive.

“Coming after four federal court decisions prohibiting the same kind of censorship,” the motion reads, FDA’s suppression of the selenium claims is “contumacious conduct.”

It “rests on the supposition that this agency is not bound by the constitutional decisions of the federal courts and may function independent of the rule of law, as a law unto itself.”

The claims

One of the submitted claims, for prostate cancer, stated in its original form:

“Selenium may reduce the risk of prostate cancer. Scientific evidence supporting this claim is convincing but not yet conclusive.”

The FDA’s disputed modification 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.”

The selenium motion goes onto state: “FDA’s speech police are . . . rogue agents who view their power to censor unanswerable to the law—beyond the reach of the First Amendment and this Court.”

Related products