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FDA faces legal challenge over selenium health claims

By Shane Starling , 31-Jul-2009
Last updated on 21-Sep-2009 at 16:50 GMT2009-09-21T16:50:23Z

A court action has been lodged today which challenges the Food and Drug Administration (FDA) qualified health claims system via five disputed selenium health claims.

The action, lodged by Jonathan W Emord of Virginia-based law firm, Emord & Associates, states that the qualified health claims system must modify its procedures as it is preventing truthful messaging from reaching consumers, and challenges five selenium cancer health claims.

Emord said the action which seeks “declaratory and injunctive relief” from the FDA and US Department of Health and Human Services, followed a 1999 case (Pearson versus Shalala) which validated qualified health claim messaging as a First Amendment freedom of speech right.

Following that decision, the FDA implemented the qualified health claims system, but Emord says the system is not abiding by the First Amendment, the Pearson v Shalala judgment and others that followed it.

“The system works from an artificially truncated universe of science so that many of the claims come with so many negative disclaimers that they become unusable,” Emord told NutraIngredients.com this morning.

“The FDA is refusing to honor the Court’s ruling in Pearson v Shalala and the mandates governing the qualified health claims system. The law states you cannot censor statements of science simply because the science is inconclusive. That is not an aspirational goal of the plaintiffs, it is the governing law presently. FDA is the radical here, going against the express constitutional mandates of the federal courts.”

An FDA spokesperson said the agency had no comment to make.

The claim has been lodged in the same court of law that heard Pearson versus Shalala and three similar cases that followed – all of which were won by clients of Emord.

Emord estimated the US District Court could deliver a verdict within 6-12 months.

Legal support

The legal complaint was supported by Colorado-based food lawyer, James Prochnow, who said the action was a response to the FDA’s, “historical, institutional, stubborn refusal to acknowledge, in an application way, the difference between drug claims and health claims”.

“The FDA, in my opinion, has been significantly overly cautious in applying the health claim principles to actual health claim and qualified health claim situations,” he said. “Either the Congress or the courts need to send a clear message to the FDA that significant efforts of dietary supplement and conventional food companies to engage in sound science should not be discouraged, but should be encouraged.”

Fellow food attorney, Marc Ullman, agreed the claim had merit as the qualified health claim system was not answering its mandate, but proving that in a court of law may prove difficult.

“FDA has adopted what I believe is a very calculated/sophisticated legal strategy for dealing with qualified health claims,” he said. “This involves trying to insulate that Agency from First Amendment challenges by ‘permitting’ every qualified health claim presented to it, but with so many qualifications/limitations as to neuter the claim to the point that the message it conveys is ‘FDA does not believe this product works".

Heavily qualified claims were being issued as if, “Pearson v Shalala was never decided”, he added.

“This is an important challenge to the Agency’s efforts to restrict the kind of important health information that you would think it would want consumers to have, especially at a time when the President is talking about the need to incorporate the concept of ‘wellness’ into out healthcare system.”

But one industry observer said, while ideas of free speech should be upheld, there was “little meat on the bone” of the action.

The plaintiffs in the case are the Alliance for Natural Health US, the Coalition to End FDA and FTC Censorship and Durk Pearson and Sandy Shaw, two supplement formulators.

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.”

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