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US Court Rules in Favour of Free Speech on Health Claims

DORKING, UK: The US Food and Drug Administration (FDA) lost its bid to overturn a health claim for selenium‐containing dietary supplements last Thursday in the United States District Court for the District of Columbia. District Court Judge Ellen Huvelle ruled unconstitutional the FDA's censorship of selenium dietary supplement claims relating to the reduction of cancer risk. Jonathan Emord of Emord & Associates on behalf of the plaintiffs in the case (including lead plaintiff Alliance for Natural Health USA (ANH‐USA); Durk Pearson and Sandy Shaw; and the Coalition to End FDA and FTC Censorship). The verdict, unless reversed on appeal, protects the First Amendment right of dietary supplement manufacturers to provide "qualified health claims" which accurately communicate the state of science concerning dietary supplements. This is a remarkable seventh victory over the FDA by the Emord firm (six of which invalidated FDA health claim censorship).

The lawsuit was initiated last summer in response to the FDA's 19th June 2009 decision to suppress selenium/cancer‐risk reduction claims. Ten of the claims (all appealed by the plaintiffs) were held unconstitutionally censored. The plaintiffs expressed their belief that this violated their right to communicate truthful health information to the public. The judge found that the FDA had denied claims despite credible evidence supporting them and had thereby infringed on free speech.

Prior to this ruling the FDA required near conclusive scientific evidence for any nutrient claim. The judge ruled that so long as the claim is an accurate reflection of the state of science, the First Amendment protects it.

European policy on health claims for foods and food constituents has yet to be tested in court. Yet, the European food and natural product industries, as well as many consumers, are currently up in arms as the European Commission attempts to implement a law, the Nutrition & Health Claims Regulation (No 1924/2006) that aims to ban all health claims on food, food constituents or supplements-unless they are specifically approved by Europe's highest authority on food, the controversial European Food Safety Authority (EFSA). Contrary to the US court verdict, EFSA is only approving claims based on conclusive evidence from studies on healthy human populations.

Commenting on the court decision and its possible impact on the European health claims environment, Robert Verkerk PhD, executive and scientific director of ANH International, said, "The verdict in our case against the FDA should be sending shock waves across the Atlantic to EFSA. If European authorities implement the Nutrition and Health Claims Regulation as planned in 2011, it is the European consumer that will be the main loser. Disease prevention using good diets and nutrients will effectively be thrown out of the window. EFSA needs to either shift to using credible evidence as in the US, or it should expect to argue its case in the courts."