Victory in Selenium Health Claims Case
We are pleased to report that the law firm of Jonathan Emord, Emord & Associates, has defeated the Food and Drug Administration in The Alliance for Natural Health USA v. Sebelius before the United States District Court for the District of Columbia. The decision issued on May 27, 2010 upsets the FDA's attempt to overturn the six prior decisions Emord has won against the agency's prior censorship of health claims. It reaffirms that the FDA is subject to the strictures of the First Amendment in its evaluation of health claims, and it faults the FDA for failing to follow that standard, holding its suppression of the selenium-cancer risk reduction claims unconstitutional.
In the present case, Emord filed suit on behalf of The Alliance for Natural Health USA; Durk Pearson and Sandy Shaw; and Coalition to End FDA and FTC Censorship against the FDA, alleging that its censorship of ten selenium-cancer risk reduction claims violated the First Amendment.
In its decision, the Court held:
The Court concludes that the FDA's position fails under Pearson I. The Agency has not provided any empirical evidence, such as 'studies' or 'anecdotal evidence,' that consumers would be misled by... plaintiffs' claims were they accompanied by qualifications.... Moreover, the explanation the FDA offers to demonstrate that plaintiffs' claims are misleading – that the claims leave out pertinent information – is not support for banning the claims entirely, but rather favors the approach of remedying any potential misleadingness by disclosure of additional information.
The Court further held FDA's lengthy and misleading disclaimers unconstitutional because they were neither succinct nor accurate but defeated the meaning of the claim rather than qualified the meaning. The Court ordered the FDA to reconsider all challenged claims and come up with reasonable disclaimers to accompany them.
This decision is the seventh won by the firm for its clients in federal court challenges against FDA claim suppression. Despite the repeat victories, the FDA continues to avoid compliance with the First Amendment mandates of the courts. Emord and Associates welcomes your inquiries at (202) 466-6937.