FDA has a month to respond to health claim contempt of court allegations

22-Jan-2010 - Last updated on 25-Jan-2010 at 09:27 GMT

Related tags Fda Appeal

The parties suing the FDA over its qualified health claims system have filed opposition to the FDA’s own opposition to their suit that accuses the regulator of health claim censorship and distortion of scientific data.

The Food and Drug Administration has one month to respond to the statement filed by the Alliance for Natural Health USA (ANH-USA) and others that accuses the FDA of ignoring four court orders dating back to 1999 and thereby breaching constitutional First Amendment freedom of speech tenets.

The parties, represented by Virgina-based attorney, Jonathan Emord, assert that the four cases including Pearson v Shalala direct the FDA to allow commercial messaging about nutrient-health benefit relations even when the science is supportive but not conclusive. They accuse the FDA of stubbornly refusing to respect the will of the courts.

The original action mounted against the FDA in August accusing it of selenium-cancer risk reduction claim sensorship can be found here.

In its opposition and cross-motion, the FDA requests the US District Court for the District of Columbia to dismiss those four cases, but Emord says a District court has no such capacity.

“We directly assert that FDA has engaged in contumacious conduct (contempt) for not abiding by four prior court orders,” Emord said. “The FDA has asked this court to overturn those prior cases – a power the district court lacks in our precedent based system.”

This is because, he asserts, it was the Court of Appeal that ruled on the first Pearson v Shalala and subsequent cases, and therefore it is that court and not a District Court that has the power to reverse a prior decision.

The FDA has one month to reply to ANH-USA statement, but Emord said with both parties indicating their appeal intentions, the case could well drag on for several years due to a backlog of cases and diminished federal bench judge numbers.

The suit, and another the same groups have lodged regarding antioxidants, hinges on the idea that inconclusive science should be able to be communicated without unreasonable disclaimers that render the claims commercially unusable.

The disputed FDA authorized claim reads: “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 FDA said it did not comment on ongoing litigation as a matter of policy.