FDA fails to appeal selenium ruling – but will it act?

29-Jul-2010 - Last updated on 02-Aug-2010 at 13:02 GMT

Related tags Fda Prostate cancer Contempt of court Judge

The Food and Drug Administration must follow a district court ruling and alter existing qualified health claims for selenium or face contempt of court charges, according to the plaintiffs in the case.

A Washington DC district court ruled the addition of lengthy disclaimers to claims linking selenium and cancer, respiratory and immunity benefits was unconstitutional and told the agency to amend them.

Now that the period in which the FDA could appeal has expired, the agency must take action to come into line with the ruling, said Virginia-based food attorney, Jonathan W Emord, from Emord and Associates. He acted as counsel to the plaintiffs - the Alliance for Natural Health, Durk Pearson and Sandy Shaw, and the Coalition Against FDA and FTC.

History repeating

But Emord and others contacted for this story were not confident the FDA would alter very much, especially when six similar court actions have yielded little change in the way the FDA issues and administers qualified health claims.

“If history repeats itself, they will disobey the order,” Emord said. “The only recourse we have is to sue them for contempt, which we most certainly will do. I tire of the agency’s contumacious disregard for the Constitution and the constitutional mandates of our federal courts. FDA may believe itself above the law, but I suspect the federal courts have a different idea.”

The FDA was not available for comment at the time of publication.

Procedural shift

Colorado-based food attorney James Prochnow, from Greenberg Traurig, said it was uncommon for a federal governmental agency to be the subject of a contempt motion, “but not revolutionary.”

“The FDA is likely to comply with the Order of the federal district court and it is unlikely that the FDA will ever be cited for civil contempt of court,” he said.

He predicted a delay by the FDA in complying with the order and ongoing communications between the FDA and the plaintiffs.

“Clearly, the FDA should reassess its internal procedures for processing petitions for qualified health claims.”

Prochnow said the FDA should convene a panel of industry experts to provide input about streamlining qualified health claim procedures.

Dan Fabricant PhD, vice president of scientific and global government affairs at the Natural Products Association reiterated his view that the ruling would not bring about any substantial change in FDA qualified health claim practices.

“The ruling in May was good in that it backs up the original Pearson v Shalala ruling from 1999 that claims should be able to represent the science, but the FDA is likely to tweak its files to indicate it is reacting to this ruling and I don’t see little else happening.”

One of the FDA’s disputed selenium claims 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.”