The action, lodged in a Washington DC District Court by Jonathan W Emord of Virginia-based law firm, Emord & Associates, seeks “declaratory and injunctive relief” from the Food and Drug Administration for withdrawing on June 19, 13 vitamin C and E cancer-related claims, and qualifying four others to the point where they are commercially unusable.
In particular, six claims are challenged relating vitamin C and lung, colon and gastric cancer; and vitamin E and bladder, gastric and lung cancer.
As with a similar action - lodged by Emord against the FDA over its approach to qualified selenium health claims - the antioxidant action lodged today cites Federal Court decisions that the FDA is accused of acting in contempt of.
The First Amendment
These include Pearson v Shalala (1999) and in particular Whitaker v Thompson I (2002), where the judgment stated that regulators must favor “disclosure over suppression” of information in line with First Amendment constitutional free speech rights.
“The FDA is blatantly flouting federal and constitutional law,” Emord told NutraIngredients-USA.com. “By saddling health claims with overbearing negative disclaimers that place subjective interpretations on science, or censoring them outright, the FDA is attempting to reverse the law in Pearson v Shalala and cases that followed it.”
He said the FDA had never been comfortable with the qualified health claims system since its creation in the wake of the Pearson v Shalala decision, and was therefore attempting to “eviscerate” it.
The FDA is interpreting scientific data, Emord said, using terms such as “weak” to describe studies that were, in his view, better cited as being either “conclusive” or “inconclusive”.
“This is a truthful appraisal of the scientific body of work. To use terms such as ‘weak’ is a presumptive and subjective leap the FDA has made which contradicts the law. It is characteristic of a rogue agent,” he said.
“This approach locks out 99 percent of the evidence pertaining to nutrients and disease. It places the FDA above the law and has pulled the leg out from under the qualified health claims system.”
The FDA has 60 days to respond to the action, which also cites the US Department of Health and Human Services. Emord estimated the US District Court could deliver a verdict within 6-12 months.
Last week the firm, representing the Alliance for Natural Health US, the Coalition to End FDA and FTC Censorship and Durk Pearson and Sandy Shaw, two supplement formulators, also sued the FDA over its Good Manufacturing Practices (GMPs) regulations.
Emord’s firm was involved in both Pearson v Shalala and Whitaker v Thompson I, making this the third time it has sued the FDA on behalf of plaintiffs over its approach to antioxidant health claims.
Citing the court judgment from Pearson v Shalala, the action states: “It is clear … that when government chooses a policy of suppression over disclosure—at least where there is no showing that disclosure would not suffice to cure misleadingness—government disregards a ‘far less restrictive means.’”
The claims
One of the health claims as petitioned to the FDA stated:
“Vitamin E may reduce the risk of bladder cancer. The scientific evidence supporting this claim is convincing, but not conclusive.”
It was amended by the FDA to read:
“One small study suggests that Vitamin E supplements may reduce the risk of bladder cancer. However, two small studies showed no reduction of risk. Based on these studies, FDA concludes that it is highly unlikely that vitamin E supplements reduce the risk of bladder cancer.”
Emord & Associates has given legal representation to more than 450 dietary supplements firms and 100 physicians in the past ten years.