Court order prompts FDA selenium health claim change

05-Oct-2010 - Last updated on 06-Oct-2010 at 17:07 GMT

Colon cancer: FDA has shortened claim but essence remains the same

The Food and Drug Administration has revised three selenium, qualified health claims, after a court reiterated earlier rulings and ordered it to do so in July.

The new shortened claims link selenium consumption with reduction in the risk of colon, prostate, bladder and thyroid cancers but are heavily qualified by the FDA.

FDA does not agree

One of the claims reads: “Selenium may reduce the risk of prostate cancer. Scientific evidence concerning this claim is inconclusive. Based on its review, FDA does not agree that selenium may reduce the risk of prostate cancer.”

Previously the same claim 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.”

The change comes after a Washington DC district court ruled on May 27 this year that the addition of lengthy disclaimers to claims linking selenium and cancer, respiratory and immunity benefits was unconstitutional under the First Amendment and demanded that the FDA amend them.

Coverage of that action can be found here.

Long overdue

Legal counsel in the case, Jonathan Emord, from the Virginia-based firm Emord and Associates, welcomed the FDA action, and noted legal precedent dating back to 1999 in Pearson versus Shalala, when the courts first found against the FDA’s use of lengthy disclaimers.

“I hope this resolution becomes a model for FDA in subsequent qualified claims cases,” he said. “Compliance with the First Amendment requirement in Pearson v Shalala that FDA favor disclosure of nutrient-disease information over its suppression is long overdue.”

Emord emphasized the succinctness of the claims as a plus even though the FDA explicitly states it does not agree with the scientific findings.

Careful what you wish for

Dan Fabricant, PhD, the Natural Products Association’s vice president of scientific and global government affairs, commended the FDA for acting swiftly on the latest court order, but said the altered claims did not alter the FDA view on selenium science.

“The settlement is a reaction to the First Amendment issue from the court ruling that upholds Pearson v Shalala but this is not a significant change,” he said. “The FDA has fulfilled its duty by amending these claims but it is debatable what impact they will have as the qualifications remain so strong. I wonder which products would want to carry these claims. Perhaps it is a case of being careful what you wish for.”

Fabricant said it was unlikely the ruling and FDA action would prompt the agency to conduct a review of its complete roster of qualified health claims.

One of the plaintiffs in the recent case – the Alliance for Natural Health USA – said the disclaimers were, “the shortest and clearest ever approved.”

“Nutrition science, like science generally, is almost never completely conclusive, so it is unremarkable that the health claims are qualified as being inconclusive. And the last sentence of the disclaimer—that the FDA does not agree—reflects not scientific fact but rather FDA’s opinion, which in turn reflects the agency’s well-known anti-supplement, pro-drug bias. This is a big step forward.”