Court Slams FDA Selenium Claim Decision

WASHINGTONJudge Ellen Segal Huvelle of the U.S. District Court for the District of Columbia has sent FDA back to work on approving a qualified health claim for selenium and cancer, ruling the agency took a misguided approach to issuing a decision on the claim and must act quickly to review proposed claims and draft disclaimers for them.

In the case, Alliance for Natural Health (ANH) v. Sebelius, the plaintiffsincluding Durk Pearson, Sandy Shaw and the Coalition to End FDA and FTC Censorshipsued FDA, based on precedent cases, over the denial of a petition for several qualified health claims for selenium and the risk of certain cancers.

Huvelle ruled the agency violated the spirit of Pearson vs. Shalala, which allows qualified claim approval with less thansubstantial scientific agreement. She also found FDA failed to accurately analyze the studies submitted by the petitioner and, in its replacement language, mischaracterized at least one study.

Huvelle remanded the case to FDA, ordering the agency to draft disclaimers for the petitioners various claims, including cancer, lung/respiratory tract, and colon/digestive tract benefits, or provide empirical evidence showing any disclaimer would fail to correct the misleading aspects of the petitioned claims.

The Council for Responsible Nutrition (CRN) noted the decision gives FDA a strong reprimand for its approach to reviewing qualified health claims for dietary supplements under the Pearson v. Shalala standard, and could lead to more favorable review of these petitions in the future.

Andrew Shao, Ph.D., Sr. VP scientific & regulatory affairs, cautioned its too early to know if the decision from this case represents a new standard for qualified health claim (QHC) language, and there is still the possibility that FDA may appeal the decision:According to the court, FDA has to go back to the drawing board to develop claim language that better reflects the state of the science, but that is not misleading to consumers.  This will take some time and effort.  On the one hand, we already know from the agencys own research (and from IFIC too) that it is difficult to come up with qualifying language that is not confusing or misleading to consumers.  On the other hand, we also know for example the statement that there is no evidence that selenium reduces the risk of certain cancers (which is what FDAs qualifying language basically amounts to) is also incorrect, because there IS evidence, and some of it quite good, but it is conflicting.  This is a huge challenge for FDA and Im not sure how they will go about striking this important balance.

I do believe that the agency recognizes (unlike EFSA) that the science behind the nutrient-disease relationship is a continuum, and an ever-evolving one at that, and that rarely is there a simple black and white answer, he continued. I still believe that the root of the problem, the rate-limiting factor, if you will, is the limitations in the research.  FDA is charged with making these difficult decisions with suboptimal data at their disposal.  If there were better and more appropriately designed studies assessing the effects of nutrients on chronic disease risk reduction, the need to extensively qualify claims would be lessened.  I see NIH heading in this direction, with both ODS and NCCAM focusing future research dollars on smaller, more rigorous  Phase-2 trials that will invest heavily in the use of biomarkers of exposure and surrogates for disease.  However, any results are years away, so this does little to help FDA today.

The full opinion is available at Leagle.com.