To Disclaim or Ban Outright – “Credible Evidence” for Health ClaimsApril 17, 2011
After more than fifteen years of related cases in the larger matter of The First Amendment v. Dietary Supplement Health Claims, FDA mostly won one. And its winning card? Knowing that the courts will not, and cannot, independently assess whether the scientific evidence provided to FDA to support a health claim for a dietary supplement constitutes “credible evidence.” So, FDA drafted Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims (Jan. 2009), in which the Agency laid out the types of studies it believed may provide credible evidence of a health claim – including the way those studies should have been conducted and the data that should have been collected –and those that will not provide credible evidence. Then, all a court has to do is ask if FDA followed the guidance document, without considering whether the standards the Agency put forth in the guidance document are a reasonable means of assessing credible evidence.
This appears to be the theory upon which the decision was reached in the case of Alliance for Natural Health US v. Sebelius (“Alliance II”). In this case, plaintiffs challenged FDA’s decision declining to approve several health claims concerning the relationship between vitamins C and E and the risk for certain types of cancer. Plaintiffs had submitted seventeen qualified health claims linking vitamins C and E with a reduction in the risk of certain types of cancer. FDA denied thirteen of the claims entirely and permitted four others to be made as qualified claims with modified language. In Alliance II, plaintiffs challenged FDA’s ruling on six of these claims – four that were denied outright, and two that FDA agreed to permit as qualified claims with modified language.
As a preliminary matter, the court stated that FDA need not conduct an empirical study on the efficacy of a disclaimer before an outright banning of a claim if there is either no evidence to support the claim, or the evidence in support of the claim is qualitatively weaker than evidence against the claim. Such claims would qualify as unprotected commercial speech and are therefore not protected under the Central Hudson analysis. However, empirical evidence of the inefficacy of disclaimers is required for FDA to ban a health claim that is based on some credible evidence.
Enter the guidance document. At its core, the opinion indicated that if FDA properly applied the process outlined in the guidance document, and, based on that process, determined that no credible evidence existed to support the claim, or the evidence in support of the claim was qualitatively weaker than that against it, FDA’s decision would stand. The court found this to be the case for each of the four claims that FDA banned outright, and therefore upheld FDA’s denial of these health claims. (These claims were: (1) Vitamin C may reduce the risk of lung cancer. The scientific evidence supporting this claim is convincing, but not conclusive. (2) Vitamin C may reduce the risk of colon cancer. The scientific evidence supporting this claim is persuasive, but not conclusive. (3) Vitamin E may reduce the risk of lung cancer. The scientific evidence for this claim is convincing, but not conclusive. (4) Vitamin E may reduce the risk of gastric cancer. The scientific evidence for this claim is persuasive, but not conclusive.)
The reason that FDA only “sort of” won this one is because the court remanded to FDA the two claims that FDA was willing to allow with additional modifications. The court stated that the modifications “replaced plaintiffs’ claim[s] entirely” and were not sufficiently precise, concluding: “Where the evidence supporting a claim is inconclusive, the First Amendment permits the claim to be made; the FDA cannot require a disclaimer that simply swallows the claim.” In other words, if FDA allowed a qualified health claim, the qualification cannot be so limiting as to essentially erase the relationship between a substance and the specified disease or health-related condition.
So where does this leave us? By drafting the guidance document, FDA regained some of the control that it lost over the years regarding health claims and allowable disclaimers. It has laid out the studies that it considers to constitute credible evidence, and no court is likely to question those determinations. If a dietary supplement manufacturer intends to support a health claim with a study on FDA’s black list, it does so at its own risk. But, if FDA approves a qualified health claim, it cannot modify the substance/condition relationship out of existence. Only one thing is certain — this is not the last we will hear of The First Amendment v. Dietary Supplement Health Claims.