FDA Modification to Dietary Supplement Qualified Health Claims Remanded by Federal Court

Apr 26, 2011   

During the first week in April, a federal judge granted the U.S. Food and Drug Administration (FDA) summary judgment in a federal case brought by dietary supplement manufacturers challenging good manufacturing practices (GMPs) for dietary supplements. During the second week in April, in a separate case, the win went to the dietary supplement manufacturers. On April 13, the U.S. District Court for the District of Columbia ruled that the FDAs decision requiring qualifying language for antioxidant claims for dietary supplements was unconstitutional under the First Amendment.

Dietary supplement formulators and industry organizations brought the lawsuit, Alliance for Natural Health US v. Sebelius, No. 09-1546 (D.D.C. April 13, 2011) (“Alliance II”), challenging an FDA decision to deny a petition for authorization of certain qualified health claims regarding dietary supplements containing vitamin C and vitamin E. The plaintiffs claimed that the FDA decision violated their First Amendment Rights and sought a declaratory judgment that the FDAs final order denying the petition was invalid. The plaintiffs also sought a permanent injunction enjoining the FDA from “taking any action that would preclude the Plaintiff from placing [their proposed] health claims on the labels and in the labeling of their dietary supplements.” Complaint at 36.

The health claims at issue in this case concerned the relationship between vitamins C and E and the risk for certain types of cancer. The FDA refused to approve these claims. A “health claim” is “any claim made on the label or labeling of a food, including a dietary supplement, that expressly or by implication, characterizes the relationship of any substance to a disease or health-related condition.” The FDA allows two types of health claims to appear on dietary supplement labeling: 1) authorized health claims; and 2) qualified health claims. A “qualified health claim” is a health claim that is supported by some scientific evidence but less evidence than an authorized health claim. The FDA requires that qualified health claims be accompanied by a disclaimer explaining the level of scientific evidence supporting the relationship between the dietary ingredient and the disease or health-related condition.

In Alliance II, the FDA required qualification of the following health claims:

  • Vitamin C may reduce the risk of gastric cancer. The scientific evidence supporting this claim is persuasive, but not conclusive.
  • Vitamin E may reduce the risk of bladder cancer. The scientific evidence for this claim is convincing, but not conclusive.

The FDA prohibited the claims as they appear above and would only allow the claims to appear in the following forms:

  • One weak study and one study with inconsistent results suggest that vitamin C supplements may reduce the risk of gastric cancer. Based on these studies, FDA concludes that it is highly uncertain that vitamin C supplements reduce the risk of gastric cancer.
  • 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.

The plaintiffs brought their claims under the First Amendment to the Constitution. The Court reasoned that it “has the authority to examine and rule on any actions of a federal agency that allegedly violate the Constitution,” apart from the power of review granted by the Administrative Procedure Act (APA). Alliance for Natural Health USI v. Sebelius, 714 F. Supp. 2d 48 (D.D.C. 2010) (citations omitted) (“Alliance I”). However, the APA “also provides for the Courts to make an independent assessment of constitutional issues,” and the role of the Court is the same “whether the plaintiff sues directly under the Constitution or under [the APA].” Id. (citations omitted). Relying on the analysis set forth by Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999) (“Pearson I”) and by Alliance I, the Alliance II court reasoned that it “is obligated to conduct an independent review of the record and must do so without reliance on the [FDAs] determinations as to constitutional questions, it must also give deference to an agency assessment of scientific or technical data within its areas of expertise.” Id. at 16 (quoting Alliance I).

The Court described the appropriate inquiry in this matter to be “whether the FDA properly determined that there was no “credible evidence” supporting the plaintiffs claims.” Alliance II at 22. The Court stated that it would “limit its consideration of this question to an assessment of whether the FDAs evaluation was inconsistent with its own standards, irrational, or arbitrary and capricious. Id. The Court evaluated the FDAs 2009 Guidance Document stating that it uses an “evidence-based review system” to evaluate the strength of the evidence supporting a health claim and held the factors the FDA uses, as enumerated in the Guidance Document, to be reasonable and consistent with the FDAs regulatory authority. See id. at 24-25. However, when the Court evaluated the modifications applied to the plaintiffs qualified claims, the Court held that the FDA did not draft “precise disclaimer[s] designed to qualify plaintifss claim[s] while adhering to the ËœFirst Amendment preference for disclosure over suppression, as mandated.” Id. at 35 (citing Alliance I).

Ultimately, the Court held that the FDAs modifications to the claims were unconstitutional under the First Amendment. The FDA did not employ the least restrictive means available to regulate the speech at issue in this matter. The Court held that “health claims that are supported by some credible evidence, and which are therefore only potentially misleading, are protected commercial speechPearson I teaches that empirical evidence of the inefficacy of using disclaimers is required for the FDA to ban a health claim that is only potentially misleading “ i.e., a claim that is based on some credible evidence. Alliance II at 20.

The Court ruled that the FDA “has replaced plaintiffs claims entirely,” and that the claim “qualification effectively negates any relationship between cancer risk and vitamin intake. The FDAs rewordingmakes it difficult to tell what the original health claims are and appears to disavow the FDAs own conclusions that those claims are supported by credible evidence.” Alliance II at 13. The Court remanded the claims regarding the relationships between vitamin C and gastric cancer and vitamin E and bladder cancer to the FDA for further action.