As reported in an article from FoodNavigator-USA.com, the Food and Drug Administration (“FDA”) responded to ConAgra Foods Inc.’s petition for a qualified health claim for whole grains and reduced risk of diabetes mellitus type 2.
ConAgra’s petition proposed that the following two model health claims be allowed on the labels or in the labeling of whole grains and food containing whole grains:
(1) Scientific evidence suggests, but does not prove, that diets low in saturated fat and cholesterol that include three servings (48 grams) of whole grains per day may reduce the risk of diabetes mellitus type 2.
(2) Scientific evidence suggests, but does not prove, that whole grains (three servings or 48 grams per day), as part of a low saturated fat, low cholesterol diet, may reduce the risk of diabetes mellitus type 2.
FDA concluded that the proposed model claims must be further qualified to prevent them from misleading consumers. The agency revised the claims to state as follows:
(1) Whole grains may reduce the risk of type 2 diabetes, although the FDA has concluded that there is very limited scientific evidence for this claim.
(2) Whole grains may reduce the risk of type 2 diabetes. FDA has concluded that there is very limited scientific evidence for this claim.
FDA’s revised claims likely violate the First Amendment of the U.S. Constitution. In Alliance for Natural Health U.S. v. Sebelius, 714 F. Supp. 2d 48 (D.D.C. 2010) (“ANH”), Emord & Associates, P.C. represented plaintiffs who challenged, inter alia, FDA’s qualification of their proposed health claim regarding the relationship between selenium and prostate cancer risk. The plaintiffs proposed the following model claim: “Selenium may reduce the risk of prostate cancer. Scientific evidence supporting this claim is convincing but not yet conclusive.” FDA found that two-nested case control studies suggested that selenium may reduce risk of prostate cancer, but it rejected the model claim because it thought it was false and misleading to characterize the evidence in support of the claim as “convincing but not yet conclusive.” FDA revised the claim to state as follows: “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 ANH plaintiffs claimed that FDA’s revision violated the First Amendment because it “constructively suppress[es] [this] claim with the imposition of an onerous, value laden set of qualifications that only allow Plaintiffs to propound a false, negatively value-laden, and inaccurate claim to the public.” The D.C. District Court agreed. It held that “FDA’s proposed claim is at odds with the Supreme Court’s mandate that there be a ‘reasonable fit’ between the government’s goal and the restrictions it imposes on commercial speech.” The court reasoned that FDA was required to draft a “precise disclaimer” that would qualify the plaintiffs’ claim while also adhering to the “First Amendment preference for disclosure over suppression,” but what FDA did was replace the Plaintiffs’ claim entirely and effectively negate any relationship between prostate cancer risk and selenium intake. As a result, the court ordered FDA to draft a new short, succinct, and accurate disclaimer.
In spite of the court’s instructions to FDA in ANH, FDA is once again drafting unreasonable, negatively value-laden disclaimers that likely violate the Constitution, as evidenced by the ConAgra decision.