Alliance for Natural Health Takes A Swing at FDA’s Regulation of Qualified Health Claims

By Ricardo Carvajal –

In conjunction with other plaintiffs, the Alliance for Natural Health has filed suit in the D.C. district court challenging FDA’s denial of plaintiffs’ petition for the use of four qualified health claims for selenium and certain forms of cancer, and FDA’s imposition of an unfavorable disclaimer on the use of a fifth claim.  Plaintiffs contend that FDA’s actions violate their First Amendment rights to communicate “scientific information vital to those who seek to reduce their risks of certain kinds of cancers through dietary means.”  Plaintiffs ask the court to declare invalid FDA’s final order denying their petition for the claims and to enjoin FDA from taking any action to preclude their use of the claims in the labeling of dietary supplements.  This is the latest in a string of actions that have been brought against the agency over its handling of health claims, some of which have been successful (see Whitaker v. Thompson, 248 F.Supp.2d 1 (D.D.C. 2002) (Whitaker I) and the cases cited therein, but see Whitaker v. Thompson, 239 F.Supp.2d 43 (D.D.C. 2003), aff'd. 353 F.3d 947 (D.C.Cir. 2004), cert denied 543 U.S. 925 (Whitaker II)).

The complaint presents a fundamental challenge to FDA’s current approach to the regulation of qualified health claims, which the agency developed in the wake of Whitaker I and its antecedents.  First, plaintiffs take issue with FDA’s refusal to consider more than 90% of the publications submitted in support of plaintiffs’ petition.  In its consideration of qualified health claim petitions, FDA routinely excludes a significant number of publications that the agency deems for one reason or another to be irrelevant.  Second, based on prior judicial opinions, plaintiffs contend that FDA can deny use of a claim only in two instances: when “no evidence” supports the claim, or when “evidence in support of the claim is qualitatively weaker than evidence against the claim – for example, where the claim rests on only one or two old studies.”  Even then, FDA must first “demonstrate with empirical evidence that disclaimers. . . would bewilder consumers and fail to correct for deceptiveness.”  Plaintiffs maintain that FDA has failed to meet this burden.  Third, plaintiffs contend that FDA is “constructively suppressing” claims through 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 case is Alliance for Natural Health US et al. v. Sebelius et al., No. 1:09-cv-01470 (D.D.C. filed August 4, 2009).