The courts have repeatedly made clear that FDA enforcement activity is subject to the First Amendment rules regarding allocation of burden of proof in First Amendment cases. For example, the U.S. Court of Appeals for the District of Columbia Circuit held recently that the First Amendment imposes strict limitations on FDAs power to restrict health claims made by manufacturers of dietary
supplements, even when the claims are made on the product label. Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999) (Pearson I). In overturning a district court decision that had upheld FDAs outright ban on such claims when use of disclaimers might have responded fully to FDAs concerns, the appeals court stated:
The government insists that it is never obliged to utilize the disclaimer approach,
because the commercial speech doctrine does not embody a preference for
disclosure over outright suppression. Our understanding of the doctrine is different.
. . . In more recent cases, the [Supreme] Court has . . . repeatedly point[ed] to
disclaimers as constitutionally preferable to outright suppression.
Id. at 657. The court added, [W]hen government chooses a policy of suppression over
disclosure at least where there is no showing that disclosure would not suffice to cure
misleadingness government disregards a far less restrictive means of achieving its policy interests. Id. at 658 (quoting Bd. of Trustees of SUNY, 492 U.S. at 479).
On remand, FDAs First Amendment arguments were again rejected. The district court granted a preliminary injunction against FDAs continued violation of First Amendment rights; the court required FDA to approve a health claim (for inclusion on product labeling for folic acid) regarding the positive relationship between consumption of folic acid and prevention of birth defects. Pearson v. Shalala, 130 F. Supp. 2d 105 (D.D.C. 2001) (Pearson II). The district court was harshly critical of FDAs continued resistance to court orders that it comply with the First Amendment; the court said:
t is clear that the FDA simply failed to comply with the constitutional guidelines
outlined in Pearson . Indeed, the agency appears to have at best, misunderstood,
and at worst, deliberately ignored, highly relevant portions of the Court of Appeals
Opinion.
Pearson II, 130 F. Supp. 2d at 112. The court held that under the First Amendment, FDA must shoulder a very heavy burden if it seeks to totally ban a particular health claim. Id. at 118. The court held that FDA had failed to meet that burden; it held that [t]he mere absence of significant affirmative evidence in support of a particular [health] claim . . . does not translate into negative evidence against it. Id. at 115. In other words, the court held, any FDA efforts to regulate manufacturer dissemination of unapproved health claims must take the form of disclaimer requirements rather than outright bans on the claims, unless FDA can demonstrate that the claims are against the great weight of the scientific literature.3 The district court later denied FDAs motion for reconsideration of the preliminary injunction order. Noting that FDAs arguments contained in the motion for reconsideration further demonstrate Defendants reluctance to fully comply with Pearson I, the court reiterated its conclusion:
[T]he philosophy underlying Pearson I is perfectly clear: that the First Amendment
analysis in Central Hudson . . . applies in this case, and that if a health claim is not
inherently misleading, the balance tilts in favor of disclaimers rather than
suppression. In its motion for reconsideration, the FDA has again refused to accept
the reality and finality of that conclusion by the Court of Appeals.
Pearson v. Thompson, 141 F. Supp. 2d 105, 112 (D.D.C. 2001).
