Food Regulation. Neal D. Fortin

Чтение книги онлайн.

СКАЧАТЬ principles which are guiding agency action.”

      The decision created legal hurdles to FDA’s efforts to reject petitions filed in support of health claims. However, the decision did not permit the plaintiffs in Pearson to make their health claims with disclaimers without any further preclearance by FDA. The decision directed FDA to reconsider the plaintiffs’ four proposed claims in light of possible value of disclaimers. Basically, the decision invalidated FDA’s regulations but put the Pearson plaintiffs back at square one in the FDA preclearance process. In addition, the Court did not rule out the possibility that “where evidence in support of a claim is outweighed by evidence against the claim,” FDA could deem the claim “incurable” by a disclaimer and, therefore, reject the claim as unlawful.

      * * * * *

       Pearson v. Shalala

       164 F.3d 650 (D.C. Cir. 1999)

      Judges: Before: WALD, SILBERMAN, and GARLAND, Circuit Judges

      Opinion for the Court filed by Circuit Judge SILBERMAN.

      Marketers of dietary supplements must, before including on their labels a claim characterizing the relationship of the supplement to a disease or health‐related condition, submit the claim to the Food and Drug Administration for preapproval. The FDA authorizes a claim only if it finds “significant scientific agreement” among experts that the claim is supported by the available evidence. Appellants failed to persuade the FDA to authorize four such claims and sought relief in the district court, where their various constitutional and statutory challenges were rejected. We reverse.

I

      Dietary supplement marketers Durk Pearson and Sandy Shaw, presumably hoping to bolster sales by increasing the allure of their supplements’ labels, asked the FDA to authorize four separate health claims… . A “health claim” is a “claim made on the label or in labeling of … a dietary supplement that expressly or by implication … characterizes the relationship of any substance to a disease or health‐related condition.” 21 C.F.R. § 101.14(a)(1) (1998). Each of appellants’ four claims links the consumption of a particular supplement to the reduction in risk of a particular disease:

      1 “Consumption of antioxidant vitamins may reduce the risk of certain kinds of cancers.”

      2 “Consumption of fiber may reduce the risk of colorectal cancer.”

      3 “Consumption of omega‐3 fatty acids may reduce the risk of coronary heart disease.”

      4 “.8 mg of folic acid in a dietary supplement is more effective in reducing the risk of neural tube defects than a lower amount in foods in common form.”

      ….

      The FDA has since promulgated 21 C.F.R. § 101.14—the “significant scientific agreement” “standard”— … for evaluating the validity of health claims on dietary supplements… . In doing so, the agency rejected arguments asserted by commenters—including appellants—that the “significant scientific agreement” standard violates the First Amendment because it precludes the approval of less‐well supported claims accompanied by a disclaimer and because it is impermissibly vague….

      Then the FDA rejected the four claims supported by appellants… . The problem with these claims, according to the FDA, was not a dearth of supporting evidence; rather, the agency concluded that the evidence was inconclusive for one reason or another and thus failed to give rise to “significant scientific agreement.” But the FDA never explained just how it measured “significant” or otherwise defined the phrase. The agency refused to approve the dietary fiber‐cancer claim because “a supplement would contain only fiber, and there is no evidence that any specific fiber itself caused the effects that were seen in studies involving fiber‐rich [foods].” The FDA gave similar reasons for rejecting the antioxidant vitamins‐cancer claim, and the omega‐3 fatty acids‐coronary heart disease claim. As for the claim that 0.8 mg of folic acid in a dietary supplement is more effective in reducing the risk of neural tube defects than a lower amount in foods in common form, the FDA merely stated that “the scientific literature does not support the superiority of any one source over others.” The FDA declined to consider appellants’ suggested alternative of permitting the claim while requiring a corrective disclaimer such as “The FDA has determined that the evidence supporting this claim is inconclusive.”

      A more general folate‐neural tube defect claim supported by appellants—that consumption of folate reduces the risk of neural tube defects—was initially rejected but ultimately approved for both dietary supplement and food labels. The parties disagree on what caused the FDA’s change of position on this claim. Appellants contend that political objections—Senator Hatch was one of the complainers—concentrated the agency’s mind. The FDA insists that its initial denial of the claim was based on a concern that folate consumption might have harmful effects on persons suffering from anemia, and that its concern was alleviated by new scientific studies published after the initial denial of the claim.

      Appellants sought relief in the district court, raising APA and other statutory claims as well as a constitutional challenge, but were rebuffed.

       II

      Appellants raise a host of challenges to the agency’s action. But the most important are that their First Amendment rights have been impaired and that under the Administrative Procedure Act the FDA was obliged, at some point, to articulate a standard a good deal more concrete than the undefined “significant scientific agreement.” …

      It is undisputed that FDA’s restrictions on appellants’ health claims are evaluated under the commercial speech doctrine. It seems also undisputed that the FDA has unequivocally rejected the notion of requiring disclaimers to cure “misleading” health claims for dietary supplements… . The government makes two alternative arguments in response to appellants’ claim that it is unconstitutional for the government to refuse to entertain a disclaimer requirement for the proposed health claims: first, that health claims lacking “significant scientific agreement” are inherently misleading and thus entirely outside the protection of the First Amendment; and second, that even if the claims are only potentially misleading, under Central Hudson, the government is not obliged to consider requiring disclaimers in lieu of an outright ban on all claims that lack significant scientific agreement.

      If such health claims could be thought inherently misleading, that would be the end of the inquiry.

      Truthful advertising related to lawful activities is entitled to the protections of the First Amendment. But when the particular content or method of the advertising suggests that it is inherently misleading or when experience has proved that in fact such advertising is subject to abuse, the States may impose appropriate restrictions. Inherently misleading advertising may be prohibited entirely. But the States may not place an absolute prohibition on … potentially misleading information … if the information also may be presented in a way that is not deceptive.

As best we understand the government, its first argument runs along the following lines: that health claims lacking “significant scientific agreement” are inherently misleading because they have such an awesome impact on consumers as to make it virtually impossible for them to exercise any judgment at the point of sale. It would be as if the consumers were asked to buy something while hypnotized, and therefore they are bound to be misled. We think this contention is almost frivolous. We reject it. But the government’s alternative argument is more substantial. It is asserted that health claims on dietary supplements should be thought at least potentially misleading because the consumer СКАЧАТЬ