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The FDA rejected four proposed health claims by the Pearson plaintiffs. Each of these four claims linked the consumption of a particular dietary supplement to the reduction in risk of a 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.”

Relying on arguments grounded in the First Amendment and the Administrative Procedures Act (APA), the U.S. Court of Appeals invalidated the FDA regulations prohibiting those health claims and required the FDA to reconsider its disapproval of the plaintiffs’ claims. The court ruled that the FDA violated the First Amendment by banning misleading health claims without considering the use of curative disclaimers, and violated the arbitrary and capricious standard of the APA by failing to clarify the standard of “significant scientific agreement.”

Health claims are a form of “commercial speech” and, under First Amendment protections, the FDA cannot unnecessarily restrain such speech. FDA argued that health claims lacking “significant scientific agreement” are inherently misleading to consumers and, therefore, are incapable of being cured by disclaimers. However, the Court of Appeals ruled that the FDA had no basis to reject the health claims without first assessing whether the use of a disclaimer could communicate meaningful, nonmisleading information to the consumer. Where commercial speech is potentially misleading but can be “presented in a way that is not deceptive,” the government cannot ban it.

The court also found that FDA had not followed appropriate administrative procedures because it failed to fully explain why the four health claims did not meet the “significant scientific agreement” standard applicable to health claims. The FDA had not defined the criteria being applied to determine whether such agreement exists. The Court noted the legal and practical need to provide a governing rationale for approving or rejecting proposed health claims on the basis of a lack of “significant scientific agreement.” The court concluded that FDA’s denial of these health claims without defining “significant scientific agreement” constituted arbitrary and capricious action under the APA. Accordingly, the court ordered FDA to explain the meaning of “significant scientific agreement.” At a minimum, the FDA must make it possible “for the regulated class to perceive the 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.

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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 would have difficulty in independently verifying these claims. We are told, in addition, that consumers might actually assume that the government has approved such claims.

Under Central Hudson, we are obliged to evaluate a government scheme to regulate potentially misleading commercial speech by applying a three‐part test. First, we ask whether the asserted government interest is substantial. The FDA advanced two general concerns: protection of public health and prevention of consumer fraud. The Supreme Court has said “there is no question that [the government’s] interest in ensuring the accuracy of commercial information in the marketplace is substantial,” and that government has a substantial interest in “promoting the health, safety, and welfare of its citizens.” At this level of generality, therefore, a substantial governmental interest is undeniable.

The more significant questions under Central Hudson are the next two factors: “whether the regulation directly advances the governmental interest asserted,” and whether the fit between the government’s ends and the means chosen to accomplish those ends “is not necessarily perfect, but reasonable,” We think that the government’s regulatory approach encounters difficulty with both factors.

It is important to recognize that the government does not assert that appellants’ dietary supplements in any fashion threaten consumer’s health and safety. The government simply asserts its “common sense judgment” that the health of consumers is advanced directly by barring any health claims not approved by the FDA. Because it is not claimed that the product is harmful, the government’s underlying—if unarticulated—premise must be that consumers have a limited amount of either attention or dollars that could be devoted to pursuing health through nutrition, and therefore products that are not indisputably health enhancing should be discouraged as threatening to crowd out more worthy expenditures. We are rather dubious that this simplistic view of human nature or market behavior is sound, but, in any event, it surely cannot be said that this notion—which the government does not even dare openly to set forth—is a direct pursuit of consumer health; it would seem a rather indirect route, to say the least.

On the other hand, the government would appear to advance directly its interest in protecting against consumer fraud through its regulatory scheme. If it can be assumed—and we think it can—that some health claims on dietary supplements will mislead consumers, it cannot be denied that requiring FDA pre‐approval and setting the standard extremely, perhaps even impossibly, high will surely prevent any confusion among consumers. We also recognize that the government’s interest in preventing consumer fraud/confusion may well take on added importance in the context of a product, such as dietary supplements, that can affect the public’s health.

The difficulty with the government’s consumer fraud justification comes at the final Central Hudson factor: Is there a “reasonable” fit between the government’s goals and the means chosen to advance those goals? 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 otherwise….

Our rejection of the government’s position that there is no general First Amendment preference for disclosure over suppression, of course, does not determine that any supposed weaknesses in the claims at issue can be remedied by disclaimers and thus does not answer whether the subregulations, 21 C.F.R. § 101.71(a), (c), (e); id. § 101‐79(c)(2)(i)(G), are valid. The FDA deemed the first three claims—(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,” and (3) “Consumption of omega‐3 fatty acids may reduce the risk of coronary heart disease”—to lack significant scientific agreement because existing research had examined only the relationship between consumption of foods containing these components and the risk of these diseases. The FDA logically determined that the specific effect of the component of the food constituting the dietary supplement could not be determined with certainty… . But certainly this concern could be accommodated, in the first claim for example, by adding a prominent disclaimer to the label along the following lines: “The evidence is inconclusive because existing studies have been performed with foods containing antioxidant vitamins, and the effect of those foods on reducing the risk of cancer may result from other components in those foods.” A similar disclaimer would be equally effective for the latter two claims.

The FDA’s concern regarding the fourth claim—“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”—is different from its reservations regarding the first three claims; the agency simply concluded that “the scientific literature does not support the superiority of any one source [of folic acid] over others.” But it appears that credible evidence did support this claim (concluding that “losses [of folic acid] in cooking and canning [foods] can be very high due to heat destruction”), and we suspect that a clarifying disclaimer could be added to the effect that “The evidence in support of this claim is inconclusive.”

The government’s general concern that, given the extensiveness of government regulation of the sale of drugs, consumers might assume that a claim on a supplement’s label is approved by the government, suggests an obvious answer: The agency could require the label to state that “The FDA does not approve this claim.” Similarly, the government’s interest in preventing the use of labels that are true but do not mention adverse effects would seem to be satisfied—at least ordinarily—by inclusion of a prominent disclaimer setting forth those adverse effects.

The government disputes that consumers would be able to comprehend appellants’ proposed health claims in conjunction with the disclaimers we have suggested—this mix of information would, in the government’s view, create confusion among consumers. But all the government offers in support is the FDA’s pronouncement that “consumers would be considerably confused by a multitude of claims with differing degrees of reliability.” Although the government may have more leeway in choosing suppression over disclosure as a response to the problem of consumer confusion where the product affects health, it must still meet its burden of justifying a restriction on speech—here the FDA’s conclusory assertion falls far short.

We do not presume to draft precise disclaimers for each of appellants’ four claims; we leave that task to the agency in the first instance. Nor do we rule out the possibility that where evidence in support of a claim is outweighed by evidence against the claim, the FDA could deem it incurable by a disclaimer and ban it outright.³⁹ For example, if the weight of the evidence were against the hypothetical claim that “Consumption of Vitamin E reduces the risk of Alzheimer’s disease,” the agency might reasonably determine that adding a disclaimer such as “The FDA has determined that no evidence supports this claim” would not suffice to mitigate the claim’s misleadingness. Finally, while we are skeptical that the government could demonstrate with empirical evidence that disclaimers similar to the ones we suggested above would bewilder consumers and fail to correct for deceptiveness, we do not rule out that possibility.

B. The Unarticulated Standard

Wholly apart from the question whether the FDA is obliged to consider appropriate disclaimers is appellants’ claim that the agency is obliged to give some content to the phrase “significant scientific agreement.” …

Consideration of this constitutional claim seems unnecessary because we agree with appellants that the APA requires the agency to explain why it rejects their proposed health claims—to do so adequately necessarily implies giving some definitional content to the phrase “significant scientific agreement.” We think this proposition is squarely rooted in the prohibition under the APA that an agency not engage in arbitrary and capricious action. It simply will not do for a government agency to declare—without explanation—that a proposed course of private action is not approved. (“The agency must … articulate a satisfactory explanation for its action… .”). To refuse to define the criteria it is applying is equivalent to simply saying no without explanation. Indeed, appellants’ suspicions as to the agency’s real reason for its volte‐face on the general folate‐neural tube defect claim highlight the importance of providing a governing rationale for approving or rejecting proposed health claims.

To be sure, Justice Stewart once said, in declining to define obscenity, “I know it when I see it,” which is basically the approach the FDA takes to the term “significant scientific agreement.” But the Supreme Court is not subject to the Administrative Procedure Act. Nor for that matter is the Congress….

That is not to say that the agency was necessarily required to define the term in its initial general regulation—or indeed that it is obliged to issue a comprehensive definition all at once. The agency is entitled to proceed case by case or, more accurately, subregulation by subregulation, but it must be possible for the regulated class to perceive the principles which are guiding agency action. Accordingly, on remand, the FDA must explain what it means by significant scientific agreement or, at minimum, what it does not mean.

….

For the foregoing reasons, we hold invalid the four subregulations, 21 C.F.R. § 101.71(a), (c), (e); § 101.79(c)(2)(i)(G), and the FDA’s interpretation of its general regulation, id. § 101.14. The decision of the district court is reversed, and the case is remanded to the district court with instructions to remand in turn to the FDA for reconsideration of appellants’ health claims.

So ordered.

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