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