government actions “may be based on rational speculation unsupported by evidence or empirical data,” and to challenge the requirement one must “negate every conceivable basis that might support it.”36
An example of application of the Zauderer standard of review appears when the court upheld New York City’s calorie labeling requirement. The court found that the “calorie disclosure rules were reasonably related to the goal of reducing obesity.”37 The court did not review the scientific literature on the effectiveness of calorie labeling but rather found it sufficient that obesity is significant public health concern, driven in large part by out‐of‐home consumption and that providing calorie information in restaurants might help to better inform consumer decision‐making. That is, the court's review and conclusion reflect the nature of a rational basis review. The government actions were supported by rational speculation, which did not require support from scientific data.
NOTE
1 5.1. Suppressing speech—ag‐gag laws. Since the 1990s, a number of states adopted “ag‐gag” laws. These laws prohibit filming or recording of agricultural activity without the consent of the owner. Some of the laws also ban applying for work at or entering an agricultural facility under false pretenses. These laws target undercover investigators who gain access to agricultural production facilities by taking jobs there to expose mistreatment of animals. Because of problems passing with laws, some states created “rapid‐reporting” legislation that requires turning over any animal abuse recordings to authorities within a short amount of time, such as 24 or 48 hours.Proponents of these laws argue that they protect farmers against propagandists presenting animal agriculture in a misleading way. Opponents argue that these are secrecy laws designed to hide animal abuse from the public. Courts have invalidated several of these state laws for violating the First Amendment's free‐speech protections. Even if a state can show a compelling interest behind these laws, they must still be narrowly tailored. See, e.g., Animal Legal Defense Fund v. Herbert, No. 13‐cv‐00679 (D. Utah Jul. 7, 2017).
5.6.3 Pearson v. Shalala38
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.
* * * * *
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