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Geoffrey A. Manne headshot

President and Founder

Geoffrey A. Manne is president and founder of the International Center for Law and Economics (ICLE), a nonprofit, nonpartisan research center based in Portland, Oregon. He is also a distinguished fellow at Northwestern University’s Center on Law, Business, and Economics. Previously he taught at Lewis & Clark Law School. Prior to teaching, Manne practiced antitrust law at Latham & Watkins, clerked for Hon. Morris S. Arnold on the 8th Circuit Court of Appeals, and worked as a research assistant for Judge Richard Posner. He was also once (very briefly) employed by the FTC. Manne holds AB & JD degrees from the University of Chicago.

Antitrust

Administrative Law First Amendment FTC

Amicus Brief

Amicus brief of Alliance for Natural Health-USA and TechFreedom, POM Wonderful LLC et al. v. FTC, D.C. Circuit

Summary

“For the first time in the FTC’s history, through its sweeping order in the POM Wonderful case (“POM”), the agency has prohibited the regulated class from communicating a disease-related claim in commerce unless the claim is backed by randomized clinical trials (RCTs) – which, given the cost of RCTs, ordinarily amounts to an outright prohibition on such claims. See Final Order, In re POM Wonderful LLC, et al., FTC Docket No. 9344 (Jan. 10, 2013), at 2 (“Final Order”). Through multiple public pronouncements by FTC officials and the POM Order, FTC intends its RCT requirement to be followed by the entire regulated class, thus establishing it as a general rule adopted without notice and comment in violation of the Federal Trade Commission Act (15 U.S.C. §§ 41-58) and the Administrative Procedure Act (5 U.S.C. § 553FTC’s new rule excludes from the ambit of permitted commercial speech the great bulk of scientific information concerning the actual and potential role of nutrients in disease risk reduction, including science conveyed by POM in qualified claims. That rule replaces the “totality of scientific evidence” and conflicts with the generally accepted scientific view that it is the totality of science, not the presence or absence of RCTs, that determines the relative validity of a nutrient-disease claim. That rule suppresses truthful qualified claims based on science other than RCTs (i.e., claims that include disclaimers that alert the public to the inconclusiveness of the evidence), thereby denying industry and consumers access in commerce to the great bulk of emerging science on the disease-risk-reduction potential of nutrients. That new rule conflicts with the First Amendment determination of this Court in Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999) (“Pearson I”), wherein the Court determined that the First Amendment required allowance of qualified claims based on the totality of the scientific evidence as a less speech-restrictive alternative to outright suppression.

In short, FTC’s new rule suppresses the republication in consumer markets of nearly all nutrition science, which science is evident in the totality of scientific evidence (and not RCTs to the exclusion of other evidence). Because precious few RCTs exist concerning foods and food elements, most science of utility to consumers arises from a combination of the following: animal studies, observational studies, case-control studies, cohort studies, cross-sectional studies, ecological studies, research synthesis studies (including meta-analyses), in vitro studies, epidemiological studies, patient series (or practitioner case series). It is that universe of science concerning foods and food elements upon which consumers must depend to exercise informed choice in an imperfect world. The FTC’s idealized conception of perfect information, backed by RCTs, has led the Commission to impose a requirement so burdensome that it will deny consumers the benefits of reasonably substantiated health claims in selecting healthier foods.

The POM Decision also violates the Administrative Procedure Act (APA) in four ways. First, FTC has promulgated the RCT requirement without explaining with reason why RCTs are necessary before any truthful disease-related claim may be made. For example, a claim predicated on science other than RCTs might be qualified with a disclaimer that alerts consumers to the fact that the supportive science is inconclusive, yet even that truthful qualified claim, held to be protected commercial speech in Pearson I, would not pass muster under the POM Decision. Second, FTC has promulgated the RCT requirement as a rule applicable to the entire regulated class, making that intent evident through the language of the decision and in public pronouncements (see supra note 1). The promulgation of a legislative rule applicable to the entire regulated class is prohibited unless adopted through notice and comment rulemaking.

Third, FTC’s RCT requirement is at odds with the standard for qualified claims adopted by its sister agency, the Food and Drug Administration. Under Pearson I, 164 F.3d 650 (D.C. Cir. 1999), the FDA is required to allow qualified health claims based on the totality of scientific evidence, not limited to claims backed by RCTs. Fourth, the FTC’s RCT requirement conflicts with, and was adopted without addressing, serious scientific criticism of dependency on RCTs for validation of nutrient-disease claims because nutrients, unlike synthetic xenobiotic drugs, exist in a milieu within the body and, thus, cannot ordinarily be isolated in their effects, which effects must instead be assessed based on the totality of non-RCT information”