In a previous Truth on the Market blog posting, I noted that the FTC recently revised its “advertising substantiation” policy in a highly problematic manner. In particular, in a number of recent enforcement actions, an FTC majority has taken the position that it will deem advertising claims “deceptive” unless they are supported by two randomized controlled tests (RCTs), and (in the case of food and drug supplements) will require companies to obtain prior U.S. Food and Drug Administration (FDA) approval for future advertising claims. As I explained in a Heritage Foundation Legal Memorandum, these and other new burdens “may deter firms from investing in new health-related product improvements, in which event consumers who are denied new and beneficial products (as well as useful information about the attributes of current products) will be the losers. Competition will also suffer as businesses shy away from informational advertising that rewards the highest quality current products and encourages firms to compete on the basis of quality. Furthermore, the broad scope of these requirements is in tension with the constitutional prohibition on restricting commercial speech no more than is necessary to satisfy legitimate statutory purposes.” (NOTABLY, Commissioner Maureen Ohlhausen has argued against categorically imposing a two RCTs requirement in all cases , explaining that “[i]f we demand too high a level of substantiation in pursuit of certainty, we risk losing the benefits to consumers of having access to information about emerging areas of science and the corresponding pressure on firms to compete on the health features of their products.” Commissioner Joshua Wright has also opined “that a reflexive approach in requiring two RCTs as fencing-in relief might not always be in the best interest of consumers.”)
In a January 30, 2015 decision, POM Wonderful, LLC v. FTC, the D.C. Circuit took an initial step that may help rein in FTC enthusiasm for imposing a “two RCTs” requirement on future advertising by a firm. The FTC ruled in 2013 that POM Wonderful, a producer and seller of pomegranate products, violated the FTC Act by making advertisements that suggested POM products could treat, prevent, or reduce heart disease, prostate cancer, and erectile dysfunction. According to the FTC, the ads were false and misleading because POM lacked valid and adequate scientific evidence to substantiate its claims. (The FTC determined that scientific findings cited by POM, based on over $35 million of pomegranate-related research, had not been supported by subsequent studies.) The FTC entered a cease and desist order that barred POM from making future disease claims (claims that its products treat, prevent, or reduce a disease) about its products without “competent and reliable” scientific evidence. Specifically, the FTC’s order required that such future claims be supported by at least two RCTs. (NOTABLY, Commissioner Ohlhausen disagreed with the majority’s view that two RCTs were warranted and would have required only one RCT, regarding that study in light of other available scientific evidence.)
POM appealed to the D.C. Circuit, which unanimously held that there was no basis for setting aside the FTC’s finding that many of POM’s ads made false or misleading claims; that there was no First Amendment protection for deceptive advertising; and that requiring an RCT was not too onerous and did not violate the First Amendment. The court concluded that “the [FTC] injunctive order’s requirement of some RCT substantiation for disease claims directly advances, and is not more extensive than necessary to serve, the interest in preventing misleading commercial speech”, consistent with the test for evaluating commercial speech enunciated by the Supreme Court in Central Hudson. The court, however, also held that “a categorical floor of two RCTs for any and all disease claims . . . fails Central Hudson scrutiny”. The court stressed that the FTC “fails to demonstrate how such a rigid remedial rule bears the requisite ‘reasonable fit’ with the interest in preventing deceptive speech.” Significantly, the court also enunciated a strong policy justification, rooted in First Amendment commercial speech concerns, for precluding a categorical “two RCTs” rule:
“Requiring additional RCTs without adequate justification exacts considerable costs, and not just in terms of the substantial resources often necessary to design and conduct a properly randomized and controlled human clinical trial. If there is a categorical bar against claims about the disease-related benefits of a food product or dietary supplement in the absence of two RCTs, consumers may be denied useful, truthful information about products with a demonstrated capacity to treat or prevent serious disease. That would subvert rather than promote the objectives of the commercial speech doctrine.”
Accordingly, the court modified the FTC’s order to require that POM possess at least one RCT in support of future health-related advertising claims. Assuming that the D.C. Circuit’s POM decision is not appealed and remains in force, future advertisers investigated by the FTC will have stronger grounds to resist FTC efforts to impose “two or more RCT” requirements as part of a decree.
This is just a small step in badly-needed reforms, however. Even a single RCT is unnecessarily onerous in many market settings (and, in my view, ignores the teachings of Central Hudson). More broadly, as I have previously argued, the FTC should rethink its entire approach and issue new advertising substantiation guidelines that state the FTC: (1) will seek to restrict commercial speech to the smallest extent possible, consistent with fraud prevention; (2) will apply strict cost-benefit analysis in investigating advertising claims and framing remedies in advertising substantiation cases; (3) will apply a reasonableness standard in such cases, consistent with general guidance found in a 1983 FTC policy statement; (4) will not require clinical studies be conducted in order to substantiate advertising claims; (5) will not require that the FDA or any other agency be involved in approving or reviewing advertising claims; and (6) will avoid excessive “fencing in” relief that extends well beyond the ambit of the alleged harm associated with statements that the FTC deems misleading. Enactment of such guidelines may be a long-term project, requiring a change in Commission thinking, but it is well worth pursuing, in order to advance both free commercial speech and consumer welfare.