FTC, RCT, POM and DNA: A Witches’ Brew of Confusion for Supplement Marketers13 May, 2014 By: William I. Rothbard
While the appeal of the Federal Trade Commission’s (FTC) order in POM Wonderful that “disease treatment” claims must be backed by two randomized controlled trials (RCT) inexorably makes its way to the Supreme Court (oral argument was heard in the D.C. Circuit Court of Appeal on May 2), the debate over the proper substantiation standard rages on within the FTC itself, among a revolving set of commissioners. The crossfire resurfaced in connection with two settlements earlier this year, but was obscured by the headline-grabbing $26.5 million settlement in SENSA, which was announced at the same time.
One settlement was with the beauty product company, L’Occitane, and the other with a company called Gene Link. L’Occitane made a slimming claim for a skin cream line and Gene Link marketed supplements and a skincare product that were purportedly customized to each consumer’s genetic profile from DNA taken from a cheek swab. Gene Link claimed its customized supplements could neutralize genetic disadvantages and help treat diseases such as diabetes, heart disease and insomnia, and that its customized skin care product could repair aging, wrinkling skin.
The FTC voted unanimously to impose a two-RTC requirement on future weight-related claims in the L’Occitane case and to apply the heretofore traditional, looser “competent and reliable scientific evidence” standard to future skincare and other non-weight-, non-disease-related health claims in the Gene Link case. Only a majority, however, supported a two-RCT requirement for disease claims in Gene Link, with Chairwoman Edith Ramirez and Commissioner Julie Brill in favor, Commissioner Maureen Ohlhausen dissenting (as she did in POM Wonderful), and Commissioner Joshua Wright, who was not at the FTC at the time of the POM decision, casting, seemingly reluctantly, the deciding yes vote. All four explained their views in separate statements.
They agree substantiation for disease (and weight-loss) claims must be grounded in science, “reasonably tailored” to prevent a recurrence of the violation, and not unduly costly for marketers and consumers. That is where the agreement ends. In a joint statement, Ramirez and Brill argue that disease treatment claims require a “rigorous level” of substantiation and that a two-RCT requirement serves “well-recognized scientific principles favoring replication of study results … provides clear rules … facilitating the setting of future research and marketing agendas, and preserves law enforcement resources by minimizing future argument over the quantity and quantity of substantiation needed for the most serious health claims.”
Ohlhausen, in her dissent, argues that a “one-size fits all” two-RCT standard to substantiate “any” disease-related claims is “unduly high” and costly because it “may, in many instances, prevent useful information from reaching consumers…and ultimately make consumers worse off.” She notes rightly that RCTs can be expensive and time-consuming and thus shouldn’t be automatically mandated for disease and other health claims for relatively safe products like food, vitamins and supplements because “if 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 … health features.”
Ohlhausen also believes the two-RCT requirement, as articulated in the FTC’s orders, unreasonably prohibits marketers from relying on ingredient studies for combined products, even where there’s no known relevant interactions, and unreasonably requires the studies to be done by separate, independent researchers, even absent reason to suspect bias or fabrication. By these orders, she says the FTC is imposing a “de facto two-RCT standard on health- and disease-related claims for food or other relatively-safe products.” Ramirez and Brill deny this but do acknowledge that to the extent other marketers “look to our orders for signals as to the type of backing required for disease treatment claims, we prefer that they understand that serious claims like those made by respondents (in Gene Link) must have hard science behind them.”
Translation: Disease treatment and weight-loss claims must have at least two RCTs behind them.
While voting with Ramirez and Brill, Wright, a Republican, seemed to signal that his true sympathies lay more with Ohlhausen by encouraging the Commission to “explore more fully whether the articulation and scope of injunctive relief in these and similar settlements strikes the right balance between deterring deceptive advertising and preserving for consumers the benefits of truthful claims.”
The FTC is now back at full strength with the swearing in last month of Commissioner Terrell McSweeny. As the likely tiebreaker in future Commission votes on a two-RCT substantiation requirement for disease treatment and weight-loss claims (and perhaps other health claims still to be added to the class of “most serious”), will she side with Ramirez-Brill or Ohlhausen-Wright? While we wait – perhaps years – for a final appellate ruling in POM Wonderful that hopefully will bring clarity to the issue, how she votes will determine whether in fact supplement marketers are now operating under a de facto two-RCT substantiation standard for weight-loss and disease treatment claims.