FTC Commissioners Remain Divided on Health Claim Substantiation

While the appeal of the Federal Trade Commission’s (FTC) decision in POM Wonderful that “disease treatment” claims must be backed by two randomized controlled trials (RCTs) inexorably makes its way to the Supreme Court (it’s currently in the Washington, D.C., Circuit Court of Appeal), the debate over proper health claim substantiation continues to flare within the FTC. The crossfire resurfaced a year ago over disease claims in GeneLink and again last month over weight-loss claims in HCG Platinum.

As in POM Wonderful, FTC commissioners split over 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 POM, casting, seemingly reluctantly, the deciding yes vote. All four explained their views in separate statements discussed previously in this space (see “FTC, RCT, POM and DNA: A Witches’ Brew of Confusion for Supplement Marketers,” May 2014)

In HCG Platinum, the FTC voted unanimously (as it normally does now in weight-loss supplement settlements) for an outright ban on “substantial” weight-loss claims, but again voted non-unanimously (3-2) to impose a two-RCT requirement on all other weight-loss claims. In another joint statement echoing their views in GeneLink, Ramirez and Brill continue to base their support for a two-RCT requirement on the:

“very real and well-recognized principles regarding the benefits of replication in scientific studies … Replication reduces the risk that the result obtained in a single study may be due to chance … reduces the risk of biases … [and] may help guard against the manipulation or falsification of data … Moreover, in testing weight-loss products, replication … is particularly important, because almost any study purporting to find a product capable of causing substantial weight loss is likely to be novel and unexpected.”

While replication has its virtues, the assertion that it is particularly needed in the HCG Platinum order or any order like it to assure that a single clinical finding of substantial weight loss is not a fluke is dubious since the order already bans “substantial” weight-loss claims, period. They can’t be made whether supported by one, two or 10 clinical studies. Commissioner Terrell McSweeney, without statement, cast the deciding vote in favor of a two-RCT requirement for all other “non-substantial” weight-loss claims.

In a separate statement in HCG Platinum, Ohlhausen continued to voice her objection to a “one-size fits all” two-RCT standard. Her concerns are rooted in its potential “chilling effect” on useful commercial speech and the expense of human clinical trials. While willing to support two-RCTs for “rapid” weight-loss claims because they can be done in relatively short order and at lower cost (marketers having to shell out six figures for even a short study may disagree), she asserts that such a rigid and expensive standard should not otherwise be automatically mandated for health claims 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…”

In Gene Link, Commissioner Joshua Wright signaled a discomfort with the two-RCT substantiation mandate, even while providing the decisive vote for it. No longer “conflicted,” in HCG Platinum he went Ohlhausen one better and announced his opposition to a two-RCT requirement under any circumstances, arguing that a:

“rigid, static, numerical count of RCT’ is a poor and unreliable proxy for an accurate measurement of the overall quality and quantity of evidence available to potentially substantiate claims … The standard that best balances consumer welfare losses from deceptive claims against consumer welfare gains from the supply of accurate information … will vary from case to case. A rigid standard establishing a fixed number of RCTs in each case … runs the risk of overdeterring truthful claims that do not meet this standard.”

To strike a better balance, he favors a more flexible standard of “human clinical testing…that is sufficient in quality and quantity, based upon standards generally accepted by relevant experts.” (The FTC, in fact, has adopted this standard for other health claims – i.e., cognitive claims – unrelated to weight loss or disease.) Commissioner Wright would apply the same substantiation standard to all health claims and all health product marketers, whether under an FTC order or not. As he put it:

“A claim either has adequate substantiation or it does not. Requiring defendants … to obtain more scientific evidence than necessary to substantiate their claims is not in the best interests of consumers. I can see no rational economic basis for prohibiting claims the FTC would otherwise deem substantiated if made in the first instance – and thus presumptively beneficial to consumers – merely because the would-be substantiated claim is uttered by a party under order.”

From its POM Wonderful decision and the subsequent public statements of FTC commissioners inGene Link and HCG Platinum, it is not entirely clear whether the FTC intends for the two-RCT substantiation standard to be remedial “fencing in” relief only for defendants under order or a guideline to all weight loss and other health product marketers. Commissioner Wright fears the industry may think the latter.

Until we have a final appellate ruling in POM Wonderful or receive further clarification from the FTC, marketers would be wise to assume that, at a bare minimum, the FTC expects them to have at least one solid RCT (if not two) to back up weight loss, disease treatment and other health claims.

Talking about Direct Response, FTC, Online Marketing



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