As I wrote late last year, the Federal Trade Commission’s (FTC) crusade to mandate randomized controlled trials (RCT) for health claims has not been receiving the warmest reception from federal judges. (“FTC Suffers Another Setback in RCT Crusade,” November, 2015). In POM Wonderful, the Washington, D.C., Circuit Court of Appeals said the FTC could not require two RCTs for “disease treatment” claims since it could suppress accurate, useful consumer information in violation of the First Amendment. A single RCT might be justified for disease claims, but for other health claims, the court said that the more flexible traditional standard of “competent and reliable scientific evidence” would still apply.
The POM holding that an RCT is mandatory only for drug claims was then followed by a ruling in an FTC contempt case against Bayer for violating a consent order. The court rejected the government’s claim that the “competent and reliable scientific evidence” standard requires an RCT to substantiate dietary supplement claims, stating, “As long as a supplement is not marketed as a drug, it is not regulated like a drug.” This is the distinction POM drew in permitting an RCT requirement for “disease treatment” (drug) claims but not for other health claims.
Undeterred, and contrary to its own official guidance, the FTC has continued to argue that “competent and reliable scientific evidence” should be interpreted to mean that efficacy claims for dietary supplements must be, and can only be, supported by an RCT. Last month, in a reversal of its recent fortunes, it got a federal district judge in Wyoming to agree with it.
In a case against COORGA Nutraceuticals, the FTC challenged claims that the company’s supplement, Grey Defence, could treat gray hair. It disputed both an “efficacy” claim” (Grey Defence prevents and reverses gray hair) and an “establishment” claim (its efficacy is scientifically confirmed). An establishment claim can be “specific” by referring to a specific type of substantiation or “non-specific” by asserting the claim is “clinically” or otherwise “scientifically proven.” The establishment claim for Grey Defence was of the non-specific variety.
The distinctions matter because they affect the type of analysis that is used in advertising substantiation cases. Under the analytical framework laid out in POM and prior precedents, which the court utilized, the Grey Defence efficacy claim needed to have a “reasonable basis,” the existence of which, under the longstanding “Pfizer test,” is determined by the: (1) “type of product;” (2) “type of claim;” (3) “benefit of a truthful claim;” (4) “ease of developing substantiation for the claim;” (5)” the “consequences of a false claim;” and (6) “amount of substantiation experts in the field would consider reasonable.” For the non-specific establishment claim, only the last Pfizer factor had to be satisfied – namely, evidence “sufficient to satisfy the relevant scientific community of the claim’s truth.” (For a specific establishment claim, the advertiser must possess the specific substantiation claimed.)
An FTC dermatology expert testified that experts in the field would require at least one RCT to support a claim that a dietary supplement can prevent and reverse gray hair. This was enough for the judge who, without giving any consideration to the five other Pfizer factors, held that the efficacy claim, as well as the non-specific establishment claim, required an RCT.
COORGA did not have an RCT. It also made the FTC’s and the court’s job easier by not countering the government expert with one of its own on the necessity for an RCT, and by relying only on research that had been done by its non-scientist owner and on a small “observational study” (user survey). Given so little to work with, it’s not surprising that the judge granted summary judgment to the FTC on both the efficacy and establishment claims. Still, it would have been nice if he at least had gone through the motions of analyzing the efficacy claim under the entire set of Pfizer factors. Without going through all of them, it is not hard to imagine a different result, at least on the efficacy claim, if they had been weighed. Among other things, there is no “ease” in developing an RCT, which can cost hundreds of thousands of dollars, and no safety risk from a false claim for a gray hair supplement, as there can be from a false drug claim.
The FTC is fine with discarding the other Pfizer factors for dietary supplement claims. Indeed, that is its de facto policy, if not its official one, which still states that:
Randomized clinical trials are not required. … “Competent and reliable scientific evidence” is a “flexible” standard, and “there is no fixed formula for the number or type of studies required … although “well-controlled human clinical studies are the most reliable form of evidence,” they are not necessary… one should look to the ‘totality of the evidence…” (See “Dietary Supplements: An Advertising Guide for Industry” at www.ftc.gov.)
For counsel defending supplement marketers who don’t have an RCT, convincing the FTC that an RCT is not required could demand the skills of a Clarence Darrow, and even that may not be enough. Wherever possible, nutraceutical firms should have an RCT, ideally on the actual advertised product – but, short of that, at least on the active ingredients drawn from the scientific literature. For those who want to engage the FTC on the merits, you absolutely must have a qualified expert who can credibly argue that the relevant scientific community wouldn’t necessarily require an RCT, and show why the other Pfizer factors also support your case. Chances are it still won’t be enough, but if you don’t settle, it could give you a shot with a fair-minded judge who doesn’t overly defer to the agency.
Also, in crafting claims without an RCT but with other potentially competent and reliable scientific evidence, supplement marketers should avoid non-specific (i.e., clinically proven) establishment claims and limit any “science” representation only to a description of its specific scientific support, together with any necessary qualifications or disclaimers. Your burden of proof could then be limited simply to showing that you possess that particular scientific evidence.