The Federal Trade Commission’s (FTC) crusade to mandate randomized controlled trials (RCT) for health claims is not faring well with the federal judiciary. Earlier this year, the U.S. Court of Appeals for the District of Columbia reversed the FTC’s decision in POM Wonderful that had mandated two RCTs for “disease treatment” claims, holding that such an onerous requirement could potentially suppress accurate, useful consumer information in violation of the First Amendment protection of truthful commercial advertising (DRMA Voice, February). While the court said a single RCT could be required for disease claims, for other health claims the more flexible traditional standard of “competent and reliable scientific evidence” would still apply.
The POM holding that an RCT is mandatory, in effect, only for drug claims has now been followed in a New Jersey federal district court decision handed down in September in an FTC contempt case against Bayer for violating a 2007 consent order. The court rejected the government’s claim that the “competent and reliable scientific evidence” standard requires an RCT to substantiate claims for dietary supplements.
Bayer had been advertising its probiotic Phillips’ Colon Health (PCH) supplements as an aid for constipation, diarrhea, gas, and bloating. Its consent order required “competent and reliable scientific evidence” for these claims, defined as:
“… tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area, that have been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results.”
The FTC argued that the provision meant an RCT had to be done on the actual PCH product, and because one hadn’t been performed, Bayer was in violation of its order and should be held in contempt.
The court based its denial of the contempt motion on the Dietary Supplement Health & Education Act of 1994 (DSHEA), the FTC’s own substantiation guidance for dietary supplement claims, and expert testimony. DSHEA, the court found, was intended by Congress to impose less stringent marketing requirements for dietary supplements than for drugs.
In contrast to new drugs, dietary supplements do not require pre-approval by the Food and Drug Administration (FDA) and traditionally do not need to be supported by RCTs. The only substantiation requirement established by DSHEA for supplement claims is that they be “truthful and not misleading.” In the court’s words, “as long as a supplement is not marketed as a drug, it is not regulated like a drug.”
The substantiation standard for evaluating the truthfulness of all other health claims is “competent and reliable scientific evidence.” Quoting from the FTC guidance, which defines the standard the same way the Bayer order does, the court found that consistent with DSHEA, this standard:
“… is not the drug standard. Randomized clinical trials are not required … ‘competent and reliable scientific evidence’ is a ‘flexible’ standard, and ‘[t]here 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’… studies on the precise formula used in the advertised product are not required.”
The court added that the FDA was in agreement with its guidance, stating that RCTs for supplements may not be “possible, practical, or ethical.”
Due process and basic fairness demand adequate notice of a legal duty before one can be sanctioned for violating it. In ruling for Bayer, the court held that the “competent and reliable scientific evidence” standard in its order – the very same one that’s in the FTC guidance, which specifically states that an RCT is “not required” for dietary supplement claims – did not give it adequate notice that the only acceptable substantiation for its PCH claims was an RCT.
This was particularly true for the RCT standard that the FTC expert espoused, which would require a: (1) randomized; (2) placebo-controlled; (3) double-blind; (4) human clinical trial; (5) done in the target population; (6) with the specific product at issue; (7) using appropriate statistical methods; and (8) designed with the desired outcome as the primary endpoint. The FTC, the court found, “presented no evidence of any law, regulation or guidance that would have provided notice to Bayer that [such] RCTs are required for the PCH claims at issue.”
Despite these recent FTC losses, dietary supplement marketers should be under no illusion that the agency’s mission to mandate RCTs for health claims, or at least for those it views as most salient to consumers, has waned in the slightest. When I cited Bayer to an FTC attorney recently, he dismissed it as an “outlier.”
Supplement marketers, therefore, should assume that, whatever the courts say (short of a final definitive decision by the U.S. Supreme Court), the FTC will expect them to have an RCT to support their claims, and will hold them accountable if they don’t. Nevertheless, in settlement negotiations, and certainly in court, they at least now have some fresh legal ammo with which to fire back.