Under the FTC’s guidance, “Dietary Supplements: An Advertising Guide for Industry,” (FTC Guide), the relevant standard for “truthful and not misleading” health-related claims for dietary supplements is “competent and reliable scientific evidence.”

The FTC defines “competent and reliable scientific evidence” (referred to herein as CRSE) 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.”

A Flexible Standard
Importantly, the FTC Guide does not require randomized clinical trials of dietary supplements and notes that “competent and reliable scientific evidence” is a “flexible” standard, and that there is “no fixed formula for the number or type of studies required.”

There is simply no requirement for clinical studies to be published in order to be relied upon. Indeed, a finished product company may forego publishing a clinical study if a competitor can simply copy its formula and rely on that published study because it lacks strong patent protection (i.e., it is easy to design around the patent without impacting the ability to use the published study to support a product claim). 

The CRSE standard permits full and careful consideration of a wide range of relevant scientific evidence. The FTC Guide clearly states that the “standard for evaluating substantiation is sufficiently flexible to ensure that consumers have access to information about emerging areas of science.”

As former FTC Chairman Robert Pitofsky has pointed out, the overall goal of evaluating advertising claims is not “a broad, theoretical effort to achieve Truth, but rather a practical enterprise to ensure the existence of reliable data, which in turn will facilitate an efficient and reliable competitive market process.”

Similarly, Acting FTC Chairman Maureen Ohlhausen noted, “adopting a one-size-fits-all approach to substantiation by imposing such rigorous and possibly costly requirements for such a broad category of health and disease-related claims may, in many instances, prevent useful information from reaching consumers in the marketplace and ultimately make consumers worse off.”

Clinical Confusion
However, much confusion has surfaced around exactly what the CRSE standard requires. Many are under the wrong impression that the CRSE requires two double-blind, placebo-controlled clinical studies, which arises out of two FTC consent decrees with Iovate and Nestle.

It should be noted that the consent decrees at best represent contract negotiations between the FTC and the company that is the subject of the inquiry. During such a negotiation, the FTC can demand whatever terms it desires in order to enter into a settlement. However, it does not mean that the insertion of that term is legally tenable. Rather, it only means that particular defendant has agreed to it in order to settle the case.

Indeed, when actually litigated, the FTC’s attempt to create such a rigid standard against its own policy guide and pronouncements has been uniformly rejected by the courts as it relates to structure/function claims for dietary supplements.

More specifically, numerous federal courts, in rejecting the FTC’s rigid interpretation of the CRSE standard, have stated that the standard of what constitutes CRSE is a question of fact that requires careful consideration of experts in the field. For example, the Seventh Circuit explicitly held that “[n]othing in the Federal Trade Commission Act … requires placebo-controlled, double-blind studies…. [p]lacebo-controlled double-blind testing is not a legal requirement for consumer products.”

Most recently, in issuing its decision in Brain Research Labs, LLC v. FTC, the Seventh Circuit found that the advertiser provided a reasonable basis for its claims based on clinical studies as well as the expert evaluations of those studies, in conjunction with animal and in vitro testing, explaining: “[w]hile competent and reliable scientific evidence may consist of a single study under certain circumstances, [it] does not require that every aspect of an advertising claim be contained in one study. Nor does it preclude drawing inferences and correlations between different studies.”

In addition, in U.S. v. Bayer, the District of New Jersey recently rejected the position that “competent and reliable scientific evidence” could be met only through “human clinical trials that (1) are randomized, placebo-controlled, and double-blind; (2) use the specific product for which the claims are made; (3) are performed in the population at which the claims are directed; and (4) use validated methods and appropriate statistical methods to assess ‘outcomes.’”

Citing the Seventh Circuit, the court noted that “placebo-controlled, double-blind testing is not a legal requirement for consumer products” and that “something less may do.” As the Bayer court instructs, the government cannot meet its burden simply by asserting that its expert disagreed with the relevant
science. 

In short, the substantiation standard applicable to dietary supplement health and safety claims do not necessarily require only placebo-controlled clinical study results at a 95% confidence level. Rather, the CRSE standard mandates an assessment of the relevant scientific information as a whole to evaluate whether the product achieved the claimed benefits—an assessment that is appropriately made by scientific experts. The key assessment here is not simply whether there is a double-blind placebo controlled study. With that said, when there is a double-blind study, where experts in the field would agree the claims are substantiated, there is little doubt that a court will find the claim substantiated.

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Todd Harrison
Venable

Todd Harrison is partner with Venable, which is located in Washington, D.C. He advises food and drug companies on a variety of FDA and FTC matters, with an emphasis on dietary supplement, functional food, biotech, legislative, adulteration, labeling and advertising issues. He can be reached at 575 7th St. NW, Washington, D.C. 20004, Tel: 202-344-4724; E-mail: taharrison@venable.com.