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DRMA

FTC Increases Scrutiny of Clinical Testing

11 Oct, 2012 By: Linda A. Goldstein


Among the most significant developments under the current Federal Trade Commission (FTC) administration have been the heightened substantiation requirements that the FTC has imposed upon marketers of weight-loss and dietary supplement products. While historically the FTC has always required health and safety claims to be substantiated by “competent and reliable scientific evidence,” this standard has previously been defined in a somewhat fluid fashion to mean tests, studies and other evidence that experts in the field would deem necessary to substantiate the claims at issue.

Beginning in 2010, the FTC issued a series of consent orders against the marketers of food and dietary supplement products, in which the general “competent and reliable scientific evidence” standard was replaced by a more rigid requirement that weight-loss, health and safety claims be substantiated by at least one, and in some cases, two double-blind, randomized, placebo-controlled clinical studies.

These new order “standards” were challenged by the marketers of POM Wonderful, who claimed that they were unprecedented and violated the First Amendment. In round one of this historical legal battle, the administrative law judge presiding over the case, while finding that many of the health claims for POM Wonderful had not been adequately substantiated, nonetheless ruled that there was no legal precedent for requiring health and safety claims for a food product to be supported by double-blind placebo-controlled clinical studies, particularly in cases where the advertised product was not being promoted as a substitute for medical treatment. While this decision is still on appeal to the full FTC, POM Wonderful also filed a declaratory judgment action against the FTC claiming that these new order standards violated the First Amendment. The judge in that case just ruled against POM Wonderful in that declaratory judgment action and deferred the entire matter to the administrative proceeding.

While the ultimate determination of whether the FTC can require these types of clinical studies to substantiate health and safety claims will have an enormous impact on the future of DRTV campaigns, marketers should be aware of another more subtle trend occurring at the FTC that also will heighten the burden on advertisers to substantiate their claims.

In a number of recent cases, the FTC has challenged advertising claims that self-regulatory bodies such as ERSP and the NAD have found to be adequately substantiated. While FTC has always made it clear that participation in and compliance with ERSP and/or NAD determinations is not a shield against future FTC actions, the FTC now appears to be looking deeper into the methodology, data and underlying protocol of clinical studies upon which advertisers are relying.

For example, the FTC brought an action against Brain-Pad challenging claims that its mouth guards can reduce the risk of concussions. Several years earlier, Brain-Pad had participated in a full NAD inquiry during which NAD concluded that the clinical study submitted by Brain Pad “was sufficient to provide a reasonable basis for the claim that its Brain Pad reduced the risk of low jaw impact concussions.” Notwithstanding this favorable NAD determination, the FTC reached exactly the opposite conclusion and determined that the scientific evidence was not adequate to support this claim.

What does this mean for marketers? Do not simply rely upon the conclusions that are provided in a clinical study report. In this evolving regulatory climate, marketers need to more closely scrutinize the clinical studies they are commissioning by carefully and independently reviewing the protocol, methodology and – most importantly – the raw data itself to ensure that it is both scientifically sound and consistent with the conclusions in the report. The message from the FTC is clear: if the underlying methodology or raw data is flawed in any way, the marketer will be held accountable even if the marketer was unaware of the flaws.
 


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