Court Rebuffs FTC’s Attempt to Redefine “Competent and Reliable Scientific Evidence”

Jun 20, 2012   
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On May 23, 2012, Judge Donald Middlebrooks of the United States District Court for the Southern District of Florida issued an order denying the Federal Trade Commission’s (“FTC”) motion to modify a consent decree entered between it and dietary supplement manufacturer Garden of Life (“GOL”) regarding what qualifies as “competent and reliable scientific evidence” for the substantiation of health and disease related claims made on GOL’s dietary supplement products. The Court’s order comes as the FTC has made increased efforts at requiring a heightened level of substantiation for health related claims. Under this heightened substantiation level, dietary supplement manufacturers must support their claims with “two well-controlled human clinical studies.” A copy of the Court’s order can be read here.

The FTC requires that claims made by dietary supplement manufacturers be both truthful and not misleading. In addition, the FTC requires that manufacturers possess “competent and reliable scientific evidence” to support all health related claims. However, the definition of “competent and reliable scientific evidence” has been under increasing debate and scrutiny. Over the past several years, dietary supplement manufacturers have had to wrangle with the Federal Trade Commission’s attempts to redefine and enforce a heightened level of substantiation for health related claims. (Our previous reports on the FTC’s efforts can be read here, here, and here.) Such was the case in the Garden of Life litigation.

The GOL litigation stems from a consent decree entered into by the FTC and GOL regarding the health related claims used in the advertising of GOL’s dietary supplement products. The consent decree prohibited GOL from making any representations: 1) that its products mitigate, treat, prevent, or cure any disease or illness; or 2) about the absolute or comparative health benefits of its products, unless GOL possessed “competent and reliable scientific evidence” to substantiate such claims. “Competent and reliable scientific evidence” is defined in the Order as “tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area, that has 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.”

However, in its motion, the FTC sought to modify the consent decree by changing the definition of “competent and reliable scientific evidence” to require: 1) “two adequate and well-controlled human clinical studies for all absolute or comparative claims” about the cognitive health benefits of GOL’s products; and 2) FDA approval for all “disease treatment and cure claims” of GOL’s products.

Generally speaking, when seeking to modify a consent decree, the moving party must demonstrate: 1) that a significant change either in factual conditions or in the law has occurred; and 2) that the proposed modifications are suitably tailored to the changed circumstances. See Sierra Club v. Meiberg, 296 F.3d 1021, 1033 (11th Cir. 2002). Here, as a basis for the proposed modifications, the FTC argued that because the consent decreed failed “to achieve its intended purpose of protecting consumers from GOL’s ‘deceptive marketing,’” a significant change in factual circumstances had occurred which warranted the court modifying the consent decree. Order at 7.

In rejecting the FTC’s position, the Court noted several things. First, the Court found that “consent decrees generally do not have overarching purposes” such as consumer protection. Instead, consent decrees are typically the product of negotiation between the parties. Thus, the actually negotiated purpose of a consent decree is usually far more limited. The Court found that such was the case here. Thus, “the decree cannot be interpreted as requiring whatever might be necessary and appropriate to achieve [consumer protection] because it was not written that way.” Order at 8 (citing Sierra Club, 296 F.3d at 1031-1032).

Second, the Court found that a mere disagreement between the FTC and GOL over the definition of “competent and reliable scientific evidence” is not sufficient for the Court to assert its authority to modify the consent decree. “The fact that the FTC is no longer satisfied in 2012 with the definition it agreed to during negotiations with GOL in 2006 does not constitute a significant change in factual circumstances.”Order at 9. The Court went on to find that given the broad definition of “competent and reliable scientific evidence” as set forth in the consent decree, the FTC should have anticipated that parties would disagree over what evidence and procedures qualify and therefore should have sought to limit such a definition at the consent decree’s inception. Id at 9-10.

For more information on FTC regulations and substantiation requirements, or on how to ensure that your business maintains regulatory compliance at both the state and federal levels, please contact us at