Court Refuses FTC Request to Modify Definition of “Reliable Scientific Evidence”
A federal court in Florida has denied the Federal Trade Commission’s (FTC’s)
request that it modify a stipulated final order resolving a 2006 dispute with
Garden of Life, Inc. over purportedly unsubstantiated representations that its
products could treat a range of serious diseases and their symptoms. FTC v.
Garden of Life, Inc., No. 06-80226 (S.D. Fla., filed May 25, 2012). The
parties had agreed that the company could make such claims if supported
by “competent and reliable scientific evidence,” defined in the stipulated
final 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.”
Claiming that the company was continuing to deceive consumers and that
“the Stipulated Final Order has failed to achieve its intended purpose of
protecting consumers from the Defendants’ deceptive marketing,” FTC sought
to modify the order by imposing a $25 million performance bond on the
company to ensure future compliance, as well as requiring “two adequate and
well-controlled human clinical studies for all absolute or comparative claims
about the bone and cognitive health benefits, efficacy, performance, safety, or
side effects of [Garden of Life’s] products.”
The court decided to apply a “significant change in factual circumstances”
standard to determine whether it had the authority to modify a consent
decree and, under that standard, found that it did not. The court disagreed
with FTC that consent decrees have overarching purposes (i.e., to protect
consumers); rather, the court said that the agreement’s objective in this case
was to enjoin the company from making representations without competent
and reliable evidence and misrepresenting the “existence, contents, validity,
results, conclusions, or interpretations of any test or study.” According to
the court, FTC was essentially seeking to re-define the term “competent and
reliable scientific evidence.” Because “it should have been foreseen that the
Parties may disagree in the future about what constitutes competent and
reliable scientific evidence,” the court ruled that a significant change in factual
circumstances had not occurred.
