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FTC loses appeal in Garden of Life contempt case

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Nature of scientific expertise called into question in health claims litigation.

What makes an expert an expert? A recent appeals decision may broaden the qualifications. On Monday, the U.S. Court of Appeals upheld a lower court's decision to dismiss the Federal Trade Commission's (FTC) motion for contempt against Garden of Life (GoL) on the basis that experts hired by both parties were equally suitable to recognize competent and reliable evidence.

The case stems back to a 2006 consent decree reached by FTC and GoL, where the agency prohibited future disease claims unless the company could back them up with evidence. Then in 2011, FTC filed a motion against GoL for violating the consent decree. In its defense, GoL retained an expert to evaluate its claims and evidence. FTC did the same. Because of this undecidable "battle of the experts," the District Court dismissed FTC's case since it failed to show that GoL violated the consent decree. FTC appealed.

Here's the Hyman, Phelps & McNamara FDA Law Blog with more analysis:

In its appeal, the FTC argued that the FTC’s expert was the only one qualified to speak to the substantiation of the claims because the FTC’s expert was an expert in the relevant subspecialty whereas GOL’s expert was an expert in pharmacology and medicine in general. In other words, the FTC sought to narrowly construe the meaning of “professionals in the relevant area.” The Court, however, was unpersuaded by the FTC’s assertion that GOL's consultant expert was not qualified to interpret the results of medical studies and held that the lower court’s interpretation that “professionals in the relevant area” means experts in medicine or pharmacology in general rather than specialists in the given medical subspecialty was reasonable.

Defining "competent and reliable evidence" has proven expensive for FTC. Previous litigation between the agency and supplement maker Lane Labs prompted FTC to better define its scientific gold standard as two randomized, double-blind, placebo-controlled, human clinical trials. This definition was further called into question during lengthy litigation with POM Wonderful over health claims made on its pomegranate products. This latest rub with Garden of Life will likely prompt the agency to better define expertise in future cases.

For the full appeal document, click here.

For the full FDA Law Blog piece, click here.

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