Judge delivers more bad news for FTC on ‘two clinical trials’ standard

By Elaine Watson

- Last updated on GMT

Related tags: Clinical trial, Ftc

Florida-based Garden of Life markets a range of products including probiotic supplement Primal Defense
Florida-based Garden of Life markets a range of products including probiotic supplement Primal Defense
Further evidence that ‘competent and reliable scientific evidence’ to support claims on dietary supplements does not have to mean two well-controlled human intervention trials has emerged in a ruling in a federal court in Florida.

Judge Donald M Middlebrooks was asked by the Federal Trade Commission (FTC) to modify a consent decree from 2006 that was designed to bring the FTC’s false advertising dispute with supplement maker Garden of Life (GOL) to an end.

Although Garden of Life had signed the decree, it had continued to make unsubstantiated and deceptive claims about its products, despite agreeing not to “make representations… without possessing competent and reliable scientific evidence substantiating​” them, claimed the FTC.

To tackle the problem, the ad watchdog wanted a judge to modify the decree by re-defining “competent and reliable scientific evidence” ​to mean “two adequate and well-controlled human clinical studies​”.

Judge: Sort it out between yourselves

But Middlebrooks was not persuaded.

In a May 25 ruling, he said it was not for him to decide whether GOL's health claims were deceptive, only whether the FTC had the right to retrospectively alter the definitions to which it had already agreed in the 2006 consent decree.

He added: “While what qualifies as competent and reliable scientific evidence… may be subject to debate, the fact remains that the parties themselves agreed to use that definition after engaging in extensive negotiations…

The FTC failed to establish that a significant change in factual circumstances occurred since the date the Parties entered into their agreement.

“Thus, this Court lacks the authority to impose additional restrictions upon GOL, and, it is hereby ordered and adjudged that Plaintiff’s ​[FTC’s] motion … is denied.”

Attorney: The Court rejected the FTC’s position

Writing about the case in the FDA law blog, Hyman, Phelps & McNamara attorney Riëtte van Laack said:

“The FTC’s proposed modifications sought to redefine competent and reliable scientific evidence to mean two adequate and well-controlled human clinical studies for claims regarding bone and cognitive health benefits of GOL’s products and FDA approval for disease treatment and cure claims for GOL’s products.

“The Court rejected the FTC’s position.

“In 2006, FTC and GOL agreed to use the more vague definition of ‘competent and reliable scientific evidence’ and the Court found that the FTC could have anticipated that experts might disagree.

“The Court ruled that the FTC cannot now, five years later, merely because it is no longer satisfied with the negotiated definition, have the Court modify this definition to suit the FTC’s purpose.”

POM Wonderful ruling

Middlebrooks’ decision follows a high profile ruling by administrative law judge Michael Chappell in the false advertising dispute between the FTC and POM Wonderful​ over evidence required to support claims about the health benefits of pomegranate juice.

While Chappell argued that many of POM’s claims did not hold up to scrutiny, he challenged the notion​ that ‘competent and reliable scientific evidence’ has to mean at least two ‘gold standard’ human trials.

Indeed, so-called 'gold-standard', randomized, double-blind placebo-controlled human clinical trials (RCTs) are not​ essential for supporting structure-function claims on foods and supplements and are “not necessarily​” even essential for products marketed as reducing the risk of disease, argued Chappell.

Click here​ to read his ruling.

Garden of Life

According to the FDA, GOL continued to make unsubstantiated advertising claims that its Primal Defense, RM-10, Living Multi, and FYI supplements could treat immune disorders, cancer, diabetes and rheumatoid arthritis respectively.

Founded in 2000, West Palm Beach, Florida-based Garden of Life markets a range of supplements from digestive health product Perfect Cleanse and probiotic supplement Primal Defense to its fücoTHIN weight management range.


Related topics: Regulation, Probiotics, Product claims

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