Attorney: POM ruling is a 'stunning rejection' of FTC's stance on 'gold standard' clinical trials to support product claims

By Elaine Watson

- Last updated on GMT

Marc Ullman: Judge refused to insist on ‘gold standard’ human clinical trials to support structure-function claims…'
Marc Ullman: Judge refused to insist on ‘gold standard’ human clinical trials to support structure-function claims…'
While POM Wonderful does not emerge from Michael Chappell’s 335-page ruling smelling entirely of roses, it has successfully challenged the accepted wisdom that firms can only make claims about food or supplements if they are backed at least two ‘gold standard’ human trials, say lawyers.

In his ruling​ in a false advertising case brought by the Federal Trade Commission (FTC) against POM in 2010, administrative law judge Michael Chappell explored what might constitute ‘competent and reliable scientific evidence’ to back claims such as ‘supports prostate health’.

Contrary to the FTC’s position - expressed in several recent consent decrees - Chappell concluded that 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.

In a lengthy analysis of the evidence needed to support claims on foods and supplements starting on page 238 of the ruling, he also notes that the cases upon which the FTC relies to make the case for RCTs to support claims "do not compel a conclusion that RCTs are required".

Ullman: A very significant victory/clarification for supplement trade

Should the FTC allow this part of Chappell’s ruling to stand on review, ”it will be a very significant victory/clarification for the supplement industry”, ​claimed Marc Ullman, partner at law firm Ullman, Shapiro & Ullman.

The administrative law judge refused to impose a ‘gold standard’ clinical trial on structure-function claims…​”

Emord: A meaningful limit on FTC powers to curb commercial speech

Should the ruling stand, added food law attorney Jonathan Emord, it "will establish a meaningful limit on the exercise of official discretion over commercial speech by agency staff who have increasingly endeavored to dumb down the information consumers may receive to a limited, state approved orthodoxy that excludes emerging science.”

Indeed, the ruling amounts to "a stunning rejection of the FTC’s theory that POM was legally required to have double-blind, randomized placebo-controlled clinical trials to make the claims that the FTC attacked​" said Hyman, Phelps & McNamara attorney Riëtte van Laack.

Writing in the FDA law blog, she said: "The ALJ’s order would merely bar POM from making certain claims unless POM possesses competent and reliable scientific evidence to support the claim.  As clarified in the Initial Decision, however, this standard is not defined as double-blind, randomized, placebo-controlled clinical studies."

Council for Responsible Nutrition (CRN) chief executive Steve Mister said the ruling was a real victory for the supplements industry, even if aspects of it were disappointing for POM: "The judge ultimately rejects randomized controlled trials as being the sole basis for substantiating claims​."

American Herbal Products Association president Michael McGuffin was equally encouraged by the ruling: “His decision... is a reminder that negotiated consent decrees between FTC and respondents do not make the law. The decisions of FTC and the federal courts in cases like this one make the law.”

NPA: Food industry can breathe a sigh of relief

Meanwhile, Chappell’s view that the FTC had exceeded its authority by requiring POM to seek pre-approval from the FDA before making claims in future was also significant, said the Natural Products Association (NPA).

Dr Cara Welch, vice president, scientific & regulatory affairs at the NPA, said: “This decision could be construed as a win for both sides. But I think the food industry can breathe a sigh of relief that the preapproval step wasn’t included in the decision.

“As we know, this is only an initial decision but it seems to be well-crafted, addressing both the FTC’s concerns as well as the company’s evidence to support its claims.”

She added: “Additionally, the judge took into account that the product is relatively safe and that consumers weren’t actually misled by some of the claims.

“This is a tactic we see with other regulatory agencies, a risk-based approach to monitoring products, and it’s nice to see it with advertising as well.”

ANH-USA: This is good news for natural products industry

The Alliance for Natural Health (ANH) USA also took great store in Chappell’s view that heavily restricting product claims might not be reasonable if the advertiser is not touting his product as a substitute for conventional medical treatment, and the product in question is safe.

He said: “The greater weight of the persuasive expert testimony in this case leads to the conclusion that where the product is absolutely safe, like POM Products, and where the claim or advertisement does not suggest that the product be used as a substitute for conventional medical care or treatment, then it is appropriate to favor disclosure.”

While bosses were still studying the ruling, said the ANH-USA last night, “It seems to indicate that other safe products may also be allowed to disclose scientifically validated studies about their health benefits.”

Chappell: POM can support some claims, but not others…

In his ruling, which you can read here​, Chappell concluded that structure/function type claims that pomegranate juice could "support prostate health​" and "promote erectile health​" could be supported by scientific evidence.

However, stronger claims that the juice could prevent, treat or reduce the risk of prostate cancer, erectile dysfunction and heart disease were not​ supported by the evidence, and must be amended, he said.

Click here​ to read more about the case.  

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