Health claims, RCTs and the curious case of the FTC v POM Wonderful: What happens next??
And did POM Wonderful cross the line with ads promoting its pomegranate juice for reducing the risk of prostate cancer and cardio disease?
Clearer answers to these questions should emerge on August 23 when five FTC Commissioners will hear oral arguments from POM and the Federal Trade Commission (FTC), which have both appealed a recent initial decision from administrative law judge Michael Chappell on a false advertising case brought by the FTC against POM in 2010.
The Commissioners will make a final decision regarding whether to adopt, in whole, in part, or not at all, Chappell’s decision, which determined that structure/function claims that POM’s juice can "support prostate health" and "promote erectile health" can be supported by the evidence.
However, claims that the juice can prevent, treat or reduce the risk of prostate cancer, erectile dysfunction and heart disease are not supported by competent and reliable scientific evidence, and must be amended, he said.
What kind of evidence do you need to make claims about foods and supplements?
The case is being followed very closely by the food and supplements industry as it addresses broader questions over the substantiation required for making claims about foods as distinct from drugs.
For example, while Chappell criticized some of POM’s claims, he also challenged the argument outlined in recent consent decrees from the FTC that ‘competent and reliable scientific evidence’ must equate to least two randomized controlled human trials (RCTs).
FTC: Only RCTs will do for claims that a product treats, prevents or reduces the risk of diseases
In its appeal of Chappell’s ruling (click here), the FTC warns that merely telling POM that disease claims must in future be substantiated by 'competent and reliable scientific evidence' without pinning down what kind of data is expected would just "engender more disputes with Respondents [POM] who insist on adhering to their own standards, regardless of those laid down by the FTC and the FDA".
And for “claims that a product treats, prevents or reduces the risk of diseases, only RCTs will do”, it concludes.
But writing in the FDA law blog yesterday, Hyman, Phelps & McNamara attorney Riëtte van Laack notes that the FTC also “stresses that the requirement for RCTs applies to disease efficacy claims and its statements should not be interpreted to mean that RCTs are automatically required for any health efficacy claims.”
POM: Our claims are all supported by science
In its appeal (click here), POM defends its science and says the Commission should reject Chappell’s ruling and dismiss the FTC’s complaint.
It adds: “First, as [Chappell] recognized, RCTs simply are not required by the FTC Act to support health-benefit claims generally.”
As for Chappell’s view that that POM’s substantiation for some of its claims was “incompetent and unreliable and thus misleading”, this “defies the evidence and flouts the First Amendment”, claims POM.
“It is undisputed that the studies on which [POM] relied were conducted by topflight researchers at top-flight institutions, and that many of the studies were published in prominent, peer-reviewed journals.
“It is also undisputed that the experts who testified for [POM] at trial and attested to the validity of the studies are themselves world-renowned in their fields.
“Even if [POM] made the ‘treat’, ‘prevent’ and ‘reduce the risk’ claims that the judge said it made, the science supports those claims too.”