In the brief, FTC contends that POM made disease-type claims for two products, its POM Wonderful pomegranate juice, and a dietary supplement which the company claimed was equivalent to the juice in nutritional content. To quote FTC, the company’s “advertising campaign was far more aggressive in its medical claims than an ad claiming general health benefits for food products. It did not merely claim that POM products were nutritious or rich in antioxidants. It claimed that POM products were ‘unique and superior’ to other antioxidant sources, that they fought ‘atherosclerosis,’ ‘prostate cancer,’ and other specific diseases; and that rigorous medical research demonstrated and even quantified those supposed disease-fighting benefits.”
FTC: Insufficient evidence to back up claims
POM’s evidence to back up these claims was insufficient, the agency asserts. FTC cited POM’s own marketing language saying, “a clinical pilot study shows that an 8 oz. glass of POM Wonderful 100% Pomegranate Juice, consumed daily, reduces plaque in the arteries up to 30%.” The problem with that statement, the agency said, is that the pilot study was “tiny and methodologically flawed.” And further, the agency contends that POM’s own subesequent larger-scale studies did not back up the results of the pilot study, but the company chose to surpress that evidence and continue to cite the pilot study in its aggressive marketing campaigns.
FTC defends its decision to apply its standard of requiring two randomized, well-controlled, human clinical trials (RCTs) to back up any future claims that POM might choose to make on its products. It’s a similar “fencing-in” tack taken in other consent decrees in recent years with companies the agency has contended were making illegal drug claims.
In effect, the message is that a particular company can no longer be trusted not to make misleading claims, justifying the diminution of the company’s First Amendment rights and that the two RCT standard ensures future compliance. FTC has said in the past that this standard applies only to the circumstances of each consent decree, but others aren’t so sure.
Chilling effect
Observers, such as industry trade groups and attorney Jonathan Emord, who has repesented a number of clients against FTC, say the series of consent decrees are forming an example of rule making by decree, and that marketers now run a risk when making claims without meeting this standard. And the standard flies in the face of significant disagreement in the scientific community that RCTs are the best study method for large swaths of nutritional science.
In a blog on the Emord and Associates website, the firm says, “There is no incentive for advertisers to conduct expensive RCTs on nutrients. After all, why would a company spend money on one RCT, let alone two, if competitors can share in the benefit of favorable results?
"Moreover, RCTs are better suited for testing the efficacy of drugs because it is relatively easy to determine if a drug is treating a disease or not. It is much more difficult to determine if a nutrient reduces the risk of getting a disease using RCTs.”
Accordingly, the firm says companies will start to self censor their claims, to the detriment of both manufacturers and consumers. “It will make it far more difficult for consumers to obtain access to emerging science associating nutrients with disease and health benefits,” the blog asserts.