FTC Commissioners Order POM Wonderful to Conduct Tests Before Asserting Health Benefits
The Federal Trade Commission (FTC) has issued a final decision in a complaint
alleging that POM Wonderful made false and misleading claims by advertising
its pomegranate juice products with health-benefit assertions that the
company contended were backed by medical research. In re POM Wonderful
LLC, No. 9344 (FTC, decided January 10, 2013). Additional information about
the matter appears in Issue 441 of this Update.
Henceforth, two randomized, controlled clinical trials (RCTs) will be required before POM can make a claim that any of its products treat, prevent or reduce the risk of heart disease, prostate cancer or erectile dysfunction (ED). Any efficacy or health benefit claims falling short of disease claims will require substantiation consisting of “competent and reliable scientific evidence . . . that must be sufficient in quality and quantity when considered in the light of the entire body of relevant and reliable scientific evidence, to substantiate that the representation is true.” FTC declined complaint counsel’s request that the company should be prohibited from making disease-related establishment and efficacy claims unless the claims are pre-approved by the Food and Drug Administration, finding that requiring two RCTs sufficiently accomplishes certainty and enforceability goals.
The commissioners voted unanimously to uphold the administrative law judge’s (ALJ’s) initial decision, but found deceptive claims in 36 ads and promotional materials, more than the 19 cited in the ALJ’s ruling. The commission also found that a higher level of substantiation would be necessary to support POM’s establishment claims because “experts in the fields of heart disease, prostate cancer, and ED would find that causation has been shown only if RCTs have been conducted and the appropriate data demonstrates that each study’s hypothesis has been fully supported.” According to FTC, an RCT requires (i) test and control groups, (ii) random assignment to test and control groups, (iii) an examination of known variables, (iv) statistical significance, and (v) double-blinding.
FTC disagreed with POM that the misleading advertising claims were
protected by the First Amendment and that the company, its owners and
marketers were denied due process. POM had claimed that FTC’s approach
to its case constituted a retroactive application of its current standard as
“articulated in both FTC policy statements and case law.” In this regard, FTC
noted that requiring RCTs to substantiate POM’s claims was “founded on the
well-established principle that determining the proper level of substantiation
is a fact-based and case-specific analysis based on expert testimony as to
what constitutes competent and reliable scientific evidence for the claims at
issue. Respondents were on notice of this long-standing standard. Therefore,
our decision in this case does not raise due process concerns.”
A petition for review of the final order may be filed with a federal appeals
court within 60 days. See FTC News Release, January 16, 2013.
