Pom part one

In the Matter of Pom Wonderful LLC, FTC Docket No. 9344 (January 10, 2013)

The FTC, with one partial concurrence and one full concurrence, largely upheld the ALJ’s earlier ruling, except that the majority found even more ads to be misleading.  An appendix analyzes individual ads.  Another appendix shows print ads. The video evidence is available here.

The ALJ found that a number of ads implied that the Pom products treated, prevented, or reduced the risk of heart disease, prostate cancer, or erectile dysfunction, and that some of the ads implied clinical proof for these claims; these were material as well as false or misleading.  The basis of Pom’s liability was its lack of sufficiently reliable evidence, here well-conducted, double-blinded, randomized clinical trials, to substantiate its claims.  Though the FTC’s experts testified that two such trials would be necessary to substantiate the heart disease claims, the Commission didn’t reach the question of how many would be required since Pom didn’t have any.  The relief issued contained fencing-in provisions requiring that any disease-related establishment or efficacy claims made in connection with Pom’s sale of any food, drug, or dietary supplement had to be supported by at least two randomized clinical trials.  However, the Commission declined to reach whether Pom was liable based on four media interviews by a principal, and it did not require FDA preapproval of future claims.

Reasonable consumers would understand the “prevent” or “reduce the risk” claims to mean that consuming Pom products substantially reduced the likelihood that a consumer would contract the disease or condition.  The ads made these claims indirectly, using words and images.  For the heart disease claims, the ads used a syllogism: “free radicals cause or contribute to heart disease; the POM Products contain antioxidants that neutralize free radicals; and, therefore, the POM Products are effective for heart disease.”  Many of the ads went on to claim that Pom products had been shown by clinical, medical, or scientific studies to reduce plaque, lower blood pressure, and/or improve blood flow to the heart, “in a context where it is readily inferable that the referenced study results involve heart disease risk factors and, therefore, constitute clinical support for the effectiveness claim.” The prostate cancer/erectile dysfunction claims worked similarly. 

The Commission disagreed with the ALJ on, for example, the “Cheat Death” ad, because it would convey to at least a significant minority of reasonable consumers that drinking 8 ounces of Pom juice daily would prevent heart disease, based on the context of the whole ad, including the claims that drinking eight ounces of Pom juice a day “can help prevent . . . heart disease,” and “[t]he sooner you drink it, the longer you will enjoy it,” as well as imagery of the POM Juice bottle with a noose around the neck of the bottle.  Similarly, an ad showing a juice bottle wrapped in a blood pressure cuff and claiming that Pom juice would help “[k]eep your ticker ticking,” with references to free radicals and $20 million in scientific research from leading universities, conveyed a prevention/risk reduction message.  Etc.

Most of the ads making these claims also represented that clinical studies supported their claims.  The FTC found such establishment claims in two ads the ALJ hadn’t; the ALJ reasoned that the only explicit reference to studies was in mouseprint at the bottom of the page, and that wasn’t enough when the rest of the ad just said Pom juice “can” reduce plaque.  The Commission pointed to the specificity of the representation in the text: drinking “eight ounces a day can reduce plaque by up to 30%!” that would lead at least a significant minority of reasonable consumers to believe that there was clinical proof of the claim.  “The specific percentage reduction of plaque in someone’s arteries cannot be ascertained by any means other than by scientific measurement, and the statement therefore implies that the claim of plaque reduction is scientifically established.”

Pom argued that it only referred to particular studies, and that it was wrong to treat reports of particular study results about things like reduced arterial plaque as claimed clinical proof of treatment or risk reduction of the end-stage disease.  Not so. “[T]hese ads drew a logical connection between the study results and effectiveness for the particular diseases. Reasonable consumers are unlikely to differentiate the precise medical differences after reading a headline proclaiming ‘Prostate Cancer Affects 1 Out of Every 6 Men,’ a statement that ‘Prostate cancer is the most commonly diagnosed cancer in men in the United States,’ or the headline ‘Amaze your cardiologist.’”

No more availing was Pom’s argument that it didn’t convey a clinical proof message because it simply reported study results with qualifications such as “preliminary,” “promising,” “encouraging,” or “hopeful.”  But “[i]t is well established that if the disclosure of information is necessary to prevent a representation from being deceptive, the disclosure must be clear,” and the use of adjectives didn’t alter the net impression, especially since they provided positive spin rather than a true disclaimer.  Plus, language like “may” or “can” didn’t modify the messages, and might even have created a stronger claim by increasing reader trust.  In these ads, the language didn’t materially alter the overall net message of clinical proof.  Among other things, many of the ads using this qualifying language also implied clinical proof by using medical imagery, statements about the overall amount of money Pom had spent on “medical” research, etc.  “When an ad represents that tens of millions of dollars have been spent on medical research, it tends to reinforce the impression that the research supporting product claims is established and not merely preliminary.”  Nor did the use of humor change things: consumers might well be attracted to the ad by the humor, but then stay for the serious message.  No extrinsic evidence was required because the establishment claims were apparent from the overall, common-sense impression of the ads themselves. 

The Commission also noted that Pom intended to make the disease claims at issue, which was some relevant evidence that the specific claims were in fact conveyed.

So, what’s the standard for substantiation?  The experts testified that both establishment and efficacy would be substantiated with the same level of evidence, given the claims at issue.  However, the Commission found that the ALJ wrongly applied the Pfizer factors (for what kind of substantiation is required) to determine the level of substantiation necessary to support the establishment claims. 

More generally, the level of evidence required depends on the claim.  But the ALJ mistakenly relied on expert testimony about the level of substantiation necessary for “broad, generalized” health benefits when evaluating the substantiation necessary for “the specific disease treatment, prevention and risk reduction claims at issue in this case.” 

Pom argued that scientific studies supported claims about broad health benefits.  But “general dietary recommendations and qualified claims regarding any health benefits of food” aren’t what Pom actually put in its ads.  Everyone’s experts agreed that different claims required different substantiation; claims regarding heart, prostate, and erectile function weren’t the same as claims to treat, prevent, or reduce the risk of heart disease, prostate cancer, and erectile dysfunction.  Pom made the latter type of claims.  Thus, the Commission didn’t need to reach Pom’s contention that “lower levels of substantiation — for instance, the totality of the evidence, including basic science and pilot studies — are sufficient” for general health benefit claims. 

The evidence was clear that randomized clinical trials were necessary to adequately substantiate treatment/prevention claims.  Thus, the Commission rejected the ALJ’s conclusion that randomized trials weren’t required when a food or supplement was safe, harmless, and not advertised as an alternative to medical advice/conventional treatment.  The Commission emphasized that it was looking at these particular claims and not all kinds of health claims—but these were false and unsubstantiated.  The claims of clinical proof were false in that Pom didn’t have the level of evidence demanded by the relevant scientific/medical communities. The ads “on their face convey the net impression that clinical studies or trials show that a causal relation has been established between consumption” and efficacy as to these diseases.  But experts in the relevant fields would require properly randomized and controlled human clinical trials to establish a causal relationship, because only RCTs could isolate the effects of Pom products on the incidence of the diseases.  No such credible RCTs existed.  (In some instances, experts recognized, blinded clinical trials of food products might be impossible; this may require some flexibility in double-blinding.  But that wasn’t true for Pom’s POMx pills, and anyway the Commission wasn’t holding Pom to an impossible standard, only to the standard applied by the relevant scientific/medical community.)

Pom complained that statistically significant proof would require studies that would be too large and expensive.  But Pom walked into this requirement by making the claims that it did: that there’s a causal link between consuming its products and treating or preventing specific serious diseases.  Anyway, RCTs don’t need to be huge, depending on what’s being tested.

Pom then argued that it shouldn’t be subjected to drug standards, but the Commission wasn’t imposing FDA new drug standards, which are much more stringent than what the Commission required here.  Pom’s in vitro and animal studies just weren’t enough to establish with the requisite confidence the effects of its products on the human body, nor were its human studies sufficient to provide competent and reliable scientific evidence for the treatment/prevention claims.  Given the ALJ’s findings using the lower standard, obviously Pom couldn’t meet the higher standard used by the Commission.

The Commission then turned to whether Pom had a reasonable basis for its claims.  Along with the establishment claims (and sometimes in their absence), Pom made efficacy claims.  What level of substantiation was required for the efficacy claims themselves?  Here the Pfizer factors were relevant: (1) the type of claim; (2) the type of product; (3) the benefits of a truthful claim; (4) the ease of developing substantiation for the claim; (5) the consequences of a false claim; and (6) the amountof substantiation experts in the field would agree is reasonable.

The Commission determined that the Pfizer factors also required RCTs here.  In general, the substantiation required for health claims is “competent and reliable scientific evidence,” which means “evidence based on the expertise of professionals in the relevant area, that have been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results.”  A high standard is important when consumers would find it difficult or impossible to evaluate the claims by themselves.  But these were more than just structure/function health claims: here, Pom made treatment/prevention claims about serious diseases, and that meant that the relevant scientific standard was proof of causation.

As for the type of product, Pom’s came from fruit known to be safe.  The ALJ thought that should lower the required substantiation—but that disregarded the particular claims at issue. “The relative safety of the product does not alter the requirement that the scientific evidence establish causality.”

The third and fourth Pfizer factors interact: the FTC doesn’t want the required level of substantiation to prevent consumers from receiving potentially valuable information.  The ALJ found that RCTs were therefore too expensive in a nutritional context, at least when an ad doesn’t suggest substituting a food/supplement for conventional treatment.  But that again assumed general health benefit claims.  A requirement of RCTs for prevention/treatment claims won’t prevent the public from learning useful information about general health benefits.  Pfizer isn’t designed to allow advertisers to overclaim and then say they did the best they could because true substantiation would be very expensive.  “Where the demands of the purse require such compromises [in methodology], the advertiser must generally limit the claims it makes for its data or make appropriate disclosures to insure proper consumer understanding of the survey’s results.” Kroger Co., 98 F.T.C. 639, 737 (1981).  Also, Pom actually tried RCTs; they just didn’t produce statistically significant results.  The failure of those trials wasn’t evidence that the substantiation standard was too high; it was evidence that Pom didn’t meet the standard.

The ALJ found that Pom wasn’t encouraging consumers to avoid conventional treatment, so the only harm was that they were paying a premium for juice.  The Commission noted that this wasn’t a small premium, especially if one followed Pom’s recommendations and consumed a lot.  (A one-year supply of juice cost at least $780 and a one-year supply of the pills cost about $315.)  In any event, a major purpose of the FTCA was to prevent economic harms.  Pom acknowledged that the putative health benefits were the source of the premium with statements such as “Health benefits – this is why they put up with the price.”

Given the final Pfizer factor, the amount of substantiation experts in the field would agree is reasonable, the conclusion was clear: RCTs were the standard for substantiation, and Pom’s claims were unsubstantiated.

Pom, for reasons known only to Pom, argued that any false or misleading claims weren’t material.  The Commission disagreed.  Express claims, health/safety claims, and claims pertaining to a product’s central characteristic can be presumed material, though this presumption can be rebutted.  An advertiser’s intent can also shed light on materiality.  The ALJ didn’t need to rely on the presumption of materiality given Pom’s own statements, and the Commission agreed.  The Resnicks, principals and proselytizers, testifed that Pom juice was “health in a bottle,” which is its “unique selling proposition,” and that a large number of POM Juice consumers purchase the product because they believed “that we’ve proven that . . . [POM Juice] really does prolong people’s lives if they are getting the onset of prostate cancer.”  The ads focused on disease, not taste, price, or other attributes.  Thus, the products’ central advertised characteristics was their impact on disease.  As the ALJ conlcuded, “it defies credulity to suggest that Respondents would advertise study results related to these conditions if such advertising did not affect consumer behavior.”  Pom submitted its own study, but it had methodological and other flaws, among them, not asking follow-up questions about purchase motivation even of the 35.2% of purchasers who said they bought Pom because it was “healthy.”