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.”
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