Pom Wonderful, LLC v. Federal Trade Commission

United States Court of Appeals
FOR THE DISTRICT OF COLUMBIA CIRCUIT
Argued May 2, 2014 Decided January 30, 2015
No. 13-1060
POM WONDERFUL, LLC, ET AL.,
PETITIONERS
v.
FEDERAL TRADE COMMISSION,
RESPONDENT
On Petition for Review of an Order
of the Federal Trade Commission
Thomas C. Goldstein argued the cause for petitioners
POM Wonderful, LLC, et al. With him on the briefs were
John Graubert, Megan L. Rodgers, and Erik S. Jaffe.
Erik S. Jaffe was on the brief for petitioner Matthew
Tupper.
Bilal K. Sayyed was on the brief for amici curiae
Consumer Healthcare Products Association and Council for
Responsible Nutrition in support of petitioners.
Jonathan W. Emord was on the brief for amici curiae
Alliance for Natural Health USA and TechFreedom in support
of petitioners.
2
Jonathan E. Nuechterlein, General Counsel, Federal
Trade Commission, argued the cause for respondent. With
him on the brief were Joel Marcus, Assistant General
Counsel, and Imad D. Abyad, Attorney. John F. Daly,
Attorney, Federal Trade Commission, entered an appearance.
Julie A. Murray, Scott L. Nelson, Allison M. Zieve, and
Stephen Gardner were on the brief for amici curiae Public
Citizen, Inc. and Center for Science in the Public Interest in
support of respondent.
Before: GARLAND, Chief Judge, SRINIVASAN, Circuit
Judge, and GINSBURG, Senior Circuit Judge.
Opinion for the Court filed by Circuit Judge SRINIVASAN.
SRINIVASAN, Circuit Judge: POM Wonderful, LLC
produces, markets, and sells a number of pomegranate-based
products. In a series of advertisements from 2003 to 2010,
POM touted medical studies ostensibly showing that daily
consumption of its products could treat, prevent, or reduce the
risk of various ailments, including heart disease, prostate
cancer, and erectile dysfunction. Many of those ads
mischaracterized the scientific evidence concerning the health
benefits of POM’s products with regard to those diseases.
In 2010, the Federal Trade Commission filed an
administrative complaint charging that POM and related
parties had made false, misleading, and unsubstantiated
representations in violation of the Federal Trade Commission
Act. After extensive administrative proceedings, the full
Commission voted to hold POM and the associated parties
liable for violating the FTC Act and ordered them to cease
and desist from making misleading and inadequately
supported claims about the health benefits of POM products.
3
The Commission’s order also bars POM and the related
parties from running future ads asserting that their products
treat or prevent any disease unless armed with at least two
randomized, controlled, human clinical trials demonstrating
statistically significant results.
POM and the associated parties petition for review of the
Commission’s order, arguing that the order runs afoul of the
FTC Act, the Administrative Procedure Act, and the First
Amendment. We deny the bulk of petitioners’ challenges.
The FTC Act proscribes—and the First Amendment does not
protect—deceptive and misleading advertisements. Here, we
see no basis for setting aside the Commission’s conclusion
that many of POM’s ads made misleading or false claims
about POM products. Contrary to petitioners’ contentions,
moreover, the Commission had no obligation to adhere to
notice-and-comment rulemaking procedures before imposing
liability in its adjudicatory proceeding. Additionally, we
affirm the Commission’s remedial order insofar as it requires
POM to gain the support of at least one randomized,
controlled, human clinical trial study before claiming a causal
relationship between consumption of POM products and the
treatment or prevention of any disease. We find inadequate
justification, however, for the Commission’s blanket
requirement of at least two such studies as a precondition to
any disease-related claim. In all other respects, we deny the
petition for review.
I.
A.
Since 1987, entrepreneurs Stewart and Lynda Resnick
have acquired and planted thousands of acres of pomegranate
orchards in California. In 1998, they began to collaborate
4
with doctors and scientists to investigate the potential health
benefits of pomegranate consumption. They formed POM
Wonderful, LLC to make, market, and sell pomegranate-
based products. The products include POM Wonderful 100%
Pomegranate Juice and two dietary supplements, POMx Pills
and POMx Liquid, which contain pomegranate extract in
concentrated form. The Resnicks are the sole owners of POM
Wonderful and an affiliated company, Roll Global LLC,
which provides advertising and other services to POM. Those
entities have engaged in a broad array of advertising
campaigns promoting POM products through various media
including magazine ads, newspaper inserts, billboards,
posters, brochures, press releases, and website materials.
POM’s promotional materials regularly referenced
scientific support for the claimed health benefits of its
pomegranate products. By 2010, the Resnicks, POM, and
Roll had spent more than $35 million on pomegranate-related
medical research, sponsoring more than one hundred studies
at forty-four different institutions. This case involves studies
examining the efficacy of POM’s products with regard to
three particular ailments: heart disease, prostate cancer, and
erectile dysfunction.
1. POM sponsored a number of studies examining the
capacity of its products to improve cardiovascular health.
One such study, led by Dr. Michael Aviram of the Technion-
Israel Institute of Technology, examined the effect of
pomegranate juice consumption by patients with carotid
artery stenosis. Carotid artery stenosis is the narrowing of the
arteries that supply oxygenated blood to the brain, usually
caused by a buildup of plaque inside the arteries.
In Dr. Aviram’s study, ten patients with carotid artery
stenosis consumed concentrated pomegranate juice daily for a
5
year, while nine patients with carotid artery stenosis served as
a control group and consumed no pomegranate juice. The
investigators measured the change in the patients’ carotid
intima-media thickness (CIMT), an indicator of plaque
buildup. They found that patients who consumed
pomegranate juice every day experienced a reduction in
CIMT of “up to 30%” after one year, while CIMT for patients
in the control group increased by 9% after one year. POM
Wonderful LLC, No. 9344, Initial Decision of ALJ at 115
¶ 791 (U.S. Fed. Trade Comm’n May 17, 2012) (ALJ Initial
Decision). As one of POM’s experts would later testify, the
Aviram study, while “suggest[ing] a benefit” from
pomegranate juice consumption for patients with carotid
artery stenosis, was “not at all conclusive,” in part because of
the study’s small sample size. Id. at 118 ¶ 802 (quoting
expert testimony). In 2004, the journal Clinical Nutrition
published the study. See M. Aviram et al., Pomegranate
Juice Consumption for 3 Years by Patients with Carotid
Artery Stenosis Reduces Common Carotid Intima-Media
Thickness, Blood Pressure and LDL Oxidation, 23 Clinical
Nutrition 423 (2004).
Subsequently, in 2005, a larger study, led by Dr. Dean
Ornish of the University of California, San Francisco and the
Preventative Medicine Research Institute, followed seventy-
three patients with at least one cardiovascular risk factor for
one year. The patients were randomly assigned either to drink
one cup of pomegranate juice daily or to drink a placebo
beverage. At the end of the study, Dr. Ornish and his co-
investigators found no statistically significant difference
between the treatment group and the placebo group in CIMT
change or any other heart-related measure.
In 2006, a third, still larger study, led by Dr. Michael
Davidson of the University of Chicago, followed 289 patients
6
with one or more coronary heart disease risk factors. As in
the Ornish study, the patients were randomly assigned to
drink either pomegranate juice or a placebo beverage each
day. At the end of eighteen months, Dr. Davidson and his co-
investigators found no statistically significant difference in
the rate of carotid intima-media thickening between patients
in the treatment group and those in the placebo group. POM
initially delayed publication of the adverse findings, but
ultimately allowed publication of the study in 2009. See
Michael H. Davidson et al., Effects of Consumption of
Pomegranate Juice on Carotid Intima-Media Thickness in
Men and Women at Moderate Risk for Coronary Heart
Disease, 104 Am. J. Cardiology 936 (2009).
In their final report, Dr. Davidson and his co-
investigators noted that they had found some evidence of an
association between pomegranate juice consumption and
decreased CIMT among subgroups of patients with high
triglyceride levels and low levels of HDL (“good”)
cholesterol. Dr. Davidson and his co-authors emphasized,
however, that the findings for those subgroups were based on
“post hoc exploratory analyses” unanticipated in the study
protocol. As Dr. Davidson and his co-authors noted, “post
hoc exploratory analyses . . . should be interpreted with
caution” because of an increased risk of “type I errors” (i.e.,
false positives). See id. at 941. Even for patients in the high-
risk subgroups, moreover, the reduction in arterial thickness
was between 4% and 9% (depending on the measurement),
substantially below the 30% decrease reported by Dr. Aviram.
Although Drs. Ornish and Davidson completed their
arterial thickness studies in 2005 and 2006, respectively, a
consumer reading POM’s promotional materials after 2006
would not have known of those studies or that they cast doubt
on Dr. Aviram’s prior findings. In June 2007, for example,
7
POM distributed a brochure featuring a statement by Dr.
Aviram that “POM Wonderful Pomegranate Juice has been
proven to promote cardiovascular health,” along with a
description of his arterial thickness study, but with no mention
of Drs. Ornish’s and Davidson’s contrary findings. POM
Wonderful LLC, No. 9344, Opinion of the Commission, App.
B fig.10, at 5 (U.S. Fed. Trade Comm’n Jan. 10, 2013) (FTC
Op.). That same summer, POM published a newsletter in
which it asserted that “NEW RESEARCH OFFERS
FURTHER PROOF OF THE HEART-HEALTHY
BENEFITS OF POM WONDERFUL JUICE.” Id. App. B
fig.16, at 3. The newsletter claimed a “30% DECREASE IN
ARTERIAL PLAQUE” on the basis of Dr. Aviram’s limited
study but again omitted any mention of the Ornish and
Davidson findings. Id. And in 2008 and 2009, POM
conducted a $1 million promotional campaign, with seventy
ads in newspapers and magazines across the country, in which
it trumpeted Dr. Aviram’s findings—including the 30%
figure—without any acknowledgement of the contrary Ornish
and Davidson studies. Id. App. B fig.25; see also id. App. B
fig.19.
Dr. Ornish also conducted a separate study examining the
relationship between pomegranate juice and blood flow. The
study followed forty-five patients with coronary heart disease
and myocardial ischemia (insufficient blood flow to the heart
due to narrowing of the arteries). The patients were randomly
assigned to drink either pomegranate juice or a placebo
beverage daily. Dr. Ornish later testified that, although his
protocol called for a twelve-month study, he terminated the
study abruptly after three months because the Resnicks did
not follow through on their previous commitment to fund a
twelve-month trial.
8
At the end of three months, patients in the treatment
group outperformed patients in the placebo group on one
measure of blood flow to the heart, known as the “summed
difference score.” The study, however, found no statistically
significant difference between the treatment and control
groups on two other measures of blood flow (the “summed
rest score” and the “summed stress score”), nor did it find any
statistically significant differences in blood pressure,
cholesterol, or triglycerides. Medical experts later noted a
number of shortcomings of the study, including that patients
in the placebo group began the study with significantly worse
blood flow than patients in the treatment group, potentially
skewing the outcomes.
POM touted the results of the second Ornish study in its
ads and promotional materials without noting the study’s
limitations or acknowledging that patients in the treatment
group showed no statistically significant improvement in
blood flow on two of three measures. In September 2005, for
instance, POM issued a press release announcing the study in
which it asserted that “blood flow to the heart improved
approximately 17% in the pomegranate juice group” and that
differences in blood flow between the two groups were
“statistically significant.” Id. App. B fig.8. POM continued
to make similar statements in its promotional materials
through 2009. See id. App. B fig.10, at 5 (June 2007 brochure
claiming that “[p]atients who consumed 8oz of POM
Wonderful 100% Pomegranate Juice daily for three months
experienced a 17% improvement in blood flow”); id. App. B
fig.16, at 3 (summer 2007 newsletter claiming “17%
IMPROVED BLOOD FLOW”); id. App. B figs.37, 38, 39
(similar claims on POM websites in 2009).
2. In addition to the cardiovascular studies, petitioners
sponsored research on the effect of pomegranate juice
9
consumption in prostate cancer patients. One study, led by
Dr. Allan Pantuck of the University of California, Los
Angeles Medical School, followed forty-six patients who had
been diagnosed with prostate cancer. All of the patients had
already been treated by radical prostatectomy, radiation
therapy, or cryotherapy. The study called for them to drink
eight ounces of pomegranate juice daily. There was no
control group. The study concluded that the patients’ “PSA
doubling time,” a measure of the rapidity of growth in
prostate tumor cells, increased from fifteen months at the
beginning of the study to fifty-four months at the end. But as
Dr. Pantuck himself noted, patients who have undergone
radical prostatectomy or radiation therapy for prostate cancer
commonly experience a lengthening in PSA doubling time
regardless of whether they consume pomegranate juice.
POM, however, made no mention of the limitations of the
Pantuck study in its public statements. In a July 2006 press
release, POM claimed that “drinking 8 ounces of POM
Wonderful pomegranate juice daily prolonged post-prostate
surgery PSA doubling time from 15 to 54 months,” without
noting that some or all of the increase in the patients’ PSA
doubling times may have resulted from the radical
prostatectomies or radiation treatments undergone by the
patients. Id. App. B fig.9, at 2. POM advanced similar claims
in a June 2007 brochure and in a fall 2007 newsletter, again
with no disclosure of the study’s limitations. See id. App. B
figs.10, 17. In 2008 and 2009, POM ads in the New York
Times Magazine and TIME Magazine asserted that prostate
cancer patients who drank eight ounces of POM Wonderful
100% Pomegranate Juice a day for at least two years
experienced “significantly slower” PSA doubling times, once
again without any acknowledgment that the patients’ PSA
doubling times may have slowed regardless of whether they
consumed pomegranate juice. Id. App. B figs.21, 27; see also
10
id. figs.36, 37, 38, 39 (similar claims on POM websites in
2009).
3. Petitioners additionally sponsored research of the
effects of pomegranate juice consumption in men with mild to
moderate erectile dysfunction. One study, led by Dr. Harin
Padma-Nathan, a urologist in Beverly Hills, California,
followed fifty-three patients over eight weeks. The study
used a “crossover” design: one group of patients consumed
pomegranate juice for the first four weeks and then consumed
a placebo beverage for the next four, while a second group
consumed the placebo beverage for the first four weeks and
pomegranate juice for the next four. Dr. Padma-Nathan and
co-investigators evaluated the results using two measures: the
International Index of Erectile Function (IIEF), a fifteen-
question instrument, and the Global Assessment
Questionnaire (GAQ), a one-question test. The IIEF is a
“validated” tool, which means that the measure has been
shown to have statistical reliability, while the one-question
GAQ is not a validated measure for assessing erectile
function. See generally R. C. Rosen et al., The International
Index of Erectile Function (IIEF): A State-of-the-Science
Review, 14 Int’l J. Impotence Res. 226, 226 (2002).
Dr. Padma-Nathan’s study showed some evidence that
patients scored higher on the GAQ measure after drinking
pomegranate juice. But the p-value—the probability of
observing at least as strong an association between
pomegranate juice consumption and GAQ scores due to
random chance—was 0.058, falling just short of statistical
significance at the conventional p<0.05 level. On the
scientifically validated IIEF measure, however, the difference
between patients’ scores after drinking pomegranate juice and
after drinking the placebo beverage came nowhere near
statistical significance: there was nearly a 3/4 likelihood of
11
observing as strong an association due to random chance
(p=0.72). See C.P. Forest, H. Padma-Nathan & H.R. Liker,
Efficacy and Safety of Pomegranate Juice on Improvement of
Erectile Dysfunction in Male Patients with Mild to Moderate
Erectile Dysfunction: A Randomized, Placebo-Controlled,
Double-Blind, Crossover Study, 19 Int’l J. Impotence Res.
564, 566 (2007).
In its public statements about Dr. Padma-Nathan’s study,
POM made no mention of the negative results with respect to
the validated IIEF measure. POM instead touted the study
outcomes based exclusively on the non-validated GAQ
measure. A 2007 POM press release thus described Dr.
Padma-Nathan’s study as follows:
At the end of . . . each four week period,
efficacy was assessed using the International
Index of Erectile Function (IIEF) and Global
Assessment Questionnaire (GAQ). The IIEF is
a validated questionnaire that has been
demonstrated to correlate with ED intensity.
The GAQ elicits the patient’s self-evaluation of
the study beverages’ effect on erectile activity.
Forty seven percent of the subjects reported
that their erections improved with POM
Wonderful Pomegranate Juice, while only 32%
reported improved erections with the placebo
(p=0.058).
FTC Op. App. B fig.15, at 2. That press release, while
referencing IIEF and thus suggesting that its description of the
findings would account for that measure, in fact promoted the
results based solely on the GAQ measure with no
acknowledgment of the adverse findings on IIEF scores. In
2009 and 2010, POM similarly touted the GAQ findings—
12
again without any mention of the negative IIEF results—on
websites and in print ads. See id. App. B figs.33, 36, 37, 38,
39.
B.
In September 2010, the Federal Trade Commission filed
an administrative complaint alleging that POM, Roll, the
Resnicks, and POM’s then-President Matthew Tupper had
made false, misleading, and unsubstantiated representations in
violation of the FTC Act. See FTC Act § 5(a)(1), 15
U.S.C. § 45(a)(1); FTC Act § 12(a), 15 U.S.C. § 52(a). The
complaint identified forty-three advertisements or
promotional materials containing claims alleged to be false,
misleading, or unsubstantiated.
In May 2012, following an administrative trial, the
Commission’s chief administrative law judge found that
nineteen of POM’s advertisements and promotional materials
contained implied claims that POM products treat, prevent, or
reduce the risk of heart disease, prostate cancer, or erectile
dysfunction. He further concluded that POM and the related
parties lacked sufficient evidence to substantiate those claims,
and that the claims were material to consumers. He therefore
held the POM parties liable under the FTC Act and ordered
them to cease and desist from making further claims about the
health benefits of any food, drug, or dietary supplement
unless the claims are non-misleading and supported by
competent and reliable scientific evidence.
Both sides appealed to the full Commission. POM and
the related parties argued that they should not have been held
liable at all, while the Commission’s complaint counsel
argued that additional ads and promotional items (beyond the
nineteen identified by the administrative law judge) made
13
false or misleading claims. The complaint counsel also urged
the Commission to impose an injunctive order barring POM
from claiming that any of its products is effective in the
treatment or prevention of any disease unless POM first gains
pre-approval from the Food and Drug Administration.
In January 2013, the Commission unanimously affirmed
the administrative law judge’s decision to impose liability on
POM and the other parties. Four of the five commissioners
found that thirty-six of POM’s ads and promotional items
made false or misleading claims, but the Commission
specified that injunctive relief would be justified even if based
solely on the nineteen ads found by the administrative law
judge (and affirmed by the Commission) to be false or
misleading. Commissioner Ohlhausen filed a concurring
statement saying that she, like the administrative law judge,
would have found a smaller number of POM ads to be false or
misleading. But she agreed that POM and the related parties
should all be held liable for violating the FTC Act.
The Commission also broadened the scope of the
injunctive order against POM and the other parties, although
it declined complaint counsel’s request to require FDA pre-
approval. Part I of the Commission’s final order prohibits
POM, Roll, the Resnicks, and Tupper from representing that
any food, drug, or dietary supplement “is effective in the
diagnosis, cure, mitigation, treatment, or prevention of any
disease”—including but not limited to heart disease, prostate
cancer, and erectile dysfunction—unless the representation is
non-misleading and supported by “competent and reliable
scientific evidence that, when considered in light of the entire
body of relevant and reliable scientific evidence, is sufficient
to substantiate that the representation is true.” The order goes
on to say:
14
For purposes of this Part I, competent and
reliable scientific evidence shall consist of at
least two randomized and controlled human
clinical trials (RCTs) . . . that are randomized,
well controlled, based on valid end points, and
conducted by persons qualified by training and
experience to conduct such studies. Such
studies shall also yield statistically significant
results, and shall be double-blinded unless
[POM, Roll, the Resnicks, or Tupper] can
demonstrate that blinding cannot be effectively
implemented given the nature of the
intervention.
POM Wonderful LLC, No. 9344, Final Order at 2 (U.S. Fed.
Trade Comm’n Jan. 10, 2013) (FTC Final Order).
Part II of the order prohibits POM and the related parties
from misrepresenting the results of scientific studies in their
ads. Part III bars them from making any claim about the
“health benefits” of a food, drug, or dietary supplement unless
the representation is non-misleading and supported by
“competent and reliable scientific evidence.” But unlike Part
I, which applies specifically and solely to disease-related
claims, Part III contains no requirement that randomized,
controlled, human clinical trials support more general claims
about health benefits.
POM, Roll, the Resnicks, and Tupper petitioned this
court for review. We have jurisdiction under sections 5(c)
and 5(d) of the FTC Act, 15 U.S.C. § 45(c)-(d).
15
II.
Per our usual practice, we first address petitioners’
statutory challenges to the Commission’s order before turning
to their constitutional claims. See In re Fashina, 486 F.3d
1300, 1302-03 (D.C. Cir. 2007). On review of an order under
the FTC Act, “[t]he findings of the Commission as to the
facts, if supported by evidence, shall be conclusive.” FTC
Act § 5(c), 15 U.S.C. § 45(c). That standard is “essentially
identical” to the familiar “substantial evidence” test under the
Administrative Procedure Act. FTC v. Ind. Fed’n of Dentists,
476 U.S. 447, 454 (1986). The Commission “is often in a
better position than are courts to determine when a practice is
‘deceptive’ within the meaning of the [FTC] Act,” and that
“admonition is especially true with respect to allegedly
deceptive advertising since the finding of a § 5 violation in
this field rests so heavily on inference and pragmatic
judgment.” FTC v. Colgate-Palmolive Co., 380 U.S. 374, 385
(1965).
A.
In determining whether an advertisement is deceptive in
violation of section 5 of the FTC Act, the Commission
engages in a three-step inquiry, considering: (i) what claims
are conveyed in the ad, (ii) whether those claims are false,
misleading, or unsubstantiated, and (iii) whether the claims
are material to prospective consumers. See Kraft, Inc. v. FTC,
970 F.2d 311, 314 (7th Cir. 1992); see also Thompson Med.
Co., 104 F.T.C. 648, 660-61 (1984), aff’d, 791 F.2d 189, 197
(D.C. Cir. 1986). At the first step, the Commission “will
deem an advertisement to convey a claim if consumers acting
reasonably under the circumstances would interpret the
advertisement to contain that message.” Thompson Med. Co.,
104 F.T.C. at 788. The Commission “examines the overall
16
net impression” left by an ad, Kraft, 970 F.2d at 314, and
considers whether “at least a significant minority of
reasonable consumers” would “likely” interpret the ad to
assert the claim, Telebrands Corp., 140 F.T.C. 278, 291
(2005), aff’d, 457 F.3d 354 (4th Cir. 2006).
In identifying the claims made by an ad, the Commission
distinguishes between “efficacy claims” and “establishment
claims.” See Thompson Med. Co. v. FTC, 791 F.2d 189, 194
(D.C. Cir. 1986). An efficacy claim suggests that a product
successfully performs the advertised function or yields the
advertised benefit, but includes no suggestion of scientific
proof of the product’s effectiveness. See id.; Removatron
Int’l Corp. v. FTC, 884 F.2d 1489, 1492 n.3 (1st Cir. 1989).
An establishment claim, by contrast, suggests that a product’s
effectiveness or superiority has been scientifically established.
See Thompson Med. Co., 791 F.2d at 194; Sterling Drug, Inc.
v. FTC, 741 F.2d 1146, 1150 (9th Cir. 1984).
The distinction between efficacy claims and
establishment claims gains salience at the second step of the
Commission’s inquiry, which calls for determining whether
the advertiser’s claim is false, misleading, or unsubstantiated.
If an ad conveys an efficacy claim, the advertiser must
possess a “reasonable basis” for the claim. See Pfizer Inc., 81
F.T.C. 23, 62 (1972). The FTC examines that question under
the so-called “Pfizer factors,” including “the type of product,”
“the type of claim,” “the benefit of a truthful claim,” “the ease
of developing substantiation for the claim,” “the
consequences of a false claim,” and “the amount of
substantiation experts in the field would consider reasonable.”
Daniel Chapter One, No. 9329, 2009 WL 5160000, at *25
(U.S. Fed. Trade Comm’n Dec. 24, 2009) (citing Pfizer, 81
F.T.C. at 64), aff’d, 405 F. App’x 505 (D.C. Cir. 2010); see
also Thompson Med. Co., 104 F.T.C. at 821.
17
For establishment claims, by contrast, the Commission
generally does not apply the Pfizer factors. See Removatron
Int’l Corp., 111 F.T.C. 206, 297 (1988), aff’d, 884 F.2d 1489
(1st Cir. 1989). Rather, the amount of substantiation needed
for an establishment claim depends on whether the claim is
“specific” or “non-specific.” See Thompson Med. Co., 791
F.2d at 194. If an establishment claim “states a specific type
of substantiation,” the “advertiser must possess the specific
substantiation claimed.” Removatron, 884 F.2d at 1492 n.3.
If an ad instead conveys a non-specific establishment claim—
e.g., an ad stating that a product’s efficacy is “medically
proven” or making use of “visual aids” that “clearly suggest
that the claim is based upon a foundation of scientific
evidence”—the advertiser “must possess evidence sufficient
to satisfy the relevant scientific community of the claim’s
truth.” Bristol-Myers Co., 102 F.T.C. 21, 321 (1983), aff’d,
738 F.2d 554 (2d Cir. 1984). The Commission therefore
“determines what evidence would in fact establish such a
claim in the relevant scientific community” and “then
compares the advertisers’ substantiation evidence to that
required by the scientific community.” Removatron, 884 F.2d
at 1498.
Even if the Commission concludes at the first step that an
advertiser conveyed efficacy or establishment claims and
determines at the second step that the claims qualify as false,
misleading, or unsubstantiated, it can issue a finding of
liability only “if the omitted information would be a material
factor in the consumer’s decision to purchase the product.”
Am. Home Prods. Corp., 98 F.T.C. 136, 368 (1981), enforced
as modified, 695 F.2d 681 (3d Cir. 1982); see also Colgate-
Palmolive, 380 U.S. at 386-88. Here, petitioners do not
dispute the materiality of POM’s disease-related claims. We
therefore confine our analysis to the first and second steps of
the Commission’s determination: its findings that petitioners’
18
ads conveyed efficacy and establishment claims and that those
claims were false, misleading, or unsubstantiated.
B.
At the first step of its inquiry, the Commission
determined that thirty-six of petitioners’ advertisements and
promotional materials conveyed efficacy claims asserting that
POM products treat, prevent, or reduce the risk of heart
disease, prostate cancer, or erectile dysfunction. The
Commission further concluded that thirty-four of those ads
also conveyed establishment claims representing that clinical
studies substantiate the efficacy of POM products in treating,
preventing, or reducing the risk of the same ailments. The
Commission set forth the basis for those findings in
considerable detail in an appendix to its opinion, with a
separate explanation for each ad.
Those ads, as described earlier, see supra Part I.A,
repeatedly claimed the benefits of POM’s products in the
treatment or prevention of heart disease, prostate cancer, or
erectile dysfunction, and consistently touted medical studies
ostensibly supporting those claimed benefits. The question
whether “a claim of establishment is in fact made is a
question of fact the evaluation of which is within the FTC’s
peculiar expertise.” Thompson Med. Co., 791 F.2d at 194; see
also Removatron, 884 F.2d at 1496. Here, we perceive no
basis for setting aside the Commission’s carefully considered
findings of efficacy and establishment claims as unsupported
by substantial evidence.
Petitioners argue that the Commission applied overly
broad claim interpretation principles by “adopt[ing] a rule that
if an advertisement correctly references research connecting a
food product to possible health benefits, it necessarily implies
19
the vastly broader claim that there is ‘clinical proof’ that the
product treats, cures, or prevents a disease.” Joint Reply Br. 6
(emphasis in original). We disagree with that characterization
of the Commission’s approach. As the Commission made
clear in its opinion, “[n]ot ‘every reference to a test or study
necessarily gives rise to an establishment claim.’” FTC Op. at
12 (alteration omitted) (quoting Bristol-Myers, 102 F.T.C. at
321 n.7). Here, however, the advertisements go beyond
merely describing specific research in sufficient detail to
allow a consumer to judge its validity. The study results are
referenced in a way that suggests they are convincing
evidence of efficacy.
As the Commission separately set forth for each ad,
“these ads drew a logical connection between the study results
and effectiveness for the particular diseases.” Id. at 13.
Moreover, they invoked medical symbols, referenced
publication in medical journals, and described the substantial
funds spent on medical research, fortifying the overall sense
that the referenced clinical studies establish the claimed
benefits. Id. at 13-14. As the Commission explained,
“[w]hen 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.” Id. at 14.
Petitioners accuse the Commission of “‘cherry-pick[ing]’
the record by focusing on a handful of the most aggressive
advertisements—most of which have not been run in over six
years.” Joint Reply Br. 5. There is no meaningful difference,
however, between the more recent ads’ reliance on medical
studies and that of the earlier ads. Consider, for instance, the
advertisement for POMx Pills appearing in Playboy magazine
in July 2010, less than three months before the Commission
filed its complaint. See FTC Op. App. B fig.33. According to
20
that ad, POMx is “backed by $34 million in medical research
at the world’s leading universities” revealing “promising
results for erectile, prostate and cardiovascular health.” Id.
The ad goes on to discuss three specific studies: Dr. Padma-
Nathan’s erectile dysfunction study, Dr. Pantuck’s PSA
doubling time study, and Dr. Ornish’s blood flow study. Of
the first, the ad says that, “[i]n a preliminary study on erectile
function, men who consumed POM Juice reported a 50%
greater likelihood of improved erections as compared to
placebo.” The ad next asserts that “[a]n initial UCLA study
on our juice found hopeful results for prostate health,
reporting ‘statistically significant prolongation of PSA
doubling times.’” Finally, the ad states that “[a] preliminary
study on our juice showed promising results for heart
health”—specifically, improved “blood flow to the heart.”
Materials appearing on POM websites in 2009-2010
convey substantially similar claims. The pomwonderful.com
site described POM juice as “backed by” $25 million in
“medical research” and clinical testing. ALJ Initial Decision
at 55 ¶ 370. The website pointed to “medical results” in the
categories of “cardiovascular health,” “prostate health,” and
“erectile function.” Id. For cardiovascular health, the
webpage characterized Dr. Ornish’s blood flow study as
showing “improved blood flow to the heart,” and Dr.
Aviram’s CIMT study as showing a decrease in arterial
plaque from daily consumption of POM juice. Id. at 56 ¶ 373.
Further links contained descriptions of studies
“demonstrat[ing] that pomegranate juice lowers blood
pressure in patients with hypertension,” and “clearly
demonstrat[ing] for the first time that pomegranate juice
consumption by patients with carotid artery stenosis possesses
anti-atherosclerotic properties.” Id. at 56-57 ¶¶ 375-76. In
the category of prostate health, the webpage described Dr.
Pantuck’s study as showing that men with prostate cancer
21
who drank pomegranate juice daily “experienced significantly
slower PSA doubling times,” id. at 56 ¶ 371, with PSA
doubling time described as “an indicator of prostate cancer
progression,” id. at 58 ¶ 381. And with regard to erectile
function, the webpage described Dr. Padma-Nathan’s study as
demonstrating that men who drank pomegranate juice “were
50% more likely to experience improved erections.” Id. at 56
¶ 372.
The Commission reviewed the claims in POM’s ads “in
light of any disclaimers or disclosures that [petitioners]
actually made.” FTC Op. at 44. For the 2010 Playboy ad, for
instance, the Commission concluded that “at least a
significant minority of reasonable consumers” would construe
the ad to claim that drinking eight ounces of POM juice or
ingesting one POMx pill a day can treat, prevent, or reduce the
risk of erectile dysfunction, prostate cancer, and heart disease.
Id. App. A at A10-A11. The ad’s references to the described
studies as “promising,” “initial” or “preliminary” did not
detract from the Commission’s conclusion. The Commission
considered the effect of such adjectives “in the context of
each ad in its entirety,” explaining that those sorts of
modifiers do “not neutralize the claims made when the
specific results are otherwise described in unequivocally
positive terms.” Id. App. A at A2. The Commission
concluded that the “use of one or two adjectives does not alter
the net impression,” especially “when the chosen adjectives”
(such as “promising”) “provide a positive spin on the studies
rather than a substantive disclaimer.” Id. at 13.
The Commission noted, though, that it might reach a
different result if an ad were to incorporate an effective
disclaimer, such as a statement that the “evidence in support
of this claim is inconclusive.” Id. at 44 (quoting Pearson v.
Shalala, 164 F.3d 650, 659 (D.C. Cir. 1999)). Because
22
POM’s ads contained no such qualifier, the Commission held
petitioners to the general substantiation standard for non-
specific establishment claims—i.e., the requirement that
petitioners possess evidence sufficient to satisfy the relevant
scientific community of the truth of their claims. Petitioners
advance no persuasive ground for rejecting that approach as
beyond the Commission’s discretion.
C.
At the second stage of its analysis, the Commission found
petitioners’ efficacy and establishment claims to be deceptive
due to inadequate substantiation. “In reviewing whether there
is appropriate scientific substantiation for the claims made,
our task is only to determine if the Commission’s finding is
supported by substantial evidence on the record as a whole.”
Removatron, 884 F.2d at 1497 (internal quotation marks
omitted). When conducting that inquiry, we are mindful of
the Commission’s “special expertise in determining what
sort of substantiation is necessary to assure that advertising is
not deceptive.” Thompson Med. Co., 791 F.2d at 196.
1. For both petitioners’ efficacy claims and their non-
specific establishment claims, the Commission found that
“experts in the relevant fields” would require one or more
“properly randomized and controlled human clinical trials”—
“RCTs”—in order to “establish a causal relationship between
a food and the treatment, prevention, or reduction of risk” of
heart disease, prostate cancer, or erectile dysfunction. FTC
Op. at 22. Without at least one such RCT, the Commission
concluded, POM’s efficacy claims and its non-specific
establishment claims were inadequately substantiated.
In reaching that conclusion, the Commission emphasized
a distinction between “generalized nutritional and health
23
benefit claims” and “the specific disease treatment and
prevention claims at issue in this case,” i.e., “that the
Challenged POM Products treat, prevent or reduce the risk of
heart disease, prostate cancer, and ED, and that such claims
are scientifically established.” Id. at 20. The Commission
declined to address the level of support required for general
health or nutritional claims. See id. at 20-21. It instead
confined its analysis to the specific disease prevention and
treatment claims in question, concluding that the “expert
evidence was clear that RCTs are necessary for adequate
substantiation of these representations.” Id.
The Commission additionally explained that lesser
substantiation might suffice for “claims that do not assert a
causal relationship.” Id. at 23. POM’s ads, though, “convey
the net impression that clinical studies or trials show that a
causal relation has been established between the consumption
of the Challenged POM Products and its efficacy to treat,
prevent or reduce the risk of the serious diseases in question.”
Id. at 22; see, e.g., id. App. B fig.2 (“Medical studies have
shown that drinking 8oz. of POM Wonderful pomegranate
juice daily minimizes factors that lead to atherosclerosis, a
major cause of heart disease.”); id. App. B fig.7 (“POM
Wonderful Pomegranate Juice . . . can help prevent premature
aging, heart disease, stroke, Alzheimer’s, even cancer.”); id.
App. B fig.20 (“Eight ounces a day is enough to keep your
heart pumping.”). The Commission found that “experts in the
relevant fields would require RCTs . . . to establish” such a
“causal relationship.” Id. at 22-23.
The Commission examined each of the studies invoked
by petitioners in their ads, concluding that the referenced
studies fail to qualify as RCTs of the kind that could afford
adequate substantiation. Id. at 28-34. Petitioners’ claims
therefore were deceptive. Id. at 34, 38. Moreover, in light of
24
petitioners’ selective touting of ostensibly favorable study
results and nondisclosure of contrary indications from the
same or a later study, the Commission found that there were
“many omissions of material facts in [the] ads that consumers
cannot verify independently.” Id. at 43; see FTC Act
§ 15(a)(1), 15 U.S.C. § 55(a)(1) (“[I]n determining whether
any advertisement is misleading, there shall be taken into
account . . . the extent to which the advertisement fails to
reveal facts material in the light of such representations.”).
Petitioners, the Commission observed, “made numerous
deceptive representations and were aware that they were
making such representations despite the inconsistency
between the results of some of their later studies and the
results of earlier studies to which [they] refer in their ads.”
FTC Op. at 49.
With regard to heart disease, for instance, petitioners
repeatedly touted the results of Dr. Aviram’s limited CIMT
study without noting the contrary findings in Drs. Ornish’s
and Davidson’s later and larger studies. See supra p. 7. For
prostate cancer, petitioners consistently relied on Dr.
Pantuck’s study of PSA doubling times but with no indication
of the study’s limitations, including, for instance, that the
study’s subjects all had undergone radical treatments
associated with prolonged PSA doubling times regardless of
consumption of pomegranate juice. See supra pp. 9-10. And
in connection with erectile dysfunction, petitioners promoted
the results of Dr. Padma-Nathan’s study based exclusively on
the non-validated, one-question GAQ measure, without
acknowledging that the study showed no improvement
according to the only scientifically validated measure used to
assess the results (the IIEF). See supra pp. 11-12.
2. Petitioners challenge the Commission’s factual
finding that experts in the relevant fields require RCTs to
25
support claims about the disease-related benefits of POM’s
products. We conclude that the Commission’s finding is
supported by substantial record evidence. That evidence
includes written reports and testimony from medical
researchers stating that experts in the fields of cardiology and
urology require randomized, double-blinded, placebo-
controlled clinical trials to substantiate any claim that a
product treats, prevents, or reduces the risk of disease. See
J.A. 1018 (expert report of Dr. James Eastham of Memorial
Sloan-Kettering Cancer Center); id. at 1048-49 (expert report
of Dr. Frank Sacks of Harvard Medical School and Harvard
School of Public Health); id. at 1081 (expert report of Dr.
Arnold Melman of Albert Einstein College of Medicine); id.
at 1104 (expert report of Dr. Meir Jonathan Stampfer of
Harvard Medical School and Harvard School of Public
Health).
The Commission drew on that expert testimony to
explain why the attributes of well-designed RCTs are
necessary to substantiate petitioners’ claims. FTC Op. at 23-
24. A control group, for example, “‘allows investigators to
distinguish between real effects from the intervention, and
other changes, including those due to the mere act of being
treated (‘placebo effect’) [and] the passage of time.’” Id. at
23 (quoting ALJ Initial Decision at 90 ¶ 611). Random
assignment of a study’s subjects to treatment and control
groups “increases the likelihood that the treatment and control
groups are similar in relevant characteristics, so that any
difference in the outcome between the two groups can be
attributed to the treatment.” Id. (quoting ALJ Initial Decision
at 90 ¶ 612). And when a study is “double-blinded” (i.e.,
when neither the study participants nor the investigators know
which patients are in the treatment group and which patients
are in the control group), it is less likely that participants or
26
investigators will consciously or unconsciously take actions
potentially biasing the results. Id. at 24.
Petitioners assert that certain of the Commission’s
experts “admit[ted]” that RCTs are not always necessary to
substantiate claims about the health benefits of foods and
nutrients. Tupper Br. 41. Petitioners take the experts’
remarks out of context. For example, Dr. Meir Jonathan
Stampfer acknowledged having made recommendations
concerning diet and exercise “even when the data are not
supported by randomized clinical trials,” but he also
emphasized that a health recommendation based on the “best
available evidence” is “not the same as stating that a causal
link has been established.” J.A. 1218 (deposition testimony).
Dr. Frank Sacks likewise acknowledged that “well-conducted,
well-executed observational research is very important” for
evaluating foods and nutrients, but he emphasized that a
causal link between a food or nutrient and a reduction in
disease risk “cannot be proven from an observational [i.e.,
non-RCT] study.” Id. at 1240 (deposition testimony). POM
nonetheless claimed a scientifically established, causal link
between its products and various disease-related benefits on
the basis of studies that were not randomized or placebo-
controlled. See, e.g., FTC Op. App. B fig.2 (asserting, on
basis of Dr. Aviram’s non-randomized and non-placebo-
controlled CIMT study, that “[m]edical studies have shown
that drinking 8oz. of POM Wonderful pomegranate juice
daily minimizes factors that lead to atherosclerosis (plaque
buildup in the arteries), a major cause of heart disease”); id.
App. B fig.3 (stating, on basis of same study, that “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%”); id. App. B fig.9 (claiming, on basis
of Dr. Pantuck’s non-controlled study, that pomegranate juice
27
consumption “prolonged post-prostate surgery PSA doubling
time”).
Petitioners observe that some of their own experts offered
divergent views about the need for RCTs to substantiate
disease-related claims for food products. But section 5(c) of
the FTC Act, 15 U.S.C. § 45(c), which addresses judicial
review, “forbids a court to ‘make its own appraisal of the
testimony, picking and choosing for itself among uncertain
and conflicting inferences.’” Ind. Fed’n of Dentists, 476 U.S.
at 454 (quoting FTC v. Algoma Lumber Co., 291 U.S. 67, 73
(1934)). The standard set forth in section 5(c) is “essentially
identical” to the “‘substantial evidence’ standard for review of
agency factfinding,” id., and “does not permit the reviewing
court to weigh the evidence, but only to determine that there
is in the record such relevant evidence as a reasonable mind
might accept as adequate to support a conclusion.” Am. Home
Prods. Corp. v. FTC, 695 F.2d 681, 686 (3d Cir. 1982)
(quoting Steadman v. SEC, 450 U.S. 91, 99 (1981)). In
asking us to substitute our own appraisal of the expert
testimony for the Commission’s, petitioners ask us to do what
section 5(c) forbids. See Thompson Med. Co., 791 F.2d at
196.
3. Petitioners contend that it is “too onerous” to require
RCTs to substantiate disease-related claims about food
products “because of practical, ethical, and economic
constraints on RCT testing in that context.” Joint Reply Br.
32. The Commission was unpersuaded by that argument, see
FTC Op. at 24-25, and so are we.
As for the practical constraints on double-blinded,
placebo-controlled, randomized trials, petitioners say that it is
“difficult, if not impossible, to ‘blind’ a fruit.” POM Br. 13.
But that argument does not apply to two of the three products
28
at issue—POMx Liquid and POMx Pills—which are dietary
supplements amenable to blinding. And as applied to POM
juice, petitioners’ argument is called into question by the fact
that several juice studies they sponsored were double-blinded
and placebo-controlled, including studies led by Dr. Ornish,
Dr. Davidson, and Dr. Padma-Nathan. See, e.g., Davidson et
al., supra, at 937 (explaining that beverage with “similar color
and energy content” as pomegranate juice could be “labeled
so that neither subjects nor staff members were aware”
whether beverage was placebo). In any event, the
Commission required double-blinding only “when feasible,”
acknowledging that, “in some instances . . . it may not be
possible to conduct blinded clinical trials of food products.”
FTC Op. at 24.
As for the ethical constraints on randomized controlled
trials, petitioners say that it is “impossible to create a zero
intake group for nutrients in an ethical manner—doctors
cannot, for example, ethically deprive a control group of
patients of all Vitamin C for a decade to determine whether
Vitamin C helps prevent cancer.” POM Br. 15 (internal
quotation marks omitted). Many of the challenged ads,
however, made claims about the short-term benefits of
consuming POM products. See, e.g., FTC Op. App. B fig.1
(asserting, on basis of ten-patient study with no control group,
that “[p]omegranate juice inhibited [angiotensin converting
enzyme (ACE)] by 36% after two weeks of consumption” and
that “[i]nhibition of ACE lessens the progression of
atherosclerosis”). And whether or not it may be unethical to
tell patients in a control group to stop consuming vitamin C,
petitioners give us no reason to believe that it would be
unethical to create a zero intake group for pomegranate juice.
We acknowledge that RCTs may be costly, although we
note that the petitioners nonetheless have been able to sponsor
29
dozens of studies, including several RCTs. Yet if the cost of
an RCT proves prohibitive, petitioners can choose to specify a
lower level of substantiation for their claims. As the
Commission observed, “the need for RCTs is driven by the
claims [petitioners] have chosen to make.” Id. at 25. An
advertiser who makes “express representations about the level
of support for a particular claim” must “possess the level of
proof claimed in the ad” and must convey that information to
consumers in a non-misleading way. Thompson Med. Co.,
791 F.2d at 194. An advertiser thus still may assert a health-
related claim backed by medical evidence falling short of an
RCT if it includes an effective disclaimer disclosing the
limitations of the supporting research. Petitioners did not do
so.
D.
Petitioners argue that the substantiation standard applied
by the Commission to POM’s establishment and efficacy
claims amounts to a new legal rule adopted in violation of the
Administrative Procedure Act’s notice-and-comment
requirements for rulemaking. See Administrative Procedure
Act § 4, 5 U.S.C. § 553; FTC Act § 18(a)-(b), 15 U.S.C.
§ 57a(a)-(b) (APA notice-and-comment requirements apply to
FTC rules). We disagree. The Commission proceeded in this
case via adjudication rather than rulemaking. And it “is well
settled that an agency ‘is not precluded from announcing new
principles in an adjudicative proceeding,’” and that “‘the
choice between rulemaking and adjudication lies in the first
instance within the agency’s discretion.’” Cassell v. FCC,
154 F.3d 478, 486 (D.C. Cir. 1998) (alteration omitted)
(quoting NLRB v. Bell Aerospace Co. Div. of Textron Inc.,
416 U.S. 267, 294 (1974)); see also Qwest Servs. Corp. v.
FCC, 509 F.3d 531, 536-37 (D.C. Cir. 2007).
30
Petitioners point to Appalachian Power Co. v. EPA, 208
F.3d 1015, 1024 (D.C. Cir. 2000), where we said that “an
agency may not escape the notice and comment requirements
. . . by labeling a major substantive legal addition to a rule a
mere interpretation.” Appalachian Power, however, involved
a guidance document that “in effect amended” a regulation,
which the agency could not “legally do without complying
with the rulemaking procedures.” Id. at 1028. Here, the
Commission did not effectively amend a notice-and-comment
regulation. It instead validly proceeded by adjudication. As
we have explained, the “fact that an order rendered in an
adjudication may affect agency policy and have general
prospective application does not make it rulemaking subject
to APA section 553 notice and comment.” Conference Grp.,
LLC v. FCC, 720 F.3d 957, 966 (D.C. Cir. 2013) (citation and
internal quotation marks omitted).
The Commission’s decision, in any event, does not
involve a “major substantive legal addition” to its
substantiation standards. Appalachian Power Co., 208 F.3d at
1024. With respect to POM’s establishment claims, the
substantiation standard applied by the Commission is
consistent with Commission precedent. When an advertiser
represents that claims have been “scientifically established,”
the FTC has long held the advertiser to “the level of evidence
required to convince the relevant scientific community of the
claim’s truthfulness.” Bristol-Meyers, 102 F.T.C. at 317-18;
accord Removatron, 111 F.T.C. at 297-99; Thompson Med.
Co., 104 F.T.C. at 821-22 & n.59. And the Commission has
required RCTs to substantiate establishment claims in other
contexts. See, e.g., Am. Home Prods. Corp., 98 F.T.C. at 200-
06. With respect to POM’s efficacy claims, the Commission
arrived at its RCT substantiation requirement by applying the
traditional Pfizer factors. That conclusion coheres with past
Commission decisions applying Pfizer, including Pfizer itself.
31
See Pfizer, 81 F.T.C. at 66 (finding that “for a test, standing
alone, to provide a reasonable basis” for a claim that a
nonprescription product is effective in treating minor burns
and sunburns, “the test should be an adequate and well-
controlled scientific test,” and noting “strong desirability” that
the test be “double-blind”); Thompson Med. Co., 104 F.T.C.
at 826 (applying “six Pfizer factors” and concluding that the
“proper level of substantiation for . . . efficacy claims” for
topical analgesic marketed to treat minor arthritis is “two
well-controlled clinical tests”).
E.
Matthew Tupper, for his part, challenges the
Commission’s decision to hold him individually liable (along
with the Resnicks) for POM’s deceptive acts and practices.
Tupper, who became POM’s chief operating officer in 2003
and served as its president from 2005 to 2011, contends that
he should not be held individually liable because Lynda
Resnick, not he, had the “final say” on the ads. Tupper Br.
33.
Tupper cites no decisions supporting his assertion that
individual liability under the FTC Act extends only to those
with “final say” over deceptive acts or practices. The other
circuits to address the issue have determined that
“[i]ndividuals may be liable for FTC Act violations
committed by a corporate entity if the individual ‘participated
directly in the deceptive practices or acts or had authority to
control them.’” FTC v. IAB Mktg. Assocs., LP, 746 F.3d
1228, 1233 (11th Cir. 2014) (alteration omitted) (quoting FTC
v. Amy Travel Serv., Inc., 875 F.2d 564, 573 (7th Cir. 1989));
accord FTC v. QT, Inc., 512 F.3d 858, 864 (7th Cir. 2008);
FTC v. Freecom Commc’ns, Inc., 401 F.3d 1192, 1204 (10th
Cir. 2005); FTC v. Publ’g Clearing House, Inc., 104 F.3d
32
1168, 1170 (9th Cir. 1997). It is undisputed that Tupper
participated directly in meetings about advertising concepts
and content, reviewed and edited ad copy, managed the day-
to-day affairs of POM’s marketing team, and possessed hiring
and firing authority over the head of POM’s marketing
department. Even assuming that “authority to control” is a
prerequisite for individual liability under the FTC Act, we
would still affirm based on the Commission’s unchallenged
finding that Tupper “had the authority to determine which
advertisements should run.” FTC Op. at 53.
Tupper next argues that the Commission failed to prove
his knowledge that POM’s ads conveyed misleading claims.
But the FTC has been required to demonstrate an individual’s
knowledge only when seeking equitable monetary relief. See
FTC v. Network Servs. Depot, Inc., 617 F.3d 1127, 1138 (9th
Cir. 2010); Freecom Commc’ns, 401 F.3d at 1197-203, 1207.
In this case, the sole remedy imposed by the FTC was
injunctive relief. And when the Commission does not seek
restitution or monetary penalties, the FTC Act “imposes a
strict liability standard” and “creates no exemption . . . for
unwitting disseminators of false advertising.” Porter &
Dietsch, Inc. v. FTC, 605 F.2d 294, 309 (7th Cir. 1979); see
Feil v. FTC, 285 F.2d 879, 896 (9th Cir. 1960); Koch v. FTC,
206 F.2d 311, 317 (6th Cir. 1953); Parke, Austin & Lipscomb,
Inc. v. FTC, 142 F.2d 437, 440 (2d Cir. 1944).
Finally, Tupper contends that there is “no justification”
for applying the Commission’s order to him because he has
“voluntarily retired from his position at POM.” Tupper Br.
37. That argument occupied just two sentences of his opening
brief, and he referenced no precedent supporting it until his
reply brief. Joint Reply Br. 43-44 (citing FTC v. Accusearch
Inc., 570 F.3d 1187, 1201 (10th Cir. 2009); Borg-Warner
Corp. v. FTC, 746 F.2d 108, 110 (2d Cir. 1984)). When a
33
litigant’s opening brief presents an argument “in conclusory
fashion and without visible support,” we have discretion to
deem the argument forfeited. See Bd. of Regents of the Univ.
of Wash. v. EPA, 86 F.3d 1214, 1221 (D.C. Cir. 1996).
Tupper’s argument fails on the merits in any event.
Injunctive relief may be inappropriate if the affected parties
“have not shown a propensity toward violating” the statute
and “nothing in the record . . . suggests the likelihood or even
the possibility” of further violations. Borg-Warner, 746 F.2d
at 110-11. But the Commission found that petitioners,
including Tupper, “have a demonstrated propensity to
misrepresent to their advantage the strength and outcomes of
scientific research” and “engaged in a deliberate and
consistent course of conduct—no mere isolated incident or
mistake.” FTC Op. at 51. Additionally, there is no assurance
that Tupper will not return to POM or join another company
that markets food products or dietary supplements.
III.
Having rejected petitioners’ statutory claims, we now
turn to their constitutional arguments. Petitioners challenge
both the Commission’s liability determination and its remedy
on First Amendment grounds. We reject both challenges
except insofar as the Commission in its remedial order
imposed an across-the-board, two-RCT substantiation
requirement for any future disease-related claims by
petitioners.
A.
“For commercial speech to come within [the First
Amendment], it at least must concern lawful activity and not
be misleading.” Cent. Hudson Gas & Elec. Corp. v. Pub.
Serv. Comm’n, 447 U.S. 557, 566 (1980). Consequently,
34
“[m]isleading advertising may be prohibited entirely.” In re
R. M. J., 455 U.S. 191, 203 (1982).
In imposing liability against petitioners, the Commission
found that POM’s ads are entitled to no First Amendment
protection because they are “deceptive and misleading.” FTC
Op. at 44. Petitioners ask us to review that finding de novo in
light of the First Amendment context, see Bose Corp. v.
Consumers Union of U.S., 466 U.S. 485, 505 (1984), and to
overturn the Commission’s decision to impose liability. Our
precedents, however, call for reviewing the Commission’s
factual finding of a deceptive claim under the ordinary (and
deferential) substantial-evidence standard, even in the First
Amendment context. Novartis Corp. v. FTC, 223 F.3d 783,
787 n.4 (D.C. Cir. 2000); FTC v. Brown & Williamson
Tobacco Corp., 778 F.2d 35, 41 n.3 (D.C. Cir. 1985); see also
Kraft, 970 F.2d at 316 (cited in Novartis Corp., 223 F.3d at
787 n.4). We conclude that the Commission’s findings of
deception are supported by substantial evidence in the record;
and we would reach the same conclusion even if we were to
exercise de novo review, at least with respect to the nineteen
ads determined misleading by the administrative law judge
and held by the Commission to form a sufficient basis for its
liability determination and remedial order.
We have addressed eighteen of those nineteen ads in the
course of our earlier discussion, and we affirm the
Commission’s determination that those ads were deceptive for
the reasons set forth above and in the FTC’s opinion. See
FTC Op. App. A at A3-A7, A9-A14; id. App. B figs.1, 2, 3, 4,
6, 7, 8, 9, 10, 15, 16, 17, 21, 27, 33, 37, 38, 39. The sole
remaining ad is one carried in two magazines in 2004 and
2005. It features an intravenous tube running through a bottle
of POM juice alongside the headline “Life support.” Id. App.
B fig.5. The ad says that POM juice “has more naturally
35
occurring antioxidants than any other drink,” and that “[t]hese
antioxidants fight hard against free radicals that can cause
heart disease” and “even cancer.” Id. The ad then tells
readers that, if they “[j]ust drink eight ounces a day,” they
will “be on life support—in a good way.” Id.
The administrative law judge concluded that, “[b]ased on
the overall, common-sense, net impression” of the ad, “a
significant minority” of “reasonable” consumers “would
interpret [the ad] to be claiming that drinking eight ounces of
POM Juice daily prevents or reduces the risk of heart
disease.” ALJ Initial Decision at 69 ¶ 455. The full
Commission adopted the administrative law judge’s findings
about the net impression conveyed by the ad, and we see no
basis to overturn that conclusion. At the time, there was
insufficient support for an unqualified efficacy claim of a link
between daily consumption of pomegranate juice and
prevention of heart disease. As a result, insofar as the FTC
imposed liability on petitioners for the nineteen ads found to
be deceptive by the administrative law judge, the Commission
sanctioned petitioners for misleading speech unprotected by
the First Amendment.
B.
Finally, we address petitioners’ First Amendment
challenge to the Commission’s injunctive order. Part III of
the order imposes a baseline requirement applicable to all of
petitioners’ ads. It bars representations about a product’s
general health benefits “unless the representation is non-
misleading” and backed by “competent and reliable scientific
evidence that is sufficient in quality and quantity” to
“substantiate that the representation is true.” FTC Final Order
at 3. For purposes of that baseline requirement, “competent
and reliable evidence” means studies that are “generally
36
accepted in the profession to yield accurate and reliable
results.” Id.
Part I of the order, meanwhile, imposes heightened
requirements in the specific context of claims about the
treatment or prevention of “any disease” (including, but not
limited to, heart disease, prostate cancer, and erectile
dysfunction). Id. at 2. Such disease-related claims, like the
broader category of health claims covered by Part III, must be
“non-misleading” and supported by “competent and reliable
scientific evidence.” Id. But “competent and reliable
scientific evidence” is more narrowly defined for purposes of
Part I to consist of “at least two randomized and controlled
human clinical trials (RCTs)” that “yield statistically
significant results” and are “double-blinded” whenever
feasible. Id. In short, Part III’s baseline requirement for all
health claims does not require RCT substantiation, whereas
the specific requirements in Part I for disease-related claims
not only contemplate RCT substantiation, but call for—as a
categorical matter—two RCTs.
The Commission clarified in a footnote of its brief that
Part I’s blanket, two-RCT-substantiation requirement for
disease claims attaches only to unqualified representations.
FTC Br. 73 n.33. But the evident leeway to make “effectively
qualified” disease claims without two RCTs, id., appears to be
highly circumscribed. Representations characterizing a
study’s results as “preliminary” or “initial”—even if
describing a gold-standard RCT yielding results with an
extremely high degree of statistical significance—would fail
to count as adequately qualified and thus would be prohibited.
See FTC Op. App. A at A2. Rather, an ad apparently would
need to contain a disclaimer stating “unambiguously” that the
evidence is “inconclusive” or that “additional research is
necessary,” FTC Br. 10, 19, even if the ad is substantiated by
37
a well-designed RCT that experts uniformly consider to be
conclusive, and regardless of the amount and quality of
additional supporting evidence other than RCTs. Short of
such a disclaimer, a disease-related claim faces a categorical
bar unless substantiated by two RCTs.
Petitioners challenge the remedial order’s blanket, two-
RCT-substantiation requirement under the First Amendment.
They contend, and the Commission accepts, that their
challenge should be examined under the general test for
commercial speech restrictions set out in Central Hudson, 447
U.S. at 566. See Joint Reply Br. 39-40; FTC Br. 74.
Central Hudson first requires that the “asserted
governmental interest [be] substantial.” 447 U.S. at 566. The
Supreme Court has made clear that the governmental “interest
in ensuring the accuracy of commercial information in the
marketplace is substantial.” Edenfield v. Fane, 507 U.S. 761,
769 (1993). The Commission asserts that its remedial order
aims to advance that concededly substantial interest,
satisfying Central Hudson’s first prong.
With regard to the means by which the Commission
seeks to further its asserted interest, Central Hudson requires
that a challenged restriction “directly advance[] the
governmental interest” and that it “is not more extensive than
is necessary to serve that interest.” 447 U.S. at 566. Here,
insofar as the Commission’s order imposes a general RCT-
substantiation requirement for disease claims—i.e., without
regard to any particular number of RCTs—the order satisfies
those tailoring components of Central Hudson review.
In finding petitioners liable for deceptive ads, the
Commission determined that petitioners’ efficacy and
establishment claims were misleading because they were
38
unsubstantiated by RCTs. We have upheld that approach in
this opinion. Requiring RCT substantiation as a forward-
looking remedy is perfectly commensurate with the
Commission’s assessment of liability for petitioners’ past
conduct: if past claims were deceptive in the absence of RCT
substantiation, requiring RCTs for future claims is tightly
tethered to the goal of preventing deception. To be sure, the
liability determination concerned claims about three specific
diseases whereas the remedial order encompasses claims
about any disease. But that broadened scope is justified by
petitioners’ demonstrated propensity to make deceptive
representations about the health benefits of their products, and
also by the expert testimony supporting the necessity of RCTs
to establish causation for disease-related claims generally.
See FTC Op. at 22, 35-36. For purposes of Central Hudson
scrutiny, then, the injunctive order’s requirement of some
RCT substantiation for disease claims directly advances, and
is not more extensive than necessary to serve, the interest in
preventing misleading commercial speech.
We reach the opposite conclusion insofar as the remedial
order mandates two RCTs as an across-the-board requirement
for any disease claim. Central Hudson “requires something
short of a least-restrictive-means standard,” Board of Trustees
v. Fox, 492 U.S. 469, 477 (1989), but the Commission still
bears the burden to demonstrate a “reasonable fit” between
the particular means chosen and the government interest
pursued, id. at 480. See Am. Meat Inst. v. U.S. Dep’t of
Agric., 760 F.3d 18, 26-27 (D.C. Cir. 2014) (en banc). Here,
the Commission fails adequately to justify a categorical floor
of two RCTs for any and all disease claims. It of course is
true that, all else being equal, two RCTs would provide more
reliable scientific evidence than one RCT, affording added
assurance against misleading claims. It is equally true that
three RCTs would provide more certainty than two, and four
39
would yield more certainty still. But the Commission
understandably does not claim a myopic interest in pursuing
scientific certitude to the exclusion of all else, regardless of
the consequences.
Here, the consequences of mandating more than one RCT
bear emphasis. Requiring additional RCTs without adequate
justification exacts considerable costs, and not just in terms of
the substantial resources often necessary to design and
conduct a properly randomized and controlled human clinical
trial. If there is a categorical bar against claims about the
disease-related benefits of a food product or dietary
supplement in the absence of two RCTs, consumers may be
denied useful, truthful information about products with a
demonstrated capacity to treat or prevent serious disease.
That would subvert rather than promote the objectives of the
commercial speech doctrine. See Edenfield, 507 U.S. at 766.
Consider, for instance, a situation in which the results of
a large-scale, perfectly designed and conducted RCT show
that a dietary supplement significantly reduces the risk of a
particular disease, with the results demonstrated to a very high
degree of statistical certainty (i.e., a very low p-value)—so
much so that experts in the relevant field universally regard
the study as conclusively establishing clinical proof of the
supplement’s benefits for disease prevention. Perhaps,
moreover, a wealth of medical research and evidence apart
from RCTs—e.g., observational studies—reinforces the
results of the blue-ribbon RCT. In that situation, there would
be a substantial interest in assuring that consumers gain
awareness of the dietary supplement’s benefits and the
supporting medical research (and without any qualifiers
stating, misleadingly, that the evidence is “inconclusive,” see
supra p. 38). After all, as the Food and Drug Administration
has explained in past guidance to the industry, “[a] single
40
large, well conducted and controlled clinical trial could
provide sufficient evidence to establish a substance/disease
relationship, provided that there is a supporting body of
evidence from observational or mechanistic studies.” U.S.
Food & Drug Admin., Guidance for Industry: Significant
Scientific Agreement in the Review of Claims for
Conventional Foods and Dietary Supplements 5 (Dec. 1999),
1999 WL 33935287 (withdrawn 2009).
The two-RCT requirement in the Commission’s order
brooks no exception for those circumstances. No matter how
robust the results of a completed RCT, and no matter how
compelling a battery of supporting research, the order would
always bar any disease-related claims unless petitioners clear
the magic line of two RCTs. The Commission has elsewhere
explained to industry advertisers that, “[i]n most situations,
the quality of studies will be more important than quantity.”
U.S. Fed. Trade Comm’n, Dietary Supplements: An
Advertising Guide for Industry 10 (Apr. 2001), available at
http://www.business.ftc.gov/documents/bus09-dietary-
supplements-advertising-guide-industry. The blanket, two-
RCT substantiation requirement at issue here is out of step
with that understanding.
The Commission fails to demonstrate how such a rigid
remedial rule bears the requisite “reasonable fit” with the
interest in preventing deceptive speech. Fox, 492 U.S. at 480;
see also Am. Meat Inst., 760 F.3d at 26. In the liability
portion of its opinion, the Commission went to great lengths
to explain why RCTs, rather than less demanding studies, are
required to substantiate the sorts of causal claims petitioners
asserted in the past. But the Commission stressed that it
“need not, and does not, reach the question of the number of
RCTs needed to substantiate the claims made.” FTC Op. at 3.
The Commission nonetheless imposed a categorical, two-
41
RCT substantiation requirement in the remedial portion of its
opinion. Id. at 51. As justification for that decision, the
Commission tendered two grounds, in a brief, five-sentence
explanation. Neither of the grounds (nor both together)
adequately justifies the Commission’s blanket two-RCT
requirement.
First, the Commission asserts that a two-RCT
requirement is consistent with its precedent. The fact that the
Commission may have imposed a remedy in the past,
however, does not necessarily establish the closeness of its fit
to a new set of facts. And here, we view the Commission’s
history with a two-RCT remedy to cut against, not in favor of,
its imposition of a two-RCT requirement for all disease
claims. It is true that this Court observed, almost thirty years
ago, that the “FTC has usually required two well-controlled
clinical tests” before certain “non-specific establishment
claim[s] may be made.” Thompson Med. Co., 791 F.2d at
194. But all of the cases cited in support of that observation,
like Thompson itself, involved a highly specific type of
representation: establishment claims about the comparative
efficacy of over-the-counter analgesics. See Sterling Drug,
Inc., 741 F.2d at 1152-53; Bristol Myers Co. v. FTC, 738 F.2d
554, 558-59 (2d Cir. 1984); Am. Home Prods. Corp., 695
F.2d at 691-93. The decision to require two well-controlled
clinical studies was confined to a particular type of claim
about a particular product—the comparative ability of
analgesics to afford pain relief. See, e.g., Thompson Med.
Co., 791 F.2d at 192. And the decision came after extended
analysis of considerations specific to that context. See Am.
Home Prods. Corp., 98 F.T.C. at 201-06.
In particular, due to the subjective nature of pain
sensitivity, the Commission concluded that “the elements of a
well-controlled clinical trial” are especially important in the
42
case of analgesics. Thompson Med. Co., 104 F.T.C. at 720.
That is even more true in a “comparative drug trial,” in which
the subjectivity of pain is compounded by the need to qualify
the relative effect of two or more alternate treatments. See id.
at 719-25. The Commission also found significant that FDA
panels on analgesics (as well as the medical scientific
community) “require[] replication of the results of a clinical
test involving an analgesic drug.” Id. at 720-21. For all of
those reasons, the Commission concluded that “[t]wo or more
independently conducted, well-controlled clinical studies are
required to establish the comparative efficacy of [over-the-
counter] analgesics for the relief of mild to moderate pain.”
Am. Home Prods. Corp., 98 F.T.C. at 201; see also Thompson
Med. Co., 104 F.T.C. at 719. Rather than supporting the
imposition of a two-RCT mandate as routinely necessary to
prevent the misleading of consumers, Thompson suggests that
the Commission has imposed two-RCT requirements only in
narrow circumstances based on particularized concerns.
More recent Commission action does not demonstrate
otherwise. After being asked at oral argument to identify
two-RCT remedial orders other than those discussed in
Thompson, the Commission produced a handful of examples
in a post-argument submission. See FTC 28(j) Letter at 2
(May 5, 2014). Most of the examples are consent orders—
entered without litigation or explanation of the Commission’s
reasoning—providing little insight into why two RCTs would
be required to prevent a claim from being misleading. See
L’Occitane, Inc., No. C-4445, 2014 WL 1493613 (U.S. Fed.
Trade Comm’n Mar. 27, 2014); Dannon Co., Inc., No. C-
4313, 2011 WL 479884 (U.S. Fed. Trade Comm’n Jan. 31,
2011); Nestle Healthcare Nutrition, Inc., No. C-4312, 2011
WL 188928 (U.S. Fed. Trade Comm’n Jan. 12, 2011). The
other examples impose two RCTs for only some subset of
future claims, while requiring less support for other claims.
43
See Schering Corp., 118 F.T.C. 1030, 1122-23 (1994)
(requiring generally acceptable scientific evidence for some
claims and two RCTs for others); Jerome Milton, Inc., 110
F.T.C. 104, 116 (1987) (requiring one RCT or generally
acceptable scientific evidence for some claims and two RCTs
for others).
Outside of those examples, several orders over the past
decade require only “competent and reliable scientific
evidence”—not necessarily RCTs, let alone two RCTs—to
substantiate disease claims akin to those made by petitioners.
See, e.g., Tropicana Prods., Inc., 140 F.T.C. 176, 184-85
(2005); Unither Pharma, Inc., 136 F.T.C. 145, 295-96 (2003).
And in other recent orders, the Commission has imposed a
one-RCT remedy. See, e.g., FTC v. Reebok Int’l Ltd., No.
1:11-cv-02046-DCN, slip op. at 5-6 (N.D. Ohio Sept. 29,
2011). Indeed, in Removatron the Commission itself
modified an ALJ’s initial order to require one RCT rather than
two. 111 F.T.C. at 206. In short, the Commission’s
precedents suggest that two-RCT remedial provisions are only
selectively imposed in specific circumstances based on
particular concerns.
The Commission observes that certain expert testimony
in this case “recognized the need for consistent results in
independently-replicated studies,” with one of its experts
noting the possibility that the results of a single RCT “may be
due to chance or may not be generalizable due to the
uniqueness of the study sample.” FTC Op. at 51 (internal
quotation marks omitted). But insofar as the results of any
particular RCT may be suspect due to deficiencies in the
sample or trial, the baseline requirement for health-related
claims independently bars any representations unless
supported by “competent and reliable scientific evidence that
. . . is sufficient to substantiate that the representation is true,”
44
which in turn requires that a study be “generally accepted in
the profession to yield accurate and reliable results.” FTC
Final Order at 3. In any event, the Commission’s own expert
testimony—as described by the Commission itself—weighs
against imposing a categorical, two-RCT-substantiation
requirement for all disease claims. As the Commission
explained, expert testimony about the need for two RCTs was
addressed to one particular disease, whereas one RCT could
suffice for the other two examined diseases: “experts testified
that two RCTs are necessary to substantiate the heart disease
claims at issue, while the prostate cancer and ED claims can
be substantiated with at least one RCT.” FTC Op. at 3. The
Commission nonetheless imposed a categorical, two-RCT
requirement for all disease claims, regardless of the quality of
any single RCT or the strength of other medical evidence.
Finally, the Commission justifies its two-RCT
requirement on the ground that petitioners “have a
demonstrated propensity to misrepresent to their advantage
the strength and outcomes of scientific research” and “have
engaged in a deliberate and consistent course of conduct.” Id.
at 51. But by definition, every party subjected to a final FTC
order has been found to have engaged in some unlawful
advertising practice. The Commission does not explain how
the two-RCT requirement is reasonably linked to the
particular history of petitioners’ wrongdoing. The
Commission does highlight petitioners’ history of selectively
drawing on favorable studies while disregarding unfavorable
results. Id. at 49. To the extent the two-RCT remedy aims to
prevent petitioners from misleadingly highlighting favorable
results alone, however, the order separately requires
petitioners to base any representations on “competent and
reliable scientific evidence that, when considered in light of
the entire body of relevant and reliable scientific evidence, is
sufficient to substantiate that the representation is true.” FTC
45
Final Order at 2 (emphasis added). With that baseline already
established by the order, the contribution of the two-RCT
requirement to the order’s effectiveness in this regard is far
from clear.
For those reasons, we hold that the Commission’s order
is valid to the extent it requires disease claims to be
substantiated by at least one RCT. But it fails Central
Hudson scrutiny insofar as it categorically requires two RCTs
for all disease-related claims. That is not at all to say that the
Commission would be barred from imposing a two-RCT-
substantiation requirement in any circumstances. See
Thompson Med. Co., 791 F.2d at 193-96. Rather, the
Commission has failed in this case adequately to justify an
across-the-board two-RCT requirement for all disease claims
by petitioners.
* * * * *
For the foregoing reasons, Part I of the Commission’s
remedial order will be modified to require petitioners to
possess at least one RCT before making disease claims
covered by that provision and, as modified, enforced. We
deny the petition for review in all other respects.
So ordered.