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.

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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.

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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

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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

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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

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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,

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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.

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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

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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

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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

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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—

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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:

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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.