A Judicial ‘Supplement’ to Advertising Law: The Fourth Circuit’s GNC Decision and Policy Implications for the Dietary Supplement Industry

By Gia Wakil*

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Introduction

Every home has a story, as the old
adage goes, and the story in this Note is set in the modern-day vitamin
cabinet. Few items are as ubiquitous in American homes as the pill bottle. From
vitamins like A and C, or minerals like iron and zinc, the supplements found in
a single household typically run the full alphabet. The majority of adults in
the United States take one or more dietary supplements occasionally, or even
every day,[1] with sales to American consumers
exceeding $35 billion per year.[2] Americans rely on supplements to
ameliorate nutritional deficiencies or to maintain their health. And yet,
despite the prevalence of supplements, concerns abound about their efficacy and
the veracity of claims supporting the use of supplements. Oftentimes, the
prospect of shorter colds, stronger nails, or improved general health justifies
the price of the “gamble” in the minds of many consumers.

It was in similar, health-conscious hopes that consumers in
the In re GNC Corp. [3] case had reached for bottles of glucosamine-chondroitin, two
common ingredients in joint health specialty products.[4]
The labels touted that the mixtures “promote[] joint mobility and flexibility”
and provide “[c]linical strength for daily long-term use.” GNC allegedly had,
and on some labels cited to, a reasonable scientific basis for these claims,
though its legitimacy was tarnished in the face of mounting scientific evidence
indicating otherwise.

After years of medical controversy examining whether
glucosamine-chondroitin is effective, lawsuits against a variety of its
manufacturers and sellers popped up across the United States.[5] Perhaps the consumers were
tired of “gambling” on glucosamine and thought that the products did not live
up to their billing. More likely, plaintiffs’ lawyers had been following the
debate, and they believed there were issues to be asserted in the form of
consumer class actions.[6] Multiple false advertising
lawsuits against GNC commenced between March and December 2013, with
allegations of consumer deception across California, Florida, Ohio, New York,
Illinois, Pennsylvania, and New Jersey.[7]

The controversy surrounding truthfulness in supplement advertising
has only grown louder in recent years, and for good reason. Over the last
fifteen years, sales of vitamins, minerals, and nutritional and herbal
supplements — which, together, comprise the dietary supplement industry — have
surged. In December 2013, McKinsey & Company estimated the global value of
the supplement market to be $82 billion, with a high concentration of that
value in the U.S.[8] High levels of sales appear
to correlate with high consumer confidence. The majority of U.S. adults — 68 percent — take
supplements, and nearly 85 percent of those consumers express “overall
confidence in the safety, quality and effectiveness of dietary supplements.”[9]
Competition in the supplement industry is fierce and no one company accounts
for more than a five percent share.[10]

Unbeknownst
to many consumers, the laws governing supplement labeling and advertising are
notoriously tricky to navigate. The Food and Drug Administration (FDA) issues
rules and regulations regarding supplement labeling, marketing, and safety,[11]
but there are significant limitations to FDA oversight. For example, the manufacturer or
seller does not need to prove that a claim is accurate to the FDA’s
satisfaction before it appears
on the product,[12] and the agency reviews
substantiation for claims periodically, as resources permit.[13] The Federal Trade Commission (FTC) polices
health and safety claims made in advertising for dietary supplements,[14] but its oversight is
similarly limited by the availability of resources.[15]

High sales, patchy government supervision, and dubious
marketing practices have created a “perfect storm” on the litigation frontier. False
advertising in the consumer class action context is a rapidly growing area of
law.[16] GNC is a rich case study for exploring issues related to truth in
advertising, particularly when dealing with scientific controversy. In GNC, the Fourth Circuit held that the existence of a single
expert in agreement with a claim bars the statement from being found literally
false.[17] Since Plaintiffs did not
challenge the validity of GNC’s study that supported the claims found on
bottles — even after an opportunity to amend their complaint — they could not
prove that glucosamine-chondroitin was not
beneficial to joint health. In other words, at least one reasonable expert or
study is sufficient to carry the claim on the bottle, even if the vast weight
of scientific evidence suggests otherwise. Furthermore, a “battle of the
experts” did not necessitate a jury trial, nor did it forestall judgment in the
supplement manufacturer’s favor.

This Note argues that the Fourth Circuit’s holding in GNC is the preferred solution to the
truth-in-advertising dilemma that is rampant in the supplement industry,
particularly in periods of scientific controversy. Scientific evidence is
neither static nor consistent; there can be two pools of reasonable evidence on
either side of a medical controversy, and the minority position may well be
proven right. Reserving judgment for juries beyond the pleadings stage would
overestimate juries’ abilities to resolve highly technical scientific
controversies. Both consumers and retailers benefit from consistent
interpretation of consumer protection measures, and the Fourth Circuit has
articulated a workable standard for these various state law claims.

The argument unfolds in three parts. Part I surveys the
landscape of advertising laws, with heightened focus on the Lanham Act and
state consumer deception statutes. Supplement advertising should be treated as
a carve-out amidst this patchwork of laws, and I will argue that the Fourth
Circuit’s ruling, if appropriately limited, does no damage to the existing
doctrines. Part II offers a detailed description of the GNC case, both at the district and appellate court levels. This background
serves to illustrate why the unanimous GNC
judgment is an interesting solution to a difficult truth-in-advertising
question. Part III assesses the policy implications of the Fourth Circuit’s
decision. It begins by addressing criticism of the GNC ruling, which was presented in an Amicus Brief submitted by a
prominent group of law professors. It then responds to the criticism provided
in the Amicus Brief and counters with the merits of the Fourth Circuit’s
holding. The Conclusion reviews the argument and demonstrates why the analysis
presented is persuasive.

Part I: The Legal
Landscape of the Supplement Industry

A. Sources of
Truth-in-Advertising Law

There is a patchwork of federal,
state, regulatory, and common law sources of truth-in-advertising law, in
addition to industry-specific trade associations that advise dietary supplement
manufacturers and retailers. Both the FTC and FDA[18] can initiate their own
investigations into false advertising and labeling of dietary supplements. Their
overlapping jurisdiction and shared enforcement responsibilities are explained
further in Section I.B., infra. However,
since actual oversight by these bodies is notoriously constrained, consumers
and business competitors have often resorted to alternative forms of legal
redress. Companies may challenge claims made by their competitors under the
federal trademark law, Lanham Act § 43(a), discussed in Section I.C., infra.[19]
While the federal cause of action is not available to consumers, the Lanham Act
remains instructive in understanding state deception laws that are available to consumers.[20] The relationship between
the Lanham Act and state consumer protection laws is explored further in
Section I.D., infra. Lastly, the
dietary supplement industry finds guidance from self-regulatory associations:
the Council for Responsible Nutrition (CRN) is its primary trade association,[21] and the Better Business
Bureau’s National Advertising Division (NAD) offers alternative forms of
dispute resolution. [22]

B. The FTC-FDA
Regulatory Regime

Congress has entrusted matters of food, drug, and supplement
policing to both the FTC and FDA,[23] which have overlapping
jurisdiction and work together to ensure consistency in consumer products.[24] “In 1971, the agencies
issued a memorandum of understanding under which the FTC assumed primary
responsibility for advertising and the FDA assumed primary responsibility for
labeling of food, medical devices, and cosmetics.”[25] Advertising in the FTC’s domain
includes print and broadcast ads, infomercials, catalogs, and similar direct
marketing materials; labeling refers to the information panels on product
itself, such as the nutritional content and manufacturer address.[26]

There is an enormous disparity between what the law permits
and what the agencies enforce. Dietary supplements have posed a unique
challenge to the joint FTC-FDA working relationship. Neither food nor drug,
dietary supplements occupied a “liminal” regulatory category for much of the 20th
century.[27] By the 1990s, however,
Congress overrode attempts by the FDA to regulate supplements more extensively.
The resulting legislation paved the way for the modern explosion of supplement
products on the American market.[28]

1. FTC Regulation
of Supplement Advertising

The FTC is the federal consumer protection agency charged
with safeguarding consumers against “unfair and deceptive trade practices,”
under the authority granted to it in Section 5(a) of the Federal Trade Commission
Act. It uses two investigative methods to challenge advertising it finds to be
false: either compelling information from a potential defendant (for example, in
the form of a subpoena), or requesting voluntary cooperation (in the form of an
access letter). Notably, consumers do not enjoy the same authority in
compelling disclosure of a corporate advertiser’s studies.

The FTC has articulated its own standard for actionable
false advertising. The 1972 Pfizer
doctrine[29] is an unsubstantiated theory
of liability: no dissemination (of an ad claim) without prior substantiation. For
an advertisement to be substantiated, the advertiser must have had a
“reasonable basis” for its advertising claims before they are disseminated. For health or safety claims, which
include representations made in connection with dietary supplements, the
Commission has typically required a relatively high level of substantiation. In
such cases, the “reasonable basis” must be “competent and reliable scientific
evidence,” typically defined as “tests, analyses, research, studies, or other
evidence based upon the expertise of professionals in the relevant area, that
has been conducted and evaluated in an objective manner by persons qualified to
do so, using procedures generally accepted in the profession to yield accurate
and reliable results.”[30] The FTC reaffirmed this
standard in its Policy Statement Regarding Advertising Substantiation, and
there are numerous representative cases applying the doctrine.[31]

2. FDA Regulation
of Supplement Labeling

Unlike drugs, dietary supplements do not need FDA approval
before being legally marketed in the United States. Under the Dietary
Supplement Health and Education Act (“DSHEA”) of 1994,[32]
the FDA’s role in regulating the dietary supplement industry is constrained. Under
DSHEA, a supplement company is responsible for determining that its products
are safe and that any representations made are substantiated by adequate
evidence of their truthfulness. A company does not have to provide the FDA with
the evidence it relies on to substantiate safety and effectiveness unless
specifically requested. Instead, the FDA has relied on a disclosure theory of
consumer protection, requiring firms to identify the product as a dietary
supplement and include a “Supplement Facts” panel that identifies each
ingredient contained in the product.[33]

C. The Lanham Act

Congress enacted the Lanham Act (codified at 15 U.S.C. §§
1051-1127 (2012)) in 1946. It serves both as the federal trademark law and as a
primary source of truth-in-advertising regulation. Section 43(a) of the Lanham
Act provides that “any person who believes that he or she is or is likely to be
damaged” by a false or misleading description or representation of fact may
sue.[34] The Trademark Revision Act
of 1988 substantially broadened the scope of section 43(a) to cover a company’s
false representations about itself and others.[35]

Section 43(a) is the core legal protection for those injured
by false advertising. The Supreme Court has interpreted standing under section
43(a) to be limited to business competitors; consumers are excluded from filing
suits under the Lanham Act. In Lexmark
International, Inc. v. Static Components, Inc.
, the Supreme Court explained
that standing to sue for false advertising under the Lanham Act requires
pleading “injury to a commercial interest in sales or business reputation,” and
that injury must be “proximately caused by the defendant’s misrepresentations.”[36] The injury cognized by Lexmark is “unfair competition” through
false or misleading advertising, rather than consumer deception or confusion. Accordingly,
consumers’ interests do not fall within the “zone of interests” protected by
section 43(a)(1)(B).[37] As a result, plaintiffs in
these lawsuits are typically commercial competitors of the alleged false
advertiser.

Since remedy under the Lanham Act is unavailable to
non-competitors, consumers often rely on state consumer protection statutes to
bring cases against advertisers. Since these state statutes effectively police
the same mischief, federal common law remains instructive in understanding the
state law cause of actions.[38]

Section 43(a)(1)(B) establishes liability for two modes of
advertising: advertising that is false and advertising that is misleading. Actionable
representations include statements made about one’s own goods or services, as
well as the commercial disparagement of others. These two categories of
advertising, as well as the specific violations that they encompass, are next
considered.

1. Two Modes of False
Advertising

Courts are tasked with determining whether representations
are either false or misleading. Both incur liability under section 43(a), but
there are important doctrinal and pleading distinctions. The analysis begins
with five basic elements: (i) whether the alleged misrepresentation is false or
misleading, as opposed to non-actionable puffery,[39]
(ii) whether a plaintiff can demonstrate actual deception or capacity for
deception as a result of the falsehood, (iii) whether the falsehood or
misleading information is material to a consumer’s decision to buy,[40] (iv) whether a plaintiff
was harmed, either by direct diversion of its sales or by a lessening of the
goodwill associated with its products, and (v) whether the falsehood or
deception occurs in interstate commerce.[41] These
elements are conjunctive, and a plaintiff must meet all five to trigger
liability.

i. Literal Falsity

Literally false representations communicate one unambiguous
message, either verbally or visually, that is untrue or unsupported. These
representations violate the Lanham Act without proof of consumer deception;
instead, courts presume that the buying public has received the false message.[42] Consequently, plaintiffs in
these cases can avoid the time and expense of preparing consumer surveys
regarding the ad’s message. The burden of proof in falsity cases is on the
plaintiff, and falsity is assessed on the basis of scientific testing or
related types of extrinsic evidence.[43]

A classic example of a literally false representation comes
from Coca-Cola.[44]
In 1982, Tropicana featured athlete Bruce Jenner in a television commercial for
orange juice, squeezing juice out of an orange directly into a Tropicana carton
while saying, “[i]t’s pure, pasteurized juice as it comes from the orange.” In
fact, the juice was heated and, in some cases, frozen before packaging. Further,
the juice did not in fact come “pasteurized” straight from the orange. The
Second Circuit granted preliminary injunctive relief against the “blatantly
false” statement. The plaintiff did not have to make a showing that the
advertisement would mislead the consuming public.

ii. Literal
Falsity by Necessary Implication

A court may evaluate an advertisement for falsity even if
the representation is implied by context, rather than stated directly. This
category of false advertising is referred to as false by necessary implication.
Actionable advertisements of this type convey one unambiguous message. While
the message is conveyed implicitly, the meaning of the message is clear and
unequivocal. Ultimately, if the impression left on the viewer conflicts with
reality, it is effectively treated as if that false impression was directly
stated.

The Second Circuit embraced the false-by-necessary-implication
doctrine for the first time in Time
Warner Cable, Inc. v. DIRECTV, Inc.
[45]— a case which provides
an excellent illustration of this type of actionable falsity. A series of
DIRECTV commercials featured celebrities touting the merits of the satellite
service provider’s 1080i high definition (HD) transmission. A commercial from
the “Source Matters” campaign concluded with William Shatner stating that
“settling for cable would be illogical.” This statement was made in the context
of surrounding text (“amazing picture quality of […] DIRECTV HD”) and images (a
very clear DIRECTV picture and a far inferior picture from an anonymous second
provider, though cable was obviously targeted). Without extrinsic evidence, the
district court determined that Mr. Shatner’s assertion (“settling for cable
would be illogical”) “could only be understood as making the literally false
claim that DIRECTV HD is superior to cable HD in picture quality.”[46] In reality, however,
DIRECTV and cable HD’s picture quality were equivalent. The Second Circuit
upheld this ruling for Time Warner, concluding that the impression left on the
viewer conflicted with reality.[47]

2.
Misleading Advertising

The second category of actionable false advertising claims
are, while not literally false, deemed misleading to consumers. Such ads
contain representations of fact about a product or service that are ambiguous
or tend to deceive consumers. The statements may be literally true, and yet
have the tendency to mislead. The language of section 43(a) deems merely
misleading representations equally as objectionable as those that are literally
false, explicitly rendering unlawful a “false or misleading description of
fact, or false or misleading representation of fact.”

There are a number of important differences between false
and misleading advertising, even though both types of representations violate
section 43(a). Although the categories are doctrinally distinct, the
evidentiary differences are more significant in practice. Literal falsehoods —
those that are false on their face — are actionable without proof of consumer
deception, as in the Coca-Cola and DIRECTV cases previously considered. In
a case of misleading advertising, plaintiffs must present extrinsic evidence to
establish consumers’ perception of the implied falsehood.[48]
Such proof typically includes consumer surveys, direct consumer testimony, or
consumer comments received in the ordinary course of business.

In Vidal Sassoon, Inc.
v. Bristol-Myers Co.
,[49] the Second Circuit addressed literally false as well as misleading
claims. This case provides a clear example of the difference between literal
falsity and misleadingness. In a television commercial, a spokesperson states
that “in shampoo tests with over 900 women, Body on Tap got higher ratings than
Prell for body. Higher than Flex for conditioning. Higher than Sassoon for
strong, healthy looking hair.” The literally false claim is that the tests
involved over 900 women; in fact, only two-thirds of testers were actually
adult women. The claims regarding higher satisfaction were deemed misleading
based on a consumer survey assessing the message of the ad. Consumers surveyed
about the commercial said that they thought each tester had tried at least two
of the named products in order to compare their quality. Since this was not the
actual testing procedure, the court held that consumers were deceived by the
ad’s claims, and that the claims were actionable as misleading.

D. State Consumer
Protection Statutes

Every state has a consumer protection law that prohibits
deceptive practices.[50] Many of these statutes take the form
of a “little” FTC Act, incorporating the language of Section 5 of the statute
for which they are named.[51] These statutes provide the
basic protections for consumers engaging in thousands of transactions across
the United States, prohibiting “unfair methods of competition or unfair
deceptive trade practices” as well as “all forms of fraudulent, deceptive, and
unfair acts.” While many statutes track the federal guideline, they
nevertheless may vary in form and strength from state to state.[52] State attorneys general and
consumers may bring suits pursuant to these acts.

As mentioned infra,
the state consumer deception statutes at issue in GNC were interpreted in accordance with the great body of federal
common law surrounding false advertising and the Lanham Act. There remains a
significant difference in the standing requirements: in a Lanham Act lawsuit,
the plaintiff is typically a competitor; in putative consumer class action
lawsuits, representatives must allege that they were personally deceived to
have standing.[53] Despite these differences
in standing, the laws have been interpreted relatively congruously. The
mischief to be corrected, in both cases, is false advertising and unfair
competition. However, there is no requirement that each state’s consumer
deception law track the Lanham Act or federal case law.

Part II: The GNC Case and the Glucosamine-Chondroitin
Problem

A. Factual
Background

General Nutrition Corporation
(GNC), a national nutritional products retailer, has manufactured and sold a
line of joint health supplements[54] for
years. These products, which list glucosamine, chondroitin, and various other
compounds as the primary active ingredients, are marketed collectively under
the “TriFlex” brand. Although the products differ slightly in their total
combination of ingredients, they advertise similar claims[55]; essentially, the TriFlex
brand improves the health, comfort, and function of joints. The label for one
product, TriFlex Fast-Acting, included a ”[c]linically studied” establishment
claim: a “12-week multi-center, randomized, double-blind, placebo controlled
study of 60 adults [. . .] taking 250 mg/day of the GNC TriFlex Fast-Acting
Blend” proved that the product was “shown to improve joint comfort and
function,” in addition to promising 20% improvement in joint function and
25-30% improvement in joint flexibility.[56] GNC produced a similar line
of products for Rite Aid, which claimed to “promote joint health” and “help[. .
.] rebuild cartilage and lubricate joints.” In compliance with FDA guidelines,
all of the TriFlex and Rite Aid products included the disclaimer: “This
statement has not been evaluated by the Food and Drug Administration. This
product is not intended to diagnose, treat, cure, or prevent any disease.”

Beginning in March 2013, class action lawsuits against GNC
and Rite Aid popped up across the United States. Plaintiffs in California,
Illinois, Florida, New York, New Jersey, Pennsylvania, and Ohio alleged violations
of an array of state consumer protection, deceptive practices and/or express
warranty statutes in regard to the glucosamine-chondroitin products.[57] In December 2013, the
pending lawsuits were consolidated by the Judicial Panel on Multidistrict
Litigation and, pursuant to 28 U.S.C. § 1407, transferred to the U.S. District
Court for the District of Maryland.[58]

B. The Complaint

In the Consolidated Amended Complaint, Plaintiffs alleged
that the “overwhelming weight of high
quality, credible and reliable studies demonstrate that glucosamine and
chondroitin…do not provide joint health benefits” (emphasis added).[59] They stated that the
inefficacy of these supplements was “generally recognize[ed]” by the scientific
community.[60] In support of their
allegations, Plaintiffs cited to thirteen studies released between 2004 and
2013.[61] In the studies, researchers
concluded that (1) glucosamine and chondroitin did not reduce symptoms for
osteoarthritic users or chronic joint pain sufferers (who, Plaintiffs alleged,
were an appropriate proxy for non-arthritic users), and (2) MSM, another
compound found in the TriFlex products, did not provide pain or joint symptom
relief for osteoarthritic consumers. Notably, the Plaintiffs did not provide
any testing of GNC’s particular products or combination of ingredients. Instead,
they relied on the “vast weight of competent and reliable scientific evidence”
(i.e., the cited studies) to infer that the “ingredients in GNC’s TriFlex
Products do not work as represented” and that the “representations [were] false.”[62]

Defendants GNC and Rite Aid filed a Motion to Dismiss,[63] arguing that the studies
did not test the products (or specific combination of ingredients) at issue,[64] that no representations
were made with regard to improving osteoarthritis symptoms, and that
osteoarthritis patients were not an appropriate proxy for non-arthritic users,
among other deficiencies. Regarding the osteoarthritis issue, Defendants
specifically cited to the FDA disclaimer on all of the labels, which state that
the products are “not intended to diagnose, treat, cure, or prevent any
disease.”[65]

C. Decision
Granting Motion to Dismiss

In spite of Plaintiffs’ allegations, District Court Judge J.
Frederick Motz dismissed the Complaint with leave to amend. He found that Plaintiffs’
allegations regarding the “vast weight of scientific evidence” — in light of
GNC’s study to the contrary — could not support the single conclusion that the
claims are false.[66] Under the Twombly/Iqbal plausibility standard,
there was a “fatal flaw” in the allegations of the CAC: it did not allege that
“experts in the field” were prepared to testify that, on the basis of the
existing scientific evidence, any reasonable expert would conclude from the
cited studies that glucosamine and chondroitin are ineffective in non-arthritic
consumers.[67] The “mere existence of a
‘battle of the experts’” was not proof of falsity, but was rather to be
“expected.”[68] The following excerpt from
Judge Motz’s Memorandum Decision provides an important glimpse into the Court’s
reasoning:

“Disagreements between experts, even under the ‘reasonable
degree of scientific certainty’ standard, are to be expected. In my judgment,
however, the fact that one set of experts may disagree with the opinions
expressed by other qualified experts does not ipso facto establish any violation of the applicable consumer
protection laws. If there are experts who
support
what defendants say in their advertisements, the advertisements are
not false and misleading . . . unless the clinical trial relied upon by
defendants was itself false and/or deceptive.”[69]

In this passage, the Court referenced the “reasonable basis”
standard that marketers must adhere to when preparing advertising claims
(discussed later in Section III, supra). Stated briefly, if
scientific evidence points in different directions, the reasonable basis
standard will allow for inconsistent messaging. In a footnote to this excerpt,
the Court addressed whether this is a burden of proof issue and concluded that
it is not, based on the nature of the advertising claims in the case.[70] The Court contrasted the
example to a product liability case, in which plaintiff must establish that a
product is defective. There, Judge Motz said, it would be “entirely appropriate
for a jury to decide the defect issue” based on expert testimony that, to a
reasonable degree of scientific certainty, a product is defective.[71] This distinction is
enormously significant for procedural and substantive reasons, reserving for
juries their fact-finder role beyond false advertising cases.

By granting the Plaintiffs leave to amend their complaint,
Judge Motz offered Plaintiffs an opportunity to revive their claim for literal
falsity. He specifically instructed that Plaintiffs must plead that the
clinical trial relied on by GNC (1) did not exist at all, (2) exists but did
not support any of GNC’s representations about TriFlex, or (3) exists and
supports the assertions on TriFlex Fast-Acting’s bottle, but was not conducted
in an appropriately scientific manner.[72]
Only under such a pleading could the Court infer, on the face of the complaint,
that the products are ineffective as to non-arthritic users. Otherwise, if at
least one expert supported what GNC and Rite Aid said in their ads, the advertisements
could not be false.[73] Plaintiffs could only file
an amended complaint if they could do so in accordance with Fed. R. Civ. P. 11,
which requires sufficient due diligence to avoid sanctions.[74]
Absent such a pleading, Plaintiffs’ claim of falsity would not be facially
plausible.

Six days after the Motion to Dismiss was granted, GNC’s
counsel sent plaintiffs a letter contending that “qualified experts” support
the TriFlex and Rite Aid products’ claims.[75]
Plaintiffs rejected the opportunity to amend, and instead filed a motion for
reconsideration on the basis of the existing complaint.[76]
Judge Motz denied the motion and reiterated the rationale presented in the
Memorandum Decision. Regarding policy, he added one additional reason to his
earlier holding: It would be unfair to consumers who wish to gamble on
glucosamine and chondroitin if lay juries could effectively ban the sale (or
artificially raise its pricing) simply because evidence of their effectiveness
is inconclusive.[77] Plaintiffs appealed to the
Fourth Circuit.

D. Plaintiffs’
Appeal

After oral argument before a three-judge panel, the Fourth
Circuit unanimously affirmed the District Court’s decision in favor of GNC.[78] The Fourth Circuit
inexplicably held that “plaintiffs must allege that all reasonable experts in
the field agree that the representations are false.”[79]
In other words, a single expert in disagreement bars a statement from being
literally false. In the Court’s words:

“[I]n order to state a false advertising claim on a theory
that representations have been proven false, plaintiffs must allege that all
reasonable experts in the field agree that the representations are false. If
plaintiffs cannot do so because the scientific evidence is equivocal, they have
failed to plead that the representations based on this disputed scientific
evidence are false.”[80]

Under the Fourth Circuit’s test, “the question of falsity
hinges on the existence (or not) of scientific consensus.”[81]
Scientific experts may — and often do — disagree about the truthfulness of a
statement, but equivocalness is not falsity.[82]
Regarding Plaintiffs’ argument that a “battle of the experts” could not be
resolved on the pleadings, the Court retorted:

“When litigants concede that some reasonable and duly
qualified scientific experts agree with a scientific proposition, they cannot
also argue that the proposition is ‘literally false.’ Either the experts
supporting the Companies are unreasonable and unqualified (in which case, there
is no real battle of the experts to begin with) or they reflect a reasonable
difference of scientific opinion (in which case the challenged representations
cannot be said to be literally false).”[83]

Indeed, by characterizing the dispute as a “battle of the
experts,” the Court held that Plaintiffs (inadvertently) conceded that “a
reasonable difference of scientific opinion exists as to whether glucosamine
and chondroitin can provide the advertised joint health benefits.”[84] The Fourth Circuit also
responded to Plaintiffs’ concern that manufacturers might hide behind so-called
experts in proffering dubious marketing claims, relying on the Federal Rules of
Evidence to ensure relevant and reliable scientific testimony.[85]

Part III: Legal and
Policy Considerations

A. Law Professors’
Amicus Brief, with Rebuttal

After the Circuit Court handed down its GNC decision, sixteen prominent law professors submitted an Amicus
Brief for the Plaintiffs in support of rehearing.[86]
The Amici describe their interest in the case as “promoting truth in
advertising, which protects consumers and promotes fair competition.”[87] In the eight-page brief,
the law professors[88] supported Plaintiffs’
petition for rehearing and criticized the Fourth Circuit’s decision. The Amici
argued that the Fourth Circuit “erred when it disregarded binding precedent” to
produce a ruling with adverse procedural and substantive consequences. They
further argued that questions of falsity cannot be resolved on the pleadings;
instead, the fact finder (presumably a jury) should evaluate competing experts
and pools of scientific evidence to determine the truth of a claim.

The brief is problematic in numerous respects. Specifically,
the Amici (i) misstate the legal standards in falsity cases, (ii) misstate the
nature of “binding” precedent, (iii) mischaracterize the nature of scientific
evidence, and (iv) fail to appropriately consider the impact of the suggested
alternative on jury instructions. This Note argues that the Amicus Brief, as
well as the alternative outcome that Amici support, is a less persuasive answer
to the truth-in-advertising dilemma presented by the GNC case. Instead, the Amici’s criticism offers insight into the
utility and strengths of the Fourth
Circuit’s logic. This section presents the Amici’s arguments and responds to
points addressed in their brief.

1. Inaccurate
Legal Standards

The Amicus Brief begins with a “Summary of Argument” that
describes the purported standard in literal falsity cases: “Literal falsity is
about how an advertisement is received by
consumers
. The adjectives ‘literal,’ ‘explicit,’ and ‘implicit’ (and
falsity ‘by necessary implication’) describe consumer reaction to a message, which is either proved by evidence such as surveys or
presumed as a matter of law.”[89] The italicized portions of
this excerpt are problematic and, pun intended, literally false. First, literal
and explicit claims are not assessed on the basis of consumer perception;
rather they are accepted as literal messages. Second, literal and explicit
claims are evaluated based on underlying substantiation, such as scientific
testing, regardless of the message received by consumers. These important
doctrinal and evidentiary distinctions are reviewed in Section I and, briefly,
below.

As mentioned in Part I, infra,
two modes of advertising are liable under Section 43(a): advertising that is
false, and advertising that is misleading. Within the umbrella of false
advertising, courts have generally recognized two types of falsity: (i)
advertising that is literally false (based on a clear and explicit
misrepresentation of fact), and (ii) advertising that is false by necessary
implication (based on a claim that, considered in context, necessarily and
unambiguously implies a message). Neither case requires surveys or other proof
of consumer deception. Amici’s emphasis on “consumer reaction to a message” and
“surveys” is misplaced, as both of those issues are irrelevant to a finding of
literal falsity.

Amici then describe an example of a potentially misleading
representation: “Vitamin B7 can remedy hair loss.” Since implied messages can
convey multiple messages to the buying public, evidence of consumer confusion
is required to determine which message consumers are receiving. While a
discussion of misleading advertising can be helpful for comparison purposes, it
is not relevant in the GNC case. First,
the TriFlex claims at issue are literal and explicit: for example, “promotes
joint mobility and flexibility” and “protects joints from wear and tear of
exercise.” Second, there was no survey evidence of the messaging received by consumers,
which would be required to sustain a cause of action for misleading
representations.[90]

There are subsequent discussions regarding advertising that
is false by necessary implication.[91]
While actionable, this mode of deception is also irrelevant to the GNC case. The claims at issue on the
TriFlex label are clear and explicit. Advertisements that are false by
necessary implication do not involve an explicit statement of fact, but rather
an unambiguous assumption that follows from a claim. Consider a comparison to
the claims at issue in DIRECTV v. Time
Warner Cable
, discussed in Part I.C.,
infra. In that case, the court
considered other words and images within the context of the statement that
“settling for cable would be illogical;” the necessary implication was that
settling for cable would be illogical because DIRECTV offers superior picture
quality (it did not). The clear and explicit TriFlex claims simply do not fit
into this category of consumer deception.

2. Misstatement of
Precedent

The Amicus Brief continues with a citation to “binding
precedent,” namely C.B. Fleet Co. v.
SmithKline Beecham Consumer Healthcare, L.P.
, which the Fourth Circuit
courts allegedly “disregarded” in dismissing the GNC case. In the opening paragraph of the Amicus Brief’s “Argument,”
Amici state: “This Court has repeatedly
held
that both inquiries involve questions of fact. C.B. Fleet Co. v. SmithKline Beecham Consumer Healthcare, L.P., 131
F.3d 430, 434 (4th Cir. 1997) (“Whether an advertisement is literally false is
an issue of fact.”).” This is both a mischaracterization of the holding as well
as the case’s precedential value.

Amici appropriately classify C.B. Fleet as a literal falsity case.[92]
At issue were “improved design” and “comparative superiority” claims for SmithKline’s
new model of a feminine hygiene product. The Amici presumably provide this
quotation in support of the alternative outcome they propose: factual disputes,
such as a battle of the experts, should be reserved for juries. However, this
proposition is conceptually distinct from the “issue of fact” identified by the
C.B. Fleet Court. In C.B. Fleet, the Fourth Circuit was
reviewing the district court’s determinations of falsity on appeal; the quote
provided by Amici stands for the proposition that district courts, in their
fact-finding role, are given deference in reaching such conclusions.[93] Furthermore, there is a
citation following the C.B. Fleet
reference — omitted without acknowledgment in the Amicus Brief — to L&F Prods. v. Procter & Gamble Co.,
45 F.3d 709, 712 (2d Cir. 1995). That underlying authority from L&F Products states as follows: “The
district court’s determination with respect to facial falsity is a finding of
fact which we review for clear error.”[94]
In both C.B. Fleet and L&F Products, the “issue of fact” is
raised with respect to the deference due to district courts, rather than
juries’ roles in resolving factual disputes.

In fact, the definition of falsity in C.B. Fleet does not conflict with the determination made in GNC. However, there remains a crucial
factual difference between the cases. As the GNC Court noted, plaintiffs were given leave to amend the
Consolidated Amended Complaint to plead that GNC’s study (1) did not exist at
all, (2) existed but did not support any of GNC’s representations about
TriFlex, or (3) existed and supported the assertions on TriFlex Fast-Acting’s
bottle, but was not conducted in an appropriately scientific manner. The Court
specifically instructed that plaintiffs could not rely on the “vast weight of
the evidence” to prove falsity. In C.B.
Fleet
, plaintiff met this burden, challenging the scientific reliability of
SmithKline’s testing procedures. In GNC,
by contrast, plaintiffs twice relied on the “weight of the evidence” without
attacking GNC’s testing – even after a second bite at the apple.

Although the Amici state that the Fourth Circuit has
“repeatedly held that [the falsity inquiry] involve[s] questions of fact,” only
C.B. Fleet is offered as support. One
might reasonably expect a string cite supporting such an assertion. While the
Fourth Circuit cemented a new rule for the meaning of literal falsity in
supplement cases, its definition is hardly inconsistent with “binding” and
“disregarded” precedent. In fact, the issue presented in GNC was a matter of first impression before the Court. While Amici’s
proposal is a permissible solution to the GNC
question, it is neither required by precedent nor, as this Note argues,
able to achieve a better outcome on policy grounds. The Fourth Circuit’s ruling
is a novel but befitting solution to truth-in-advertising questions in the
dietary supplement industry.

3. The Nature of
Scientific Evidence

The most persuasive portion of the Amicus Brief comes in the
form of a hypothetical regarding the medical cause of ulcers. Amici present the
following scenario: In 1910, a doctor would have said that stress and diet
caused stomach ulcers, and that bacteria did not. We now know that this is
untrue; the bacterium H. pylori — not
stress and diet — causes many stomach ulcers. [95]
The Amici use this illustration to argue that, despite expert support for a
claim, it may be false. The fear is that corporate defendants may insulate
themselves from lawsuits by hiding behind one unreliable study. This illustration
lends support to Amici’s claim that experts are not infallible, and perhaps
that juries serve as a valuable check on expert elitism.

Understood another way, the ulcer hypothesis could be
marshaled in support of the Fourth Circuit’s ruling. Indeed, scientific
knowledge is always a work in progress, and our understanding of medical issues
is constantly evolving in the face of new research and methodology. Consider an
alternative analysis of the ulcer illustration. In 1910, the majority of
doctors, based on our understanding of ulcers at the time, would have said that
the claim that bacteria cause ulcers is literally false. In the decades that
followed, medical explanation for ulcers changed in light of evolving research.
By 1950, the weight of scientific evidence would indicate that bacteria do, in
fact, cause ulcers. Today, it is scientific truth that H. pylori is the culprit behind stomach ulcers — a proposition that
would have been literally false in 1910 if the “vast weight of scientific
evidence” set the standard in falsity cases.

The point is that the minority opinion in a scientific
debate may turn out to be correct. The GNC
holding corrects for the mistaken understanding that a minority position is
wrong simply because it is not supported by a majority of scientists at that
time. In a 1910 jury trial, the jury would likely — and incorrectly — have
discounted the minority position because it would not meet the preponderance of
the evidence standard. Then, the question becomes, why should we let a jury
decide such matters? In the ulcer case, how and why would a jury have reached a
better result?

The Fourth Circuit recognized a key difference between
claims that, in light of the existing scientific evidence, are inherently
false, as opposed to claims that are reasonably debatable. The GNC standard is most receptive to the
changing nature of scientific evidence and techniques. Until consensus among
duly qualified and reasonable experts emerges around the veracity of a claim,
it would simply be premature to rule out the minority opinion as false. The
ulcer anecdote, perhaps inadvertently, stands for this proposition.

Amici would likely retort that the GNC rule too easily insulates corporate advertisers, hiding behind
a single study, in literal falsity cases. However, as the GNC Court noted, plaintiffs remain protected due to the rules of
evidence and by alternative causes of action. As Judge Floyd explained,
“Plaintiffs remain protected from dubious experts by the Federal Rules of
Evidence, which ‘ensure that any and all scientific testimony…is not only
relevant, but reliable.’” The importance of relevant and reliable scientific
testing cannot be overstated, since plaintiff must prove that no reasonable
scientific expert could find merit in the advertiser’s claims. The Fourth
Circuit is careful to rule out quackery as a source of substantiation. If no reasonable study exists in support of a
proposition, then the plaintiff meets their burden of proof in literal falsity
cases. Additionally, Judge Floyd noted that “[p]laintiffs who cannot meet the
burden of proving literal falsity may avail themselves of a claim regarding
misleading representations.” This is helpful to plaintiffs who cannot or do not
challenge the scientific legitimacy of a claim, but consider the messaging to
consumers to be deceptive. Plaintiffs may then rely on survey evidence to
establish consumer deception or confusion regarding an ad claim.

4. Jury
Instructions

Finally, a crucial issue is not addressed in the Amicus Brief,
but is relevant to the alternative outcome that Amici support: if the GNC case were assigned to a jury, what
would the jury instructions look like? Juries undeniably serve an important
fact-finding role in courtrooms across the United States, but play no part in
the GNC story. Amici aptly draw
attention to this procedural predicament, but serious questions remain if a
panel of jurors would have reached a better outcome in the glucosamine case.

GNC is
procedurally significant because the Court ruled, on a motion to dismiss, that
a literal falsity case could be resolved on the pleadings. The Fourth Circuit
articulated a very specific pleading standard with respect to plausibility in
falsity cases. To recall, future plaintiffs must allege that no reasonable
study (or scientist) exists or supports the challenged advertising claims;
reliance on the so-called “vast weight of evidence” is insufficient to survive
a motion to dismiss. In so ruling, the Fourth Circuit held that a jury would
not resolve conflicting disagreements among experts.

One could say, as Plaintiffs argued, that a battle of
opinions among qualified and competent experts creates a genuine issue of
material fact, and that juries can handle highly technical scientific evidence.
The involvement of juries seems even more urgent when considering the resource
limitations of the FTC and FDA. GNC’s
resolution at the plausibility stage usurped the jury of its central province,[96] and corporate defendants
can more easily evade liability from the FTC, FDA, and courts alike.

While plaintiffs’ argument prevails in principle, it has
less purchase in practice. When there is reasonable evidence on both sides of a
scientific controversy, why should six jurors decide if a product cannot be
sold or advertised? Reserving judgment for juries beyond the pleadings stage
would overestimate juries’ abilities to resolve highly technical scientific
controversies. However, if plaintiffs plead issues related to the credibility
or reliability of the defendant’s studies (which the GNC plaintiffs did not), a jury’s intervention seems far more
befitting. In such case, if the evidence on one side is unreliable, there is no
“battle of the experts” to begin with, and we can trust juries to side with the
(only) party bearing substantiation. GNC preserves
this crucial distinction beyond the pleadings stage.

Lastly, the GNC holding
should be cabined to the dietary supplement area. Judges, academics (including
Amici), and others would likely agree with this assertion. The GNC ruling does not rob the jury of its
fact-finder role in cases involving product liability, wrongful death, and
related matters. The District Court specifically addressed this concern,
distinguishing the question in GNC from
other burden of proof issues. In the words of Judge Motz:

“I have considered whether the issue is one of burden of
proof, and I have concluded that it is not. Rather, the basis of my holding
lies in the nature of the claims asserted by plaintiffs that rely upon the
falsity, deceptiveness, or unfairness of defendants’ advertisements. In
contrast, for example, in a product liability case in which a plaintiff must establish
that a product is defective, it would be entirely appropriate for the jury to
decide the defect on the basis of expert testimony that, to a reasonable degree
of scientific certainty, a product is defective.”[97]

As is evident in the Court’s language, the decision is meant
to be narrowly construed, and this message appears to have been received by
other courts. As of February 2018, the GNC
holding has not been applied outside of advertising cases.

B. Additional Merits of the Fourth Circuit’s Decision

There is useful criticism of the GNC ruling from Amici and others.[98]
On the one hand, the GNC ruling seems
like a massive victory for corporate defendants — and a massive loss for
consumer plaintiffs — on both substantive and procedural grounds. GNC arguably imposes a high hurdle on
consumer plaintiffs in literal falsity cases; without alleging perfect
scientific consensus or attacking defendant’s study, plaintiff’s case can no
longer survive a motion to dismiss. But this is only part of the story.

Prior to the GNC decision,
the question of what constituted false advertising during a period of
scientific controversy was unanswered by the case law. Despite the prevailing
criticism, the Fourth Circuit’s position is a persuasive solution to a
previously unresolved legal dilemma. The arguments that follow address the
policy merits of the GNC standard for
literal falsity in supplement cases. Specifically, this Section argues that (i)
the Fourth Circuit’s standard fits neatly into the patchwork of pre-existing
consumer protection measures, namely those of the FTC and FDA, (ii) the
decision promotes fair competition and preserves consumer choice, and (iii) the
res judicata effect in these cases is limited, preserving opportunities for
future plaintiffs to take a bite at the proverbial apple as scientific
knowledge evolves.

1. FTC, FDA, and Fourth
Circuit Parity

The falsity standard articulated in GNC is consistent with other consumer protection measures, namely,
the FTC and FDA’s approaches to truth-in-advertising. The Fourth Circuit’s
holding reflects the policy rationales underlying the FTC’s prior
substantiation doctrine and the FDA’s
disclosure regime. Both agencies, which are most directly involved in
regulating consumer communications about supplements, would not take issue with
the TriFlex ads.

Under the FTC’s advertising standards, the TriFlex claims
are truthfully advertised. The FTC’s prior substantiation rule, discussed in
Section I.B., states that an advertiser must have a “reasonable basis” for making
objective claims and must “possess substantiation, prior to running the ad, for
affirmative product claims.”[99] GNC cited to a particular
study in its possession on the bottle of one of the TriFlex products. Plaintiffs
nowhere alleged that GNC did not have a reasonable basis for making the joint
health improvement claims; they failed to allege this deficiency even after the
District Court granted them leave to amend their complaint. While the FTC has
investigated other glucosamine-chondroitin products, the author has no
information indicating that the FTC acted (or would need to act) with respect
to the TriFlex claims.

GNC was also compliant with the FDA’s supplement labeling
requirements, since each TriFlex label included the ingredients in each bottle,
the standard disclaimer, and other required information. In broader
perspective, the Fourth Circuit’s ruling is consistent with the FDA’s position
on supplement labeling and advertising. Consider the evolution of the FDA’s
approach to regulating the supplement industry. The 1906 Federal Food and Drugs
Act used the label as a tool to empower consumers to have a much better
conception of what they were putting into their bodies. In the 1930s, the FDA
confronted the question of allowable representations in the face of scientific
uncertainty, further extending the “informative labeling” approach:
representations could be made, even if not reflective of the consensus of
scientific opinion, as long as there was reliable scientific basis behind them.
In such cases, the statements would have to be qualified with a disclaimer that
reliable scientific opinion differed on such claims.[100]
The goal was to preserve freedom of consumer choice, with the agency’s primary
concern being the safety of the products. The Fourth Circuit’s ruling follows
the hands-off approach that the FDA has taken towards safe and properly labeled
dietary supplements.

Sources of truth-in-advertising law are too numerous to
recount here, but the Fourth Circuit’s position achieves congruity across axes.
Both the District Court and the Fourth Circuit interpreted the state consumer
protection laws similarly; the fact that the laws come from different states is
a distinction without a difference.[101]
The overall objective of these statutes remains the same: protecting consumers
from false and misleading advertising. It seems reasonable that a federal court
seeking guidance on false advertising issues would look to the Lanham Act on
regulating advertising and consumer communications. In view of these considerations,
an ad that is false under the Lanham Act should likewise be deemed false under
a state consumer deception statute. Furthermore, both industry and consumers
benefit from consistent interpretations of state consumer protection statutes,
which provide adequate notice to both parties about pleading requirements and
possible defenses.

2. Fair
Competition and Consumer Choice

Over the last decade, dozens of false advertising lawsuits
have been brought against purveyors of glucosamine-chondroitin. The claims
typically reflect the conventional wisdom about improving joint health and
flexibility, just as GNC’s TriFlex did. These cases across the United States
are undoubtedly expensive for advertisers to defend. Ultimately, the price is
borne by the consumer who continues to “gamble” on glucosamine because, in her
subjective opinion, it works. Both GNC decisions
consider this economic dimension, limiting litigation beyond the motion to
dismiss stage for cases in which there are two legitimate medical understandings
of a supplement’s efficacy. Furthermore, from a policy perspective, it seems
unadvisable to “put out of business” an approach for which there is a sound
medical view.

As Judge Motz aptly noted in his Memorandum Decision, “It is
unfair to consumers who wish to gamble that glucosamine and chondroitin may be
effective if lay juries can effectively ban the sale of glucosamine and
chondroitin simply because the evidence of their effectiveness is
inconclusive.” Satisfied consumers are free to purchase the products, and
dissatisfied consumers are, of course, free to seek alternatives. Unlike drugs,
which operate under completely different advertising standards, consumers are
not required to take supplements. The perspective of jurors adds no value to
this highly individual decision. The Court continued: “After all, damage awards
and even the cost of defending against high stakes litigation has the effect of
increasing the cost of glucosamine/chondroitin pills or, potentially, driving
the pills from the market. Should those who choose to purchase the pills have
to pay more for them (or be deprived of the opportunity to purchase them at
all) when the science is uncertain merely because juries disagree with their
own judgment about the pills’ efficacy?”[102]

In addition to preserving consumer choice, the GNC ruling respects that whether the
supplements work is an enormously subjective inquiry. In another case involving
glucosamine-chondroitin products, the court neatly summarized the dilemma:

“The health and comfort of joints is probably influenced by a
number of variables. Did [plaintiff] keep all of them constant, adjust for ones
that can’t be kept constant (like aging), and then somehow have her cartilage
and joints examined? Did she keep precise records of how much [glucosamine-chondroitin] she took, why she took it, and just how long she took it for? Can she document
what her physical condition was before and after she took
[glucosamine-chondroitin]? Probably not. What’s more likely is that she took
[glucosamine-chondroitin] casually and just didn’t feel much better, but that
makes her own claims just as speculative as she alleges [the supplement’s] benefits are.”[103]

We could, as Amici argue, send these cases to juries and let
them decide if the minority view does not hold water. But should we? The Court
asked and answered this very question, stating: juries serve as “a proper check
on expert elitism. However, in this case the question is not whether the views
of jurors should prevail over the views of asserted experts and judges. Rather
the question is whether the views of jurors should prevail over the views of
those who choose to purchase glucosamine/chondroitin pills. What is
‘democratic’ in one instance may be tyrannical in another. . . .”[104]

Finally, there is a hidden narrative beneath these lawsuits.
At first glance, it may seem that consumers are fired up about wasting money on
useless products. However, a closer look at the court dockets suggests an
alternative story: many of the glucosamine-chondroitin lawsuits seem to be
brought by the same lawyers, not consumers. Bonnett, Fairbourn and Denlea & Carton have been
heavily involved in various glucosamine-chondroitin product lawsuits. The
results have been lucrative for law firms. In the Plaintiffs’ Memorandum
supporting its Motion for Reconsideration, counsel noted “at least three
nationwide settlements against manufacturers of similar joint relief
supplements are in various stages of review.”[105]
Should law firms be able to line their pockets from consumers’ purses? The FDA,
FTC, state attorneys general, and corporate competitors are better safeguards
of truth-in-advertising than plaintiffs’ firms would care to admit.

3. Res Judicata
Effects

Critics of the GNC ruling
may rest assured that claim preclusion in false advertising cases is limited to
the named plaintiff(s). The res judicata effect does not bind anyone to the
result aside from the person or persons who brought the suit. If a party sued
GNC for its TriFlex claims in Texas today, nothing is settled, and the court is
well within its discretion to hear the case. It is particularly important to
preserve these opportunities for litigation as scientific knowledge evolves and
the conventional wisdom shifts.

On the other hand, the limits of the res judicata effects in
these cases reveal a troubling pattern. As mentioned previously, there have
been dozens of lawsuits across the United States involving
glucosamine-chondroitin supplements, many of which were brought within the last
ten years. These cases, which have not utilized the GNC pleading standard, have resulted in disparate verdicts and
settlements. For example, the glucosamine-chondroitin cases in California have
come out all over the place: it is entirely possible that a Los Angeles jury
would find the claims to be truthful, and a jury in San Francisco would deem
them falsely advertised. As a result, glucosamine products may bear dissimilar
advertising claims depending solely on the location where the product is
purchased. This result seems arbitrary and premature, given the conflicting
scientific evidence on the claims at issue.

Conclusion

During periods of scientific
controversy, how should advertisers, regulators, and courts address
truth-in-advertising dilemmas? As the GNC
case has shown, this is a complex and interesting issue that is worth
examining. The Fourth Circuit’s answer to this question is a fair and
reasonable standard, relying on expert consensus to establish literal falsity. While
respected academics and courts have greeted the Fourth Circuit’s ruling with
caution, advertisers and consumers may be more satisfied with its outcome. Corporate
defendants are once again reminded of the prior substantiation requirement in
articulating advertising claims and can, with assurance, hang their hats on
reasonable scientific testing. Consumers enjoy the continued availability of
supplements that, in their subjective opinions, provide symptom relief –
without paying for the extra costs associated with consumer class actions. Consumer
plaintiffs are also given clear guidance on surviving a motion to dismiss, as
the Fourth Circuit neatly articulated the pleading requirements in alleging
literal falsity.

The novelty and significance of
the GNC decision are only beginning
to be understood, but it offers compelling policy advantages to proposed
alternatives. The Fourth Circuit’s ruling fits into the preexisting patchwork
of consumer protection measures, announcing similar principles to the FTC’s
substantiation theory and the FDA’s disclosure theory of liability. The solution
is well suited to the nature of scientific evidence, which is continually
changing in response to new research and technology. It is hard to argue that,
if qualified scientists disagree about the efficacy of a dietary supplement,
lay juries would achieve a better outcome in determining truth from falsity. Elevating
the opinions of six jurors over experts and consumers does not provide any more
certainty in arriving at the truthful result.

Questions remain about what
impact, if any, the GNC decision should
have on false advertising law. The author hopes that this unanimous decision by
a panel of respected appellate judges will receive thoughtful consideration. In
broader perspective, the standard does no damage to the existing falsity
doctrines, and can be carefully confined to the dietary supplement space. The
new standard articulated in GNC may
seem like a big pill to swallow, but it is an effective remedy to the
truth-in-advertising question that plagued the dietary supplementary industry.


*J.D. Candidate, New York University School of Law, 2018; B.A., Political Science, Columbia University, 2011. The author would like to thank Kenneth A. Plevan for his guidance and support, as well as the invitation to explore this research topic. She thanks Professor Barton Beebe, her faculty advisor, for his edits and insights, and her fellow JIPEL Notes Program participants: Julian Pymento, Ryan Jin, Vincent Honrubia, and Neil Yap.

[1] National
Institutes of Health, Dietary
Supplements: What You Need To Know
, U.S.
Dep’t of Health & Hum. Servs.
(June 17, 2011), https://ods.od.nih.gov/HealthInformation/DS_WhatYouNeedToKnow.aspx.

[2] See National Institutes of Health, Multivitamin/mineral Supplements: Fact Sheet
for Health Professionals
, U.S. Dep’t of Health & Hum. Servs. (July 8, 2015), https://ods.od.nih.gov/factsheets/MVMS-HealthProfessional/ (“In 2014, sales of all dietary supplements in
the United States totaled an estimated $36.7 billion.”).

[3] See Brown v. GNC Corp. (In re GNC Corp.), 789 F.3d 505 (4th Cir.
2015), reh’g denied Ct. Order Den.
Mot. for Reh’g and Reh’g En Banc (July 27, 2015), ECF No. 47.

[4] There
is a well-publicized association between glucosamine-chondroitin and joint
health. An article on WebMD states that the natural glucosamine in our bodies
“helps keep up the health of your cartilage – the rubbery tissue that cushions
bones at your joints.” As we age, levels of the natural compound begin to drop,
which leads to the gradual breakdown of the joint. WebMD reports that there is
“some evidence” that glucosamine sulfate supplements help counteract this
problem, though experts “aren’t sure how.” There are a plethora of glucosamine
supplements advertising joint health benefits, such as Osteo Bi-flex and
Nature’s Bounty glucosamine-chondroitin compound. The widespread use of
glucosamine-chondroitin has even reached our pets, with supermarket giant
Trader Joe’s and others proffering a line of the supplement for dogs. Is Glucosamine Good for Joint Pain?, WebMD (Jan. 17, 2018), https://www.webmd.com/vitamins-and-supplements/supplement-guide-glucosamine.

[5] The
glucosamine-chondroitin lawsuits are too numerous to list here, but are
discussed later in Section III.B. See,
e.g.
, Lerma v. Schiff Nutrition Int’l, Inc., No. 11-cv-1056 (S.D. Cal.
filed May 13, 2011); Padilla v. Costco Wholesale Corp., No. 11-C-7686 (N.D. Ill.
filed Oct. 28, 2011); Quinn v. Walgreen Co., No. 12-cv-8187 (S.D.N.Y. filed
Nov. 9, 2012). According to
TruthInAdvertising.org, at least nine class action lawsuits had been filed by
October 2013 claiming that companies were falsely marketing the health benefits
of glucosamine supplements. Consumers
Claim This Joint Is Not Jumping
, Truth
in Advertising Organization
(Oct. 22, 2013), https://www.truthinadvertising.org/consumers-claim-joint-jumping/. Some of the lawsuits have resulted in
settlements. See, e.g., McCrary v.
The Elations Company, LLC, No. 13-cv-00242 (C.D. Cal. filed Feb. 07, 2013);
Pearson v. NBTY, Inc., No. 1:11-cv-07972 (N.D. Ill. filed Nov. 09, 2011). Additionally,
there is no indication that these lawsuits will stop being filed. As of
December 2017, glucosamine-chondroitin is still a hot topic in false
advertising. According to a consumer class action blog, plaintiffs’ firms have
commenced investigations into Osteo Bi-flex, Schiff Move Free and Glucosamine,
Walmart’s Spring Valley Glucosamine, and Nature Made Triple Flex, among others.
Tracy Colman, Different Brands of
Glucosamine Chondroitin May Be Falsely Advertised
, Top Class Actions (Dec. 21, 2017), https://topclassactions.com/lawsuit-settlements/lawsuit-news/828289-different-brands-of-glucosamine-chondroitin-may-be-falsely-advertised/.

[6] It is
the author’s suggestion that the facts of these cases offer support for the
latter. Section III.B. offers commentary on this aspect of the glucosamine
lawsuits.

[7] Procedurally,
these cases are as complex and interesting as the ruling itself. Ultimately,
according to the Fourth Circuit’s order, there were five GNC plaintiffs
(Howard, Toback, Lerma, Calvert, and Gaatz) and three Rite Aid plaintiffs
(Flowers, George, and Gross). GNC,
789 F.3d at 509 n.1. The underlying lawsuits were consolidated in the U.S.
District Court for the District of Maryland. The consolidated cases are
docketed as: Howard v. GNC Corp., No. 14-cv-00002 (D. Md. filed Jan. 3, 2014);
Toback v. GNC Holdings, Inc., No. 14-cv-00122 (D. Md. filed Jan. 14, 2014);
Lerma v. GNC Corp., No. 14-cv-00120 (D. Md. filed Apr. 18, 2013); Calvert v.
GNC Corp., No. 14-cv-00123 (D. Md. filed Jan. 16, 2014). The Rite Aid product
case was Flowers v. Rite Aid, No. 14-cv-00465 (D. Md. filed Feb. 18, 2014). Flowers was effectively a lawsuit
against GNC, as the products at issue were manufactured for Rite Aid by GNC,
and GNC was contractually obligated to indemnify Rite Aid for the claims at
issue in the litigation. Consolidated Amended Complaint at ∂ 2, In re GNC Corp.
Triflex Prods. Mktg. & Sales Practices Litig. (No. II), No. 14-2491, 2014
U.S. Dist. LEXIS 84184 (D. Md. June 20, 2014), ECF No.20. To the best of the
author’s knowledge, GNC did not contest this assertion. There are multiple
related lawsuits that were resolved separately, such as Galvin v. GNC, No.
14-cv-00810 (D. Md. filed Mar. 21, 2014). Although Brown v. GNC Corp., No.
13-05890 (N.D. Cal. filed Dec. 19, 2013), was also transferred to the district
court by the Multidistrict Litigation Panel, the Consolidated Amended Complaint
does not include Yvonne Brown (the plaintiff in that action) among the named
plaintiffs. GNC, 789 F.3d at 509 n.2.
Galvin was voluntarily dismissed in October 2015, and therefore did not proceed
with the other consolidated cases.

[8] Warren
Teichner & Megan Lesko, Cashing in on
the booming market for dietary supplements
, McKinsey
& Company Marketing & Sales Insights
(Dec. 2013), https://www.mckinsey.com/business-functions/marketing-and-sales/our-insights/cashing-in-on-the-booming-market-for-dietary-supplements.

[9] Council
for Responsible Nutrition, The Dietary
Supplement Consumer
: 2015 CRN
Consumer Survey on Dietary Supplements
, CRN
USA
(2015), http://www.crnusa.org/CRNconsumersurvey/2015/.

[10] Country
Report: Vitamins in the US,
Euromonitor
International (Nov. 2017),
http://www.euromonitor.com/vitamins-and-dietary-supplements-in-the-us/report.
This insight into the brutally competitive landscape offers some explanation
for GNC’s insistence on keeping its joint health tag line. Marketing and
advertising claims, such as “promotes joint health,” are valued shortcuts for
consumers as they navigate supplement shelves. The alternative is a sea of
supplements that are labeled and identified solely by their active
ingredient(s), like a bottle that simply reads “Vitamin D” or
“Glucosamine-Chondroitin” on the front, without further description of health
benefits. A consumer who is unfamiliar with glucosamine-chondroitin may not buy
the product, were it not for the “promotes joint health” byline. The
explanation provides quick information and incentive to buy.

[11] See
National Institutes of Health, supra
note 2.

[12] FDA 101: Dietary Supplements, U.S. Food & Drug Admin. (Nov. 6,
2017), http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm050803.htm.

[13] Id.

[14] See
National Institutes of Health, supra
2.

[15] For more
information about the FDA and FTC’s roles in policing supplement labeling and
advertising, see Section I.B., infra.

[16] Kenneth
A. Plevan, Recent Trends in the Use of
Surveys in Advertising and Consumer Deception Disputes
, 15 Chi.-Kent J. Intell. Prop. 49, 61 (2016)
(commenting on the “recent explosion of consumer deception lawsuits brought as
putative class actions, filed by private plaintiffs under state consumer
protection laws . . .”); see also
Theodore V.H. Mayer, Recent Developments
and Current Trends in United States Class Action Law
, 826 PLI/Lit 313, 325
(May 24, 2010) (citing Federal Judicial Center, The Impact of the Class Action Fairness Act of 2005 on the Federal Courts 4 (4th interim
report, 2008)) (“Among the most remarkable trends from the period between 2001
and 2007 [was] . . . the continuing growth of consumer-protection or
consumer-fraud class actions, which increased by more than 150 percent and now
account for 20 percent of all federal class actions.”) Private plaintiffs have
increasingly availed themselves of consumer protection statutes. According to
one study of over 17,000 reported federal district and state appellate
decisions, “[b]etween 2000 and 2007 the number of [consumer protection act] decisions reported in federal district and state appellate courts increased by
119%. This large increase in CPA litigation far exceeds increases in tort
litigation as well as overall litigation during the same period.” See Searle Civil Justice Institute, State Consumer Protection Acts: An Empirical
Investigation of Private Litigation Preliminary Report
(Dec. 2009). An
additional concern is the “double litigation” frontier: “There is nothing to
prevent a private litigant from filing suit against a consumer product
advertiser or manufacturer after a federal regulatory agency, such as the
Federal Trade Commission, takes action against the same company and obtains
full monetary redress for consumers.” Dana Rosenfeld & Daniel Blynn, The “Prior Substantiation” Doctrine: An
Important Check On the Piggyback Class Action
, 26 Antitrust 1, 68 (Fall 2011). Rosenfeld and Blynn state that
there is an emerging trend of plaintiffs filing class action complaints that
are “virtually identical to or rely heavily upon” FTC complaints or FDA warning
letters. Id.

[17] Brown v.
GNC Corp. (In re GNC Corp.), 789 F.3d 505, 515 (4th Cir. 2015).

[18] Plaintiffs
may seek redress from the Federal Trade Commission under the FTC Act, 15 U.S.C.
§§ 41-58. Barton Beebe, Trademark Law: An
Open-Source Casebook
, Part IV, 2 (Jul. 20, 2017), http://tmcasebook.org/wp-content/uploads/2017/08/BeebeTMLaw-4.0-Introduction.pdf.

[19]
Lanham Act § 43(a)(1)(B) is codified at 15 U.S.C. § 1125(a)(1)(B).

[20] The
state consumer deception statutes are also known as “little” or “baby” FTC Acts.
See Beebe, supra note 18.

[21] Denise
E. DeLorme, Jisu Huh, Leonard N. Reid & Soontae An, Dietary supplement advertising in the US: A review and research agenda,
31 Int’l J. of Advert. 547, 555
(2012).

[22] See Beebe, supra note 18. See also Joshua M. Dalton & Jared A.
Craft, What You Should Know About NAD
False Advertising Claims
, Law360
(Jan. 4, 2013), https://www.law360.com/articles/403099/what-you-should-know-about-nad-false-advertising-claims.

[23] Note
that the FDA and FTC are agencies of different stature. Unlike the FTC, the FDA
is not an independent entity of the U.S. government. The FDA is nestled under
the Department of Health and Human Services and funded by the Department of
Agriculture.

[24] Advertising Dietary Supplements, Consumer Healthcare Products Association,
http://www.chpa.org/DS_Advertising.aspx (last
visited Mar. 23, 2017).

[25] Rebecca Tushnet, Advertising and Marketing Law 1289 (3rd
ed. 2014).

[26] U.S. Food & Drug Admin. Guidance for Industry: A Food Labeling Guide, (revised Jan.
2013), https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm2006828.htm.

[27] Mark
Nichter & J.J. Thompson, For my
wellness, not just my illness: North Americans’ use of dietary supplements
,
30 Culture, Med. & Psychiatry
175, 176 (2006). Unlike drugs, supplements can be readily purchased without a
prescription in a wide variety of brick-and-mortar stores and online.

[28] 15
U.S.C. § 45 (2012).

[29] Pfizer,
Inc., 81 F.T.C. 23 (1972).

[30] Lesley
Fair, Federal Trade Commission
Advertising Enforcement
, Fed. Trade
Comm’n
(revised Mar. 1, 2008), https://www.ftc.gov/sites/default/files/attachments/training-materials/enforcement.pdf; see, e.g., Brake Guard Products, Inc.,
125 F.T.C. 138 (1998); ABS Tech Sciences, Inc., 126 F.T.C. 229 (1998).

[31] See, e.g.,
Removatron International Corp., 111 F.T.C. 206 (1988), aff’d 884 F.2d 1489 (1st Cir. 1989) (“adequate and well-controlled…clinical testing” is required to substantiate claims for hair removal product);
Schering Corp., 118 F.T.C. 1030 (1994) (consent order) (tests and studies
relied upon as “reasonable basis” must employ appropriate methodology and
address specific claims made in the advertisement).

[32] Dietary
Supplement Health and Education Act of 1994, Pub. L. No. 103-417, 108 Stat.
4325 (codified in scattered sections of 21 U.S.C.).

[33] Questions and Answers on Dietary Supplements, U.S. Food & Drug Admin., https://www.fda.gov/Food/DietarySupplements/UsingDietarySupplements/ucm480069.html (last
updated Nov. 29, 2017).

[34] In its
current form, section 43(a)(1)(B) states: (1) Any person who, on or in
connection with any goods or services, or any container for goods, uses in
commerce any word, term, name, symbol, or device, or any combination thereof,
or any false designation of origin, false or misleading description of fact, or
false or misleading representation of fact, which — . . . (B) in commercial
advertising or promotion, misrepresents the nature, characteristics, qualities,
or geographic origin of his or her or another person’s goods, services, or
commercial activities, shall be liable in a civil action by any person who
believes that he or she is or is likely to be damaged by such act. 15 U.S.C. §
1125(a)(1)(B) (2018).

[35] See Beebe, supra note 18, at
Part IV, 2.

[36] 134 S.
Ct. 1377, 1395 (2014).

[37] Id. at
1389; see also J. Thomas McCarthy, McCarthy on Trademarks and
Unfair Competition § 27.30 (5th ed. 2017).

[38] See Brown
v. GNC Corp. (In re GNC Corp.), 789 F.3d 505, 514 (4th Cir. 2015) (noting that,
although consumers cannot invoke the protections of the Lanham Act, the “considerable body of federal
common law construing the Act is instructive in construing the state laws at
issue here”).

[39] Puffery
is a safe harbor for advertisers who proffer exaggerated and unsupported (or,
perhaps, unsupportable) claims. It is a non-actionable carve-out from the false
advertising provisions of the Lanham Act, since the statements are typically so
exaggerated that no reasonable consumer could be deemed to rely on them. To
fall out of the test for false advertising, statements of puffery are not
considered to be statements of fact; consequently, a plaintiff would fail to
meet the first element of the test. Courts have different definitions of
puffery. In Time Warner Cable, Inc. v.
DIRECTV, Inc.
, the Second Circuit described one party’s internet ads as
“inaccurate descriptions” of the television service, but “so grossly distorted
and exaggerated that no reasonable buyer would take them to be accurate
depictions.” 497 F.3d 144, 159 (2d Cir. 2007). In United Industries Corp. v. Clorox Co., “[p]uffery is ‘exaggerated
advertising, blustering, and boasting upon which no reasonable buyer would rely
and is not actionable under § 43(a).’” 140 F.3d 1175, 1180 (8th Cir.1998)
(quoting Southland Sod Farms v. Stover Seed Co., 108 F.3d 1134, 1145 (9th Cir.
1997)). In other iterations, the puffery doctrine has protected purveyors of
“The Best Beer in America,” In re
Bos. Beer Co., 198 F.3d 1370 (Fed. Cir. 1999), “The Most Advanced Home Gaming
System in the Universe,” Atari Corp. v. 3D0 Co., No. C 94-20298 RMW (EAI), 1994
U.S. Dist. LEXIS 8677 (N.D. Cal. May 16, 1994), and “Better Ingredients. Better
Pizza,” Pizza Hut, Inc. v. Papa John’s Int’l, Inc., 227 F.3d 489 (5th Cir.
2005).

[40] Under National Basketball Ass’n v. Motorola, Inc.,
the test for materiality is whether the statement “misrepresent[s] an inherent
quality or characteristic of a product.” 105 F.3d 841, 855 (2d Cir. 1997).

[41] Schick
Mfg., Inc. v. Gillette Co., 372 F.Supp.2d 273, 276 (D. Conn. 2005).

[42] See Tushnet,
supra note 25, at
259; see also Coca-Cola Co. v.
Tropicana Prods., Inc., 690 F.2d 312, 317 (2d Cir. 1982) (“[T]he Court may
grant relief without reference to the advertisement’s [actual] impact on the
buying public.”), abrogated on other
grounds by
Fed. R. Civ. P. 52(a)(6), as
recognized in
Johnson & Johnson v. GAC Int’l, Inc., 862 F.2d 975, 979
(2d Cir. 1988).

[43] Consumer
surveys are not valid supporting evidence in a falsity case, discussed further
in Section I.B.2. The GNC case fits neatly within the question of literally
false advertising, as the TriFlex ads and packaging presented explicit,
unambiguous statements, and no evidence of consumer deception was presented. See generally GNC, 789 F.3d 505.

[44] See generally Coca-Cola, 690
F.2d 312.

[45] See Time
Warner Cable, Inc. v. DIRECTV, Inc., 497 F.3d 144, 158 (2d Cir. 2007).

[46] Id. at
152.

[47] See id. at
158. Note that the Second Circuit ruled on numerous commercials and Internet
ads in this case, and some of the district court’s opinion was reversed.

[48] Where an
advertisement is literally true but misleading, the advertisement “has left an
impression on the listener that conflicts with reality[;]” with proof of
consumer confusion, the representations are considered misleading. See id. at 153.

[49] 661 F.2d 272 (2d Cir. 1981). See also 2-7 Gilson on Trademarks § 7.02
(2017).

[50] Carolyn L. Carter, Consumer Protection in the States: A 50-State
Report on UDAP Statutes, 5 (Feb. 2009), http://www.nclc.org/images/pdf/udap/report_50_states.pdf.

[51] 2-7
Gilson on Trademarks § 7.02 (2017).

[52] Carter, supra
note 50, at 5.

[53] See Kenneth
A. Plevan & Angela Colt, Consumer
Surveys: Certification
, Bloomberg BNA
Prod. Safety & Liab. Rep
. 4 (Sept. 12, 2016).

[54] See
Consolidated Amended Complaint at ∂ 26-35, In re GNC Corp. Triflex Prods. Mktg.
& Sales Practices Litig. (No. II), No. 14-2491, 2014 U.S. Dist. LEXIS 84184
(D. Md. June 20, 2014) ECF No.20. For reference, the four GNC products at
issue, according to the Plaintiffs, were TriFlex, TriFlex Sport, TriFlex
Fast-Acting, and TriFlex Complete Vitapak. The six Rite Aid products at issue
are Rite Aid Glucosamine/Chondroitin, Rite Aid Natural Glucosamine/Chondroitin,
Rite Aid Glucosamine Chondroitin Advanced Complex, Rite Aid Glucosamine
Chondroitin, Triple Strength + MSM, Rite Aid Glucosamine Chondroitin + MSM, and
Rite Aid Glucosamine Chondroitin Advanced Complex with HA. The court does not
distinguish between the GNC and Rite Aid brands, nor does it distinguish
between the individual products at issue.

[55] See
Consolidated Amended Complaint at ∂ 26-37, In re GNC Corp. Triflex Prods. Mktg.
& Sales Practices Litig. (No. II), No. 14-2491, 2014 U.S. Dist. LEXIS 84184
(D. Md. Jun. 20, 2014) ECF No.20; see
also
In re GNC Corp. Triflex Prods. Mktg. & Sales Practices Litig. (No.
II), No. 14-2491, 2014 U.S. Dist. LEXIS 84184 (D. Md. June 20, 2014). The
claims on the labels, as presented by Plaintiffs and GNC, are as follows. The
GNC TriFlex Dietary Supplement label contains “Maximum strength now with
hyaluronic acid” and “Promotes joint mobility and flexibility.” The GNC TriFlex
Sport label contains: “Protects joints from wear and tear of exercise,”
“Maximum strength joint comfort for active individuals,” and “Clinical strength
for daily long-term use.” TriFlex Fast-Acting label contains: “Now with a joint
cushioning blend including hyaluronic acid and vitamin C,” “Maximum strength,
fast-acting support – works in days,” and “Clinical strength for daily
long-term use.” Lastly, the TriFlex Complete Vitapak label contains: “Maximum
strength, fast-acting joint comfort – works in days,” “Rebuilds cartilage and
lubricates joints,” and “Supports natural anti-inflammatory response.” The Rite
Aid Glucosamine/Chondroitin Dietary Supplement label contains “helps rebuild
cartilage and lubricate joints.” Each label contains an FDA disclaimer: “This
statement has” or “these statements have” “not been evaluated by the Food and
Drug Administration. This product is not intended to diagnose, treat, cure, or
prevent any disease.” It appears that the only product to include a “here’s
proof” claim is TriFlex Fast-Acting. There is a reference to a scientific study
that supports GNC’s representations: “Clinically studied doses of glucosamine
and chondroitin combined with MSM and a proprietary herbal blend, which is
shown to improve joint comfort and function. In a 12-week multi-center,
randomized, double blind, placebo controlled study of 60 adults, subjects
taking 250 mg/day of the GNC TriFlexTM Fast-Acting Blend showed statistically
significant improvements in measures of joint function and joint flexibility
within 30 days compared to subjects on placebo.”

[56] See
Defendant’s Memorandum in Support of its Motion to Dismiss Class Action
Complaint, In re GNC Corp. Triflex Prods. Mktg. & Sales Practices Litig.
(No. II), No. 14-2491, 2014 U.S. Dist. LEXIS 84184 (D. Md. June 20, 2014) ECF
No.38; see also Rebecca Tushnet, Fourth Circuit Destroys Literal Falsity,
Rebecca Tushnet’s 43(B)log (June
30, 2015), http://tushnet.blogspot.com/2015/06/fourth-circuit-destroys-literal-falsity.html. The
GNC study was not published or otherwise publicly available, and there is
currently no law requiring such disclosure.

[57] Some of
the state consumer protection laws at issue include the California False
Advertising Law, § 17500, et seq.
(“FAL”), the California Unfair Competition Law, Cal. Bus. & Prof. Code §
17200, et seq. (“UCL”), the Florida Deceptive and Unfair Trade Practices Act,
Fla. Stat. §§ 501.201, et seq.
(“FDUTPA”), Illinois Consumer Fraud and Deceptive Business Practice Act, 815
Ill. Comp. Stat. 502/1, et seq.
(“ICFA”), the New York Consumer Protection From Deceptive Acts and Practices
Law, N.Y. Gen. Bus. Law § 349, et seq.
(“NYGBL”), Ohio Rev. Code Ann. § 1302.26, the New Jersey Consumer Fraud Act,
N.J.S.A. 56:8-1, et seq. (“NJCFA”),
Pennsylvania Unfair Trade Practices and Consumer Protection Law, 73 Pa. Stat.
Ann. §§ 201-1, et seq. (“PUTPCPL”).

[58] In re
GNC Corp. TriFlex Prods. Mktg. & Sales Practices Litig. (No. II), No.
14-120, 2014 U.S. Dist. LEXIS 84184 at *1 (D. Md. June 20, 2014).

[59] Consolidated
Amended Complaint at ∂ 38, In re GNC Corp. Triflex Prods. Mktg. & Sales
Practices Litig. (No. II), No. 14-2491, 2014 U.S. Dist. LEXIS 84184 (D. Md.
June 20, 2014) ECF No.20.

[60] Id.

[61] The
studies can be found in the Consolidated Amended Complaint at ∂∂ 39-48, In re
GNC Corp. Triflex Prods. Mktg. & Sales Practices Litig. (No. II), No.
14-2491, 2014 U.S. Dist. LEXIS 84184 (D. Md. June 20, 2014) ECF No.20.

[62] Consolidated
Amended Complaint at ∂ 32, In re GNC Corp. Triflex Prods. Mktg. & Sales
Practices Litig. (No. II), No. 14-2491, 2014 U.S. Dist. LEXIS 84184 (D. Md.
June 20, 2014) ECF No.20.

[63] Since
this case is considered procedurally significant, it is important to say a word
about the legal standard on a motion to dismiss. A Rule 12(b)(6) motion to
dismiss challenges the legal sufficiency of a complaint. Fed. R. Civ. P.
12(b)(6); see also Presley v. City of
Charlottesville, 464 F.3d 480, 483 (4th Cir. 2006). The court has drawn a line
between the “mere possibility” and “plausibility” that a defendant has acted
unlawfully; plaintiff must meet the latter to survive a motion to dismiss.
Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009). The issue is whether plaintiff has
stated enough factual matter, rising above the speculative level, to warrant a
claim for relief. To defeat a 12(b)(6) motion, a complaint’s factual
allegations must be sufficient to “raise a right to relief above the speculative
level.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007). The complaint
must contain “sufficient factual matter, accepted as true, to state a claim for
relief that is plausible on its face.” Ashcroft,
556 U.S. at 678. The “mere possibility of misconduct” is insufficient to avoid
dismissal. Id. at 679. Likewise,
“[l]abels and conclusions” and “naked assertion devoid of further factual
enhancement” will fail to show that plaintiff is entitled to relief. Id. at 678. Ultimately, Plaintiffs’ bare
assertions were insufficient to establish that the representations are false.

[64] Notably,
similar and even predicate cases challenging the efficacy of
glucosamine-chondroitin had been dismissed on similar grounds. See, e.g., Toback v. GNC Holdings, Inc.,
No. 13-80526, 2013 U.S. Dist. LEXIS 131135, at *16 (S.D. Fla. Sept. 13, 2013)
(“Plaintiff’s allegations regarding the inefficacy of glucosamine and
chondroitin simply fail to address the efficacy of the TriFlex Vitapak’s
multifarious composition in promoting joint health . . .”); Eckler v. Wal-Mart
Stores, Inc., No. 12-727, 2012 WL 5382218, at *6 (S.D. Cal. 2012) (plaintiff’s
studies did not assess the “overall formulation that’s behind the
representations at issue,” and so “the Court would be left with no facts from
which to infer that [defendant] is liable for false advertising.”).

[65] Defendants’
Memorandum in Support of their Motion to Dismiss Consolidated Amended Complaint
at 5, In re GNC Corp. Triflex Prods. Mktg. & Sales Practices Litig. (No.
II), No. 14-2491, 2014 U.S. Dist. LEXIS 84184 (D. Md. June 20, 2014), ECF
No.25.

[66] The
Consolidated Amended Complaint repeatedly described the TriFlex advertising as
“false, misleading, and reasonably likely to deceive the public.” Consolidated
Amended Complaint, In re GNC Corp. Triflex Prods. Mktg. & Sales Practices
Litig. (No. II), No. 14-2491, 2014 U.S. Dist. LEXIS 84184 (D. Md. June 20,
2014), ECF No.20. However, to plead that an advertisement is misleading, the
allegation must be supported by evidence of consumer confusion. Since
Plaintiffs did not provide any evidence of consumer confusion, the Court
appropriately limited its analysis to a claim of literal falsity.

[67] Memorandum
at 7, In re GNC Corp. Triflex Prods. Mktg. & Sales Practices Litig. (No.
II), No. 14-2491, 2014 U.S. Dist. LEXIS 84184 (D. Md. June 20, 2014), ECF No.
38.

[68] Id.

[69] Id.
(emphasis added).

[70] Id. at
n.2.

[71] See id.; see also Memorandum at 4 n.4, In re GNC
Corp. Triflex Prods. Mktg. & Sales Practices Litig. (No. II), No. 14-2491,
2014 U.S. Dist. LEXIS 84184 (D. Md. June
20, 2014), ECF No. 51. The significance of this carve-out for advertising cases
is discussed further in Part III, supra.

[72] Memorandum
at 7, In re GNC Corp. Triflex Prods. Mktg. & Sales Practices Litig. (No.
II), No. 14-2491, 2014 U.S. Dist. LEXIS 84184 (D. Md. June 20, 2014), ECF No.
38. An obvious issue, then, becomes whether Plaintiffs could so allege without
appropriate discovery. Judge Motz addressed this question in his second
Memorandum Decision, denying the motion for reconsideration: “[I]f plaintiffs
can specify discovery requests that would aid them in alleging the above facts,
they should file a motion setting forth the discovery that they request.
Presumably, however, if plaintiffs’ experts are of the view that no reasonable
expert would reach the conclusion reached by the expert upon whom defendant
relies, they are already, by virtue of their asserted expertise, in possession
of the relevant factual information.” Memorandum at 5, In re GNC Corp. Triflex
Prods. Mktg. & Sales Practices Litig. (No. II), No. 14-2491, 2014 U.S.
Dist. LEXIS 84184 (D. Md. June 20, 2014), ECF No. 51.

[73] Memorandum
at 4, In re GNC Corp. Triflex Prods. Mktg. & Sales Practices Litig. (No. II),
No. 14-2491, 2014 U.S. Dist. LEXIS 84184 (D. Md. June 20, 2014), ECF No. 51.

[74] Memorandum
at 8, In re GNC Corp. Triflex Prods. Mktg. & Sales Practices Litig. (No.
II), No. 14-2491, 2014 U.S. Dist. LEXIS 84184 (D. Md. June 20, 2014), ECF No.
38.

[75]
Exhibit 1 to Plaintiffs’ Memorandum of Law in Support of Motion to Correct
Mistake of Law Pursuant to F.R.C.P. 60, In re GNC Corp. Triflex Prods. Mktg.
& Sales Practices Litig. (No. II), No. 14-2491, 2014 U.S. Dist.
LEXIS 84184 (D. Md. June 20, 2014), ECF No. 44-1.

[76] See
Plaintiffs’ Motion to Correct Mistake of Law Pursuant to F.R.C.P. Rule 60, In
re GNC Corp. Triflex Prods. Mktg. & Sales Practices Litig. (No. II), No.
14-2491, 2014 U.S. Dist. LEXIS 84184 (D. Md. June 20, 2014), ECF No. 43;
Plaintiffs’ Memorandum of Law in Support of Motion to Correct Mistake of Law
Pursuant to F.R.C.P. 60, In re GNC Corp. Triflex Prods. Mktg. & Sales
Practices Litig. (No. II), No. 14-2491, 2014 U.S. Dist. LEXIS 84184 (D. Md.
June 20, 2014), ECF No. 44.

[77] Memorandum
at 4, In re GNC Corp. Triflex Prods. Mktg. & Sales Practices Litig. (No.
II), No. 14-2491, 2014 U.S. Dist. LEXIS 84184 (D. Md. June 20, 2014), ECF No.
51; see also Brown v. GNC Corp. (In
re GNC Corp.), 789 F.3d 505, 512 (4th Cir. 2015).

[78] There
are some important differences between the District Court’s Memorandum Decision
and the Fourth Circuit’s Order. First, the Court included alternative grounds
for affirming the District Court, noting that Plaintiffs “failed to allege that
all of the purportedly active ingredients in each product are
ineffective at promoting joint comfort, health, and flexibility.” Second, the
Fourth Circuit disagreed with Judge Motz that specific formulations of the GNC
and Rite Aid products needed to be tested to assess the truth of the labels’
representations; instead, at the motion to dismiss stage, the scientific
studies in the CAC could render the claim facially plausible. Lastly, the court
found that the factual dispute regarding the effectiveness of glucosamine-chondroitin
for non-arthritic users was not appropriate for resolution on a motion to
dismiss. The Fourth Circuit declined to adopt the latter grounds for affirming
the District Court’s Order. See Brown
v. GNC Corp. (In re GNC Corp.), 789 F.3d 505 (4th Cir. 2015).

[79] See GNC, 789
F.3d at 516.

[80] Id.

[81] Id. at 514
n.7.

[82] See generally id. at
515-16.

[83] Id. at
515.

[84] Id.

[85] Id.

[86] See Brief
of Law Professors as Amici Curiae in Support of Plaintiffs-Appellants’ Petition
for Rehearing and for Rehearing En Banc, and in the Alternative, for
Modification of Opinion and Judgment, Brown v. GNC Corp. (In re GNC Corp.), 789
F.3d 505 (4th Cir. 2015) (No. 14-1724) ECF No.45.

[87] Id. at 1.

[88] Professor
Rebecca Tushnet, whose advertising textbook is extensively cited in this Note,
appears to have been the lead academic on the Amicus Brief. It is co-signed
with Brian Wolfman, then a Visiting Professor at Stanford Law School. Other
Amici include Mark Lemley of Stanford Law School, Jessica Litman of the
University of Michigan Law School, and Barton Beebe of New York University
School of Law, who supervised this Note’s completion. Notably, Professor Eric
Goldman of Santa Clara University School of Law is not a signatory to the
Amicus Brief, although he co-authored the seminal textbook on advertising law, Advertising & Marketing Law, with
Professor Tushnet.

[89] Brief of
Law Professors as Amici Curiae in Support of Plaintiffs-Appellants’ Petition
for Rehearing and for Rehearing En Banc, and in the Alternative, for
Modification of Opinion and Judgment at 1-2, Brown v. GNC Corp. (In re GNC
Corp.), 789 F.3d 505 (4th Cir. 2015) (No. 14-1724) ECF No.45. The brief is
inexplicably wrought with references to consumer messaging in literal falsity
cases. As Amici later state, “To determine if an ad makes a false claim, a
court must determine what message consumers will perceive . . . .”

[90] Perhaps
there is some suggestion that Plaintiffs’ should have argued that the joint
health claims were misleading, rather than literally false. The argument would
appear to be that glucosamine-chondroitin is particularly attractive to
osteoarthritis patients, who seek to alleviate the pain of their condition.
Plaintiffs offered numerous studies that allegedly prove that
glucosamine-chondroitin is not beneficial to osteoarthritis sufferers. On that
basis, and with an allegation of consumer confusion, the claims could have been
deemed misleading to a segment of consumers. However, a claim of misleading
advertising would, too, seem to fail, as the District Court noted that “the
TriFlex labels expressly disclaim any ability to ‘diagnose, treat, cure, or
prevent any disease.” (citations omitted). In re GNC Corp. TriFlex Prods. Mktg.
& Sales Practices Litig. (No. II), No. 14-2491, 2014 U.S. Dist. LEXIS 84184
at *3-4 (D. Md. June 20, 2014).

[91] Brief of
Law Professors as Amici Curiae in Support of Plaintiffs-Appellants’ Petition
for Rehearing and for Rehearing En Banc, and in the Alternative, for
Modification of Opinion and Judgment at 5, Brown v. GNC Corp. (In re GNC Corp.),
789 F.3d 505 (4th Cir. 2015) (No. 14-1724) ECF No.45.

[92] Id at 2.

[93] In the
discussion that follows that quote, the C.B.
Fleet Court
states: “Fleet challenges the district court’s determinations
of no literal falsity on the grounds that the court imposed upon Fleet a
wrong– overly stringent– ‘burden of proof’ on the issue, and, relatedly, that
both of the ultimate fact findings
were clearly erroneous[;]” “[W]e think that whether an advertising claim
implicitly, though not expressly, asserts that it is test-validated must be
considered a question of fact whose resolution is subject to clearly erroneous
review[;]” “Our standard of review of district court fact findings is greatly
deferential under controlling authority[]” (emphasis added). C.B. Fleet Co. v.
SmithKline Beecham Consumer Healthcare, L.P., 131 F.3d 430, 434-436 (4th Cir.
1997).

[94] L&F
Prods. v. Procter & Gamble Co., 45 F.3d 709, 712 (2d Cir. 1995).

[95] Brief of
Law Professors as Amici Curiae in Support of Plaintiffs-Appellants’ Petition
for Rehearing and for Rehearing En Banc, and in the Alternative, for
Modification of Opinion and Judgment at 3, Brown v. GNC Corp. (In re GNC
Corp.), 789 F.3d 505 (4th Cir. 2015) (No. 14-1724) ECF No.45.

[96] Plaintiffs’
Reply Memorandum of Law in Further Support of Motion to Correct Mistake of Law
Pursuant to F.R.C.P. 60 at 4, In re GNC Corp. TriFlex Prods. Mktg. & Sales
Practices Litig. (No. II), No. 14-2491, 2014 U.S. Dist. LEXIS 84184 (D. Md.
June 20, 2014) ECF No.50.

[97] Defendant’s
Memorandum in Support of its Motion to Dismiss Class Action Complaint at n.2,
In re GNC Corp. Triflex Prods. Mktg. & Sales Practices Litig. (No. II), No.
14-2491, 2014 U.S. Dist. LEXIS 84184 (D. Md. June 20, 2014) ECF No.38.

[98] See generally Brief
of Law Professors as Amici Curiae in Support of Plaintiffs-Appellants’ Petition
for Rehearing and for Rehearing En Banc, and in the Alternative, for
Modification of Opinion and Judgment, Brown v. GNC Corp. (In re GNC Corp.), 789
F.3d 505 (4th Cir. 2015) (No. 14-1724) ECF No.45; Olamide Orebamjo, Comment, Brown v. GNC Corp.: The Fourth Circuit’s New
Standard for Literal Falsity
, 12 J.
Bus. & Tech. L. Proxy
1 (2017).

[99] Pfizer, 81
F.T.C. at 29 (1972).

[100] John P.
Swann, The history of efforts to regulate
dietary supplements in the USA
, 8
Drug Testing & Analysis
271, 275 (2016).

[101] Brown v.
GNC Corp. (In re GNC Corp.), 789 F.3d 505, 514 (4th Cir. 2015) (“In construing
the diverse state statutes at issue here, we apply this broadly shared
understanding of the difference between false and misleading
representations.”).

[102] See Memorandum
at 4 n.4, In re GNC Corp. Triflex Prods. Mktg. & Sales Practices Litig.
(No. II), No. 14-2491, 2014 U.S. Dist. LEXIS 84184 (D. Md. June 20, 2014), ECF
No. 51.

[103] Eckler
v. Wal-Mart Stores, Inc., No. 12-727, 2012 WL 5382218, at *8 n.2 (S.D. Cal.
2012.

[104] Memorandum
at 4 n.4, In re GNC Corp. Triflex Prods. Mktg. & Sales Practices Litig.
(No. II), No. 14-2491, 2014 U.S. Dist. LEXIS 84184 (D. Md. June 20, 2014), ECF
No. 51.

[105] Plaintiffs’
Memorandum of Law in Support of Motion to Correct Mistake of Law Pursuant to
F.R.C.P. 60, In re GNC Corp. Triflex Prods. Mktg. & Sales Practices Litig.
(No. II), No. 14-2491, 2014 U.S. Dist. LEXIS 84184 (D. Md. June 20, 2014), ECF
No. 44.