Federal Trade Commission v. Lane Labs-USA, Inc.

PRECEDENTIAL

UNITED STATES COURT OF APPEALS
FOR THE THIRD CIRCUIT

09-3909

FEDERAL TRADE COMMISSION,
Appellant

v.

LANE LABS-USA, INC; CARTILAGE
CONSULTANTS, INC.;
I. WILLIAM LANE; ANDREW J. LANE

On Appeal from the United States District Court
for the District of New Jersey
District Court No. 2-00-cv-03174
District Judge: The Honorable Dennis M. Cavanaugh

Argued September 14, 2010

Before: SLOVITER, BARRY, and SMITH,
Circuit Judges
 (Filed: October 26, 2010)

Theodora T. McCormick
Jack Wenik (argued)
Sills, Cummis & Gross
One Riverfront Plaza
Newark, NJ 07102
Counsel for Appellee Lane Labs-USA, Inc. and
Andrew J. Lane

Paul F. Carvelli (argued)
McCusker, Anselmi, Rosen & Carvelli
210 Park Avenue
Suite 301
Florham Park, NJ 07932
Counsel for Appellee I. William Lane

Michele Arington (argued)
John F. Daly
Federal Trade Commission
Room H-582
600 Pennsylvania Avenue, N.W.
Washington, DC 20580

Elsie B. Kappler
Constance M. Vecellio
Federal Trade Commission
600 Pennsylvania Avenue, N.W.
Washington, DC 20580
2
Susan J. Steele
Office of United States Attorney
970 Broad Street
Room 700
Newark, NJ 07102

Amanda C. Basta
Kirkland & Ellis
655 15th Street, N.W.
Suite 1200
Washington, DC 20005
Counsel for Appellant

OPINION

SMITH, Circuit Judge.

The Federal Trade Commission (“FTC”) appeals
from an order of the United States District Court for the
District of New Jersey denying its motion to hold Lane
Labs-USA, Inc., I. William Lane, and Andrew J. Lane in
contempt for violation of consent judgments entered by the
District Court on July 6, 2000 and September 26, 2000.
For the reasons set forth below, we conclude that the
District Court committed clear error. Accordingly, we will

3
vacate the order of the District Court and remand for
further proceedings.

I.

Lane Labs-USA, Inc. (“Lane Labs”) is a
manufacturing distributor of specialty dietary supplements
and cosmetic products.1 The company was founded in
1994 by its current president and sole shareholder, Andrew
J. Lane (“Lane”). Lane’s father, I. William Lane, is not an
employee of Lane Labs, but has served as a consultant to
the company since its founding.2

In June of 2000, the FTC charged the Lane
defendants with deceptive acts in violation of § 5 of the
Federal Trade Commission Act (“FTC Act”).3 The FTC’s

1
Although Lane Labs is considered a “products manufacturer”
under the Standard Industrial Classification Code, it outsources all
manufacturing work for offsite production. The company’s in-house
staff is primarily concerned with distributing and marketing its
products.
2
For ease of reference, we collectively refer to Lane Labs,
Andrew J. Lane, and I. William Lane as “the Lane defendants.”
3
Section 5 of the FTC Act prohibits “[u]nfair methods of
competition in or affecting commerce, and unfair or deceptive acts or
practices in or affecting commerce.” 15 U.S.C. § 45(a)(1).

4
complaint focused upon unsubstantiated representations
pertaining to two products: BeneFin, a dietary supplement,
and SkinAnswer, a cosmetic cream.4 Shortly after the
litigation was commenced, however, each of the Lane
defendants reached a settlement with the FTC and agreed
to the terms of a consent decree. The District Court
entered the decree as a stipulated final order for permanent
injunction (hereinafter, the “Final Order”),5 and adjudged
Lane Labs liable for the sum of $1 million.

Two provisions of the Final Order are pertinent to

4
In a related action, the Food and Drug Administration
(“FDA”) filed a complaint against Lane Labs and Lane on December
10, 1999, alleging violations of the Federal Food, Drug, and Cosmetic
Act (“FDCA”), 21 U.S.C. § 301 et seq. Specifically, the government
accused both defendants of misbranding and falsely advertising three
products: BeneFin, SkinAnswer, and MGN-3. The United States
District Court for the District of New Jersey agreed with the FDA,
permanently enjoined the offensive conduct, and ordered payment of
restitution to consumers who purchased these products. United States
v. Lane Labs-USA, Inc., 324 F. Supp. 2d 547 (D.N.J. 2004). We
affirmed the District Court’s decision the following year. United
States v. Lane Labs-USA, Inc., 427 F.3d 219 (3d Cir. 2005).
5
The District Court actually entered two stipulated final
orders for permanent injunction, one against William Lane on July 6,
2000, and the other against Lane Labs and Lane on September 26,
2000. Both orders are identical in all material respects, except that
monetary penalties were imposed against Lane Labs.

5
this appeal. In Section III, the Lane defendants agreed that
“in connection with the manufacturing, labeling,
advertising, promotion, offering for sale, or distribution of
any food, dietary supplement, or drug,” they would refrain
from

mak[ing] any representation, in any manner,
. . . expressly or by implication, about the
effect of [a] product on any disease or
disorder, or the effect of such product on the
structure or function of the human body, or
about any other health benefits of such
product, unless, at the time the representation
is made, [they] possess[ed] and rel[ied] upon
competent and reliable scientific evidence
that substantiates the representation.

“Competent and reliable scientific evidence” was defined
as “tests, analyses, research, studies, or other evidence
based on the expertise of professionals in the relevant area,
that have been conducted and evaluated in an objective
manner by persons qualified to do so, using procedures
generally accepted in the profession to yield accurate and
reliable results.” Section IV of the Final Order forbade
express or implied misrepresentations regarding “the
existence, contents, validity, results, conclusions, or
interpretations of any test, study or research” in connection

6
with “the manufacturing, labeling, advertising, promotion,
offering for sale, sale, or distribution of any food, dietary
supplement, or drug.” Two other provisos, Sections IX and
XIV, imposed record keeping and periodic reporting
requirements, respectively.

Two products are at issue: AdvaCal, a calcium
supplement, and Fertil Male, which, as the name suggests,
purports to improve male fertility. We shall briefly
consider the development and marketing of both products
before turning to the proceedings that occasioned the
instant appeal.

A. AdvaCal

AdvaCal was developed by a renowned Japanese
scientist named Takuo Fujita. The product primarily
consists of calcium hydroxide derived from oyster shells
smelted at extremely high temperatures. Once the smelting
process is complete, the calcium component is combined
with a heated algae ingredient (“HAI”) extracted from
Hijiki seaweed. This combination of active ingredients
purportedly yields a calcium hydroxide product that is
significantly more absorbable by the human body than
competing calcium supplements.

7
 Lane Labs began marketing AdvaCal in 2000 as a
means to increase bone strength and combat osteoporosis.
Over the next several years, the company utilized an array
of print, television, and online media to promote its
product. Each of these advertisements contained numerous
representations regarding AdvaCal’s efficacy, and many
compared AdvaCal to competing calcium supplements.
Typical among the claims appearing in AdvaCal marketing
materials were assertions that the supplement (1) was
unique in its ability to increase bone mineral density, (2)
was clinically proven to be more absorbable than other
calcium supplements, and (3) was clinically shown to
increase bone density in the hip. In addition, Lane Labs
distributed literature promoting AdvaCal as comparable or
superior to prescription osteoporosis medicine, and Lane
told at least one prospective retail purchaser that the
calcium supplement was “on par with” prescription
pharmaceuticals.

Consistent with its obligations under the Final Order,
Lane Labs provided the FTC with compliance reports
pertaining to AdvaCal in 2001, 2004, and 2006. Each
report attached print copies of AdvaCal-specific
advertisements, as well as the scientific research upon
which Lane Labs relied for its representations. The parties
do not dispute that many of the marketing claims at issue

8
in this matter were disclosed to the FTC in the 2001
compliance report.

B. Fertil Male

Fertil Male is derived from a Peruvian plant known
as “maca.” After it is gelatinised and heated, the plant is
combined with HAI. This combination allegedly enhances
the human body’s capacity to absorb maca, which
purportedly improves male fertility parameters such as
sperm production and sperm motility.6 In October 2003,
Lane Labs began marketing Fertil Male. One
advertisement featured a customer who proclaimed that
Fertil Male caused his sperm count to “skyrocket” within
one month. Just as it had with AdvaCal, Lane Labs
submitted an FTC compliance report disclosing its Fertil
Male advertisements in 2006.

C. The Contempt
Proceeding

On July 12, 2006, the FTC notified Lane Labs that

6
The FTC’s expert, Dr. Craig Niederberger, described sperm
motility as “the wiggling of the sperm as if they were . . . going
towards an egg.”

9
certain Fertil Male advertisements contained
misrepresentations which amounted to violations of the
Final Order. One month later, the FTC provided Lane Labs
with a similar notice concerning the marketing of AdvaCal.
Both notices threatened litigation absent the negotiation of
an appropriate settlement agreement. The parties did not
reach a settlement. Thus, on January 12, 2007, the FTC
filed a motion with the District Court to hold the Lane
defendants in contempt for violating Sections III and IV of
the Final Order. To remedy these purported violations, the
FTC requested $24 million in monetary damages.

The District Court held a five-day evidentiary
hearing on the motion beginning on April 20, 2009. Two
expert witnesses testified on behalf of the FTC: Robert
Heaney, a physician and researcher at Creighton
University, offered testimony concerning AdvaCal, while
Craig Niederberger, a urologist at the University of Illinois
at Chicago, addressed matters pertaining to Fertil Male.
The Lane defendants presented the testimony of two
opposing experts. Boston University physician Michael
Holick discussed Lane Labs’ marketing of AdvaCal, and
University of Massachusetts professor Machelle Seibel
testified as an expert in reproductive medicine. Each of
these witnesses discussed scientific studies relied upon by
Lane Labs to support its marketing claims. The FTC

10
experts generally opined that the claims in question were
not substantiated by competent or reliable scientific
research; not surprisingly, experts for the Lane defendants
contradicted this viewpoint.

In addition to these dueling experts, the Court heard
testimony from, among others, Lane and Jennifer Morganti,
a naturopathic doctor employed by Lane Labs from 2001
to 2004. Lane testified that he took the Final Order
“extremely serious[ly],” and he spoke at length about the
measures the company pursued to comply with the decree.
Lane explained that: the Final Order was distributed to all
senior management personnel; copies were sent to Lane
Labs’ customers; an outside company was retained to
compile existing research and to monitor research updates;
and Lane hired Morganti to serve as manager of nutritional
research. Morganti testified that her primary responsibility
was to scrutinize Lane Labs’ marketing claims to ensure
that each representation was supported by scientific
research.7 In all circumstances, however, the ultimate
decision to utilize a particular claim was Lane’s alone.

By order dated August 10, 2009, the District Court

7
Lane also testified that marketing claims were vetted by
Lane Labs’ marketing department and its outside counsel.

11
denied the FTC’s motion for contempt. The Court
explained that it reached its decision after “carefully
considering the complete record” and weighing the
testimony of each party’s witnesses. In the Court’s view,
“[a]ll four expert witnesses were credible and
knowledgeable in their respective fields of expertise,” but
those testifying on behalf of the Lane defendants were
more impressive “because their testimony and approach to
the subject matter seemed more reasonable and in
accordance with the [Final] Order[].” The Court also
characterized Lane’s testimony in a favorable fashion,
stating that it “found Mr. Lane to be forthcoming and
credible, and consider[ed] his testimony to be evidence of
the efforts undertaken by Defendants to comply with the
[Final Order].”

Against this backdrop, the Court ultimately found
that the Lane defendants’ marketing claims were supported
by competent and reliable scientific evidence. Absent from
the decision, however, was any detailed examination of the
particular representations challenged by the FTC. Rather,
the Court simply set forth, in a series of bullet points, a
“representative selection” of the challenged assertions,8

8
According to the District Court, the following claims
comprised a “representative selection” of the AdvaCal-specific claims

12
eschewing an analysis of whether each claim found support
in the record. It emphasized that AdvaCal was generally
recognized as “a good source of calcium,” and that there
was little to no evidence that either AdvaCal or Fertil Male
was ineffective or potentially dangerous. The Court went
on to summarize the evidence as follows: “Lane Labs
found a product and obtained scientific evidence that the
product is efficacious. Lane Labs then consulted experts
who opined that the research supporting the product and
the product itself were good. Lane Labs acted in
accordance with the spirit of the [the Final] Order[].” For
the District Court, then, this matter was no more than a
dispute over “good” products about which there was a

challenged by the FTC: (1) AdvaCal has been “clinically shown to be
three times more absorbable than other calciums”; (2) AdvaCal is
“absorbed three times better than typical calcium carbonate/coral
calcium supplements”; (3) AdvaCal is the “only” calcium that can
increase bone mineral density; (4) AdvaCal produced a 3 percent per
year increase in bone density “over a period of years”; (5) results from
a “group” study demonstrate that AdvaCal caused a 13.5% increase
in bone density over two years; (6) AdvaCal has been shown in
clinical tests to increase bone density in the hip; and (7) a testimonial
from a twenty-five-year-old woman who claimed that after taking
AdvaCal, her bone density increased by 50% in six months. With
respect to Fertil Male, the Court simply stated that “the FTC
challenges Defendants’ general claim that Fertil Male has been
‘clinically-shown’ to increase sperm production, sperm motility, and
semen production.”

13
“difference of opinion.” The Court found the opinions
proffered by the Lane defendants more persuasive and,
consequently, determined that they had not disobeyed the
Final Order.

The Court further concluded that even if the Lane
defendants violated the Final Order, they were entitled to
a defense of substantial compliance. According to the
Court, the Lane defendants undertook “considerable
effort[s] to comply with the [Final] Order[],” even if “the
materials relied upon by Defendants are in hindsight not
perfect.” These efforts were frustrated by the FTC, which
failed for several years to notify Lane Labs of potential
Final Order violations. The Court explained that such
governmental foot dragging “raise[s] a significant issue of
fundamental fairness.” In other words, the Lane
defendants attempted to comply with the Final Order,
believed in good faith that they were successful in doing
so, and received no indication from the government that
their efforts were misguided. Under these circumstances,
the Court found that “Defendants took all reasonable steps
to substantially comply with the [Final] Order[].” The
motion for contempt was accordingly denied.

14
 The FTC timely appealed.9

II.

We review the denial of a contempt motion for abuse
of discretion. See Marshak v. Treadwell, 595 F.3d 478,
485 (3d Cir. 2009). “Reversal is appropriate ‘only where
the denial is based on an error of law or a finding of fact
that is clearly erroneous.’” Roe v. Operation Rescue, 54
F.3d 133, 137 (3d Cir. 1995) (quoting Harley-Davidson,
Inc. v. Morris, 19 F.3d 142, 145 (3d Cir. 1994)). A factual
finding is clearly erroneous if it is “completely devoid of a
credible evidentiary basis or bears no rational relationship
to the supporting data.” Interfaith Cmty. Org. v. Honeywell
Int’l, Inc., 399 F.3d 248, 254 (3d Cir. 2005) (internal
quotations omitted); see also Giles v. Kearney, 571 F.3d
318, 322 (3d Cir. 2009) (explaining that “[c]lear error
review is deferential” and that the district court’s factual
findings should be upheld when they are “plausible in light
of the record viewed in its entirety” (internal quotations
omitted)). Where factual findings are based upon the
testimony of live witnesses, the deference due the district

9
The District Court had subject matter jurisdiction pursuant
to 15 U.S.C. § 45 and 28 U.S.C. § 1331. We have appellate
jurisdiction under 28 U.S.C. § 1291.

15
court is even more considerable. See Anderson v.
Bessemer City, 470 U.S. 564, 575 (1985); United States v.
Igbonwa, 120 F.3d 437, 441 (3d Cir. 1997) (stating that
“when the district court’s decision is based on testimony
that is coherent and plausible, not internally inconsistent
and not contradicted by external evidence, there can almost
never be a finding of clear error”). However, “a court may
not insulate its findings from review by ‘denominating
them credibility determinations, [because] factors other
than demeanor . . . go into the decision whether or not to
believe a witness.’” Giles, 571 F.3d at 322 (alteration in
original) (quoting Anderson, 470 U.S. at 575). With these
principles in mind, we turn our attention to the contempt
proceedings conducted by the District Court.

III.

Proof of contempt requires a movant to demonstrate
“(1) that a valid order of the court existed; (2) that the
defendants had knowledge of the order; and (3) that the
defendants disobeyed the order.” Marshak, 595 F.3d at
485 (internal quotations omitted); Roe, 919 F.2d at 871.
These elements “must be proven by ‘clear and convincing’
evidence, and ambiguities must be resolved in favor of the
party charged with contempt.” John T. v. Del. Cnty.
Intermediate Unit, 318 F.3d 545, 552 (3d Cir. 2003).

16
Although courts should hesitate to adjudge a defendant in
contempt when “‘there is ground to doubt the wrongfulness
of the conduct,’” Robin Woods Inc. v. Woods, 28 F.3d 396,
399 (3d Cir. 1994) (quoting Quinter v. Volkswagen of Am.,
676 F.2d 969, 974 (3d Cir. 1982)), an alleged contemnor’s
behavior need not be willful in order to contravene the
applicable decree, John T., 318 F.3d at 552; Harley-
Davidson, 19 F.3d at 148-49. In other words, “good faith
is not a defense to civil contempt.” Robin Woods, 28 F.3d
at 399.

The first two elements of contempt are not in
dispute. Both parties agree that the Final Order constitutes
a valid court order and that the Lane defendants were well
aware of its existence and prohibitions. Thus, it is only the
final element of contempt—disobedience of a valid court
order—about which the parties quarrel. The FTC argues
that the Lane defendants disobeyed Sections III and IV of
the Final Order, and that the District Court erred in holding
otherwise. Section III requires that each of Lane Labs’
marketing claims find substantiation in competent or
reliable scientific research. According to the FTC, the
District Court failed to consider the specific marketing
claims challenged during the contempt proceeding. The
FTC challenges four claims pertaining to AdvaCal:

17
 A. Only AdvaCal can increase bone
density.

B. AdvaCal has been shown in clinical
tests to increase bone density in the
hip.

C. AdvaCal is three to four times more
absorbable than other calcium
supplements.

D. AdvaCal is comparable or superior to
prescription osteoporosis drugs.

The FTC also challenges the assertion that Fertil Male can
cause sperm count to “skyrocket” in as little as one month.
Finally, the government argues that it proved Lane Labs
violated Section IV of the Final Order by distorting
research regarding AdvaCal and other forms of calcium.
We will address each of these contentions in turn.

A. Only AdvaCal Can
Increase Bone Density

In various marketing fora, the Lane defendants
claimed that AdvaCal was unique in its ability to increase
bone density. One full-page print advertisement

18
proclaimed, “Clinical studies show that AdvaCal does what
no other calcium does: actually increases bone density in
women.” A direct mail circular asserted, “Other calcium
supplements cannot increase bone mass. AdvaCal can.”
Yet another print publication explains,

When LaneLabs introduced AdvaCal
and AdvaCal Ultra in the mid 1990s, the
scientific view of calcium changed forever.
Up until then, calcium supplements, at best,
could only PREVENT bone loss. AdvaCal
was different. AdvaCal demonstrated in
multiple clinical studies that it could actually
BUILD bone density quickly, naturally and
safely.

In a 2003 infomercial, William Lane described AdvaCal as
“the only calcium that I know of where you can actually
increase bone density.” Finally, on two occasions in 2005,
Lane wrote to a book publisher to promote AdvaCal. In a
February 9, 2005 email, Lane portrayed AdvaCal as “the
one calcium clinically shown to build bone density in
multiple human clinical studies. No other calcium can
make that claim.” Lane followed this electronic
correspondence with a March 2005 letter stating, “AdvaCal
offers the following benefits versus other calciums:
Actually builds bone density. That’s something no calcium

19
has demonstrated consistently in clinical research.”
Although each of these marketing claims were admitted
into the record, none was substantively discussed in the
District Court’s order.

The FTC presented evidence demonstrating that
these claims of uniqueness were unsupported by competent
and reliable scientific research. According to its expert,
Dr. Heaney, nearly all calcium supplements “produce a
measurable increase in bone density.” He characterized
this effect of calcium intake as “common,” and reinforced
his opinion by pointing to his own research and the results
of at least two other peer-reviewed calcium studies. Both
studies showed increases in bone density when human
subjects were provided with calcium supplements other
than AdvaCal. Dr. Morganti, Lane Labs’ former manager
of nutritional research, bolstered Dr. Heaney’s opinion,
explaining that “there’s a general consensus that calcium
can build bone density.” She also remarked, “[t]o say that
no other calciums can build bone is probably not true.”

The record is devoid of credible evidence to
contradict the government’s proffer. Dr. Holick did not
even address AdvaCal’s purported uniqueness, much less
dispute Dr. Heaney’s interpretation of research indicating
that most calcium supplements increase bone density. In

20
fact, Lane was the sole witness who testified in defense of
this claim, but his effort was without scientific support.
Lane stated that clinical research on other forms of calcium
had not produced results demonstrating an increase in bone
density above baseline value; the peer-reviewed studies
discussed and introduced into evidence by Dr. Heaney
show otherwise. While Lane disputed the findings of these
studies, his lay speculation does not constitute credible
evidence sufficient to refute the expert testimony and
evidence entered into the record through Dr. Heaney.10

On the basis of Lane’s lay speculation, and in spite
of expert testimony to the contrary, the District Court ruled
that the Lane defendants “offered support and
substantiation” for the claim that AdvaCal was unique in
its ability to increase human bone density. The Court’s
finding is not plausible in view of the entire record. The
Lane defendants were not merely asserting that AdvaCal

10
Lane questioned the results of one study after “reading the
abstract very quickly” on the stand. As a witness with no medical or
scientific expertise, Lane was unequipped to credibly refute the
government’s expert after “quickly” skimming a research abstract
during cross examination. What is more, the Lane defendants’ own
expert, Dr. Holick, undermined Lane’s lay opinion, explaining that
the analysis appearing in an abstract does not typically represent
competent or reliable scientific evidence sufficient to support a given
proposition.

21
produced beneficial bone-building results or outcomes that
were superior to other calcium supplements; rather, the
claims indicated that other supplements did not build bone
at all. Dr. Heaney showed that such an assertion was
untrue, and Dr. Holick offered no testimony to contradict
him. We are thus left with the definite conviction that the
District Court’s finding is clearly erroneous and must be
reversed.

B. AdvaCal Has Been
Shown in Clinical Tests
to Increase Bone Density
in the Hip

The FTC moved into evidence two print
documents—one a direct mailing, the other a two-page
advertisement—in which Lane Labs touts clinical research
exhibiting AdvaCal’s ability to increase bone density in the
hip. It is undisputed that no such clinical research exists,11
a fact that the District Court did not address in its
memorandum. In spite of this omission, our review of the
record leaves us satisfied that the Court did not clearly err
by finding that these representations were in accord with

11
A clinical study is one performed upon human subjects.
The studies relied upon by the Lane defendants, however, were
animal studies.

22
Section III of the Final Order.

Dr. Holick pointed to two clinical studies supportive
of Lane Labs’ claims. Both appeared in peer-reviewed
journals, and both showed that calcium increased bone
density in the human hip. Although neither study
administered AdvaCal to its subjects, Dr. Holick explained
that the results were applicable to AdvaCal because “[o]nce
the calcium is in your bloodstream, it doesn’t make any
difference what it was associated with before.”12 Thus, one
could “extrapolate” the data generated in these generic
calcium trials and apply the conclusions drawn therefrom
to the likely effect of taking AdvaCal. In Dr. Holick’s
opinion, competent and reliable clinical research therefore
showed that AdvaCal increases bone density in the human
hip.13 The District Court was entitled to rely upon this

12
We note that the logic of Dr. Holick’s opinion serves to
undermine Lane Labs’ uniqueness claim, addressed supra.
13
Although Dr. Heaney disagreed with Dr. Holick’s ultimate
opinion concerning these particular marketing claims, he did not
dispute Dr. Holick’s statement concerning the extent to which one
could “extrapolate” data from one clinical trial and apply it to a
similar product. For example, when Dr. Heaney was presented with
one of the two reports cited by Dr. Holick in support of Lane Labs’
claims, he testified as follows:

23
testimony, to credit Dr. Holick’s reliance on data
“extrapolated” from generic calcium studies, and to find
that the Lane defendants did not violate the Final Order by
making the claims in question. Accordingly, we will
affirm the District Court’s finding.

C. AdvaCal is Three to
Four Times More
Absorbable Than Other
Calcium Supplements

In direct mailers, print advertisements, and in an
infomercial, the Lane defendants represented that AdvaCal
was three to four times more absorbable than other calcium
supplements. One assertion characteristic of these claims
appeared in a direct mail article distributed to Lane Labs’
customers. In it, AdvaCal was described as “an extremely
high-potency calcium supplement that is absorbed four
times better than typical calcium-carbonate supplements.”

Q: My question, Doctor, was, could one rely on
this study for the proposition that AdvaCal
reduces the risk of fracture in the hip?
A: One can—one can rely upon it for a statement
that calcium reduces the risk of fracture at the
hip.
Q: And therefore, AdvaCal does.
A: And therefore, presumably, AdvaCal does.

24
 Dr. Heaney characterized such a contention as “not
physically possible.” He explained that the typical calcium
carbonate supplement is absorbed at a rate of 30-35%;
were AdvaCal capable of performing at the advertised rate,
its absorption value would rise to 120%. Dr. Heaney
testified that this is physio lo gi cally—and
mathematically—unattainable. In fact, Dr. Heaney stated,
“No adult that I’ve ever measured under any circumstance
would ever have an absorption value above, say, 60
percent, and that’s highly unusual.”

The Lane defendants argue that AdvaCal was not
marketed to the average individual, but rather to elderly
females, a substantial number of whom suffer from
conditions of achlorhydria and osteoporosis. Achlorhydric
individuals cannot produce stomach acid and, as a result,
absorb calcium at a rate significantly below average. In
some patients, this rate is as low as 4%. Dr. Holick
explained that it would not be unusual for an achlorhydric
individual, whose calcium absorption rate is far below 30-
35%, to absorb AdvaCal three to four times more
effectively than calcium carbonate. In such circumstances,
Dr. Heaney’s criticism is inapplicable, for an achlorhydric
patient may absorb AdvaCal three to four times more
effectively and still not attain the average absorption rate
of 30-35%.

25
 The problem with this argument is its failure to
account for the actual language of the challenged
representations. Lane Labs’ marketing did not include
phraseology limiting its claims to elderly females suffering
conditions of achlorhydria. A 2003 infomercial was
typical: “Osteoporosis now strikes women and men of all
ages, races and nationalities. But osteoporosis can be
prevented. A key is taking the right calcium and the right
calcium supplement is AdvaCal. . . . AdvaCal has been
clinically shown to be three times more absorbable than
other calciums.”14 Thus, although AdvaCal may in fact
have been targeted at a particular population segment, the
challenged representations do not, on their face, limit their

14
The record contains several additional advertisements
whose focus is not limited to elderly females suffering conditions of
achlorhydria. For example, the Lane defendants’ AdvaCal
infomercial warned that an individual’s long-term health would be
impacted by “decisions that you make as early as your thirties.”
Another promotional document states in bold letters, “It’s never too
early to act,” and describes AdvaCal as “an excellent supplement for
women of all ages [and] . . . an excellent supplement for men.” Yet
another advertisement notes that “while most of us still think of
osteoporosis as something that strikes women aged 60-plus, its
precursor, osteopenia, is beginning to appear in women of 30 or even
younger. And increasing numbers of men are also being diagnosed
with this potentially debilitating condition. . . . [T]he good news is
that there is a calcium supplement [AdvaCal] available right now that
is clinically proven to fight osteoporosis.”

26
claims to any particular target group.

The District Court did not address the incongruity
between the Lane defendants’ argument and the actual
language of the marketing claims identified by the FTC.
We consider this omission problematic, for the record
contains some evidence that AdvaCal was, as a matter of
fact, marketed toward individuals at risk of, or suffering
from, achlorhydria. Lane testified that the company
targeted “[o]lder women, [or] postmenopausal women,”
and much of its advertising generally appears to focus upon
this segment of the population. In addition, Dr. Holick’s
testimony indicates that among this population segment,
AdvaCal could be three to four times more absorbable than
calcium carbonate. The District Court credited the
testimony of both Lane and Dr. Holick, but it did not
indicate whether AdvaCal was, as a matter of fact,
marketed to elderly females at risk of, or suffering from,
achlorhyrdria.

Clearly, AdvaCal does not produce ideal outcomes
in every patient, but the question is whether Lane Labs’
claims promised results that were unattainable for large
segments of its audience. The District Court implicitly
found that they did not. Were we sitting as the finder of
fact, we likely would reach the opposite result. We are not,

27
of course, sitting as a court of first impression; rather, our
role is to review the District Court’s factual findings.
Unfortunately, our attempt to do so is frustrated by the
absence of a detailed discussion of whether Lane Labs
over-promised on results that could not be attained. In
fact, we are unable to say with certainty that the District
Court implicitly addressed these claims because the
opinion fails to discuss the AdvaCal target market, and
gives no indication that the Court considered—and
disposed of—this factual dispute. We therefore consider
it appropriate to remand so that the District Court may
address these particular claims more exhaustively.

D. AdvaCal is Comparable
or Superior to
P r e s c r i p t i o n
Osteoporosis Medicine

In 1999, Lane sent a “pitch letter” to Monica
Reinagel, who was then the editor of the Health Sciences
Institute (“HSI”) newsletter. In this correspondence, Lane
lauded AdvaCal’s potential, describing it as “a
revolutionary calcium supplement . . . that has been
clinically shown to actually build postmenopausal bone
density, without the side effects of hormonal drugs or
supplements.” HSI published an article praising AdvaCal

28
shortly thereafter. The article proclaimed, inter alia, that
AdvaCal “works as well or better than [leading prescription
drugs], and without the substantial side effects and risks.”

AdvaCal has never undergone scientific testing for
comparison with any prescription drug, and Dr. Heaney
opined that the above-described claim of
comparability/superiority was without competent or
reliable substantiation. Notably, the Lane defendants made
no attempt to dispute Dr. Heaney’s opinion, and our review
of the record has revealed no evidence supportive of this
particular marketing claim. However, the Lane defendants
argued before the District Court that the representation was
not their own, and that they had no control over the content
appearing in HSI’s newsletter. This assertion was, quite
simply, more than a stretch. And, surprisingly, the Lane
defendants persist in pressing the argument on appeal.
Lane himself acknowledged that Lane Labs paid for the
right to distribute the article, and then did so “extensively.”
It was distributed to past and current customers in direct
mailing packets and featured in retail store displays. In
short, the Lane defendants adopted HSI’s characterization
by aggressively promoting the newsletter’s content.15 They

15
The Final Order requires that the use of third party
publications in advertising and promotion not be “false, deceptive, or

29
cannot run from the representation now that its veracity has
been subjected to the spotlight.

The District Court did not address Lane Labs’
comparability/superiority claim or its use of the HSI article
to promote AdvaCal. It is therefore unclear whether the
Court found substantiation for the claim or whether it
accepted Lane Labs’ attempt to absolve itself from
propagating the representation. In either event, the District
Court’s finding was clearly erroneous; there is no dispute
that the comparability/superiority claim was unsupported
by competent or reliable scientific evidence and, by their
own admission, the Lane defendants used this claim to
market AdvaCal. Thus, this claim violates Section III of
the Final Order and the District Court’s holding to the
contrary is clear error.

misleading” under § 5 of the FTC Act, and precludes the Lane
defendants from disseminating to “any distributor any material
containing any representation prohibited by [the Final] Order.”
During cross examination, Lane acknowledged that the HSI article
constituted a third party publication.

30
 E. Fertil Male Can Cause
Sperm Count to
“Skyrocket” in as Little
as One Month

Lane Labs published an advertisement for Fertil
Male which claims, inter alia, that the supplement caused
a male customer’s sperm count to “skyrocket” after one
month’s use. This is the sole Fertil Male representation
challenged by the FTC on appeal. Although the District
Court did not discuss this specific representation, it
expressly credited the testimony of Dr. Seibel, who stated
that there was competent or reliable scientific evidence
suggesting that Fertil Male improves male fertility
parameters such as sperm count, sperm motility, and sperm
production.

The FTC attempts to overcome Dr. Seibel’s
testimony by focusing on the one-month time span
identified in Lane Labs’ advertisement. According to the
FTC, it is impossible for a fertility supplement to increase
sperm count in such a short time. The government did not
challenge this specific aspect of the Fertil Male claim
during the contempt hearing, however, and thus there is
little testimony which addresses the contention directly.
Dr. Seibel explained that the process of spermatogenesis

31
requires at least three months,16 but he did not explicate the
precise manner in which spermatogenesis is related to
changes in sperm count. Moreover, when the FTC
confronted Dr. Seibel with the print advertisement in
question, the following exchange transpired:

Q: Let’s look at the next paragraph: “The
results were dramatic. In the first
month Joe’s sperm count skyrocketed.”

Now, Doctor, in a month, Fertil Male
could not have caused the sperm count
to skyrocket because the sperm
wouldn’t have been created yet[?] . . .

A: Well, the entire impact would require a
longer time.

Q: But particularly, sperm count, you told
us that sperm takes three months to go
from inception to emission; correct?

A: To see an absolute effect, yes.

16
Dr. Seibel defined spermatogenesis as “the evolution of the
sperm into a mature sperm.”

32
The Court then attempted to clarify whether it was possible
for male sperm count to increase over the course of one
month’s time.

THE COURT: Could a male’s sperm
count increase in the first
month , or is that
something that just
couldn’t happen?

THE WITNESS: It could have happened as
part of the regression to
the mean. It could have
happened because the
sperm—the maca had
some effect inside the
testes in a way I don’t
understand.

But in general, it’s a—it’s
a three-month window.

Neither party pursued this line of questioning any further
after this exchange.

Dr. Seibel testified unequivocally that there was
competent or reliable scientific research to substantiate the
claim that Fertil Male increased sperm count. In the

33
excerpt above, he indicates that the “absolute effect” of an
increase requires a period of three months, but appears to
imply that some positive change also occurs within the first
month. The FTC declined to delve further into this inquiry
when it had the opportunity, but now asks that we set aside
the District Court’s factual findings on the basis of
testimony that is ambiguous at best. We decline this
invitation. The finding of the District Court with respect to
this marketing claim will stand.

F. Distortion of Research

According to the FTC, the District Court committed
error by finding that Lane Labs did not violate Section IV
of the Final Order. Section IV forbids express or implied
misrepresentations regarding “the existence, contents,
validity, results, conclusions, or interpretations of any test,
study or research” pertaining to “the manufacturing,
labeling, advertising, promotion, offering for sale, sale, or
distribution of any food, dietary supplement, or drug.” The
District Court’s Section IV analysis is brief. It began by
acknowledging that “some of the statements contained in
the advertising claims made by [the Lane defendants] were
incorrect,” and that “errors were made over a number of
years.” These misstatements and errors are nowhere
identified. Instead, the Court focused upon AdvaCal’s

34
general efficacy, noting that the supplement was
considered to be “a good source of calcium” and “will most
likely help the people who take [it].” The Court then
concluded that the evidence was insufficient to show that
the representations in question created a “false impression”
in violation of Section IV.

The District Court’s analysis is problematic. Section
IV of the Final Order prohibits the Lane defendants from
misrepresenting the results of research and data; it is
simply unconcerned with a product’s overall salutary
effects. That AdvaCal is efficacious in delivering calcium
to the body does not, ipso facto, preclude the Lane
defendants from misrepresenting scientific research. Nor
did the District Court’s characterization of AdvaCal as a
“good product[]” relieve it of the duty to make
particularized findings of fact germane to the purported
misrepresentations challenged by the FTC. Rather, it was
incumbent upon the Court to examine the alleged
misrepresentations in detail and to explicitly find whether
each transgressed the proscriptions of Section IV.

The District Court’s failure to provide us with a
reasoned basis for concluding that Lane Labs did not
violate Section IV prevents us from exercising meaningful
review. Many of the challenged representations appear

35
misleading on their face, and the District Court provides no
rationale for its conclusion that they are not. For example,
a direct mailing advertisement asserted, “In clinical tests
[AdvaCal] has been shown to actually increase bone
density—even in the critical hip bones . . . .” It was not
disputed, however, that the Lane defendants lacked such
clinical research. Even Lane conceded, “There are no
clinical studies on AdvaCal in the hip. . . . [W]e can’t
verify that statement.” Without any explanation from the
District Court, we are unable to determine if this claim was
even considered in its Section IV analysis. And, if it was,
it is difficult to comprehend how the representation did not
“create[] a false impression in violation of Section IV.”

Other challenged representations appear equally
misleading. Rather than speculate as to the factual basis
underlying the District Court’s ultimate conclusions, we
will return this matter to the District Court so that it may
make findings that are more specific than those presently
before us. Some of the representations are unlikely to
survive careful factual scrutiny, but we leave the initial
resolution of each issue to the District Court. The findings
pertaining to the Lane defendants’ alleged violation of
Section IV will therefore be vacated.

36
 IV.

The District Court held that even if the Lane
defendants violated Sections III and IV of the Final Order,
they were entitled to a defense of substantial compliance.
We have never explicitly recognized the validity of the
substantial compliance defense, see Robin Woods, 28 F.3d
at 399, but we note that several of our sister circuits have
done so, see Morales-Feliciano v. Parole Bd. of P.R., 887
F.2d 1, 4-5 (1st Cir. 1989); Gen. Signal Corp. v. Donallco,
Inc., 787 F.2d 1376, 1379 (9th Cir. 1986); see also Food
Lion, Inc. v. United Food & Commercial Workers Int’l
Union, AFL-CIO-CLC, 103 F.3d 1007, 1017 (D.C. Cir.
1997) (assuming substantial compliance defense “survives”
in the D.C. Circuit). Neither party has objected to the
District Court’s application of the defense, and, in fact,
both appear to proceed under the assumption that the
defense is cognizable under this Court’s jurisprudence.

In Robin Woods, we favorably referenced a decision
of the Court of Appeals for the Ninth Circuit and set forth
the two-part substantial compliance defense adopted
therein. The rule permits a party cited for contempt to
assert the defense if it (1) has taken all reasonable steps to
comply with the court order at issue, and (2) has violated
the order in a manner that is merely “‘technical’” or

37
“‘inadvertent.’” See 28 F.3d at 399 (quoting Gen. Signal
Corp., 787 F.2d at 1379). Other courts apply a variation on
this rule. The District of Columbia Circuit has stated the
defense this way: “In order to prove good faith substantial
compliance, a party must demonstrate that it ‘took all
reasonable steps within [its] power to comply with the
court’s order.’” Food Lion, 103 F.3d at 1017 (quoting
Glover v. Johnson, 934 F.2d 703, 708 (6th Cir. 1991)); see
also Salazar v. District of Columbia, 602 F.3d 431, 441
(D.C. Cir. 2010) (same). In the First Circuit, the rule is
even less definitive: “substantiality,” like reasonableness,
“depend[s] on the circumstances of each case, including the
nature of the interest at stake and the degree to which
noncompliance affects that interest.” Fortin v. Comm’r of
Mass. Dep’t of Pub. Welfare, 692 F.2d 790, 795 (1st Cir.
1982).

The Lane defendants cite to our decision in Harris
v. City of Philadelphia, 47 F.3d 1311 (3d Cir. 1995), and
urge us to adopt a substantial compliance test akin to that
which is applied in the District of Columbia Circuit. In
other words, they argue that “‘a defendant may not be held
in contempt as long as it took all reasonable steps to
comply.’” Appellee’s Br. at 42 (quoting Harris, 47 F.3d at
1324). In Harris, we were concerned not with substantial
compliance, but the defense of impossibility. The City of

38
Philadelphia was under court order to improve conditions
in its prisons; it failed to fulfill the terms of the order and
contempt sanctions were pursued. On appeal, we
recognized that “the City would have a valid defense were
it able to show physical impossibility” to comply with the
court order. Id. at 1324. We then cited authority
recognizing the impossibility defense and holding that such
a position is available only to those defendants that show
they have made “in good faith all reasonable efforts to
comply.” Id. (internal quotations omitted).

The impossibility defense necessarily requires the
defending party to assert a present inability to comply with
the relevant court order. See Hicks v. Feiock, 485 U.S.
624, 638 n.9 (1988); United States v. Rylander, 460 U.S.
752, 757 (1983). It “refers to physical impossibility
beyond the control of the alleged contemnor.”17 Inmates of
Allegheny County v. Wecht, 874 F.2d 147, 152 (3d Cir.
1989) (citing United States v. Bryan, 339 U.S. 323, 330-31
(1950)), vacated on other grounds, 493 U.S. 948 (1989).
Such an assertion will naturally precipitate judicial inquiry

17
An alleged contemnor may also argue that a change in the
law has rendered compliance illegal, even if it is physically possible.
See, e.g., Halderman v. Pennhurst State Sch. & Hosp., 673 F.2d 628,
638-39 (3d Cir. 1981). This defense is not implicated in the present
matter.

39
into the feasibility of the defendant’s compliance. See,
e.g., Spallone v. United States, 487 U.S. 1251, 1256, 1258
(1988) (rejecting impossibility defense when city had not
attempted certain extreme measures to obtain city council
compliance with court order); Harris, 47 F.3d at 1340-42
(rejecting impossibility defense when city underfunded and
understaffed court-ordered rehabilitation center, thereby
leading to its failure to comport with required standards);
Wecht, 874 F.2d at 152 (rejecting impossibility defense
when government officials took insufficient steps to enable
prison warden to comply with court order). Thus, a
tribunal that concludes that contempt is excused on
grounds of impossibility is essentially declaring that the
defendant was incapable of compliance in spite of his or
her best efforts. Substantial compliance evokes a standard
somewhat less demanding. A party substantially complies
when it takes all reasonable steps to do so, but nonetheless
contravenes the court order by good faith mistake or
excusable oversight.18 The distinction is important, for a

18
According to the FTC, the Lane defendants’ good faith
efforts to comply with the Final Order are irrelevant and should have
no bearing on the substantial compliance inquiry. This argument is
based upon a misreading of our jurisprudence. As we explained in
Robin Woods, an alleged contemnor may not invoke its good faith
efforts as a defense on the elements of civil contempt. See Robin
Woods, 28 F.3d at 399 (stating that “willfulness is not a necessary

40
party that substantially complies is physically capable of
doing so; it has simply erred in a manner for which it
would be inequitable to impose contempt sanctions.

Recognizing that we did not formally adopt the
defense of substantial compliance in Robin Woods, we do
so here. In order to avail oneself of the defense, a party
must show that it (1) has taken all reasonable steps to
comply with the valid court order, and (2) has violated the
order in a manner that is merely “technical” or
“inadvertent.” The District Court’s application of the
appropriate test for substantial compliance is a legal issue
to be reviewed de novo. See Anderson v. City of Phila.,
845 F.2d 1216, 1220 (3d Cir. 1988). Whether the alleged
contemnors took all reasonable steps to comply with the

element of civil contempt,” and that “good faith does not bar the
conclusion . . . that [the defendant] acted in contempt” (alterations in
original) (internal quotations omitted)). When assessing the
affirmative defense of substantial compliance, however, good faith
efforts inherently factor into the inquiry. See id. (considering
contemnor’s good faith efforts but nevertheless concluding that
violations were neither technical nor inadvertent); see also Food
Lion, 103 F.3d at 1017 (explaining that good faith is relevant when
assessing substantial compliance). Indeed, an “inadvertent” error is
one that is, by its very nature, made in good faith. This is not to say
that a party’s good faith efforts necessarily convert its contumacious
conduct into inadvertent violations; rather, good faith is relevant to
the substantial compliance inquiry, no more, no less.

41
court order, and the extent to which contumacious conduct
constitutes a “technical” or “inadvertent” violation, are
factual questions subject to review for clear error.
Resolution of these questions will naturally depend upon
the unique facts of each case, the nature of the conduct
precluded, and the capabilities of the parties subject to the
order.

In the instant matter, the District Court set forth the
correct standard for substantial compliance, explaining that
“[i]f a respondent has made in good faith all reasonable
efforts to comply with a court order, technical or
inadvertent violations of the order will not support a
finding of contempt.” The Court then applied this rule to
the facts, emphasizing the Lane defendants’ considerable
efforts to comply with the Final Order. In particular, the
Lane defendants submitted timely compliance reports
disclosing the representations in question; the FTC did not
respond to these disclosures and, as the Court explained,
“to tell Defendants that their efforts were not good enough
years after not advising them of any compliance issues is
disingenuous and is highly relevant to the inquiry into
whether Defendants should have done something different
in the first instance.” The Court concluded by recognizing
“that the materials relied upon by Defendants are in
hindsight not perfect,” but that “Defendants took all

42
reasonable steps to substantially comply with the [Final
Order].” It did not explicitly address the extent to which
violations of the Final Order were “technical” or
“inadvertent.”

The FTC assails this omission, arguing that the
District Court’s opinion contains no findings addressing
the second step of the substantial compliance inquiry. We
are hard-pressed to disagree. The entirety of the Court’s
substantial compliance analysis is focused upon the
reasonableness of the Lane defendants’ actions. The Court
underscores Lane Labs’ submission of compliance reports;
its retention of additional compliance personnel; and the
government’s delay in commencing an enforcement
proceeding.19 Each of these considerations inherently

19
The FTC mistakenly accuses the District Court of applying
a laches defense in favor of the Lane defendants. Although the laches
defense was briefed by the parties before the District Court, that
Court correctly characterized it as a “mis-conceptualiz[ation]” of the
issue. We are satisfied that the Court considered the FTC’s
prolonged delay in initiating contempt proceedings only insofar as it
reflected upon the reasonableness of the Lane defendants’ conduct.
Such consideration is eminently appropriate. In fact, we share the
District Court’s concerns. In 2007, the FTC accused the Lane
defendants of numerous misrepresentations, many of which were
disclosed in compliance reports as early as 2001. After providing the
government with its advertising and the research relevant thereto, the
Lane defendants heard nothing for a period of years. To construe the

43
impacts the reasonableness inquiry, but does little to
illuminate the justification for violating the Final Order.
Moreover, although the Court implicitly recognized that
some violations occurred, it neither identified this
misconduct nor explained why the conduct qualified as a
“technical” or “inadvertent” violation of the Final Order.
Absent specific findings addressing this second step of the
substantial compliance test, we are reduced to guesswork:
speculating at that which the District Court considered
contumacious conduct; speculating whether it found that
such conduct technically violated the court order, or did so
inadvertently; and speculating whether the District Court
overlooked this necessary second step and neglected to
consider the nature of the violations at all. In short, we are
unable to conduct meaningful appellate review.

Accordingly, we will vacate the District Court’s
finding that the Lane defendants substantially complied
with the Final Order, and will remand for reconsideration
consistent with the discussion set forth above.

FTC’s silence as approval was technically mistaken, but it was not
unreasonable. We are, of course, sympathetic to the FTC’s
significant regulatory and enforcement responsibilities, but delays of
this extraordinary length are inordinate. In sum, it was proper for the
District Court to consider these facts in its reasonableness assessment.

44
 V.

The District Court examined the record in its
entirety and concluded that the Lane defendants
complied with “the spirit” of the Final Order. This was
insufficient. The District Court was not petitioned for an
assessment of the general efficacy of AdvaCal and Fertil
Male. Rather, the FTC contended that specific
marketing claims were violations of two previously-
entered consent decrees. Unfortunately, the able District
Judge did not provide sufficiently detailed findings or
sufficient rationale to allow us to perform effective
appellate review. For the reasons set forth above, we
will remand this matter to the District Court for further
proceedings consistent with this opinion.

45