Case 1:04-cv-03294-CAP Document 966 Filed 10/10/17 Page 1 of 132 

UNITED STATES DISTRICT COURT 

NORTHERN DISTRICT OF GEORGIA 

ATLANTA DIVISION
 

FEDERAL TRADE COMMISSION,

 Plaintiff, CIVIL ACTION NO. 

v. 1:04-CV-3294-CAP 

NATIONAL UROLOGICAL GROUP, 

INC., et al., 

Defendants. 

ORDER 

This matter is before the court to determine whether defendants HiTech Pharmaceuticals, Inc. (“Hi-Tech”), Jared Wheat, Stephen Smith, and 

Dr. Terrill Mark Wright are in contempt for violating certain provisions of 

the court’s permanent injunctions, and, if so, what sanctions are appropriate 

to redress any violation(s) [Doc. No. 880, ¶ 17]. Although both the court and 

parties are familiar with the procedural posture of the case, the court believes 

that a brief recitation of the facts will be helpful. 

I. Case Overview 

A. The Initial Proceedings 

This civil action began over thirteen years ago when the Federal Trade 

Commission (“FTC”) filed a complaint against Hi-Tech; Hi-Tech’s Chief 

Executive Officer, Wheat; Hi-Tech’s Senior Vice President, Smith; and 
Case 1:04-cv-03294-CAP Document 966 Filed 10/10/17 Page 2 of 132 

Wright (among others) for violations of sections 5 and 12 of the Federal Trade 

Commission Act, 15 U.S.C. §§ 45(a), 52. The FTC alleged that the defendants 

had made certain unsubstantiated representations about two weight-loss 

products, Thermalean and Lipodrene. The FTC moved for summary 

judgment, and the court found as a matter of law that the defendants had 

violated the Trade Commission Act because they had not substantiated the 

representations about the products with clinical trials of the products 

themselves. See F.T.C. v. Nat'l Urological Grp., Inc., 645 F. Supp. 2d 1167 

(N.D. Ga. 2008), aff’d, 356 Fed. App’x 358 (11th Cir. 2009) (“2008 summary 

judgment order”). 

With respect to the issue of substantiation, the undisputed record at 

that time established that the defendants had “not countered the testimonies 

of the FTC’s experts regarding what level of substantiation is required for the 

claims made in this case. Accordingly, the court conclude[d] that there [was] 

no issue of fact regarding the requisite levels of substantiation . . .”, so the 

court relied upon the standard articulated by the FTC’s expert, Dr. Louis 

Aronne. Id. at 1202. According to Dr. Aronne, the type of evidence required 

to substantiate efficacy claims for weight-loss dietary supplements is 

independent, well-designed, well-conducted, randomized, doubleblind, placebo-controlled clinical trials, given at the recommended 

dosage involving an appropriate sample population in which 

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reliable data on appropriate end points are collected over an

appropriate period of time . . . conducted on the product itself. 

Id. (hereinafter “RCTs”). Notably, when adopting Dr. Aronne’s RCT standard 

of substantiation, the court rejected the ingredient studies the defendants 

had referenced in opposing summary judgment [see, e.g., Doc. No. 196, p. 56] 

to support their purported “ingredient-specific claims,” finding those 

arguments were “unavailing.” Id. at 1203 n.21. 

After granting summary judgment in favor of the FTC, the court 

determined that Hi-Tech, Wheat, and Smith were jointly and severally liable 

for consumer redress in the amount of $15,882,436.00 and that Wright was 

liable for disgorgement of ill-gotten gains in the amount of $15,454.00 for his 

participation in the deceptive marketing of the products. Id. at 1214. The 

court also held that the FTC was entitled to a permanent injunction against 

Hi-Tech, Wheat, and Smith based on the evidence that demonstrated the 

corporate defendants’ previous and ongoing violations of the FTC Act “were 

numerous and grave.” Id. at 1209. The court found that the FTC was 

entitled to injunctive relief as to Wright as well because his violations of the 

FTC Act were also significant. Id. at 1214. 

After giving the defendants an opportunity to object to the FTC’s 

proposed injunctions, on December 16, 2008, the court entered a permanent 

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injunction against Hi-Tech, Wheat, and Smith [Doc. No. 230] (“Hi-Tech 

injunction”), and a separate injunction against Wright [Doc. No. 229] 

(“Wright injunction”). 

The defendants appealed the 2008 summary judgment order. While 

the defendants’ notice of appeal states that they also appealed the final 

judgments and permanent injunctions, their briefing to the Eleventh Circuit 

revolves almost exclusively around the summary judgment order and not the 

scope of, or really anything related to, the injunctions themselves [See Brief 

of Appellants, Federal Trade Commission v. National Urological Group, Inc., 

(No. 09-10617), 2009 WL 5408404 (11th Cir.) (“Appeal Brief”); see also Reply 

Brief of Appellants, Federal Trade Commission v. National Urological Group, 

Inc., (No. 09-10617), 2009 WL 5408406 (11th Cir.)]. The Eleventh Circuit 

affirmed this court’s decision. F.T.C. v. Nat'l Urological Grp., Inc., 356 Fed. 

App’x 358 (11th Cir. 2009) (per curiam). 

B. The Initial Contempt Proceedings 

Almost two years later, on November 1, 2011, the FTC filed a motion 

for an order directing Hi-Tech, Wheat, and Smith (hereinafter “the Hi-Tech 

defendants”) to show cause why they should not be held in contempt for 

violating the Hi-Tech injunction [Doc. No. 332]. According to the FTC, the 

Hi-Tech defendants continued to make representations through a national 

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advertising campaign about four weight-loss products – Fastin, Stimerex-ES, 

Benzedrine, and a reformulated version of Lipodrene – that lacked adequate 

substantiation in violation of Sections II and VII of the Hi-Tech injunction. 

The FTC also alleged that the Hi-Tech defendants had failed to include the 

required yohimbine warning on each of the four products in violation of 

Section VI of the injunction. On March 21, 2012, the FTC filed a separate 

motion for an order to show cause why Wright should not be held in contempt 

for violating Section II of the Wright injunction by endorsing Fastin with 

unsubstantiated claims [Doc. No. 377]. 

On May 11, 2012, the court granted both motions and scheduled a 

status conference to address scheduling and discovery [Doc. No. 390] (“the 

May 11 Order”). In the May 11 Order, the court observed that, in their briefs 

in opposition to the motion for a show cause order, the defendants had argued 

that the claims surrounding the four products were substantiated by 

“competent and reliable scientific evidence,” in accordance with the 

injunctions. The court disagreed, finding that what constitutes “competent 

and reliable scientific evidence” for purposes of this case had already been 

established during the 2008 summary judgment proceedings because the 

defendants had failed to counter Dr. Aronne’s opinion that RCTs were 

necessary to substantiate efficacy claims. Consequently, the court held that 

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what constitutes “competent and reliable scientific evidence” for purposes of 

meeting the substantiation requirement of the injunctions was law of the 

case and was not subject to re-litigation. Id. at 7-10. The court later 

expounded upon its rationale, finding the doctrine of collateral estoppel 

barred re-litigation of the substantiation standard, as opposed to merely 

being the law of the case [Doc. No. 422]. 

After completing the remaining contempt proceedings prescribed in the 

May 11 Order, the court entered an order on August 8, 2013, finding that the 

FTC had presented clear and convincing evidence that the injunctions were 

valid and lawful, the terms of the injunctions were clear and unambiguous, 

and the defendants had the ability to comply but did not when they made 

unsubstantiated statements about the four products at issue [Doc. No. 524]. 

Consequently, the court found that the defendants were liable for contempt 

and proceeded with a determination regarding the appropriate sanctions. 

After a fairly expansive, four-day sanctions hearing, the court entered an 

order on May 14, 2014, holding the Hi-Tech defendants jointly and severally 

liable for compensatory sanctions in the amount of $40,000,950.00, and 

ordered Wright to pay compensatory sanctions in the amount of $120,000.00 

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[Doc. No. 650] (“contempt order”).1 The court detailed in the contempt order 

previous and ongoing contumacious conduct, noting, among other things, that 

such conduct was “troubling.” [Id.]. 

C. The Defendants’ Second Appeal 

On July 11, 2014, the defendants appealed the contempt order. The 

defendants articulated two primary arguments in their appeal: (1) that this 

court erred by holding the defendants to the RCT substantiation standard 

because that “cannot be found within the four corners of the injunction and 

was, instead, implicitly incorporated by reference from a prior ruling in the 

same case,” and (2) this court erred by relying on the defendants’ “attorneyclient privileged communications and protected work product to support its 

sanctions award.” Brief of Appellants, Federal Trade Commission v. Hi-Tech 

Pharmaceuticals, Inc., (No. 14-13131), 2014 WL 5793778, *2 (11th Cir.).2 

According to the defendants, “[t]he central issue on appeal [was] whether 

[this court] erred by applying a substantiation standard that does not appear 

within the four corners of the injunction.” Id. at *11. The defendants 

1 The sum total compensatory sanctions equaled the gross receipts for the 

sale of the four products – Fastin, Lipodrene, Benzedrine, and Stimerex-ES – 

during the time period in which the court found the defendants had engaged 

in contumacious conduct. 

2 Wright and Smith simply adopted these two primary arguments raised by 

Hi-Tech in their respective appellate briefs. 

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recognized in their briefing that they “did not appeal the contempt finding as 

to Section VI of the injunction, which required a specific warning on products 

that contained yohimbine.” [Doc. No. 829-7, p. 40]. 

The Eleventh Circuit held that both primary grounds for appeal – the 

scope of the substantiation standard and the court’s reliance on attorneyclient communications – were “premature.” F.T.C. v. Nat'l Urological Grp., 

Inc., 785 F.3d 477, 483 (11th Cir. 2015). Instead, the appellate court held 

“only that [this court] misapplied collateral estoppel when it barred Hi–Tech, 

Wheat, Smith, and Wright from presenting evidence to prove their 

compliance with the injunctions.” Id. at 483. The appellate court vacated the 

contempt order and remanded the case, instructing this court to “exercise its 

discretion to determine the admissibility of any evidence offered by the 

Commission and by the contempt defendants and make findings about 

whether any evidence of substantiation, if admissible, satisfies the standard 

of the injunctions for ‘competent and reliable scientific evidence.’” Id. 

D. The Proceedings Following Remand 

After the case was remanded, the parties submitted a proposed 

scheduling order to complete the contempt proceedings in a manner 

consistent with the Eleventh Circuit’s instructions [Doc. No. 828]. In the 

ensuing two years, the court provided both parties a full and complete 

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opportunity to identify and depose expert witnesses, who offered opinions 

relative to the issue of whether the defendants’ claims were substantiated. 

The parties also conducted expert discovery surrounding the alleged violation 

of Section VI of the injunction regarding the yohimbine warning, 

notwithstanding the fact that the defendants had already conceded that they 

did not challenge the court’s finding that they violated Section VI3 when the 

case was appealed to the Eleventh Circuit. 

At the conclusion of the expert discovery, the parties filed several 

motions to exclude opposing experts.4 Since the court is in the unique 

position of being both the gatekeeper for purposes of Daubert 5 and also the 

fact finder, it reserved ruling on the motions to exclude but will do so now 

3 See Doc. No. 524, pp. 23-24 (holding that “there is no genuine dispute of 

material fact that the advertisements do not contain the yohimbine warning 

required by Section VI of the Hi-Tech Order. . . . The defendants contend that 

there is a genuine issue of material fact as to whether they complied with the 

yohimbine-warning requirement. Wheat argues, ‘[I]t is not undisputed that 

[he] has taken no steps to include this warning in Hi-Tech’s advertising or 

labels,’ and that it was ‘an apparent oversight’ that ‘is in the process of being 

corrected.’ The injunction did not require Wheat to ‘take steps’ to include the 

warning; the order required the warning to be made. There is no question 

that the Hi-Tech defendants’ conduct violated the injunction.”) (citations 

omitted). 

4 The FTC seeks to exclude the testimony of defense experts Gerald M. 

Goldhaber, Ph.D. [Doc. No. 855] and Linda Gilbert [Doc. No. 875]. The 

defendants filed motions to exclude the following FTC expert witnesses, 

Susan Blalock [Doc. No. 858], Richard van Breeman [Doc. No. 865], and Louis

J. Aronne, M.D. [Doc. No. 866]. 

5 Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579 (1993). 

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that the court has had an opportunity to hear each witness testify in court. 

Also pending is the defendants’ motion for summary judgment seeking an 

order denying the FTC’s application for an order of contempt [Doc. No. 876]. 

For the reasons discussed in detail below, that motion is DENIED. 

With this procedural history in mind, the court turns its attention to 

the two-week bench trial following remand, which commenced on March 27, 

2017 and concluded on April 7, 2017. Given the totality of the proceedings 

and the entirety of the record before the court, it makes the following findings 

of fact and conclusions of law based on the clear and convincing evidence 

presented by the parties or otherwise stipulated.6 

6 The court reiterates here that the Eleventh Circuit opinion vacating and 

remanding the case held “only that [this court] misapplied the doctrine of 

collateral estoppel”, and the limited issue on remand is whether “any 

evidence of substantiation, if admissible, satisfies the standard of the 

injunctions for ‘“competent and reliable scientific evidence.’” F.T.C., 785 F.3d 

at 483. Therefore, the court’s findings in the contempt order that are 

unrelated to the issue of substantiation (e.g., the defendants’ control over HiTech’s marketing, the alleged violative advertising claims, etc.) were never 

disturbed on appeal. Nevertheless, since the court’s entire contempt order 

was vacated, it will again recount these other findings of fact for purposes of 

this order as they become pertinent. The court notes further that neither 

party presented any evidence during the bench trial to contradict the court’s 

earlier findings of fact that were unrelated to whether the defendants had 

satisfied the competent and reliable scientific evidence standard. Indeed, the 

defendants’ proposed findings of facts and conclusions of law do not mention 

Hi-Tech’s operations or even the purported violative advertising claims but 

rather cite almost exclusively to facts relative to the substantiation and 

yohimbine issues [See generally Doc. No. 903]. 

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II. Findings of Fact 

A. Hi-Tech’s Operations 

Hi-Tech is a Georgia corporation that manufactures and distributes a 

variety of its own branded dietary supplements (also referred to as 

nutraceuticals), including the four products that are at issue in these 

proceedings—Fastin, Lipodrene, Benzedrine, and Stimerex-ES. Each of the 

four products is marketed as a dietary weight-loss supplement. Hi-Tech sells 

these products directly to consumers, as well as through distributors and 

retailers nationwide. 

Wheat is the sole owner, President, Chief Executive Officer, Secretary, 

and Treasurer of Hi-Tech. He held these positions from January 1, 2009 

through the present, except for the period from November 2009 through April 

2010, a portion of the time in which he was incarcerated in federal prison 

after having pled guilty to criminal charges in an unrelated case for 

conspiracy to commit mail and wire fraud and to introduce and deliver 

unapproved new and adulterated drugs into interstate commerce, in violation 

of 18 U.S.C. §§ 1341, 1343, and 371, and 21 U.S.C. §§ 331(a) and (d), 

333(a)(2), 351 and 355(a). See United States of America v. Jared Robert 

Wheat, 1:06-cr-382 (N.D. Ga. 2009) [Doc. No. 685]. In total, Wheat was 

incarcerated for those criminal charges from March 16, 2009 to September 

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15, 2010. While in prison, Wheat still communicated with Hi-Tech 

employees, including details about the contents of the company’s print and 

web advertising, product packaging, and labels for the four products. 

With respect to the labeling and promoting of Fastin, Lipodrene, 

Benzedrine, and Stimerex-ES, Wheat admits that he is ultimately 

responsible for the creation of the ad content and product labeling [Doc. No. 

700-13, pp. 12, 17, 23, 28]. He also oversees the manufacturing of the 

products, and he designed the formulations. The defendants consider Wheat 

“essential to the operations of Hi-Tech.” [Doc. No. 903, ¶ 4]. Thus, Wheat 

was responsible for and had the authority to give final approval of the claims 

at issue. 

Smith contends he was “merely a salesman” in his post-trial briefing 

and, as such, did not have the requisite control over Hi-Tech and its 

advertising necessary to be subject to contempt. His arguments are 

unavailing. Relative to the time many of the alleged violative advertising 

claims were made, Smith was the senior vice-president in charge of sales of 

Hi-Tech products, including the four products at issue. In this role, Smith 

oversaw the sales force that marketed Hi-Tech products to retailers and had 

the authority to decide which retailers sold their products. Smith was also 

responsible for landing retail accounts with food stores, drug chains, and 

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mass merchandisers. He also marketed and promoted Hi-Tech products to 

retailers and distributors through brokers, who were not employed by HiTech and were crucial to Hi-Tech’s product placement. Smith made 

presentations to brokers about Hi-Tech products and pitched the products 

using the labels and packaging. Although Smith contends that Wheat was 

responsible for adding retailers who sold Hi-Tech products at the bottom of 

the print ads, Wheat obviously could not add those retailers to the ads 

without Smith first obtaining the account and then telling Wheat which 

account he had landed. 

Moreover, while Wheat was in prison, Smith oversaw the day-to-day 

operations and his job was to “hold down the fort” at Hi-Tech. As of May 24, 

2010, Wheat specifically instructed Smith, “At this time you [Smith] are the 

senior officer of HT [Hi-Tech] running day-to-day operations . . . .” [Doc. No. 

700-71, p. 3]. Even outside the time of Wheat’s incarceration, Smith helped 

to secure Fastin, Lipodrene, Benzedrine, and Stimerex-ES advertising on HiTech’s behalf with various publications and advertising agencies. To this 

day, Hi-Tech’s website claims Smith has “expertise in Hi-Tech operations and 

marketing,” which make him a valuable asset.7 Accordingly, the court finds 

7 http://hitechpharmaceuticals.com/about_corporate.php (last viewed August 

3, 2017). 

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that Smith played an integral part in Hi-Tech’s marketing and advertising 

practices, as well as product procurement and placement.8 

Dr. Wright is a physician with a primary specialty in internal medicine, 

and he has a subspecialty in bariatric medicine. Wright considers himself a 

“weight loss physician,” who provides expert endorsements for Hi-Tech’s 

Fastin product. From 2009 through 2011, Wright received compensation 

from Hi-Tech for his work assisting Wheat in advertising and endorsing HiTech products. 

B. The Pertinent Sections of the Injunctions 

The portions of the Hi-Tech injunction that the FTC contends the HiTech defendants violated are Sections II, VI, and VII. Section II prohibits the 

Hi-Tech defendants from making representations that any product is an 

effective treatment for obesity, causes rapid or substantial loss of weight or 

fat, causes a specified loss of weight or fat, affects human metabolism, 

appetite, or body fat, is safe, has virtually no side effects, or is equivalent or 

superior to any drug that the Food and Drug Administration has approved 

8 The court also notes that Smith did not submit any evidence during the 

2017 bench trial to cause the court to depart from its earlier findings in 2014 

regarding Smith’s control and ability to comply with the injunction. Indeed, 

the court does not recall Smith ever attending the 2017 bench trial, and he 

certainly did not testify during it. 

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for sale in the United States for the purpose of treating obesity or causing 

weight loss, unless 

the representation, including any such representation made 

through the use of endorsements, is true and non-misleading,

and, at the time the representation is made, Defendants possess 

and rely upon competent and reliable scientific evidence that 

substantiates the representation. 

[Doc. No. 230]. The phrase “competent and reliable scientific evidence” is 

defined in the “Definitions” section of the injunction as: 

tests, analyses, research, studies, or other evidence based on 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. 

[Id.]. Section VI of the Hi-Tech injunction requires that, “in any 

advertisement, promotional material, or product label for any covered 

product or program containing yohimbine that contains any representation 

about the efficacy, benefits, performance, safety, or side effects of such 

product,” the Hi-Tech defendants make clearly and prominently, the 

following disclosure: 

WARNING: This product can raise blood pressure

and interfere with other drugs you may be taking. 

Talk to your doctor about this product. 

[Doc. No. 230 (bold in original)]. 

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Finally, Section VII mirrors Section II in that it prohibits the Hi-Tech 

defendants from making representations about “the health benefits, absolute 

or comparative benefits, performance, safety, or efficacy” of their products, 

unless “at the time the representation is made, Defendants possess and rely 

upon competent and reliable scientific evidence that substantiates the 

representation.” [Id.] 

C. The Alleged Unsubstantiated Representations 

The FTC contends that the defendants made the following 

representations, which violate the aforementioned sections of the injunctions. 

The defendants do not materially dispute that the representations were made 

nor do they dispute the medium through which they were presented to 

consumers. The representations, as well as the time period in which they 

were made, are as follows: 

1. Fastin 

The claims relative to the Fastin product include the following: 

“EXTREME WEIGHT LOSS GUARANTEED!” (Fastin product 

packaging); 

The “World’s Most Advanced Weight Loss Aid Ever Developed!”

(Fastin print ad); 

“[A] Truly Extraordinary Weight Loss Product . . . Fastin is 

unlike anything you have ever tried before and will help you lose 

weight.” (Fastin print ad); 

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A “Revolutionary Diet Aid Taking the Market by Storm!” (Fastin 

product page, www.hitechpharma.com); 

“Fastin® is a pharmaceutical-grade dietary supplement indicated 

for weight loss in extremely overweight individuals.” (Fastin 

product packaging); 

“WARNING: EXTREMELY POTENT DIET AID! DO NOT 

CONSUME UNLESS RAPID FAT AND WEIGHT LOSS ARE 

YOUR DESIRED RESULT.” (Fastin product packaging)
 

Is an “Extreme Fat Burner.” (Fastin print ad); 

Is a “Novel Fat Burner.” (Fastin print ad); 

[I]s the Gold Standard by which all Fat Burners should be

judged.” (Fastin print ad); 

Is a “Rapid Fat Burner.” (Fastin product packaging); 

Is a “Rapid Fat Loss Catalyst.” (Fastin product packaging); 

“Curbs the Appetite!” . . . (Fastin ad); 

“Increases the metabolic rate, promoting thermogenesis (The 

Burning of Stored Body Fat).” . . . (Fastin ad); and 

“[H]as both immediate and delayed release profiles for appetite 

suppression, energy and weight loss.” (Fastin ad). 

From at least October 2010 through at least December 14, 2012, the HiTech defendants disseminated print advertisements for Fastin containing the 

representations identified above through national magazines such as Allure, 

Cosmopolitan, First, Fitness, Flex, Globe, In Touch, Life & Style, Martha 

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Stewart Weddings, Muscle & Fitness, MuscleMag International, Muscular 

Development, National Enquirer, OK, Redbook, Self, Star, US Weekly, USA 

Today Women’s Health Guide, Whole Living, Women’s Day, and Women’s 

World. In addition to magazine advertisements, the Hi-Tech defendants 

disseminated Fastin print advertisements through their company website, 

www.hitechpharma.com, through early January 2014. Since January 1, 

2009, the Hi-Tech defendants also advertised Fastin through product 

packaging and labels that also contained the representations above, through 

and including the contempt sanctions hearing the court held, beginning on 

January 21, 2014. From 2010 to 2011 Hi-Tech roughly tripled its advertising 

budget from $1.3 million to $3.9 million, which enabled it to acquire more 

retail accounts. According to Wheat, the sale of Fastin increased the most 

during this time as a result of the increased advertising budget. 

2. Lipodrene 

The claims for the reformulated Lipodrene product include: 

“Join the millions of American’s [sic] who have consumed over 1 

Billion dosages of Lipodrene® . . . And watch the pounds Melt

Away!” (Lipodrene print ad); 

“Try Lipodrene® and watch the inches melt away.” (Lipodrene 

print ad); 

“LIPODRENE WILL CAUSE RAPID FAT AND WEIGHT LOSS 

WITH USAGE” (Lipodrene product packaging); 

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“DO NOT CONSUME UNLESS FAT LOSS AND WEIGHT LOSS 

ARE YOUR INTENDED RESULT” (Lipodrene product
 

packaging); 

“[I]s the Gold Standard in the weight loss industry for one simple 

reason . . . It Works!” . . . (Lipodrene product page,

www.hitechpharma.com); 

A “Novel Fat Burner that Helps Melt Away Pounds.” . . . 

(Lipodrene print ad); 

“[A] Fat Assassin unlike any other ‘Fat Burner.’” (Lipodrene print 

ad);
 

“Hi-Tech’s Flagship Fat Loss Product with 25 mg Ephedra 

Extract – Annihilate Fat.” . . . (Lipodrene product page,

www.hitechpharma.com); and 

“[T]he right move to strip away fat.”. . . (Lipodrene product page).
 

From October 2010 through at least December 14, 2012, the Hi-Tech 

defendants advertised Lipodrene through print ads containing the aboveclaims in national magazines such as Flex, Muscle & Fitness, and 

MuscleMag International. In addition, they disseminated Lipodrene print 

advertisements through the company website through early January 2014. 

From September 17, 2010 through January 21, 2014, the Hi-Tech defendants 

advertised and offered Lipodrene for sale on the company website using these 

claims. Since January 1, 2009 through at least November 10, 2014, the HiTech defendants advertised Lipodrene through product packaging and labels. 

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3. Benzedrine 

The representations for the Benzedrine product include: 

“ANNIHILATE THE FAT WHILE FIRING UP YOUR ENERGY!” 

(Benzedrine print ad); 

“BenzedrineTM simply blows fat away!” (Benzedrine product page, 

www.hitechpharma.com); 

“The Strongest Fat Burner/Energizer Ever Produced.” . . . 

(Benzedrine print ad); 

“[T]he most potent Fat Burner/Energizer known to man.” 

(Benzedrine print ad); 

Has “Unmatched Anorectic Activity to Manage Caloric Intake.” 

. . . (Benzedrine product page, www.hitechpharma.com); and 

Is “the first anorectic supplement ever produced.” . . . (Benzedrine 

product packaging). 

The Hi-Tech defendants disseminated Benzedrine print advertisements 

containing these representations from September 2010 through at least 

November 2011 in national magazines such as Flex, Muscle & Fitness, 

MuscleMag International, and Muscular Development. They also 

disseminated the print advertisements on the Hi-Tech company website 

through early January 2014 and offered the product for sale on the company 

website using these representations through January 21, 2014. Since 

January 1, 2009, the Hi-Tech defendants advertised Benzedrine through 

product packaging and labels that also contain these representations. 

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4. Stimerex-ES 

The claims for Stimerex-ES are as follows: 

“Stimerex-ES® is hardcore stimulant action for those who want 

their fat-burner to light them up all day as their pounds melt 

away!” (Stimerex-ES print ad); 

“[U]ndeniably the most powerful, fat loss . . . formula ever 

created.” . . . (Print ad for multiple Hi-Tech products including 

Stimerex-ES); 

“[T]he Strongest Fat Burner/Energizer to ever hit the market!” 

(Stimerex-ES print ad); . . . 

“Stimerex-ES® is designed as the ultimate fat burner/energizer.” 

(Stimerex-ES product page, www.hitechpharma.com); and 

“The Ultimate Fat Burner Ever Created!” (Stimerex-ES product 

page, www.hitechpharma.com). 

The FTC also presented evidence of an advertisement containing a 

cartoon drawing that depicts an overweight woman walking through “The 

Lean Machine aka: Stimerex-ES®,” a device that looks like a metal detector 

attached to a bottle of Stimerex-ES, and emerges shapely and toned. 

The FTC further contends that the defendants made unsubstantiated 

representations that Stimerex-ES has comparable efficacy to ephedrinecontaining dietary supplements in violation of Section VII of the injunction 

through the following statements: 

“The benefits of ephedra are now ‘Back in Black!’” (Stimerex-ES 

print ad); and 

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“Don’t be fooled by the rumors, Hi-Tech’s Thermo-ZTM Brand 

Ephedra Extract does not violate any federal or state ban on 

ephedrine-containing dietary supplements. We can still provide 

you with 25mg ephedra you’ve always enjoyed.” (Stimerex-ES 

print ad). 

From October 2010 through at least December 14, 2012, the Hi-Tech 

defendants disseminated print ads for Stimerex-ES that contained the 

representations above in national magazines such as Flex, Muscle & Fitness, 

MuscleMag International, and Muscular Development. They also 

disseminated print advertisements using the company website through 

January 21, 2014. Like the other products, since September 17, 2010, the HiTech defendants advertised and offered Stimerex-ES for sale on the company 

website and this continued through January 21, 2014. From January 1, 2009 

until November 10, 2014, the Hi-Tech defendants advertised Stimerex-ES 

through product packaging and labels that contain these representations. 

5. Dr. Wright’s Endorsement 

The alleged unsubstantiated endorsement made by Wright appeared in 

a Fastin print ad: 

“As a Weight Loss Physician I am proud to join Hi-Tech 

Pharmaceuticals in bringing you a Truly Extraordinary Weight

Loss Product. I believe Fastin® is the Gold Standard by which 

all Fat Burners should be judged. Fastin® is unlike anything you 

have ever tried before and will help you lose weight!” Dr. Mark 

Wright – Bariatric (Weight Loss Physician). 

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The dates for the endorsement are the same as those relative to the HiTech defendants’ advertising of Fastin, discussed above. Wheat testified that 

Wright had reviewed the Fastin print ad containing the endorsement, Wright 

knew that he had appeared in it, and Wright had approved it. In addition to 

providing the Fastin endorsement, Wright authored articles printed in the 

Hi-Tech Health & Fitness magazine promoting Hi-Tech products. 

For the sake of brevity, the court will discuss its remaining findings of 

facts in conjunction with its analysis of whether the FTC has proven the 

defendants’ contempt by clear and convincing evidence. 

III. Discussion 

A. Civil Contempt Framework 

The parties agree that a finding of civil contempt must be supported by 

clear and convincing evidence that (1) the allegedly violated order was valid 

and lawful, (2) the order was clear and unambiguous, and (3) the alleged 

violator had the ability to comply with the order but did not. F.T.C. v. 

Leshin, 618 F.3d 1221, 1232 (11th Cir. 2010).9 The clear and convincing 

9 The court notes that it uses the past tense when referring to the injunctions 

because the court is addressing whether the defendants’ past conduct 

violated the injunctions. The court’s use of the past tense when referring to 

the injunctions and the alleged violations in this order should not be 

interpreted to mean the injunctions are no longer in effect. To the contrary, 

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standard “is more exacting than the ‘preponderance of the evidence’ standard 

but, unlike criminal contempt, does not require proof beyond a reasonable 

doubt.” Jordan v. Wilson, 851 F.2d 1290, 1292 (11th Cir. 1988). 

“Once this prima facie showing of a violation is made, the burden then 

shifts to the alleged contemnor to produce evidence explaining his 

noncompliance at a ‘show cause’ hearing.” Chairs v. Burgess, 143 F.3d 1432, 

1436 (11th Cir. 1998) (internal quotation marks omitted). “[T]he contemnor 

is ‘allowed to show either that he did not violate the court order or that he 

was excused from complying.’” Id. (citing Mercer v. Mitchell, 908 F.2d 763, 

768 (11th Cir. 1990) (explaining a “typical (although by no means exclusive) 

contempt proceeding” process)). “At the end of the day, the court determines 

whether the defendant has complied with the injunctive provision at issue 

and, if not, the sanction(s) necessary to ensure compliance.” Reynolds v. 

Roberts, 207 F.3d 1288, 1298 (11th Cir. 2000). 

B. Section II and Section VII Violations 

Applying this framework to the case sub judice, and specifically the 

defendants’ arguments surrounding the alleged violations of Sections II and 

both injunctions are still binding, and the parties are reminded of their 

continuing obligations thereunder. 

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VII,10 they posit two primary arguments: the FTC failed to carry its burden of 

establishing contempt because the injunction is not clear and unambiguous, 

and the FTC has not proved that the defendants violated the injunction 

because there is a reasonable “battle of the experts” regarding whether the 

defendants possessed adequate substantiation. These two arguments, as the 

defendants recognize in their briefing, are premised upon “many of the same 

reasons.” [Doc. No. 961, pp. 36-37]. Thus, the defendants conflate their 

arguments regarding the validity/enforceability of the injunction with the 

defendants’ explanation of their alleged noncompliance. While the 

arguments are somewhat intertwined, the court will proceed through the civil 

contempt framework discussed above, while addressing each of the 

defendants’ defenses thereto. 

1. Valid and Lawful 

Within a footnote in their post-trial briefing, the defendants 

incorporate by reference an earlier argument that the injunction is “not valid 

and enforceable” because it “incorporates a substantiation standard outside of 

10 The court focuses here on Sections II and VII because the Hi-Tech 

defendants concede that they did not place the yohimbine warning on the 

four products, as required by Section VI of the Hi-Tech injunction. Thus, the 

defendants do not contest that they violated Section VI. They instead take

issue with the appropriateness of sanctioning their noncompliance of that 

section, which the court will discuss further below. 

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its four corners . . . and . . . because it is an impermissible obey-the-law 

injunction” [Doc. No. 961, p. 31 n.14 (citing Doc. Nos. 879, 861-1)].11 While 

the defendants couch these two arguments in terms of “valid and 

enforceable,” thus appearing to challenge the first element on these grounds, 

both their “four corners” argument and “obey-the-law” argument are really 

challenges to element two: whether the injunctions are clear and 

unambiguous. Indeed, the cases the defendants cite to support their four 

corners and obey-the-law arguments discuss those defenses in the context of 

the specificity requirement of Fed. R. Civ. P. 65(d). See, e.g., S.E.C. v. Smyth, 

420 F.3d 1225, 1233 n.14 (11th Cir. 2005) (collecting cases). And, the 

Supreme Court has interpreted Rule 65(d) in terms of the clear and 

unambiguous inquiry. See Int'l Longshoremen's Ass'n v. Phila. Marine Trade 

Ass'n, 389 U.S. 64, 76 (1967); see also Drywall Tapers & Pointers of Greater 

New York, Local 1974 of I.B.P.A.T. AFL-CIO v. Local 530 of Operative 

Plasterers & Cement Masons Int'l Ass'n, 889 F.2d 389, 400 (2d Cir. 1989) 

11 The court notes that the defendants have not properly incorporated by 

reference their earlier arguments. The two docket entries they cite to 

support their “obey-the-law” argument are Doc. Nos. 879 and 861-1. Doc. No. 

879 is the FTC’s brief in opposition to the defendants’ motion for summary

judgment, which cites to contra authority from the defendants’ position. Doc. 

No. 861-1 is a certificate of service for the FTC’s reply in support of its motion 

to exclude the testimony of one of the defendants’ experts. The court will 

assume the defendants’ intended to incorporate the arguments from Doc. No. 

876-1, their motion for summary judgment. 

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(Mahoney, J., concurring in part and dissenting in part) (“The . . . element . . . 

requiring that an injunction be ‘clear and unambiguous,’ builds upon the 

requirements of Fed.R.Civ.P. 65(d).”). Therefore, the court will address both 

arguments below when addressing whether the injunctions are clear and 

unambiguous. After properly framing the defendants’ arguments, the court 

concludes that they largely do not contest the first element. Nevertheless, 

the court will examine whether the injunctions are valid and lawful since the 

defendants have invoked – albeit tenuously – a challenge that the injunctions 

are “not valid.” 

In 2008, after granting summary judgment in favor of the FTC, the 

court found that Hi-Tech’s previous and ongoing “violations of the FTC Act 

were numerous and grave.” Nat’l Urological Grp., 645 F. Supp. 2d at 1209. 

The court noted further that a risk of recurrent violations “could cause 

significant harm to consumers,” thus warranting the imposition of permanent 

injunctions against the defendants. Id. at 1209-1210 (addressing Hi-Tech, 

Wheat, and Smith); id. at 1214 (addressing Wright). The court thoroughly 

discussed both the reasons why the FTC had the authority to seek injunctive 

relief12 and why injunctive relief was appropriate in this case. Id. 

12 See 15 U.S.C. § 53(b); FTC v. Evans Products Co., 775 F.2d 1084, 1086 (9th

Cir. 1985). 

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Before entering the injunctions, however, the court gave the defendants 

an opportunity “in the interest of justice” to file objections to the FTC’s 

proposed injunctions that had been filed contemporaneously with its motion 

for summary judgment. While the defendants did file objections, they did not 

object to the FTC’s ability to seek injunctive relief, as noted in the Preamble, 

nor did they object to any of the “Findings” noted in the order that authorized 

injunctive relief [Doc. Nos. 220-221]. Moreover, when the defendants filed 

their appeal, they never challenged the imposition of injunctive relief. Thus, 

even assuming arguendo that the defendants impliedly challenged the 

appropriateness of the injunctions by appealing the 2008 summary judgment 

order, the Eleventh Circuit disposed of that challenge when it affirmed this 

court’s final judgment and order. See F.T.C. v. Nat'l Urological Grp., Inc., 

356 Fed. App’x 358 (11th Cir. 2009). In sum, the record is clear that the 

imposition of injunctive relief and the injunctions themselves were valid and 

lawful orders of the court. Cf. S.E.C. v. Pension Fund of Am., L.C., 396 Fed. 

App’x 577, 581 (11th Cir. 2010) (finding an injunction was not valid and 

lawful because the threshold requirements of entering injunctive relief had 

not been met). 

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2. Clear and Unambiguous 

Virtually the entire thrust of the defendants’ arguments surrounding 

the alleged violations of Sections II and VII of the injunctions focuses on this 

element. As noted above, they contend the FTC has failed to meet its burden 

of proving by clear and convincing evidence that the four corners of the 

injunctions were clear and unambiguous and the injunctions are 

impermissible “obey-the-law” injunctions. The court will address each 

argument in turn. 

a. The Hi-Tech Defendants’ Understanding of the 

Injunction 

The defendants have been correct throughout the entirety of these 

contempt proceedings that, for an injunction to be sufficiently clear and 

unambiguous to support a finding of contempt, Fed. R. Civ. P. 65(d) requires 

the injunction to “state its terms specifically; and . . . describe in reasonable 

detail – and not by referring to the complaint or other document – the act or 

acts restrained or required.” The FTC, as the moving party, shoulders the 

burden of proving the injunction is clear and unambiguous. 

The specificity requirement of Rule 65(d) and the “four corners” rule 

the defendants reference are functionally the same thing: “[a] person enjoined 

by court order should only be required to look within the four corners of the 

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injunction to determine what he must do or refrain from doing.” S.E.C. v. 

Goble, 682 F.3d 934, 952 (11th Cir. 2012) (citing Hughey v. JMS Dev. Corp., 

78 F.3d 1523, 1532 n.12 (11th Cir. 1996)). 

The problem with the premise of the defendants’ Rule 65(d) argument, 

however, is that they omit what follows the “[b]ut” in Goble, where the 

Eleventh Circuit continues the specificity requirement analysis: “But, we will 

not apply Rule 65(d) ‘rigidly,’ and we ‘determine the propriety of an injunctive 

order by inquiring into whether the parties subject thereto understand their 

obligations under the order.” Goble, 682 F.3d at 952 (citing Planetary 

Motion, Inc. v. Techsplosion, Inc., 261 F.3d 1188, 1203 (11th Cir. 2001)); see 

also United States v. Goehring, 742 F.2d 1323, 1324 (11th Cir. 1984) (per 

curiam ) (upholding a contempt order where the district court found the 

defendant had violated an order that had incorporated findings of an earlier 

order because the record contained “sufficient findings of fact and conclusions 

of law for [the appellate court] to perform its proper function and for the 

appellant to clearly understand the basis for the contempt order,” though 

Rule 65(d) was not specifically invoked); cf. Int’l Longshoremen’s Ass’n, Local 

1291, 389 U.S. 64 (finding the district court’s decree was invalid under Rule 

65(d), but noted, “We do not deal here with a violation of a court order by one 

who fully understands its meaning but chooses to ignore its mandate.”). 

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Stated another way, “while the preference is to enforce the 

requirements of Rule 65(d) ‘scrupulously,’ failure to abide by the precise 

terms of the Rule does not compel finding [the district court’s contempt 

judgment] void.” United States v. Sarcona, 457 Fed. App’x 806, 811–12 (11th 

Cir. 2012) (citing Combs v. Ryan's Coal Co., 785 F.2d 970, 978 (11th Cir. 

1986). Thus, the clear and unambiguous inquiry can be satisfied “if it is clear 

from the totality of the language in the various documents that the 

contemnors understood their obligations under the injunction.” Combs, 785 

F.2d at 978; see also S.C. Johnson & Son, Inc. v. Clorox Co., 241 F.3d 232, 

241 (2d Cir. 2001) (finding an injunction was not impermissibly vague 

because the district court’s prohibition was “sufficiently specific when read in 

the context” with another order the court previously had entered). 

The notion that an injunction may still be enforceable – 

notwithstanding a purported Rule 65(d) defect – if there is evidence the 

contemnors understood their obligations under the injunction makes sense 

because, as the defendants point out, the purpose of Rule 65(d) is to provide a 

putative contemnor with “fair notice” of exactly what is required of him. 

Hughey, 78 F.3d at 1531. Accordingly, the crux of the clear and 

unambiguous inquiry is whether the record contains clear and convincing 

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evidence that the defendants understood their obligations under the 

injunctions. 

Each of the Hi-Tech defendants received a copy of the Hi-Tech 

injunction on December 16, 2008. The FTC has put forth voluminous 

documentary evidence demonstrating that, after the injunctions had been 

entered and throughout the time period in which the alleged contemptuous 

advertising claims were made, both Wheat and Smith understood that in 

order for their advertising claims to be substantiated by “competent and 

reliable scientific evidence,” the injunction required RCTs of the products. A 

bulk of the evidence includes communications to and from Wheat and Smith 

while Wheat was incarcerated. The court will divide the communications 

into two separate categories – those among Hi-Tech employees and those that 

include Hi-Tech’s attorneys. 

i. Hi-Tech Defendants’ Communications 

The record contains numerous emails Wheat authored while he was 

incarcerated showing an express understanding of what the injunction’s 

substantiation standard entailed. In a March 16, 2010, email Wheat sent to 

Hi-Tech employees Jeff Jones, Brandon Schopp, and Mike Smith using the 

prison email system, Wheat stated in pertinent part: 

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With the FTC’s verdict in essence saying ‘ingredient-specific 

advertising’ is excluded from ‘valid and scientific substantiation,’ 

which is the FTC standard . . . . If the FTC verdict stands there is 

nothing we can say without doing a double-blind placebo study so

nobody would sign off on that. 

[Doc. No. 700-88, p. 3 (emphasis added)].13 Several days later, on March 22, 

2010, in an email he wrote from prison to just Smith, Wheat stated “I talked 

to Vic [Kelley] for a minute about the need for us to advertise in order to 

build Fastin more and he wants to see if he can get an opinion letter out of 

Jody [Schilleci] and Tim [Fulmer] as I think he wants to stay on a little 

longer. We will see what happens as I don’t see any of our attorneys agreeing 

on advertising especially in light of the FTC’s current position.” [Doc. No. 

700-89, p. 4]. The following day, on March 23, 2010, Wheat emailed Smith 

again, saying “. . . I believe if we are going to advertise we will need to make a 

change as Jody [Schilleci] will never sign off on those product pages nor the 

ads as the way the FTC verdict stands it would be false advertising as well.” 

[Doc. No. 700-89, p. 3]. On March 28, 2010, Wheat sent Smith another email 

13 The “verdict” Wheat was referring to could only mean the 2008 summary

judgment order [Doc. No. 219], which adopted Dr. Aronne’s RCT 

substantiation standard, because the defendants’ appeal of that order was 

still pending at the time Wheat sent the March 16, 2010, email. Although the

Eleventh Circuit had entered its judgment on December 15, 2009 affirming 

the summary judgment order, the defendants requested a rehearing, which 

was denied, and the appellate court’s mandate was not issued to this court 

until May 4, 2010 [Doc. No. 277]. 

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saying, “. . . Ullman and Shapiro are not aware of the recent ruling in the 

11th circuit against us because if the verdict stands it will allow FTC to win 

any advertisement case that a company has not done a double-blind placebo 

study on the product itself.” [Doc. No. 700-90]. 

 On July 20, 2010, during a telephone call made while Wheat was 

incarcerated, he spoke with Smith about a draft Fastin ad [Doc. No. 700-100]. 

Wheat stated that, after having looked at the injunction, “[t]here were some 

things like fat loss . . . and there’s a couple other things that we’re prohibited 

from saying. Increasing the metabolic rate was claim one. We can’t say 

that.” [Id. at 5:2-12]. During the same call, Wheat and Smith discussed HiTech attorney Ed Novotny’s suggestion to do away with the claim “warning, 

extremely potent diet aid, do not consume.” [Id. at 5:14-6:9]. Wheat stated 

during the call, “[R]apid fat loss catalyst . . . would be a claim that [the] FTC 

would have an issue on” and that with regard to the “rapid fat burner” claim, 

“we can’t say rapid, that’s part of our consent decree.” [Id. at 7:6-14; 8:19-9:1]. 

At the outset of the 2017 contempt proceedings, the Hi-Tech defendants 

renewed an objection to the admissibility of correspondence sent to and from 

Wheat during his incarceration based on the attorney-client privilege. The 

court overruled the objection at the beginning of the proceedings, and, later, 

while the proceedings were still ongoing, the court entered an order providing 

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in more detail the court’s rationale for overruling the renewed objection [Doc. 

No. 935]. When the defendants renewed their objection, however, they 

asserted a blanket objection and did not indicate specifically which 

communications they claim were cloaked under the privilege. Although the 

court has already deemed all the communications to be admissible [see id.], it 

finds that the privilege may not even be implicated with respect to the emails 

identified above and the telephone call between Smith and Wheat. 

Even if portions of some of the emails reference Hi-Tech’s attorneys, 

the court finds that “the communication was not ‘for the purpose of securing 

legal advice or assistance.’ The communications were, rather, for the purpose 

of maximizing the business value of [Hi-Tech] and [its marketing].” Capital 

Sec. Sys., Inc. v. NCR Corp., 1:14-CV-1516-WSD, 2016 WL 4191028, at *3 

(N.D. Ga. May 26, 2016). Thus, “legal advice does not predominate in many 

of the emails,” meaning the communications among the Hi-Tech employees 

are not privileged in the first place. Id. Furthermore, in light of the 

defendants’ failure to specifically identify which email communications they 

contend are privileged, the defendants have also failed to carry their burden 

of showing which communications were “for the purpose of obtaining legal 

advice, not business advice” among employees. Id. 

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Accordingly, when looking at these emails and the telephone call in 

isolation, the court finds that they clearly and convincingly demonstrate that 

Wheat and Smith knew that the only way for Hi-Tech to substantiate 

advertising claims under the injunction was to do RCTs on the products. 

ii. Hi-Tech Defendants’ Communications with 

Counsel 

In addition to the communications identified above, the record contains 

additional correspondence among the Hi-Tech defendants and their counsel, 

which might ordinarily fall under the attorney-client privilege. For the 

reasons discussed in the court’s April 5, 2017, order, however, the court 

reaffirms its findings that the attorney-client privilege objection is unfounded 

[Doc. No. 935]. These communications are even more telling of the Hi-Tech 

defendants’ understanding of the substantiation requirement under the 

injunction. 

On April 27, 2010, in an email he wrote from prison to Arthur Leach, 

Tim Fulmer, and Victor Kelley, Wheat stated: “Over the past few months, I 

have brought up the subject of advertising with Vic and he said he was not 

opposed to it. But the truth remains there is NO lawyer who could render an 

opinion that an ad is Kosher with the 11th circuit ruling” [Doc. No. 700-92, p. 

3 (emphasis original)]. On July 7, 2010, in connection with Hi-Tech’s motion 

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for a writ of certiorari to the Supreme Court, after the Eleventh Circuit had 

affirmed this court’s 2008 summary judgment order and injunctions, Wheat 

authored an email from prison to Arthur Leach and Joseph Schilleci, stating: 

“[I]f our set of facts is not good enough then a double-blind placebo study 

would be required.” [Doc. No. 700-94, p. 3]. Two days later, on July 9, 2010, 

Wheat stated in a prison email to Victor Kelley, “I agree with you about the 

website and have stayed on Jody [Schilleci] about the site. His opinion is 

anything short of a double-blind study on each product leaves HT [Hi-Tech] 

open to exposure to the FTC. I somply [sic] can not [sic] quit advertising” 

[Doc. No. 700-95, p. 3]. 

Perhaps most telling of Wheat’s and his attorneys’ understanding of the 

Hi-Tech injunction’s substantiation requirement is a letter Hi-Tech’s 

attorneys provided to Wheat while he was incarcerated. In a memorandum 

dated June 4, 2010, four Hi-Tech attorneys wrote to Wheat specifically 

warning him that several proposed Fastin advertising claims would run afoul 

of the injunction [Doc. No. 700-105, pp. 2-6] (“June 4, 2010 Memo”).14 Victor 

Kelley testified in the 2014 proceedings that his concern about the very real 

14 The court previously determined that the June 4, 2010 Memo is admissible 

for the reasons discussed in its January 20, 2012, September 18, 2012, and 

again in its April 5, 2017, orders [Doc. Nos. 365, 433, 935]. 

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potential for contempt sanctions predicated his role in drafting the June 4, 

2010 Memo to Wheat. 

Specifically, Hi-Tech’s attorneys stated in the letter that they had 

reviewed several of the proposed Fastin claims in conjunction with the HiTech injunction. Their assessment included a review of the following claims: 

“Rapid Fat Loss Catalyst, Rapid Fat Loss Thermogenic Intensifier, Increases 

the Metabolic Rate, Promoting Thermogenesis (The Burning of Stored Body 

Fat), Increases the Release of Norepinephrine and Dopamine for Dramatic 

Weight Loss, Rapid Fat Burner, DO NOT CONSUME UNLESS RAPID FAT 

AND WEIGHT LOSS ARE YOUR DESIRED RESULT” Id. at p. 3 (bold and 

italics in original). Each of these claims is included within the totality of 

claims the FTC alleges violated the injunctions, identified in full above [See 

Part II(B), supra.]. 

In their 2010 review of the claims, Hi-Tech’s attorneys noted that these 

representations “were based upon prior scientific studies on the ingredients 

in the product, rather than the product itself”, which the attorneys believed 

ordinarily would be compliant with “FTC law” [Doc. No. 700-105, p. 3]. But, 

the attorneys went on to state that this court’s findings “in the FTC 

Injunction” meant that an ingredient specific argument would be 

“extraordinarily difficult to make at this time” Id. In fact, counsel specifically 

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cautioned Wheat, “[I]t would seem unlikely that ‘ingredient specific 

substantiation’ would be considered compliant with [the competent and 

reliable scientific evidence] provision.” Id. at 5. Further, Hi-Tech’s attorneys 

specifically addressed the competent and reliable scientific evidence provision 

found in Section II of the injunction. Under that standard, counsel again 

warned Wheat, 

[I]t is safe to say that Judge Pannell did not then and would not

now find this form of ingredient specific substantiation to be 

consistent with the express language in the FTC Injunction 

requiring “competent and reliable scientific evidence.” Rather, 

based upon Judge Pannell’s previous findings, it is reasonable to 

assume that he would take a position consistent with the FTC 

that double-blind, clinical trials of the products were necessary to 

substantiate the representation. Although we certainly have not

and do not now agree with this position, at present, it is the 

premise upon which the FTC Injunction is based. 

Id. at 4 (emphasis added). Thus, Hi-Tech counsel stated a clear recognition 

that the Hi-Tech injunction required RCTs to substantiate efficacy claims. 

Counsel, therefore, expressed that it was “unlikely that in its current form 

[the proposed Fastin advertisements] would satisfy the prohibitions of the 

FTC Injunction” Id. at 4. Wheat’s counsel cautioned him further in the letter 

saying, “[I]t is our belief that if challenged by the FTC, the Fastin® 

advertisement, as presently drafted, would be found to be in violation of the 

FTC Injunction” Id. at 5. Consequently, they concluded that “the very real 

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potential for such serious consequences [such as civil and/or criminal 

penalties] should dictate [Wheat’s] decision to withhold the publication of the 

Fastin® advertisement as currently printed.” Id. 

These communications provide even more evidence that the Hi-Tech 

defendants understood the injunction to require RCTs of the products in 

order to substantiate efficacy claims. In fact, Hi-Tech’s counsel specifically 

cautioned Wheat that, if he continued forward with the Fastin 

advertisements, he could end up in the very situation he now finds himself. 

iii. The Hi-Tech Defendants’ Inactions 

In addition to the Hi-Tech defendant’s actions, the record contains 

evidence of their inactions that further demonstrate the Hi-Tech defendants 

understood their obligations under the injunction. See, e.g., Combs, 785 F.2d 

at 979 (upholding contempt of injunction, noting inter alia that “at no time 

before the trial court did [contemnors] ever complain about the adequacy of 

the consent decree . . . . They made no attempt to request more specific 

language; they chose not to exercise their right to the usual remedy for 

inadequacies of this sort: a motion for clarification or modification of the 

consent decree.”). While this court does not find the absence of seeking 

clarification on a term of an injunction dispositive on the clear and 

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unambiguous inquiry, it is simply another indication that the defendants 

understood their obligations under the injunction. 

Here, the injunctions provide for ongoing compliance monitoring and 

the record shows that such monitoring took place. If the Hi-Tech defendants 

were unsure of what constituted “competent and reliable scientific” evidence 

while the FTC was monitoring their compliance, they could have easily 

asked, but they did not. See Sarcona, 457 Fed. App’x at 812 (noting that the 

court was unpersuaded by the contemnor’s argument that an injunction 

violated Rule 65(d) because the contemnor “could have easily asked” about 

what a term of an injunction meant but did not). The only time Wheat did 

seek clarity, it was not from the FTC, but from his attorneys. Yet, when 

Wheat inquired of his attorneys whether several of the exact Fastin claims 

that are at issue in these proceedings would run afoul of the injunction, his 

attorneys not only advised Wheat that the claims were not substantiated 

because they were not backed by any RCTs, but they also specifically 

cautioned Wheat of the likelihood that he could be found in contempt of the 

injunction if he went forward with them [Doc. No. 700-105]. 

Furthermore, the defendants were given an opportunity to object to the 

scope of the injunctions before they were entered, but they did not object to 

any of the provisions they ostensibly challenge now. The definition of 

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“competent and reliable scientific evidence” found in the “Definition” section, 

as well as Sections II, VI, and VII of the FTC’s proposed injunctions – the 

four provisions that are implicated in the instant proceedings – were 

identical to the final judgments and permanent injunctions that were 

ultimately entered against the defendants [Cf. Doc. Nos. 172-30, 172-31 with 

229, 230]. Notably though, the Hi-Tech defendants did not object at all to the 

definition of “competent and reliable scientific evidence”; they objected only to 

Section II insofar as it related to Erectile Dysfunction Products, products 

which are not currently at issue; and they raised no objections of any kind to 

Sections VI and VII [Doc. No. 220]. 

Moreover, in the defendants’ 2008 appeal, they also did not challenge 

the injunctions, but rather the court’s findings at summary judgment. [See 

Appeal Brief]. Federal courts have observed, “The time to appeal the scope of 

an injunction is when it is handed down, not when a party is later found to be 

in contempt.” TiVo, Inc. v. EchoStar Corp., 646 F.3d 869, 880 (Fed. Cir. 2011) 

(citing Maggio v. Zeitz, 333 U.S. 56, 69 (1948) (“It would be a disservice to the 

law if we were to depart from the long-standing rule that a contempt 

proceeding does not open to reconsideration the legal or factual basis of the 

order alleged to have been disobeyed and thus become a retrial of the original 

controversy.”)). While, again, the court does not find the absence of a timely 

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appellate challenge dispositive, it is yet another indication of the Hi-Tech 

defendants’ understanding of the injunction. 

iv. Context 

The court can also look to the context in which the injunctions were 

entered when determining if the defendants’ obligations thereunder were 

unambiguous. “Context is often important to meaning, and so it is here.” 

Riccard v. Prudential Ins. Co., 307 F.3d 1277, 1297 (11th Cir. 2002) (finding 

the context and purpose behind the injunction assisted in interpreting terms 

contained within the injunction). 

When this court granted summary judgment in 2008, it relied on Dr. 

Aronne’s RCT standard as “competent and reliable scientific evidence” for 

this case because the defendants had failed to challenge that level of 

substantiation with their own expert evidence. After finding injunctive relief 

was proper in the same order, the court cautioned the defendants that, when 

the court imposed the injunctive relief, it “may be broader than the violations 

alleged in the complaint.” Nat'l Urological Grp., Inc., 645 F. Supp. 2d at 

1215. When the injunctions were ultimately entered several weeks later, 

they contained the very same “competent and reliable scientific evidence” 

language that was discussed in the summary judgment order. Given the 

defendants’ lack of opposition to the RCT substantiation standard, the court’s 

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adoption of that standard, and the court’s statement of its intention that 

injunctive relief might be broader than the precise violations alleged, the 

court does not find it unreasonable to interpret the injunctions’ 

substantiation requirement precisely the same way the court interpreted it 

weeks earlier at summary judgment.15 Cf. Riccard, 307 F.3d at 1297 (finding 

contempt was proper where the district court stated its purpose in imposing 

injunctive relief and the appellate court found “[t]hat purpose supports 

interpreting the injunction to cover non-judicial filings,” a term that was not 

specifically included in the injunction itself). Indeed, Hi-Tech’s attorneys 

likewise advised Wheat that it was “reasonable” for the court to find RCTs 

were necessary to substantiate future claims [Doc. No. 700-105, p. 4]. 

Contrast the foregoing with the context in which the injunction was 

entered in United States v. Bayer Corp., CV 07-01(JLL), 2015 WL 5822595 

(D.N.J. Sept. 24, 2015), a case upon which the defendants extensively and 

repeatedly rely. While the facts surrounding the litigation in Bayer are 

indeed similar to this case, the procedural posture is noticeably different. 

15 See F.T.C. v. Garden of Life, Inc., 516 Fed. App’x 852, 856 (11th Cir. 2013) 

(“In cases involving the construction of an injunction by the district court that 

entered it, however, we defer to the district court's interpretation as long as it 

is reasonable.” (citing Ala. Nursing Home Ass'n v. Harris, 617 F.2d 385, 388 

(5th Cir. 1980) (“Great deference is due the interpretation placed on the 

terms of an injunctive order by the court who issued and must enforce it.”)). 

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In Bayer, the Department of Justice sought to find Bayer, a company 

that manufactured and distributed dietary supplements, in contempt for 

violating a consent decree by making claims about its products that the 

government claimed were unsubstantiated. The district court in Bayer held 

that the RCT level of substantiation was not found within the four corners of 

the consent decree, and as such, it was not sufficiently clear and 

unambiguous for Bayer to be found in contempt. The facts giving rise to that 

holding are patently different from this case. 

First, before the consent decree was entered in Bayer, the parties 

settled the case “without adjudication of the merits of any issue of fact or 

law.” Id. at *1. Here, before the injunctions were entered, the court made 

extensive findings of fact surrounding the defendants’ advertising practices, 

and given the severity of the defendants past and ongoing practices, found 

injunctive relief was proper. 

Second, the court in Bayer noted: 

In the seven years after entering the Consent Decree, the 

Government never told Bayer . . . that drug-level clinical trials or 

[the government’s expert’s]–Level RCTs were required. Indeed, 

counsel for the Government conceded in closing argument that

“you have to go outside of the four corners of the consent decree”

in order to find support for the Government's standard. 

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Id. at *14. The facts in this case are starkly different. At no point in the nine 

years after the summary judgment order and injunctions were entered did 

anyone from the FTC tell the defendants that anything but RCTs were 

required. And, at no point in these proceedings, has the FTC taken the 

position that one has to go outside the four corners of the injunction to find 

support for the substantiation standard. 

Third, and perhaps most distinguishably, it was not until the 

commencement of the contempt proceedings in Bayer, after the injunction 

had been entered, that the government for the first time disclosed a 

substantiation standard similar to what Dr. Aronne provided in this case. Id. 

at *9 (noting that, in moving for contempt, “the Government for the first time 

disclosed the expert opinion of Dr. Loren Laine, who opined that competent 

and reliable scientific evidence for the . . . claims at issue requires a 

randomized controlled trial . . . ”) (emphasis added). Conversely, the FTC in 

this case provided Dr. Aronne’s RCT standard before the FTC moved for 

summary judgment in 2008. The defendants then had an opportunity to 

depose Dr. Aronne over the course of two days in which he was questioned 

about that standard [Doc. Nos. 186-187]. When the FTC later moved for 

summary judgment, the defendants failed to counter Dr. Aronne’s opinions, 

so the court relied upon and adopted the RCT standard. Then, after adopting 

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that substantiation standard, the court entered the injunction that had the 

same “competent and reliable scientific evidence” language as the summary 

judgment order, in which the court had already found as a matter of 

undisputed fact to mean RCTs. The timing in which the FTC’s 

substantiation standard was disclosed, the defendant’s opportunity to explore 

it, their failure to challenge it, and the court’s reliance on it, all preceded the 

date on which the injunctions were entered. These facts are noticeably 

distinguishable from those in Bayer. 

The other case the defendants principally rely upon, Garden of Life, 

Inc., supra, is inapposite for the same reasons. Although neither the district 

court nor the Eleventh Circuit discussed the timing in which the FTC’s 

experts provided the level of evidence necessary substantiate the advertising 

claims in that case, it is clear from the district court’s docket16 that the FTC’s 

experts were disclosed after it had moved for contempt against the defendant. 

Thus, similar to Bayer and unlike this case, the court in Garden of Life, Inc. 

had not adopted the government’s substantiation standard before the 

contempt proceedings began. 

 When looking at the totality of the evidence, which the defendants 

implore this court to do, the court finds that the record clearly and 

16 See F.T.C. v. Garden of Life, Inc., Case No. 9:06-CV-80226, (S.D. Fla. 2012). 

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convincingly demonstrates that Wheat understood the injunction required 

RCTs on the products themselves to substantiate the advertising claims that 

were made. The evidence also clearly shows that Smith had the same 

understanding. In fact, in Smith’s post-trial briefing he notes while 

discussing “compliance with the injunction” that “he did not have the power 

to . . . order double-blind, placebo controlled clinical trials” [Doc. No. 959, pp. 

7-8]. This statement is a tacit recognition that RCTs were required in order 

to comply with the injunction. And, pretermitting whether Smith had 

enough control to “order” RCTs of the products themselves, the court already 

found as a matter of fact that Smith had enough independent control of HiTech’s product procurement, promotion, and placement, in addition to the 

running of the day-to-day operations during the time period in question, to 

effectuate compliance. 

Wheat’s and Smith’s understanding of their obligations under the 

injunction was also not limited to just the two products that were involved in 

the 2008 summary judgment proceedings – Thermalean and Lipodrene – 

because Wheat expressly communicated with Smith and others that RCTs 

were necessary to substantiate claims for Fastin, a weight-loss product that 

was not at issue in the 2008 proceedings. In sum, to claim the Hi-Tech 

defendants believed the term “competent and reliable scientific evidence” as 

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set forth in the Hi-Tech injunction was unclear to them when the 

advertisements at issue were made is not just unsupported by the record, it is 

contradicted by it. The FTC has sufficiently carried its burden of proving the 

Hi-Tech defendants understood their obligations under the injunctions; it is, 

therefore, clear and unambiguous. 

b. Wright’s Substantiation 

Wright largely incorporates the Hi-Tech defendants’ Rule 65(d) 

arguments to claim Section II of his injunction was likewise not sufficiently 

clear and unambiguous. However, the analysis of that inquiry as to Wright is 

different than that of the other defendants. Section II of the Wright 

injunction adds a provision that is not included in the Hi-Tech injunction: 

Provided, however, that for any representation made as an expert 

endorser, Defendant must possess and rely upon competent and

reliable scientific evidence, and an actual exercise of his 

represented expertise, in the form of an examination or testing of

the product. 

[Doc. No. 229 (italics in original, bold added)]. 

The Wright injunction explicitly required him not only to possess 

competent and reliable scientific evidence when endorsing a product, but also 

to possess and rely upon “an actual exercise of his represented expertise, in 

the form of an examination or testing of the product.” Wright did not appear 

or testify in the 2017 bench trial and nowhere in any of his briefs does he 

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contend the express requirement to examine or test the product he endorsed 

was unclear or ambiguous to him. Simply incorporating and adopting the HiTech defendants’ arguments is unavailing because the two provisions are not 

identically worded. While the court believes there is sufficient evidence that 

Wright also understood his obligations under his injunction, though 

differently worded, he has not sufficiently challenged this point.17 Given the 

plain meaning of the terms contained in Section II of the Wright injunction, 

his lack of opposition and the evidence in the record, the court finds that the 

injunction is sufficiently clear and unambiguous. 

c. Law of the Case 

Putting aside all of the foregoing, the court remains unconvinced that 

the law of case doctrine is inapplicable and, as such, finds the doctrine 

provides a separate and distinct basis to conclude that the substantiation 

standard was clear and unambiguous. See, e.g., CBS Broad., Inc. v. EchoStar 

Commc'ns Corp, 472 F. Supp. 2d 1367, 1371 (S.D. Fla. 2006) (noting that, 

under the law of the case doctrine, an earlier finding in the litigation was 

17 Wright also did not object to the substantiation requirement; he did not 

appeal the scope of it; he did not seek clarity from the FTC; and the context in 

which his injunction was entered is the same as it was for the Hi-Tech 

defendants. 

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clear and unambiguous, and therefore, the court could not later limit the 

scope of an injunction because of the earlier ruling). 

Although the law of the case rule requires this court to adhere to the 

Eleventh Circuit’s remand order, the appellate court did not find this court 

erred when it originally relied upon the law of the case doctrine to preclude 

re-litigation of what constituted competent and reliable scientific evidence in 

the contempt proceedings. Instead, the Eleventh Circuit held “only that [this 

court] misapplied collateral estoppel” after “it clarified that it based its ruling 

that only clinical trials could establish ‘competent and reliable scientific 

evidence’ on the doctrine of collateral estoppel, instead of the ‘law of the 

case.’” Nat'l Urological Grp., Inc., 785 F.3d at 481 (emphasis added). The 

Eleventh Circuit has explained the differences between collateral estoppel, or 

issue preclusion, and the law of the case doctrine. See In re Justice Oaks II, 

Ltd., 898 F.2d 1544, 1550 n.3 (11th Cir. 1990). 

The law of the case “is a rule of practice, based upon sound policy that 

when an issue is once litigated and decided, that should be the end of the 

matter.” United States v. U. S. Smelting Ref. & Min. Co., 339 U.S. 186, 198 

(1950). “Under the law-of-the-case doctrine, [the resolution of] an issue 

decided at one stage of a case is binding at later stages of the same case.” 

Toole v. Baxter Healthcare Corp., 235 F.3d 1307, 1313 (11th Cir. 2000). 

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“Furthermore, the law-of-the-case doctrine bars relitigation of issues that 

were decided either explicitly or by necessary implication.” This That And 

The Other Gift And Tobacco, Inc. v. Cobb Cty., Ga., 439 F.3d 1275, 1283 (11th 

Cir. 2006) (citing Klay v. All Defendants, 389 F.3d 1191, 1198 (11th Cir. 

2004) (“Realizing that a prior decision is law of the case as to matters decided 

explicitly and by necessary implication, we find that our prior affirmation of 

the district court constitutes law of the case here . . . .”) (other citations 

omitted)); see also Wheeler v. City of Pleasant Grove, 746 F.2d 1437, 1440 

(11th Cir. 1984) (per curiam) (holding that the law of the case doctrine 

“comprehends things decided by necessary implication as well as those 

decided explicitly”) (italics in original). 

As noted above, the court found in the 2008 summary judgment 

proceedings that the defendants had failed to challenge “the testimonies of 

the FTC’s experts regarding what level of substantiation is required for the 

claims made in this case.” Nat'l Urological Grp., Inc., 645 F. Supp. 2d at 1202 

(emphasis added). The phrase “in this case” is important because the instant 

contempt proceedings are in the same case in which the court already has 

held “that some form of clinical trial must have been conducted on the 

product itself or an exact duplicate of the product.” Id. Thus, while the 

products and claims at issue in the 2008 proceedings are different from those 

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in the instant contempt proceedings, the court has already resolved the issue 

of what type of “evidence [is] required to substantiate weight loss claims for 

any product, including a dietary supplement” in this case. Id. (emphasis 

added). That resolution is from an earlier stage of the litigation, making it 

binding at this later stage of the same litigation. See Toole, supra; see also 

Sherley v. Sebelius, 689 F.3d 776, 782 (D.C. Cir. 2012) (holding law of the 

case applied to an earlier ruling from a preliminary injunction review to a 

subsequent motion for summary judgment because the ruling “was 

established in a definitive, fully considered legal decision based on a fully 

developed factual record and a decisionmaking process that included full 

briefing and argument without unusual time constraints”); Entm't Prods., 

Inc. v. Shelby Cty., Tenn., 721 F.3d 729, 742 (6th Cir. 2013) (rejecting the 

appellant’s challenges to the scope of terms of an ordinance on appeal 

because the court had previously defined those terms when ruling on a 

preliminary injunction). 

While these contempt proceedings were ongoing in 2013, Hi-Tech filed 

a declaratory judgment action against the FTC in the United States District 

Court for the District of Colombia. It sought an order “declaring that the 

term ‘competent and reliable scientific evidence,’ as used in a Final Judgment 

and Permanent Injunction issued in [this case], ‘has no fixed meaning’ and 

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‘requires case, product and claim specific adjudication and may result in 

different meanings even in the same case.’” Hi Tech Pharm., Inc. v. Fed. 

Trade Comm'n, 6 F. Supp. 3d 95, 97 (D.D.C. 2013).18 

District Judge Emmet Sullivan recounted the procedural posture of the 

case. Judge Sullivan noted that this court in the 2008 summary judgment 

order “accepted the FTC expert’s conclusions regarding the appropriate level 

of substantiation,” and that, in order to substantiate claims, Hi-Tech was 

required to conduct RCTs on the product itself or an exact duplicate of the 

product. Id. at 97. According to Judge Sullivan, “[t]hese standards were 

incorporated in a permanent injunction entered in December 2008.” Id. 

Consequently, as it related to the declaratory judgment action, Judge 

Sullivan held: 

Hi–Tech cannot circumvent Judge Pannell’s multiple rulings on 

the substantiation standard, made after years presiding over the 

case, by trying to re-litigate an already-decided question in this 

Court. Contrary to [Hi-Tech’s] allegations that the FTC has

somehow amended the substantiation standard and now requires

‘in all cases, a double blind, placebo-controlled, product specific 

study,’. . . that requirement was imposed by the Court and is the 

law of the case in the Enforcement Action. 

18 The court takes judicial notice of this other case. United States v. Jones, 

29 F.3d 1549, 1553 (11th Cir. 1994) (“[A] court may take notice of another 

court's order only for the limited purpose of recognizing the ‘judicial act’ that 

the order represents or the subject matter of the litigation.”). 

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Id. at 100 (emphasis added). Thus, Judge Sullivan not only independently 

concluded that the RCT standard had been incorporated into the injunction 

and that the law of the case doctrine prevented relitigation of that 

requirement, but he applied the doctrine to prevent precisely what the HiTech defendants were attempting to do through filing the declaratory 

judgment action: “panel shopping” the question of what constitutes 

competent and reliable scientific evidence. Klay, 389 F.3d at 1191 (noting 

one of the purposes of the doctrine is “the discouragement of panel 

shopping”). 

 Although the defendants claim that it is unjust for the court to 

impose the substantiation standard relied upon and adopted in the 2008 

summary judgment order in these contempt proceedings, the court finds it 

would be unjust not to. The defendants had a full and complete opportunity 

to challenge the substantiation standard before the summary judgment 

stage, but they did not. They instead argue now that their claims are 

substantiated by ingredient-specific studies which the court previously found 

to be unavailing. Nat'l Urological Grp., Inc., 645 F. Supp. 2d 1203 n.21. It is 

both illogical and improper for the court to unwind all of its findings of fact 

and conclusions of law from an earlier stage of the litigation and the 

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foundation upon which the injunctions now stand only to impose a totally 

different standard at a later stage of the same proceedings. 

The court agrees with the defendants’ position that RCTs may not 

necessarily be required in other FTC enforcement actions, given the FTC’s 

own guidance through its Dietary Supplements: An Advertising Guide for 

Industry (“FTC Advertising Guide”) [Doc. No. 701-3]. But, the court has 

already decided the issue of what evidence is necessary to substantiate claims 

for any products in this case, and that does not mean an RCT standard 

should be imposed on all products in all cases. See Fed. Trade Comm’n v. 

Coorga Nutraceuticals Corp., 201 F. Supp. 3d 1300, 1311 (D. Wy. 2016) 

(“While it is true . . . that the FTC’s advertising guide suggests there may be 

other evidence that could be sufficient and that a double-blind study is not 

necessarily required in all instances, the FTC has established that a human 

clinical trial is required for the claims made by Defendants.”) (emphasis 

original). 

To be clear, the court does not reference the law of the case doctrine so 

as to preclude the defendants of an opportunity to present evidence regarding 

whether they met the injunction’s substantiation standard when advertising 

the products at issue. Rather, the court references the doctrine as a means of 

demonstrating that the scope of the injunctions’ substantiation standard has 

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been a decided issue in this litigation for almost a decade, thus further 

evidencing the defendants’ understanding of their obligations under the 

injunctions. Indeed, given the voluminous evidence showing the Hi-Tech 

defendants and their attorneys similarly understood the substantiation 

standard to mean RCTs before the FTC even moved for contempt, confirms 

their implicit recognition of the appropriateness of the law of the case 

doctrine even before the court applied it. 

d. Obey The Law Defense 

The court has already expressly rejected the defendants’ arguments 

that the injunctions are invalid “obey-the-law” injunctions [see Doc. No. 422, 

pp. 7-9], and the defendants did not raise the argument in their Appeal Brief. 

Upon reviewing the defendants’ new iteration of this same argument, they do 

not point to any change in authority or circumstances to warrant this court 

departing from its earlier findings. The defendants previously cited many of 

the same cases they now rely upon (which this court previously reviewed and 

distinguished), perhaps explaining why the argument has been relegated to a 

footnote in their post-trial briefing. In any event, the court will address the 

argument again. 

Challenging an injunction on the grounds that it is an obey the law 

injunction is simply a Rule 65(d) argument, just stated in different terms. 

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See Burton v. City of Belle Glade, 178 F.3d 1175, 1201 (11th Cir. 1999) 

(stating that injunction which only instructed defendant to “obey the law” 

would not satisfy the specificity requirements of Rule 65(d)); see also Smyth, 

420 F.3d at 1233 n.14 (same). “As the name implies, an obey-the-law 

injunction does little more than order the defendant to obey the law.” Goble, 

682 F.3d at 949. Thus, an injunction that requires someone to simply obey 

the law fails to meet the specificity requirement of Rule 65(d) because those 

enjoined must know what conduct the court has prohibited. Smyth, 420 F.3d 

1225, 1233 n.14. 

As the court discussed in detail above, the defendants clearly 

understood their obligations under the injunctions. For this reason alone, 

their alternative Rule 65(d) argument fails. Even if, however, the “competent 

and reliable scientific evidence” terminology used in the injunctions is 

derived from the FTC Advertising Guide, the guide does not have the force of 

law and cannot be independently enforced by the FTC. See Perez v. 

Mortgage Bankers Ass’n, 135 S. Ct. 1199, 1204 (2015) (holding that 

interpretive rules, which are rules “issued by an agency to advise the public 

of the agency’s construction of the statutes and rules which it administers . . . 

do not have the force and effect of law and are not accorded that weight in the 

adjudicatory process”); see also Hi-Tech Pharms., Inc. v. Crawford, 505 F. 

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Supp. 2d 1341, 1351 (N.D. Ga. 2007) (explaining the difference between 

substantive and interpretive rules). The cases relied upon by the defendants 

are inapposite because they involve injunctions that incorporated substantive 

federal statutes that prohibit certain conduct regardless of whether an 

injunction is in place. Cf. Payne v. Travenol Labs., Inc., 565 F.2d 895, 898 

(5th Cir. 1978) (Title VII); Burton, 178 F.3d at 1175 (§ 1983); Goble, 682 F.3d 

948 (§ 10(b) of 15 U.S.C. § 78j(b)). Requiring the defendants to substantiate 

advertising claims with RCTs did not obligate them to simply obey the law. 

The court prohibited certain conduct, and the record is clear that the Hi-Tech 

defendants were equally aware of that prohibited conduct. See SEC v. N. 

Am. Clearing, Inc., 656 Fed. App’x 969, 972 (11th Cir. 2016) (“[A] broad, but 

properly drafted injunction, which largely uses the statutory or regulatory 

language may satisfy the specificity requirement of Rule 65(d) so long as it 

clearly lets the defendant know what he is ordered to do or not do.”). 

e. Wheat’s First Amendment Violation Claim 

In a somewhat related argument, Wheat raises a separate claim that 

imposing product-specific RCTs raises “serious First Amendment concerns.” 

Wheat goes on to state, “[U]nder the government’s substantiation standard, 

scientific certainty would be required before a company like Hi-Tech or an 

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individual like Mr. Wheat could lawfully speak about its products . . . .” [Doc. 

No. 963, p. 13]. Wheat’s argument is specious. 

The purported First Amendment violation is simply a repackaged 

argument the defendants already put forth in the 2008 summary judgment 

proceedings, which this court found the defendants to have “misapplied.” 

Nat'l Urological Grp., Inc., 645 F. Supp. 2d at 1185 (holding that “the 

defendants employ circular logic” by contending the court “must use the 

Central Hudson test—which applies only to protected speech—to determine 

whether speech is protected). Perhaps the court’s prior rejection of the 

defendants’ First Amendment violation claim is the reason Wheat concedes 

shortly after raising the First Amendment concern that the “Court need not 

wrestle with that [First Amendment] constitutional question” [Doc. No. 963, 

p. 15]. Wheat raising “serious First Amendment concerns” only to effectively 

abandon the claim in the same brief is just one example of many illustrating 

the defendants’ attempts to muddy the water with numerous and competing 

arguments to presumably divert the court from the primary question before 

it: whether the defendants are in contempt of a court order. 

The First Amendment argument overlooks the fact that the contempt 

proceedings are exactly that—proceedings to determine whether the 

defendants violated an order of the court, not whether the government is able 

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to, for example, prospectively restrain certain speech. Cf. Pearson v. Shalala, 

164 F.3d 650 (D.C. Cir. 1999) (the only case Wheat substantively relies upon, 

which notably does not involve contempt proceedings for contumacious 

conduct). By enforcing the terms of an order that prohibits certain conduct, 

this court is not attempting to restrain “a company like Hi-Tech or an 

individual like Mr. Wheat” from lawfully speaking about its products, as 

Wheat contends. To the contrary, the court is enforcing a restriction that was 

placed upon specifically Hi-Tech and specifically Wheat to prevent further 

deceptive advertising practices. See Virginia State Bd. of Pharmacy v. 

Virginia Citizens Consumer Council, Inc, 425 U.S. 748, 771 (1976) (noting 

that untruthful commercial speech “has never been protected for its own 

sake”); Bristol–Myers Co. v. FTC, 738 F.2d 554, 562 (2d Cir. 1984) 

(“[D]eceptive advertising enjoys no constitutional protection.”). 

Wheat’s “one goal” defined on the Hi-Tech website is to “produce the 

highest-quality, scientifically proven sports nutrition supplements and 

performance nutraceuticals in the world,” and they are “dedicated to setting a 

higher standard of scientific excellence for the dietary supplement 

industry.”19 Requiring Hi-Tech to substantiate its product efficacy claims 

19 http://hitechpharmaceuticals.com/about_corporate.php (last viewed August 

3, 2017). 

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with a specific level of scientific evidence did not impose any restriction on 

Hi-Tech that exceeded the high standard of scientific excellence Hi-Tech 

claims to have already imposed on itself. 

3. The Ability to Comply 

Having found the injunctions were clear and unambiguous, the court 

now determines whether the defendants had the ability to comply. Cases 

that involve a contemnor’s inability to comply with an injunction typically 

involve monetary payments that are required under the injunction. See, e.g., 

United States v. Hayes, 722 F.2d 723, 725 (11th Cir. 1984); see also Combs, 

785 F.2d at 984. Here, the record clearly establishes that the Hi-Tech 

defendants had the ability to comply with the injunctions in a number of 

ways: refraining from selling these products altogether, conducting RCTs on 

the products to substantiate the existing claims, or advertising by means 

other than asserting causal efficacy claims. As to Wright, he could have 

either not endorsed the products or substantiated the endorsement in a 

manner consistent with the injunction. The evidence clearly and 

convincingly demonstrates that the defendants had the ability to comply with 

the injunctions.20 

20 The court notes that Wheat does posit an inability defense when explaining 

his noncompliance. At this stage of the contempt framework, however, the 

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4. Whether the Defendants Complied 

Having found that the FTC has proven by clear and convincing 

evidence that the injunctions were valid and lawful, they were clear and 

unambiguous, and the defendants had the ability to comply, the court will 

determine whether the defendants violated the injunctions. 

a. The Hi-Tech Defendants 

Section II of the Hi-Tech injunction prohibits the Hi-Tech defendants 

from claiming their products “cause[] rapid or substantial loss of weight or 

fat,” or “affect[] human metabolism, appetite, or body fat,” unless those 

claims are true and are substantiated by “competent and reliable scientific 

evidence” at the time the representation was made. Section VII of the HiTech injunction prohibits “any . . . representation . . . about the . . .absolute or 

comparative benefits of any covered product or service, unless, at the time the 

representation is made, Defendants possess and rely upon competent and 

reliable scientific evidence.” 

Based on its review of the advertisements, the court finds the following: 

the Hi-Tech defendants made express claims that Fastin, Lipodrene, and 

Stimerex-ES cause rapid or substantial loss of weight; the Hi-Tech 

court focuses on the FTC’s burden and it has convincingly demonstrated that 

the defendants had the ability to comply. The court will address Wheat’s and 

the other defendants’ explanations of their noncompliance below. 

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defendants made express claims that Fastin, Lipodrene, Benzedrine, and 

Stimerex-ES cause rapid or substantial loss of fat and affect body fat; the HiTech defendants made express claims that Fastin and Lipodrene affect 

human metabolism; the Hi-Tech defendants made express claims that Fastin, 

Lipodrene, and Benzedrine affect appetite; and the Hi-Tech defendants made 

an express claim that Stimerex-ES has comparable efficacy to supplements 

containing ephedrine alkaloids. Accordingly, these claims trigger the 

substantiation requirement under Sections II and VII of the Hi-Tech 

injunction, which means that at the time the representations were made, the 

Hi-Tech defendants must have possessed competent and reliable scientific 

evidence in the form of RCTs on the products to substantiate the claims. 

When the court considers the testimony of all the defendants’ experts, it is 

clear that no one, whether retained by Hi-Tech for this case or not, performed 

an RCT of any kind on any of the four products. Although some of the HiTech defendants’ experts relied on RCTs, those clinical trials were done on 

other products, not Fastin, Lipodrene, Benzedrine, and Stimerex-ES. 

For example, Wheat purportedly relied upon the results from RCTs a 

competitor did of a product named Meltdown, a dietary supplement that has 

a different product formulation than each of the four Hi-Tech products at 

issue. The Meltdown studies fail to satisfy the RCT requirement for this case 

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because it was not done on the products themselves or an exact duplicate. 

Instead, the studies examined a dietary supplement with significantly 

different ingredients, potencies, and formulations than the four products in 

this case. Moreover, none of the Meltdown studies measured end points such 

as weight loss, fat loss, or appetite suppression and thus cannot be used to 

substantiate such claims for Hi-Tech’s products. 

Notably, Wheat did commission three RCTs on behalf of Hi-Tech, and 

he points to those studies as competent and reliable scientific evidence to 

substantiate claims for the four products. Those RCTs, however, were done 

on variants of Fastin: Fastin-XR and Fastin-RR. Consequently, these studies 

also fail to satisfy the RCT requirement for this case because they were not 

done on the Fastin product itself or an exact duplicate. Like the Meltdown 

studies, Fastin-XR and Fastin-RR have ingredients that are not common to 

Fastin, and of the common ingredients, the ingredients are not present in 

identical amounts as those in Fastin. 

Since the introduction of the Fastin-XR and RR studies, the court has 

been perplexed by the defendants’ apparent reliance on them because they 

undermine the defendants’ position. To begin with, they clearly do not 

constitute competent and reliable scientific evidence for purposes of this case 

because they were not done on Fastin or an exact duplicate of it. 

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Moreover, Hi-Tech commissioning an RCT dismantles their argument 

that RCTs are fiscally and temporally unviable. Completing RCTs on 

different products clearly shows the defendants had the means and 

opportunity to conduct RCTs on the four products at issue, but simply did 

not. Dr. Jacobs, who performed the tests, was essentially on a retainer 

during the time period at issue and was qualified, at least from the 

defendants’ perspective, to conduct the clinical trial. Wheat previously 

testified that he paid Dr. Jacobs “around $42,000” to complete the Fastin-XR 

metabolism study [Doc. No. 619, 49:12-50:1]. Assuming Wheat had 

commissioned a similar study of Fastin to substantiate claims for that 

product, the price for the study would be an infinitesimal portion of the 

$29,510,292 of billings Hi-Tech made on Fastin during the time period in 

question [Doc. No. 905]. Hi-Tech was clearly able to afford RCTs on the four 

products at issue because it did them for other products. Hi-Tech was also 

able to commission the RCTs for Fastin-XR and RR in time to make claims 

for those products without them becoming obsolete. Indeed, Wheat admitted 

in an email to Smith on March 28, 2010, that “[Hi-Tech] could get a [RCT] 

study done in 3-4 months if we had to . . . .” [Doc. No. 700-90, p. 3]. 

Furthermore, if the Hi-Tech defendants believed RCTs were not 

necessary to substantiate efficacy claims, as they claim, the court questions 

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why they were done at all. Wheat testified in the 2014 proceedings that he 

had asked Dr. Jacobs to conduct the Fastin XR study because he “wanted to 

be able to make some real claims, some claims as to what the product does 

rather than generalities. . . . I wanted to make much more certain 

advertisements.” Id. at 50:2-8. Yet, when the Hi-Tech defendants attempt to 

substantiate the claims for Fastin and the other three products, they point to 

RCTs of different products, containing different product ingredients, having 

different formulations, during a different time period. The court can only 

presume the Hi-Tech defendants chose not to commission RCTs of the four 

products at issue because of the concern that they might not receive the 

desired outcome necessary to corroborate the claims that they had made. Of 

course, the court does not know whether any such study would provide the 

data to support the causal efficacy claims made for these four products, which 

is precisely why those claims remain unsubstantiated. The record is devoid 

of any evidence that the Hi-Tech defendants relied upon RCTs to 

substantiate the advertising claims for the four products. The claims are 

unsubstantiated and thus violate the Hi-Tech injunction. 

b. Wright 

Section II of the Wright injunction requires that, in addition to 

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Tech product, Wright also rely on “an actual exercise of his represented 

expertise, in the form of an examination or testing of the product.” Wright 

has not pointed to any evidence showing he tested Fastin before endorsing it. 

He does claim, however, that he examined the product through an analysis of 

the particular ingredients [Doc. No. 483, ¶ 22]. In his declaration the court 

assumes he relies upon to support this statement,21 Wright does not include 

any details about actually examining or testing the Fastin product. Rather, 

he simply refers to ingredient studies that Wheat also purportedly relied 

upon and then claims, in conclusory fashion, that those studies constitute 

competent and reliable scientific evidence. Wright’s averments do not 

reference any actual testing or examination of the specific ingredients, 

quantities of ingredients, or formulations in Fastin. Nor does Wright explain 

how, based on an actual exercise of his represented expertise in bariatrics, 

the specific ingredients within Fastin substantiate his endorsement that 

Fastin is, for example, an “extreme fat burner.” Surprisingly, Wright even 

states in another declaration that he “did not believe that the Injunction 

21 Wright cited to Doc. No. 372-2, ¶¶ 6-9 to support the statement, but that 

document is a declaration of Wheat and offers no explanation of Wright’s 

purported examination. The court assumes Wright intended to cite to Doc. 

No. 372-1, which is Wright’s earlier declaration he submitted in opposition to 

the FTC’s motion to show cause why the defendants should not be held in 

contempt. 

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required testing on the product itself,” which is a pronouncement of his 

candid refusal to comply with that provision [Doc. No. 483, ¶25]. The court 

finds Wright’s endorsement of Fastin violated his injunction. 

5. Explanation for Noncompliance 

Since a prima facie showing of a violation has been made, the burden 

shifts to the defendants to explain their noncompliance. Chairs, 143 F.3d at 

1436. The Supreme Court has made clear, however, that “[t]he absence of 

wilfulness does not relieve from civil contempt.” McComb v. Jacksonville 

Paper Co., 336 U.S. 187, 191 (1949). The Eleventh Circuit has similarly 

recognized that “substantial, diligent, or good faith efforts are not enough; 

the only issue is compliance.” Leshin, 618 F.3d at 1232 (citing Combs, 785 

F.2d at 984; Newman v. Alabama, 683 F.2d 1312, 1318 n.16 (11th Cir. 1982)). 

a. Wheat’s Noncompliance 

Wheat contends in his post-trial briefing that Dr. Aronne has offered 

conflicting testimony regarding the size and scope of the RCTs necessary to 

substantiate efficacy claims. The original standard provided by Dr. Aronne 

in the 2008 proceedings, according to Wheat, required a clinical trial similar 

to a Phase III drug trial, which needed up to one thousand test subjects over 

an eighteen-month period. Wheat estimated that study would cost Hi-Tech 

$600 million per product to complete. In the 2017 proceedings, however, 

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Wheat claims Dr. Aronne testified that a smaller RCT, having no less than 30 

subjects per arm22 over a six-month period, would constitute competent and 

reliable scientific evidence. Wheat claims that “had he been aware that he 

only needed to meet the Aronne Standard version [i.e. the smaller and 

shorter RCT] . . . he would have acted differently.” [Doc. No. 963, p. 11]. 

Wheat referred to Dr. Aronne’s supposed conflicting RCT standard as a 

“moving goalpost,” which was “problematic and inhibited [Wheat’s] ability to 

comply with the Injunction” Id. at 10. Thus, Wheat effectively argues that, 

while he may have had a “general notice of the RCT requirement,”23 he was 

unable to comply because the RCT standard itself was unclear.24 

Where, as here, the putative contemnor claims an inability defense, he 

“must go beyond a mere assertion of inability.” Hayes, 722 F.2d at 725. 

“Rather, in this circuit, a party subject to a court’s order demonstrates 

22 An “arm” of a clinical trial is another word for a group of test subjects. For 

instance, if a clinical trial tests a compound against a placebo, the study 

would have two arms: a compound group and a placebo group [Doc. No. 945, 

55:18-56:2]. 

23 Doc. No. 963, p. 10 n.2. The court notes here that Wheat’s admission in his 

post-trial brief of having general notice of the RCT standard is yet another 

example that Wheat did not have to go outside the four corners of the 

injunction to understand his obligations. 

24 Wheat appears to have asserted this argument primarily to support his 

lack of specificity challenge under Rule 65(d). The court rejects that 

argument for the reasons discussed in Part III(B)(2) supra. Since Wheat has 

also raised the argument to explain his noncompliance, the court will address 

it in that light herein. 

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inability to comply only by showing that he has made ‘in good faith all 

reasonable efforts to comply.’” United States v. Roberts, 858 F.2d 698, 701 

(11th Cir. 1988) (citing United States v. Rizzo, 539 F.2d 458, 465 (5th Cir. 

1976)). The Eleventh Circuit “construe[s] this requirement strictly,” thus 

making it a “high standard” to overcome. Combs, 785 F.2d at 984; see also 

Hayes, 722 F.2d at 725 (finding that not even “some effort” was enough to 

support an inability to comply defense). 

The premise of Wheat’s reason for noncompliance – that Dr. Aronne 

provided conflicting RCT standards – is unsupported by the record. Dr. 

Aronne testified in the 2017 proceedings that the minimum number of 

participants one could have in a clinical trial in order to show efficacy is “30 

subjects in each arm” [Doc. No. 945, 55:6-17]. Wheat claims that number is 

inconsistent with Dr. Aronne’s opinion from his original expert report, which 

states “side effects may occur at a rate of 1 in 1000 subjects studied would not 

necessarily be discoverable in a small study of 20 or 40 subjects. In fact, side 

effects that may occur at an even higher incidence rate of 1 in 100 subjects 

studied may still not necessarily be discoverable in such small studies” [Doc. 

No. 946, 35:14-36:5]. This appears to be Wheat’s basis for claiming that Dr. 

Aronne initially opined that RCTs involving thousands of enrollees were 

required. Such an argument is unfounded for a number of reasons. 

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First, the opening sentence to the paragraph of Dr. Aronne’s report 

from which Wheat pulls the moving goalpost theory plainly states, “[T]here is 

no one magic number of subjects for scientific studies.” Hi-Tech’s counsel 

made clear during the 2017 cross examination of Dr. Aronne that the three 

different versions of his expert reports throughout the years of this litigation 

have remained unchanged [Doc. No. 946, p. 36]. Therefore, Dr. Aronne has 

always held the opinion that there is no “magic number” of participants. 

Second, Dr. Aronne’s opinion regarding larger studies of 1,000 subjects 

very clearly pertained to trials that measured “side effects” associated with 

the product. None of the purported violative advertising claims Hi-Tech 

made were claims about the products having virtually no side effects. Thus, 

it is neither the FTC’s nor Dr. Aronne’s position that a study size of 1,000 

people is necessary to substantiate the efficacy claims that were made. 

Third, when asked what Dr. Aronne would consider the minimum 

number of subjects necessary to show the effectiveness of a product, Dr. 

Aronne clearly testified both in his 2016 deposition and in the 2017 bench 

trial that thirty people per arm would be sufficient. Hi-Tech’s counsel 

attempted to impeach Dr. Aronne during the 2017 bench trial by claiming he 

previously opined in his deposition that 200 subjects were necessary to 

establish efficacy claims [Doc. No. 866-4, 199:24-202-18]. But, as Dr. Aronne 

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explained during his deposition and at the bench trial, that figure would be 

the minimum necessary to determine efficacy, as well as side effects. In fact, 

during the same line of questioning that Hi-Tech’s counsel omitted from his 

attempted impeachment during the 2017 proceedings, counsel asked Dr. 

Aronne if he agreed that a trial could be smaller than 200 if one was only 

trying to determine efficacy, and Dr. Aronne agreed. Elsewhere in the 

deposition, Dr. Aronne specifically testified consistent with his in-court 

testimony that a clinical trial having only thirty subjects per arm would be 

sufficient [Doc. No. 866-4, 45:20-46:19]. 

Fourth, Dr. Aronne was first deposed in 2006, and Hi-Tech’s counsel 

questioned him about the RCT standard. Defense counsel has not pointed to 

any 2006 testimony where Dr. Aronne was asked what he believed the 

minimum number of subjects would be needed to substantiate causal efficacy 

claims, and the court, after reviewing the deposition testimony, is also 

unaware of any such opinion [Doc. No. 186-187]. Therefore, Dr. Aronne did 

not originally set some unattainable number of study subjects only to reduce 

that figure in the contempt proceedings as part of some gamesmanship to 

claim that Hi-Tech could have easily complied but did not. Rather, it was HiTech, who took a snippet from Dr. Aronne’s report after the FTC moved for 

contempt, and claimed Dr. Aronne had advocated an RCT of similar 

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proportion to a pharmaceutical drug trial was the only the type of evidence 

Hi-Tech could rely upon for efficacy claims. And, because Hi-Tech could not 

afford such an RCT that Wheat speculated would cost $600 million, its 

noncompliance should be excused. 

However, the record is devoid of any evidence demonstrating Wheat 

made any effort, much less “all reasonable efforts,” to perform an RCT of any 

size or duration on the products at issue. Neither he nor any of the Hi-Tech 

defendants sought clarity from Dr. Aronne or the FTC to clear up any 

apparent confusion he had about the size of the trial needed. Wheat also did 

not present any evidence of even an attempt to commission an RCT. He 

instead chiefly relied upon ingredient specific studies, which Dr. Aronne had 

rejected, and this court previously found to be unavailing. Hi-Tech then, 

perplexingly, commissioned RCTs of different products. Since those studies 

were not done on any of the four products at issue, the only probative value of 

such evidence is to show Hi-Tech had the wherewithal to complete RCTs but 

chose not to for these four products. Had Hi-Tech completed RCTs on the 

four products and the FTC’s experts challenged the veracity of those clinical 

trials, the court would likely agree with the defendants that this case 

amounted to a battle of the experts. But, those are not the facts before the 

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court. Hi-Tech was not even playing on the same field on which the 

purported moving goalpost was located. 

It bears repeating that Hi-Tech was required to complete RCTs to 

substantiate the causal efficacy claims that were identified in the injunction. 

Hi-Tech could have foregone these trials altogether by not making as brazen 

of claims as it did, like guaranteeing “extreme weight loss,” comparing Fastin 

to a “pharmaceutical-grade dietary supplement indicated for weight loss,” or 

warning consumers not to take the product unless “rapid fat and weight loss” 

were the desired result. 

The record is clear that Wheat knew RCTs were required, and he 

admits as much in his post-trial brief. Yet, Wheat and Hi-Tech did nothing 

at all, a far cry from “all reasonable efforts,” to effectuate compliance with the 

RCT requirement. In fact, the evidence in the record demonstrates that 

Wheat decided to disregard his attorney’s advice, which sternly cautioned 

him against making several of the claims, and the express requirements of 

the injunction. An email Wheat sent from prison shortly after learning the 

Eleventh Circuit had denied Hi-Tech’s petition for rehearing on the appellate 

court’s opinion affirming the 2008 summary judgment order and injunctions 

provides a glimpse into his reasoning: “I [Wheat] believe the FTC will 

probably not start their enforcement until after the Supreme Court rules. In 

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the meantime I am going to go for broke advertising Fastin and HT [Hi-Tech] 

products.” [Doc. No. 700-92, p. 3]. It was time to “swing for the fence” Id. 

Wheat has failed to support his inability defense with any credible 

evidence. His explanation does not relieve him from contempt. 

b. Smith’s Noncompliance 

Smith contends he could not effectuate compliance with the injunction 

because he did not have the requisite control. The court has already rejected 

the contention that Smith did not have sufficient control in the initial 

findings of facts. The court similarly rejects that contention here for the 

reasons enumerated above. 

c. Wright’s Noncompliance 

Wright’s attempt at excusing his noncompliance is that his 

endorsement is adorned with puffery, so those claims are not actionable. 

Wright’s argument is unsupported. This court has observed that 

representations generally attributed to puffery include “general opinion . . . 

such as a representation that [the product] is ‘the best’ or ‘superb,’ or other 

subjective, imprecise representations.” In re Wright Med. Tech. Inc., 

Conserve Hip Implant Products Liab. Litig., 178 F. Supp. 3d 1321, 1359 n.25 

(N.D. Ga. 2016), aff'd in part sub nom. Christiansen v. Wright Med. Tech., 

Inc., 851 F.3d 1203 (11th Cir. 2017). Here, Wright, like the other 

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defendants,25 made express causal efficacy claims that the product(s) burned 

fat and caused weight loss, for example. Thus, unlike the claims in Basic 

Research, L.L.C. v. Cytodyne Techs., Inc., 2:99-CV-343K, 2000 WL 33363261, 

at *9 (D. Utah Dec. 20, 2000) – an extrajurisdictional case, and the only case, 

upon which Wright and the Hi-Tech defendants rely – the representations in 

the Fastin endorsement and the other product advertisements are not “the 

type of blustering and boasting on which no reasonable person would rely.” 

Id. While the court agrees that some of the claims, including the Fastin 

endorsement, may contain puffery, those claims were “based on the factual 

predicate” that the products actually caused weight loss, fat loss, etc. In re 

Wright, 178 F. Supp. 3d at 1359 n.25. As the court noted in the 2008 

summary judgment order, “[t]he fact that puffery is present cannot serve as a 

shield for the advertisements’ deceptive, factual representations . . . puffery is 

not a justifiable defense.” Nat'l Urological Grp., Inc., 645 F. Supp. 2d at 1206. 

The court was not “persuaded by the single paragraph the [defendants] 

devoted to this argument” in 2012, and the court remains unpersuaded by the 

25 Because the Hi-Tech defendants discuss puffery in their briefing – albeit 

more indirectly – the court rejects their argument for the same reasons 

discussed herein. 

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single paragraph they devote to the argument now.26 Wright has failed to 

explain his noncompliance; he also cannot be relieved from contempt. 

6. The Defendants Violated Sections II and VII 

After a careful review of the parties’ arguments and the record and 

applying them to this Circuit’s civil contempt framework, the court finds the 

FTC has established by clear and convincing evidence that both the Hi-Tech 

and Wright injunctions were valid and lawful; Sections II and VII of the HiTech injunction and Section II of the Wright injunction were clear and 

unambiguous; and the defendants had the ability to comply with those 

respective provisions but did not. The defendants failing to satisfy the 

“competent and reliable scientific evidence” standard of the injunctions by not 

possessing substantiation evidence in the form of RCTs of the four products 

themselves authorizes a finding of contempt. 

C. The Expert Testimony Surrounding the Substantiation Requirement 

Rather than relying upon RCTs of the products themselves, the 

defendants claim to have relied upon numerous other scientific studies that 

they contend constitute “competent and reliable scientific evidence.” This 

reliance further belies the defendants’ assertion that the injunctions were not 

sufficiently clear and unambiguous because the defendants evidently 

26 Doc. No. 390, pp.6-7. 

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recognized the need to possess “competent and reliable scientific evidence,” 

just not the same type of evidence the FTC claims (and the court agrees) was 

and continues to be required under the injunctions. Yet, even if the court 

were to credit the defendants’ position as to what type of “competent and 

reliable scientific evidence” was necessary to comply with the injunctions – as 

advocated by the defendants at the 2017 hearing – the inquiry does not end. 

In other words, even if the court agreed with the defendants’ stated 

understanding of what type of evidence they must possess to comply with the 

injunctions, the defendants would still be in contempt if that evidence does 

not substantiate the claims they made. 

The phrase “competent and reliable scientific evidence” and the word 

“substantiates” are contained within the same sentence in both Sections II 

and VII of the injunctions, thus requiring the defendants to “possess and rely 

upon competent and reliable scientific evidence that substantiates the 

representation” [Doc. Nos. 229, 230]. As noted above, “competent and reliable 

scientific evidence” is defined in the injunction. The term “substantiates” is 

not explicitly defined, but it is a word of ordinary meaning. To substantiate 

means “[t]o prove the truth of (a charge, claim, etc.).” Substantiate, OXFORD 

ENGLISH DICTIONARY (June 2017). Tying all of this together, when the 

defendants made claims that triggered Sections II and VII of their respective 

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injunctions, to avoid violating those sections, they needed to not only possess 

“competent and reliable scientific evidence” at the time the representations 

were made, but that evidence must also prove the truth of the claims 

asserted. 

The defendants devote a majority of their attention to the issue of 

whether the studies they relied upon constitute “competent and reliable 

scientific evidence,” but when discussing whether that evidence actually 

“substantiates” the claims, their experts shy away from that word and use 

others like “aid” and “support.” While the difference may be seemingly 

minor, the court finds that it is not simply a coincidence. Selectively relying 

upon the word “possess” untethered to the words that follow –“that 

substantiates the representation” – excludes a central requirement of the 

injunctions and one of the primary reasons they were issued in the first place. 

Accordingly, if the court, in “exercis[ing] its discretion to determine the 

admissibility of any evidence offered by the Commission and by the contempt 

defendants,” finds that the defendants’ reliance materials do not actually 

substantiate the defendants’ claims, a finding of contempt is appropriate. 

Nat'l Urological Grp., Inc., 785 F.3d at 483. 

Before discussing the expert testimony in more detail, the court 

reiterates that both the 2014 and 2017 contempt proceedings were bench 

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trials, which means the court is in the unique position of being both the fact 

finder and gatekeeper for expert testimony. To that end, the court must not 

only examine each expert’s testimony through the lens of Daubert and its 

progeny, but it must also weigh the testimony of each expert in the court’s 

role as fact finder. The court recognizes that the primary purpose behind 

Daubert of protecting a jury from unreliable expert testimony is relaxed when 

the court is making both the reliability and fact finding determinations itself. 

See United States v. Brown, 415 F.3d 1257, 1270 (11th Cir. 2005). 

 The court will review the testimony of each expert to demonstrate why 

it believes the defendants’ claims have yet to be proven and, thus, why they 

are unsubstantiated. Before discussing the FTC’s expert evidence, the court 

will address the defendants’ pending motions to exclude. 

1. Dr. Aronne 

The defendants moved to exclude Dr. Aronne’s opinions before the 2017 

bench trial commenced [Doc. No. 866]. In their motion, the defendants do not 

challenge Dr. Aronne’s qualifications and recognize that he is a “wellrespected physician.” Given their lack of opposition, the court does not need 

to discuss Dr. Aronne’s qualifications in great detail. Dr. Aronne is qualified 

as an expert in the fields of weight loss and obesity. 

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Turning to the defendants’ primary argument to exclude Dr. Aronne’s 

testimony, they claim his opinions are not helpful. The court readily finds 

that argument baseless. In order to analyze whether the defendants 

complied with the injunctions, the court must determine what constitutes 

“competent and reliable scientific evidence” sufficient to substantiate the 

defendants’ causal efficacy claims and whether the studies the defendants 

relied upon meet that standard. Dr. Aronne addresses both of these issues 

precisely and in great detail. He articulated at the beginning of this case that 

RCTs are necessary to substantiate causal efficacy claims. The court, as 

discussed in extensive detail above, adopted that standard, which the 

Eleventh Circuit affirmed on appeal. That standard has remained 

unchanged throughout the course of this litigation, so his opinions in the 

current proceedings are not a departure from what this court has already 

found to be helpful and credible. Moreover, Dr. Aronne does not only opine as 

to the appropriate “competent and reliable scientific evidence” standard, but 

he also addressed in detail the scientific evidence the defendants relied upon 

and explained why that evidence does not substantiate the claims. Dr. 

Aronne plainly addressed the issues before the court. 

While the defendants also claim that Dr. Aronne’s testimony is 

unhelpful because it is based on his “personal opinion” from “his own practice 

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and experience,” the court finds that this argument similarly lacks merit. 

Not only does Fed. R. Evid. 702(a) specifically allow for an expert to opine 

based upon his “knowledge, skill, experience, training, or education,” but the 

competent and reliable scientific evidence standard is explicitly defined in the 

injunction as “evidence based upon the expertise of professionals in the 

relevant area.” Thus, to answer the question of what level of evidence 

experts in the field require to substantiate causal efficacy claims, Dr. Aronne 

drew upon his experience in the field. Contrary to the defendants’ contention 

that Dr. Aronne’s “personal” opinion conflicts with the “context-specific” 

flexible standard of the FTC’s Advertising Guide, his opinion is consistent 

with the Guide [Doc. No. 701-3]. By its very nature, the Advertising Guide 

does not address a specific type of dietary supplement and specific types of 

claims for those products. It is merely a guide. Even so, the Advertising 

Guide provides that, “[a]s a general rule” RCTs are “the most reliable form of 

evidence” when substantiating claims, which is entirely consistent with Dr. 

Aronne’s opinions. Id. at 10. 

The court finds that Dr. Aronne “employ[ed] in the courtroom the same 

level of intellectual rigor that characterizes the practice of an expert in the 

relevant field.” Kumho Tire v. Carmichael, 526 U.S. 137, 152 (1999). The 

defendants’ motion to exclude his testimony [Doc. No. 866] is DENIED. 

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2. Richard van Breemen, Ph.D. 

The defendants moved to exclude the FTC’s other substantiation 

expert, Dr. van Breemen, because they claim his opinions are also not 

helpful. The court again disagrees. As the FTC pointed out in opposing the 

motion to exclude, the defendants’ expert witnesses criticized Dr. Aronne 

because the RCT standard he proposed is not, as they claim, the standard 

that experts in the “dietary supplement field” recognize because Dr. Aronne’s 

expertise is in weight loss and obesity, not dietary supplements. The FTC 

states that it retained Dr. van Breemen for the purpose of rebutting those 

contentions. Rebuttal testimony is helpful to the trier of fact, and, sitting as 

such, the court finds Dr. van Breeman’s testimony helpful. 

Dr. van Breemen rebuts the notion that experts in the field of dietary 

supplements do not require product-specific RCTs to prove that a supplement 

is efficacious. To support that opinion, Dr. van Breemen cited to both his 

experience and that of other researchers of dietary supplements. Dr. van 

Breemen also rebuts the defendants’ assertion that RCTs are impracticable 

because such trials cost hundreds of millions of dollars, as Wheat claims. Dr. 

van Breemen described numerous examples of experts in his field doing 

precisely what Wheat and Hi-Tech’s experts claimed to be virtually 

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impossible. Dr. van Breemen also offered opinions challenging the 

defendants’ purported substantiation, which the court finds helpful. 

The defendants also contend that Dr. van Breemen is not qualified to 

render opinions as to either the substantiation standard or the feasibility of 

RCTs for dietary supplements. This court has recognized that “it is not 

necessary that the witness be recognized as a leading authority in the field in 

question . . . . Gaps in an expert witness’s qualifications or knowledge 

generally go to the weight of the witness's testimony not its admissibility.” 

Leathers v. Pfizer, Inc., 233 F.R.D. 687, 692 (N.D. Ga. 2006). As noted above, 

experts can be qualified in “various ways,” and “the plain language of Rule 

702 makes this clear: expert status may be based on ‘knowledge, skill, 

experience, training, or education.’” United States v. Frazier, 387 F.3d 1244, 

1260-61 (11th Cir. 2004). 

Dr. van Breemen is qualified to offer the opinions he provided in this 

case. He obtained a Ph.D. in pharmacology from Johns Hopkins University 

and is currently a Professor of Pharmacy at the University of Illinois at 

Chicago (“UIC”). He has served as the Director or co-Director of the UIC/NIH 

Center for Botanical Dietary Supplements Research since the Center was 

founded. The UIC Center is one of only three botanical centers supported by 

the National Institutes of Health’s Office of Dietary Supplements. Dr. van 

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Breemen is a member of AOAC International, an organization that develops 

methods of analysis for botanical dietary supplements. He received the 

highest honor given by the organization in 2008. He has published over 200 

papers on dietary supplements, many of which relate to the research and 

development of dietary supplements or to methods of developing safe and 

effective supplements. Dr. van Breemen drew from this training and 

experience in reaching his opinions in this case. 

The court finds that the defendants have raised no valid objections to 

Dr. van Breemen’s qualifications. Having found their arguments to exclude 

his testimony are groundless, their motion [Doc. No. 865] is DENIED. 

3. The RCT Standard 

The FTC’s substantiation expert from the very beginning of this case 

has been Dr. Aronne, who explained from the outset that the standard 

applied by weight-loss experts to evaluate causal efficacy claims is RCTs. Dr. 

van Breemen corroborated that opinion and opined that it is also the 

appropriate standard in the dietary supplement field. 

The RCT standard is comprised of several components. The court is 

unable to distill the days of testimony regarding the RCT standard into a few 

pages, but it will nevertheless attempt to succinctly review each component. 

More importantly, the court will note various defense experts’ concessions 

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regarding why each component is necessary, thus shedding light on why the 

defendants’ own substantiation evidence that is not comprised of these 

components is not just inferior but also deficient. 

a. Human Clinical Trials 

The first aspect of the RCT standard is that a clinical trial of the 

product needs to be conducted on humans. Dr. Aronne explained in detail 

why the non-human trials referenced by the defendants and their experts – 

animal and in vitro studies27 – are insufficient, either alone or in 

combination. With respect to in vitro studies, Dr. Aronne testified that 

understanding certain biochemical reactions outside the body are not 

indicative of what will occur inside the human body and thus cannot be 

extrapolated to humans. Regarding animal studies, Dr. Aronne opined that 

they, too, are insufficient to substantiate efficacy claims because there are 

many findings that come from animals that are not substantiated in human 

trials because animals are different from humans. Consequently, animals 

respond to treatments differently from humans with regard to efficacy. Dr. 

Aronne provided specific examples of efficacy being shown in animal studies 

but not human studies. 

27 Colloquially referred to as “test tube” studies, in vitro studies are done in a 

controlled environment outside of a living organism. 

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Several of the defendants’ experts agreed that in vitro and animal 

studies alone are not sufficient. For example, defense expert Dr. Timothy 

Gaginella, a pharmacologist, agreed that the primary purpose of in vitro 

studies is to serve as a screening tool and there are situations where a 

scientist might predict that a substance is going to have certain effect on 

humans, but it ultimately does not. Indeed, a book co-authored by Dr. 

Gaginella notes, “Herbal medicines, before appearing in the pharmacy’s [sic] 

as a medicine, should be required to undergo pharmacological and 

toxicological testing on animals and clinical trials in humans” [Doc. No. 941­

10 at 2]. The defendants’ other pharmacologist expert, Dr. Matthew Lee, 

agreed that, even where a substance has a plausible mechanism of action, it 

may not have efficacy once administered to humans. Dr. Lee admitted that 

animal studies cannot be used to predict how a human is going to absorb a 

substance because animal studies bypass certain limitations that might exist 

in the human body. Another one of the defendants’ expert witnesses, Dr. Jay 

Hoffman, a clinical researcher and professor of medicine, agreed that many 

dietary supplements have little to no scientific support in human subjects. 

Dr. John La Puma, another defense expert physician and nutritionist, 

testified that one can only project what will likely happen physiologically in a 

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person when looking at in vitro studies, and one can only know what happens 

in a person by studying people. 

Accordingly, as recognized by the defendants’ experts, only human 

studies can confirm that a specific substance actually has an effect in humans 

and extrapolating data obtained from animal studies and in vitro studies to 

humans has significant limitations. 

b. Placebo Controls and Double Blinding 

A second component to the RCT standard is that studies must be both 

placebo-controlled and double-blinded in order to yield accurate and reliable 

results. A placebo control means a study includes a control group, or one that 

does not participate in the intake of the substance that is being examined. 

Commonly referred to as “the placebo effect,” the need for a control group is 

accepted by experts in the field. When human subjects know that a product 

is being tested to determine its effect on a condition, that knowledge can 

influence the results in a way that is unrelated to the content of the product. 

Double-blinding is where neither the active treatment group nor the 

control group knows which treatment it is receiving. The second blinding is 

that the investigator should also not know what treatment a subject is 

getting. The purpose of the double blinding is similar to the reasons for the 

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“placebo effect” – to prevent the researchers and subjects from being 

influenced by a belief that the treatment will or will not be effective. 

Like the necessity for human trials, the defendants’ experts agreed that 

placebo controls and double blinding are necessary. For instance, Dr. 

Hoffman testified that to establish efficacy of a product for weight loss in 

humans, one needs to have a placebo-controlled study. Dr. Gaginella 

similarly agreed that it is essential to rule out the placebo effect when 

evaluating human studies. Dr. Lee also agreed that use of a placebo control 

and double blinding are procedures generally accepted in the profession to 

yield accurate and reliable results, as that phrase is used in the definition of 

“competent and reliable scientific evidence.” 

c. Randomization 

Studies must also be randomized in order to yield accurate and reliable 

results, according to the FTC’s experts. In other words, subjects should be 

assigned to either the treatment group or the control group randomly through 

a process called “randomization.” Randomization eliminates selection bias by 

the researcher and allows the researcher to rely upon the statistical 

likelihood that the makeup of the treatment and placebo groups will be 

statistically similar. Defense experts Drs. Lee, Hoffman, and La Puma 

recognized that randomized studies yield more reliable results. 

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d. Sufficiently Sized Studies 

RCTs should also test enough subjects to permit the conclusion that 

any measured effect is reliable and generalizable. The defendants’ own 

experts agreed with Dr. Aronne that one can determine the appropriate size 

of a trial by doing a “power” calculation. Power is affected chiefly by the size 

of the effect and the size of the sample being used to detect it. Small, or 

“underpowered,” studies could result in findings that occur at random, and 

Dr. Aronne explained that such studies have a low probability of finding true 

effects. For example, a ten-person study can be swayed by effects in a single 

subject, so that if one subject loses weight and nine do not, the data would 

demonstrate a weight-loss result. Conversely, studies having more 

participants result in a greater probability of detecting a real treatment 

effect. While all the experts agree that there is no uniform baseline number 

of study subjects necessary to substantiate efficacy claims, the defendants’ 

experts recognize that a power calculation is necessary to determine the 

number of study subjects that were needed. Indeed, this is precisely what Dr. 

Jacobs did when he performed the clinical trials on the other Hi-Tech 

products that are not implicated in these proceedings, Fastin-XR and RR. 

Thus, the necessity of appropriately sized trials is one that is shared by 

experts in the field. 

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e. Appropriate Duration 

RCTs must also be of an appropriate duration in order to yield accurate 

and reliable results. More specifically, Dr. Aronne testified that six months 

would be the minimum duration for a study to constitute competent and 

reliable scientific evidence, although most researchers in the field would 

require a one-year minimum. A shorter duration study, according to Dr. 

Aronne, may demonstrate results that are transient and may not be 

sustained beyond a few weeks. Dr. Aronne testified that examples of Prozac 

and Zoloft illustrate this principle. Both substances were hypothesized to 

have efficacy for weight loss, and short-term studies supported that 

hypothesis. Longer duration studies, however, showed that people who 

initially lost weight on these substances regained it with longer-term use. 

Both products were rejected as efficacious weight-loss aids. Consequently, 

“acute metabolic studies” – studies where measurements are made over a few 

hours – cannot be extrapolated to longer periods of time, and according to Dr. 

Aronne, a metabolic study lasting three hours cannot substantiate a claim of 

metabolic effect beyond three hours. 

The defendants’ experts largely agree with this principle. Dr. Jacobs 

admitted that taking an acute study by itself does not show what the 

prolonged effect would be. Dr. Marvin Heuer, a medical doctor with 

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experience in the supplement industry, agreed that one cannot determine 

whether actual weight loss occurs based on an acute study. Dr. Gaginella 

also conceded that one can only hypothesize that an effect seen in an acute 

test will continue over time. Dr. Hoffman testified that an acute study 

measuring metabolism over a few hours cannot be extrapolated as to the 

effect on metabolism beyond a few hours. Dr. Lee similarly opined that a 

study of longer duration can provide better evidence that the claimed effect 

will persist. 

f. Product and Dosage Specific 

Dr. Aronne further opined that product-specific and dosage-specific 

testing is necessary. He explained that product-specific testing is necessary 

because, even where an individual ingredient has been shown to be 

efficacious for the treatment of a particular condition, the ingredient may not 

have the same properties when combined with other ingredients. Productspecific testing, according to Dr. Aronne, is essential to assess any 

confounding factors or antagonistic effects. Confounding occurs, for example, 

when a combination (ingredient A + ingredient B) is reported to promote 

weight loss in a study, while ingredient C was also part of the combination 

and contributing to the weight loss observed. Dr. Aronne testified that one 

cannot extrapolate from the results of a study of one product to a separate 

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product that has different ingredients because the effectiveness is unknown 

due to the presence of extra components. He pointed to studies in the 

defendants’ own reliance materials that were provided to the FTC, which 

supported his opinion that one cannot extrapolate results from a combination 

of ingredients to a product that did not have the same combination. 

Antagonistic effects occur when two or more agents in combination 

have an overall effect that is less than the sum of their individual effects. For 

instance, Dr. van Breemen explained that Citrus aurantium, an ingredient 

contained in the Hi-Tech products, inhibits an enzyme responsible for 

metabolizing over half of all drugs and natural products. Therefore, Dr. van 

Breemen opined that mixtures of ingredients have very different effects than 

those of individual ingredients, and this is especially true of dietary 

supplements because of the chemical diversity and complexity of botanical 

dietary supplements. Thus, a product made up of multiple compounds must 

be studied as a whole, a notion that the defense experts concede. 

The defendants’ pharmacologist expert, Dr. Gaginella, agreed that 

ingredients in a product might interfere with each other even though that 

had not been predicted. Dr. Hoffman has observed that one cannot draw 

conclusions when examining combination products, like the ones Hi-Tech 

manufactured, unless one tests the combination product itself. Dr. La Puma 

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conceded at his deposition that it is difficult to identify the single ingredient 

effect in any dietary supplement that is a combination. He also conceded that 

he could not rule out the antagonistic effect of a particular study the 

defendants relied upon because the product being tested was comprised of 

seven different ingredients. 

For many of the same reasons, Dr. Aronne opined that dosage-specific 

testing is important because higher or lower dosages of a product will not 

result in the same efficacy as a particular tested dosage. Dr. Aronne 

explained by way of example that, if 5 grams of a treatment has been shown 

to cause a particular effect, scientists cannot assume that 2.5 grams would 

cause one-half the observed effect. To the contrary, 5 grams might be the 

threshold amount needed to cause any effect. As a result, studies of larger 

quantities of a product’s ingredients do not constitute reliable evidence that a 

smaller amount of that ingredient will cause a proportionally reduced effect 

or any effect at all. One is similarly unable to extrapolate the results of a test 

of a substance at a low dosage to higher dosages. Dr. Hoffman recognized 

that it is a problem that many companies rely on research of key ingredient 

studies, but those studies often involve dosages that are much higher than 

the dosage of the ingredients used in the product that is actually sold. Dr. 

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Gaginella agreed that, in order to make claims based on scientific testing, the 

testing should be done on the same dosage. 

g. Appropriate Endpoints 

RCTs must also examine the appropriate endpoints, or what the study 

is attempting to quantitatively measure at the end. To determine whether a 

product is efficacious for causing weight loss, for instance, the study must 

actually evaluate a change in weight as an endpoint. So, a study that 

established metabolic endpoints cannot determine whether weight loss will 

also occur. Therefore, one simply cannot know if a product causes weight loss 

unless the study itself measures whether the subjects actually lost weight. 

This notion seems rudimentary to the court. Dr. Jacobs conceded that 

metabolic studies do not substantiate fat loss claims, and Drs. Gaginella and 

Hoffman agreed that studies measuring metabolic or energy expenditure 

endpoints do not support claims of fat or weight loss. 

h. Statistical Significance 

Studies also need to have statistically significant result between the 

treatment and control groups, and according to Dr. Aronne, if there are no 

differing results between groups, it is difficult to draw any conclusions about 

a substance’s efficacy. Defense experts Drs. Lee, Gaginella, and La Puma 

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agreed that requiring studies to have statistical significance is an accepted 

scientific technique. 

4. Hi-Tech Defendants’ Substantiation Evidence 

The defendants, on the other hand, pointed not so much to a precise 

substantiation standard but rather an amalgamation of studies that they 

contend support their claims for the four products. The studies are 

summarized in a bibliography Wheat provided to the FTC [Doc. Nos. 944-11, 

944-12]. This list of materials was also provided to the defendants’ experts, 

and they relied upon primarily these materials when offering their opinions. 

The studies fall into two overall categories: ingredient studies and clinical 

trials of other products. 

With respect to the ingredient studies, the defendants maintain that, 

because Fastin, Lipodrene, Benzedrine, and Stimerex-ES contain many of the 

ingredients (in varying combinations and amounts) that are examined in the 

ingredient studies, their product-specific, efficacy claims for the four products 

at issue are substantiated. The court finds that the ingredient studies do not 

substantiate the defendants’ claims because of three major flaws articulated 

by Dr. Aronne. 

First, the studies were not specific to Hi-Tech’s products, and, as such, 

it is not possible to predict what will happen when various ingredients are 

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combined, like they are in the four products at issue. This criticism invokes 

the necessity for product/dosage specific testing, which is a concept that 

several of the defense experts corroborated. 

Second, Dr. Aronne convincingly explained that the results of these 

ingredient studies, which measure a particular endpoint such as metabolism, 

cannot be extrapolated to substantiate the claims at issue, which are derived 

from different endpoints, like weight loss or fat loss. Dr. Aronne discussed 

how an increase in metabolism can trigger counter-regulatory mechanisms in 

the body that increases appetite, thus actually making weight or fat loss 

more difficult. Further, Dr. Aronne opined that the human body can 

habituate to ingredients like caffeine, which means that even though some of 

the Hi-Tech products contain caffeine, to achieve the same effects from 

caffeine over time, one must ingest a correspondingly higher amount. 

Several of the defendants’ experts agreed with these concepts. 

Third, Dr. Aronne explained that many of these ingredient studies were 

of a shorter duration, and therefore, may only demonstrate transient effects. 

The examples of Prozac and Zoloft Dr. Aronne provided confirm this point. 

Dr. Aronne also discussed why the studies that occur over only a few hours 

cannot be extrapolated to longer periods of time, a concept, again, that 

several of the defendants’ experts recognized. 

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The defendants and their experts also rely on clinical trials of 

Meltdown, a competing dietary supplement, and clinical trials of Fastin-XR 

and Fastin-RR, two Hi-Tech products having different product formulations 

than the four products at issue, as substantiation evidence. Dr. Aronne 

explained why all of these trials are inadequate for a number of reasons. 

With respect to the Meltdown studies, Dr. Aronne opined that each was 

acute and not sufficiently sized. Moreover, Meltdown has a different 

formulation from the Hi-Tech products. There are a number of ingredients in 

Meltdown that are not present in any of the Hi-Tech products. The inclusion 

of these ingredients is not trivial for the reasons explained above and 

recognized by some of the defendants’ own experts. Dr. Aronne also 

explained why the Meltdown studies are insufficient because they do not 

measure the appropriate endpoints. Finally, Dr. Aronne explained why the 

Meltdown studies cannot be extrapolated beyond their acute time frames. 

For many of the same reasons, Dr. Aronne demonstrated why the 

Fastin-XR and RR studies do not substantiate the claims at issue. The 

variants of Fastin have a different formulation than all of the products at 

issue. Not only do they contain additional ingredients, but the common 

ingredients are not present in the same amounts as in the four products at 

issue. Indeed, the reason Hi-Tech saw fit to create an entirely different 

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Fastin product was to market to its consumers a new and improved product 

that achieved different results from the original Fastin product. 

The FTC also pointed to numerous methodological flaws that discredit 

the reliability of the Fastin-XR and RR studies. For example, the FTC 

offered evidence that Dr. Jacobs, who performed the studies, reported results 

for a smaller amount of participants even though the power calculation called 

for a great number. Moreover, the FTC presented evidence to suggest Dr. 

Jacobs concealed that he self-enrolled in the study and that his results were 

less favorable than the other study participants. Dr. Jacobs also admitted 

that, during the Fastin-RR metabolism study, he “broke the blind” and readministered dosages when the results did not meet his expectations. The 

court also heard evidence that Dr. Jacobs misrepresented the side effects 

experienced by some of the study participants. Dr. Aronne opined that, due 

to Dr. Jacobs’ breaches of protocol and repeated instances of misreporting the 

facts of his studies, Dr. Jacobs is not a person in the field qualified to conduct 

these types of studies. 

The court does not stop there, however. In addition to the significant 

gaps between the science Hi-Tech purportedly relied upon and the claims it 

made, the court has concerns regarding the credibility of the defendants’ 

experts and their ultimate substantiation opinions. 

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a. Dr. Gaginella 

Hi-Tech’s relationship with the first expert who testified on its behalf, 

Dr. Gaginella, is particularly suspect. Dr. Gaginella’s relationship with 

Wheat and Hi-Tech began around 1999, when Wheat began running some of 

his own research through Dr. Gaginella. Relative to the violative advertising 

claims at issue, however, Hi-Tech had ceased its relationship with Dr. 

Gaginella when those claims were made. It was not until the contempt 

litigation arose that Wheat resumed his consulting relationship with Dr. 

Gaginella. Leading up to the termination of his consulting relationship with 

Hi-Tech, Dr. Gaginella received $60,000 per year from Wheat or his 

companies. Thus, not only has Dr. Gaginella been paid for years by Hi-Tech 

but he resumed his relationship with Hi-Tech after the contempt litigation 

began. The more prudent approach would have been to simply consult with 

Dr. Gaginella at the time the claims were actually made – something Hi-Tech 

apparently had a history of doing before these proceedings began – to 

determine if the claims were substantiated at that time, before the FTC 

moved for contempt. Perhaps most concerning though, the FTC presented 

evidence that, during the time Dr. Gaginella had consulted with Hi-Tech 

before this case, there were at least two separate occasions where Wheat or 

his companies forged Dr. Gaginella’s signature on letters purporting to show 

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Dr. Gaginella endorsed a particular Hi-Tech product. In each case, Dr. 

Gaginella’s name and fake signatures were placed on letters that he had 

never seen. Despite the fact that Dr. Gaginella’s consulting relationship with 

Hi-Tech ended in 2006, Hi-Tech continued to hold him out as their “Research 

& Development Group Chief.” While this evidence is more reflective of 

Wheat’s guile, the court mentions it here because the history between Dr. 

Gaginella and Hi-Tech is dubious. 

The court also has concerns with Dr. Gaginella’s qualifications. His 

limited experience in the field of weight loss is derived from his work as a 

consultant for Hi-Tech. Outside of his work for Hi-Tech, Dr. Gaginella has 

never done any work in the fields of weight loss or obesity. He retired as a 

pharmacist in 2010. The last lab research he participated in was in 1994, 

and, even then, he focused mainly in the field of gastroenterology. Dr. 

Gaginella’s familiarity with dietary supplements comes solely from reading 

literature. He has never conducted a human clinical trial measuring weight 

or fat loss. Nor has Dr. Gaginella ever been an investigator on any human 

clinical trial. Finally, Dr. Gaginella avoided the opinion that the defendants’ 

claims were substantiated and instead opined that there is “competent and 

reliable scientific evidence” the four products “[a]id in rapid or substantial 

weight loss, as part of a program of diet and exercise” and “[a]id in 

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substantial fat loss, as part of a program of diet and exercise.” When asked 

specifically about whether the claims for Fastin were substantiated, he said, 

“[I]t’s quite possible, but I – I can’t say absolutely yes it would or it wouldn’t.” 

b. Dr. Lee 

The court also has concerns regarding Dr. Lee’s qualifications, who is a 

primary care physician having very little experience in the field of weight 

loss. He has never published any papers or given any presentations in the 

field of weight loss. He is not a member of any professional societies that 

focus on weight management. Further, Dr. Lee has never conducted any 

human clinical trials, animal studies, or in vitro studies to measure fat loss, 

appetite suppression, metabolism, thermogenesis, or lipolysis, concepts he 

discusses in his report. The only peer reviewed article he has done involved 

the effects THC has on mice. 

Even if the court were to assume Dr. Lee is qualified, his 

substantiation opinions are tenuous at best. Like Dr. Gaginella, Dr. Lee 

opined that the four products “[a]id in rapid or substantial weight loss, as a 

part of a program of diet and exercise” and “[a]id in substantial fat loss, as 

part of program [sic] of diet and exercise.” At trial, Dr. Lee testified that the 

products, based on the mechanism of action, could cause weight loss. 

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c. Dr. La Puma 

Although the court does not question whether Dr. La Puma is qualified, 

he did testify that, in forming his opinions, he relied on the opinions of Drs. 

Gaginella and Jacobs, which effectively imputes the court’s concerns with 

those experts into its view of Dr. La Puma. Putting that aside, Dr. La Puma’s 

substantiation opinions were equally as feeble as the defendants’ other 

experts. Dr. La Puma testified on direct examination that the products 

would “aid” or help with weight loss. He similarly opined not that the 

products would cause fat loss, but rather they would aid in fat loss. La Puma 

admitted at his deposition that his opinion was that the Hi-Tech products 

merely aid in the suppression of appetite, but at trial he attempted to change 

his testimony to claim that the products suppress appetite. At his deposition, 

Dr. La Puma testified that the products aid in increasing metabolism, but at 

trial he changed his testimony to affirmatively claim that they increase 

metabolism. 

d. Dr. Hoffman 

Dr. Hoffman admitted that he is not an expert in the field of weight 

loss, but he does have proven experience as a researcher of dietary 

supplements, including as a principal investigator in one of the Meltdown 

studies. Somewhat surprisingly though, Dr. Hoffman conceded at trial that 

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he is not offering any opinions in this case on the products themselves. 

Rather, Dr. Hoffman’s opinions are limited to the ingredients in the four 

products, but even with respect to those opinions, Dr. Hoffman testified that 

the ingredients of the products have only “the potential to cause weight loss” 

[Doc. No. 948, 175:18-19 (italics added)]. Dr. Hoffman expressly admitted 

that he is offering no opinion as to whether the four products cause weight or 

fat loss, even though those are the type of claims the defendants are required 

to substantiate. 

Dr. Hoffman even admitted that several of Hi-Tech’s claims were not 

substantiated. At his deposition, Dr. Hoffman agreed that the Fastin claim 

“Increases the release of norepinephrine and dopamine for dramatic weight 

loss” was not substantiated. He also said he would not feel comfortable 

offering the opinion that the defendants’ possessed substantiation for the 

Fastin claim, “EXTREMELY POTENT DIET AID! DO NOT CONSUME 

UNLESS RAPID FAT AND WEIGHT LOSS ARE YOUR DESIRED 

RESULTS!”, or the Benzedrine claim, “simply blows fat away!” In fact, 

defense counsel objected to Dr. Hoffman being questioned about several of 

these specific representations Hi-Tech made on the grounds that he had 

never reviewed the claims in his expert report. 

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e. Dr. Jacobs 

Dr. Jacobs performed the clinical trials on Fastin-XR and RR. The court 

has already highlighted some of the evidence discrediting the results of those 

studies relative to the issues in this case. In addition to Dr. Jacobs’ bias 

towards the results of those studies, the FTC presented evidence showing Dr. 

Jacobs’ bias towards Hi-Tech itself. For example, in 2015, over half of the 

revenue for Dr. Jacobs’ company, Superior Performance Research, came from 

Hi-Tech. The FTC also elicited evidence that Dr. Jacobs sought money from 

Wheat to conduct additional studies on Hi-Tech’s products, explaining that he 

was “under a cash flow problem at this time due to other issues.” 

With respect to his substantiation opinions, Dr. Jacobs, like the other 

experts, admitted that his opinion regarding weight loss was limited insofar 

as the products will aid in rapid or substantial weight loss as part of a 

program of diet and exercise. Paradoxically, Dr. Jacobs even testified that he 

believes it is inappropriate to use the word “cause” in connection with any of 

the Hi-Tech products, when the claims Dr. Jacobs was retained to 

substantiate are causal efficacy claims. The court finds that this is a tacit 

recognition that the claims either are not, or cannot be, substantiated. 

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f. Dr. Heuer 

Dr. Heuer is perhaps the most qualified of the defendants’ 

substantiation experts. Although he did testify that each of the claims is 

substantiated, he testified that one must make two extrapolations and an 

assumption in arriving at that conclusion. The extrapolations are extending 

results from acute studies to long term studies and taking the results seen 

from animal and in vitro studies and applying them to humans. The 

assumption is that raising heart rate and metabolism causes weight loss and 

fat reduction [Doc. No. 951, 162:12-164:11]. The FTC also presented evidence 

that Dr. Heuer is newly employed as CEO of a Canadian dietary supplement 

company, thus suggestive of a potential bias towards advocating for a more 

relaxed substantiation standard. 

g. Wheat and Wright 

The final two substantiation experts are Dr. Wright and Wheat. 

Although Dr. Wright did not testify in the 2017 bench trial, he has provided 

declarations in this case claiming to have reviewed the ingredient-specific 

studies and offered his opinion that the defendants’ claims are substantiated. 

The court finds his reliance on the ingredient specific studies insufficient for 

the reasons discussed above. In addition, the court has grave concerns with 

Dr. Wright’s credibility. 

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First, Dr. Wright takes a position that product-specific testing is not 

required, which is in direct contravention to an explicit requirement of his 

injunction. Second, the record contains evidence showing Dr. Wright’s bias 

towards Hi-Tech. Between 2009 and 2011, Hi-Tech paid Wright $170,454 for 

helping Wheat and Hi-Tech with advertising the Hi-Tech products. Third, 

and perhaps most damaging, Dr. Wright has been reprimanded publically by 

the Georgia Composite Medical Board. The public consent order identifies 

various ways in which Dr. Wright’s treatment of two patients fell below the 

standard of care, including improper use of prescription medication, resulting 

in Dr. Wright being placed on probation. Several years earlier, Dr. Wright 

received another public reprimand for treating patients in 1997-1998, and the 

violations note treatment for obese patients that fell below the standard of 

care. He was placed on probation for five years following that consent order. 

Pleadings in a trademark infringement case Hi-Tech instituted in 2003 

in this court compound the court’s concerns regarding the relationship 

between Dr. Wright, Hi-Tech, and Wheat.28 The defendant in that case 

sought to take Wheat’s deposition, and after he failed to appear, moved to 

compel his deposition. According to Wheat’s attorney, Wheat was ill and 

28 See Hi-Tech Pharmaceuticals, Inc. v. Herbal Health Products, Inc., 1:03­

CV-2486 (N.D. Ga. 2003). 

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under a doctor’s order not to participate in a deposition at that time [Doc. No. 

97]. On the advice of his treating physician, Wheat had “taken up residence 

in Belize.” Id. Because Judge Willis Hunt was unsatisfied with the lack of 

specificity of Wheat’s claimed illness, he ordered Wheat to file a sworn 

statement from his treating physician. In response, Wheat, through his 

attorney, filed “an initial report made by Dr. Mark Wright, Mr. Wheat’s 

treating psychiatrist in June of 2004.” [Doc. No. 101 (emphasis added)]. The 

response stated, “Mr. Wheat and Dr. Wright have had a physician-patient 

relationship since 1997.” [Doc. No. 101]. Subsequent briefing removes any 

doubt as to whether T. Mark Wright, M.D. is the same Dr. Wright in this case 

because he was noted to specialize in “bariatrics” [Doc. No. 115, p. 3 n.2]. 

Thus, Wright appears to have misrepresented to Judge Hunt that he is 

a psychiatrist when, in fact, he specializes in bariatrics. Moreover, the court 

has concerns that Hi-Tech’s expert endorser is simply Wheat’s treating 

physician, at least based on what the two represented to Judge Hunt in 2004. 

Finally, the representation that Wheat moved to Belize for medical reasons is 

belied by a 2006 indictment, in which the U.S. Attorney for the Northern 

District of Georgia contended that Wheat had been travelling to Belize 

around the time the trademark infringement case was pending, not because 

of an illness, but in furtherance of a conspiracy to manufacture, import, and 

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distribute prescription drugs and controlled substances into the United 

States, including anabolic steroids, Schedule III narcotic controlled 

substances, and Schedule IV narcotic controlled substances, to which Wheat 

ultimately pled guilty. See United States of America v. Jared Robert Wheat, 

1:06-cr-382 (N.D. Ga. 2009) [Doc. Nos. 1; 740]. 

With respect to Wheat’s opinions, some of the defendants’ experts 

believed that they would consider him a “professional[] in the relevant area” 

to offer competent and reliable substantiation evidence, while other defense 

experts believed he is not. The court agrees with the latter. Although Wheat 

has experience with dietary supplements, he is self educated in the area. He 

has no formal training or education in the field and no scientific background. 

He does not participate in any continuing education. He has no publications 

of his own or peer-reviewed studies that he has participated in. 

Wheat also appears to have implemented no reliable methodology in 

using the scientific material when crafting the claims for the products at 

issue. Wheat repeatedly referred to a “war room” that housed numerous 

research studies from which he created the bibliography that he provided to 

the FTC, itemizing the substantiation materials he claims Hi-Tech relied 

upon. Wheat appears to have accumulated this “war room” for situations 

where he needed to “pacify” retailers before they would put Hi-Tech products 

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on their shelves, so that Wheat could give the retailer “the science that [he] 

relied upon for whatever claim [he was] making” [Doc. No. 952, 28:9-24]. 

This process is particularly concerning because one of the requirements 

under the injunction was that the defendants had to possess competent and 

reliable substantiation evidence “at the time the representation[s were] 

made.” Since Wheat was not a professional in the relevant area, he did not 

have the qualifications or expertise to determine which studies in his “war 

room” actually substantiated the claims at the time they were crafted. It 

appears that Hi-Tech and Wheat consulted with professionals in the relevant 

area only after the FTC had initiated these contempt proceedings. The 

process of Hi-Tech using this “war room” to then craft product-specific 

efficacy claims was completely unscientific. 

The email correspondence and telephone call between Wheat and 

Smith discussing the wording of the Fastin advertisement, for example, 

confirms the absence of a scientific basis when Hi-Tech crafted these claims. 

Wheat and Smith focus on all the claims they could not make because of the 

limitations of the injunction as opposed to claims they could make based on 

the science that supported it. Indeed, the defendants’ own expert, Dr. 

Hoffman, testified that had Hi-Tech retained him sooner, he would have 

“advise[d] them differently” on some of the claims, including the Fastin ad, 

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“EXTREME WEIGHT LOSS GUARANTEED!” [Doc. No. 948, 180:12-181:19]. 

Cf. Basic Research, LLC, 2014 WL 12596497 * 2 (noting that the alleged 

contemptuous defendant had retained a substantiation expert to confirm that 

the claims were compliant with an injunction before the contempt 

proceedings were initiated). 

Hi-Tech appears to have had no professional in the relevant area 

advising it when the claims were made. Rather, it was Wheat, someone who 

is unqualified, making the decision whether the claims were substantiated 

under the guise of scientific validation, when no scientist ever connected the 

results of the studies to the claims Hi-Tech was making about its products. 

As noted by one commentator on the subject, this is not an infrequent 

occurrence in the dietary supplement industry: 

[L]argely unregulated supplement labels . . . often express 

unrealistic claims and inaccurate content . . . For example,

studies show that consumers tend not only to believe associations 

that are promoted in the marketing of food supplements . . . but

also that the claims have received scientific validation, which is 

often not the case. 

David G. Yosifon, The Consumer Interest in Corporate Law, 43 U.C. DAVIS L. 

REV. 253, 279 (2009). 

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5. The FTC’s Advertising Guide 

To further buttress their substantiation argument, the defendants 

repeatedly cited to the FTC’s Advertising Guide for the proposition that the 

substantiation standard is flexible, and, as such, the FTC wrongly advocates 

for an overly stringent substantiation standard like RCTs. Contrary to the 

defendants’ argument, the court finds that the Advertising Guide actually 

supports a finding that the RCT standard is appropriate and further 

demonstrates why the defendants’ substantiation evidence is lacking. 

Part 5 of section B, which is entitled “Substantiating Claims,” states, 

“A common problem in substantiation of advertising claims is that an 

advertiser has valid studies, but the studies do not support the claim made in 

the ad” [Doc. 701-3, p. 20]. Advertisers are, therefore, instructed to “make 

sure that the research on which they rely is not just internally valid but also 

relevant to the specific product being promoted and to the specific benefit 

being advertised.” Id. The Advertising Guide also warns, “If there are 

significant discrepancies between the research conditions and the real life use 

being promoted, advertisers need to evaluate whether it is appropriate to 

extrapolate from the research to the claimed effect. . . .” Id. (emphasis 

added). If the defendants had relied upon the Advertising Guide when 

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making the representations, as they claim, they should have asked 

themselves the questions the FTC provides in the Advertising Guide: 

How does the dosage and formulation of the advertised product 

compare to what was used in the study? 

Does the advertised product contain additional ingredients that 

might alter the effect of the ingredient in the study? 

Is the advertised product administered in the same manner as 

the ingredient used in the study? 

Does the study population reflect the characteristics and lifestyle 

of the population targeted by the ad? 

Id. Based on the record before the court, it is clear that the defendants did 

not ask themselves any of these questions, but rather, made “[c]laims that do 

not match the science,” and as the Advertising Guide states, “[N]o matter 

how sound that science is, [the claims] are likely to be unsubstantiated.” Id. 

6. The Defendants’ Claims Are Unsubstantiated 

In sum, the defendants argue that, when looking at their scientific 

evidence in its totality, the claims are substantiated. In order to reach that 

conclusion, the court would have to pile speculation on top of speculation, 

making an analytical leap between the science and the claims made. “[A] 

district judge asked to admit scientific evidence must determine whether the 

evidence is genuinely scientific, as distinct from being unscientific 

speculation offered by a genuine scientist.” Allison v. McGhan Med. Corp., 

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184 F.3d 1300, 1316 (11th Cir. 1999). Claiming these ingredient studies and 

clinical trials of other products substantiate the defendants’ product specific 

representations is simply “unscientific speculation offered by . . . genuine 

scientist[s].” Id. 

At the risk of belaboring the point, the court reiterates that it must look 

to the claims Hi-Tech actually made and whether those representations are 

substantiated. The defendants very clearly made claims that these four 

products caused a specific result—whether it be weight loss, fat loss, effects 

on body fat, effects on appetite, or effects on metabolism. They did not 

represent that the products contained an ingredient that has been shown to 

increase metabolism, for example. As the Supreme Court observed, “Trained 

experts commonly extrapolate from existing data . . . [but a] court may 

conclude that there is simply too great an analytical gap between the data 

and the opinion proffered.” Gen. Elec. Co. v. Joiner, 522 U.S. 136, 146 (1997). 

The court is simply unable to bridge the analytical gap between the studies 

the defendants relied upon and the product-specific, causal efficacy claims HiTech made. See, e.g., Jack v. Glaxo Wellcome, Inc., 239 F. Supp. 2d 1308, 

1319 (N.D. Ga. 2002) (finding expert testimony unreliable where it was 

“extrapolated from incomplete data”); Rider v. Sandoz Pharm. Corp., 295 F.3d 

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1194 (11th Cir. 2002) (finding the district court did not abuse its discretion by 

not extrapolating the results of animal studies to humans). 

Notwithstanding the court’s concerns with several of the defendants’ 

substantiation experts’ qualifications, the court has considered all of their 

testimony and finds it unconvincing. “In other words, the court-asgatekeeper [will] let the court-as-factfinder consider [the defendants’ experts’] 

testimony, but the court-as-factfinder decide[s] not to give it much weight.” 

Brown, 415 F.3d at 1270. Simply because the parties offered differing expert 

testimony and the defendants had more experts than the FTC, does not 

preclude the court from finding contempt is appropriate. See St. Martin v. 

Mobil Exploration & Producing U.S., Inc., 224 F.3d 402, 408 (5th Cir. 2000) 

(“The district court admitted testimony from experts on both sides, and was 

entitled to weigh the evidence presented by each . . . . It did not commit clear 

error in choosing one explanation over another where both were properly 

admitted.”). 

Had the studies the defendants relied upon contained the various 

components of the RCT standard which Dr. Aronne discussed (e.g., 

product/dosage specific, double-blinding, randomization, etc.), such evidence 

would lessen the analytical gap that exists. In the absence of those 

components, however, when confronted with the question of whether the 

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defendants’ evidence substantiates the claims made, the court, like the 

defendants and their experts, is left with only assumptions, which is the 

antithesis of substantiation.29 

Accordingly, even if the court were to assume that the Hi-Tech 

defendants did not know RCTs of the products were required under the 

injunction (an assumption that is unequivocally belied by the record), and 

assuming further that the evidence the defendants claim to have relied upon 

constituted “competent and reliable scientific evidence” as defined in the 

injunction, the defendants’ claims are not substantiated. It is not the 

function of this court to determine what the substantiation standard should 

be for all cases, but it is the function of the court, serving as the fact finder, to 

determine whether the evidence presented before it demonstrates that HiTech’s products do what the defendants represented them to do; the court 

finds the defendants have fallen short. The FTC has clearly and convincingly 

established that the defendants did not possess “competent and reliable 

29 The court notes that it has already provided an exhaustive discussion 

regarding the defendants’ and their experts’ failure to rely upon the specific 

type of “competent and reliable scientific evidence” that the court previously 

adopted (i.e., RCTs) for this case. And, since the defendants had notice of 

that requirement when making the representations for these four products, a 

finding of contempt is proper. Thus, the court makes its finding of a lack of

substantiation in the alternative to its earlier findings regarding the 

defendants’ failure to satisfy the RCT standard of the injunctions. 

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scientific evidence that substantiates the representation[s]” when they were 

made. 

E. Section VI Violation 

Compounding the violations of Sections II and VII, the record is 

unequivocal that the Hi-Tech defendants also violated Section VI of the HiTech injunction by not placing the required yohimbine warning on the four 

products. It is undisputed that the advertising and/or promotional material 

for Fastin, Lipodrene, Benzedrine, and Stimerex-ES all make efficacy claims 

and each of the products contains yohimbine, thus triggering the warning 

requirement of Section VI. It is also undisputed that the product packaging 

and labels for the four products from January 1, 2009 through late 2012 did 

not contain the required warning. Wheat admitted at his deposition that the 

warning was not incorporated. Despite this admission, however, Wheat 

believed the product labels “encompassed these warnings” [Dep. Wheat 

125:13-25]. Due to an apparent “misunderstanding” that the warning “had to 

be word-for-word” – notwithstanding the explicit language of the injunction 

that plainly required it – he claimed that it was not until the FTC moved for 

contempt that he decided to “purge” himself by “redoing those labels to 

contain this verbiage.” Id. The FTC presented evidence, however, that more 

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than a year after Wheat claims to have placed the warning on the products, it 

was still absent from some of the products. 

Despite all of these undisputed facts, the Hi-Tech defendants 

nevertheless contend that the court should overlook the violation and not 

sanction them because they claim the FTC failed to show consumers acted in 

reliance on the warning label or its omission. They argue, “In order to obtain 

sanctions, the FTC must establish consumers acted in reliance on the 

statement or omission at issue” [Doc. No. 961 (citing McGregor v. Chierico, 

206 F.3d 1378, 1388 (11th Cir. 2000)]. The Hi-Tech defendants continue, 

citing again to Chierico, stating that a “presumption of actual reliance arises 

once the [FTC] has proved that the defendant made material 

misrepresentations, that they were widely disseminated, and that consumers 

purchased the defendant’s product.” Id.30 

Thus, according to the Hi-Tech defendants, by eliciting testimony that 

the yohimbine warning was not material, they have rebutted the 

presumption of consumer reliance, and, therefore, sanctions are not 

30 Like many of their other legal arguments, the defendants cherry-pick the 

legal standard the Eleventh Circuit espoused in Chierico and omit the 

sentence that is between the two sentences referenced above: “Proof of 

individual reliance by each purchasing customer is not a prerequisite to the 

provision of equitable relief needed to redress fraud.” Chierico, 206 F.3d at 

1388. 

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warranted. They posit two grounds for their immateriality argument: (1) the 

on-product warning labels are ineffective at communicating with consumers 

and (2) consumers would have understood the main messages of the 

yohimbine warning from the Hi-Tech’s labels that had similar warning 

language and/or from other sources. The two experts the Hi-Tech defendants 

relied upon to support these arguments are Dr. Gerald Goldhaber and Linda 

Gilbert, respectively. 

1. Dr. Goldhaber 

Dr. Goldhaber opined that the products’ warning labels – even though 

they did not comply with injunction – would have communicated to all 

consumers who read them the content of the warning contained in Section VI 

of the injunction. The court heard evidence, unchallenged by the FTC, that 

Dr. Goldhaber is qualified in the area of product warnings. Despite his 

undisputed expertise, the FTC moved to exclude Dr. Goldhaber’s opinions 

because it contends he failed to apply any reliable methodology in forming his 

opinions, instead relying on his own ipse dixit. The court agrees. 

The gatekeeping function of the court “requires more than simply 

‘taking the expert’s word for it.’” Frazier, 387 F.3d at 1261 (quoting Fed. R. 

Evid. 702 advisory committee note). “If the witness is relying solely or 

primarily on experience, then the witness must explain how that experience 

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leads to the conclusion reached, why that experience is a sufficient basis for 

the opinion, and how that experience is reliably applied to the facts.” Id. 

The FTC argues that, in his expert report, Dr. Goldhaber disclosed no 

methodology at all in forming his opinion. The Hi-Tech defendants’ response 

to this point simply references Dr. Goldhaber’s credentials and they argue 

that the court is permitted to find the testimony reliable “based on his 

significant experience alone” [Doc. No. 857 (citing Long v. Amada, 2004 WL 

5492705 (N.D. Ga. Mar. 31, 2004)]. By repeatedly pointing to Dr. Goldhaber’s 

qualifications, without identifying any methodology he used to connect those 

qualifications to his opinions, the Hi-Tech defendants simply evade the FTC’s 

reliability challenge. 

The notion that an expert may generally rely on his experience alone to 

support his opinions is contrary to Eleventh Circuit jurisprudence. The 

Eleventh Circuit has recognized that the “reliability criterion remains a 

discrete, independent, and important requirement for admissibility.” Frazier, 

387 F.3d at 1261. “Our caselaw plainly establishes that one may be 

considered an expert but still offer unreliable testimony.” Quiet Tech. DC-8, 

Inc. v. Hurel-Dubois UK Ltd., 326 F.3d 1333, 1342 (11th Cir. 2003); see also 

Rider, 295 F.3d at 1197 (“[T]estimony based solely on the experience of an 

expert [is] not . . . admissible.”); Dukes v. Georgia, 428 F. Supp. 2d 1298, 1315 

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(N.D. Ga. 2006) (“Accepting [the expert’s] experience alone as evidence of the 

reliability of his statements is tantamount to disregarding entirely the 

reliability prong of the Daubert analysis.”). 

In Kumho Tire, a case on which the defendants also rely, “the Supreme 

Court made it clear that testimony based solely on the experience of an 

expert would not be admissible.” Rider, 295 F.3d at 1197. Indeed, the only 

case the Hi-Tech defendants substantively rely upon, Long, supra, similarly 

held that, in order for an expert opinion to be considered reliable, the expert 

must “explain how [his] experience leads to the conclusion reached” and “how 

that experience is reliably applied to the facts.” Id. at *12. 

If the court were to remove from Dr. Goldhaber’s expert report and 

testimony his background information, his recitation of the Hi-Tech product 

warning language, and warning language of competitors’ products, what 

remains are conclusory opinions that the noncompliant warnings on the HiTech products “would, in all probability, have communicated to the average 

consumer” the net effect of the injunction’s yohimbine warning. The general 

principles he outlines that form the basis of his opinions reference a single 

academic reference, but Dr. Goldhaber fails to explain how that excerpt 

relates to his opinions in this case. 

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The only possible explanation Dr. Goldhaber provides connecting his 

experience to the labels and opinions in this case is his review of third party 

materials. However, his reliance on these materials and any opinions derived 

therefrom are irrelevant. Dr. Goldhaber testified that the three most 

important things he considers are hazards known to exist with the product, 

labels of competitors’ products, and the regulatory environment [Doc. No. 

949, 32:21-33:11]. These issues would be relevant for developing a warning 

and deciding whether one needs to be added to a product, something Dr. 

Goldhaber undoubtedly has experience with, but they are of no importance to 

a situation where, as here, a specific manufacturer is explicitly ordered by a 

court to place a specific warning on specific products. 

The Hi-Tech defendants effectively ask the court to simply take Dr. 

Goldhaber’s word for it that the noncompliant warning would have 

communicated to consumers the content of the warning contained in Section 

VI of the injunction, which does not satisfy the rigors of Daubert. See 

Frazier, 387 F.3d at 1261; Fed. R. Evid. 702. Accordingly, the court GRANTS 

the FTC’s motion to exclude Dr. Goldhaber’s opinions regarding the Hi-Tech 

warnings [Doc. No. 855] as unreliable. 

Since the gatekeeping function of the court is relaxed because the court 

is also the fact finder, the court notes that, even if Dr. Goldhaber’s opinions 

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were not excluded, the court would give his testimony little weight. Hi-Tech’s 

noncompliant warning language was buried in a larger warning in small font 

in a large block of capital letters. Some of the products also required the 

label to be peeled back in order to expose the warning. Moreover, Dr. 

Goldhaber opined that the product warnings at issue would have 

communicated “to the average consumer who has high blood pressure” the 

intended warning, but the warning in Section VI of the injunction is targeted 

to all potential consumers, not just those with a pre-existing condition like 

high blood pressure. Given the differing context of the warning labels Dr. 

Goldhaber reviewed and the one provided in the injunction, his opinions do 

nothing to rebut the presumption of materiality.31 

2. Linda Gilbert 

The FTC moved to exclude the defendants’ other warnings expert, 

Linda Gilbert, a purported consumer research survey expert, who designed 

and executed a survey that she claimed was intended to determine whether 

language on the warning labels “successfully communicate[s] that this 

supplement can increase one’s blood pressure” and “that consumers should 

31 Because the court has excluded Dr. Goldhaber’s opinions, and, 

alternatively gives them little weight, it is unnecessary for the court to rule 

on the defendants’ motion to exclude Susan Blalock, Ph.D., who was retained 

for the purpose of rebutting Dr. Goldhaber’s opinions. Accordingly, that 

motion [Doc. No. 858] is DENIED as MOOT. 

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consult with their doctor before using this supplement.” The court has to look 

no further than Ms. Gilbert’s own testimony to determine whether she is an 

expert in this field. On March 29, 2013, Ms. Gilbert provided deposition 

testimony in an unrelated case, where she admitted, under oath, that she did 

not consider herself to be “an expert in survey design or analytics,” the 

expertise that underpins the survey she created for this case [Doc. No. 949, 

88:9-89:6]. Given Ms. Gilbert’s recent admission that she is not an expert in 

the areas in which she is being offered, the court GRANTS the FTC’s motion 

[Doc. No. 875], thus excluding her testimony. See Bowers v. Norfolk S. Corp., 

300 Fed. App’x 700, 703 (11th Cir. 2008) (finding the district court did not 

abuse its discretion excluding an expert witness “because he admitted he was 

not qualified” to offer the opinions he was retained to provide in the case). 

Even if the court were to not exclude Ms. Gilbert, the court would give 

the opinions she derived from her survey little weight for the reasons offered 

by the FTC’s rebuttal expert, Dr. Kenneth L. Bernhardt. Dr. Bernhardt 

provided numerous reasons why Ms. Gilbert’s survey results are unreliable 

and cannot be used to provide credible evidence of what consumers would 

have gathered from the Hi-Tech product packaging and labels because of 

methodological and design flaws. 

First, Ms. Gilbert’s survey did not replicate marketplace conditions. 

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Rather than show survey respondents the actual, noncompliant product 

labels, Ms. Gilbert showed them excerpted language from the labels in 

isolation from the rest of the labels’ statements and in an easier-to-read 

format. Ms. Gilbert even testified that she designed the survey “to focus 

consumers’ attention on those things that we felt were most important.” 

The survey also contained true/false questions. As explained by Dr. 

Bernhardt, focusing respondents’ attention on certain statements and then 

asking true/false questions, effectively turned the survey into an “open-book 

reading comprehension test” rather than an appropriate test of how the 

consumers would understand warnings from having actually experienced 

them. Dr. Bernhardt also explained how inherent within Ms. Gilbert’s 

survey were biases that primed and telegraphed to consumers the 

researchers’ interests, thus skewing the results in the defendants’ favor. Dr. 

Bernhardt also discussed how the survey encouraged guessing, which results 

in a tendency to endorse any assertion made in a question, regardless of its 

content. Accordingly, even assuming that Ms. Gilbert has the requisite 

survey design expertise, which she admitted she does not, the FTC 

sufficiently discredited her opinions that the noncompliant warnings 

successfully communicated the spirit of the warning found in the injunction. 

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The court finds that the Hi-Tech defendants have failed to rebut the 

presumption of materiality. Accord Nat’l Urological Grp., 645 F. Supp. 2d at 

1191 (“[W]hen a customer makes a decision to purchase a health product that 

he or she will ingest for purported health benefits, any claim on the label 

regarding the health benefits (i.e., any product efficacy claims) or any claims 

regarding the safety of the product can be presumed material”). 

F. Sanctions 

The FTC has established that the defendants violated the injunctions. 

The record is clear that the misrepresentations were material, were widely 

disseminated, and that consumers purchased these four products. Thus, the 

presumption of consumer reliance applies. See Chierico, 206 F.3d at 1387; 

see also Fed. Trade Comm’n v. BlueHippo Funding, LLC, 762 F.3d 238, 244 

(2d Cir. 2014) (holding that in a contempt case “the FTC is entitled to a 

presumption of consumer reliance upon showing,” among other things, that 

“the defendant made material misrepresentations or omissions”). 

“Given this presumption, the FTC need not prove subjective reliance by 

each customer, as it would be virtually impossible for the FTC to offer such 

proof, and to require it would thwart and frustrate the public purposes of 

FTC action.” Chierico, 206 F.3d at 1388 (11th Cir. 2000) (quotation and 

citation omitted). Because it is clear from the record that the defendants 

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failed to successfully rebut the presumption of consumer reliance raised by 

the FTC’s evidence, “all that is left for [the court] to review is the . . . 

valuation of the losses sustained by [Hi-Tech’s] customers.” Id. 

The FTC seeks compensatory sanctions to redress the defendants’ 

numerous violations. The Eleventh Circuit has held that disgorgement of 

gross receipts is an appropriate compensatory remedy. Leshin, 618 F.3d at 

1237. The court, using its discretion,32 finds that valuing losses in terms of 

profits is not the proper form of relief because, as the court previously noted, 

“[r]equiring the defendants to return the profits that they received rather 

than the costs incurred by the injured consumer would be the equivalent of 

making the consumer bear the defendants’ expenses.” National Urological 

Group, Inc., 645 F. Supp. 2d at 1213. 

Due to the conduct of Hi-Tech, Wheat, and Smith in violating Sections 

II and VII of the Hi-Tech injunction from January 1, 2009, through at least 

August 31, 2013, the court concludes that consumer redress in the amount of 

the gross receipts for the four products is appropriate. The court finds by a 

32 See FTC v. Leshin, 719 F.3d 1227, 1235 (11th Cir. 2013) (holding that 

district court’s have “wide discretion in fashioning an equitable remedy for 

civil contempt”) (quotation and citation omitted). 

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preponderance of the evidence33 (and by stipulation of the parties), that the 

gross receipts for the sale of the violative products—Fastin, Lipodrene, 

Benzedrine, and Stimerex-ES—during this period of time total $40,120,950. 

The FTC also requests that the court impose a separate sanction of 

$34,441,22734 to compensate consumers for the Hi-Tech defendants’ violation 

of Section VI. The court declines the FTC’s request. Although the violations 

of Sections II and VII are separate from the Section VI violation, since there 

is an overlap of time in which both violations occurred, the court finds 

imposing separate compensatory sanctions results in duplicity. The court 

notes, however, that the Hi-Tech defendants’ violation of Section VI during 

the same time period they violated Sections II and VII demonstrates the 

pervasiveness of their contumacious conduct, thus further demonstrating 

why $40,120,950 in compensatory sanctions is appropriate. 

The court has also found that Wright engaged in conduct violating the 

Wright injunction from at least September 1, 2010, through at least August 

26, 2013. A preponderance of the evidence and stipulation of the parties 

shows that the gross receipts for the sale of Fastin during this period of time 

33 Chierico, 206 F.3d at 1387 (finding that, “in a civil contempt action, we hold

that damages must be proven by a preponderance of the evidence”). 

34 This figure is the amount of revenues Hi-Tech received for the four 

products between January 1, 2009 and December 21, 2012, which is the time 

period in which the products did not have the required yohimbine warning. 

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totals $21,493,557.64. The court elects not to exercise its authority to impose 

a sanction of this magnitude in light of Wright’s earlier agreement to be 

banned from the industry and his voluntary disassociation with Hi-Tech, 

Wheat, and the entire supplement industry [Doc. No. 964, pp. 5-6]. Instead, 

the court finds that Wright must pay compensatory sanctions of $120,000, 

the amount he was paid by Hi- Tech in 2010, 2011, and 2012, combined. 

The court concludes that Hi-Tech, Wheat, and Smith must pay 

compensatory sanctions, jointly and severally,35 in the amount of 

$40,000,950; and that Wright must pay compensatory sanctions in the 

amount of $120,000. The court orders that the FTC must use these funds to 

reimburse consumers who purchased these products during the relevant time 

period. The court further orders that all funds, either voluntarily paid by the 

defendants or otherwise collected by the FTC, must be paid into the Registry 

of the Court. The FTC may access the funds only with an order by the court 

granting permission to access and distribute the funds to the affected 

consumers. The FTC may use a reasonable portion of the compensatory 

sanction award to cover the costs of reimbursement, including locating the 

affected consumers and other expenses. Finally, if any funds remain after 

35 See Leshin, 618 F.3d at 1236–37 (“Where . . . parties join together to 

evade a judgment, they become jointly and severally liable for the amount of 

damages resulting from the contumacious conduct.”). 

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proper distribution to the affected consumers, the court will then make a 

determination of the appropriate distribution of those funds. 

The court recognizes that the compensatory sanctions are significant, 

but so, too, was the defendants’ contumacious conduct. While the defendants 

essentially claim that several of the violations were honest mistakes, the 

record is replete with evidence – both direct and circumstantial – showing an 

intentional defiance of the court’s injunctions. Moreover, the court has not 

gone into great detail regarding the other evidence that was elicited during 

the 2014 bench trial, but the record contains additional evidence that the HiTech defendants repeatedly provided inaccurate and incomplete information 

in compliance reports submitted to the FTC, and they did not attempt in good 

faith to pay the underlying 2008 judgment. The defendants very clearly 

exhibited a pattern of contemptuous conduct since these proceedings began. 

Additionally, the amount of compensatory sanctions awarded accounts for 

only a percentage of Hi-Tech’s overall sales.36 As the court observed once 

before, “the defendants dispensed deception to those with the greatest need to 

believe it, and—not surprisingly—generated a handsome profit for their 

efforts.” Nat'l Urological Grp., Inc., 645 F. Supp. 2d at 1209. 

36 Hi-Tech’s 2012 U.S. Income Tax Return shows that the total billings for 

these four products was only 20 percent of Hi-Tech’s gross receipts or sales 

less returns and allowances for that year. 

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IV. Summary 

For the reasons discussed above, the court rules on the parties’ pending 

motions as follows: the motion to exclude Dr. Goldhaber [Doc. No. 855] is 

GRANTED; the motion to exclude Linda Gilbert [Doc. No. 875] is GRANTED; 

the motion to exclude Susan Blalock [Doc. No. 858] is DENIED as MOOT; the 

motion to exclude Dr. van Breemen [Doc. No. 865] is DENIED; the motion to 

exclude Dr. Aronne [Doc. No. 866] is DENIED; and the defendants’ motion for 

summary judgment [Doc. No. 876] is DENIED. 

The court ORDERS disgorgement of $40,120,950 in compensatory 

sanctions. Hi-Tech, Wheat, and Smith are jointly and severally liable for 

$40,000,950. Wright is liable for $120,000. The parties are ORDERED to 

administer the compensatory sanctions as directed above. In addition, the 

court ORDERS Hi-Tech, Wheat, and Smith, to the extent it has not been 

done already, to recall from retail outlets all Fastin, Lipodrene, Benzedrine, 

and Stimerex-ES with violative product packaging and labels. The FTC is 

DIRECTED to submit a proposed judgment within twenty (20) days of this 

order, after giving the defendants the opportunity to review same as to form. 

SO ORDERED this 10th day of October, 2017. 

/s/ Charles A. Pannell, Jr.

 CHARLES A. PANNELL, JR. 

 United States District Judge 

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