Full opinion text
ORDER CHARLES A. PANNELL, Jr., District Judge. This matter is before the court on the following motions: (1) the defendants’ motion for summary judgment [Doc. No. 168]; (2) defendant Hi-Tech Pharmaceuticals, Inc.’s (“Hi-Tech”) motion for summary judgment [Doc. No. 170]; (3) the plaintiffs motion for summary judgment [Doc. No. 172]; and (4) the defendants’ motion to strike the declaration of Jennifer A. Thomas [Doc. No. 214]. I. Case Overview A. The Plaintiff The Federal Trade Commission (“FTC”) is an independent agency of the United States Government created by statute. 15 U.S.C. §§ 41-58. The FTC is tasked with enforcement of the Federal Trade Commission Act (the “FTC Act”). The FTC Act prohibits unfair or deceptive acts or practices in or affecting commerce. 15 U.S.C. § 45(a). The FTC Act also prohibits false advertisements for food, drugs, devices, services, or cosmetics in or affecting commerce. 15 U.S.C. § 52. To aid its enforcement of the FTC Act, the FTC has promulgated regulations that require advertisements: (1) to be truthful and not misleading, and (2) to be supported by adequate substantiation for product claims prior to dissemination. The FTC refers to a violation of the former as a “falsity claim,” while a violation of the latter requirement is a “lack of reasonable basis (“LORB”) claim.” B. The Defendants Defendants National Urological Group (“NUG”), National Institute for Clinical Weight Loss (“NICWL”) and Hi-Tech (collectively, the “corporate defendants”) are corporations that are or were marketing, distributing and selling weight loss and/or erectile performance dietary supplements under the brand names Thermalean, Lipodrene, and/or Spontane-ES. Defendants Jared Wheat and Thomasz Holda are or were officers and shareholders of NUG and Hi-Tech, and were officers and shareholders of NICWL prior to its dissolution. Defendant Stephen Smith is or was an officer and shareholder of NUG, and was an officer and shareholder of NICWL before its dissolution. Defendant Terrill Mark Wright, M.D., is a medical doctor who promoted the dietary supplements at issue in this case. C.Brief Synopsis of Facts According to the defendants, the FTC began investigating their advertising practices in May of 2002. During the course of the investigation, the FTC requested from the defendants the substantiation for their advertising. The defendants allegedly complied and provided the FTC with substantiation based on each individual active ingredient in their dietary supplements (“ingredient-specific substantiation”), as opposed to substantiation based on the product as a whole. While the FTC investigation was ongoing, the United States Food and Drug Administration (“FDA”) filed a complaint for injunctive relief against the corporate defendants and Wheat in his individual capacity (collectively, the “FDA defendants”), alleging that they introduced misbranded drugs into commerce. Not long after the suit was filed, the FDA defendants entered into a consent decree with the FDA (the “Consent Decree”). The Consent Decree regulates the FDA defendants’ behavior along three pertinent veins. First, before the FDA defendants can sell a dietary supplement that is not considered a drug, the Consent Decree requires them to retain an independent expert to inspect their product labeling, including their promotional materials and internet web sites, and certify to the FDA that the FDA defendants are not making drug claims for their products. In addition to the independent expert’s report, the FDA defendants must submit to the FDA a written report that details, among other things, the actions they have taken to comply with the FDA Consent Decree. After this, the FDA defendants must await the FDA’s approval to resume or initiate operations. After resuming sales, the FDA defendants are prohibited from “directly or indirectly introducing] or delivering] for introduction into interstate commerce, or directly or indirectly causing] the introduction or delivery for introduction into interstate commerce of, any misbranded or unapproved new drug.” Consent Decree, ¶ 4(A) [Doc. No. 168, Ex. I], Finally, the Consent Decree permits FDA representatives to make unannounced inspections of the FDA defendants’ facilities, during which the FDA is allowed to investigate, among other things, all equipment, finished and unfinished drugs and dietary supplements, and all labeling, including promotional materials and internet site information. If the FDA determines that the FDA defendants are not in compliance with the Consent Decree, the FDA may take any other reasonable measures to monitor and ensure the FDA defendants’ continuing compliance. On November 10, 2004, months after the defendants entered into the Consent Decree, the FTC filed the instant suit pursuant to Section 13(b) of the Act, 15 U.S.C. § 53(b), to secure injunctive and other equitable relief against the defendants. In its complaint, the FTC asserts that the defendants have violated Section 5 of the Act, 15 U.S.C. § 45(a), and Section 12 of the Act, 15 U.S.C. § 52. Specifically, the FTC claims that the defendants have made deceptive representations to the public in their advertisements for the dietary supplements Thermalean, Lipodrene, and Spontane-ES. The FTC has petitioned this court for injunctive relief as well as relief in the form of consumer redress and disgorgement of profits. On August 24, 2007, the defendants, defendant Hi-Tech, individually, and the FTC filed cross motions for summary judgment [Doc. Nos. 168, 170, and 172]. On December 13, 2007, the defendants filed a motion to strike the affidavit of Jennifer Thomas [Doc. No. 214]. II. The Defendants’ Motion to Strike the Affidavit of Jennifer Thomas [Doc. No. 214] Before considering the parties’ motions for summary judgment, the court will address the defendants’ motion to strike the declaration of Jennifer A. Thomas [Doc. No. 214]. Thomas is Director of the Division of Enforcement in the Center for Food Safety and Applied Nutrition at the FDA. The FTC filed Thomas’s declaration in response to the defendants’ motion for summary judgment and Hi-Tech’s motion for summary judgment on November 5, 2007. Prior to filing Thomas’s declaration, the FTC did not disclose Thomas to the defendants as a party likely to have discoverable information. The defendants contend that the FTC’s failure to identify Thomas at an earlier date was prejudicial to their case and a violation of the Federal Rules of Civil Procedure. Accordingly, the defendants request that the court strike her affidavit. A. The Defendants’ Motion to Strike Is Denied. The courts in this district have repeatedly found that it is improper to strike an affidavit attached to a summary judgment brief. Lentz v. Hospitality Staffing Solutions, LLC, No. 1:06-cv-1893-WSD, 2008 U.S. Dist. LEXIS 6291, at *30-31, 2008 WL 269607, at *10 (N.D.Ga. Jan. 28, 2008) (noting that Federal Rule of Civil Procedure 12(f) permits the court to strike a pleading, not an affidavit attached to a motion for summary judgment). As this court stated in Lentz, “the proper method to challenge such an affidavit is to challenge the admissibility of the evidence contained in the affidavit.” Id.; see also Pinkerton & Laws Co. v. Roadway Express, Inc., 650 F.Supp. 1138, 1141 (N.D.Ga.1986) (concluding that a party should file a notice of objection rather than a motion to strike to challenge the admissibility of evidence in an affidavit). Because a motion to strike is a procedurally improper vehicle for challenging Thomas’s affidavit, the court must deny the defendants’ motion. However, the court “may only consider admissible evidence when deciding a motion for summary judgment,” and the defendants’ motion raises important questions regarding the admissibility of the Thomas affidavit. Id. Accordingly, the court, “in the interest of efficiency,” will “proceed to assess the admissibility of the challenged affidavit.” Spratlin Outdoor Media, Inc. v. City of Douglasville, No. 1:04-cv-3444-JEC, 2006 U.S. Dist. LEXIS 20797, at *13, 2006 WL 826077, at *4 (N.D.Ga. Mar. 27, 2006). B. The Thomas Declaration is Inadmissible. Federal Rule of Civil Procedure 26(a)(1) requires parties to provide initial disclosures including “the name and, if known, the address and telephone number of each individual likely to have discoverable information ... that the disclosing party may use to support its claims or defenses, unless the use would be solely for impeachment.” By rule, the obligation to disclose pertinent parties is continuing, so that a party must supplement its disclosures or discovery responses “in a timely manner if the party learns that in some material respect the disclosure or response is incomplete or incorrect, and if the additional or corrective information has not otherwise been made known to the other parties during the discovery process or in writing.” Fed.R.Civ.P. 26(e)(1)(A). If a party does not “provide information or identify a witness as required by Rule 26(a) or (e), the party is not allowed to use that information or witness to supply evidence on a motion, at a hearing, or at trial, unless the failure was substantially justified or is harmless.” Fed.R.Civ.P. 37(c)(1). ? It is undisputed that the FTC neither initially disclosed Thomas as a potential witness nor listed her as a witness in response to pertinent interrogatories. Although the FTC supplemented its initial disclosures in February 2006 to note that an “as yet unknown” FDA representative may have information relevant to the case, the FTC did not further supplement its disclosures in April 2006 when it identified Thomas as the FDA representative that it intended to use as a witness. FTC’s First Am. Initial Disclosures, ¶ 3(N) [Doc. No. 118], In fact, the FTC did not notify the defendants of Thomas or indicate in any other way that it had identified a FDA witness until it filed her declaration at the end of 2007. The FTC does not offer justification for its substantial delay in disclosing Thomas as a witness, but instead simply contends that her declaration should be admitted because the defendants were neither surprised nor prejudiced by its failure to disclose her as a witness at an earlier date. Essentially, the FTC contends that its disclosure in February 2006 that it was looking for a witness was enough to put the defendants on notice of Thomas’s potential role in this case. Moreover, the FTC contends that it was not required to disclose Thomas because she was a “witness used solely for impeachment,” and thus was not subject to Federal Rule of Civil Procedure 26. Fed.R.Civ.P. 26(a)(1). The FTC’s arguments are unconvincing. First, the fact that the FTC notified the defendants that they were looking for a witness in 2006, without more, does not mean that the defendants were not surprised when such a witness suddenly appeared on the record a year and a half later. Moreover, the court is convinced that the FTC’s failure to disclose Thomas’s identity was prejudicial to the defendants. Thomas’s declaration addresses the meaning and effect of the Consent Decree, a topic of critical importance to the defendants’ summary judgment briefs. The FTC’s failure to disclose Thomas as a potential witness prevented the defendants from deposing her or anticipating her testimony before expending the significant resources required to file their dispositive motions. Such a failure can hardly be considered harmless. Similarly, this court cannot conclude that the FTC presented Thomas’s declaration “solely for impeachment.” Impeachment evidence is evidence that is “offered to discredit a witness ... to reduce the effectiveness of her testimony by bringing forth evidence which explains why the jury should not put faith in her or her testimony.” Chiasson v. Zapata Gulf Marine Corp., 988 F.2d 513, 517 (5th Cir.1993). Although Rule 26(a)(1) does not require a party to disclose a witness that it intends to use “solely for impeachment,” the Eleventh Circuit has indicated that this is a narrow exception that should be limited to circumstances where the evidence offered by the witness plays no role other than impeachment. See Cooley v. Great Southern Wood Preserving, 138 Fed.Appx. 149, 161 (11th Cir.2005) (affirming a district court’s decision to exclude affidavits because the plaintiff failed to show that the evidence was offered solely for impeachment). Here, Thomas’s declaration does not simply discredit one particular witness or even a group of witnesses; rather, it is substantive evidence supporting the FTC’s defense to one of the defendants’ key summary judgment contentions. In their motion for summary judgment, the defendants have argued that the FTC’s action is not in the public interest because all of the relief the FTC seeks has already been achieved by the FDA’s Consent Decree. Thomas’s declaration, which the FTC offered “to clarify many of the facts surrounding the FDA consent decree,” provides substantive evidence that the relief the FTC seeks is not redundant and that the action the FTC pursues is in the public interest. FTC’s Resp. to Defs.’ Mot. for Summ. J., p. 52 [Doc. No. 195]. This evidence was provided to preserve the FTC’s case by demonstrating that there is a genuine issue for trial. Accordingly, it cannot simply be considered impeachment evidence offered solely “to discredit” the defendants. The FTC’s reliance on Sessoms v. Ghertner & Co., C.A. No. 3:05-0257, 2006 U.S. Dist. LEXIS 29863, 2006 WL 1102323 (M.D. Tenn. April 25, 2006), is misplaced. In Sessoms, the defendant, in response to a summary judgment motion, sought to impeach specific deposition testimony by filing declarations of individuals not previously disclosed in interrogatories or initial disclosures. Id. at *9, 2006 WL 1102323, at *3. That is not the situation here, where Thomas’s declaration is offered to rebut legal arguments and interpret the Consent Decree rather than to simply impeach deposition testimony. The court concludes that Thomas’s declaration was not offered solely for impeachment, and thus holds that the FTC was not exempt from disclosing her as required by Federal Rule of Civil Procedure 26. The FTC has offered no justification for its year and a half delay in disclosing Thomas to the defendants, and the court concludes that this delay was harmful and inexcusable. Consequently, the court will not consider Thomas’s declaration or its supporting exhibits in any summary judgment proceeding currently before the court. III. Summary Judgment Motions On August 24, 2007, defendant Hi-Tech individually filed a motion for summary judgment [Doc. No. 170], the defendants collectively filed a motion for summary judgment [Doc. No. 168] and the FTC filed a motion for summary judgment [Doc. No. 172]. These summary judgment motions will be addressed in turn. A. Summary Judgment Standard Summary judgment is proper where “the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and the moving party is entitled to a judgment as a matter of law.” Fed. R.CivJP. 56(c). The moving party bears the initial burden of showing that there is no genuine issue of material fact. See Celotex Corp. v. Catrett, 477 U.S. 317, 323, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986). This may be accomplished by showing that the nonmoving party will be unable to “establish the existence of an element essential to [the nonmoving] party’s case, and on which [the nonmoving] party will bear the burden of proof at trial.” Id. at 322, 106 S.Ct. 2548. Once the moving party has met its burden, the burden shifts to the nonmoving party to “designate specific facts showing that there is a genuine issue for trial.” Id. at 324, 106 S.Ct. 2548 (internal quotation marks omitted). There is a genuine issue if the combined body of evidence, viewed in the light most favorable to the nonmoving party, would allow a reasonable jury to find in favor of the nonmoving party. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). In other words, the relevant inquiry is “whether the evidence presents a sufficient disagreement to require submission to a jury or whether it is so one-sided that one party must prevail as a matter of law.” Id. at 251-52, 106 S.Ct. 2505. When, as here, a district court is presented cross motions for summary judgment on the same issues, “[t]he court must rule on each party’s motion on an individual and separate basis, determining, for each side, whether a judgment may be entered in accordance with the Rule 56 standard.” 10A Charles Alan Wright, Arthur R. Miller & Mary Kay Kane, Federal Practice and Procedure § 2720, at 335-36 (3d ed.1998) (footnote omitted). B. Hi-Tech’s Motion for Summary Judgment [Doc. No. 170] Hi-Tech premises its motion for summary judgment on one simple contention: it claims that it did not manufacture, advertise, or market the Lipodrene product at issue in this case and, thus, is not liable on the FTC’s allegations. Although Hi-Tech admits that it has produced and marketed multiple products under the name Lipodrene, it claims that these products are “completely different in look and formulation” from the Lipodrene that its co-defendant, NUG, marketed in the advertisements targeted in this action. Hi-Tech’s Resp. to FTC’s Statement of Additional Facts, ¶ 9 [Doc. No. 202, Ex. 1]. Hi-Tech contends that it did not participate in or fund the advertisements for the old Lipodrene or any other product, and thus, cannot be held liable for them. The FTC argues that Hi-Tech is not entitled to summary judgment because Hi-Tech participated in all of the advertising at issue in this case, particularly the Lipodrene advertisements. Specifically, the FTC contends that Hi-Tech, NUG, and NICWL acted as a common enterprise. Accordingly, the FTC contends that Hi-Tech should be jointly and severally liable with its corporate co-defendants for all of the advertising at issue in this case. 1. Legal Standard for Finding a Common Enterprise “The general rule is that, absent highly unusual circumstances, the corporate entity will not be disregarded.” P.F. Collier & Son Corp. v. FTC, 427 F.2d 261, 266 (6th Cir.1970). However, “where the public interest is involved, as it is in the enforcement of Section 5 of the Federal Trade Commission Act, a strict adherence to common law principles is not required ... where strict adherence would enable the corporate device to be used to circumvent the policy of the statute.” Id. at 267 (making this statement in the context of determining whether a parent should be held liable for the acts of its subsidiary). Thus, in situations where corporations are so entwined that a judgment absolving one of them of liability would provide the other defendants with “a clear mechanism for avoiding the terms of the order,” courts have been willing to find the existence of a common enterprise. See Delaware Watch Co. v. FTC, 332 F.2d 745, 746-47 (2d Cir.1964) (affirming a FTC order holding a company liable because it was part of a “maze of interrelated companies” through which “the same individuals were transacting an integrated business”). When corporations act as a common enterprise, each may be held liable for the deceptive acts and practices of the other. CFTC v. Wall Street Underground, Inc., 281 F.Supp.2d 1260, 1271 (D.Kan.2003) (citing Sunshine Art Studios, Inc. v. FTC, 481 F.2d 1171, 1175 (1st Cir.1973)). When determining whether a common enterprise exists, “the pattern and frame-work of the whole enterprise must be taken into consideration.” Delaware Watch Co., 332 F.2d at 746 (citations omitted). Some of the factors that courts evaluate to determine whether a common enterprise exists include common control; the sharing of office space and officers; whether business is transacted through a maze of interrelated companies; the commingling of corporate funds and failure to maintain separation of companies; unified advertising; and evidence that reveals that no real distinction exists between the corporate defendants. FTC v. Wolf, No. 94-8119-CIV-FERGUSON, 1996 U.S. Dist. LEXIS 1760, at *22-23, 1996 WL 812940, at *7-8 (S.D.Fla. Jan.30, 1996) (citations omitted). 2. Application of Legal Standard to Facts In this case, it is clear that all three companies at issue operated as a common enterprise. First, all three companies were under the common control of Wheat and Holda, and were at least influenced by Smith. Wheat served as the president and primary decision maker of all three companies. He developed all of the products at issue in this case, owned all of their trademarks, developed all of their advertising (or at least provided the information for all of the advertisements), wrote checks for all three companies, made deposits and withdrawals on behalf of all three companies, and had the authority to enter into contracts and terminate contracts for all three companies. Holda likewise served as an officer of all three companies. In that role, he participated in business decisions. Holda also ran the shipping operations for each of the companies and testified that he reviewed the advertisements for errors before they were disseminated. Smith served as an officer of NICWL and NUG, and served as an independent contractor for Hi-Tech beginning in 2003. In all three companies, Smith served as the employee/independent contractor manager. Smith, like Holda, testified that he reviewed all of the advertisements for errors. Wheat, Holda, and Smith ran the three companies out of the same office space in an integrated fashion. For instance, Hi-Tech — the only company with its name on the door — assumed the duty of leasing the office space, often served as the addressee and mail distributor for the other companies, and ordered goods on behalf of the other companies so that all of the companies could save money. Similarly, NICWL served as the payroll manager for itself, NUG, and other affiliated, non-party companies. All three companies shared in the allocation of a number of indirect costs and expense items, including bank charges, credit card fees, depreciation, and — most importantly — consulting fees for the Thermalean and Lipodrene products. Significantly, the defendants’ own expert identified NUG, NICWL, and Hi-Tech as among “five companies [that] have overlapping ownership and [which] incur costs and expenses in relation to [Thermalean, Lipodrene, and Spontane-ES].” Abernathy Expert Report, attached as Ex. 2 to Knight Decl. [Doc. No. 172, Ex. 7]. In addition, the companies worked together to develop and advertise their products. For example, in a related trademark infringement action, Hi-Tech alleges that it worked for years with now-dissolved United Metabolic Research Center, Inc. (“UMRC”), which it ultimately equates with NUG, to develop the original Lipodrene product. Trademark Compl., ¶¶ 14-17, attached as Ex. 1 to Knight Decl. [Doc. No. 195, Ex. 30]. Hi-Tech goes on to represent that NUG/UMRC marketed the original Lipodrene through mail order until the product was reformulated. At that point, Hi-Tech, using some of the same advertising materials for the original Lipodrene, began to market the new Lipodrene through wholesale and retail outlets. Hi-Tech later used — almost verbatim— NICWL’s Thermalean brochure to market its new Lipodrene. Similarly, Hi-Tech also used claims, language, and artwork from NUG’s Spontane-ES advertisement to market its male potency product, Stamina-RX. When the operations of the companies are considered as a whole, it is clear that they functioned as a common enterprise. All were controlled by the same primary parties, all used and/or shared advertising generated by these controlling individuals, all worked together to achieve profitability, and all shared costs and expenses in relation to the same products. Most importantly, if one of these companies escaped liability, it would afford all three a means for continuing their operations. The few distinctions between the corporations (i.e., the fact that they maintained separate bank, merchant, and UPS accounts and filed their taxes separately) are superficial in nature and would not, when considered in light of the overwhelming evidence of the corporations’ interrelated functions, provide a reasonable jury with a basis to reject the application of the common enterprise theory here. The evidence compels that the court find a common enterprise; thus, NUG, NICWL, and Hi-Tech should share liability for the advertisements at issue. Accordingly, Hi-Tech is not entitled to summary judgment here. C. The Defendants’ Motion for Summary Judgment [Doc. No. 168] The defendants’ summary judgment argument is two-pronged. First, the defendants contend that the court should not use the FTC’s standards in applying the FTC Act because it argues that those standards are unconstitutional. Second, the defendants contend that they are entitled to summary judgment because the FTC is not eligible for injunctive relief under Section 13(b) of the FTC Act. Because the defendants have requested that the court consider their arguments regarding injunctive relief in the FTC’s motion for summary judgment, the court will defer a discussion on these arguments until it addresses that motion. Accordingly, the court need only address the defendants’ constitutional arguments at this juncture. The defendants dedicate a large portion of their briefing to an argument that the FTC’s standards in applying the FTC Act are unconstitutional. Using a test articulated in Central Hudson Gas & Electric Corporation v. Public Service Commission, 447 U.S. 557, 100 S.Ct. 2343, 65 L.Ed.2d 341 (1980), the defendants argue that many of the standards that the FTC uses to determine whether advertising is deceptive violate the First Amendment. In addition, the defendants contend that the standards that the FTC uses to review advertisements for violations of the FTC Act are unconstitutionally vague and over-broad. The court will address these arguments separately below. 1. The Defendants’ Central Hudson Arguments In Central Hudson, 447 U.S. 557, 100 S.Ct. 2343, 65 L.Ed.2d 341 (1980), the Supreme Court articulated a four-part analysis for reviewing whether a regulation governing commercial speech violates the First Amendment. The court stated, At the outset, we must determine whether the expression is protected by the First Amendment. For commercial speech to come within that provision, it at least must concern lawful activity and not be misleading. Next, we ask whether the asserted governmental interest is substantial. If both inquiries yield positive answers, we must determine whether the regulation directly advances the governmental interest asserted, and whether it is not more extensive than is necessary to serve that interest. Id. at 566, 100 S.Ct. 2343. Focusing on the last three elements of this analysis, the defendants claim that the following standards that the FTC uses in determining whether advertising is false or deceptive violate the First Amendment: • The FTC does not consider proof of intent to deceive or permit a good faith defense when an advertisement is challenged as deceptive; • The FTC relies on its own facial analysis of an advertisement, rather than extrinsic evidence of consumer perceptions, to determine what implicit claims an advertisement promotes; • The FTC has not promulgated a trade rule to define what misleading implications flow from specified product claims or descriptions, particularly with respect to advertising containing ingredient specific substantiation; and • The FTC requires all advertising claims that pertain to a supplement’s health related benefits to be substantiated by competent and reliable scientific evidence but does not define “competent and reliable scientific evidence.” The court concludes that the defendants have misapplied the Central Hudson test in this situation. The test the Court articulated in Central Hudson was promulgated to assist courts in determining whether a regulation that limits protected commercial speech is constitutional. Here, the defendants do not attack any particular regulation restricting speech; instead, the defendants attack the guidelines the FTC uses to determine whether speech is protected. See Bristol-Myers Co. v. FTC, 738 F.2d 554, 562 (2d Cir.1984) (“[Deceptive advertising enjoys no constitutional protection.”). Thus, the defendants employ circular logic: they contend that the court must use the Central Hudson test — which only applies to protected speech — to determine whether or not speech is protected. The court is unpersuaded by this confusing and illogical argument. Whether or not the advertisements are deceptive, and thus unprotected speech, is a matter that is in the sound discretion of the court. Kraft, Inc. v. FTC, 970 F.2d 311, 316 (7th Cir.1992) (citing FTC v. Colgate-Palmolive Co., 380 U.S. 374, 385, 85 S.Ct. 1035, 13 L.Ed.2d 904 (1965)) (“[T]he words ‘deceptive advertising’ set forth a legal standard that derives its final meaning from judicial construction.”). Accordingly, the court finds that Central Hudson does not apply in this situation. 2. The Defendants’ Vagueness and Overbreadth Challenges In addition to the Central Hudson concerns presented above, the defendants allege that the FTC’s standards regulating advertising are vague and overbroad. As an initial matter, the defendants’ arguments regarding the overbreadth doctrine are unsustainable. The Supreme Court has explicitly held that the overbreadth doctrine cannot be used to challenge regulations of commercial speech. Village of Hoffman Estates v. Flipside, 455 U.S. 489, 497, 102 S.Ct. 1186, 71 L.Ed.2d 362 (1982) (“the over-breadth doctrine does not apply to commercial speech.”). All of the standards challenged by the defendants in this case concern commercial speech; accordingly, the overbreadth doctrine does not apply. The defendants’ vagueness challenges center around the standards the FTC uses to determine whether claims that an advertisement makes regarding health and/or safety are adequately substantiated. The FTC requires advertising claims that pertain to a health benefit to be substantiated by competent and reliable scientific evidence. The defendants argue that this standard is unconstitutionally vague because it does not provide sufficient certainty about the criteria the FTC uses to evaluate the scientific support for ingredient-specific claims, does not establish requirements for size, duration, or protocol of a scientific study, does not provide any single fixed formula for the number or type of scientific studies required to substantiate a claim, and does not specify the proper mechanism for extrapolating results of a study. The defendants’ arguments are not persuasive. As the defendants point out, “A statute can be impermissibly vague for either of two independent reasons. First, if it fails to provide people of ordinary intelligence a reasonable opportunity to understand what conduct it prohibits. Second, if it authorizes or even encourages arbitrary and discriminatory enforcement.” Hill v. Colorado, 530 U.S. 703, 732, 120 S.Ct. 2480, 147 L.Ed.2d 597 (2000). Here, the defendants have not demonstrated that the FTC’s standard fails for either of these reasons. “Competent and reliable scientific evidence” has been defined in various contexts, including in guidelines promulgated by the FTC, as “tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area, that have been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results.” Bureau of Consumer Protection, Federal Trade Commission, Dietary Supplements, An Advertising Guide for the Industry (2001), p. 9, attached as Ex. H to Defs.’ Mot. for Summ. J. [Doc. No. 168]. The court can find no reason why this definition would not give people of ordinary intelligence a reasonable opportunity to understand what evidence is required to substantiate their health-related claims. Obviously, this definition is context specific and permits different variations on “competent and reliable scientific evidence” depending on what pertinent professionals would require for the particular claim made. Thus, the size, duration or protocol of a scientific study, the number or type of scientific studies required to substantiate a claim, and the proper mechanism for extrapolating results from studies will obviously vary from circumstance to circumstance depending upon the expert evidence presented. However, the standard by which these issues of fact are resolved is clear, and an advertiser can be reasonably certain of what substantiation will be required by conferring with appropriate professionals or experts. The fact that different scientific evidence is required for different claims impacting different products does not mean that the FTC can enforce its act arbitrarily; instead, it simply means that different claims require different substantiation. As Judge Dimock wrote in his concurring opinion in United States v. Shackney, 333 F.2d 475, 488 (2nd Cir.1964), “Statutes are not ... void for vagueness because they raise difficult questions of fact. They are void for vagueness only where they fail to articulate a definite standard.” Here the FTC has articulated a definite standard; accordingly, the issues of fact that it generates do not render it unconstitutionally vague. The defendants have failed to demonstrate that the FTC’s standards at issue in this case are unconstitutional and, thus, are not entitled to summary judgment on this issue. D. The FTC’s Motion for Summary Judgment [Doc. No. 172] In the FTC’s motion for summary judgment, the FTC argues that it is entitled to summary judgment on all of its claims because the defendants’ advertisements violate the FTC Act. The defendants respond to the FTC’s motion by first asserting that the FTC is legally precluded from litigating its claims by the doctrines of res judicata and collateral estoppel. The defendants then argue the merits of the case, contending that the FTC does not have sufficient evidence to demonstrate that the advertising was false and misleading and that most of the challenged advertising was non-actionable puffery. The court will first address the defendants’ affirmative defenses before turning to the merits of the case. 1. The Defendants’ Affirmative Defenses The defendants allege that the doctrines of res judicata and collateral estoppel preclude the FTC’s claims. Specifically, they argue that the Consent Decree that the defendants entered into with the FDA resolved the claims and issues presented in the current action. Collateral estoppel and res judicata are affirmative defenses. Fed. R.Civ.P.R. 8(c). Eleventh Circuit courts have held that the “failure to include an affirmative defense in the answer or have it included in the pre-trial order of the district court, which supersedes the pleadings, will normally result in waiver of the defense.” Jackson v. Seaboard C.L.R. Co., 678 F.2d 992, 1012 (11th Cir.1982); see also Palmer v. Braun, 376 F.3d 1254, 1257 n. 2 (11th Cir.2004) (finding that the defendant waived his affirmative defense when he failed to include it in either his answer or the pretrial order). While parties may raise the res judicata and collateral estoppel defenses in a summary judgment motion if the motion is filed in place of an answer, Concordia v. Bendekovic, 693 F.2d 1073, 1075 (11th Cir.1982), or if events subsequent to the filing of the answer give rise to the defenses and the .assertion of the defenses is not prejudicial to the plaintiff, In re Air Disaster at Brunswick, Georgia, 879 F.Supp. 1196, 1200 (N.D.Ga.1994), a party may not revive an available defense that he failed to assert in his answer by arguing it on summary judgment. Funding Systems Leasing Corp. v. Pugh, 530 F.2d 91, 96 (5th Cir.1976). This is consistent with Supreme Court rulings, which hold that preclusion defenses must be asserted in a timely manner. Arizona v. California, 530 U.S. 392, 410, 120 S.Ct. 2304, 147 L.Ed.2d 374 (2000). In this case, the defendants base their preclusion defenses on a Consent Decree that they entered into with the FDA on September 22, 2003. Although the Consent Decree had been in place for almost sixteen months, the defendants did not assert res judicata or collateral estoppel when they filed their answers on January 18, 2005. In fact, it was not until the defendants filed their response to the FTC’s motion for summary judgment on November 5, 2007 — over four years after the Consent Decree was signed — that the defendants raised these preclusion defenses. The court finds the defendants’ delay in asserting these defenses inexcusable. The preclusion defenses that the defendants now attempt to assert have been available to them throughout the three plus years that this case has been pending. The defendants cannot assert them at this late point simply because the “light finally dawned” that they might be available. Arizona v. California, 530 U.S. at 410, 120 S.Ct. 2304 (“We disapprove of the notion that a party may wake up because a ‘light finally dawned,’ years after the first opportunity to raise a defense, and effectively raise it so long as the party was (though no fault of anyone else) in the dark until its late awakening.”). Accordingly, this court concludes that the defendants have waived their right to assert these defenses. 2. Analysis of the Defendants’ Advertisements for False and Misleading Claims As noted above, the FTC has asserted that the defendants violated Sections 5 and 12 the FTC Act by (1) making false claims regarding Thermalean, Lipodrene, and Spontane-ES; (2) making unsubstantiated claims regarding Thermalean, Lipodrene and Spontane-ES; and (3) making false claims regarding research and medical facilities. The FTC has also alleged that Dr. Wright violated the FTC Act by making false and unsubstantiated claims in his role as an expert endorser for Thermalean. The court will first address the legal framework for analyzing the advertisements for violations of the FTC Act and then will apply that framework to the advertisements at issue. Finally, the court will address the defendants’ defense that much of the advertising constitutes non-actionable puffery. a. Overview of the Law The FTC’s claims are premised on the defendants’ alleged violations of Sections 5 and 12 of the FTC Act. Section 5 of the FTC Act prohibits unfair or deceptive acts or practices in or affecting commerce. 15 U.S.C. § 45(a). Section 12 addresses false advertising and provides that the dissemination of false advertisements — defined as advertisements that are misleading in a material respect — is an unfair or deceptive practice in commerce. 15 U.S.C. §§ 52(b) and 55. “Thus, a violation of Section 12, dissemination of false advertising, constitutes a violation of Section 5(a).” FTC v. QT, Inc., 448 F.Supp.2d 908, 957 (N.D.Ill.2006). To establish liability under Sections 5 and 12 of the FTC Act, the FTC must prove: (1) that there was a representation; (2) that the representation was likely to mislead customers acting reasonably under the circumstances; and (3) that the representation was material. FTC v. Tashman, 318 F.3d 1273, 1277 (11th Cir.2003); see also Kraft, Inc., 970 F.2d at 314 (citing Sections 5 and 12 to state that “an advertisement is deceptive under the Act if it is likely to mislead customers, acting reasonably under the circumstances, in a material respect”); QT, Inc., 448 F.Supp.2d at 957 (using this three part test to find violations of Sections 5 and 12). The court will address each of these elements in depth. i. Was the Representation Made? The first step that the court must take to analyze whether the defendants violated the FTC Act is to determine whether the advertisements made the claims asserted by the FTC in the complaint. QT, Inc., 448 F.Supp.2d at 957. The meaning of an advertisement, the claims or net impressions communicated to reasonable consumers, is fundamentally a question of fact. See, e.g., id. at 957-58 (citing National Bakers Services, Inc. v. FTC, 329 F.2d 365, 367 (7th Cir.1964)). This question of fact may be resolved by the terms of the advertisement itself or by evidence of what consumers interpreted the advertisement to convey. When assessing the meaning and representations conveyed by an advertisement, the court must look to the advertisement’s overall, net impression rather than the literal truth or falsity of the words in the advertisement. FTC v. Peoples Credit First, LLC, No. 8:03-cv-2353-T-TBM, 2005 U.S. Dist. LEXIS 38545, at *20-25, 2005 WL 3468588, at *5-6 (M.D.Fla. Dec. 18, 2005) (finding that an advertisement was implicitly deceptive by looking at the net impression that it was likely to make on the general public). If the advertisement explicitly states or clearly and conspicuously implies a claim, the court need not look to extrinsic evidence to ascertain whether the advertisement made the claim. See In re Thompson Med. Co., Inc., 104 F.T.C. 648, 311-12 (1984) (noting that when an advertisement unequivocally states a claim, “it is reasonable to interpret the ads as intending to make [it]”); QT, Inc., 448 F.Supp.2d at 958 (“Where implied claims are conspicuous and reasonably clear from the face of the advertisements, extrinsic evidence is not required.”) (internal citations omitted). However, if the advertisement faintly implies a claim, the court may certainly decline from concluding that the advertisement makes such a representation without extrinsic evidence of consumer perceptions. As another district court noted, “implied claims fall along a continuum from those which are so conspicuous as to be virtually synonymous with express claims to those which are barely discernable. It is only at the latter end of the continuum that extrinsic evidence is necessary.” FTC v. Febre, C.A. No. 94-C-3625, 1996 U.S. Dist. LEXIS 9487, at *14-15, 1996 WL 396117, at *4 (N.D.Ill. July 2, 1996). In this case, the FTC has not presented any evidence of what claims consumers perceived the advertisements to make; accordingly, any claims that the FTC contends that the advertisements make must be clear and conspicuous from the face of the advertisements. ii. Is the Representation Likely to Mislead? To demonstrate that a claim is likely to mislead a reasonable customer, the FTC may proceed under a “falsity theory,” a “reasonable basis theory,” or both. QT, Inc., 448 F.Supp.2d at 957-58. If the FTC proceeds under a falsity theory, it “must demonstrate either that the express or implied message conveyed by the ad is false.” FTC v. Natural Solutions, Inc., C.A. No. 06-6112-JFW, 2007 U.S. Dist. LEXIS 60783, at *10 (C.D.Cal. Aug. 7, 2007). If the FTC proceeds under a “reasonable basis” theory, it must demonstrate that the advertiser lacked a reasonable basis — or adequate substantiation' — for asserting that the message was true. Id. As discussed in the defendants’ motion for summary judgment, in the case of health-related claims or claims concerning the efficacy or safety of dietary supplements, this reasonable basis must, at a minimum, consist of competent and reliable scientific evidence. QT, Inc., 448 F.Supp.2d at 961. All of the products at issue in this case are dietary supplements and/or drugs that are marketed as promoting health benefits in the form of weight loss and sexual enhancement. Not surprisingly, all of the unsubstantiated representations that the FTC claims the advertisements make are related to the safety and/or efficacy of the dietary supplements and, correspondingly, implicate health concerns. Thus, all of the lack of reasonable basis claims discussed in this case must be supported by “competent and reliable scientific evidence.” As noted in the discussion of the defendants’ motion for summary judgment [Doc. No. 168], the FTC has defined competent and reliable scientific evidence as “tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area, that have been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results.” Dietary Supplements, An Advertising Guide for the Industry, supra, at 9. The court adopts this definition. Thus, what constitutes competent and reliable scientific evidence in this case is a question of fact for expert interpretation. Id. iii. Is the Representation Material? “A representation or omission is material if it is the kind usually relied on by a reasonably prudent person.” FTC v. Windward Marketing, No. 1:96-cv-615, 1997 U.S. Dist. LEXIS 17114, at *27, 1997 WL 33642380, at *9 (N.D.Ga. Sept. 30, 1997); see also QT, Inc., 448 F.Supp.2d at 960 (“A claim is considered material if it involves information that is important to consumers and, hence, likely to affect their choice of, or conduct regarding, a product.”) (internal citations omitted). “Express claims, or deliberately made implied claims, used to. induce the purchase of a particular product or service are presumptively material.” Windward Marketing, 1997 U.S. Dist. LEXIS 17114, at *28, 1997 WL 33642380, at *10. In addition, other courts have also found claims that “significantly involve health, safety, or other issues that would concern reasonable customers” to be presumptively material. QT, Inc., 448 F.Supp.2d at 960, 965-66. As noted above, all of the representations that the FTC claim's the ads make are related to health and/or safety. As a matter of practicality, this court finds it hard to imagine that any reasonable customer would find claims regarding how a product affects his or her health or safety immaterial, but the court need not reach that question at this juncture. For purposes of this case, it is sufficient to state that when 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. Thus, the court will presume that all of the asserted claims in this case, if made, were material to the customers’ purchasing decisions. b. Application of the Law to Product Claims and False Endorsement Claims The FTC asserts that the defendants’ advertising violates the FTC Act by making false and unsubstantiated claims regarding Thermalean, Lipodrene, and Spontane-ES. The FTC also alleges that Dr. Wright made false claims and claims without a reasonable basis in his endorsement of Thermalean. The court will examine the advertisements on a product-byproduct basis to determine whether the claims were made. The court will then address (1) whether the claims are likely to mislead a reasonable consumer; and (2) whether the claims are material. i. Do the Advertisements Make the Claims? (A) Thermalean Claims and Wright False Endorsement Claims As a basis for its allegations, the FTC attached to the complaint a nine-page Thermalean brochure and a two-page letter “from the desk of Dr. Mark Wright, M.D., Chief of Staff, NICWL” (“the Wright letter”) endorsing Thermalean. [Doc. No. 1, Exs. A and B]. Based on these advertisements, the FTC has asserted that the defendants made the following false and deceptive claims: Falsity Claim 1: Thermalean is clinically proven to be an effective treatment for obesity; Falsity Claim 2: Thermalean causes rapid and substantial weight loss, including as much as 30 pounds in 2 months; Falsity Claim 3: Thermalean is clinically proven to cause rapid and substantial weight loss, including as much as 30 pounds in 2 months; Falsity Claim 4: Thermalean is clinically proven to enable users to lose 19% of their total body weight, lose 20-35% of abdominal fat, reduce their overall fat by 40-70%, decrease their stored fat by 300%, and increase their metabolic rate by 76.9%; and Falsity Claim 5: Thermalean is clinically proven to inhibit the absorption of fat, suppress appetite, and safely increase metabolism without dangerous side effects. Compl., ¶¶ 21-22 [Doc No. 1]. The FTC has also asserted that the defendants made the following representations (“Lack of Reasonable Basis (“LORB”) Claims”) without possessing or relying upon a reasonable basis to substantiate the claims: LORB Claim 1: Thermalean is an effective treatment for obesity; LORB Claim 2: Thermalean causes rapid and substantial weight-loss, including as much as 30 pounds in two months; LORB Claim 3: Thermalean causes users to lose 19% of their total body weight, lose 20-35% of abdominal fat, reduce their overall fat by 40-70%, decrease their stored fat by 300%, and increase their metabolic rate by 76.9%; LORB Claim 4: Thermalean inhibits the absorption of fat, suppresses appetite, and safely increases metabolism without dangerous side effects; LORB Claim 5: Thermalean is equivalent or superior to the prescription weight loss drugs Xenical, Meridia, and Fastin in providing weight loss benefits; and LORB Claim 6: Thermalean is safe. Id. at ¶¶ 23-24. In addition, the FTC has used the two Thermalean advertisements as the basis for its expert endorsement claims against Dr. Wright. The FTC asserts that Dr. Wright made the following false endorsements regarding Thermalean: False Endorsement Claim 1: Thermalean is clinically proven to be an effective treatment for obesity; False Endorsement Claim 2: Thermalean is clinically proven to cause rapid and substantial weight loss, including as much as 30 pounds in two months; False Endorsement Claim 3: Thermalean is clinically proven to enable users to lose 20-35% of abdominal fat, reduce their body fat by 42%, decrease their stored fat by 300%, and increase their metabolic rate by 76.9%; and False Endorsement Claim 4: Thermalean is clinically proven to inhibit the absorption of fat, suppress appetite, and safely increase metabolism without dangerous side effects. Id. at ¶¶ 34-35. The FTC also claims that Dr. Wright made the following claims without a reasonable basis: Wright LORB Claim 1: Thermalean is an effective treatment for obesity; Wright LORB Claim 2: Thermalean causes rapid and substantial weight loss, including as much as 30 pounds in 2 months; Wright LORB Claim 3: Thermalean causes users to lose 20-35% of abdominal fat, reduce their body fat by 42%, decrease their stored fat by 300%, and increase their metabolic rate by 76.9%; Wright LORB Claim 4: Thermalean inhibits the absorption of fat, suppresses appetite, and safely increases metabolism without dangerous side effects; Wright LORB Claim 5: Thermalean is equivalent or superior to the prescription weight loss drugs Xenical, Meridia, and Fastin in providing weight loss benefits; and Wright LORB Claim 6: Thermalean is safe. The court will analyze the advertisements for each of these claims. Where the claims are closely linked and supported by the same or similar evidence, the court will examine the claims in tandem. (1) Falsity Claim 1, LORB Claim 1, False Endorsement Claim 1, and Wright LORB Claim 1 The FTC argues that the advertisements and Dr. Wright falsely represent that Thermalean is clinically proven to be an effective treatment for obesity and represent, without a reasonable basis, that Thermalean is an effective treatment for obesity. The court has surveyed the advertisements, and has identified the following express statements related to obesity: • Introducing Thermalean (575 mg Capsule) [-][t]hree specific causes linked to obesity with one solution Thermalean [Doc. No. 1, Ex. A — 2]; • At the National Institute for Clinical Weight Loss, [o]ur research and development team has developed a nonprescription formulation that incorporates a naturally occurring equivalent and substitute for Meridia, Xenical, and Fastin. Thermalean is the most complete, omni-faceted nutriceutical ever developed for the diet industry! After four full years of product development and feedback from hundreds of thousands of clients, we are very proud to announce that Thermalean is the FIRST over-the-counter (OTC) nutriceutical to incorporate all three aspects of obesity into one amazing product called Thermalean [Id.]; • Why Thermalean? Why now? Thermalean is a product of decades of research and development in the field of weight loss. Thermalean was designed to help the person only needing to los[e] 5 or 10 pounds, as well as the person needing to lose 100 or more pounds. Pharmaceutical “mega-firms” would have you believe that their product is the only product to fight obesity. If this were true then why is America the most overweight society in the history of the world? With an estimated 75 million Americans clinically considered obese the question should be, Why not now? [Doc. No. 1, Ex. A-7]; • With 75 million Americans clinically considered “obese” [sic] Thermalean could not have come at a better time [Doc. No. 1, Ex. A-6, Wright Endorsement Section]; • Try Thermalean today and win the battle against obesity [Wright Letter, Doc. No. 1, Ex. B-2]. After reviewing these express statements in light of the advertisements in full, the court is persuaded that the defendants’ advertisements, including Dr. Wright’s endorsement, clearly imply that Thermalean is an effective treatment for obesity. However, the court is not convinced that the advertisements clearly and conspicuously imply that Thermalean is clinically proven to treat obesity. Throughout the advertisements, the defendants heavily imply that Thermalean is clinically proven to cause weight loss. However, the defendants have presented evidence that the disease of obesity is different from general weight loss; thus, the court will not presume, without extrinsic evidence, that a recipient of these advertisements would infer that Thermalean is clinically proven to treat obesity from the clinical weight loss claims. Since the FTC has presented no extrinsic evidence, the court concludes that the advertisements do not represent that Thermalean is clinically proven to treat obesity and thus do not make Falsity Claim 1 or False Endorsement Claim 1. (2) Falsity Claims 2 and 3, LORE Claim 2, Wright False Endorsement Claim 2 and Wright LORE Claim 2 The FTC contends that the Thermalean advertisements and defendant Wright as an endorser falsely and without a reasonable basis represent that Thermalean causes rapid and substantial weight-loss, including as much as 30 pounds in two months. In addition, the FTC contends that the advertisements and Wright falsely represent that Thermalean is clinically proven to cause rapid and substantial weight-loss, including as much as 30 pounds in two months. The court has reviewed the advertisements, and concludes that they, through Wright’s endorsements, make the asserted representations. The Wright letter states, “Thermalean is the most complete product on the market today for rapid[,] sustainable weight loss ... Whether you need to lose 10, 20, 100 pounds or more, Thermalean will work for you.” [Doc. No. 1, Ex. B], Obviously, this portion of the letter expressly states that Thermalean delivers fast, significant weight loss. However, the court need not hang its hat on this statement alone, as the brochure also unambiguously makes the claims at issue here. In the “Questions for Dr. Mark Wright, M.D.” portion of the brochure, the advertisement states: Q: How much weight can I expect to lose with Thermalean? A: Clinical trials based on Thermalean’s proprietary components have yielded weight loss to nearly 15% of beginning body weight within the first two months Example: (to put this statistic in perspective) Starting Date June 1 Starting Weight 200 lbs Weight after 60 days 170 lbs Weight loss in 60 days 30 lbs [Doc. No. 1, Ex. A]. This question and answer segment establishes that Thermalean causes rapid, significant weight loss, and the example given indicates that a consumer can lose up to thirty pounds in two months. In addition, the answer is purportedly based on “clinical trials,” providing support for the falsity claims at issue here. Although the defendants have highlighted the language regarding “proprietary components” and argued that the clinical trials and the results thereof were explicitly referring to the ingredients rather than the product as a whole, the court is not persuaded by this argument. The question part of the segment asks about the overall Thermalean product, and the answer, though phrased as an answer regarding the proprietary components, was clearly meant to respond to the query regarding the benefits of the product as a whole. The advertisement’s generic reference to “Thermalean’s proprietary components” emphasizes not the unnamed ingredients but the overall product, and thus achieves the advertisement’s goal of promoting the product the defendants are attempting to sell. The unambiguous intent and meaning of the advertisement is that Thermalean — not its “proprietary components”— causes rapid and substantial weight loss, including as much as thirty pounds in two months; thus, the court concludes that the advertisements make the representations alleged by the FTC. (3) Falsity Claim 4 and LORE Claim 3 The FTC asserts that the advertisements falsely convey that Thermalean is clinically proven to enable users to lose 19% of their total body weight, lose 20-35% of abdominal fat, reduce their overall fat by 40-70%, decrease their stored fat by 300%, and increase them metabolic rate by 76.9%. The FTC also asserts that the advertisements, without a reasonable basis, represent that Thermalean causes users to accomplish these same statistical results. The Thermalean brochure states, Clinical studies show the active components in Thermalean yield the following extraordinary results: — Loss of 19% total body weight — Increase metabolic rate by 76.9% without exercise — Reduction of 40-70% overall fat under the skin — Loss of 20-35% of abdominal fat. [Doc. No. 1, Ex. A-2], Similarly, the brochure also states, In their precise ratios, the thermogenic components used in Thermalean have achieved the following results in University-sponsored clinical trials (all of these statistics have been reported in such professional journals as the International Journal of Obesity, American Journal of Clinical Nutrition, and The New England Journal of Medicine): — 300% decrease in stored fat vs. placebo — 29% greater weight loss vs. RE-DUX — 600% increase in total weight loss vs. placebo — 42% reduction in body fat in a specified time period Id. atA-3. A quick analysis of the language above demonstrates that the Thermalean brochure conveys the asserted claims. The brochure unequivocally states that Thermalean’s “active components” and “thermogenic components” enable users to lose 19% of their total body weight, lose 20-35% of abdominal fat, reduce their overall fat by 40-70%, decrease their stored fat by 300%, and increase their metabolic rate by 76.9%. It also unequivocally represents that these results are backed by clinical studies and independent, university-sponsored clinical trials. Although the defendants go to great lengths to establish that this express language is language about the ingredients rather than language about the Thermalean product, the court is not persuaded by such meaningless distinctions. The brochure does not define these active and/or thermogenic components by name or proportion; instead, it simply uses these references to mysterious ingredients as synonyms for “Thermalean.” The obvious implication from the brochure is that Thermalean — as a whole — is scientifically and clinically proven to yield the touted results; accordingly, the court concludes that it makes the alleged claims. (4) W