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UNITED STATES OF AMERICA 

BEFORE THE FEDERAL TRADE COMMISSION 

OFFICE OF THE ADMINISTRATIVE LAW JUDGES 

In the Matter of 

HEALTH RESEARCH LABORATORIES, LLC, 

a limited liability company, 

DOCKET NO. 9397 

WHOLE BODY SUPPLEMENTS, LLC, 

a limited liability company, and 

KRAMER DUHON, 

Individually and as an officer of HEALTH 

RESEARCH LABORATORIES, LLC and 

WHOLE BODY SUPPLEMENTS, LLC 

RESPONDENTS’ RESPONSE TO CROSS MOTION TO AMEND COMPLAINT 

Complaint Counsel’s Cross Motion to Amend Complaint should be denied because 

it is unauthorized and unnecessary and because it seeks to inject issues into this case that 

are beyond a Part 3 Administrative Proceeding. 

I. SUMMARY 

Rather than continue a fight that has been ongoing for more than six years, 

Respondents elected to admit all material facts–an action expressly permitted by 16 

C.F.R. § 3.12. Remarkably, Complaint Counsel opposes Respondents’ efforts to admit 

the material facts alleged in the FTC’s Complaint. To prolong any resolution of this case, 

Complaint Counsel now seeks to amend the Part 3 Administrative Complaint to allege, 

among other things, that Respondents violated the Maine Consent Order—an issue that is 

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exclusively within the jurisdiction of the federal court that issued the Consent Order. For 

the reasons set forth below, the Cross Motion to Amend the Complaint should be denied. 

II. BACKGROUND FACTS 

On February 12, 2021, Respondents filed a motion for leave to amend the 

complaint pursuant to Rule 3.12(b)(2). Rule 3.12(b)(2) provides as follows: 

(2) If allegations of complaint are admitted. If the respondent elects not to 

contest the allegations of fact set forth in the complaint, the answer shall 

consist of a statement that the respondent admits all of the material 

allegations to be true. Such an answer shall constitute a waiver of hearings 

as to the facts alleged in the complaint, and together with the complaint will 

provide a record basis on which the Commission shall issue a final decision 

containing appropriate findings and conclusions and a final order disposing 

of the proceeding. In such an answer, the respondent may, however, reserve 

the right to submit proposed findings of fact and conclusions of law under § 

3.46. 

16 C.F.R. § 3.12 (emphasis added). Respondents cited Rule 3.12(b)(2) and tracked the 

language of the rule in Respondents’ proposed Answer. Respondents’ proposed Answer 

includes the “statement” referenced in Rule 3.12(b) that Respondents “admit all of the 

material allegations to be true.” In an effort to nullify Respondents’ election under 16 

C.F.R. § 3.12 and start this case from square one, Complaint Counsel requests permission 

to amend the Complaint to add the following new facts and theories: 

4. The FTC and Respondents HRL and Kramer Duhon signed a Stipulated 

Final Judgment and Order (“Order”) entered by U.S. District Judge Jon D. Levy on 

January 16, 2018 in FTC and State of Maine v. Health Research Laboratories, et 

al., 2:17-cv-00467 (Dkt. 15). Section III of the Order prohibits Respondents from 

making “any representation about the health benefits, safety, performance, or 

efficacy” of a dietary supplement, food, or drug “unless the representation is nonmisleading, and, at the time of making such representation, they possess and rely 

upon competent and reliable scientific evidence that is sufficient in quality and 

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quantity based on standards generally accepted by experts in the relevant disease, 

condition, or function to which the representation relates, when considered in light 

of the entire body of relevant and reliable scientific evidence, to substantiate that 

the representation is true.” Section III further provides that “competent and 

reliable scientific evidence means tests, analyses, research, or studies (1) that have 

been conducted and evaluated in an objective manner by experts in the relevant 

disease, condition, or function to which the representation relates; (2) that are 

generally accepted by such experts to yield accurate and reliable results; and (3) 

that are randomized, double-blind, and placebo-controlled human clinical testing 

of the Covered Product, or of an Essentially Equivalent Product, when such experts 

would generally require such human clinical testing to substantiate that the 

representation is true.” 

6. Respondents’ advertisements for Black Garlic Botanicals, BG18, The 

Ultimate Heart Formula, and Neupathic included representations that the products 

would effectively prevent, reduce the risk of, cure, treat, or mitigate cardiovascular 

disease, atherosclerosis, hypertension, or diabetic neuropathy without adequate 

substantiation to support the representations. 

8. HRL began selling Black Garlic Botanicals in November 2016 and 

continued to sell it following entry of the Order and after the filing of a contempt 

motion against Respondents in FTC and State of Maine v. Health Research 

Laboratories, LLC, et al., 2:17-cv-00467-JDL. HRL continued to sell the product 

to consumers through at least January 2021, despite the filing of the contempt 

motion and the Complaint in this administrative proceeding. 

9. ...HRL also sold the product to consumers in other quantities and at 

different prices. 

12. WBS began selling BG18 in August 2017 and continued to sell it after entry 

of the Order and after the filing of a contempt motion against Respondents in FTC 

and State of Maine v. Health Research Laboratories, LLC, et al., 2:17-cv-00467-

JDL in December 2019. 1 

14. ...Following entry of the Order, WBS disseminated or caused to be 

disseminated more than 400,000 mailers to consumer residences in the United 

States and Canada. WBS continued to disseminate these mailers as late as June 

2019 despite Respondents’ awareness that the FTC was investigating whether 

advertising for BG18 violated the Order. 

1

 The italicized part of paragraph 12 includes the new allegations. 

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16. HRL began selling The Ultimate Heart Formula (“UHF”) in November 

2008 and continued to sell it following entry of the Order and after the filing of a 

contempt motion against Respondents in FTC and State of Maine v. Health 

Research Laboratories, LLC, et al., 2:17-cv-00467-JDL. HRL continued to sell 

the product to consumers through at least January 2021, despite the filing of the 

contempt motion and the Complaint in this administrative proceeding. 

17. UHF contains Vitamins C, E, and B12 as well as garlic extract (25 mg), 

Tetrasodium EDTA (40 mg), Ubiquinol (CoEnzyme Q-10) (5 mg), and 

Nattokinase (10 mg). The recommended dosage is 20 drops or 1ml, twice per day. 

HRL sold a one-month’s supply of UHF for $39.95, plus shipping and handling. 

HRL also sold the product to consumers in other quantities and at different prices. 

18. HRL disseminated or caused to be disseminated advertisements for UHF, 

including multipage mailers and company websites. Following entry of the Order, 

HRL disseminated or caused to be disseminated more than 200,000 mailers to 

consumer residences in the United States and Canada. 

20. ...HRL continued to sell the product following entry of the Order and after 

the filing of a contempt motion against Respondents in FTC and State of Maine v. 

Health Research Laboratories, LLC, et al., 2:17-cv-00467-JDL.... The 

recommended dosage is two capsules per day. ... HRL also sold the product to 

consumers in other quantities and at different prices. 

21. ...Following entry of the Order, HRL disseminated or caused to be 

disseminated more than 400,000 mailers to consumer residences in the United 

States and Canada. HRL continued to disseminate these mailers as late as June 

2019 despite Respondents’ awareness that the FTC was investigating whether their 

advertising for Neupathic violated the Order 

23. Respondents did not have competent and reliable scientific evidence to 

support the representations in their advertisements. Further, they relied in part on 

advice from consultants and/or advisors who did not have appropriate 

qualifications or expertise to evaluate substantiation for the representations. 

In the Declaration of Jonathan Cohen attached to the Cross Motion to Amend, Jonathan 

Cohen states the following: 

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The allegations in the proposed Amended Complaint derive substantially 

from limited information that Respondents have disclosed within the past 

month. 

Respondents have no idea why Complaint Counsel would make this statement. It is not 

true. First, Complaint Counsel Elizabeth J. Averill was involved in all of the proceedings 

in FTC and State of Maine v. Health Research Laboratories, LLC, et al., 2:17-cv-00467-

JDL so none of those allegations were “disclosed within the past month.” Second, as 

Elizabeth J. Averill swore in her February 19, 2021 Declaration, the majority of 

documents produced by Respondents in this case “had been produced to the FTC as part 

of the contempt investigation related to FTC and State of Main v. Health Research 

Laboratories, LLC, et al., Case No. 2:17-cv-00467-JDL (D. Me.).” See Ex. D 

(Declaration of Elizabeth J. Averill), p. 3. Despite the statement from Complaint Counsel, 

the allegations in the proposed Amended Complaint are not “derive[d] substantially” 

from information disclosed within the past month. 

III. ARGUMENT 

A. Affirmative defenses do not justify an amendment. 

Complaint Counsel contends that two specific affirmative defenses, that the action 

is not in the public interest and mootness, raise issues of material facts that justify 

amending the Complaint. In particular, Complaint Counsel argues: 

Regardless of how the ALJ resolves Respondents’ pending motion, the 

parties will litigate the public interest at stake, alleged mootness, and the 

scope of relief—including facts that support the broad relief Complaint 

Counsel seeks. Accordingly, Complaint Counsel seeks leave to file an 

Amended Complaint, which adds factual allegations related to these issues. 

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Cross-Motion to Amend, p. 7. (emphasis added). The defenses of mootness and lack of a 

public interest were asserted in the Original Answer and have been on file for almost three 

months. Complaint Counsel does not explain why these affirmative defenses now require 

an amendment to the Complaint or how any of the new facts relate to these affirmative 

defenses. 

The three issues raised by Complaint Counsel (i.e., lack of public interest, 

mootness, and scope of relief) do not justify the proposed amendments. The scope of 

relief provided by the FTC Act is a pure question of law, not a factual issue that needs to 

be alleged. See United States v. Williams, 733 F.3d 448, 452 (2d Cir. 2013) 

(“Interpretations of statutes are pure questions of law, and we therefore review [them] de 

novo....”); see also In re Zale Corp., 77 F.T.C. 1635, 1970 WL 117293 (June 17, 1970) 

(noting that the scope of the remedy is not governed by the allegations in the complaint). 

With regard to the affirmative defenses of mootness and lack of public interest, 

Respondents waived these two affirmative defenses. See Ex. C (Waiver filed on February 

25, 2021). To the extent there is any confusion regarding this waiver, Respondents again 

affirm that the affirmative defense of mootness and lack of public interest are hereby 

waived and will not be asserted in the Amended Answer. 

In summary, there are no outstanding factual issues that justify the proposed 

amendments. 

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B. A motion for discovery is not before the Court. 

Complaint Counsel includes one paragraph requesting that the Court “should 

permit discovery to continue concerning all remaining issues.” The scope and extent of 

any future discovery is not before the Court. The current issue before the Court is 

whether to allow Respondents to elect to not contest the allegations in the [Original] 

Complaint and whether to allow Complaint Counsel to add new facts and theories 

through a proposed Amended Complaint. Respondents request the opportunity to 

address any issues regarding discovery if and when those issues are properly before the 

Court. 

C. The proposed amendments are not “appropriate” amendments. 

“In contrast to Federal Rule 15, FTC Rule 3.15(a), which requires that leave to 

amend be freely granted, FTC Rule 3.15(a) provides that ‘appropriate’ amendments ‘may’ 

be allowed, upon such conditions as will avoid prejudice to the parties and the public 

interest, if the amendments will facilitate a determination on the merits.” In re Matter of 

Daniel Chapter One, Dkt. No. 9329, 2009 WL 871702 (Mar. 9, 2009) (citing 16 C.F.R § 

3.15(a)(1). 16 C.F.R. § 3.15(a)(1) provides: 

(a) Amendments—(1) By leave. If and whenever determination of a 

controversy on the merits will be facilitated thereby, the Administrative Law 

Judge may, upon such conditions as are necessary to avoid prejudicing the 

public interest and the rights of the parties, allow appropriate amendments 

to pleadings or notice of hearing: Provided, however, That a motion for 

amendment of a complaint or notice may be allowed by the Administrative 

Law Judge only if the amendment is reasonably within the scope of the 

original complaint or notice. Motions for other amendments of complaints 

or notices shall be certified to the Commission. 

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16 C.F.R. § 3.15(a) (emphasis added). Complaint Counsel does not explain how the 

amendment is “necessary” to avoid “prejudicing the public interest” or to avoid 

prejudicing “rights of the parties.” More importantly, Complaint Counsel does not 

explain how the proposed amendments will “facilitate a determination on the merits.” In 

other words, how will the new allegations “facilitate” a determination on the merits? 

What determination, if any, will be made based on these new facts and legal theories? 

These critical questions are not addressed in Complaint Counsel’s motion to amend. 

D. The proposed amendments are futile and will hinder, not facilitate, a 

determination on the merits. 

Rule 3.15(a) requires that the proposed amendment “facilitate a determination on 

the merits.” However, even under the federal rules’ liberal amendment policy, the federal 

courts exercise discretion to deny leave to amend where an amendment would be futile. 

See In re Matter of Daniel Chapter One, Dkt. No. 9329, 2009 WL 871702 (Mar. 9, 

2009) (citing Foman v. Davis, 371 U.S. 178, 182 (1962)). In this case, the proposed 

amendments will not facilitate a determination on the merits, but would be futile and, 

therefore, should be denied. See In the Matter of LabMD, Inc., Dkt. 9357, 2015 WL 

5453096 (July 24, 2015) (noting that the court should deny proposed amendments that 

are futile); See Great Western Mining & Mineral Co. v. Fox Rothschild LLP, 615 F.3d 

159, 174 (3d Cir. 2010) (“futility of amendment is a sufficient basis to deny leave to 

amend”)(quoting Foman v. Davis, 371 U.S. 178, 182 (1962)). 

Pursuant to Rule 3.12(b)(2), Respondents have admitted all material facts in the 

Complaint. The amendment is futile because none of the new facts are necessary to 

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obtain a cease-and-desist order—which is the only relief that can be awarded in a Part III 

Administrative Action. This Court should be guided by what facts are necessary to award 

the relief provided by Sections 5 and 12 of the FTC Act. Permitting the FTC to inject 

unnecessary facts into this proceeding—so the FTC can attempt to use those facts in other 

proceedings—is an abuse of the FTC Act. Finally, by injecting unnecessary and 

inflammatory facts, Complaint Counsel hinders or delays a determination on the merits 

by making it impossible for Respondents to “elect” not to contest the material facts. 

Forcing a private citizen to continue a fight against the government even when the citizen 

seeks to admit all material facts in the Complaint is an abuse of process. 

E. The ALJ lacks authority to permit the amended complaint. 

“ALJ lacks authority to permit modifications where the effect is an alteration of 

the underlying theory behind the complaint.” In the Matter of Century 21 Commodore 

Plaza, Inc., 89 F.T.C. 238, 1977 WL 188998 (Apr. 20, 1977). Complaint Counsel’s 

original theory was that Respondents violated Section 5 and 12 of the FTC Act by making 

representations that “were not substantiated at the time the representations were made.” 

See Complaint, p. 11 and 12. Complaint Counsel’s new theory is that Respondents 

knowingly violated a Court Order (a finding that the federal court rejected), and that this 

conduct was allegedly done based on reliance from unqualified “consultants and/or 

advisors.” 

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The new facts are reasonably within the scope of the Original Complaint. In fact, 

Complaint Counsel admits that the amendment seeks to expand the scope of relief.2 

Alleging new facts and theories and seeking an expanded scope of relief are clearly 

matters that must be approved by the Commission. Allowing this case to proceed under a 

new Complaint that has not been authorized by the Commission will only lead to other 

legal challenges later. 

F. Statements about the Maine Consent Order are improper. 

Most of the new allegations relate to Consent Judgment in FTC and State of Maine 

v. Health Research Laboratories, et al., 2:17-cv-00467. The ALJ should not re-litigate or 

interpret the Consent Judgment, especially after the federal judge that signed the Consent 

Judgment has already interpreted it within the last six months. Furthermore, at the 

request of the FTC, Judge Levy retained jurisdiction “for the purposes of construction, 

modification, and enforcement of this Order.” See Ex. B, p. 31 (Consent Judgment). 

Complaint Counsel cites no statute, law, or regulation that grants the ALJ or the 

Commission the authority to construe or interpret the Consent Judgment, and there is no 

reason to make the Consent Judgment a part of the FTC’s claims against Respondents. 

Furthermore, had Respondents known that the Consent Judgment could be interpreted by 

the Commission and the ALJ—rather than a federal district judge—Respondents would 

have never agreed to the entry of the Consent Judgment. 

2 In footnote 3, Complaint Counsel states that the amendment “adds facts related to the 

scope of relief” and that Complaint Counsel seeks to ban Respondents from the 

supplements industry. 

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G. Amendment is prejudicial. 

The FTC issued its Part III Administrative Complaint on November 13, 2020. 

Because the Complaint sought a cease-and-desist order for acts or practices that had 

ceased more than a year prior to the Complaint, Respondents relied on the allegations in 

the Complaint to not conduct any discovery. See Ex. A (Declaration of Joel W. Reese); see 

also Respondents’ Answer, p. 2. Respondents have prepared their case based on the 

pleadings that were on file from the beginning of the case, not a new complaint filed on 

the eve of trial. See id. In other words, if the FTC was seeking a cease-and-desist order 

regarding acts or practices that had already ceased long before the administrative 

complaint was filed and the only available relief is a cease-and-desist order, then there 

was no reason to incur the cost and expense of hiring experts and conducting discovery to 

fight an irrelevant cease-and-desist order. Furthermore, pursuant to the Court’s 

Scheduling Order and based on the allegations on file at the time, Respondents identified 

fact witnesses on January 29, 2021 and elected not to designate expert witnesses on 

February 26, 2021. See id. 

In summary, changing the material facts, theories, and allegations in a case that is 

set for trial on a very tight schedule is prejudicial and should not be permitted. 

CONCLUSION 

For the reasons set forth herein, the ALJ should deny Complaint Counsel’s Cross 

Motion to Amend the Complaint. 

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Dated: February 26, 2021 Respectfully submitted, 

REESE MARKETOS LLP 

By: /s/ Joel W. Reese 

Joel W. Reese 

Texas Bar No. 00788258 

joel.reese@rm-firm.com 

Joshua M. Russ 

Texas Bar No. 24074990 

josh.russ@rm-firm.com 

750 N. Saint Paul St., Suite 600 

Dallas, TX 75201-3201 

Telephone: (214) 382-9810 

Facsimile: (214) 501-0731 

ATTORNEYS FOR RESPONDENTS 

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CERTIFICATE OF SERVICE 

I hereby certify that on February 26, 2021, I filed the foregoing document 

electronically using the FTC’s E-Filing system, which will send notification to: 

April J. Tabor The Honorable D. Michael Chappell 

Acting Secretary Administrative Law Judge 

Federal Trade Commission Federal Trade Commission 

600 Pennsylvania Ave., NW, Rm. H-113 600 Pennsylvania Ave., NW, Rm. H-110 

Washington, DC 20580 Washington, DC 20580 

ElectronicFilings@ftc.gov 

Elizabeth Averill 

eaverill@ftc.gov 

Jonathan Cohen 

jcohen2@ftc.gov 

COMPLAINT COUNSEL 

/s/ Joel W. Reese 

Joel W. Reese 

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EXHIBITA	
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UNITED STATES OF AMERICA 

BEFORE THE FEDERAL TRADE COMMISSION 

OFFICE OF THE ADMINISTRATIVE LAW JUDGES 

In the Matter of 

HEALTH RESEARCH LABORATORIES, LLC, 

a limited liability company, 

DOCKET NO. 9397 

WHOLE BODY SUPPLEMENTS, LLC, 

a limited liability company, and 

KRAMER DUHON, 

individually and as an officer of HEALTH 

RESEARCH LABORATORIES, LLC and 

WHOLE BODY SUPPLEMENTS, LLC 

DECLARATION OF JOEL W. REESE 

I, Joel W. Reese, hereby declare: 

1. My name is Joel W. Reese. I am counsel for the Respondents, Health 

Research Laboratories, LLC, \v'hole Body Supplements, LLC and Kramer Duhon. I make 

this declaration based on personal knowledge of the facts set forth herein. 

2. In the Declaration of Jonathan Cohen attached to the Cross Motion to 

Amend, Jonathan Cohen states: 

The allegations in the proposed Amended Complaint derive substantially from 

limited information that Respondents have disclosed within the past month. 

3. I am familiar with all information disclosed by Respondents. I am also 

familiar with the allegations in the proposed Amended Complaint. After carefully 

reviewing the new allegations in the proposed Amended Complaint and the information 

that has been disclosed by Respondents, I am not aware of "[t]he allegations in the 
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proposed Amended Complaint" that would "derive substantially" from information 

Respondents have "disclosed within the past month." 

4. The Commission filed this Administrative Complaint alleging that 

Respondents have "disseminated or [have] caused to be disseminated advertising and 

promotional materials" 1 for four supplements that the Commission contends were "not 

substantiated at the time the representations were made. " 2 Respondents relied on the 

allegations in the Complaint to not conduct any discovery. Respondents have prepared 

their case based on the pleadings that were on file from the beginning of the case. In 

other words, if the FTC was seeking a cease-and-desist order regarding acts or practices 

that had already ceased long before the administrative complaint was filed and the only 

available relief is a cease-and-desist order, then there was no reason to incur the cost and 

expense of hiring experts and conducting discovery to fight an irrelevant cease-and-desist 

order. 

5. Pursuant to the Court's Scheduling Order and based on the allegations in 

the Complaint, Respondents identified fact witnesses on January 29, 2021 and elected not 

to designate expert witnesses on February 26, 2021. Changing the allegations or the 

scope of relief could affect Respondents' decisions on fact witnesses or expert witnesses, 

depending on what new allegations and scope of relief are permitted. 

1 See Complaint, '!I'll 7, 9, 11 and 13. 

2 See Complaint, '!I'll 15, 17, 19, and 21. 

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Pursuant to 28 U.S. C. § 1746, I declare under penalty of peq ury that the 

foregoing is true and correct based on my personal knowledge. ... 

1===----:::L:::::_'vf!L( --1.:/ ~/4 ~ ~ ~ -~--- JOEL W. REESE 

V 

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EXHIBIT B		
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__________________________________________ 

Case 2:17-cv-00467-JDL Document 15 Filed 01/16/18 Page 1 of 33 PageID #: 138 

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IN THE UNITED STATES DISTRICT COURT 

FOR THE DISTRICT OF MAINE 

) 

FEDERAL TRADE COMMISSION and ) 

STATE OF MAINE, ) 

) Case No. 2:17-cv-00467-JDL 

Plaintiffs, ) 

) 

v. ) STIPULATED FINAL JUDGMENT 

) AND ORDER FOR PERMANENT 

HEALTH RESEARCH LABORATORIES, LLC, ) INJUNCTION AND OTHER 

a limited liability company, and ) EQUITABLE RELIEF 

) 

KRAMER DUHON, individually and as an owner ) 

and officer of HEALTH RESEARCH ) 

LABORATORIES, LLC, ) 

) 

Defendants. ) 

__________________________________________) 

Plaintiffs, the Federal Trade Commission (“FTC” or “Commission”) and the State of 

Maine, as represented in this matter by the Office of the Attorney General of Maine (“Maine 

AG”) (collectively, “Plaintiffs”), filed a Complaint for Permanent Injunction and Other Equitable 

Relief against Defendants pursuant to Section 13(b) of the Federal Trade Commission Act (“FTC 

Act”), 15 U.S.C. § 53(b), pursuant to Section 4(a) of the Telemarketing and Consumer Fraud and 

Abuse Prevention Act (“Telemarketing Act”), 15 U.S.C. § 6103(a), and pursuant to Section 209 

of the Maine Unfair Trade Practices Act (“Maine UTPA”), 5 M.R.S.A. § 209, to obtain 

permanent injunctive relief, rescission or reformation of contracts, restitution, the refund of 

monies paid, disgorgement of ill-gotten monies, and other equitable relief for Defendants’ acts or 

practices in violation of Sections 5(a) and 12 of the FTC Act, 15 U.S.C. §§ 45(a) and 52, the 

Telemarketing Act, 15 U.S.C. §§ 6101-6108, the FTC’s Trade Regulation Rule entitled 

“Telemarketing Sales Rule” (“TSR”), 16 C.F.R. Part 310, the Electronic Fund Transfer Act 
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(“EFTA”), 15 U.S.C. §§ 1693-1693r, and its implementing Regulation E, 12 C.F.R. § 1005.10, 

and Section 207 of the Maine UTPA, 5 M.R.S.A. § 207, in connection with the labeling, 

advertising, marketing, distribution, and sale of products purported to cause weight loss, treat 

arthritis and relieve joint and back pain, and prevent or mitigate cognitive decline. 

The Commission, the State of Maine, and Defendants Health Research Laboratories, LLC 

and Kramer Duhon (hereafter collectively, “Defendants”), stipulate to the entry of this Final 

Judgment and Order for Permanent Injunction and Other Equitable Relief to resolve all matters 

in dispute in this action between them, including the allegations in the Complaint. 

FINDINGS 

1. This Court has jurisdiction over this matter. 

2. The Complaint charges that Defendants participated in deceptive acts or practices 

in violation of Sections 5(a) and 12 of the FTC Act, 15 U.S.C. §§ 45(a) and 52, the 

Telemarketing Act, 15 U.S.C. §§ 6101-6108, the TSR, 16 C.F.R. Part 310, the EFTA, 15 U.S.C. 

§§ 1693-1693r, and its implementing Regulation E, 12 C.F.R. § 1005.10, and Section 207 of the 

Maine UTPA, 5 M.R.S.A. § 207, in connection with the labeling, advertising, marketing, 

distribution, and sale of products purported to cause weight loss, treat arthritis and relieve joint 

and back pain, and prevent or mitigate cognitive decline. 

3. Defendants neither admit nor deny any of the allegations in the Complaint, except 

as specifically stated in this Order. Defendants admit the facts necessary to establish jurisdiction 

only for purposes of this action. 

4. Defendants waive any claim that they may have under the Equal Access to Justice 

Act, 28 U.S.C. § 2412, concerning the prosecution of this action through the date of this Order. 

The parties agree to bear their own costs and attorney fees. 
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5. Defendants and Plaintiffs waive all rights to appeal or otherwise challenge or 

contest the validity of this Order. 

DEFINITIONS 

For the purpose of this Order, the following definitions apply: 

1. “Charge” or “Charged” means any attempt to collect money or other 

consideration from a consumer, including but not limited to causing billing information to be 

submitted for payment, including against the consumer’s credit card, debit card, bank account, 

telephone bill, or other account. 

2. “Clear(ly) and Conspicuous(ly)” means that a required disclosure is difficult to 

miss (i.e., easily noticeable) and easily understandable by ordinary consumers, including in all of 

the following ways: 

A. In any communication that is solely visual or solely audible, the disclosure 

must be made through the same means through which the communication is presented. In any 

communication made through both visual and audible means, such as a television advertisement, 

the disclosure must be presented simultaneously in both the visual and audible portions of the 

communication even if the representation requiring the disclosure is made in only one means; 

B. A visual disclosure, by its size, contrast, location, the length of time it 

appears, and other characteristics, must stand out from any accompanying text or other visual 

elements so that it is easily noticed, read, and understood; 

C. An audible disclosure, including by telephone or streaming video, must be 

delivered in a volume, speed, and cadence sufficient for ordinary consumers to easily hear and 

understand it; 
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D. In any communication using an interactive electronic medium, such as the 

Internet or software, the disclosure must be unavoidable; 

E. The disclosure must use diction and syntax understandable to ordinary 

consumers and must appear in each language in which the representation that requires the 

disclosure appears; 

F. The disclosure must comply with these requirements in each medium 

through which it is received, including all electronic devices and face-to-face communications; 

G. The disclosure must not be contradicted or mitigated by, or inconsistent 

with, anything else in the communication; and 

H. When the representation or sales practice targets a specific audience, such 

as children, the elderly, or the terminally ill, “ordinary consumers” includes reasonable members 

of that group. 

3. “Close Proximity” means that the disclosure is very near the triggering 

representation. For example, a disclosure made through a hyperlink, pop-up, interstitial, or other 

similar technique is not in close proximity to the triggering representation. 

4. “Corporate Defendant” means Health Research Laboratories, LLC, and its 

successors and assigns.

 5. “Covered Product” means any Dietary Supplement, Food, or Drug, including 

BioTherapex and NeuroPlus. 

6. “Defendants” means the Individual Defendant and the Corporate Defendant, 

individually, collectively, or in any combination. 

7. “Dietary Supplement” means: (1) any product labeled as a dietary supplement 

or otherwise represented as a dietary supplement; or (2) any pill, tablet, capsule, powder, softgel, 
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gelcap, liquid, or other similar form containing one or more ingredients that are a vitamin, 

mineral, herb or other botanical, amino acid, probiotic, or other dietary substance for use by 

humans to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, 

constituent, extract, or combination of any ingredient described above, that is intended to be 

ingested, and is not represented to be used as a conventional food or as a sole item of a meal or 

the diet. 

8. “Drug” means: (1) articles recognized in the official United States 

Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National 

Formulary, or any supplement to any of them; (2) articles intended for use in the diagnosis, cure, 

mitigation, treatment, or prevention of disease in humans or other animals; (3) articles (other 

than food) intended to affect the structure or any function of the body of humans or other 

animals; and (4) articles intended for use as a component of any article specified in (1), (2), or 

(3); but does not include devices or their components, parts, or accessories.

 9. “Essentially Equivalent Product” means a product that contains the identical 

ingredients, except for inactive ingredients (e.g., binders, colors, fillers, excipients), in the same 

form and dosage, and with the same route of administration (e.g., orally, sublingually), as the 

Covered Product; provided that the Covered Product may contain additional ingredients if 

reliable scientific evidence generally accepted by experts in the field indicates that the amount 

and combination of additional ingredients is unlikely to impede or inhibit the effectiveness of the 

ingredients in the Essentially Equivalent Product. 

10. “Food” means: (1) any article used for food or drink for humans or other 

animals; (2) chewing gum; and (3) any article used for components of any such article. 

11. “Including” means including but not limited to. 
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12. “Individual Defendant” means Kramer Duhon. 

13. “Negative Option Feature” means, in an offer or agreement to sell or provide 

any good, program, or service, a provision under which the consumer’s silence or failure to take 

an affirmative action to reject a good, program, or service, or to cancel the agreement, is 

interpreted by the seller or provider as acceptance or continuing acceptance of the offer.

 14. “Person” means a natural person, an organization, or other legal entity, including 

a corporation, partnership, sole proprietorship, limited liability company, association, 

cooperative, or any other group or combination acting as an entity.

 15. “Preauthorized Electronic Fund Transfer” as defined by the Electronic Fund 

Transfer Act, 15 U.S.C. § 1693a(10), means an electronic fund transfer authorized in advance to 

recur at substantially regular intervals. 

I. 

BANNED WEIGHT-LOSS CLAIMS 

IT IS HEREBY ORDERED that Defendants, Defendants’ officers, agents, employees, 

and all other persons in active concert or participation with any of them, who receive actual 

notice of this Order, whether acting directly or indirectly, in connection with the manufacturing, 

labeling, advertising, promotion, offering for sale, sale, or distribution of any Dietary 

Supplement, over-the-counter Drug, patch, cream, wrap, or other product worn on the body or 

rubbed into the skin, are permanently restrained and enjoined from representing, or assisting 

others in representing, in any manner, expressly or by implication, including through the use of a 

product name, endorsement, depiction, illustration, trademark, or trade name, that such product: 

A. Causes weight loss of two pounds or more a week for a month or more without 

dieting or exercise; 
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B. Causes substantial weight loss no matter what or how much the consumer eats; 

C. Causes permanent weight loss; 

D. Blocks the absorption of fat or calories to enable consumers to lose substantial 

weight; 

E. Safely enables consumers to lose more than three pounds per week for more than 

 four weeks; 

F. Causes substantial weight loss for all users; or 

G. Causes substantial weight loss by wearing a product on the body or rubbing it into 

 the skin. 

II. 

PROHIBITED REPRESENTATIONS: OTHER WEIGHT-LOSS CLAIMS, JOINTRELATED DISEASE CLAIMS, AND ALZHEIMER’S DISEASE, MEMORY, AND 

COGNITIVE PERFORMANCE CLAIMS 

IT IS FURTHER ORDERED that Defendants, Defendants’ officers, agents, employees, 

and all other persons in active concert or participation with any of them, who receive actual 

notice of this Order, whether acting directly or indirectly, in connection with the manufacturing, 

labeling, advertising, promotion, offering for sale, sale, or distribution of any Covered Product, 

are permanently restrained and enjoined from making, or assisting others in making, expressly or 

by implication, including through the use of a product name, endorsement, depiction, or 

illustration, any representation, other than representations covered under the Section of this 

Order entitled Banned Weight-Loss Claims, that, in humans, such product: 

A. Causes or assists in causing weight loss, including any specific amount of weight 

loss; 

B. Causes or assists in causing fat loss, including any specific amount of fat loss; 
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C. Treats or cures rheumatism, arthritis, or osteoarthritis; 

D. Relieves joint pain, back pain, or muscle pain; 

E. Protects the brain against Alzheimer’s disease or dementia; 

F. Reverses memory loss; 

G. Improves memory, concentration, or cognitive performance; or 

H. Cures, mitigates, or treats any disease, 

unless the representation is non-misleading and, at the time of making such representation, they 

possess and rely upon competent and reliable scientific evidence substantiating that the 

representation is true. For purposes of this Section, competent and reliable scientific evidence 

shall consist of human clinical testing of the Covered Product, or of an Essentially Equivalent 

Product, that is sufficient in quality and quantity based on standards generally accepted by 

experts in the relevant disease, condition, or function to which the representation relates, when 

considered in light of the entire body of relevant and reliable scientific evidence, to substantiate 

that the representation is true. Such testing must be: (1) randomized, double-blind, and placebocontrolled; and (2) conducted by researchers qualified by training and experience to conduct 

such testing. In addition, all underlying or supporting data and documents generally accepted by 

experts in the field as relevant to an assessment of such testing as described in the Section 

entitled Preservation of Records Relating to Competent and Reliable Human Clinical Tests or 

Studies must be available for inspection and production to Plaintiffs. Persons covered by this 

Section have the burden of proving that a product satisfies the definition of Essentially 

Equivalent Product. 
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III. 

PROHIBITED REPRESENTATIONS: OTHER HEALTH-RELATED CLAIMS 

IT IS FURTHER ORDERED that Defendants, Defendants’ officers, agents, and 

employees, and all other persons in active concert or participation with any of them, who receive 

actual notice of this Order, whether acting directly or indirectly, in connection with the 

manufacturing, labeling, advertising, promotion, offering for sale, sale, or distribution of any 

Covered Product, are permanently restrained and enjoined from making, or assisting others in 

making, expressly or by implication, including through the use of a product name, endorsement, 

depiction, or illustration, any representation about the health benefits, safety, performance, or 

efficacy of any Covered Product, other than representations covered under the Sections of this 

Order entitled Banned Weight-Loss Claims and Prohibited Representations: Other Weight-Loss 

Claims, Joint-Related Disease Claims, and Alzheimer’s Disease, Memory, and Cognitive 

Performance Claims, unless the representation is non-misleading, and, at the time of making 

such representation, they possess and rely upon competent and reliable scientific evidence that is 

sufficient in quality and quantity based on standards generally accepted by experts in the relevant 

disease, condition, or function to which the representation relates, when considered in light of the 

entire body of relevant and reliable scientific evidence, to substantiate that the representation is 

true. 

For purposes of this Section, competent and reliable scientific evidence means tests, 

analyses, research, or studies (1) that have been conducted and evaluated in an objective manner 

by experts in the relevant disease, condition, or function to which the representation relates; 

(2) that are generally accepted by such experts to yield accurate and reliable results; and (3) that 

are randomized, double-blind, and placebo-controlled human clinical testing of the Covered 
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Product, or of an Essentially Equivalent Product, when such experts would generally require 

such human clinical testing to substantiate that the representation is true. In addition, when such 

tests or studies are human clinical tests or studies, all underlying or supporting data and 

documents generally accepted by experts in the field as relevant to an assessment of such testing 

as set forth in the Section entitled Preservation of Records Relating to Competent and Reliable 

Human Clinical Tests or Studies must be available for inspection and production to Plaintiffs. 

Persons covered by this Section have the burden of proving that a product satisfies the definition 

of Essentially Equivalent Product. 

IV. 

PROHIBITED REPRESENTATIONS REGARDING TESTS, STUDIES, 

OR OTHER RESEARCH 

IT IS FURTHER ORDERED that Defendants, Defendants’ officers, agents, employees, 

and all other persons in active concert or participation with any of them, who receive actual 

notice of this Order, whether acting directly or indirectly, in connection with the manufacturing, 

labeling, advertising, promotion, offering for sale, sale, or distribution of any Covered Product 

are permanently restrained and enjoined from misrepresenting, in any manner, expressly or by 

implication, including through the use of any product name, endorsement, depiction, or 

illustration: 

A. That any Covered Product is scientifically proven to protect the brain against 

Alzheimer’s disease or dementia, reverse memory loss, or improve memory, 

concentration, or cognitive performance; 

B. That the performance or benefits of any Covered Product are scientifically or 

clinically proven or otherwise established; or 
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C. The existence, contents, validity, results, conclusions, or interpretations of any 

test, study, or other research. 

V. 

FDA-APPROVED CLAIMS 

IT IS FURTHER ORDERED that nothing in this Order prohibits Defendants, 

Defendants’ officers, agents, employees, or all other persons in active concert or participation 

with any of them from: 

A. For any drug, making a representation that is approved in labeling for such drug 

under any tentative final or final monograph promulgated by the Food and Drug Administration, 

or under any new drug application approved by the Food and Drug Administration; and 

B. For any product, making a representation that is specifically authorized for use in 

labeling for such product by regulations promulgated by the Food and Drug Administration 

pursuant to the Nutrition Labeling and Education Act of 1990 or permitted under Sections 303-

304 of the Food and Drug Administration Modernization Act of 1997. 

VI. 

PRESERVATION OF RECORDS RELATING TO COMPETENT AND RELIABLE 

HUMAN CLINICAL TESTS OR STUDIES 

IT IS FURTHER ORDERED that, with regard to any human clinical test or study 

(“test”) upon which Defendants rely to substantiate any claim covered by this Order, Defendants 

shall secure and preserve all underlying or supporting data and documents generally accepted by 

experts in the field as relevant to an assessment of the test, including: 

A. All protocols and protocol amendments, reports, articles, write-ups, or other 

accounts of the results of the test, and drafts of such documents reviewed by the 

test sponsor or any other person not employed by the research entity; 
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B. All documents referring or relating to recruitment; randomization; instructions, 

including oral instructions, to participants; and participant compliance; 

C. Documents sufficient to identify all test participants, including any participants 

who did not complete the test, and all communications with any participants 

relating to the test; all raw data collected from participants enrolled in the test, 

including any participants who did not complete the test; source documents for 

such data; any data dictionaries; and any case report forms; 

D. All documents referring or relating to any statistical analysis of any test data, 

including any pretest analysis, intent-to-treat analysis, or between-group analysis 

performed on any test data; and 

E. All documents referring or relating to the sponsorship of the test, including all 

communications and contracts between any sponsor and the test’s researchers. 

Provided, however, the preceding preservation requirement does not apply to a reliably 

reported test, unless the test was conducted, controlled, or sponsored, in whole or in part by: (1) 

any Defendant; (2) any Defendant’s officers, agents, representatives, or employees; (3) any other 

person or entity in active concert or participation with any Defendant; (4) any person or entity 

affiliated with or acting on behalf of any Defendant; (5) any supplier of any ingredient contained 

in the product at issue to any of the foregoing or to the product’s manufacturer; or (6) the 

supplier or manufacturer of such product. 

For purposes of this Section, “reliably reported test” means a report of the test has been 

published in a peer-reviewed journal, and such published report provides sufficient information 

about the test for experts in the relevant field to assess the reliability of the results. 
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For any test conducted, controlled, or sponsored, in whole or in part, by Defendants, 

Defendants must establish and maintain reasonable procedures to protect the confidentiality, 

security, and integrity of any personal information collected from or about participants. These 

procedures must be documented in writing and must contain administrative, technical, and 

physical safeguards appropriate to Corporate Defendant’s size and complexity, the nature and 

scope of Defendants’ activities, and the sensitivity of the personal information collected from or 

about the participants. 

VII. 

PROHIBITED REPRESENTATIONS 

RELATED TO ENDORSEMENTS 

IT IS FURTHER ORDERED that Defendants, Defendants’ officers, agents, employees, 

and all other persons in active concert or participation with any of them, who receive actual 

notice of this Order, whether acting directly or indirectly, in connection with the manufacturing, 

labeling, advertising, promotion, offering for sale, sale, or distribution of any Covered Product, 

are permanently restrained and enjoined from misrepresenting, in any manner, expressly or by 

implication, including through the use of any good or service name, endorsement, depiction, or 

illustration, that: 

A. Any person is an expert with respect to the endorsement message provided by 

 that person; 

B. Purported consumers who appear in advertising obtained a reported result through 

use of those goods or services; and 

C. Experts are providing their objective, independent opinions regarding the efficacy 

of any good or service. 
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VIII. 

OTHER PROHIBITED MISREPRESENTATIONS 

IT IS FURTHER ORDERED that Defendants, Defendants’ officers, agents, employees, 

and all other persons in active concert or participation with any of them, who receive actual 

notice of this Order, whether acting directly or indirectly, in connection with the advertising, 

marketing, promotion, offering for sale, sale, or distribution of any good or service, are 

permanently restrained and enjoined from misrepresenting, or assisting others in 

misrepresenting, expressly or by implication: 

A. That consumers are receiving a money-back guarantee, a free trial offer, a riskfree trial offer, a free gift, or a bonus; 

B. The total cost to purchase, receive, or use the good or service, including shipping, 

handling, processing, and any additional financial obligations that may be 

incurred as a result of accepting the free product, service, or offer; 

C. The timing or manner of any Charge or bill; 

D. Any material restrictions, limitations, or conditions to purchase, receive, or use 

 the good or service; 

E. Any material aspect of the performance, efficacy, nature, or central characteristics 

of the good or service; 

F. To the extent applicable, that customs duties or taxes may be assessed by the 

relevant taxing authority; and 

G. Any material aspect of the nature or terms of a refund, return, cancellation, 

exchange, or repurchase policy for the good or service, including the deadline (by 

date or frequency) by which the consumer must act. 
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IX. 

REQUIRED DISCLOSURES 

IT IS FURTHER ORDERED that, in connection with the advertising, marketing, 

promotion, offering for sale, sale, or distribution of any good or service, Defendants and their 

officers, agents, employees, and all other persons in active concert or participation with any of 

them who receive actual notice of this Order, whether acting directly or indirectly, are 

permanently restrained and enjoined from: 

A. Failing to Clearly and Conspicuously disclose, or assisting others in failing to 

Clearly and Conspicuously disclose, before consumers are asked to reveal billing information 

such as account number or to consent to any purchase in connection with any claim that a good 

or service is offered on a “free,” “risk-free,” “trial,” “no obligation,” “reduced,” discounted basis, 

or words of similar import, the following material terms and conditions of any offer: 

1. In Close Proximity to such claim, the total cost to purchase, or receive, or 

use any good or service that is the subject of the sales offer, including 

 shipping, handling, and processing; 

2. The amount, timing, and manner of payment of all fees, Charges, or other 

amounts that a consumer will be Charged or billed, and any 

 additional financial obligations that may be incurred as a result of 

accepting the free product, service, or offer; and 

3. The terms and conditions of any refund, cancellation, exchange, or 

purchase policy or policies, including the specific steps and means by 

which such requests must be submitted, and the telephone number, email 

address, web address, or street address to which such requests must be 
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directed, including the deadline (by date or frequency) by which the 

consumer must act, and, if there is a policy of not making refunds, 

cancellations, exchanges, or repurchases, a statement regarding this 

policy; and 

B. Obtaining, or assisting others in obtaining, billing information such as account 

number from a consumer for any transaction involving a good or service that includes a Negative 

Option Feature, without first disclosing Clearly and Conspicuously, and in Close Proximity to 

where a consumer provides billing information: 

1. The extent to which the consumer must take affirmative action(s) to avoid 

any Charges: a) for the offered good or service, b) of an increased amount 

after any trial or promotional period ends, and c) on a recurring basis; 

2. The total cost (or range of costs) the consumer will be Charged (including

 shipping, handling, and processing), the date the initial Charge will be 

submitted for payment, and, if applicable, the frequency of such Charges 

unless the consumer timely takes affirmative steps to prevent or stop such 

 Charges; 

3. The deadline(s) (by date or frequency) by which the consumer must 

affirmatively act in order to stop all recurring Charges, whether such 

recurring charges are refundable and, if so, the terms and conditions of any

 refund policy; 

4. The name of the seller or provider of the good or service and, if the name 

of the seller or provider will not appear on billing statements, the billing 

 descriptor that will appear on such statements; 
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5. A description of the good or service; 

6. Any Charge or cost for which the consumer is responsible in connection 

 with the cancellation of an order or the return of a good; and 

7. The mechanism to stop any recurring Charges. 

In addition, for any transaction involving a sale of a good or service to a consumer 

through a Negative Option Feature, within 10 days after the date of the sale, Defendants must 

send the consumer written confirmation of the transaction, either by email or first class mail, 

according to the consumer’s preference, which is identified as a written confirmation in the email 

subject line or on the outside of the envelope. Such written confirmation must include Clear and 

Conspicuous disclosure of all the information required by this Subsection IX.B(1)-(7) above, and 

must specify the procedures by which consumers can cancel or obtain a refund if a refund is 

offered. 

X. 

EXPRESS INFORMED CONSENT 

IT IS FURTHER ORDERED that Defendants, Defendants’ officers, agents, 

employees, and all other persons in active concert or participation with any of them, who receive 

actual notice of this Order, whether acting directly or indirectly, in connection with the 

advertising, marketing, promotion, offering for sale, sale, or distribution of any good or service, 

are permanently restrained and enjoined from using billing information to obtain payment from a 

consumer, unless, prior to using such billing information to obtain payment, they obtain the 

express informed consent of the consumer. 

A. For all written offers with a Negative Option Feature (including over the Internet 

or other web-based applications or services), a consumer’s express informed consent must be 
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obtained, prior to Defendants’ obtaining any billing information from consumers, through a 

check box, signature, or other substantially similar method, that consumers must affirmatively 

select or sign to accept the Negative Option Feature. Immediately adjacent to such check box, 

signature, or substantially similar method, Defendants must disclose all costs associated with the 

Negative Option Feature, including shipping, handling, and processing, that the consumer is 

agreeing to pay such costs, the length of any trial period, and the date by which consumers must 

cancel to avoid being Charged. This disclosure must contain no additional information and must 

be Clear and Conspicuous in relation to any other information provided on the page relating to 

costs, risks, or obligations associated with any Negative Option Feature, including any terms 

referring to “free,” “trial,” and “processing fee.” 

B. For all oral offers including a Negative Option Feature, Defendants must, in 

addition to disclosing the information identified in the Section entitled Required Disclosures, and 

prior to obtaining any billing information such as account number from a consumer, obtain 

affirmative and unambiguous oral confirmation that the consumer: 

1. Consents to authorizing payment for any goods or services, including 

 shipping, handling, and processing; 

2. Understands that the transaction includes a Negative Option Feature; and 

3. Understands the specific affirmative steps the consumer must take to 

prevent further Charges. 

Defendants must maintain for 3 years from the date of each transaction an unedited voice 

recording of the entire transaction, including the prescribed statements set out in the Section 

entitled Required Disclosures. Each recording must be retrievable by date and by the 
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consumer’s name, telephone number, or billing information and must be provided upon request 

and without Charge to the consumer, the consumer’s bank, or any law enforcement entity. 

XI. 

PROHIBITIONS CONCERNING REFUNDS AND CANCELLATIONS 

IT IS FURTHER ORDERED that Defendants, Defendants’ officers, agents, employees, 

and all other persons in active concert or participation with any of them, who receive actual 

notice of this Order, whether acting directly or indirectly, in connection with the advertising, 

marketing, promotion, offering for sale, sale, or distribution of any good or service, are 

permanently restrained and enjoined from: 

A. Failing to honor a refund, return, or cancellation request that complies with any 

policy to make refunds or allow returns or cancellations; and 

B. Failing to provide a simple mechanism for a consumer to immediately stop any 

recurring Charge for such good or service, at least one of which is as simple and easy to use as 

the mechanism the consumer used to initiate the Charges. 

1. For consumers who entered into the agreement to purchase a good or 

service including a Negative Option Feature over the Internet or through 

other web-based applications or services, Defendants must provide a 

mechanism for consumers to stop the recurring Charge over the Internet or 

through such other web-based application or service. 

2. For consumers who entered into the agreement to purchase a good or 

service including a Negative Option Feature through an oral offer and 

 acceptance, Defendants must maintain a telephone number through which 

the consumer can easily cancel the good or service, seek a refund for past 
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Charges where such refund is offered, and immediately stop all further 

Charges. Defendants must answer all calls to this telephone number 

during normal business hours. 

XII. 

COMPLIANCE WITH THE ELECTRONIC FUND TRANSFER ACT 

IT IS FURTHER ORDERED that Defendants, Defendants’ officers, agents, employees, 

and all other persons in active concert or participation with any of them, who receive actual 

notice of this Order, whether acting directly or indirectly, in connection with the advertising, 

marketing, promotion, offering for sale, sale, or distribution of any good or service, are 

permanently restrained and enjoined, in connection with any person who purchases any good or 

service subsequent to the date of this Order, and who uses a debit card or other means of 

electronic fund transfer, from: 

A. Failing to obtain written authorization for Preauthorized Electronic Fund 

Transfers from a consumer’s account before initiating any Preauthorized Electronic Fund 

Transfer, as required by Section 907(a) of the Electronic Fund Transfer Act, 15 U.S.C. § 

1693e(a), and Section 1005.10(b) of Regulation E, 12 C.F.R. § 1005.10(b), as more fully set out 

in Section 1005.10 of the Consumer Financial Protection Bureau’s Official Staff Commentary to 

Regulation E, 12 C.F.R. § 1005, Supp. I; and 

B. Failing to maintain procedures reasonably adapted to avoid an unintentional 

failure to obtain written authorization for a Preauthorized Electronic Fund Transfer, as required 

in Section 1005.10 of the Consumer Financial Protection Bureau’s Official Staff Commentary to 

Regulation E, 12 C.F.R. § 1005, Supp. I. 
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XIII. 

MONETARY JUDGMENT AND CONSUMER REDRESS 

IT IS FURTHER ORDERED that: 

A. Judgment in the amount of $3,700,514 is hereby entered in favor of the 

Commission against Defendants, jointly and severally, as equitable monetary relief. 

B. Defendants are ordered to pay to the Commission $800,000. Defendants stipulate 

that they have posted $450,000 into the escrow account of their undersigned counsel for no 

purpose other than payment to the Commission. Defendants will remit the balance of $350,000 

to the escrow account of their undersigned counsel prior to submission of this Order to the Court 

for approval. The escrowed funds shall be paid to the Commission within 7 days of the Court’s 

entry of this Order and shall be transferred in accordance with the wire transfer instructions 

previously provided to counsel by a representative of the Commission. 

C. Upon satisfaction of the obligations described in Subsection B above, the 

remainder of the judgment as to the Defendants shall be suspended subject to Subsections E and 

F below. 

D. In the event of default of any obligation to make payments under this Order, 

including, but not limited to, failure to pay $800,000 to the Commission pursuant to Section B, 

above, interest shall accrue as computed pursuant to 28 U.S.C. § 1961(a) from the date of default 

to the date of payment. In the event such default continues for 10 calendar days beyond the date 

any payments are due, the entire judgment amount of $3,700,514 shall immediately become due 

and payable. 

E. Plaintiffs’ agreement to the suspension of part of the judgment is expressly 

premised upon the truthfulness, accuracy, and completeness of Defendants’ sworn financial 
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statements and related documents (collectively, “financial representations”) submitted to 

Plaintiffs, namely the following: 

1. the Financial Statement of Individual Defendant Kramer Duhon signed on 

December 19, 2016, including the attachments (HRL003490-3504; HRL004034); 

2. the Financial Statement of Corporate Defendant Health Research 

Laboratories, LLC, signed by Kramer Duhon, President, on December 18, 2016, including the 

attachments (HRL003474-3489); and 

3. the additional documentation and information submitted by letter from 

Defendants’ counsel Andrew Lustigman to Commission counsel Elizabeth Nach, dated 

December 22, 2016; January 13, 2017; February 8, 2017; February 17, 2017; February 28, 2017; 

March 31, 2017; and April 20, 2017; including all attachments thereto (bates-stamped 

HRL003227-4894 and 117 un-stamped JP Morgan investment account statements). 

F. The suspension of the judgment will be lifted as to any Defendant if, upon motion 

by either of Plaintiffs, the Court finds that such Defendant failed to disclose any material asset, 

materially misstated the value of any asset, or made any other material misstatement or omission 

in the financial representations identified in Subsection E above. 

G. If the suspension of the judgment is lifted, the judgment becomes immediately 

due as to the Defendant or Defendants causing the suspension to be lifted in the amount specified 

in Subsection A above (which the parties stipulate only for purposes of this Section represents 

the consumer injury alleged in the Complaint), less any payment previously made pursuant to 

this Section, plus interest computed from the date of entry of this Order. 

H. All money paid to the Commission pursuant to this Order may be deposited into a 

fund administered by the Commission or its designee to be used for equitable relief, including 
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consumer redress and any attendant expenses for the administration of any redress fund. If a 

representative of the Commission decides that direct redress to consumers is wholly or partially 

impracticable or money remains after redress is completed, the money shall be divided with the 

State of Maine. Any money not transferred to the State of Maine or not used by the Commission 

for equitable relief, including consumer information remedies, is to be deposited to the U.S. 

Treasury as disgorgement. Defendants have no right to challenge any actions the Commission or 

its representatives may take pursuant to this Subsection. 

I. All money paid to the State of Maine pursuant to this Order must be deposited 

into the Attorney General’s other special revenue account and used for consumer education, 

consumer protection, antitrust enforcement, or for any lawful purpose at the sole discretion of the 

Attorney General. 

J. Defendants relinquish dominion and all legal and equitable right, title, and interest 

in all assets transferred pursuant to this Order and may not seek the return of any assets. 

K. The facts alleged in the Complaint will be taken as true, without further proof, in 

any subsequent civil litigation by or on behalf of either of Plaintiffs, in a proceeding to enforce 

their rights to any payment or monetary judgment pursuant to this Order, such as a 

nondischargeability complaint in any bankruptcy case. 

L. The facts alleged in the Complaint establish all elements necessary to sustain an 

action by either of Plaintiffs pursuant to Section 523(a)(2)(A) of the Bankruptcy Code, 11 U.S.C. 

§ 523(a)(2)(A), and this Order will have collateral estoppel effect for such purposes. 

M. Defendants acknowledge that their Taxpayer Identification Numbers (Social 

Security Numbers or Employer Identification Numbers), which Defendants previously submitted 
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to Plaintiffs, may be used for collecting and reporting on any delinquent amount arising out of 

this Order, in accordance with 31 U.S.C. § 7701. 

XIV. 

COOPERATION WITH FTC AND MAINE 

IT IS FURTHER ORDERED that Defendants must fully cooperate with representatives 

of the Commission, the Maine AG, and any of their representatives in this case and in any 

investigation related to or associated with the transactions or the occurrences that are the subject 

of the Complaint. Defendants must provide truthful and complete information, evidence, and 

testimony. Individual Defendant must appear and Corporate Defendant must cause its officers, 

employees, representatives, or agents to appear for interviews, discovery, hearings, trials, and 

any other proceedings that a representative of the Commission or the Maine AG may reasonably 

request upon 5 days’ written notice, or other reasonable notice, at such places and times as a 

Commission or Maine AG representative may designate, without the service of a subpoena. 

Defendants may have counsel present. 

XV. 

CUSTOMER INFORMATION 

IT IS FURTHER ORDERED that Defendants’ officers, agents, and employees, and all 

other persons in active concert or participation with any of them, who receive actual notice of 

this Order, are permanently restrained and enjoined from directly or indirectly: 

A. Failing to provide sufficient customer information to enable the Commission to 

efficiently administer consumer redress. If a representative of the Commission requests in 

writing any information related to redress, Defendants must provide it, in the form prescribed by 

the Commission, within 14 days. 
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B. Disclosing, using, or benefitting from customer information, including the name, 

address, telephone number, email address, Social Security number, other identifying information, 

or any data that enables access to a customer’s account (including a credit card, bank account, or 

other financial account), that any Defendant obtained prior to entry of this Order in connection 

with the labeling, advertising, marketing, distribution, or sale of any formulation of BioTherapex 

or NeuroPlus; and 

C. Failing to destroy such customer information in all forms in their possession, 

custody, or control within 30 days after receipt of written direction to do so from representatives 

of both the Commission and the Maine AG. 

Provided, however, that customer information need not be destroyed, and may be 

disclosed, to the extent requested by a government agency or required by law, regulation, or 

court order. 

XVI. 

ORDER ACKNOWLEDGMENTS 

IT IS FURTHER ORDERED that Defendants obtain acknowledgments of receipt of 

this Order: 

A. Each Defendant, within 7 days of entry of this Order, must submit to the 

Commission and the Maine AG an acknowledgment of receipt of this Order sworn under penalty 

of perjury. 

B. For 10 years after entry of this Order, the Individual Defendant for any business 

involved in the sale or marketing of any Covered Product that such Defendant, individually or 

collectively with the Corporate Defendant, is the majority owner or controls directly or 

indirectly, and the Corporate Defendant, must deliver a copy of this Order to: 
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1. All principals, officers, directors, and LLC managers and members; 

2. All employees, agents, and representatives with managerial responsibility 

 who participate in the manufacturing, labeling, advertising, marketing, 

 distribution, or sale of any Covered Product or service; and 

3. Any business entity resulting from any change in structure as set forth in 

the Section titled Compliance Reporting. 

Delivery must occur within 7 days of entry of this Order for current personnel. For all others, 

delivery must occur before they assume their responsibilities. 

C. From each individual or entity to which a Defendant delivered a copy of this 

Order, that Defendant must obtain, within 30 days, a signed and dated acknowledgment of 

receipt of this Order. 

XVII. 

COMPLIANCE REPORTING 

IT IS FURTHER ORDERED that Defendants make timely submissions to the 

Commission and to the Maine AG: 

A. Sixty days after entry of this Order, each Defendant must submit a compliance 

report, sworn under penalty of perjury: 

1. Each Defendant must: (a) identify the primary physical, postal, and email 

 address and telephone number as designated points of contact, which 

Plaintiffs’ representatives may use to communicate with Defendant; 

(b) identify all of that Defendant’s businesses by all of their names, 

telephone numbers, and physical, postal, email, and Internet addresses; 

(c) describe the activities of each business, including the goods and 
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services offered, the means of advertising, marketing, and sales, and the 

involvement of the other Defendant (which Individual Defendant must 

describe if he knows or should know due to his own involvement); 

(d) describe in detail whether and how that Defendant is in compliance 

with each Section of this Order; and (e) provide a copy of each 

Order Acknowledgment obtained pursuant to this Order, unless 

previously submitted to Plaintiffs. 

2. Additionally, the Individual Defendant must: (a) identify all telephone 

numbers and all physical, postal, email, and Internet addresses, including 

 all residences; (b) identify all business activities, including any business 

for which such Defendant performs services whether as an employee or 

 otherwise and any entity in which such Defendant has any ownership 

interest; and (c) describe in detail such Defendant’s involvement in each 

 such business, including title, role, responsibilities, participation, 

 authority, control, and any ownership. 

B. For 10 years after entry of this Order, each Defendant must submit a compliance 

notice, sworn under penalty of perjury, within 14 days of any change in the following: 

1. Each Defendant must report any change in: (a) any designated point of 

contact; (b) the structure of the Corporate Defendant or any entity that 

 Defendants have any ownership interest in or control directly or indirectly 

that may affect compliance obligations arising under this Order, 

including: creation, merger, sale, or dissolution of the entity or any 

subsidiary, parent, or affiliate that engages in any acts or practices subject 
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 to this Order. 

2. Additionally, the Individual Defendant must report any change in: 

(a) names, including aliases or fictitious names, or residence addresses; or 

(b) titles or roles in any business activity, including any business for which 

such Defendant performs services whether as an employee or otherwise 

and any entity in which such Defendant has any ownership interest, and 

identify the name, physical address, and any Internet address of the 

 business or entity. 

C. For a period of 20 years, each Defendant must submit to the Commission and the 

Maine AG notice of the filing of any bankruptcy petition, insolvency proceeding, or similar 

proceeding by or against such Defendant within 14 days of its filing. 

D. Any submission to the Commission or the Maine AG required by this Order to be 

sworn under penalty of perjury must be true and accurate and comply with 28 U.S.C. § 1746, 

such as by concluding: “I declare under penalty of perjury under the laws of the United States of 

America that the foregoing is true and correct. Executed on: ________” and supplying the date, 

signatory’s full name, title (if applicable), and signature. 

E. Unless otherwise directed by a Commission representative in writing, all 

submissions to the Commission pursuant to this Order must be emailed to DEBrief@ftc.gov or 

sent by overnight courier (not the U.S. Postal Service) to: Associate Director for Enforcement, 

Bureau of Consumer Protection, Federal Trade Commission, 600 Pennsylvania Avenue, N.W., 

Washington, D.C. 20580. The subject line must begin: FTC v. Health Research Laboratories, 

LLC, et al., and the number X180007. 
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F. Unless otherwise directed by a Maine AG representative in writing, all 

submissions to the Maine AG pursuant to this Order must be sent by overnight courier (not the 

U.S. Postal Service) to: Office of the Attorney General of Maine, Consumer Protection Division, 

111 Sewall Street, 6th Floor, Augusta, ME 04330. The subject line must begin: Order in re 

State of Maine v. Health Research Laboratories, LLC, et al., and must identify the Court and 

docket number of this Order as ordered by the Court. 

XVIII. 

RECORDKEEPING 

IT IS FURTHER ORDERED that in connection with the sale of any Covered Product, 

Defendants must create certain records for 10 years after entry of the Order, and retain each such 

record for 8 years. Specifically, the Corporate Defendant and the Individual Defendant for any 

business that such Defendants, individually or collectively, is a majority owner or controls 

directly or indirectly, must create and retain the following records: 

A. Accounting records showing the revenues from all goods or services sold, all 

costs incurred in generating those revenues, and the resulting net profit or loss; 

B. Personnel records showing, for each person providing services, whether as an 

employee or otherwise, that person’s: name; address; telephone numbers; job title or position; 

dates of service; and (if applicable) the reason for termination; 

C. Complaints and full or partial refund requests, whether received directly or 

indirectly, such as through a third party, and any response; 

D. All records necessary to demonstrate full compliance with each provision of this 

Order, including all submissions to the Commission and the Maine AG; and 

E. A copy of each unique advertisement or other marketing material. 
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XIX. 

COMPLIANCE MONITORING 

IT IS FURTHER ORDERED that, for the purpose of monitoring Defendants’ 

compliance with this Order: 

A. Within 14 days of receipt of a written request from a representative of the 

Commission or the Maine AG, each Defendant must: submit additional compliance reports or 

other requested information, which must be sworn under penalty of perjury; appear for 

depositions; and produce documents for inspection and copying. Plaintiffs are also authorized to 

obtain discovery, without further leave of court, using any of the procedures prescribed by 

Federal Rules of Civil Procedure 29, 30 (including telephonic depositions), 31, 33, 34, 36, 45, 

and 69. 

B. For matters concerning this Order, Plaintiffs are authorized to communicate 

directly with each Defendant. Defendants must permit Plaintiffs’ representatives to interview 

any employee or other person affiliated with any Defendant who has agreed to such an interview. 

The person interviewed may have counsel present. 

C. Plaintiffs may use all other lawful means, including posing, through their 

representatives, as consumers, suppliers, or other individuals or entities, to Defendants or any 

individual or entity affiliated with Defendants, without the necessity of identification or prior 

notice. Nothing in this Order limits the Commission’s lawful use of compulsory process, 

pursuant to Sections 9 and 20 of the FTC Act, 15 U.S.C. §§ 49, 57b-1. Nothing in this Order 

limits the Maine AG’s lawful use of compulsory process, pursuant to section 211 of the Maine 

UTPA, 5 M.R.S.A. § 211. Defendants hereby consent to the disclosure by the Maine AG to any 

law enforcement agency and any representative of the State of Maine of any material or 
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information produced by Defendants pursuant to section 211 of the Maine UTPA, whether 

produced before or after the date of this Order. 

D. Upon written request from a representative of the Commission or the Maine AG, 

any consumer reporting agency must furnish consumer reports concerning Individual Defendant, 

pursuant to Section 604(1) of the Fair Credit Reporting Act, 15 U.S.C. § 1681b(a)(1). 

XX. 

RETENTION OF JURISDICTION 

IT IS FURTHER ORDERED that this Court shall retain jurisdiction of this matter for 

purposes of construction, modification, and enforcement of this Order. 

IT IS SO ORDERED this 16th day of January, 2018. 

/s/ Jon D. Levy 

U.S. DISTRICT JUDGE 
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IT IS SO STIPULATED this 30th day of November, 2017. 

 DAVID C. SHONKA 

 Acting General Counsel 

/s/ Elizabeth K. Nach 

 Elizabeth K. Nach 

 James A. Prunty 

 Federal Trade Commission 

600 Pennsylvania Avenue, NW 

Washington, D.C. 20580 

Telephone: 202-326-2611, -2438 

Facsimile: 202-326-3259 

Email: enach@ftc.gov, jprunty@ftc.gov 

Attorneys for Plaintiff

 FEDERAL TRADE COMMISSION 

IT IS SO STIPULATED this 30th day of November, 2017. 

JANET T. MILLS 

Attorney General, State of Maine 

/s/ Brendan F.X. O’Neil 

 Brendan F.X. O’Neil

 Linda J. Conti 

 Assistant Attorney General

 Office of the Attorney General of Maine 

 6 State House Station

 Augusta, Maine 04333-0006 

 Telephone: 207-626-8842, -8591 

 Facsimile: 207-624-7730 

Email: brendan.oneil@maine.gov 

linda.conti@maine.gov 
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IT IS SO STIPULATED this 30th day of November, 2017. 

 HEALTH RESEARCH LABORATORIES, LLC 

 By:

 /s/ Kramer Duhon 

 KRAMER DUHON, individually, and as an owner 

 and officer of HEALTH RESEARCH 

 LABORATORIES, LLC 

IT IS SO STIPULATED this 30th day of November, 2017. 

 ATTORNEYS FOR DEFENDANTS HEALTH 

 RESEARCH LABORATORIES, LLC AND

 KRAMER DUHON 

 /s/ Andrew B. Lustigman 

 Andrew B. Lustigman, Esq. 

 Olshan Frome Wolosky LLP

 1325 Avenue of the Americas 

 New York, NY 10019 

 Telephone: (212) 451-2258 

 Facsimile: (212) 451-2222 

 Email: alustigman@olshanlaw.com 

Pro hac vice forthcoming 

/s/ David J. Marchese 

 Appearing on behalf of Defendants 

 Health Research Laboratories, LLC and 

 Kramer Duhon

 David J. Marchese, Esq. 

 Drummond & Drummond, LLP 

 1 Monument Way 

 Portland, ME 04101 

 Telephone: 207-774-0317 

 Email: dmarchese@ddlaw.com 
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EXHIBIT C		
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UNITED STATES OF AMERICA 

BEFORE THE FEDERAL TRADE COMMISSION 

OFFICE OF THE ADMINISTRATIVE LAW JUDGES 

In the Matter of 

HEALTH RESEARCH LABORATORIES, LLC, 

a limited liability company, 

DOCKET NO. 9397 

WHOLE BODY SUPPLEMENTS, LLC, 

a limited liability company, and 

KRAMER DUHON, 

individually and as an officer of HEALTH 

RESEARCH LABORATORIES, LLC and 

WHOLE BODY SUPPLEMENTS, LLC 

RESPONDENTS’ WAIVER OF AFFIRMATIVE DEFENSES OF MOOTNESS AND 

LACK OF PUBLIC INTEREST 

Respondents hereby unconditionally waive the following affirmative defenses and 

agree not to assert these particular affirmative defenses in any future answer: 

1. Mootness and Lack of Statutory Authority: The causes of action alleged in 

the Complaint are barred by mootness because all alleged conduct (i.e., marketing 

and advertising) referenced in the Complaint ceased more than a year prior to the 

filing of the Complaint and will not reoccur in the future. The FTC has alleged no 

facts regarding a likelihood of reoccurrence. Further, the FTC Act does not grant 

the FTC the authority to seek a cease and desist order under these circumstances. 

2. Not in the public interest: Neither the filing of the administrative action 

nor the contemplated relief is in the public interest as required by 15 U.S.C. § 45. 

/s/ Joel W. Reese 

Joel W. Reese 

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CERTIFICATE OF SERVICE 

I hereby certify that on February 25, 2021, I filed the foregoing document 

electronically using the FTC’s E-Filing system, which will send notification to: 

April J. Tabor The Honorable D. Michael Chappell 

Acting Secretary Administrative Law Judge 

Federal Trade Commission Federal Trade Commission 

600 Pennsylvania Ave., NW, Rm. H-113 600 Pennsylvania Ave., NW, Rm. H-110 

Washington, DC 20580 Washington, DC 20580 

ElectronicFilings@ftc.gov 

Elizabeth Averill 

eaverill@ftc.gov 

Jonathan Cohen 

jcohen2@ftc.gov 

COMPLAINT COUNSEL 

/s/ Joel W. Reese 

Joel W. Reese 

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EXHIBIT D		
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________________________________________________ 

________________________________________________ 

PUBLIC 

UNITED STATES OF AMERICA 

BEFORE THE FEDERAL TRADE COMMISSION 

OFFICE OF ADMINISTRATIVE LAW JUDGES 

In the Matter of 

HEALTH RESEARCH LABORATORIES, LLC, 

a limited liability company, 

WHOLE BODY SUPPLEMENTS, LLC, 

a limited liability company, and DOCKET NO. 9397 

KRAMER DUHON, 

individually and as an officer of 

HEALTH RESEARCH LABORATORIES, LLC 

and WHOLE BODY SUPPLEMENTS, LLC. 

DECLARATION OF ELIZABETH J. AVERILL 

I, Elizabeth J. Averill, hereby state that I have personal knowledge of the facts set forth 

below. I submit this declaration in support of Complaint Counsel’s Motion to Compel 

Respondents to Produce Documents. If called as a witness, I could and would testify as follows: 

1. I am a United States citizen and am over eighteen years of age. I am employed by 

the Federal Trade Commission (“FTC”) as an attorney in the Division of Enforcement, Bureau of 

Consumer Protection. I am acting as Complaint Counsel in the above-captioned matter. I also 

worked as an attorney representing the Federal Trade Commission in FTC and State of Maine v. 

Health Research Laboratories, LLC, et al., Case No. 2:17-cv-00467-JDL (D. Me.). 

2. On December 9, 2020, I served Complaint Counsel’s Initial Disclosures on 

Respondents’ counsel via email. A true and correct copy of those Initial Disclosures are attached 

as CCX-A1. 
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3. On December 10, 2020, I received Respondents’ Initial Disclosures from 

Respondents’ counsel, Joel Reese. A true and correct copy of these Initial Disclosures are 

attached as CCX-A2. They appeared to have been largely copied from Complaint Counsel’s 

Initial Disclosures, and they do not provide any information about where Respondents are storing 

potentially relevant documents. Respondents also did not list categories of relevant documents 

one would expect to be in their custody such as emails, documents related to work performed by 

non-attorney consultants and copywriters related to the challenged ads, or business records 

related to advertising or marketing strategy for Black Garlic Botanicals, BG18, The Ultimate 

Heart Formula, or Neupathic. 

4. On December 22, 2020, I served Complaint Counsel’s First Requests for 

Production to Respondents (“RFPs”) by email to their counsel, Joel Reese and Joshua Russ. A 

true and correct copy of the RFPs are attached as CCX-A3. 

5. On January 6, 2021, my co-counsel, Jonathan Cohen, and I had a telephone 

conference with Joel Reese to discuss questions related to the RFPs and Respondents’ request 

that Complaint Counsel provide search terms. During that conference, I asked Mr. Reese for 

specific information about the Respondents’ document collection efforts, the custodians 

searched, how and where ESI was stored, as well as the volume and format of stored ESI. Mr. 

Reese did not provide any specific information about Respondents’ collection efforts or any 

information relevant to assessing burden. On January 11, 2021, I sent a letter to Mr. Reese 

following up about some of these unanswered questions. A true and correct copy of this letter is 

attached as CCX-A4. I never received any information from Mr. Reese in response to these 

questions. 

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6. On January 21, 2021, I received Respondents’ Objections and Responses to 

Complaint Counsel’s First Requests for Production (“Responses”). A true and correct copy of 

the Responses are attached as CCX-A5. 

7. A vendor working with Respondents’ counsel produced documents on January 

25, 2021 (“January 25 Production”). This is the only document production Complaint Counsel 

has received in response to the RFPs. It included 492 documents. 

8. On January 25, 2021, Respondents’ counsel stated he planned to review and 

produce additional responsive documents to Complaint Counsel within two weeks. A true and 

correct copy of this email is attached as CCX-A6. 

9. I personally reviewed all of the documents in the January 25 Production. During 

my review, I noticed the majority of the documents had previously been produced to the FTC as 

part of the contempt investigation related to FTC and State of Maine v. Health Research 

Laboratories, LLC, et al., Case No. 2:17-cv-00467-JDL (D. Me.). 

10. Furthermore, the January 25 Production includes multiple copies of the same 

articles, random website content, and excerpted sections of alternative health books related to 

individual ingredients in the four challenged products. For example, six copies of an article 

entitled “Aged Garlic Extract Reduces Low Attenuation Plaque in Coronary Arteries of Patients 

with Metabolic Syndrome in a Prospective Randomized Double-Blind Study” authored by 

Matsumoto et al. were produced with Bates numbers of HRLAC_00186 to 00191; 

HRLAC_00720 to 00725; HRLAC_01444 to 01449; HRLAC_01991 to 01996; HRLAC_02566 

to 02571; and HRLAC_03113 to 03118. Six copies of an article entitled “Garlic Shows Promise 

for Improving Some Cardiovascular Risk Factors” authored by Ackermann et al. were produced 

with Bates numbers of HRLAC_00672 to 00683; HRLAC_00684 to 00695; HRLAC_01943 to 

3 
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001954; HRLAC_01955 to 01966; HRLAC_03065 to 03076; and HRLAC_03077 to 03088. 

Three copies of an abstract related to an article entitled “Inhibiting progression of coronary 

calcification using Aged Garlic Extract in patients receiving statin therapy: a preliminary study” 

authored by Budoff et al. were produced with Bates numbers of HRLAC_00016 to 00017; 

HRLAC_01262 to 01263; and HRLAC_02384 to 02385. There are three copies of a website 

article entitled “14 Biggest Myths About Type 2 Diabetes” apparently downloaded from 

http://community.ihealthlabs.com that was produced with Bates numbers HRLAC_01426 to 

01431; HRLAC_00168 to 00173; and HRLAC_02548 to 02553. Respondents produced three 

copies of an article entitled “Applicable People fermented black garlic; green natural org” 

apparently downloaded from http://www.iblackgarlic.com and produced with Bates numbers 

HRLAC_01305 to 01306; HRLAC_00059 to 00060; and HRLAC_02427 to 02428. 

Respondents produced three copies of an excerpt entitled “Chelation Therapy” from a book 

entitled “Alternative Medicine: the definitive guide” with Bates numbers HRLAC_01832 to 

01842; HRLAC_00561 to 00571; and HRLAC_02954 to 02964. This is just a very small sample 

of the extensive amount of duplicative materials in the January 25 Production. 

11. Based on my review, the January 25 Production did not include any documents 

related to the development, analysis, review, or approval of the challenged advertisements other 

than a few statements of ad approval apparently signed by Richard Cohen. The production did 

not include any communications or documents clearly related to work done by individuals or 

entities who assisted the Respondents on projects related to advertising and substantiation such 

as documents involving Inna Yegerova, Inna Consulting, Curtis Walcker, Dietary Supplement 

Experts, LLC, or Stephen Kimball. The production did not include documents or any 

communications related to either Respondents’ advertising and marketing strategy or product 

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development for Black Garlic Botanicals, BG18, The Ultimate Heart Formula, or Neupathic. 

Respondents have not produced any contemporaneous emails, notes, or correspondence. 

Respondents have not produced any documents clearly authored by, or addressed to, either 

Kramer Duhon or Kyle Duhon. The January 25 Production does not include any documents 

related to Respondents’ alleged defense that Kramer Duhon was not responsible for the conduct 

of the corporate Respondents. 

12. Respondents have not produced a privilege log. 

13. On January 27, 2021, I sent an email to Respondents’ counsel asking to schedule 

a time to meet and confer about issues related to Respondents’ Initial Disclosures, the Responses, 

as well as Respondents’ Objections and Answers to the First Set of Interrogatories. 

Respondents’ counsel advised that the earliest date he was available for such a conference was 

February 1, 2021. A true and correct copy of an email string between counsel related to 

scheduling the time to meet and confer is attached as CCX-A7. 

14. On February 1, a few hours prior to the scheduled time for counsel to meet and 

confer about discovery issues, Respondents’ counsel, Joel Reese, sent an email indicating 

Respondents would agree to all relief requested in the Notice of Contemplated Relief without 

any conditions. Mr. Reese further indicated he believed, as a result, the scheduled meet and 

confer was not necessary. I responded by advising him it was important for us to meet and 

confer as scheduled to try to resolve issues related to Respondents’ Initial Disclosures, the 

Responses, and Respondents’ Objections and Answers to the First Set of Interrogatories. A true 

and correct copy of an email string reflecting this exchange between counsel is attached as CCXA8. 

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15. On February 1, 2021 starting at 4:30 PM (Eastern), Jonathan Cohen and I spoke 

by telephone with Joel Reese in an effort to discuss and resolve the issues raised in the Motion to 

Compel Respondents to Produce Documents as well other issues related to their Objections and 

Answers to the First Set of Interrogatories. A FTC paralegal, Celia Garrett, also listened to the 

call. I repeatedly tried to focus the conversation on specific questions and issues related to 

document production, the Responses, and Respondents’ Objections and Answers to the First Set 

of Interrogatories in an effort to determine if issues could be narrowed by agreement. Mr. Reese 

was generally unwilling to engage in a detailed discussion about specific discovery issues and 

instead insisted that all of those issues were irrelevant because Respondents would not 

participate further in discovery in the administrative action because of cost. During the 

conference, Mr. Reese stated Respondents were willing to admit to all allegations in the 

Complaint. He stated that Respondents intended to terminate the administrative proceeding 

either by settlement, withdrawing their answer, filing a motion to amend their answer to admit 

allegations in the Complaint, or by declining to participate further in discovery and eventually 

incurring what he referred to as “death penalty” sanctions from the Court that would terminate 

the administrative proceeding. During the conference, Mr. Reese also stated Respondents would 

not review or produce additional documents, produce a privilege log, or otherwise supplement 

their discovery responses. I did not note the exact time when the conference concluded, but 

estimate that we spoke for a total of approximately 75 minutes. 

16. Following the conference on February 1, counsel for the parties had a discussion 

related to settlement that was ultimately not successful. 

17. During the conversation on February 1 and during a subsequent telephone call on 

February 11, 2021, Mr. Reese advised us Respondents’ position is that attorney-client privilege 

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and/or the work product doctrine applies to documents related to unidentified non-attorney 

consultants who were involved in reviewing the challenged advertisements and evaluating 

substantiation. He told us the law firm of Olshan Frome Wolosky LLP referred Respondents to 

those consultants, and that such documents would not be produced to Complaint Counsel on the 

grounds they are protected by the attorney-client privilege or the work product doctrine. 

I declare under penalty of perjury under the laws of the United States that the foregoing is 

true and correct. 

Executed on: February 19, 2021 /s/ Elizabeth J. Averill 

Alexandria, VA 

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