Analysis of Proposed Consent Order to Aid Public Comment

In the Matter of Health Research Laboratories, LLC, et al., Docket No. 9397

The Federal Trade Commission (“FTC” or “Commission”) has accepted, subject to final

approval, an agreement containing a consent order from Health Research Laboratories, LLC,

Whole Body Supplements, LLC and their Managing Member and officer, Kramer Duhon

(“Respondents”).

The proposed consent order has been placed on the public record for thirty (30) days for

receipt of comments by interested persons. Comments received during this period will become

part of the public record. After thirty (30) days, the Commission will again review the

agreement and the comments received, and will decide whether it should withdraw from the

agreement and take appropriate action or make final the agreement’s proposed order.

This matter involves the Respondents’ advertising for Black Garlic Botanicals, BG18,

The Ultimate Heart Formula, and Neupathic. The complaint alleges Respondents violated

Sections 5(a) and 12 of the FTC Act by disseminating false and unsubstantiated advertisements

claiming that: (1) Black Garlic Botanicals, BG18, and The Ultimate Heart Formula will prevent,

reduce the risk of, cure, mitigate, or treat cardiovascular disease, atherosclerosis, and/or

hypertension; and (2) Neupathic will cure, treat, or mitigate diabetic neuropathy. Respondents

Kramer Duhon and Health Research Laboratories are also parties to a previous federal court

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

JDL (D. Me. Jan. 16, 2018).

The proposed consent order includes injunctive relief that addresses these alleged

violations and contains provisions designed to prevent Respondents from engaging in similar

acts and practices in the future.

Part I would ban Respondents from advertising, marketing, promoting, or offering for

sale any dietary supplements.

Part II would ban Respondents from making any disease prevention, reduction of risk,

cure, mitigation, or treatment claim when advertising, marketing, promoting, or offering for sale

any product.

Part III prohibits Respondents from making any representation about the health benefits,

safety, performance, or efficacy of any food or drug, unless the representation is non-misleading,

and at the time such representation is made, Respondents possess and rely upon competent and

reliable scientific evidence that substantiates that the representation is true. For purposes of this

provision, “competent and reliable scientific evidence” means tests, analyses, research, or studies

that: (1) have been conducted and evaluated in an objective manner by experts in the relevant

condition or function to which the representation relates; (2) are generally accepted by such

experts to yield accurate and reliable results; and (3) are randomized, double-blind, and placebocontrolled human clinical testing of the product or of an essentially equivalent product, when

experts would generally require such human clinical testing to substantiate that the representation

is true. In addition, this provision requires that when such tests or studies are human clinical
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

tests or studies, all underlying or supporting data and documents generally accepted by experts as

relevant to an assessment of such testing must be available for inspection and production to the

Commission.

Part IV prohibits Respondents from making misrepresentations: (1) that the

performance or benefits of any food or drug are scientifically or clinically proven or otherwise

established; or (2) about the existence, contents, validity, results, conclusions, or interpretations

of any test, study, or other research.

Part V requires Respondents to preserve supporting data and documents relevant to

assessing human clinical tests that they rely on to support claims within the scope of Part III of

the proposed order.

Part VI requires Respondents to send notices to consumers who purchased Black Garlic

Botanicals, BG18, The Ultimate Heart Formula, or Neupathic informing them about this matter

and the Commission’s order.

Part VII prohibits Respondents and their officers, agents, and employees from

disclosing, using, or receiving any benefit from customer information that Respondents obtained

in connection with sales of Black Garlic Botanicals, BG18, The Ultimate Heart Formula, or

Neupathic.

Part VIII requires Respondents to cancel any subscription plan with a negative option

feature related to Black Garlic Botanicals, BG18, The Ultimate Heart Formula, or Neupathic.

Parts IX through XII of the proposed order relate to compliance reporting and

monitoring. Part IX is an order acknowledgment and distribution provision requiring

Respondents to acknowledge the order, to provide the order to current and future owners,

managers, business partners, certain employees, and to obtain an acknowledgement from each

such person that they received a copy of the order. Part X requires Respondents to submit a

compliance report one year after the order is entered, and to promptly notify the Commission of

corporate changes that may affect compliance obligations. Part XI requires Respondents to

maintain, and upon request make available, certain compliance-related records. Part XII requires

Respondents to provide additional information or compliance reports, as requested.

Part XIII states that the proposed order will remain in effect for 20 years, with certain

exceptions.

The purpose of this analysis is to aid public comment on the proposed order. It is not

intended to constitute an official interpretation of the complaint or proposed order, or to modify

in any way the proposed order’s terms.