[Federal Register Volume 87, Number 56 (Wednesday, March 23, 2022)]
[Notices]
[Pages 16475-16477]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-06079]


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FEDERAL TRADE COMMISSION

[File No. 152 3021/Docket No. 9397]


Health Research Laboratories, LLC; Analysis of Proposed Consent 
Order To Aid Public Comment

AGENCY: Federal Trade Commission.

ACTION: Proposed consent agreement; request for comment.

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SUMMARY: The consent agreement in this matter settles alleged 
violations of federal law prohibiting unfair or deceptive acts or 
practices. The attached Analysis of Proposed Consent Order to Aid 
Public Comment describes both the allegations in the complaint and the 
terms of the consent order--embodied in the consent agreement--that 
would settle these allegations.

DATES: Comments must be received on or before April 22, 2022.

ADDRESSES: Interested parties may file comments online or on paper by 
following the instructions in the Request for Comment part of the 
SUPPLEMENTARY INFORMATION section below. Please write ``Health Research 
Laboratories, LLC; Docket No. 9397'' on your comment, and file your 
comment

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online at https://www.regulations.gov by following the instructions on 
the web-based form. If you prefer to file your comment on paper, mail 
your comment to the following address: Federal Trade Commission, Office 
of the Secretary, 600 Pennsylvania Avenue NW, Suite CC-5610 (Annex D), 
Washington, DC 20580.

FOR FURTHER INFORMATION CONTACT: Elizabeth Averill (202-326-2993), 
Bureau of Consumer Protection, Federal Trade Commission, 600 
Pennsylvania Avenue NW, Washington, DC 20580.

SUPPLEMENTARY INFORMATION: Pursuant to Section 6(f) of the Federal 
Trade Commission Act, 15 U.S.C. 46(f), and FTC Rule 2.34, 16 CFR 2.34, 
notice is hereby given that the above-captioned consent agreement 
containing a consent order to cease and desist, having been filed with 
and accepted, subject to final approval, by the Commission, has been 
placed on the public record for a period of thirty (30) days. The 
following Analysis to Aid Public Comment describes the terms of the 
consent agreement and the allegations in the complaint. An electronic 
copy of the full text of the consent agreement package can be obtained 
at https://www.ftc.gov/news-events/commission-actions.
    You can file a comment online or on paper. For the Commission to 
consider your comment, we must receive it on or before April 22, 2022. 
Write ``Health Research Laboratories, LLC; Docket No. 9397'' on your 
comment. Your comment--including your name and your state--will be 
placed on the public record of this proceeding, including, to the 
extent practicable, on the https://www.regulations.gov website.
    Due to the COVID-19 pandemic and the agency's heightened security 
screening, postal mail addressed to the Commission will be subject to 
delay. We strongly encourage you to submit your comments online through 
the https://www.regulations.gov website.
    If you prefer to file your comment on paper, write ``Health 
Research Laboratories, LLC; Docket No. 9397'' on your comment and on 
the envelope, and mail your comment to the following address: Federal 
Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW, 
Suite CC-5610 (Annex D), Washington, DC 20580. If possible, submit your 
paper comment to the Commission by overnight service.
    Because your comment will be placed on the publicly accessible 
website at https://www.regulations.gov, you are solely responsible for 
making sure your comment does not include any sensitive or confidential 
information. In particular, your comment should not include sensitive 
personal information, such as your or anyone else's Social Security 
number; date of birth; driver's license number or other state 
identification number, or foreign country equivalent; passport number; 
financial account number; or credit or debit card number. You are also 
solely responsible for making sure your comment does not include 
sensitive health information, such as medical records or other 
individually identifiable health information. In addition, your comment 
should not include any ``trade secret or any commercial or financial 
information which . . . is privileged or confidential''--as provided by 
Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 
16 CFR 4.10(a)(2)--including in particular competitively sensitive 
information such as costs, sales statistics, inventories, formulas, 
patterns, devices, manufacturing processes, or customer names.
    Comments containing material for which confidential treatment is 
requested must be filed in paper form, must be clearly labeled 
``Confidential,'' and must comply with FTC Rule 4.9(c). In particular, 
the written request for confidential treatment that accompanies the 
comment must include the factual and legal basis for the request and 
must identify the specific portions of the comment to be withheld from 
the public record. See FTC Rule 4.9(c). Your comment will be kept 
confidential only if the General Counsel grants your request in 
accordance with the law and the public interest. Once your comment has 
been posted on the https://www.regulations.gov website--as legally 
required by FTC Rule 4.9(b)--we cannot redact or remove your comment 
from that website, unless you submit a confidentiality request that 
meets the requirements for such treatment under FTC Rule 4.9(c), and 
the General Counsel grants that request.
    Visit the FTC website at http://www.ftc.gov to read this document 
and the news release describing the proposed settlement. The FTC Act 
and other laws that the Commission administers permit the collection of 
public comments to consider and use in this proceeding, as appropriate. 
The Commission will consider all timely and responsive public comments 
that it receives on or before April 22, 2022. For information on the 
Commission's privacy policy, including routine uses permitted by the 
Privacy Act, see https://www.ftc.gov/site-information/privacy-policy.

Analysis of Proposed Consent Order To Aid Public Comment

    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

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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 placebo-controlled 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.

    By direction of the Commission.
April J. Tabor,
Secretary.
[FR Doc. 2022-06079 Filed 3-22-22; 8:45 am]
BILLING CODE 6750-01-P