Notice2022-06079
Health Research Laboratories, LLC; Analysis of Proposed Consent Order To Aid Public Comment
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
March 23, 2022
Issuing agencies
Federal Trade Commission
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 56 (Wednesday, March 23, 2022)</title>
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[Federal Register Volume 87, Number 56 (Wednesday, March 23, 2022)]
[Notices]
[Pages 16475-16477]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.ftc.gov/news-events/commission-actions">https://www.ftc.gov/news-events/commission-actions</a>.
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>, 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="http://www.ftc.gov">http://www.ftc.gov</a> 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 <a href="https://www.ftc.gov/site-information/privacy-policy">https://www.ftc.gov/site-information/privacy-policy</a>.
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
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