Health Research Laboratories, LLC; Analysis of Proposed Consent Order To Aid Public Comment, 16475-16477 [2022-06079]
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collection of information is necessary
for the proper performance of the
functions of the Agency, including
whether the information will have
practical utility; (ii) evaluate the
accuracy of the Agency’s estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(iii) enhance the quality, utility, and
clarity of the information to be
collected; and (iv) minimize the burden
of the collection of information on those
who are to respond, including through
the use of appropriate automated
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses. The EPA will consider the
comments received and amend the ICR
as appropriate. The final ICR package
will then be submitted to OMB for
review and approval. At that time, the
EPA will issue another Federal Register
notice to announce the submission of
the ICR to OMB and the opportunity to
submit additional comments to OMB.
Abstract: Subtitle C of the Resource
Conservation and Recovery Act (RCRA)
creates a comprehensive program for the
safe management of hazardous waste.
Section 3004 of RCRA requires owners
and operators of facilities that treat,
store, or dispose of hazardous waste to
comply with standards established by
EPA that are to protect the environment.
Section 3005 provides for
implementation of these standards
under permits issued to owners and
operators by EPA or authorized States.
Section 3005 also allows owners and
operators of facilities in existence when
the regulations came into effect to
comply with applicable notice
requirements to operate until a permit is
issued or denied. This statutory
authorization to operate prior to permit
determination is commonly known as
‘‘interim status.’’ Owners and operators
of interim status facilities also must
comply with standards set under
Section 3004.
This ICR examines the ground-water
monitoring standards for permitted and
interim status facilities at 40 CFR parts
264 and 265, as specified. The groundwater monitoring requirements for
regulated units follow a tiered approach
whereby releases of hazardous
contaminants are first detected
(detection monitoring), then confirmed
(compliance monitoring), and if
necessary, are required to be cleaned up
(corrective action). Each of these tiers
requires collection and analysis of
ground-water samples. Owners or
operators that conduct ground-water
monitoring are required to report
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information to the oversight agencies on
releases of contaminants and to
maintain records of ground-water
monitoring data at their facilities. The
goal of the ground-water monitoring
program is to prevent and quickly detect
releases of hazardous contaminants to
groundwater, and to establish a program
whereby any contamination is
expeditiously cleaned up as necessary
to protect human health and
environment.
Form Numbers: None.
Respondents/affected entities:
Business or other for-profit; and State,
Local, or Tribal Governments.
Respondent’s obligation to respond:
Mandatory (RCRA Sections 3004 and
3005).
Estimated number of respondents:
813.
Frequency of response: Quarterly,
semi-annually, and annually.
Total estimated burden: 104,861
hours per year. Burden is defined at 5
CFR 1320.03(b).
Total estimated cost: $20,491,681 (per
year), includes $16,090,478 annualized
capital or operation & maintenance
costs.
Changes in Estimates: The burden
hours are likely to stay substantially the
same.
16475
https://www.federalreserve.gov/foia/
request.htm. Interested persons may
express their views in writing on the
standards enumerated in paragraph 7 of
the Act.
Comments regarding each of these
applications must be received at the
Reserve Bank indicated or the offices of
the Board of Governors, Ann E.
Misback, Secretary of the Board, 20th
Street and Constitution Avenue NW,
Washington, DC 20551–0001, not later
than April 7, 2022.
A. Federal Reserve Bank of St. Louis
(Holly A. Rieser, Manager) P.O. Box 442,
St. Louis, Missouri 63166–2034.
Comments can also be sent
electronically to
Comments.applications@stls.frb.org:
1. The George N. Schulte Trust,
George N. Schulte, as trustee, both of
Dixon, Missouri; David R. Tritten and
Elizabeth A. Tritten, both of
Waynesville, Missouri; Beth A. Wright
and Richard R. Wright, both of Iberia,
Missouri; to retain voting shares of
Milco Bancorporation, Inc., and thereby
indirectly retain voting shares of Bank
of Iberia, both of Iberia, Missouri.
Board of Governors of the Federal Reserve
System, March 18, 2022.
Michele Taylor Fennell,
Deputy Associate Secretary of the Board.
Dated: March 11, 2022.
Carolyn Hoskinson,
Director, Office of Resource Conservation and
Recovery.
[FR Doc. 2022–06152 Filed 3–22–22; 8:45 am]
[FR Doc. 2022–06106 Filed 3–22–22; 8:45 am]
FEDERAL TRADE COMMISSION
BILLING CODE 6560–50–P
[File No. 152 3021/Docket No. 9397]
FEDERAL RESERVE SYSTEM
Health Research Laboratories, LLC;
Analysis of Proposed Consent Order
To Aid Public Comment
Change in Bank Control Notices;
Acquisitions of Shares of a Bank or
Bank Holding Company
The notificants listed below have
applied under the Change in Bank
Control Act (Act) (12 U.S.C. 1817(j)) and
§ 225.41 of the Board’s Regulation Y (12
CFR 225.41) to acquire shares of a bank
or bank holding company. The factors
that are considered in acting on the
applications are set forth in paragraph 7
of the Act (12 U.S.C. 1817(j)(7)).
The public portions of the
applications listed below, as well as
other related filings required by the
Board, if any, are available for
immediate inspection at the Federal
Reserve Bank(s) indicated below and at
the offices of the Board of Governors.
This information may also be obtained
on an expedited basis, upon request, by
contacting the appropriate Federal
Reserve Bank and from the Board’s
Freedom of Information Office at
PO 00000
Frm 00023
Fmt 4703
Sfmt 4703
BILLING CODE P
Federal Trade Commission.
Proposed consent agreement;
request for comment.
AGENCY:
ACTION:
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
SUMMARY:
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16476
Federal Register / Vol. 87, No. 56 / Wednesday, March 23, 2022 / Notices
online at https://www.regulations.gov by
following the instructions on the webbased 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/commissionactions.
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
VerDate Sep<11>2014
20:07 Mar 22, 2022
Jkt 256001
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 https://
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.
PO 00000
Frm 00024
Fmt 4703
Sfmt 4703
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
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Jkt 256001
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–0335]
Advisory Committee; Obstetrics,
Reproductive and Urologic Drugs
Advisory Committee; Renewal
AGENCY:
Food and Drug Administration,
HHS.
Notice; renewal of Federal
advisory committee.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
renewal of the Obstetrics, Reproductive
and Urologic Drugs Advisory Committee
(formerly known as the Bone,
Reproductive and Urologic Drugs
Advisory Committee) by the
Commissioner of Food and Drugs (the
Commissioner). The Commissioner has
determined that it is in the public
interest to renew the Obstetrics,
Reproductive and Urologic Drugs
Advisory Committee for an additional 2
years beyond the charter expiration
date. The new charter will be in effect
until the March 23, 2024, expiration
date.
DATES: Authority for the Obstetrics,
Reproductive and Urologic Drugs
Advisory Committee (formerly known
as the Bone, Reproductive and Urologic
Drugs Advisory Committee) will expire
on March 23, 2024, unless the
Commissioner formally determines that
renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT:
Joyce Frimpong, Division of Advisory
SUMMARY:
PO 00000
Frm 00025
Fmt 4703
Sfmt 4703
16477
Committee and Consultant
Management, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, email: ORUDAC@
fda.hhs.gov.
Pursuant
to 41 CFR 102–3.65 and approval by the
Department of Health and Human
Services, FDA is announcing the
renewal of the Obstetrics, Reproductive
and Urologic Drugs Advisory Committee
(the Committee). The Committee is a
discretionary Federal advisory
committee established to provide advice
to the Commissioner. The Committee
advises the Commissioner or designee
in discharging responsibilities as they
relate to helping to ensure safe and
effective drugs for human use and, as
required, any other product for which
FDA has regulatory responsibility.
The Committee reviews and evaluates
data on the safety and effectiveness of
marketed and investigational human
drug products for use in the practice of
obstetrics, gynecology, urology and
related specialties, and makes
appropriate recommendations to the
Commissioner.
The Committee shall consist of a core
of 11 voting members, including the
Chair. Members and the Chair are
selected by the Commissioner or
designee from among authorities
knowledgeable in the fields of
obstetrics, gynecology, urology,
pediatrics, epidemiology, or statistics
and related specialties. Members will be
invited to serve for overlapping terms of
up to 4 years. Non-Federal members of
this committee will serve as Special
Government Employees, representatives
or Ex-Officio members. Federal
members will serve as Regular
Government Employees or Ex-Officios.
The core of voting members may
include one technically qualified
member, selected by the Commissioner
or designee, who is identified with
consumer interests and is recommended
by either a consortium of consumeroriented organizations or other
interested persons. In addition to the
voting members, the Committee may
include one non-voting representative
member who is identified with industry
interests. There may also be an alternate
industry representative.
Further information regarding the
most recent charter and other
information can be found at https://
www.fda.gov/advisory-committees/
human-drug-advisory-committees/
obstetrics-reproductive-and-urologicdrugs-advisory-committee or by
SUPPLEMENTARY INFORMATION:
E:\FR\FM\23MRN1.SGM
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]]>Agencies
[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
[[Page 16476]]
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 https://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
[[Page 16477]]
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
