Health Research Laboratories, LLC; Analysis of Proposed Consent Order To Aid Public Comment, 16475-16477 [2022-06079]

Download as PDF jspears on DSK121TN23PROD with NOTICES1 Federal Register / Vol. 87, No. 56 / Wednesday, March 23, 2022 / Notices 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 VerDate Sep<11>2014 20:07 Mar 22, 2022 Jkt 256001 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: E:\FR\FM\23MRN1.SGM 23MRN1 jspears on DSK121TN23PROD with NOTICES1 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 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. 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 E:\FR\FM\23MRN1.SGM 23MRN1 jspears on DSK121TN23PROD with NOTICES1 Federal Register / Vol. 87, No. 56 / Wednesday, March 23, 2022 / Notices 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 VerDate Sep<11>2014 20:07 Mar 22, 2022 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 23MRN1

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]


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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.

-----------------------------------------------------------------------

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 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

[[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