A & O Enterprises Inc and Aaron K. Roberts; Analysis To Aid Public Comment, 50372-50374 [2018-21749]

Download as PDF 50372 Federal Register / Vol. 83, No. 194 / Friday, October 5, 2018 / Notices assets of a company, including the companies listed below, that engages either directly or through a subsidiary or other company, in a nonbanking activity that is listed in § 225.28 of Regulation Y (12 CFR 225.28) or that the Board has determined by Order to be closely related to banking and permissible for bank holding companies. Unless otherwise noted, these activities will be conducted throughout the United States. Each notice is available for inspection at the Federal Reserve Bank indicated. The notice also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the question whether the proposal complies with the standards of section 4 of the BHC Act. Unless otherwise noted, comments regarding the applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than October 29, 2018. A. Federal Reserve Bank of Chicago (Colette A. Fried, Assistant Vice President) 230 South LaSalle Street, Chicago, Illinois 60690–1414: 1. HSBC Holdings plc, London, England; HSBC Overseas Holdings (UK) Limited, London, England; HSBC North America Holdings Inc., New York, New York; and HSBC USA, Inc., New York, New York; to engage de novo through a newly formed entity, The Consortium, LLC, in data processing activities, pursuant to section 225.28(b)(14) of Regulation Y. Board of Governors of the Federal Reserve System, October 1, 2018. Yao-Chin Chao, Assistant Secretary of the Board. [FR Doc. 2018–21658 Filed 10–4–18; 8:45 am] Board of Governors of the Federal Reserve System, October 1, 2018. Yao-Chin Chao, Assistant Secretary of the Board. [FR Doc. 2018–21643 Filed 10–4–18; 8:45 am] BILLING CODE 6210–01–P FEDERAL TRADE COMMISSION BILLING CODE P [File No. 172 3016] FEDERAL RESERVE SYSTEM A & O Enterprises Inc and Aaron K. Roberts; Analysis To Aid Public Comment Formations of, Acquisitions by, and Mergers of Bank Holding Companies daltland on DSKBBV9HB2PROD with NOTICES inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States. Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than November 1, 2018. A. Federal Reserve Bank of San Francisco (Gerald C. Tsai, Director, Applications and Enforcement) 101 Market Street, San Francisco, California 94105–1579: 1. JBNV Holding Corp., Sparks, Nevada; to become a bank holding company by acquiring 100 percent of the voting shares of Kirkwood Bancorporation of Nevada, Inc., and thereby indirectly acquire Kirkwood Bank of Nevada, both of Las Vegas, Nevada. The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 et seq.) (BHC Act), Regulation Y (12 CFR part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below. The applications listed below, as well as other related filings required by the Board, are available for immediate VerDate Sep<11>2014 17:11 Oct 04, 2018 Jkt 247001 Federal Trade Commission. Proposed consent agreement. AGENCY: ACTION: The consent agreement in this matter settles alleged violations of federal law prohibiting unfair or deceptive acts or practices. The attached Analysis 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. SUMMARY: Comments must be received on or before October 22, 2018. ADDRESSES: Interested parties may file a comment online or on paper, by following the instructions in the DATES: PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 Request for Comment part of the section below. Write: ‘‘A & O Enterprises Inc’’ on your comment, and file your comment online at https:// ftcpublic.commentworks.com/ftc/ aoenterprisesivbarsconsent by following the instructions on the web-based form. If you prefer to file your comment on paper, write ‘‘A & O Enterprises Inc; File No. 1723016’’ 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; or deliver your comment to: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW, 5th Floor, Suite 5610 (Annex D), Washington, DC 20024. FOR FURTHER INFORMATION CONTACT: Thomas Carter (214–979–9372) or James Golder (214–979–9376), Southwest Region, Federal Trade Commission, 1999 Bryan Street, Suite 2150, Dallas, TX 75201. 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 from the FTC Home Page (for September 20, 2018), on the World Wide Web, 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 October 22, 2018. Write ‘‘A & O Enterprises Inc; File No. 1723016’’ 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 public Commission website, at https://www.ftc.gov/policy/ public-comments. Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, we encourage you to submit your comments online. To make sure that the Commission considers your online comment, you must file it at https:// ftcpublic.commentworks.com/ftc/ SUPPLEMENTARY INFORMATION E:\FR\FM\05OCN1.SGM 05OCN1 daltland on DSKBBV9HB2PROD with NOTICES Federal Register / Vol. 83, No. 194 / Friday, October 5, 2018 / Notices aoenterprisesivbarsconsent by following the instructions on the web-based form. If this Notice appears at http:// www.regulations.gov/#!home, you also may file a comment through that website. If you prefer to file your comment on paper, write ‘‘A & O Enterprises Inc; File No. 1723016’’ 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; or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW, 5th Floor, Suite 5610 (Annex D), Washington, DC 20024. If possible, submit your paper comment to the Commission by courier or overnight service. Because your comment will be placed on the publicly accessible FTC website at https://www.ftc.gov, you are solely responsible for making sure that your comment does not include any sensitive or confidential information. In particular, your comment should not include any 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 that your comment does not include any 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 VerDate Sep<11>2014 17:11 Oct 04, 2018 Jkt 247001 request in accordance with the law and the public interest. Once your comment has been posted on the public FTC website—as legally required by FTC Rule 4.9(b)—we cannot redact or remove your comment from the FTC 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 Notice and the news release describing it. 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 October 22, 2018. 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 A & O Enterprises Inc, a corporation, doing business as iV Bars Incorporated and iV Bars, and Aaron K. Roberts, also known as Aaron Keith (‘‘respondents’’). The proposed consent order (‘‘order’’) has been placed on the public record for 30 days for receipt of comments by interested persons. Comments received during this period will become part of the public record. After 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 respondents’ advertising, promotion and sale of intravenous drip cocktails (‘‘iV Cocktails’’), including the Myers Cocktail, which contain a mixture of water, vitamins, minerals and amino acids. According to the FTC complaint, respondents made false or unsubstantiated representations that their iV Cocktails are effective treatments for cancer, angina, cardiovascular disease, congestive heart failure, myocardial infarction, multiple sclerosis, diabetes, fibromyalgia and neurodegenerative disorders, and that their cocktails produce fast, lasting results, are safe for all ages and cause no side effects. The FTC also alleges that respondents falsely represented that their iV Cocktails are clinically or PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 50373 scientifically proven to effectively treat the enumerated diseases and produce fast, lasting results. The complaint alleges that respondents’ actions constitute unfair or deceptive acts or practices and the making of false advertisements, in violation of Sections 5(a) and 12 of the Federal Trade Commission Act. The order is designed to prevent respondents from engaging in similar acts or practices in the future. It includes injunctive relief to address these alleged violations and to prohibit similar and related conduct. • The order defines ‘‘covered product’’ to mean any intravenous therapy, including all of respondents’ iV Cocktails, and any intramuscular injection. • Part I of the order prohibits express or implied claims that any covered product: (1) Is an effective treatment for cancer, angina, cardiovascular disease, congestive heart failure, myocardial infarction, multiple sclerosis, diabetes, fibromyalgia, or neurodegenerative disorders; (2) produces fast, lasting results; or (3) cures, mitigates, or treats any disease, unless the claim is supported by competent and reliable scientific evidence that is sufficient in quality and quantity, based on standards generally accepted by experts in the relevant area. It further requires that such substantiation include a randomized, double-blind, and placebocontrolled human clinical trial. • Part II of the order prohibits express or implied health benefit, efficacy, safety, or side effects claims for any covered product, unless the representation is non-misleading, and, at the time the representation is made, proposed respondents possess and rely upon competent and reliable scientific evidence that is sufficient in quality and quantity to support the claim, based on standards generally accepted by experts in the area. It further provides that such substantiation must include a randomized, double-blind, and placebocontrolled human clinical trial, when experts generally require such human clinical testing to substantiate the representation. • Part III of the order prohibits respondents, in connection with the advertising, promotion, offering for sale, or sale of any covered product, from misrepresenting, expressly or by implication, that they assembled physicians, biochemists, or physiologists to create, test or approve the products, or that they maintain a research facility, including an iV Bars Research Lab. • Part IV of the order prohibits respondents, in connection with the E:\FR\FM\05OCN1.SGM 05OCN1 50374 Federal Register / Vol. 83, No. 194 / Friday, October 5, 2018 / Notices daltland on DSKBBV9HB2PROD with NOTICES advertising, promotion, offering for sale, or sale of any product or service, from making any misrepresentation about the existence, contents, validity, results, conclusions, or interpretations of any test, study, or other research, or that any product or service is scientifically or clinically proven to produce any benefit. • Part V of the order requires that respondents, with regard to any human clinical test or study upon which they rely to substantiate any claim covered by the order, must preserve all underlying data and documents generally accepted by experts in the field as relevant to an assessment of the test. • Part VI of the order provides that nothing in the order prohibits respondents from making a representation for any drug that is approved in labeling for such drug under any tentative final or final monograph promulgated by the Food and Drug Administration, or under any new drug application approved by the FDA. Parts VII through XI are reporting and compliance provisions. Part VII mandates that respondents acknowledge receipt of the order and, for 10 years, distribute the order to certain employees and agents and secure acknowledgments from recipients of the order. Part VIII requires that respondents submit compliance reports to the FTC one year after the order’s issuance and submit additional reports when certain events occur. Part IX requires that, for 10 years, respondents create certain records and retain them for at least 5 years. Part X provides for the FTC’s continued compliance monitoring of respondents’ activity during the order’s effective dates. Part XI is a provision ‘‘sunsetting’’ the order after 20 years, with certain exceptions. The purpose of this analysis is to facilitate public comment on the proposed order. It is not intended to constitute an official interpretation of the complaint or order, or to modify in any way the order’s terms. By direction of the Commission. Donald S. Clark, Secretary. [FR Doc. 2018–21749 Filed 10–4–18; 8:45 am] BILLING CODE 6750–01–P VerDate Sep<11>2014 17:11 Oct 04, 2018 Jkt 247001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Board of Scientific Counselors, Office of Public Health Preparedness and Response, (BSC, OPHPR) Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice of meeting. AGENCY: In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Board of Scientific Counselors, Office of Public Health Preparedness and Response, (BSC, OPHPR). This meeting is open to the public, limited only by the space available. The meeting room accommodates up to 80 people. Public participants should pre-register for the meeting as described below. Members of the public that wish to attend this meeting in person should pre-register by submitting the following information by email, facsimile, or phone (see contact person for more information) no later than 12:00 noon (EDT) on Wednesday, October 22, 2018: • Full Name • Organizational Affiliation • Complete Mailing Address • Citizenship • Phone Number or Email Address The public is also welcome to listen to the meeting via Adobe Connect. Preregistration is required by clicking the links below. WEB ID: October 29, 2018 (1500 Seats) https://adobeconnect.cdc.gov/ e7gc21b4wp1/event/registration.html. WEB ID: October 30, 2018 (1500 Seats) https://adobeconnect.cdc.gov/ e5j7o9ulmi8/event/registration.html. Dial in number: 888–603–9747; Participant code: 3564724 (100 Seats). DATES: The meeting will be held on October 29, 2018, 10:00 a.m.–to 5:00 p.m., EDT and October 30, 2018, 8:30 a.m.–3:30 p.m., EDT. ADDRESSES: Centers for Disease Control and Prevention (CDC), Global Communications Center, Building 19, Auditorium B3, 1600 Clifton Road NE, Atlanta, Georgia 30329–4027. FOR FURTHER INFORMATION CONTACT: Dometa Ouisley, Office of Science and Public Health Practice, Centers for Disease Control and Prevention, 1600 Clifton Road NE, Mailstop D–44, Atlanta, Georgia 30329–4027, Telephone: (404) 639–7450; Fax: (404) 471–8772; Email: OPHPR.BSC.Questions@cdc.gov. SUMMARY: PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 SUPPLEMENTARY INFORMATION: Purpose: This Board is charged with providing advice and guidance to the Secretary, Department of Health and Human Services (HHS), the Assistant Secretary for Health (ASH), the Director, Centers for Disease Control and Prevention (CDC), and the Director, Office of Public Health Preparedness and Response (OPHPR), concerning strategies and goals for the programs and research within OPHPR, monitoring the overall strategic direction and focus of the OPHPR Divisions and Offices, and administration and oversight of peer review for OPHPR scientific programs. For additional information about the Board, please visit: http:// www.cdc.gov/phpr/science/ counselors.htm. Matters to be Considered: The agenda for day one of the meeting will include discussions that will cover briefings and BSC deliberation on the following topics: Interval updates from the OPHPR Director and OPHPR Divisions and Offices; Presentation on Private Sector and PH Emergency Preparedness & Response Collaboration; and updates from the Biological Agent Containment working group. Day two of the meeting will cover briefings and BSC deliberation on the following topics: Preparedness updates from Liaison representatives; CDC’s Public Health Data Strategy and Data Preparedness initiatives; and updates on Pandemic Flu Activities and Planning Updates. Agenda items are subject to change as priorities dictate. The Chief Operating Officer, Centers for Disease Control and Prevention, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Sherri Berger, Chief Operating Officer, Centers for Disease Control and Prevention. [FR Doc. 2018–21702 Filed 10–4–18; 8:45 am] BILLING CODE 4163–19–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Statement of Organization, Functions, and Delegations of Authority Part C (Centers for Disease Control and Prevention) of the Statement of Organization, Functions, and Delegations of Authority of the E:\FR\FM\05OCN1.SGM 05OCN1

Agencies

[Federal Register Volume 83, Number 194 (Friday, October 5, 2018)]
[Notices]
[Pages 50372-50374]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21749]


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FEDERAL TRADE COMMISSION

[File No. 172 3016]


A & O Enterprises Inc and Aaron K. Roberts; Analysis To Aid 
Public Comment

AGENCY: Federal Trade Commission.

ACTION: Proposed consent agreement.

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

SUMMARY: The consent agreement in this matter settles alleged 
violations of federal law prohibiting unfair or deceptive acts or 
practices. The attached Analysis 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 October 22, 2018.

ADDRESSES: Interested parties may file a comment online or on paper, by 
following the instructions in the Request for Comment part of the 
SUPPLEMENTARY INFORMATION section below. Write: ``A & O Enterprises 
Inc'' on your comment, and file your comment online at https://ftcpublic.commentworks.com/ftc/aoenterprisesivbarsconsent by following 
the instructions on the web-based form. If you prefer to file your 
comment on paper, write ``A & O Enterprises Inc; File No. 1723016'' 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; or deliver your comment to: Federal Trade Commission, Office of 
the Secretary, Constitution Center, 400 7th Street SW, 5th Floor, Suite 
5610 (Annex D), Washington, DC 20024.

FOR FURTHER INFORMATION CONTACT: Thomas Carter (214-979-9372) or James 
Golder (214-979-9376), Southwest Region, Federal Trade Commission, 1999 
Bryan Street, Suite 2150, Dallas, TX 75201.

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 
from the FTC Home Page (for September 20, 2018), on the World Wide Web, 
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 October 22, 
2018. Write ``A & O Enterprises Inc; File No. 1723016'' 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 public Commission website, at https://www.ftc.gov/policy/public-comments.
    Postal mail addressed to the Commission is subject to delay due to 
heightened security screening. As a result, we encourage you to submit 
your comments online. To make sure that the Commission considers your 
online comment, you must file it at https://ftcpublic.commentworks.com/
ftc/

[[Page 50373]]

aoenterprisesivbarsconsent by following the instructions on the web-
based form. If this Notice appears at http://www.regulations.gov/#!home, you also may file a comment through that website.
    If you prefer to file your comment on paper, write ``A & O 
Enterprises Inc; File No. 1723016'' 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; or deliver your comment to the 
following address: Federal Trade Commission, Office of the Secretary, 
Constitution Center, 400 7th Street SW, 5th Floor, Suite 5610 (Annex 
D), Washington, DC 20024. If possible, submit your paper comment to the 
Commission by courier or overnight service.
    Because your comment will be placed on the publicly accessible FTC 
website at https://www.ftc.gov, you are solely responsible for making 
sure that your comment does not include any sensitive or confidential 
information. In particular, your comment should not include any 
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 that your comment does not include 
any 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 public FTC website--as legally required by FTC Rule 
4.9(b)--we cannot redact or remove your comment from the FTC 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 Notice and 
the news release describing it. 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 October 22, 2018. 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 A & O Enterprises Inc, a corporation, doing business as iV 
Bars Incorporated and iV Bars, and Aaron K. Roberts, also known as 
Aaron Keith (``respondents''). The proposed consent order (``order'') 
has been placed on the public record for 30 days for receipt of 
comments by interested persons. Comments received during this period 
will become part of the public record. After 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 respondents' advertising, promotion and sale 
of intravenous drip cocktails (``iV Cocktails''), including the Myers 
Cocktail, which contain a mixture of water, vitamins, minerals and 
amino acids. According to the FTC complaint, respondents made false or 
unsubstantiated representations that their iV Cocktails are effective 
treatments for cancer, angina, cardiovascular disease, congestive heart 
failure, myocardial infarction, multiple sclerosis, diabetes, 
fibromyalgia and neurodegenerative disorders, and that their cocktails 
produce fast, lasting results, are safe for all ages and cause no side 
effects. The FTC also alleges that respondents falsely represented that 
their iV Cocktails are clinically or scientifically proven to 
effectively treat the enumerated diseases and produce fast, lasting 
results. The complaint alleges that respondents' actions constitute 
unfair or deceptive acts or practices and the making of false 
advertisements, in violation of Sections 5(a) and 12 of the Federal 
Trade Commission Act.
    The order is designed to prevent respondents from engaging in 
similar acts or practices in the future. It includes injunctive relief 
to address these alleged violations and to prohibit similar and related 
conduct.
     The order defines ``covered product'' to mean any 
intravenous therapy, including all of respondents' iV Cocktails, and 
any intramuscular injection.
     Part I of the order prohibits express or implied claims 
that any covered product: (1) Is an effective treatment for cancer, 
angina, cardiovascular disease, congestive heart failure, myocardial 
infarction, multiple sclerosis, diabetes, fibromyalgia, or 
neurodegenerative disorders; (2) produces fast, lasting results; or (3) 
cures, mitigates, or treats any disease, unless the claim is supported 
by competent and reliable scientific evidence that is sufficient in 
quality and quantity, based on standards generally accepted by experts 
in the relevant area. It further requires that such substantiation 
include a randomized, double-blind, and placebo-controlled human 
clinical trial.
     Part II of the order prohibits express or implied health 
benefit, efficacy, safety, or side effects claims for any covered 
product, unless the representation is non-misleading, and, at the time 
the representation is made, proposed respondents possess and rely upon 
competent and reliable scientific evidence that is sufficient in 
quality and quantity to support the claim, based on standards generally 
accepted by experts in the area. It further provides that such 
substantiation must include a randomized, double-blind, and placebo-
controlled human clinical trial, when experts generally require such 
human clinical testing to substantiate the representation.
     Part III of the order prohibits respondents, in connection 
with the advertising, promotion, offering for sale, or sale of any 
covered product, from misrepresenting, expressly or by implication, 
that they assembled physicians, biochemists, or physiologists to 
create, test or approve the products, or that they maintain a research 
facility, including an iV Bars Research Lab.
     Part IV of the order prohibits respondents, in connection 
with the

[[Page 50374]]

advertising, promotion, offering for sale, or sale of any product or 
service, from making any misrepresentation about the existence, 
contents, validity, results, conclusions, or interpretations of any 
test, study, or other research, or that any product or service is 
scientifically or clinically proven to produce any benefit.
     Part V of the order requires that respondents, with regard 
to any human clinical test or study upon which they rely to 
substantiate any claim covered by the order, must preserve all 
underlying data and documents generally accepted by experts in the 
field as relevant to an assessment of the test.
     Part VI of the order provides that nothing in the order 
prohibits respondents from making a representation for any drug that is 
approved in labeling for such drug under any tentative final or final 
monograph promulgated by the Food and Drug Administration, or under any 
new drug application approved by the FDA.
    Parts VII through XI are reporting and compliance provisions. Part 
VII mandates that respondents acknowledge receipt of the order and, for 
10 years, distribute the order to certain employees and agents and 
secure acknowledgments from recipients of the order. Part VIII requires 
that respondents submit compliance reports to the FTC one year after 
the order's issuance and submit additional reports when certain events 
occur. Part IX requires that, for 10 years, respondents create certain 
records and retain them for at least 5 years. Part X provides for the 
FTC's continued compliance monitoring of respondents' activity during 
the order's effective dates. Part XI is a provision ``sunsetting'' the 
order after 20 years, with certain exceptions.
    The purpose of this analysis is to facilitate public comment on the 
proposed order. It is not intended to constitute an official 
interpretation of the complaint or order, or to modify in any way the 
order's terms.

    By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. 2018-21749 Filed 10-4-18; 8:45 am]
 BILLING CODE 6750-01-P