83_FR_50566 83 FR 50372 - A & O Enterprises Inc and Aaron K. Roberts; Analysis To Aid Public Comment

83 FR 50372 - A & O Enterprises Inc and Aaron K. Roberts; Analysis To Aid Public Comment

FEDERAL TRADE COMMISSION

Federal Register Volume 83, Issue 194 (October 5, 2018)

Page Range50372-50374
FR Document2018-21749

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.

Federal Register, Volume 83 Issue 194 (Friday, October 5, 2018)
[Federal Register Volume 83, Number 194 (Friday, October 5, 2018)]
[Notices]
[Pages 50372-50374]
From the Federal Register Online  [www.thefederalregister.org]
[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



                                               50372                          Federal Register / Vol. 83, No. 194 / Friday, October 5, 2018 / Notices

                                               assets of a company, including the                      inspection at the Federal Reserve Bank                Request for Comment part of the
                                               companies listed below, that engages                    indicated. The applications will also be              SUPPLEMENTARY INFORMATION      section
                                               either directly or through a subsidiary or              available for inspection at the offices of            below. Write: ‘‘A & O Enterprises Inc’’
                                               other company, in a nonbanking activity                 the Board of Governors. Interested                    on your comment, and file your
                                               that is listed in § 225.28 of Regulation Y              persons may express their views in                    comment online at https://
                                               (12 CFR 225.28) or that the Board has                   writing on the standards enumerated in                ftcpublic.commentworks.com/ftc/
                                               determined by Order to be closely                       the BHC Act (12 U.S.C. 1842(c)). If the               aoenterprisesivbarsconsent by following
                                               related to banking and permissible for                  proposal also involves the acquisition of             the instructions on the web-based form.
                                               bank holding companies. Unless                          a nonbanking company, the review also                 If you prefer to file your comment on
                                               otherwise noted, these activities will be               includes whether the acquisition of the               paper, write ‘‘A & O Enterprises Inc; File
                                               conducted throughout the United States.                 nonbanking company complies with the                  No. 1723016’’ on your comment and on
                                                  Each notice is available for inspection              standards in section 4 of the BHC Act                 the envelope, and mail your comment to
                                               at the Federal Reserve Bank indicated.                  (12 U.S.C. 1843). Unless otherwise                    the following address: Federal Trade
                                               The notice also will be available for                   noted, nonbanking activities will be                  Commission, Office of the Secretary,
                                               inspection at the offices of the Board of               conducted throughout the United States.               600 Pennsylvania Avenue NW, Suite
                                               Governors. Interested persons may                         Unless otherwise noted, comments                    CC–5610 (Annex D), Washington, DC
                                               express their views in writing on the                   regarding each of these applications                  20580; or deliver your comment to:
                                               question whether the proposal complies                  must be received at the Reserve Bank                  Federal Trade Commission, Office of the
                                               with the standards of section 4 of the                  indicated or the offices of the Board of              Secretary, Constitution Center, 400 7th
                                               BHC Act.                                                Governors not later than November 1,                  Street SW, 5th Floor, Suite 5610 (Annex
                                                  Unless otherwise noted, comments                     2018.                                                 D), Washington, DC 20024.
                                               regarding the applications must be                        A. Federal Reserve Bank of San                      FOR FURTHER INFORMATION CONTACT:
                                               received at the Reserve Bank indicated                  Francisco (Gerald C. Tsai, Director,                  Thomas Carter (214–979–9372) or James
                                               or the offices of the Board of Governors                Applications and Enforcement) 101                     Golder (214–979–9376), Southwest
                                               not later than October 29, 2018.                        Market Street, San Francisco, California              Region, Federal Trade Commission,
                                                  A. Federal Reserve Bank of Chicago                   94105–1579:                                           1999 Bryan Street, Suite 2150, Dallas,
                                               (Colette A. Fried, Assistant Vice                         1. JBNV Holding Corp., Sparks,                      TX 75201.
                                               President) 230 South LaSalle Street,                    Nevada; to become a bank holding                      SUPPLEMENTARY INFORMATION: Pursuant
                                               Chicago, Illinois 60690–1414:                           company by acquiring 100 percent of
                                                  1. HSBC Holdings plc, London,                                                                              to Section 6(f) of the Federal Trade
                                                                                                       the voting shares of Kirkwood                         Commission Act, 15 U.S.C. 46(f), and
                                               England; HSBC Overseas Holdings (UK)                    Bancorporation of Nevada, Inc., and
                                               Limited, London, England; HSBC North                                                                          FTC Rule 2.34, 16 CFR 2.34, notice is
                                                                                                       thereby indirectly acquire Kirkwood                   hereby given that the above-captioned
                                               America Holdings Inc., New York, New                    Bank of Nevada, both of Las Vegas,
                                               York; and HSBC USA, Inc., New York,                                                                           consent agreement containing a consent
                                                                                                       Nevada.                                               order to cease and desist, having been
                                               New York; to engage de novo through a
                                               newly formed entity, The Consortium,                      Board of Governors of the Federal Reserve           filed with and accepted, subject to final
                                                                                                       System, October 1, 2018.                              approval, by the Commission, has been
                                               LLC, in data processing activities,
                                               pursuant to section 225.28(b)(14) of                    Yao-Chin Chao,                                        placed on the public record for a period
                                               Regulation Y.                                           Assistant Secretary of the Board.                     of thirty (30) days. The following
                                                                                                       [FR Doc. 2018–21643 Filed 10–4–18; 8:45 am]           Analysis to Aid Public Comment
                                                 Board of Governors of the Federal Reserve
                                                                                                       BILLING CODE 6210–01–P                                describes the terms of the consent
                                               System, October 1, 2018.
                                                                                                                                                             agreement, and the allegations in the
                                               Yao-Chin Chao,
                                                                                                                                                             complaint. An electronic copy of the
                                               Assistant Secretary of the Board.                                                                             full text of the consent agreement
                                               [FR Doc. 2018–21658 Filed 10–4–18; 8:45 am]             FEDERAL TRADE COMMISSION
                                                                                                                                                             package can be obtained from the FTC
                                               BILLING CODE P                                          [File No. 172 3016]                                   Home Page (for September 20, 2018), on
                                                                                                                                                             the World Wide Web, at https://
                                                                                                       A & O Enterprises Inc and Aaron K.                    www.ftc.gov/news-events/commission-
                                               FEDERAL RESERVE SYSTEM                                  Roberts; Analysis To Aid Public                       actions.
                                                                                                       Comment                                                  You can file a comment online or on
                                               Formations of, Acquisitions by, and
                                                                                                       AGENCY:    Federal Trade Commission.                  paper. For the Commission to consider
                                               Mergers of Bank Holding Companies
                                                                                                                                                             your comment, we must receive it on or
                                                 The companies listed in this notice                   ACTION:   Proposed consent agreement.                 before October 22, 2018. Write ‘‘A & O
                                               have applied to the Board for approval,                 SUMMARY:   The consent agreement in this              Enterprises Inc; File No. 1723016’’ on
                                               pursuant to the Bank Holding Company                    matter settles alleged violations of                  your comment. Your comment—
                                               Act of 1956 (12 U.S.C. 1841 et seq.)                    federal law prohibiting unfair or                     including your name and your state—
                                               (BHC Act), Regulation Y (12 CFR part                    deceptive acts or practices. The attached             will be placed on the public record of
                                               225), and all other applicable statutes                 Analysis to Aid Public Comment                        this proceeding, including, to the extent
                                               and regulations to become a bank                        describes both the allegations in the                 practicable, on the public Commission
                                               holding company and/or to acquire the                   complaint and the terms of the consent                website, at https://www.ftc.gov/policy/
                                               assets or the ownership of, control of, or              order—embodied in the consent                         public-comments.
                                               the power to vote shares of a bank or                   agreement—that would settle these                        Postal mail addressed to the
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                                               bank holding company and all of the                     allegations.                                          Commission is subject to delay due to
                                               banks and nonbanking companies                                                                                heightened security screening. As a
                                               owned by the bank holding company,                      DATES: Comments must be received on                   result, we encourage you to submit your
                                               including the companies listed below.                   or before October 22, 2018.                           comments online. To make sure that the
                                                 The applications listed below, as well                ADDRESSES: Interested parties may file a              Commission considers your online
                                               as other related filings required by the                comment online or on paper, by                        comment, you must file it at https://
                                               Board, are available for immediate                      following the instructions in the                     ftcpublic.commentworks.com/ftc/


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                                                                              Federal Register / Vol. 83, No. 194 / Friday, October 5, 2018 / Notices                                           50373

                                               aoenterprisesivbarsconsent by following                 request in accordance with the law and                scientifically proven to effectively treat
                                               the instructions on the web-based form.                 the public interest. Once your comment                the enumerated diseases and produce
                                               If this Notice appears at http://                       has been posted on the public FTC                     fast, lasting results. The complaint
                                               www.regulations.gov/#!home, you also                    website—as legally required by FTC                    alleges that respondents’ actions
                                               may file a comment through that                         Rule 4.9(b)—we cannot redact or                       constitute unfair or deceptive acts or
                                               website.                                                remove your comment from the FTC                      practices and the making of false
                                                  If you prefer to file your comment on                website, unless you submit a                          advertisements, in violation of Sections
                                               paper, write ‘‘A & O Enterprises Inc; File              confidentiality request that meets the                5(a) and 12 of the Federal Trade
                                               No. 1723016’’ on your comment and on                    requirements for such treatment under                 Commission Act.
                                               the envelope, and mail your comment to                  FTC Rule 4.9(c), and the General                         The order is designed to prevent
                                               the following address: Federal Trade                    Counsel grants that request.                          respondents from engaging in similar
                                               Commission, Office of the Secretary,                      Visit the FTC website at http://                    acts or practices in the future. It
                                               600 Pennsylvania Avenue NW, Suite                       www.ftc.gov to read this Notice and the               includes injunctive relief to address
                                               CC–5610 (Annex D), Washington, DC                       news release describing it. The FTC Act               these alleged violations and to prohibit
                                               20580; or deliver your comment to the                   and other laws that the Commission                    similar and related conduct.
                                               following address: Federal Trade                        administers permit the collection of                     • The order defines ‘‘covered
                                               Commission, Office of the Secretary,                    public comments to consider and use in                product’’ to mean any intravenous
                                               Constitution Center, 400 7th Street SW,                 this proceeding, as appropriate. The                  therapy, including all of respondents’ iV
                                               5th Floor, Suite 5610 (Annex D),                        Commission will consider all timely                   Cocktails, and any intramuscular
                                               Washington, DC 20024. If possible,                      and responsive public comments that it                injection.
                                               submit your paper comment to the                        receives on or before October 22, 2018.                  • Part I of the order prohibits express
                                               Commission by courier or overnight                      For information on the Commission’s                   or implied claims that any covered
                                               service.                                                privacy policy, including routine uses                product: (1) Is an effective treatment for
                                                  Because your comment will be placed                  permitted by the Privacy Act, see                     cancer, angina, cardiovascular disease,
                                               on the publicly accessible FTC website                  https://www.ftc.gov/site-information/                 congestive heart failure, myocardial
                                               at https://www.ftc.gov, you are solely                  privacy-policy.                                       infarction, multiple sclerosis, diabetes,
                                               responsible for making sure that your                                                                         fibromyalgia, or neurodegenerative
                                               comment does not include any sensitive                  Analysis of Proposed Consent Order To                 disorders; (2) produces fast, lasting
                                               or confidential information. In                         Aid Public Comment                                    results; or (3) cures, mitigates, or treats
                                               particular, your comment should not                        The Federal Trade Commission                       any disease, unless the claim is
                                               include any sensitive personal                          (‘‘FTC’’ or ‘‘Commission’’) has accepted,             supported by competent and reliable
                                               information, such as your or anyone                     subject to final approval, an agreement               scientific evidence that is sufficient in
                                               else’s Social Security number; date of                  containing a consent order from A & O                 quality and quantity, based on standards
                                               birth; driver’s license number or other                 Enterprises Inc, a corporation, doing                 generally accepted by experts in the
                                               state identification number, or foreign                 business as iV Bars Incorporated and iV               relevant area. It further requires that
                                               country equivalent; passport number;                    Bars, and Aaron K. Roberts, also known                such substantiation include a
                                               financial account number; or credit or                  as Aaron Keith (‘‘respondents’’). The                 randomized, double-blind, and placebo-
                                               debit card number. You are also solely                  proposed consent order (‘‘order’’) has                controlled human clinical trial.
                                               responsible for making sure that your                   been placed on the public record for 30                  • Part II of the order prohibits express
                                               comment does not include any sensitive                  days for receipt of comments by                       or implied health benefit, efficacy,
                                               health information, such as medical                     interested persons. Comments received                 safety, or side effects claims for any
                                               records or other individually                           during this period will become part of                covered product, unless the
                                               identifiable health information. In                     the public record. After 30 days, the                 representation is non-misleading, and,
                                               addition, your comment should not                       Commission will again review the                      at the time the representation is made,
                                               include any ‘‘trade secret or any                       agreement, and the comments received,                 proposed respondents possess and rely
                                               commercial or financial information                     and will decide whether it should                     upon competent and reliable scientific
                                               which . . . is privileged or                            withdraw from the agreement and take                  evidence that is sufficient in quality and
                                               confidential’’—as provided by Section                   appropriate action or make final the                  quantity to support the claim, based on
                                               6(f) of the FTC Act, 15 U.S.C. 46(f), and               agreement’s proposed order.                           standards generally accepted by experts
                                               FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2)—                    This matter involves respondents’                  in the area. It further provides that such
                                               including in particular competitively                   advertising, promotion and sale of                    substantiation must include a
                                               sensitive information such as costs,                    intravenous drip cocktails (‘‘iV                      randomized, double-blind, and placebo-
                                               sales statistics, inventories, formulas,                Cocktails’’), including the Myers                     controlled human clinical trial, when
                                               patterns, devices, manufacturing                        Cocktail, which contain a mixture of                  experts generally require such human
                                               processes, or customer names.                           water, vitamins, minerals and amino                   clinical testing to substantiate the
                                                  Comments containing material for                     acids. According to the FTC complaint,                representation.
                                               which confidential treatment is                         respondents made false or                                • Part III of the order prohibits
                                               requested must be filed in paper form,                  unsubstantiated representations that                  respondents, in connection with the
                                               must be clearly labeled ‘‘Confidential,’’               their iV Cocktails are effective                      advertising, promotion, offering for sale,
                                               and must comply with FTC Rule 4.9(c).                   treatments for cancer, angina,                        or sale of any covered product, from
                                               In particular, the written request for                  cardiovascular disease, congestive heart              misrepresenting, expressly or by
                                               confidential treatment that accompanies                 failure, myocardial infarction, multiple              implication, that they assembled
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                                               the comment must include the factual                    sclerosis, diabetes, fibromyalgia and                 physicians, biochemists, or
                                               and legal basis for the request, and must               neurodegenerative disorders, and that                 physiologists to create, test or approve
                                               identify the specific portions of the                   their cocktails produce fast, lasting                 the products, or that they maintain a
                                               comment to be withheld from the public                  results, are safe for all ages and cause no           research facility, including an iV Bars
                                               record. See FTC Rule 4.9(c). Your                       side effects. The FTC also alleges that               Research Lab.
                                               comment will be kept confidential only                  respondents falsely represented that                     • Part IV of the order prohibits
                                               if the General Counsel grants your                      their iV Cocktails are clinically or                  respondents, in connection with the


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                                               50374                          Federal Register / Vol. 83, No. 194 / Friday, October 5, 2018 / Notices

                                               advertising, promotion, offering for sale,              DEPARTMENT OF HEALTH AND                              SUPPLEMENTARY INFORMATION:
                                               or sale of any product or service, from                 HUMAN SERVICES                                           Purpose: This Board is charged with
                                               making any misrepresentation about the                                                                        providing advice and guidance to the
                                               existence, contents, validity, results,                 Centers for Disease Control and                       Secretary, Department of Health and
                                               conclusions, or interpretations of any                  Prevention                                            Human Services (HHS), the Assistant
                                               test, study, or other research, or that any                                                                   Secretary for Health (ASH), the Director,
                                                                                                       Board of Scientific Counselors, Office                Centers for Disease Control and
                                               product or service is scientifically or
                                                                                                       of Public Health Preparedness and                     Prevention (CDC), and the Director,
                                               clinically proven to produce any                        Response, (BSC, OPHPR)
                                               benefit.                                                                                                      Office of Public Health Preparedness
                                                                                                       AGENCY: Centers for Disease Control and               and Response (OPHPR), concerning
                                                  • Part V of the order requires that                                                                        strategies and goals for the programs
                                               respondents, with regard to any human                   Prevention (CDC), Department of Health
                                                                                                       and Human Services (HHS).                             and research within OPHPR, monitoring
                                               clinical test or study upon which they                                                                        the overall strategic direction and focus
                                               rely to substantiate any claim covered                  ACTION: Notice of meeting.
                                                                                                                                                             of the OPHPR Divisions and Offices,
                                               by the order, must preserve all                         SUMMARY:    In accordance with the                    and administration and oversight of
                                               underlying data and documents                           Federal Advisory Committee Act, the                   peer review for OPHPR scientific
                                               generally accepted by experts in the                    CDC announces the following meeting                   programs. For additional information
                                               field as relevant to an assessment of the               for the Board of Scientific Counselors,               about the Board, please visit: http://
                                               test.                                                   Office of Public Health Preparedness                  www.cdc.gov/phpr/science/
                                                  • Part VI of the order provides that                 and Response, (BSC, OPHPR). This                      counselors.htm.
                                                                                                       meeting is open to the public, limited                   Matters to be Considered: The agenda
                                               nothing in the order prohibits
                                                                                                       only by the space available. The meeting              for day one of the meeting will include
                                               respondents from making a
                                                                                                       room accommodates up to 80 people.                    discussions that will cover briefings and
                                               representation for any drug that is                                                                           BSC deliberation on the following
                                               approved in labeling for such drug                      Public participants should pre-register
                                                                                                       for the meeting as described below.                   topics: Interval updates from the OPHPR
                                               under any tentative final or final                                                                            Director and OPHPR Divisions and
                                               monograph promulgated by the Food                       Members of the public that wish to
                                                                                                       attend this meeting in person should                  Offices; Presentation on Private Sector
                                               and Drug Administration, or under any                                                                         and PH Emergency Preparedness &
                                               new drug application approved by the                    pre-register by submitting the following
                                                                                                       information by email, facsimile, or                   Response Collaboration; and updates
                                               FDA.                                                                                                          from the Biological Agent Containment
                                                                                                       phone (see contact person for more
                                                  Parts VII through XI are reporting and               information) no later than 12:00 noon                 working group.
                                               compliance provisions. Part VII                                                                                  Day two of the meeting will cover
                                                                                                       (EDT) on Wednesday, October 22, 2018:
                                               mandates that respondents acknowledge                                                                         briefings and BSC deliberation on the
                                                                                                       • Full Name                                           following topics: Preparedness updates
                                               receipt of the order and, for 10 years,                 • Organizational Affiliation
                                               distribute the order to certain employees                                                                     from Liaison representatives; CDC’s
                                                                                                       • Complete Mailing Address                            Public Health Data Strategy and Data
                                               and agents and secure acknowledgments                   • Citizenship                                         Preparedness initiatives; and updates on
                                               from recipients of the order. Part VIII                 • Phone Number or Email Address                       Pandemic Flu Activities and Planning
                                               requires that respondents submit                           The public is also welcome to listen               Updates. Agenda items are subject to
                                               compliance reports to the FTC one year                  to the meeting via Adobe Connect. Pre-                change as priorities dictate.
                                               after the order’s issuance and submit                   registration is required by clicking the                 The Chief Operating Officer, Centers
                                               additional reports when certain events                  links below.                                          for Disease Control and Prevention, has
                                               occur. Part IX requires that, for 10 years,                WEB ID: October 29, 2018 (1500                     been delegated the authority to sign
                                               respondents create certain records and                  Seats) https://adobeconnect.cdc.gov/                  Federal Register notices pertaining to
                                               retain them for at least 5 years. Part X                e7gc21b4wp1/event/registration.html.                  announcements of meetings and other
                                               provides for the FTC’s continued                           WEB ID: October 30, 2018 (1500                     committee management activities, for
                                               compliance monitoring of respondents’                   Seats) https://adobeconnect.cdc.gov/                  both the Centers for Disease Control and
                                               activity during the order’s effective                   e5j7o9ulmi8/event/registration.html.                  Prevention and the Agency for Toxic
                                               dates. Part XI is a provision                              Dial in number: 888–603–9747;                      Substances and Disease Registry.
                                               ‘‘sunsetting’’ the order after 20 years,                Participant code: 3564724 (100 Seats).
                                                                                                                                                             Sherri Berger,
                                               with certain exceptions.                                DATES: The meeting will be held on
                                                                                                                                                             Chief Operating Officer, Centers for Disease
                                                  The purpose of this analysis is to                   October 29, 2018, 10:00 a.m.–to 5:00                  Control and Prevention.
                                               facilitate public comment on the                        p.m., EDT and October 30, 2018, 8:30                  [FR Doc. 2018–21702 Filed 10–4–18; 8:45 am]
                                               proposed order. It is not intended to                   a.m.–3:30 p.m., EDT.
                                                                                                                                                             BILLING CODE 4163–19–P
                                               constitute an official interpretation of                ADDRESSES: Centers for Disease Control
                                               the complaint or order, or to modify in                 and Prevention (CDC), Global
                                               any way the order’s terms.                              Communications Center, Building 19,                   DEPARTMENT OF HEALTH AND
                                                                                                       Auditorium B3, 1600 Clifton Road NE,                  HUMAN SERVICES
                                                 By direction of the Commission.                       Atlanta, Georgia 30329–4027.
                                               Donald S. Clark,                                                                                              Centers for Disease Control and
                                                                                                       FOR FURTHER INFORMATION CONTACT:
                                               Secretary.                                              Dometa Ouisley, Office of Science and                 Prevention
daltland on DSKBBV9HB2PROD with NOTICES




                                               [FR Doc. 2018–21749 Filed 10–4–18; 8:45 am]             Public Health Practice, Centers for
                                                                                                                                                             Statement of Organization, Functions,
                                               BILLING CODE 6750–01–P                                  Disease Control and Prevention, 1600
                                                                                                                                                             and Delegations of Authority
                                                                                                       Clifton Road NE, Mailstop D–44,
                                                                                                       Atlanta, Georgia 30329–4027,                            Part C (Centers for Disease Control
                                                                                                       Telephone: (404) 639–7450; Fax: (404)                 and Prevention) of the Statement of
                                                                                                       471–8772; Email:                                      Organization, Functions, and
                                                                                                       OPHPR.BSC.Questions@cdc.gov.                          Delegations of Authority of the


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Document Created: 2018-10-05 01:52:38
Document Modified: 2018-10-05 01:52:38
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionProposed consent agreement.
DatesComments must be received on or before October 22, 2018.
ContactThomas Carter (214-979-9372) or James Golder (214-979-9376), Southwest Region, Federal Trade Commission, 1999 Bryan Street, Suite 2150, Dallas, TX 75201.
FR Citation83 FR 50372 

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