John Matthew Dwyer III; Analysis To Aid Public Comment, 56375-56377 [2014-22388]
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Federal Register / Vol. 79, No. 182 / Friday, September 19, 2014 / Notices
tkelley on DSK3SPTVN1PROD with NOTICES
variety of environmental claims
including consumer packaging and
recycling habits, as well as consumer
attitudes, trust, and purchasing
behaviors related to organic products.
NMI contended that it could provide
information about cost, timing, and
specific participation procedures. It
noted that data results are typically
available five weeks after collection.
As explained in this Notice, the FTC
has already contracted through the
normal competively bid process with a
firm experienced in such consumer
studies to field this research project.
This contracting process is complete.
Iberdrola Renewables: Iberdrola
Renewables expressed general support
for the overall objective of the Green
Guides—to ensure the ‘‘honesty,
accuracy, and integrity of environmental
marketing claims.’’
V. Request for Comment
Pursuant to Section 3506(c)(2)(A) of
the PRA, the FTC invites comments on:
(1) Whether the reporting requirements
are necessary, including whether the
information will be practically useful;
(2) the accuracy of our burden estimates,
including whether the methodology and
assumptions used are valid; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) ways to minimize the burden of the
collection of information.
You can file a comment online or on
paper. For the Commission to consider
your comment, we must receive it on or
before October 20, 2014. Write ‘‘Green
Marketing Consumer Perception Study,
Project No. P954501’’ 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 Web site, at
https://www.ftc.gov/os/
publiccomments.shtm. As a matter of
discretion, the Commission tries to
remove individuals’ home contact
information from comments before
placing them on the Commission Web
site.
Because your comment will be made
public, you are solely responsible for
making sure that your comment does
not include any sensitive personal
information, like anyone’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, like medical records or
other individually identifiable health
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17:15 Sep 18, 2014
Jkt 232001
information. In addition, do not include
any ‘‘[t]rade secret or any commercial or
financial information which is obtained
from any person and which is privileged
or confidential,’’ as provided in 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).
In particular, do not include
competitively sensitive information
such as costs, sales statistics,
inventories, formulas, patterns, devices,
manufacturing processes, or customer
names.
If you want the Commission to give
your comment confidential treatment,
you must file it in paper form, with a
request for confidential treatment, and
you have to follow the procedure
explained in FTC Rule 4.9(c), 16 CFR
4.9(c).8 Your comment will be kept
confidential only if the FTC General
Counsel grants your request in
accordance with the law and the public
interest.
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/
organicstudypra2, by following the
instructions on the Web-based form. If
this Notice appears at https://
www.regulations.gov/#!home, you also
may file a comment through that Web
site.
If you prefer to file your comment on
paper, mail your comment to the
following address: Federal Trade
Commission, Office of the Secretary,
600 Pennsylvania Avenue NW., Suite
CC–5610 (Annex J), 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 J),
Washington, DC 20024. If possible,
submit your paper comment to the
Commission by courier or overnight
service.
Comments on the information
collection requirements subject to
review under the PRA should
additionally be submitted to OMB. If
sent by U.S. mail, they should be
addressed to Office of Information and
Regulatory Affairs, Office of
Management and Budget, Attention:
Desk Officer for the Federal Trade
Commission, New Executive Office
8 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), 16 CFR 4.9(c).
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56375
Building, Docket Library, Room 10102,
725 17th Street NW., Washington, DC
20503. Comments sent to OMB by U.S.
postal mail, however, are subject to
delays due to heightened security
precautions. Thus, comments instead
should be sent by facsimile to (202)
395–5806.
Visit the Commission Web site at
https://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 20, 2014. You can find
more information, including routine
uses permitted by the Privacy Act, in
the Commission’s privacy policy, at
https://www.ftc.gov/ftc/privacy.htm.
David C. Shonka,
Principal Deputy General Counsel.
[FR Doc. 2014–22359 Filed 9–18–14; 8:45 am]
BILLING CODE 6750–01–P
FEDERAL TRADE COMMISSION
[File No. 122 3287]
John Matthew Dwyer III; Analysis To
Aid Public Comment
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
draft 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 14, 2014.
ADDRESSES: Interested parties may file a
comment at https://
ftcpublic.commentworks.com/ftc/
healthylifedwyerconsent online or on
paper, by following the instructions in
the Request for Comment part of the
SUPPLEMENTARY INFORMATION section
below. Write ‘‘In the Matter of John
Matthew Dwyer III,
a/k/a Matthew Dwyer; File No. 122
3287’’ on your comment and file your
comment online at https://
ftcpublic.commentworks.com/ftc/
healthylifedwyerconsent by following
the instructions on the web-based form.
If you prefer to file your comment on
paper, mail your comment to the
following address: Federal Trade
SUMMARY:
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tkelley on DSK3SPTVN1PROD with NOTICES
56376
Federal Register / Vol. 79, No. 182 / Friday, September 19, 2014 / Notices
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.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Nach, Bureau of Consumer
Protection, (202–326–2611), 600
Pennsylvania Avenue NW., Washington,
DC 20580.
SUPPLEMENTARY INFORMATION: Pursuant
to Section 6(f) of the Federal Trade
Commission Act, 15 U.S.C. 46(f), and
FTC Rule 2.34, 16 CFR 2.34, notice is
hereby given that the above-captioned
consent agreement containing 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 11, 2014), on
the World Wide Web, at https://
www.ftc.gov/os/actions.shtm.
You can file a comment online or on
paper. For the Commission to consider
your comment, we must receive it on or
before October 14, 2014. Write ‘‘In the
Matter of John Matthew Dwyer III,
a/k/a Matthew Dwyer; File No. 122
3287’’ 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 Web site, at https://
www.ftc.gov/os/publiccomments.shtm.
As a matter of discretion, the
Commission tries to remove individuals’
home contact information from
comments before placing them on the
Commission Web site.
Because your comment will be made
public, you are solely responsible for
making sure that your comment does
not include any sensitive personal
information, like anyone’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, like medical records or
other individually identifiable health
information. In addition, do not include
VerDate Sep<11>2014
17:15 Sep 18, 2014
Jkt 232001
any ‘‘[t]rade secret or any commercial or
financial information which . . . is
privileged or confidential,’’ as discussed
in 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). In particular, do not include
competitively sensitive information
such as costs, sales statistics,
inventories, formulas, patterns, devices,
manufacturing processes, or customer
names.
If you want the Commission to give
your comment confidential treatment,
you must file it in paper form, with a
request for confidential treatment, and
you have to follow the procedure
explained in FTC Rule 4.9(c), 16 CFR
4.9(c).1 Your comment will be kept
confidential only if the FTC General
Counsel, in his or her sole discretion,
grants your request in accordance with
the law and the public interest.
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/
healthylifedwyerconsent by following
the instructions on the web-based form.
If this Notice appears at https://
www.regulations.gov/#!home, you also
may file a comment through that Web
site.
If you file your comment on paper,
write ‘‘In the Matter of John Matthew
Dwyer III, a/k/a Matthew Dwyer; File
No. 122 3287’’ 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.
Visit the Commission Web site at
https://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
1 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), 16 CFR 4.9(c).
PO 00000
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Fmt 4703
Sfmt 4703
public comments that it receives on or
before October 14, 2014. You can find
more information, including routine
uses permitted by the Privacy Act, in
the Commission’s privacy policy, at
https://www.ftc.gov/ftc/privacy.htm.
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 John
Matthew Dwyer III, a/k/a Matthew
Dwyer (‘‘Dwyer’’).
The proposed consent order
(‘‘proposed order’’) has been placed on
the public record for thirty (30) days for
receipt of comments by interested
persons. Comments received during this
period will become part of the public
record. After thirty (30) days, the
Commission will again review the
agreement and the comments received,
and will decide whether it should
withdraw from the agreement or make
final the agreement’s proposed order.
This matter involves advertising for
HealthyLife Sciences, LLC’s Healthe
Trim line of weight loss dietary
supplements (‘‘Healthe Trim’’). The
complaint alleges that Dwyer, a cofounder of HealthyLife Sciences, LLC,
and former chief executive officer and
spokesman for Healthe Trim, violated
Sections 5(a) and 12 of the Federal
Trade Commission Act by making false
or unsubstantiated representations that
Healthe Trim would cause rapid and
substantial weight loss, including as
much as 35, 130, and 165 pounds.
Dwyer also claimed that users would
lose weight without dieting, and that
Healthe Trim would burn fat, increase
metabolism, and suppress appetite. The
complaint also alleges that Dwyer
violated Sections 5(a) and 12 by falsely
representing that Healthe Trim is
clinically proven to cause weight loss.
The proposed order includes
injunctive relief that prohibits these
alleged violations and fences in similar
and related violations. For purposes of
the order, ‘‘Covered Product’’ means any
dietary supplement, food, or drug.
Part I of the proposed order bans
Dwyer from manufacturing, marketing,
or distributing any weight-loss product
or program, or assisting others in any of
the foregoing.
Part II of the proposed order prohibits
any representation about the health
benefits, performance, or efficacy of any
Covered Product, unless it is nonmisleading and supported by competent
and reliable scientific evidence that is
sufficient in quality and quantity based
on standards generally accepted in the
relevant scientific fields, when
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tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 182 / Friday, September 19, 2014 / Notices
considered in light of the entire body of
relevant and reliable scientific evidence,
to substantiate that the representation is
true. For purposes of this Part,
competent and reliable scientific
evidence is defined as tests, analyses,
research, or studies that have been
conducted by qualified persons in an
objective manner and are generally
accepted in the profession to yield
accurate and reliable results. When that
evidence consists of human clinical
tests or studies, Dwyer must maintain
all underlying or supporting data and
documents that experts in the field
generally would accept as relevant to an
assessment of such testing.
Part III of the proposed order
prohibits Dwyer from misrepresenting
the existence, contents, validity, results,
conclusions, or interpretations of any
test, study, or research in connection
with the manufacturing, labeling,
advertising, promotion, offering for sale,
and sale or distribution of any Covered
Product.
Part IV provides a safe harbor for
representations permitted under any
tentative final or final standard
promulgated by the Food and Drug
Administration (‘‘FDA’’), any new drug
application approved by the FDA, or
FDA regulations pursuant to the
Nutrition Labeling and Education Act of
1990 or the FDA Modernization Act of
1997.
Triggered when the human clinical
testing requirement in Part II applies,
Part V of the proposed order requires
Dwyer to secure and preserve all
underlying or supporting data and
documents generally accepted by
experts in the field as relevant to an
assessment of the test, such as protocols,
instructions, participant-specific data,
statistical analyses, and contracts with
the test’s researchers. There is an
exception for a ‘‘Reliably Reported’’ test,
defined as a test published in a peerreviewed journal that was not
conducted, controlled, or sponsored by
Dwyer, his affiliates, or others in the
manufacturing or supply chain. Also,
the published report must provide
sufficient information about the test for
experts in the relevant field to assess the
reliability of the results.
Parts VI through IX of the proposed
order require Dwyer to: Deliver a copy
of the order to principals, officers,
directors, and other employees having
responsibilities with respect to the
subject matter of the order; notify the
Commission of changes in employment
that might affect compliance obligations
under the order; and file compliance
reports with the Commission.
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17:15 Sep 18, 2014
Jkt 232001
Part X provides that the order will
terminate after twenty (20) years, with
certain exceptions.
The purpose of this analysis is to
facilitate public comment on the
proposed order, and it is not intended
to constitute an official interpretation of
the complaint or proposed order, or to
modify the proposed order’s terms in
any way.
By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. 2014–22388 Filed 9–18–14; 8:45 am]
BILLING CODE 6750–01–P
FEDERAL TRADE COMMISSION
[File No. 122 3287]
HealthyLife Sciences, LLC; Analysis
To Aid Public Comment
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
draft 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 14, 2014.
ADDRESSES: Interested parties may file a
comment at https://
ftcpublic.commentworks.com/ftc/
healthylifesciencesconsent online or on
paper, by following the instructions in
the Request for Comment part of the
SUPPLEMENTARY INFORMATION section
below. Write ‘‘In the Matter of
HealthyLife Sciences, LLC—Consent
Agreement; File No. 122 3287’’ on your
comment and file your comment online
at https://ftcpublic.commentworks.com/
ftc/healthylifesciencesconsent by
following the instructions on the webbased form. If you prefer to file your
comment on paper, mail your comment
to the following address: Federal Trade
Commission, Office of the Secretary,
600 Pennsylvania Avenue NW., Suite
CC–5610 (Annex D), Washington, DC
20580, 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.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Nach, Bureau of Consumer
Protection, (202–326–2611), 600
DATES:
PO 00000
Frm 00043
Fmt 4703
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56377
Pennsylvania Avenue NW., Washington,
DC 20580.
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 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 11, 2014), on
the World Wide Web, at https://
www.ftc.gov/os/actions.shtm.
You can file a comment online or on
paper. For the Commission to consider
your comment, we must receive it on or
before October 14, 2014. Write ‘‘In the
Matter of HealthyLife Sciences, LLC—
Consent Agreement; File No. 122 3287’’
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
Web site, at https://www.ftc.gov/os/
publiccomments.shtm. As a matter of
discretion, the Commission tries to
remove individuals’ home contact
information from comments before
placing them on the Commission Web
site.
Because your comment will be made
public, you are solely responsible for
making sure that your comment does
not include any sensitive personal
information, like anyone’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, like medical records or
other individually identifiable health
information. In addition, do not include
any ‘‘[t]rade secret or any commercial or
financial information which . . . is
privileged or confidential,’’ as discussed
in 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). In particular, do not include
competitively sensitive information
such as costs, sales statistics,
inventories, formulas, patterns, devices,
manufacturing processes, or customer
names.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\19SEN1.SGM
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Agencies
[Federal Register Volume 79, Number 182 (Friday, September 19, 2014)]
[Notices]
[Pages 56375-56377]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-22388]
-----------------------------------------------------------------------
FEDERAL TRADE COMMISSION
[File No. 122 3287]
John Matthew Dwyer III; 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 draft 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 14, 2014.
ADDRESSES: Interested parties may file a comment at https://ftcpublic.commentworks.com/ftc/healthylifedwyerconsent online or on
paper, by following the instructions in the Request for Comment part of
the SUPPLEMENTARY INFORMATION section below. Write ``In the Matter of
John Matthew Dwyer III, a/k/a Matthew Dwyer; File No. 122 3287'' on
your comment and file your comment online at https://ftcpublic.commentworks.com/ftc/healthylifedwyerconsent by following the
instructions on the web-based form. If you prefer to file your comment
on paper, mail your comment to the following address: Federal Trade
[[Page 56376]]
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.
FOR FURTHER INFORMATION CONTACT: Elizabeth Nach, Bureau of Consumer
Protection, (202-326-2611), 600 Pennsylvania Avenue NW., Washington, DC
20580.
SUPPLEMENTARY INFORMATION: Pursuant to Section 6(f) of the Federal
Trade Commission Act, 15 U.S.C. 46(f), and FTC Rule 2.34, 16 CFR 2.34,
notice is hereby given that the above-captioned consent agreement
containing 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 11, 2014), on the World Wide Web,
at https://www.ftc.gov/os/actions.shtm.
You can file a comment online or on paper. For the Commission to
consider your comment, we must receive it on or before October 14,
2014. Write ``In the Matter of John Matthew Dwyer III, a/k/a Matthew
Dwyer; File No. 122 3287'' 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 Web site, at https://www.ftc.gov/os/publiccomments.shtm. As a
matter of discretion, the Commission tries to remove individuals' home
contact information from comments before placing them on the Commission
Web site.
Because your comment will be made public, you are solely
responsible for making sure that your comment does not include any
sensitive personal information, like anyone'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, like medical records or other
individually identifiable health information. In addition, do not
include any ``[t]rade secret or any commercial or financial information
which . . . is privileged or confidential,'' as discussed in 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). In particular, do not include competitively sensitive
information such as costs, sales statistics, inventories, formulas,
patterns, devices, manufacturing processes, or customer names.
If you want the Commission to give your comment confidential
treatment, you must file it in paper form, with a request for
confidential treatment, and you have to follow the procedure explained
in FTC Rule 4.9(c), 16 CFR 4.9(c).\1\ Your comment will be kept
confidential only if the FTC General Counsel, in his or her sole
discretion, grants your request in accordance with the law and the
public interest.
---------------------------------------------------------------------------
\1\ 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), 16 CFR 4.9(c).
---------------------------------------------------------------------------
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/healthylifedwyerconsent by following the instructions on the web-
based form. If this Notice appears at https://www.regulations.gov/#!home, you also may file a comment through that Web site.
If you file your comment on paper, write ``In the Matter of John
Matthew Dwyer III, a/k/a Matthew Dwyer; File No. 122 3287'' 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.
Visit the Commission Web site at https://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 14, 2014. You can find more
information, including routine uses permitted by the Privacy Act, in
the Commission's privacy policy, at https://www.ftc.gov/ftc/privacy.htm.
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 John Matthew Dwyer III, a/k/a Matthew Dwyer (``Dwyer'').
The proposed consent order (``proposed order'') has been placed on
the public record for thirty (30) days for receipt of comments by
interested persons. Comments received during this period will become
part of the public record. After thirty (30) days, the Commission will
again review the agreement and the comments received, and will decide
whether it should withdraw from the agreement or make final the
agreement's proposed order.
This matter involves advertising for HealthyLife Sciences, LLC's
Healthe Trim line of weight loss dietary supplements (``Healthe
Trim''). The complaint alleges that Dwyer, a co-founder of HealthyLife
Sciences, LLC, and former chief executive officer and spokesman for
Healthe Trim, violated Sections 5(a) and 12 of the Federal Trade
Commission Act by making false or unsubstantiated representations that
Healthe Trim would cause rapid and substantial weight loss, including
as much as 35, 130, and 165 pounds. Dwyer also claimed that users would
lose weight without dieting, and that Healthe Trim would burn fat,
increase metabolism, and suppress appetite. The complaint also alleges
that Dwyer violated Sections 5(a) and 12 by falsely representing that
Healthe Trim is clinically proven to cause weight loss.
The proposed order includes injunctive relief that prohibits these
alleged violations and fences in similar and related violations. For
purposes of the order, ``Covered Product'' means any dietary
supplement, food, or drug.
Part I of the proposed order bans Dwyer from manufacturing,
marketing, or distributing any weight-loss product or program, or
assisting others in any of the foregoing.
Part II of the proposed order prohibits any representation about
the health benefits, performance, or efficacy of any Covered Product,
unless it is non-misleading and supported by competent and reliable
scientific evidence that is sufficient in quality and quantity based on
standards generally accepted in the relevant scientific fields, when
[[Page 56377]]
considered in light of the entire body of relevant and reliable
scientific evidence, to substantiate that the representation is true.
For purposes of this Part, competent and reliable scientific evidence
is defined as tests, analyses, research, or studies that have been
conducted by qualified persons in an objective manner and are generally
accepted in the profession to yield accurate and reliable results. When
that evidence consists of human clinical tests or studies, Dwyer must
maintain all underlying or supporting data and documents that experts
in the field generally would accept as relevant to an assessment of
such testing.
Part III of the proposed order prohibits Dwyer from misrepresenting
the existence, contents, validity, results, conclusions, or
interpretations of any test, study, or research in connection with the
manufacturing, labeling, advertising, promotion, offering for sale, and
sale or distribution of any Covered Product.
Part IV provides a safe harbor for representations permitted under
any tentative final or final standard promulgated by the Food and Drug
Administration (``FDA''), any new drug application approved by the FDA,
or FDA regulations pursuant to the Nutrition Labeling and Education Act
of 1990 or the FDA Modernization Act of 1997.
Triggered when the human clinical testing requirement in Part II
applies, Part V of the proposed order requires Dwyer to secure and
preserve all underlying or supporting data and documents generally
accepted by experts in the field as relevant to an assessment of the
test, such as protocols, instructions, participant-specific data,
statistical analyses, and contracts with the test's researchers. There
is an exception for a ``Reliably Reported'' test, defined as a test
published in a peer-reviewed journal that was not conducted,
controlled, or sponsored by Dwyer, his affiliates, or others in the
manufacturing or supply chain. Also, the published report must provide
sufficient information about the test for experts in the relevant field
to assess the reliability of the results.
Parts VI through IX of the proposed order require Dwyer to: Deliver
a copy of the order to principals, officers, directors, and other
employees having responsibilities with respect to the subject matter of
the order; notify the Commission of changes in employment that might
affect compliance obligations under the order; and file compliance
reports with the Commission.
Part X provides that the order will terminate after twenty (20)
years, with certain exceptions.
The purpose of this analysis is to facilitate public comment on the
proposed order, and it is not intended to constitute an official
interpretation of the complaint or proposed order, or to modify the
proposed order's terms in any way.
By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. 2014-22388 Filed 9-18-14; 8:45 am]
BILLING CODE 6750-01-P