Bioque Technologies, Inc., et al.; Analysis of Proposed Consent Order to Aid Public Comment, 57625-57627 [E8-23328]
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Federal Register / Vol. 73, No. 193 / Friday, October 3, 2008 / Notices
Those attendees needing such assistance
should call (703) 562–6067 (Voice or
TTY), to make necessary arrangements.
Requests for further information
concerning the meeting may be directed
to Mr. Robert E. Feldman, Executive
Secretary of the Corporation, at (202)
898–7043.
Dated: September 30, 2008.
Federal Deposit Insurance Corporation.
Robert E. Feldman,
Executive Secretary.
[FR Doc. E8–23494 Filed 10–2–08; 8:45 am]
BILLING CODE 6714–01–P
FEDERAL RESERVE SYSTEM
Change in Bank Control Notices;
Acquisition of Shares of Bank or Bank
Holding Companies
mstockstill on PROD1PC66 with NOTICES
The notificants listed below have
applied under the Change in Bank
Control Act (12 U.S.C. 1817(j)) and
§ 225.41 of the Board’s Regulation Y (12
CFR 225.41) to acquire a bank or bank
holding company. The factors that are
considered in acting on the notices are
set forth in paragraph 7 of the Act (12
U.S.C. 1817(j)(7)).
The notices are available for
immediate inspection at the Federal
Reserve Bank indicated. The notices
also will be available for inspection at
the office of the Board of Governors.
Interested persons may express their
views in writing to the Reserve Bank
indicated for that notice or to the offices
of the Board of Governors. Comments
must be received not later than October
20, 2008.
A. Federal Reserve Bank of Atlanta
(Steve Foley, Vice President) 1000
Peachtree Street, N.E., Atlanta, Georgia
30309:
1. Mark Allen Conner, Canton,
Georgia, to acquire additional voting
shares of FirstCity Bancorp, Inc., and
thereby indirectly acquire additional
voting shares of FirstCity Bank, both of
Stockbridge, Georgia.
2. James C. Jones, Waycross, Georgia;
Patrick C. Jones and Carole C. Jones,
both of Blackshear, Georgia; to retain
voting shares of Jones Bancshares, LP,
and thereby indirectly retain voting
shares of Primesouth Bank, both of
Blackshear, Georgia.
Board of Governors of the Federal Reserve
System, September 30, 2008.
Robert deV. Frierson,
Deputy Secretary of the Board.
[FR Doc. E8–23383 Filed 10–2–08; 8:45 am]
BILLING CODE 6210–01–S
VerDate Aug<31>2005
23:33 Oct 02, 2008
Jkt 217001
FEDERAL RESERVE SYSTEM
Formations of, Acquisitions by, and
Mergers of Bank Holding Companies
The companies listed in this notice
have applied to the Board for approval,
pursuant to the Bank Holding Company
Act of 1956 (12 U.S.C. 1841 et seq.)
(BHC Act), Regulation Y (12 CFR Part
225), and all other applicable statutes
and regulations to become a bank
holding company and/or to acquire the
assets or the ownership of, control of, or
the power to vote shares of a bank or
bank holding company and all of the
banks and nonbanking companies
owned by the bank holding company,
including the companies listed below.
The applications listed below, as well
as other related filings required by the
Board, are available for immediate
inspection at the Federal Reserve Bank
indicated. The applications also will be
available for inspection at the offices of
the Board of Governors. Interested
persons may express their views in
writing on the standards enumerated in
the BHC Act (12 U.S.C. 1842(c)). If the
proposal also involves the acquisition of
a nonbanking company, the review also
includes whether the acquisition of the
nonbanking company complies with the
standards in section 4 of the BHC Act
(12 U.S.C. 1843). Unless otherwise
noted, nonbanking activities will be
conducted throughout the United States.
Additional information on all bank
holding companies may be obtained
from the National Information Center
website at www.ffiec.gov/nic/.
Unless otherwise noted, comments
regarding each of these applications
must be received at the Reserve Bank
indicated or the offices of the Board of
Governors not later than October 30,
2008.
A. Federal Reserve Bank of
Richmond (A. Linwood Gill, III, Vice
President) 701 East Byrd Street,
Richmond, Virginia 23261–4528:
1. CapGen Capital Group II LLC, and
CapGen Capital Group II LP, both of
New York, New York, to become bank
holding companies by acquiring 12.4
percent of the voting shares of PacWest
Bancorp, and thereby indirectly acquire
voting shares of Pacific Western Bank,
both of San Diego, California.
B. Federal Reserve Bank of Chicago
(Burl Thornton, Assistant Vice
President) 230 South LaSalle Street,
Chicago, Illinois 60690–1414:
1. First Community Financial
Partners, Inc., Joliet, Illinois, to acquire
at least 50 percent of the voting shares
of First Community Bank of Homer Glen
& Lockport (in organization), Homer
Glen, Illinois.
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57625
Board of Governors of the Federal Reserve
System, September 30, 2008.
Robert deV. Frierson,
Deputy Secretary of the Board.
[FR Doc. E8–23382 Filed 10–2–08; 8:45 am]
BILLING CODE 6210–01–S
FEDERAL TRADE COMMISSION
[File No. 082 3095]
Bioque Technologies, Inc., et al.;
Analysis of Proposed Consent Order
to Aid Public Comment
Federal Trade Commission.
Proposed Consent Agreement.
AGENCY:
ACTION:
SUMMARY: The consent agreement in this
matter settles alleged violations of
federal law prohibiting unfair or
deceptive acts or practices or unfair
methods of competition. 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.
Comments must be received on
or before October 17, 2008.
ADDRESSES: Interested parties are
invited to submit written comments.
Comments should refer to ‘‘Bioque
Technologies, File No. 082 3095,’’ to
facilitate the organization of comments.
A comment filed in paper form should
include this reference both in the text
and on the envelope, and should be
mailed or delivered to the following
address: Federal Trade Commission/
Office of the Secretary, Room 135-H,
600 Pennsylvania Avenue, N.W.,
Washington, D.C. 20580. Comments
containing confidential material must be
filed in paper form, must be clearly
labeled ‘‘Confidential,’’ and must
comply with Commission Rule 4.9(c).
16 CFR 4.9(c) (2005).1 The FTC is
requesting that any comment filed in
paper form be sent by courier or
overnight service, if possible, because
U.S. postal mail in the Washington area
and at the Commission is subject to
delay due to heightened security
precautions. Comments that do not
contain any nonpublic information may
instead be filed in electronic form by
following the instructions on the webDATES:
1 The comment must be accompanied by an
explicit request for confidential treatment,
including the factual and legal basis for the request,
and must identify the specific portions of the
comment to be withheld from the public record.
The request will be granted or denied by the
Commission’s General Counsel, consistent with
applicable law and the public interest. See
Commission Rule 4.9(c), 16 CFR 4.9(c).
E:\FR\FM\03OCN1.SGM
03OCN1
mstockstill on PROD1PC66 with NOTICES
57626
Federal Register / Vol. 73, No. 193 / Friday, October 3, 2008 / Notices
based form at (https://
secure.commentworks.com/ftcBioqueTechnologies). To ensure that the
Commission considers an electronic
comment, you must file it on that webbased form.
The Federal Trade Commission Act
(‘‘FTC Act’’) and other laws 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,
whether filed in paper or electronic
form. Comments received will be
available to the public on the FTC
website, to the extent practicable, at
(https://www.ftc.gov/os/
publiccomments.shtm). As a matter of
discretion, the Commission makes every
effort to remove home contact
information for individuals from the
public comments it receives before
placing those comments on the FTC
website. More information, including
routine uses permitted by the Privacy
Act, may be found in the FTC’s privacy
policy, at (https://www.ftc.gov/ftc/
privacy.shtm)
FOR FURTHER INFORMATION CONTACT:
Richard Cleland, FTC Bureau of
Consumer Protection, 600 Pennsylvania
Avenue, NW, Washington, D.C. 20580,
(202) 326-3088.
SUPPLEMENTARY INFORMATION: Pursuant
to section 6(f) of the Federal Trade
Commission Act, 38 Stat. 721, 15 U.S.C.
46(f), and § 2.34 of the Commission
Rules of Practice, 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 18, 2008), on
the World Wide Web, at https://
www.ftc.gov/os/2008/09/index.htm. A
paper copy can be obtained from the
FTC Public Reference Room, Room 130H, 600 Pennsylvania Avenue, NW,
Washington, D.C. 20580, either in
person or by calling (202) 326-2222.
Public comments are invited, and may
be filed with the Commission in either
paper or electronic form. All comments
should be filed as prescribed in the
ADDRESSES section above, and must be
received on or before the date specified
in the DATES section.
VerDate Aug<31>2005
23:33 Oct 02, 2008
Jkt 217001
Analysis of Agreement Containing
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 Bioque
Technologies, Inc., Vittorio A. Bonomo,
and Christine A. Guilman (together,
‘‘Respondents’’).
The proposed consent order has been
placed on the public record for thirty
(30) days for receipt of comments by
interested persons. Comments received
during this period will become part of
the public record. After thirty (30) days,
the Commission will again review the
agreement and the comments received,
and will decide whether it should
withdraw from the agreement or make
final the agreement’s proposed order.
This matter involves the advertising
and promotion of Serum GV, a topical
serum that, according to its label,
contains, among other ingredients,
extract of annona muricata, also known
as graviola, derived from the soursop or
guanabana tree. According to the FTC
complaint, Respondents represented
that Serum GV is an effective treatment
for skin cancer, including melanoma,
and that it prevents melanoma. The
complaint alleges that Respondents
failed to have substantiation for these
claims. Also according to the FTC
complaint, Respondents represented
that Serum GV is recognized by the
medical profession as an effective
treatment for skin cancer and that it is
clinically proven to prevent or treat
melanoma. The complaint alleges that
these claims are false and misleading
because Serum GV is not recognized by
the medical profession as an effective
treatment for skin cancer and is not
clinically proven to prevent or treat
melanoma. The proposed consent order
contains provisions designed to prevent
Respondents from engaging in similar
acts and practices in the future.
Part I of the proposed order requires
Respondents to have competent and
reliable scientific evidence
substantiating any claims that a covered
product or service is an effective
treatment for skin cancer, including
melanoma; prevents melanoma; is
recognized by the medical profession as
an effective treatment for skin cancer; or
is clinically proven to prevent or treat
melanoma. The provision further
requires that such claims be true and
non-misleading. A ‘‘covered product or
service’’ is defined in the order as ‘‘any
health-related service or program; or any
food, dietary supplement, device, or
drug, including, but not limited to,
Serum GV.’’
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Frm 00039
Fmt 4703
Sfmt 4703
Part II of the proposed order requires
the Proposed Respondents to possess
competent and reliable scientific
evidence for any claims about the
absolute or comparative benefits,
performance, efficacy, safety, or side
effects of any covered product or
service. The claims also must be truthful
and non-misleading.
Part III of the proposed order
prohibits Respondents from making
future misrepresentations about the
existence, contents, validity, results,
conclusions, or interpretations of any
test or study.
Part IV of the proposed order provides
that the order does not prohibit
Respondents from making
representations for any drug that are
permitted in labeling for the drug under
any tentative final or final Food and
Drug Administration (‘‘FDA’’) standard
or under any new drug application
approved by the FDA and
representations for any product that are
specifically permitted in labeling for
that product by regulations issues by the
FDA under the Nutrition Labeling and
Education Act of 1990.
Part V of the proposed order requires
Respondents to provide the FTC with a
list of all consumers that they know
purchased Serum GV and prohibits
Respondents from using or disclosing
the consumer information, except to a
law enforcement agency or as required
by law.
Part VI of the proposed order requires
Respondents to send to the consumers
identified in Part V a notification letter
drafted by the FTC to inform them about
the consent agreement.
Part VII of the proposed order
provides for the payment of $9,035.85,
the full amount of sales of the product,
to the Commission.
Parts VIII through XII of the proposed
order require Respondents to keep
copies of relevant advertisements and
materials substantiating claims made in
the advertisements; to provide copies of
the order to certain of their personnel;
to notify the Commission of changes in
corporate structure (for the corporate
respondent) and changes in
employment (for the individual
respondents) that might affect
compliance obligations under the order;
and to file compliance reports with the
Commission. Part XIII provides that the
order will terminate after twenty (20)
years under certain circumstances.
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 agreement and proposed order or to
modify in any way their terms.
E:\FR\FM\03OCN1.SGM
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Federal Register / Vol. 73, No. 193 / Friday, October 3, 2008 / Notices
By direction of the Commission.
Donald S. Clark
Secretary
[FR Doc. E8–23328 Filed 10–2–08; 8:45 am]
BILLING CODE 6750–01–S
FEDERAL TRADE COMMISSION
[File No. 082 3116]
Daryl C. Jenks, d/b/a Premium Essiac
Tea 4less; Analysis of Proposed
Consent Order to Aid Public Comment
Federal Trade Commission.
Proposed Consent Agreement.
AGENCY:
ACTION:
SUMMARY: The consent agreement in this
matter settles alleged violations of
federal law prohibiting unfair or
deceptive acts or practices or unfair
methods of competition. 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.
Comments must be received on
or before October 17, 2008.
ADDRESSES: Interested parties are
invited to submit written comments.
Comments should refer to ‘‘Daryl C.
Jenks, File No. 082 3116,’’ to facilitate
the organization of comments. A
comment filed in paper form should
include this reference both in the text
and on the envelope, and should be
mailed or delivered to the following
address: Federal Trade Commission/
Office of the Secretary, Room 135-H,
600 Pennsylvania Avenue, N.W.,
Washington, D.C. 20580. Comments
containing confidential material must be
filed in paper form, must be clearly
labeled ‘‘Confidential,’’ and must
comply with Commission Rule 4.9(c).
16 CFR 4.9(c) (2005).1 The FTC is
requesting that any comment filed in
paper form be sent by courier or
overnight service, if possible, because
U.S. postal mail in the Washington area
and at the Commission is subject to
delay due to heightened security
precautions. Comments that do not
contain any nonpublic information may
instead be filed in electronic form by
following the instructions on the webbased form at (https://
mstockstill on PROD1PC66 with NOTICES
DATES:
1 The comment must be accompanied by an
explicit request for confidential treatment,
including the factual and legal basis for the request,
and must identify the specific portions of the
comment to be withheld from the public record.
The request will be granted or denied by the
Commission’s General Counsel, consistent with
applicable law and the public interest. See
Commission Rule 4.9(c), 16 CFR 4.9(c).
VerDate Aug<31>2005
23:33 Oct 02, 2008
Jkt 217001
secure.commentworks.com/ftcDarylCJenks). To ensure that the
Commission considers an electronic
comment, you must file it on that webbased form.
The Federal Trade Commission Act
(‘‘FTC Act’’) and other laws 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,
whether filed in paper or electronic
form. Comments received will be
available to the public on the FTC
website, to the extent practicable, at
(https://www.ftc.gov/os/
publiccomments.shtm). As a matter of
discretion, the Commission makes every
effort to remove home contact
information for individuals from the
public comments it receives before
placing those comments on the FTC
website. More information, including
routine uses permitted by the Privacy
Act, may be found in the FTC’s privacy
policy, at (https://www.ftc.gov/ftc/
privacy.shtm)
FOR FURTHER INFORMATION CONTACT:
Richard Cleland, FTC Bureau of
Consumer Protection, 600 Pennsylvania
Avenue, NW, Washington, D.C. 20580,
(202) 326-3088.
Pursuant
to section 6(f) of the Federal Trade
Commission Act, 38 Stat. 721, 15 U.S.C.
46(f), and § 2.34 of the Commission
Rules of Practice, 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 18, 2008), on
the World Wide Web, at (https://
www.ftc.gov/os/2008/09/index.htm). A
paper copy can be obtained from the
FTC Public Reference Room, Room 130H, 600 Pennsylvania Avenue, NW,
Washington, D.C. 20580, either in
person or by calling (202) 326-2222.
Public comments are invited, and may
be filed with the Commission in either
paper or electronic form. All comments
should be filed as prescribed in the
ADDRESSES section above, and must be
received on or before the date specified
in the DATES section.
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
57627
Analysis of Agreement Containing
Consent Order to Aid Public Comment
The Federal Trade Commission has
accepted, subject to final approval, an
agreement containing a consent order
from Daryl C. Jenks, individually, and
d/b/a Premium Essiac Tea 4less
(‘‘respondent’’).
The proposed consent order has been
placed on the public record for thirty
(30) days for reception of comments by
interested persons. Comments received
during ths period will become par of the
public record. Afer 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 concerns the advertising
and promotion of a product known as
Premium Essiac Tea, a powder for mag
a tea beverage that, according to its
label, contains. burdock root, rhubarb
root, sheep sorrel, slippery elm,
watercress, blessed thistle, red clover,
and kelp.
The Commission’s complaint charges
that respondent claimed that Premium
Essiac Tea was effective to treat, prevent
or cure cancer and other serious
diseases. The complaint alleges that
respondent did not have a reasonable
basis for ths claim. The complaint also
charges that respondent claimed that
Premium Essiac Tea was clinically
proven to be superior to other types of
essiac tea. The complaint alleges that
ths claim was false. The proposed
consent order contains provisions
designed to prevent respondent from
engaging in similar acts and practices in
the future.
Part I requires respondent to have
competent and reliable scientific
evidence substantiating any claim that
any covered product or service is
effective in the treatment, cure or
prevention of any disease or condition,
or is superior to other similar products
or services. A ‘‘covered product or
service’’ is defined as any food, dietary
supplement or drug, including, but not
limited to any essiac tea product; or any
health-related product, service or
program.
Part II requires that any future claim
about the absolute or comparative
benefits, performance, efficacy, safety or
side effects of any covered product or
service be truth and supported by
competent and reliable scientific
evidence.
Part III of the consent order prohibits
the misrepresentation of the results of
any test, study or research in connection
with the advertising, promotion or sale
of any covered product or service.
E:\FR\FM\03OCN1.SGM
03OCN1
Agencies
[Federal Register Volume 73, Number 193 (Friday, October 3, 2008)]
[Notices]
[Pages 57625-57627]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-23328]
=======================================================================
-----------------------------------------------------------------------
FEDERAL TRADE COMMISSION
[File No. 082 3095]
Bioque Technologies, Inc., et al.; Analysis of Proposed Consent
Order 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 or unfair methods of competition. 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 17, 2008.
ADDRESSES: Interested parties are invited to submit written comments.
Comments should refer to ``Bioque Technologies, File No. 082 3095,'' to
facilitate the organization of comments. A comment filed in paper form
should include this reference both in the text and on the envelope, and
should be mailed or delivered to the following address: Federal Trade
Commission/Office of the Secretary, Room 135-H, 600 Pennsylvania
Avenue, N.W., Washington, D.C. 20580. Comments containing confidential
material must be filed in paper form, must be clearly labeled
``Confidential,'' and must comply with Commission Rule 4.9(c). 16 CFR
4.9(c) (2005).\1\ The FTC is requesting that any comment filed in paper
form be sent by courier or overnight service, if possible, because U.S.
postal mail in the Washington area and at the Commission is subject to
delay due to heightened security precautions. Comments that do not
contain any nonpublic information may instead be filed in electronic
form by following the instructions on the web-
[[Page 57626]]
based form at (https://secure.commentworks.com/ftc-BioqueTechnologies).
To ensure that the Commission considers an electronic comment, you must
file it on that web-based form.
---------------------------------------------------------------------------
\1\ The comment must be accompanied by an explicit request for
confidential treatment, including the factual and legal basis for
the request, and must identify the specific portions of the comment
to be withheld from the public record. The request will be granted
or denied by the Commission's General Counsel, consistent with
applicable law and the public interest. See Commission Rule 4.9(c),
16 CFR 4.9(c).
---------------------------------------------------------------------------
The Federal Trade Commission Act (``FTC Act'') and other laws 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,
whether filed in paper or electronic form. Comments received will be
available to the public on the FTC website, to the extent practicable,
at (https://www.ftc.gov/os/publiccomments.shtm). As a matter of
discretion, the Commission makes every effort to remove home contact
information for individuals from the public comments it receives before
placing those comments on the FTC website. More information, including
routine uses permitted by the Privacy Act, may be found in the FTC's
privacy policy, at (https://www.ftc.gov/ftc/privacy.shtm)
FOR FURTHER INFORMATION CONTACT: Richard Cleland, FTC Bureau of
Consumer Protection, 600 Pennsylvania Avenue, NW, Washington, D.C.
20580, (202) 326-3088.
SUPPLEMENTARY INFORMATION: Pursuant to section 6(f) of the Federal
Trade Commission Act, 38 Stat. 721, 15 U.S.C. 46(f), and Sec. 2.34 of
the Commission Rules of Practice, 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 18, 2008), on the World Wide Web, at https://www.ftc.gov/
os/2008/09/index.htm. A paper copy can be obtained from the FTC Public
Reference Room, Room 130-H, 600 Pennsylvania Avenue, NW, Washington,
D.C. 20580, either in person or by calling (202) 326-2222.
Public comments are invited, and may be filed with the Commission
in either paper or electronic form. All comments should be filed as
prescribed in the ADDRESSES section above, and must be received on or
before the date specified in the DATES section.
Analysis of Agreement Containing 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 Bioque Technologies, Inc., Vittorio A. Bonomo, and Christine
A. Guilman (together, ``Respondents'').
The proposed consent order has been placed on the public record for
thirty (30) days for receipt of comments by interested persons.
Comments received during this period will become part of the public
record. After thirty (30) days, the Commission will again review the
agreement and the comments received, and will decide whether it should
withdraw from the agreement or make final the agreement's proposed
order.
This matter involves the advertising and promotion of Serum GV, a
topical serum that, according to its label, contains, among other
ingredients, extract of annona muricata, also known as graviola,
derived from the soursop or guanabana tree. According to the FTC
complaint, Respondents represented that Serum GV is an effective
treatment for skin cancer, including melanoma, and that it prevents
melanoma. The complaint alleges that Respondents failed to have
substantiation for these claims. Also according to the FTC complaint,
Respondents represented that Serum GV is recognized by the medical
profession as an effective treatment for skin cancer and that it is
clinically proven to prevent or treat melanoma. The complaint alleges
that these claims are false and misleading because Serum GV is not
recognized by the medical profession as an effective treatment for skin
cancer and is not clinically proven to prevent or treat melanoma. The
proposed consent order contains provisions designed to prevent
Respondents from engaging in similar acts and practices in the future.
Part I of the proposed order requires Respondents to have competent
and reliable scientific evidence substantiating any claims that a
covered product or service is an effective treatment for skin cancer,
including melanoma; prevents melanoma; is recognized by the medical
profession as an effective treatment for skin cancer; or is clinically
proven to prevent or treat melanoma. The provision further requires
that such claims be true and non-misleading. A ``covered product or
service'' is defined in the order as ``any health-related service or
program; or any food, dietary supplement, device, or drug, including,
but not limited to, Serum GV.''
Part II of the proposed order requires the Proposed Respondents to
possess competent and reliable scientific evidence for any claims about
the absolute or comparative benefits, performance, efficacy, safety, or
side effects of any covered product or service. The claims also must be
truthful and non-misleading.
Part III of the proposed order prohibits Respondents from making
future misrepresentations about the existence, contents, validity,
results, conclusions, or interpretations of any test or study.
Part IV of the proposed order provides that the order does not
prohibit Respondents from making representations for any drug that are
permitted in labeling for the drug under any tentative final or final
Food and Drug Administration (``FDA'') standard or under any new drug
application approved by the FDA and representations for any product
that are specifically permitted in labeling for that product by
regulations issues by the FDA under the Nutrition Labeling and
Education Act of 1990.
Part V of the proposed order requires Respondents to provide the
FTC with a list of all consumers that they know purchased Serum GV and
prohibits Respondents from using or disclosing the consumer
information, except to a law enforcement agency or as required by law.
Part VI of the proposed order requires Respondents to send to the
consumers identified in Part V a notification letter drafted by the FTC
to inform them about the consent agreement.
Part VII of the proposed order provides for the payment of
$9,035.85, the full amount of sales of the product, to the Commission.
Parts VIII through XII of the proposed order require Respondents to
keep copies of relevant advertisements and materials substantiating
claims made in the advertisements; to provide copies of the order to
certain of their personnel; to notify the Commission of changes in
corporate structure (for the corporate respondent) and changes in
employment (for the individual respondents) that might affect
compliance obligations under the order; and to file compliance reports
with the Commission. Part XIII provides that the order will terminate
after twenty (20) years under certain circumstances.
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 agreement and proposed order or to modify in any
way their terms.
[[Page 57627]]
By direction of the Commission.
Donald S. Clark
Secretary
[FR Doc. E8-23328 Filed 10-2-08; 8:45 am]
BILLING CODE 6750-01-S