Cytodyne, LLC, Evergood Products Corp., and Melvin Rich; Analysis of Agreement Containing Consent Order to Aid Public Comment, 41225-41227 [05-14082]
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Federal Register / Vol. 70, No. 136 / Monday, July 18, 2005 / Notices
Number of Annual Respondents: The
Commission estimates an annual
respondent universe of 3,500.
Estimated Time Per Response: The
time per response for completing Form
FMC–1 averages .5 person hours, and
approximately 5.6 person-hours for
related tariff publication.
Total Annual Burden: The
Commission estimates the total personhour burden at 364,200 person-hours.
Title: 46 CFR Part 530—Service
Contracts and Related Form FMC–83.
OMB Approval Number: 3072–0065
(Expires August 31, 2005).
Abstract: The Shipping Act of 1984,
46 U.S.C. app. 1707, requires service
contracts, except those dealing with
bulk cargo, forest products, recycled
metal scrap, new assembled motor
vehicles, waste paper or paper waste,
and their related amendments and
notices to be filed confidentially with
the Commission.
Current Actions: There are no changes
to this information collection, and it is
being submitted for extension purposes
only.
Type of Review: Extension.
Needs and Uses: The Commission
monitors service contract filings for acts
prohibited by the Shipping Act of 1984.
Frequency: The Commission has no
control over how frequently service
contracts are entered into; this is solely
a matter between the negotiating parties.
When parties enter into a service
contract, it must be filed with the
Commission.
Type of Respondents: Parties that
enter into service contracts are ocean
common carriers and agreements among
ocean common carriers on the one hand,
and shippers or shipper’s associations
on the other.
Number of Annual Respondents: The
Commission estimates an annual
respondent universe of 140.
Estimated Time Per Response: The
time per response for completing Form
FMC–83 averages .5 person hours, and
approximately 27 person-hours for
reporting and recordkeeping
requirements contained in the rules.
Total Annual Burden: The
Commission estimates the total personhour burden at 528,770 person-hours.
Bryant L. VanBrakle,
Secretary.
[FR Doc. 05–14040 Filed 7–15–05; 8:45 am]
BILLING CODE 6730–01–P
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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 application 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 August 11,
2005.
A. Federal Reserve Bank of New
York (Jay Bernstein, Bank Supervision
Officer) 33 Liberty Street, New York,
New York 10045-0001:
1. New York Private Bank & Trust and
Emigrant Bancorp, both of New York,
New York; to acquire 100 percent of the
voting shares of Emigrant Savings Bank
– Long Island, Westbury, New York;
Emigrant Savings Bank – Brooklyn/
Queens, Brooklyn, New York; Emigrant
Savings Bank – Manhattan, New York,
New York; and Emigrant Savings Bank
– Bronx/Westchester, Bronx, New York,
all de novo banks.
B. Federal Reserve Bank of San
Francisco (Tracy Basinger, Director,
Regional and Community Bank Group)
101 Market Street, San Francisco,
California 94105-1579:
1. Eggemeyer Advisory Corp., WJR
Corp., Castle Creek Capital LLC, Castle
PO 00000
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41225
Creek Capital Partners Fund I, LP,
Castle Creek Capital Partners Fund IIB,
LP, and Castle Creek Capital Partners
Fund IIb, LP all of Rancho Santa Fe,
California; to indirectly acquire Heritage
Financial Corporation, Granbury, Texas;
and State National Bancshares, Inc., Fort
Worth, Texas, to directly acquire 100
percent of Heritage Financial
Corporation and thereby indirectly
acquire its subsidiaries Heritage
Associated Services, Inc., and Heritage
National Bank, all of Granbury, Texas.
Board of Governors of the Federal Reserve
System, July 12, 2005.
Robert deV. Frierson,
Deputy Secretary of the Board.
[FR Doc. 05–14011 Filed 7–15–05; 8:45 am]
BILLING CODE 6210–01–S
FEDERAL TRADE COMMISSION
[File No. 032 3144]
Cytodyne, LLC, Evergood Products
Corp., and Melvin Rich; Analysis of
Agreement Containing 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 August 10, 2005.
ADDRESSES: Interested parties are
invited to submit written comments.
Comments should refer to ‘‘Cytodyne,
LLC, et al., File No. 032 3144,’’ 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 159–H,
600 Pennsylvania Avenue, NW.,
Washington, DC 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
DATES:
1 The comment must be accompanied by an
explicit request for confidential treatment,
including the factual and legal basis for the request,
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18JYN1
41226
Federal Register / Vol. 70, No. 136 / Monday, July 18, 2005 / Notices
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 as
part of or as an attachment to e-mail
messages directed to the following email box: consentagreement@ftc.gov.
The FTC Act and other laws the
Commission administers permit the
collection of public comments to
consider and use in this proceeding as
appropriate. All timely and responsive
public comments, whether filed in
paper or electronic form, will be
considered by the Commission, and will
be available to the public on the FTC
Web site, to the extent practicable, at
https://www.ftc.gov. As a matter of
discretion, the FTC makes every effort to
remove home contact information for
individuals from the public comments it
receives before placing those comments
on the FTC Web site. 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.htm.
FOR FURTHER INFORMATION CONTACT:
Peter Miller (202) 326–2629 or Michael
Ostheimer (202) 326–2699, Bureau of
Consumer Protection, Room NJ–3223,
600 Pennsylvania Avenue, NW.,
Washington, DC 20580.
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 July 13, 2005), on the
World Wide Web, at https://www.ftc.gov/
os/2005/07/index.htm. A paper copy
can be obtained from the FTC Public
Reference Room, Room 130–H, 600
Pennsylvania Avenue, NW.,
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).
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Washington, DC 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 has
accepted, subject to final approval, an
agreement containing a consent order
from Cytodyne, LLC, Evergood Products
Corp., and Melvin Rich, individually
and as a manager of Cytodyne, LLC and
an officer of Evergood Products Corp.
(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 practices relating
to the advertising and promotion of
Xenadrine EFX, a dietary supplement
marketed for weight loss. According to
the FTC complaint, respondents
represented that Xenadrine EFX causes
rapid and substantial weight and fat
loss, causes permanent or long-term
weight loss, and causes rapid and
substantial weight loss without the need
to diet or increase exercise. The
complaint alleges that these claims are
false and that the company failed to
have substantiation for them. It further
alleges that respondents falsely
represented that scientific studies prove
that Xenadrine EFX causes rapid and
substantial weight loss and that it is
more effective than leading ephedrinebased diet products. The FTC complaint
also alleges that respondents falsely
represented that persons appearing in
Xenadrine EFX advertisements achieved
the weight loss reported in those ads
solely through the use of Xenadrine
EFX. According to the FTC complaint,
persons who appeared in the Xenadrine
EFX advertisements engaged in rigorous
diet and/or exercise programs in order
to lose weight, and some were provided
with a personal trainer. Finally, the
complaint alleges that, in presenting
testimonials for Xenadrine EFX by
consumer endorsers who purportedly
lost weight in the ordinary course of
using Xenadrine EFX, respondents
failed to disclose that the endorsers
were paid from $1000 to $20,000 in
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connection with their endorsement, a
fact that would be material to
consumers in their decisions about
purchasing or using the product.
The proposed consent order contains
provisions designed to prevent the
respondents from engaging in similar
acts and practices in the future.
Part I of the order prohibits
representations that Xenadrine EFX or
any other product containing green tea
extract, bitter orange, or caffeine causes
rapid and substantial weight loss or fat
loss. It also prohibits representations
that any weight loss product causes
rapid or substantial weight loss without
the need to diet or increase exercise.
Part II prohibits respondents from
representing that any weight loss
product, dietary supplement, food, drug,
or device causes weight or fat loss,
causes permanent or long-term weight
loss, or enables users to lose weight or
fat without the need to diet or increase
exercise unless the claim is true and
respondents possess competent and
reliable scientific evidence that
substantiates the claim. It also prohibits
respondents from making any other
claims about the health benefits,
performance, efficacy, safety, or side
effects of any such product unless the
claim is true and respondents possess
competent and reliable scientific
evidence that substantiates the claim.
Part III prohibits any
misrepresentation of the existence,
contents, validity, results, conclusions,
or interpretations of any test or study in
connection with the marketing or sale of
any weight loss product, dietary
supplement, food, drug, or device.
Part IV prohibits any
misrepresentation that the experience
described in any user testimonial for
any weight loss product, dietary
supplement, food, drug, or device
represents the actual experience of the
endorser as a result of using the product
under the circumstances depicted in the
endorsement.
Part V prohibits any representation
about any endorser of any weight loss
product, dietary supplement, food, drug,
or device unless the respondents
disclose any material connection that
exists between the endorser and the
respondents or any other person or
entity involved in manufacturing,
marketing, or selling the product.
Part VI of the proposed order allows
the respondents to make any
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.
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Federal Register / Vol. 70, No. 136 / Monday, July 18, 2005 / Notices
Part VII of the proposed order allows
the respondents to make representations
for any product that are specifically
permitted in labeling for that product by
regulations issued by the FDA under the
Nutrition Labeling and Education Act of
1990.
Part VIII provides for the payment of
$100,000 to the Commission.
Part IX requires respondents to
cooperate in good faith with the
Commission’s reasonable requests for
documents and testimony in connection
with this action or any investigations
related to or associated with the
transactions or the occurrences that are
the subject of the FTC complaint.
Part X requires respondents to send a
letter to purchasers for resale of
Xenadrine EFX notifying them of the
Commission’s order. It also provides
that if respondents learn that any of its
resellers or distributors are
disseminating any advertisement or
promotional material containing
prohibited representations, they are
required to request that the resellers or
distributors stop making such
representations and to stop doing
business with resellers or distributors
that do not comply with this request.
Part XI requires respondents to keep
copies of the communications required
by Part X.
Parts XII through XVI 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
respondents) and changes in
employment (for the individual
respondent) that might affect
compliance obligations under the order;
and to file compliance reports with the
Commission. Part XVII 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.
By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. 05–14082 Filed 7–15–05; 8:45 am]
BILLING CODE 6750–01–P
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GENERAL SERVICES
ADMINISTRATION
Office of Governmentwide Policy;
Cancellation of Standard Form by the
Department of the Treasury
Office of Governmentwide
Policy, GSA.
ACTION: Notice.
AGENCY:
SUMMARY: The Department of the
Treasury cancelled the following
Standard Form:
SF 1034A, Public Voucher for Purchases
and Services Other Than Personal.
This form is no longer required by
Treasury.
DATES: Effective July 18, 2005.
FOR FURTHER INFORMATION CONTACT:
Renee Speed, Department of the
Treasury, (202) 622–2784.
Dated: July 8, 2005.
Barbara M. Williams,
Standard and Optional Forms Management
Officer, General Services Administration.
[FR Doc. 05–14018 Filed 7–15–05; 8:45 am]
BILLING CODE 6820–34–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Fragile X Syndrome Cascade Testing
and Genetic Counseling Protocols
Announcement Type: New.
Funding Opportunity Number:
AA097.
Catalog of Federal Domestic
Assistance Number: 93.283.
Key Dates: Letter of Intent (LOI)
Deadline: July 28, 2005.
Application Deadline: August 17,
2005.
I. Funding Opportunity Description
Authority: This program is authorized
under Sections 301, 311 and 317(C) of
the Public Health Service Act [42 U.S.C.
241, 243, and 247b–4 as amended].
Purpose: The purpose of the program
is to develop and disseminate cascade
testing and genetic counseling protocols
for conditions related to changes in the
Fragile X Mental Retardation 1 (FMR–1)
gene, including Fragile X syndrome,
Fragile X-associated Tremor/Ataxia
Syndrome (FXTAS), and premature
ovarian insufficiency and related
fertility problems. This program
addresses the ‘‘Healthy People 2010’’
focus area of Maternal, Infant and Child
Health.
Measurable outcomes of the program
will be in alignment with one (or more)
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41227
of the following performance goal(s) for
the National Center on Birth Defects and
Developmental Disabilities (NCBDDD):
Prevent birth defects and developmental
disabilities, and improve the health and
quality of life of Americans with
disabilities.
This announcement is only for nonresearch activities supported by CDC. If
research is proposed, the application
will not be reviewed. For the definition
of research, please see the CDC Web site
at the following Internet address:
https://www.cdc.gov/od/ads/
opspoll1.htm.
Activities
• Using literature review and expert
opinion, identify key issues related to
cascade testing and genetic counseling
for FMR–1 genetic testing.
• Develop protocols for cascade
testing of family members of people
identified with a mutation in the FMR–
1 gene, including people with mental
retardation or developmental delays,
males with FXTAS, and females with
premature ovarian insufficiency and
related fertility problems.
• Develop protocols for genetic
counseling to be used in conjunction
with genetic testing for FMR–1
mutations. Protocols will include issues
related to the likelihood of repeat allele
expansion, impact of mosaicism, and
prevalence of mental retardation and
developmental delay among individuals
with intermediate repeat alleles,
premutations or full mutations.
• Ensure that the protocols address
the key issues identified by literature
review and expert opinion.
• Ensure that the protocols are
appropriate for consumer needs and
scientifically valid.
• Disseminate protocols to key
stakeholders, including pediatricians,
family practitioners, obstetricians,
gynecologists, neurologists, nurses,
clinical geneticists, genetic counselors,
and parents.
• Develop a carefully designed and
well-planned evaluation plan to monitor
progress on activities and to assess the
timeliness, completeness, and success of
the project (applicants are encouraged to
review the Morbidity and Mortality
Weekly Report (MMWR)
Recommendations and Reports
‘‘Framework for Program Evaluation in
Public Health’’ September 17, 199/50
(RR13); 1–35 available at https://
www.cdc.gov/mmwr/PDF/RR/
RR4811.pdf). The plan should be based
on a clear rational relating the activities
within the cooperative agreement,
projects goals, and evaluation measures.
Applicants are encouraged to include
evaluation plans for both outputs (for
E:\FR\FM\18JYN1.SGM
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]]>Agencies
[Federal Register Volume 70, Number 136 (Monday, July 18, 2005)]
[Notices]
[Pages 41225-41227]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-14082]
=======================================================================
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FEDERAL TRADE COMMISSION
[File No. 032 3144]
Cytodyne, LLC, Evergood Products Corp., and Melvin Rich; Analysis
of Agreement Containing 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 August 10, 2005.
ADDRESSES: Interested parties are invited to submit written comments.
Comments should refer to ``Cytodyne, LLC, et al., File No. 032 3144,''
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 159-H, 600
Pennsylvania Avenue, NW., Washington, DC 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
[[Page 41226]]
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 as part
of or as an attachment to e-mail messages directed to the following e-
mail box: consentagreement@ftc.gov.
---------------------------------------------------------------------------
\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 FTC Act and other laws the Commission administers permit the
collection of public comments to consider and use in this proceeding as
appropriate. All timely and responsive public comments, whether filed
in paper or electronic form, will be considered by the Commission, and
will be available to the public on the FTC Web site, to the extent
practicable, at https://www.ftc.gov. As a matter of discretion, the FTC
makes every effort to remove home contact information for individuals
from the public comments it receives before placing those comments on
the FTC Web site. 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.htm.
FOR FURTHER INFORMATION CONTACT: Peter Miller (202) 326-2629 or Michael
Ostheimer (202) 326-2699, Bureau of Consumer Protection, Room NJ-3223,
600 Pennsylvania Avenue, NW., Washington, DC 20580.
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 July 13, 2005), on the World Wide Web, at https://www.ftc.gov/os/
2005/07/index.htm. A paper copy can be obtained from the FTC Public
Reference Room, Room 130-H, 600 Pennsylvania Avenue, NW., Washington,
DC 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 has accepted, subject to final
approval, an agreement containing a consent order from Cytodyne, LLC,
Evergood Products Corp., and Melvin Rich, individually and as a manager
of Cytodyne, LLC and an officer of Evergood Products Corp. (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 practices relating to the advertising and
promotion of Xenadrine EFX, a dietary supplement marketed for weight
loss. According to the FTC complaint, respondents represented that
Xenadrine EFX causes rapid and substantial weight and fat loss, causes
permanent or long-term weight loss, and causes rapid and substantial
weight loss without the need to diet or increase exercise. The
complaint alleges that these claims are false and that the company
failed to have substantiation for them. It further alleges that
respondents falsely represented that scientific studies prove that
Xenadrine EFX causes rapid and substantial weight loss and that it is
more effective than leading ephedrine-based diet products. The FTC
complaint also alleges that respondents falsely represented that
persons appearing in Xenadrine EFX advertisements achieved the weight
loss reported in those ads solely through the use of Xenadrine EFX.
According to the FTC complaint, persons who appeared in the Xenadrine
EFX advertisements engaged in rigorous diet and/or exercise programs in
order to lose weight, and some were provided with a personal trainer.
Finally, the complaint alleges that, in presenting testimonials for
Xenadrine EFX by consumer endorsers who purportedly lost weight in the
ordinary course of using Xenadrine EFX, respondents failed to disclose
that the endorsers were paid from $1000 to $20,000 in connection with
their endorsement, a fact that would be material to consumers in their
decisions about purchasing or using the product.
The proposed consent order contains provisions designed to prevent
the respondents from engaging in similar acts and practices in the
future.
Part I of the order prohibits representations that Xenadrine EFX or
any other product containing green tea extract, bitter orange, or
caffeine causes rapid and substantial weight loss or fat loss. It also
prohibits representations that any weight loss product causes rapid or
substantial weight loss without the need to diet or increase exercise.
Part II prohibits respondents from representing that any weight
loss product, dietary supplement, food, drug, or device causes weight
or fat loss, causes permanent or long-term weight loss, or enables
users to lose weight or fat without the need to diet or increase
exercise unless the claim is true and respondents possess competent and
reliable scientific evidence that substantiates the claim. It also
prohibits respondents from making any other claims about the health
benefits, performance, efficacy, safety, or side effects of any such
product unless the claim is true and respondents possess competent and
reliable scientific evidence that substantiates the claim.
Part III prohibits any misrepresentation of the existence,
contents, validity, results, conclusions, or interpretations of any
test or study in connection with the marketing or sale of any weight
loss product, dietary supplement, food, drug, or device.
Part IV prohibits any misrepresentation that the experience
described in any user testimonial for any weight loss product, dietary
supplement, food, drug, or device represents the actual experience of
the endorser as a result of using the product under the circumstances
depicted in the endorsement.
Part V prohibits any representation about any endorser of any
weight loss product, dietary supplement, food, drug, or device unless
the respondents disclose any material connection that exists between
the endorser and the respondents or any other person or entity involved
in manufacturing, marketing, or selling the product.
Part VI of the proposed order allows the respondents to make any
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.
[[Page 41227]]
Part VII of the proposed order allows the respondents to make
representations for any product that are specifically permitted in
labeling for that product by regulations issued by the FDA under the
Nutrition Labeling and Education Act of 1990.
Part VIII provides for the payment of $100,000 to the Commission.
Part IX requires respondents to cooperate in good faith with the
Commission's reasonable requests for documents and testimony in
connection with this action or any investigations related to or
associated with the transactions or the occurrences that are the
subject of the FTC complaint.
Part X requires respondents to send a letter to purchasers for
resale of Xenadrine EFX notifying them of the Commission's order. It
also provides that if respondents learn that any of its resellers or
distributors are disseminating any advertisement or promotional
material containing prohibited representations, they are required to
request that the resellers or distributors stop making such
representations and to stop doing business with resellers or
distributors that do not comply with this request. Part XI requires
respondents to keep copies of the communications required by Part X.
Parts XII through XVI 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 respondents) and changes in employment (for the
individual respondent) that might affect compliance obligations under
the order; and to file compliance reports with the Commission. Part
XVII 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.
By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. 05-14082 Filed 7-15-05; 8:45 am]
BILLING CODE 6750-01-P
