[Federal Register Volume 79, Number 193 (Monday, October 6, 2014)]
[Notices]
[Pages 60167-60169]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-23681]
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FEDERAL TRADE COMMISSION
[File No. 132 3095]
Wacoal America, Inc.; Analysis To Aid Public Comment
AGENCY: Federal Trade Commission.
ACTION: Proposed consent agreement.
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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 29, 2014.
ADDRESSES: Interested parties may file a comment at https://ftcpublic.commentworks.com/ftc/wacoalamericaconsent 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
Wacoal America, Inc.--Consent Agreement; File No. 132 3095'' on your
comment. File your comment online at https://ftcpublic.commentworks.com/ftc/wacoalamericaconsent 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
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: David Newman, Western Region--San
Francisco, (415) 848-5123, 901 Market Street, Suite 570, San Francisco,
CA 94103.
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 29, 2014), on the World Wide Web,
at http://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 29,
2014. Write ``In the Matter of Wacoal America, Inc.--Consent Agreement;
File No. 132 3095'' 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 http://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
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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.
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\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).
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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/wacoalamericaconsent by following the instructions on the web-based
form. If this Notice appears at http://www.regulations.gov/#!home, you
also may file a comment through that Web site.
If you file your comment on paper, write ``In the Matter of Wacoal
America, Inc.--Consent Agreement; File No. 132 3095'' 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 http://www.ftc.gov to read this
Notice and the news release describing it. The FTC Act and other laws
that the Commission administers permit the collection of public
comments to consider and use in this proceeding as appropriate. The
Commission will consider all timely and responsive public comments that
it receives on or before October 29, 2014. You can find more
information, including routine uses permitted by the Privacy Act, in
the Commission's privacy policy, at http://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 Consent
Order from Wacoal America, Inc. (``respondent''). 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
and take appropriate action or make final the agreement's proposed
order.
This matter involves the advertising, marketing, and sale by
respondent of iPants, women's undergarments that are infused with
microencapsulated caffeine and other ingredients. Respondent has
marketed the iPants garments to consumers through third-party retailers
and through its Web site. According to the FTC complaint, respondent
claimed the iPants garments would slim and reshape the body and reduce
cellulite.
Specifically, the FTC complaint alleges that respondent represented
that wearing iPants garments eliminates or substantially reduces
cellulite; causes a substantial reduction in the wearer's thigh
measurements; and that iPants garments contain caffeine that causes the
destruction of fat cells and results in substantial slimming. The
complaint alleges that these claims are unsubstantiated and thus
violate the FTC Act. The complaint also alleges that respondent
represented that scientific tests prove that most iPant wearers achieve
a substantial reduction in thigh measurement and that scientific tests
prove that wearing the iPants garments for eight hours a day for 28
days will substantially reduce a wearer's thigh measurement. The
complaint alleges that these claims are false and thus violate the FTC
Act.
The proposed consent order contains provisions designed to prevent
respondent from engaging in similar acts or practices in the future.
Specifically, Parts I-III address the unsubstantiated claims alleged in
the complaint. Part I prohibits respondent from claiming that any
Covered Product--i.e., a garment that contains any drug or cosmetic--
causes substantial weight or fat loss or a substantial reduction in
unclad body size. The Commission has publicly advised that any claim
that a product worn on the body causes substantial weight loss is
always false.
Part II covers any representation, other than representations
covered under Part I, that any Covered Product or any drug or cosmetic
causes weight or fat loss or a reduction in unclad body size. Part II
prohibits respondent from making such representations unless the
representation is non-misleading, and, at the time of making such
representation, respondent possesses and relies upon competent and
reliable scientific evidence that substantiates that the representation
is true. For purposes of Part II, the proposed order defines
``competent and reliable scientific evidence'' as at least two
randomized, double-blind, placebo-controlled human clinical studies
that are conducted by independent, qualified researchers and that
conform to acceptable designs and protocols, and whose results, when
considered in light of the entire body of relevant and reliable
scientific evidence, are sufficient to substantiate that the
representation is true.
Part III of the proposed order prohibits respondent from making any
representation, other than representations covered under Parts I or II,
that use of a Covered Product or a drug or cosmetic reduces or
eliminates cellulite, unless the representation is non-misleading, and,
at the time of making such representation, respondent possesses and
relies upon competent and reliable scientific evidence that is
sufficient in quality and quantity based on standards generally
accepted in the relevant scientific fields, when considered in light of
the entire body of relevant and reliable scientific evidence, to
substantiate that the representation is true. For purposes of Part III,
the proposed order defines ``competent and reliable scientific
evidence'' as tests, analyses, research, or studies that have been
conducted and evaluated in an objective manner by qualified persons,
and that are generally accepted in the profession to yield accurate and
reliable results.
Part IV of the proposed order addresses the allegedly false claims
that scientific tests prove that wearing iPants garments result in
reduction of the wearer's thigh measurement. Part IV prohibits
respondent, when advertising any product, from misrepresenting the
existence, contents, validity, results, conclusions, or interpretations
of any test, study, or research, or misrepresenting that the benefits
of the product are scientifically proven.
Part V of the proposed order provides a safe harbor for
representations that are permitted in labeling for that drug under any
tentative 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.
Part VII of the proposed order requires respondent to pay one
million three
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hundred thousand dollars ($1,300,000) to the Commission to be used for
equitable relief, including restitution, and any attendant expenses for
the administration of such equitable relief. To facilitate the payment
of redress, Part VI of the proposed order requires Wacoal America to
provide to the Commission a searchable electronic file containing the
name and contact information of all consumers who purchased the iPants
garments directly from respondent from January 1, 2011, through the
date of entry of the order. Part VIII of the proposed order requires
respondent to comply with the provisions of Appendix A to the order,
which sets out the methods for notifying consumers who may be entitled
to file a claim for consumer redress.
Part IX of the proposed order is triggered whenever the human
clinical testing requirement in either Part II or Part III applies.
Part IX of the proposed order requires the company 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. 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 any proposed respondent or supplier. Also,
the published report must provide sufficient information about the test
for experts in the relevant field to assess the reliability of the
results.
Part X of the proposed order contains recordkeeping requirements
for advertisements and substantiation relevant to any representation
covered by the proposed order. Parts XI, XII and XIII of the proposed
order require respondent to provide copies of the order to its
personnel; to notify the Commission of changes in corporate structure
that might affect compliance obligations under the order; and to file
compliance reports with the Commission. Part XIV 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 and proposed order or to modify the
proposed order's terms in any way.
By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. 2014-23681 Filed 10-3-14; 8:45 am]
BILLING CODE 6750-01-P