Norm Thompson Outfitters, Inc.; Analysis To Aid Public Comment, 60165-60167 [2014-23680]

Download as PDF mstockstill on DSK4VPTVN1PROD with NOTICES Federal Register / Vol. 79, No. 193 / Monday, October 6, 2014 / Notices other individually identifiable health 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). 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).2 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, or to send them to the Commission by courier or overnight service. To make sure that the Commission considers your online comment, you must file it at https:// ftcpublic.commentworks.com/ftc/ NegOptionPRA2 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 ‘‘Negative Option Rule: FTC File No. P064202’’ on your comment and on the envelope, and mail it 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. Visit the Commission Web site at http://www.ftc.gov to read this Notice. 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 November 5, 2014. You can find more information, including routine 2 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). VerDate Sep<11>2014 17:17 Oct 03, 2014 Jkt 235001 uses permitted by the Privacy Act, in the Commission’s privacy policy, at http://www.ftc.gov/ftc/privacy.htm. 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 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. David C. Shonka, Principal Deputy General Counsel. [FR Doc. 2014–23682 Filed 10–3–14; 8:45 am] BILLING CODE 6750–01–P FEDERAL TRADE COMMISSION [File No. 132 3094] Norm Thompson Outfitters, Inc.; 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 29, 2014. ADDRESSES: Interested parties may file a comment at https:// ftcpublic.commentworks.com/ftc/ normthompsonconsent/ 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 Norm Thompson Outfitters, Inc.—Consent Agreement; File No. 132 3094’’ on your comment. File your comment online at https://ftcpublic.commentworks.com/ ftc/normthompsonconsent/ 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 SUMMARY: PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 60165 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 Norm Thompson Outfitters, Inc.—Consent Agreement; File No. 132 3094’’ 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 E:\FR\FM\06OCN1.SGM 06OCN1 mstockstill on DSK4VPTVN1PROD with NOTICES 60166 Federal Register / Vol. 79, No. 193 / Monday, October 6, 2014 / Notices 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/ normthompsonconsent/ 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 Norm Thompson Outfitters, Inc.—Consent Agreement; File No. 132 3094’’ 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 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). VerDate Sep<11>2014 17:17 Oct 03, 2014 Jkt 235001 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 Norm Thompson Outfitters, 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 women’s undergarments that are infused with microencapsulated caffeine and other ingredients. Respondent has marketed the garments through its mail order catalogs and through Web sites under the names Norm Thompson Outfitters, Sahalie, Solutions, Body Essentials and Body*Belle. According to the FTC complaint, respondent claimed the garments would slim and reshape the body and reduce cellulite. Specifically, the FTC complaint alleges that respondent represented that wearing the garments eight hours a day for 30 days eliminates or substantially reduces cellulite; causes a reduction of up to two inches in the wearer’s hip measurements and up to one inch in the wearer’s thigh measurements in one month or less; and that the reduction in thigh and hip measurements can be achieved without effort. 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 wearing the garments results in a substantial reduction in hip and thigh measurement and that scientific tests prove that wearing the garments five days a week, for eight hours a day, for 28 days will reduce a wearer’s hip measurement by two inches and a wearer’s thigh measurement by one inch. 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 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 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 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 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, placebocontrolled 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 the advertised garments results in the reduction in the wearer’s body size. Part IV prohibits respondent, when E:\FR\FM\06OCN1.SGM 06OCN1 mstockstill on DSK4VPTVN1PROD with NOTICES Federal Register / Vol. 79, No. 193 / Monday, October 6, 2014 / Notices 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 two hundred thirty thousand dollars ($230,000) to the Commission to be used for equitable relief, including restitution. The order also requires respondent to administer and bear the costs of the redress program. To facilitate the payment of redress, Part VI of the proposed order requires respondent to provide to the Commission a searchable electronic file containing the name and contact information of all consumers who purchased the garments from respondent from March 20, 2011, through the date of entry of the order. Part VIII of the proposed order is triggered whenever the human clinical testing requirement in either Part II or Part III applies. Part VIII 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 IX of the proposed order contains recordkeeping requirements for advertisements and substantiation relevant to any representation covered by the proposed order. Parts X, XI and XII 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 XIII provides that the order will terminate after twenty (20) years, with certain exceptions. VerDate Sep<11>2014 17:17 Oct 03, 2014 Jkt 235001 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 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. 2014–23680 Filed 10–3–14; 8:45 am] BILLING CODE 6750–01–P FEDERAL TRADE COMMISSION [File No. 132 3095] Wacoal America, Inc.; 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 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. DATES: PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 60167 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 SUPPLEMENTARY INFORMATION: E:\FR\FM\06OCN1.SGM 06OCN1

Agencies

[Federal Register Volume 79, Number 193 (Monday, October 6, 2014)]
[Notices]
[Pages 60165-60167]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-23680]


-----------------------------------------------------------------------

FEDERAL TRADE COMMISSION

[File No. 132 3094]


Norm Thompson Outfitters, Inc.; 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 29, 2014.

ADDRESSES: Interested parties may file a comment at https://ftcpublic.commentworks.com/ftc/normthompsonconsent/ 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 Norm 
Thompson Outfitters, Inc.--Consent Agreement; File No. 132 3094'' on 
your comment. File your comment online at https://ftcpublic.commentworks.com/ftc/normthompsonconsent/ 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 Norm Thompson Outfitters, Inc.--Consent 
Agreement; File No. 132 3094'' 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

[[Page 60166]]

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/normthompsonconsent/ 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 Norm 
Thompson Outfitters, Inc.--Consent Agreement; File No. 132 3094'' 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 Norm Thompson Outfitters, 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 women's undergarments that are infused with 
microencapsulated caffeine and other ingredients. Respondent has 
marketed the garments through its mail order catalogs and through Web 
sites under the names Norm Thompson Outfitters, Sahalie, Solutions, 
Body Essentials and Body*Belle. According to the FTC complaint, 
respondent claimed the garments would slim and reshape the body and 
reduce cellulite.
    Specifically, the FTC complaint alleges that respondent represented 
that wearing the garments eight hours a day for 30 days eliminates or 
substantially reduces cellulite; causes a reduction of up to two inches 
in the wearer's hip measurements and up to one inch in the wearer's 
thigh measurements in one month or less; and that the reduction in 
thigh and hip measurements can be achieved without effort. 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 wearing the garments 
results in a substantial reduction in hip and thigh measurement and 
that scientific tests prove that wearing the garments five days a week, 
for eight hours a day, for 28 days will reduce a wearer's hip 
measurement by two inches and a wearer's thigh measurement by one inch. 
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 
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 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 the advertised garments 
results in the reduction in the wearer's body size. Part IV prohibits 
respondent, when

[[Page 60167]]

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 two 
hundred thirty thousand dollars ($230,000) to the Commission to be used 
for equitable relief, including restitution. The order also requires 
respondent to administer and bear the costs of the redress program. To 
facilitate the payment of redress, Part VI of the proposed order 
requires respondent to provide to the Commission a searchable 
electronic file containing the name and contact information of all 
consumers who purchased the garments from respondent from March 20, 
2011, through the date of entry of the order.
    Part VIII of the proposed order is triggered whenever the human 
clinical testing requirement in either Part II or Part III applies. 
Part VIII 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 IX of the proposed order contains recordkeeping requirements 
for advertisements and substantiation relevant to any representation 
covered by the proposed order. Parts X, XI and XII 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 XIII 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 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. 2014-23680 Filed 10-3-14; 8:45 am]
BILLING CODE 6750-01-P