HealthyLife Sciences, LLC; Analysis To Aid Public Comment, 56377-56379 [2014-22402]

Download as PDF tkelley on DSK3SPTVN1PROD with NOTICES Federal Register / Vol. 79, No. 182 / Friday, September 19, 2014 / Notices considered in light of the entire body of relevant and reliable scientific evidence, to substantiate that the representation is true. For purposes of this Part, competent and reliable scientific evidence is defined as tests, analyses, research, or studies that have been conducted by qualified persons in an objective manner and are generally accepted in the profession to yield accurate and reliable results. When that evidence consists of human clinical tests or studies, Dwyer must maintain all underlying or supporting data and documents that experts in the field generally would accept as relevant to an assessment of such testing. Part III of the proposed order prohibits Dwyer from misrepresenting the existence, contents, validity, results, conclusions, or interpretations of any test, study, or research in connection with the manufacturing, labeling, advertising, promotion, offering for sale, and sale or distribution of any Covered Product. Part IV provides a safe harbor for representations permitted under any tentative final or final standard promulgated by the Food and Drug Administration (‘‘FDA’’), any new drug application approved by the FDA, or FDA regulations pursuant to the Nutrition Labeling and Education Act of 1990 or the FDA Modernization Act of 1997. Triggered when the human clinical testing requirement in Part II applies, Part V of the proposed order requires Dwyer to secure and preserve all underlying or supporting data and documents generally accepted by experts in the field as relevant to an assessment of the test, such as protocols, instructions, participant-specific data, statistical analyses, and contracts with the test’s researchers. There is an exception for a ‘‘Reliably Reported’’ test, defined as a test published in a peerreviewed journal that was not conducted, controlled, or sponsored by Dwyer, his affiliates, or others in the manufacturing or supply chain. Also, the published report must provide sufficient information about the test for experts in the relevant field to assess the reliability of the results. Parts VI through IX of the proposed order require Dwyer to: Deliver a copy of the order to principals, officers, directors, and other employees having responsibilities with respect to the subject matter of the order; notify the Commission of changes in employment that might affect compliance obligations under the order; and file compliance reports with the Commission. VerDate Sep<11>2014 17:15 Sep 18, 2014 Jkt 232001 Part X provides that the order will terminate after twenty (20) years, with certain exceptions. The purpose of this analysis is to facilitate public comment on the proposed order, and it is not intended to constitute an official interpretation of the complaint or proposed order, or to modify the proposed order’s terms in any way. By direction of the Commission. Donald S. Clark, Secretary. [FR Doc. 2014–22388 Filed 9–18–14; 8:45 am] BILLING CODE 6750–01–P FEDERAL TRADE COMMISSION [File No. 122 3287] HealthyLife Sciences, LLC; Analysis To Aid Public Comment Federal Trade Commission. Proposed consent agreement. AGENCY: ACTION: The consent agreement in this matter settles alleged violations of federal law prohibiting unfair or deceptive acts or practices. The attached Analysis to Aid Public Comment describes both the allegations in the draft complaint and the terms of the consent order—embodied in the consent agreement—that would settle these allegations. SUMMARY: Comments must be received on or before October 14, 2014. ADDRESSES: Interested parties may file a comment at https:// ftcpublic.commentworks.com/ftc/ healthylifesciencesconsent online or on paper, by following the instructions in the Request for Comment part of the SUPPLEMENTARY INFORMATION section below. Write ‘‘In the Matter of HealthyLife Sciences, LLC—Consent Agreement; File No. 122 3287’’ on your comment and file your comment online at https://ftcpublic.commentworks.com/ ftc/healthylifesciencesconsent by following the instructions on the webbased form. If you prefer to file your comment on paper, mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW., Suite CC–5610 (Annex D), Washington, DC 20580, or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW., 5th Floor, Suite 5610 (Annex D), Washington, DC 20024. FOR FURTHER INFORMATION CONTACT: Elizabeth Nach, Bureau of Consumer Protection, (202–326–2611), 600 DATES: PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 56377 Pennsylvania Avenue NW., Washington, DC 20580. Pursuant to Section 6(f) of the Federal Trade Commission Act, 15 U.S.C. 46(f), and FTC Rule 2.34, 16 CFR 2.34, notice is hereby given that the above-captioned consent agreement containing consent order to cease and desist, having been filed with and accepted, subject to final approval, by the Commission, has been placed on the public record for a period of thirty (30) days. The following Analysis to Aid Public Comment describes the terms of the consent agreement, and the allegations in the complaint. An electronic copy of the full text of the consent agreement package can be obtained from the FTC Home Page (for September 11, 2014), on the World Wide Web, at https:// www.ftc.gov/os/actions.shtm. You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before October 14, 2014. Write ‘‘In the Matter of HealthyLife Sciences, LLC— Consent Agreement; File No. 122 3287’’ on your comment. Your comment— including your name and your state— will be placed on the public record of this proceeding, including, to the extent practicable, on the public Commission Web site, at https://www.ftc.gov/os/ publiccomments.shtm. As a matter of discretion, the Commission tries to remove individuals’ home contact information from comments before placing them on the Commission Web site. Because your comment will be made public, you are solely responsible for making sure that your comment does not include any sensitive personal information, like anyone’s Social Security number, date of birth, driver’s license number or other state identification number or foreign country equivalent, passport number, financial account number, or credit or debit card number. You are also solely responsible for making sure that your comment does not include any sensitive health information, like medical records or other individually identifiable health information. In addition, do not include any ‘‘[t]rade secret or any commercial or financial information which . . . is privileged or confidential,’’ as discussed in Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2). In particular, do not include competitively sensitive information such as costs, sales statistics, inventories, formulas, patterns, devices, manufacturing processes, or customer names. SUPPLEMENTARY INFORMATION: E:\FR\FM\19SEN1.SGM 19SEN1 56378 Federal Register / Vol. 79, No. 182 / Friday, September 19, 2014 / Notices tkelley on DSK3SPTVN1PROD with NOTICES 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/ healthylifesciencesconsent by following the instructions on the web-based form. If this Notice appears at https:// www.regulations.gov/#!home, you also may file a comment through that Web site. If you file your comment on paper, write ‘‘In the Matter of HealthyLife Sciences, LLC—Consent Agreement; File No. 122 3287’’ on your comment and on the envelope, and mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW., Suite CC–5610 (Annex D), Washington, DC 20580, or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW., 5th Floor, Suite 5610 (Annex D), Washington, DC 20024. If possible, submit your paper comment to the Commission by courier or overnight service. Visit the Commission Web site at https://www.ftc.gov to read this Notice and the news release describing it. The FTC Act and other laws that the Commission administers permit the collection of public comments to consider and use in this proceeding as appropriate. The Commission will consider all timely and responsive public comments that it receives on or before October 14, 2014. You can find more information, including routine uses permitted by the Privacy Act, in the Commission’s privacy policy, at https://www.ftc.gov/ftc/privacy.htm. Analysis of Proposed Consent Order To Aid Public Comment The Federal Trade Commission (‘‘FTC’’ or ‘‘Commission’’) has accepted, 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 17:15 Sep 18, 2014 Jkt 232001 subject to final approval, an agreement containing a consent order from HealthyLife Sciences, LLC (‘‘HealthyLife Sciences’’). The proposed consent order (‘‘proposed order’’) has been placed on the public record for thirty (30) days for receipt of comments by interested persons. Comments received during this period will become part of the public record. After thirty (30) days, the Commission will again review the agreement and the comments received, and will decide whether it should withdraw from the agreement or make final the agreement’s proposed order. This matter involves HealthyLife Science’s advertising for its Healthe Trim line of weight-loss dietary supplements (‘‘Healthe Trim’’). The complaint alleges that the company violated Sections 5(a) and 12 of the Federal Trade Commission Act by making false or unsubstantiated representations that Healthe Trim would cause rapid and substantial weight loss, including as much as 35, 130, and 165 pounds. It also claimed that users would lose weight without dieting, and that Healthe Trim would burn fat, increase metabolism, and suppress appetite. The complaint also alleges that HealthyLife Sciences violated Sections 5(a) and 12 by falsely representing that Healthe Trim is clinically proven to cause weight loss. The proposed order includes injunctive relief that prohibits these alleged violations and fences in similar and related violations. For purposes of the order, ‘‘Covered Product’’ means any dietary supplement, food, or drug. Part I of the proposed order bans HLS from making any of the seven ‘‘gut check’’ weight loss claims that the Commission has publicly advised are always false, specifically that any dietary supplement, over-the-counter drug, or patch, cream, wrap, or other product worn on the body or rubbed into the skin: (1) Causes weight loss of two pounds or more a week for a month or more without dieting or exercise; (2) causes substantial weight loss no matter what or how much the user eats; (3) causes permanent weight loss; (4) blocks the absorption of fat or calories to enable users to lose substantial weight; (5) safely enables users to lose more than three pounds per week for more than four weeks; (6) causes substantial weight loss for all users; or (7) causes substantial weight loss by wearing a product on the body or rubbing it into the skin. Part II of the proposed order prohibits HLS from making claims that any Covered Product causes weight loss, causes substantial or rapid weight loss, PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 causes weight loss without the need to diet or make lifestyle changes, burns fat or causes fat loss, boosts metabolism, or suppresses appetite, unless it possesses and relies upon competent and reliable scientific evidence, defined as at least two adequate and well-controlled human clinical studies. The studies must have been conducted by qualified persons, and have been randomized, double-blinded, and placebo-controlled. In addition, the company must maintain all underlying or supporting data that experts in weight-loss research generally would accept as relevant to an assessment of such testing. Part III of the proposed order prohibits any representation about the health benefits, performance, or efficacy of any Covered Product, unless it is nonmisleading and supported by competent and reliable scientific evidence that is sufficient in quality and quantity based on standards generally accepted in the relevant scientific fields, when considered in light of the entire body of relevant and reliable scientific evidence, to substantiate that the representation is true. For purposes of this Part, competent and reliable scientific evidence is defined as tests, analyses, research, or studies that have been conducted by qualified persons in an objective manner and are generally accepted in the profession to yield accurate and reliable results. When that evidence consists of human clinical tests or studies, HLS must maintain all underlying or supporting data and documents that experts in the field generally would accept as relevant to an assessment of such testing. Part IV of the proposed order prohibits HLS from misrepresenting the existence, contents, validity, results, conclusions, or interpretations of any test, study, or research in connection with the manufacturing, labeling, advertising, promotion, offering for sale, and sale or distribution of any Covered Product. Part V provides a safe harbor for representations permitted under any tentative final or final standard promulgated by the Food and Drug Administration (‘‘FDA’’), any new drug application approved by the FDA, or FDA regulations pursuant to the Nutrition Labeling and Education Act of 1990 or the FDA Modernization Act of 1997. Triggered when the human clinical testing requirement in Part II or III applies, Part VI of the proposed order requires HLS 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 human clinical test or E:\FR\FM\19SEN1.SGM 19SEN1 Federal Register / Vol. 79, No. 182 / Friday, September 19, 2014 / Notices study, such as protocols, instructions, participant-specific data, statistical analyses, and contracts with the test’s researchers. There is an exception for a ‘‘Reliably Reported’’ test, defined as a test published in a peer-reviewed journal that was not conducted, controlled, or sponsored by HLS, its affiliates, or others in the manufacturing and supply chain. Also, the published report must provide sufficient information about the test for experts in the relevant field to assess the reliability of the results. Parts VII through X of the proposed order require HLS to: Deliver a copy of the order to principals, officers, directors and other employees having responsibilities with respect to the subject matter of the order; notify the Commission of changes in corporate structure that might affect compliance obligations under the order; and file compliance reports with the Commission. Part XI provides that the order will terminate after twenty (20) years, with certain exceptions. The purpose of this analysis is to facilitate public comment on the proposed order, and it is not intended to constitute an official interpretation of the complaint or proposed order, or to modify the proposed order’s terms in any way. By direction of the Commission. Donald S. Clark, Secretary. [FR Doc. 2014–22402 Filed 9–18–14; 8:45 am] BILLING CODE 6750–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifiers: CMS–10137, CMS– 10305, CMS–10068 and CMS–10343] Agency Information Collection Activities: Submission for OMB Review; Comment Request ACTION: Notice. The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS’ intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow tkelley on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:15 Sep 18, 2014 Jkt 232001 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency’s functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. DATES: Comments on the collection(s) of information must be received by the OMB desk officer by October 20, 2014. ADDRESSES: When commenting on the proposed information collections, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be received by the OMB desk officer via one of the following transmissions: OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk Officer, Fax Number: (202) 395–5806 OR Email: OIRA_submission@omb.eop.gov. To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following: 1. Access CMS’ Web site address at https://www.cms.hhs.gov/Paperwork ReductionActof1995. 2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to Paperwork@cms.hhs.gov. 3. Call the Reports Clearance Office at (410) 786–1326. FOR FURTHER INFORMATION CONTACT: Reports Clearance Office at (410) 786– 1326. SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501–3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term ‘‘collection of information’’ is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 56379 reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice that summarizes the following proposed collection(s) of information for public comment: 1. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Solicitation for Applications for Medicare Prescription Drug Plan 2015 Contracts; Use: The information will be collected under the solicitation of proposals from PDP, MA– PD, Cost Plan, PACE, and EGWP applicants. We will use the information to ensure that applicants meet our requirements and support the determination of contract awards. Participation in the Part D program is voluntary in nature. Only organizations that are interested in participating in the program will respond to the solicitation. The MA–PDs that voluntarily participate in the Part C program must submit a Part D application and successful bid. Form Number: CMS– 10137 (OMB control number: 0938– 0936); Frequency: Yearly; Affected Public: Private sector—Business or other for-profits and Not-for-profit institutions; Number of Respondents: 254; Total Annual Responses: 254; Total Annual Hours: 2,193. (For policy questions regarding this collection contact Arianne Spaccarelli at 410–786– 5715). 2. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Medicare Part C and Part D Data Validation; Use: Organizations contracted to offer Medicare Part C and Part D benefits are required to report data to us on a variety of measures. For the data to be useful for monitoring and performance measurement, the data must be reliable, valid, complete, and comparable among sponsoring organizations. To meet this goal, we have developed reporting standards and data validation specifications with respect to the Part C and Part D reporting requirements. These standards provide a review process for Medicare Advantage Organizations, Cost Plans, and Part D sponsors to use to conduct data validation checks on their reported Part C and Part D data. The currently approved information collection is being revised to reflect decreases in the number of reporting sections being validated and an increase in the average number of data elements per reporting section for 2015–2017. The package has been revised subsequent to the publication of the 60-day Federal E:\FR\FM\19SEN1.SGM 19SEN1

Agencies

[Federal Register Volume 79, Number 182 (Friday, September 19, 2014)]
[Notices]
[Pages 56377-56379]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-22402]


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

FEDERAL TRADE COMMISSION

[File No. 122 3287]


HealthyLife Sciences, LLC; Analysis To Aid Public Comment

AGENCY: Federal Trade Commission.

ACTION: Proposed consent agreement.

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

SUMMARY: The consent agreement in this matter settles alleged 
violations of federal law prohibiting unfair or deceptive acts or 
practices. The attached Analysis to Aid Public Comment describes both 
the allegations in the draft complaint and the terms of the consent 
order--embodied in the consent agreement--that would settle these 
allegations.

DATES: Comments must be received on or before October 14, 2014.

ADDRESSES: Interested parties may file a comment at https://ftcpublic.commentworks.com/ftc/healthylifesciencesconsent online or on 
paper, by following the instructions in the Request for Comment part of 
the SUPPLEMENTARY INFORMATION section below. Write ``In the Matter of 
HealthyLife Sciences, LLC--Consent Agreement; File No. 122 3287'' on 
your comment and file your comment online at https://ftcpublic.commentworks.com/ftc/healthylifesciencesconsent by following 
the instructions on the 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: Elizabeth Nach, Bureau of Consumer 
Protection, (202-326-2611), 600 Pennsylvania Avenue NW., Washington, DC 
20580.

SUPPLEMENTARY INFORMATION: Pursuant to Section 6(f) of the Federal 
Trade Commission Act, 15 U.S.C. 46(f), and FTC Rule 2.34, 16 CFR 2.34, 
notice is hereby given that the above-captioned consent agreement 
containing consent order to cease and desist, having been filed with 
and accepted, subject to final approval, by the Commission, has been 
placed on the public record for a period of thirty (30) days. The 
following Analysis to Aid Public Comment describes the terms of the 
consent agreement, and the allegations in the complaint. An electronic 
copy of the full text of the consent agreement package can be obtained 
from the FTC Home Page (for September 11, 2014), on the World Wide Web, 
at https://www.ftc.gov/os/actions.shtm.
    You can file a comment online or on paper. For the Commission to 
consider your comment, we must receive it on or before October 14, 
2014. Write ``In the Matter of HealthyLife Sciences, LLC--Consent 
Agreement; File No. 122 3287'' on your comment. Your comment--including 
your name and your state--will be placed on the public record of this 
proceeding, including, to the extent practicable, on the public 
Commission Web site, at https://www.ftc.gov/os/publiccomments.shtm. As a 
matter of discretion, the Commission tries to remove individuals' home 
contact information from comments before placing them on the Commission 
Web site.
    Because your comment will be made public, you are solely 
responsible for making sure that your comment does not include any 
sensitive personal information, like anyone's Social Security number, 
date of birth, driver's license number or other state identification 
number or foreign country equivalent, passport number, financial 
account number, or credit or debit card number. You are also solely 
responsible for making sure that your comment does not include any 
sensitive health information, like medical records or other 
individually identifiable health information. In addition, do not 
include any ``[t]rade secret or any commercial or financial information 
which . . . is privileged or confidential,'' as discussed in Section 
6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 16 CFR 
4.10(a)(2). In particular, do not include competitively sensitive 
information such as costs, sales statistics, inventories, formulas, 
patterns, devices, manufacturing processes, or customer names.

[[Page 56378]]

    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/healthylifesciencesconsent by following the instructions on the 
web-based form. If this Notice appears at https://www.regulations.gov/#!home, you also may file a comment through that Web site.
    If you file your comment on paper, write ``In the Matter of 
HealthyLife Sciences, LLC--Consent Agreement; File No. 122 3287'' on 
your comment and on the envelope, and mail your comment to the 
following address: Federal Trade Commission, Office of the Secretary, 
600 Pennsylvania Avenue NW., Suite CC-5610 (Annex D), Washington, DC 
20580, or deliver your comment to the following address: Federal Trade 
Commission, Office of the Secretary, Constitution Center, 400 7th 
Street SW., 5th Floor, Suite 5610 (Annex D), Washington, DC 20024. If 
possible, submit your paper comment to the Commission by courier or 
overnight service.
    Visit the Commission Web site at https://www.ftc.gov to read this 
Notice and the news release describing it. The FTC Act and other laws 
that the Commission administers permit the collection of public 
comments to consider and use in this proceeding as appropriate. The 
Commission will consider all timely and responsive public comments that 
it receives on or before October 14, 2014. You can find more 
information, including routine uses permitted by the Privacy Act, in 
the Commission's privacy policy, at https://www.ftc.gov/ftc/privacy.htm.

Analysis of Proposed Consent Order To Aid Public Comment

    The Federal Trade Commission (``FTC'' or ``Commission'') has 
accepted, subject to final approval, an agreement containing a consent 
order from HealthyLife Sciences, LLC (``HealthyLife Sciences'').
    The proposed consent order (``proposed order'') has been placed on 
the public record for thirty (30) days for receipt of comments by 
interested persons. Comments received during this period will become 
part of the public record. After thirty (30) days, the Commission will 
again review the agreement and the comments received, and will decide 
whether it should withdraw from the agreement or make final the 
agreement's proposed order.
    This matter involves HealthyLife Science's advertising for its 
Healthe Trim line of weight-loss dietary supplements (``Healthe 
Trim''). The complaint alleges that the company violated Sections 5(a) 
and 12 of the Federal Trade Commission Act by making false or 
unsubstantiated representations that Healthe Trim would cause rapid and 
substantial weight loss, including as much as 35, 130, and 165 pounds. 
It also claimed that users would lose weight without dieting, and that 
Healthe Trim would burn fat, increase metabolism, and suppress 
appetite. The complaint also alleges that HealthyLife Sciences violated 
Sections 5(a) and 12 by falsely representing that Healthe Trim is 
clinically proven to cause weight loss.
    The proposed order includes injunctive relief that prohibits these 
alleged violations and fences in similar and related violations. For 
purposes of the order, ``Covered Product'' means any dietary 
supplement, food, or drug.
    Part I of the proposed order bans HLS from making any of the seven 
``gut check'' weight loss claims that the Commission has publicly 
advised are always false, specifically that any dietary supplement, 
over-the-counter drug, or patch, cream, wrap, or other product worn on 
the body or rubbed into the skin: (1) Causes weight loss of two pounds 
or more a week for a month or more without dieting or exercise; (2) 
causes substantial weight loss no matter what or how much the user 
eats; (3) causes permanent weight loss; (4) blocks the absorption of 
fat or calories to enable users to lose substantial weight; (5) safely 
enables users to lose more than three pounds per week for more than 
four weeks; (6) causes substantial weight loss for all users; or (7) 
causes substantial weight loss by wearing a product on the body or 
rubbing it into the skin.
    Part II of the proposed order prohibits HLS from making claims that 
any Covered Product causes weight loss, causes substantial or rapid 
weight loss, causes weight loss without the need to diet or make 
lifestyle changes, burns fat or causes fat loss, boosts metabolism, or 
suppresses appetite, unless it possesses and relies upon competent and 
reliable scientific evidence, defined as at least two adequate and 
well-controlled human clinical studies. The studies must have been 
conducted by qualified persons, and have been randomized, double-
blinded, and placebo-controlled. In addition, the company must maintain 
all underlying or supporting data that experts in weight-loss research 
generally would accept as relevant to an assessment of such testing.
    Part III of the proposed order prohibits any representation about 
the health benefits, performance, or efficacy of any Covered Product, 
unless it is non-misleading and supported by competent and reliable 
scientific evidence that is sufficient in quality and quantity based on 
standards generally accepted in the relevant scientific fields, when 
considered in light of the entire body of relevant and reliable 
scientific evidence, to substantiate that the representation is true. 
For purposes of this Part, competent and reliable scientific evidence 
is defined as tests, analyses, research, or studies that have been 
conducted by qualified persons in an objective manner and are generally 
accepted in the profession to yield accurate and reliable results. When 
that evidence consists of human clinical tests or studies, HLS must 
maintain all underlying or supporting data and documents that experts 
in the field generally would accept as relevant to an assessment of 
such testing.
    Part IV of the proposed order prohibits HLS from misrepresenting 
the existence, contents, validity, results, conclusions, or 
interpretations of any test, study, or research in connection with the 
manufacturing, labeling, advertising, promotion, offering for sale, and 
sale or distribution of any Covered Product.
    Part V provides a safe harbor for representations permitted under 
any tentative final or final standard promulgated by the Food and Drug 
Administration (``FDA''), any new drug application approved by the FDA, 
or FDA regulations pursuant to the Nutrition Labeling and Education Act 
of 1990 or the FDA Modernization Act of 1997.
    Triggered when the human clinical testing requirement in Part II or 
III applies, Part VI of the proposed order requires HLS 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 
human clinical test or

[[Page 56379]]

study, such as protocols, instructions, participant-specific data, 
statistical analyses, and contracts with the test's researchers. There 
is an exception for a ``Reliably Reported'' test, defined as a test 
published in a peer-reviewed journal that was not conducted, 
controlled, or sponsored by HLS, its affiliates, or others in the 
manufacturing and supply chain. Also, the published report must provide 
sufficient information about the test for experts in the relevant field 
to assess the reliability of the results.
    Parts VII through X of the proposed order require HLS to: Deliver a 
copy of the order to principals, officers, directors and other 
employees having responsibilities with respect to the subject matter of 
the order; notify the Commission of changes in corporate structure that 
might affect compliance obligations under the order; and file 
compliance reports with the Commission.
    Part XI provides that the order will terminate after twenty (20) 
years, with certain exceptions.
    The purpose of this analysis is to facilitate public comment on the 
proposed order, and it is not intended to constitute an official 
interpretation of the complaint or proposed order, or to modify the 
proposed order's terms in any way.

    By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. 2014-22402 Filed 9-18-14; 8:45 am]
BILLING CODE 6750-01-P
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