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


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FEDERAL TRADE COMMISSION

[File No. 122 3287]


HealthyLife Sciences, LLC; 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 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 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 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 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.

[[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.
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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/healthylifesciencesconsent 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 
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 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 14, 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 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