[Federal Register Volume 79, Number 106 (Tuesday, June 3, 2014)]
[Notices]
[Pages 31939-31941]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-12734]


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FEDERAL TRADE COMMISSION

[File No. 122 3255]


Lornamead, Inc.; Analysis of Proposed Consent Order 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 of Proposed Consent Order 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 June 27, 2014.

ADDRESSES: Interested parties may file a comment at https://ftcpublic.commentworks.com/ftc/lornameadconsent online or on paper, by 
following the instructions in the Request for Comment part of the 
SUPPLEMENTARY INFORMATION section below. Write ``Lornamead, Inc.--
Consent Agreement; File No. 122 3255'' on your comment and file your 
comment online at https://ftcpublic.commentworks.com/ftc/lornameadconsent 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: Linda K. Badger, FTC Western Region, 
San Francisco (415-848-5100), 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 May 28, 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 June 27, 2014. 
Write ``Lornamead, Inc.--Consent Agreement; File No. 122 3255'' on your 
comment.

[[Page 31940]]

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 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/lornameadconsent 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 ``Lornamead, Inc.--Consent 
Agreement; File No. 122 3255'' 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 June 27, 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 Lornamead, 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 respondent's advertising, marketing, and sale 
of a line of products including ``Lice Shield Shampoo & Conditioner in 
1,'' ``Lice Shield Leave In Spray,'' and ``Lice Shield Gear Guard'' 
(collectively, ``Lice Shield products''). Respondent marketed Lice 
Shield products in retail stores and on the Internet. According to the 
FTC's proposed complaint, respondent promoted Lice Shield products, 
which contain essential oils such as citronella, as a way to avoid, or 
to reduce the risk of, getting a head lice infestation 
(``pediculosis''). Lice Shield products are intended strictly as a 
means to deter lice, and not as a means to treat an existing head lice 
infestation. These products do not kill head lice or their eggs.
    The proposed complaint alleges that respondent made several claims 
in various advertisements regarding the efficacy of Lice Shield 
products to deter lice, including that applying the products to hair or 
head gear: prevents head lice infestations; decreases the likelihood of 
an infestation by over 80%; dramatically reduces the likelihood of an 
infestation during an outbreak; or reduces the likelihood of an 
infestation during an outbreak. Respondent also allegedly represented 
that Lice Shield products are more effective when consumers use both 
the shampoo and the leave-in spray. The proposed complaint alleges that 
these claims are unsubstantiated and thus violate the FTC Act. Further, 
the proposed complaint alleges that respondent represented, in various 
advertisements, that scientific tests prove that, when used as 
directed, Lice Shield products will significantly reduce the likelihood 
or chance of a head lice infestation. The complaint alleges that this 
claim is false and thus violates the FTC Act.
    The proposed consent order contains provisions designed to prevent 
respondent from engaging in similar acts or practices in the future. 
Part I of the order prohibits respondent from representing that use of 
any drug, cosmetic, or pesticide is effective in: (a) Preventing 
pediculosis, (b) eliminating or reducing the risk of pediculosis by a 
specific percentage or amount, or (c) repelling all lice, or a specific 
percentage or amount of lice from a person's head, unless the 
representation is non-misleading, and, at the time it is made, 
respondent possesses and relies upon competent and reliable scientific 
evidence that substantiates that the representation is true. For 
purposes of this Part I, competent and reliable scientific evidence 
shall consist of at least one adequate and well-controlled human 
clinical study of the product, or of an essentially equivalent product, 
that conforms to an acceptable design and protocol 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 II of the proposed order prohibits any representation, other 
than those covered under Part I, that use of any drug, cosmetic, or 
pesticide, will reduce the risk of a head lice infestation or repel 
lice, unless the representation is non-misleading, and, at the time of

[[Page 31941]]

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 this Part, competent and 
reliable scientific evidence means 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 III of the proposed order prohibits any representation, other 
than those covered under Part I, about the health benefits of any drug, 
cosmetic, or pesticide, unless the representation is non-misleading, 
and at the time of making such representation, the 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 this 
Part, competent and reliable scientific evidence means 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 claim 
that scientific tests prove that use of Lice Shield products 
significantly reduces the risk or likelihood of a head lice 
infestation. Part IV prohibits respondent from misrepresenting the 
existence, contents, validity, results, conclusions, or interpretations 
of any test, study, or research, when advertising any drug, cosmetic, 
or pesticide.
    Part V of the proposed order states that the order does not 
prohibit respondent from making representations for any drug that are 
permitted in labeling for that drug under any tentative or final 
standard promulgated by the Food and Drug Administration (``FDA''), or 
under any new drug application approved by the FDA.
    Part VI of the proposed order requires respondent to pay five 
hundred thousand dollars ($500,000) to the Commission. This payment 
shall be deposited in the United States Treasury as disgorgement.
    Parts VII, VIII, IX, and X of the proposed order require respondent 
to keep copies of relevant advertisements and materials substantiating 
claims made in the advertisements; 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 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. It is not intended to constitute an official 
interpretation of the proposed order or to modify its terms in any way.

    By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. 2014-12734 Filed 6-2-14; 8:45 am]
BILLING CODE 6750-01-P