[Federal Register Volume 72, Number 198 (Monday, October 15, 2007)]
[Notices]
[Pages 58302-58303]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-20272]


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FEDERAL TRADE COMMISSION

[File No. 072 3144]


The Green Willow Tree LLC, et al.; 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 or unfair methods of competition. 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 November 7, 2007.

ADDRESSES: Interested parties are invited to submit written comments. 
Comments should refer to ``Green Willow Tree, File No. 071 3144,'' to 
facilitate the organization of comments. A comment filed in paper form 
should include this reference both in the text and on the envelope, and 
should be

[[Page 58303]]

mailed or delivered to the following address: Federal Trade Commission/
Office of the Secretary, Room 135-H, 600 Pennsylvania Avenue, NW., 
Washington, DC 20580. Comments containing confidential material must be 
filed in paper form, must be clearly labeled ``Confidential,'' and must 
comply with Commission Rule 4.9(c). 16 CFR 4.9(c) (2005).\1\ The FTC is 
requesting that any comment filed in paper form be sent by courier or 
overnight service, if possible, because U.S. postal mail in the 
Washington area and at the Commission is subject to delay due to 
heightened security precautions. Comments that do not contain any 
nonpublic information may instead be filed in electronic form as part 
of or as an attachment to email messages directed to the following e-
mail box: [email protected].
    The FTC Act and other laws the Commission administers permit the 
collection of public comments to consider and use in this proceeding as 
appropriate. All timely and responsive public comments, whether filed 
in paper or electronic form, will be considered by the Commission, and 
will be available to the public on the FTC website, to the extent 
practicable, at www.ftc.gov. As a matter of discretion, the FTC makes 
every effort to remove home contact information for individuals from 
the public comments it receives before placing those comments on the 
FTC Web site. More information, including routine uses permitted by the 
Privacy Act, may be found in the FTC's privacy policy, at http://www.ftc.gov/ftc/privacy.htm.

FOR FURTHER INFORMATION CONTACT: Laura DeMartino (202) 326-3030, Bureau 
of Consumer Protection, Room NJ-2122, 600 Pennsylvania Avenue, NW., 
Washington, DC 20580.
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    \1\ The comment must be accompanied by an explicit request for 
confidential treatment, including the factual and legal basis for 
the request, and must identify the specific portions of the comment 
to be withheld from the public record. The request will be granted 
or denied by the Commission's General Counsel, consistent with 
applicable law and the public interest. See Commission Rule 4.9(c), 
16 CFR 4.9(c).

SUPPLEMENTARY INFORMATION: Pursuant to section 6(f) of the Federal 
Trade Commission Act, 38 Stat. 721, 15 U.S.C. 46(f), and Sec.  2.34 of 
the Commission Rules of Practice, 16 CFR 2.34, notice is hereby given 
that the above-captioned consent agreement containing a 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 October 5, 2007), on the World Wide Web, at http://www.ftc.gov/os/2007/10/index.htm. A paper copy can be obtained from the FTC Public 
Reference Room, Room 130-H, 600 Pennsylvania Avenue, NW., Washington, 
DC 20580, either in person or by calling (202) 326-2222.
    Public comments are invited, and may be filed with the Commission 
in either paper or electronic form. All comments should be filed as 
prescribed in the ADDRESSES section above, and must be received on or 
before the date specified in the DATES section.

Analysis of Agreement Containing 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 The Green Willow Tree LLC, a limited liability company, and 
Robert Burns, individually and as a member and manager of The Green 
Willow Tree (together, ``respondents'').
    The proposed consent order has been placed on the public record for 
thirty (30) days for reception 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 the advertising and promotion of Progesta Care 
Plus, EST, and Restored Balance, transdermal creams that, according to 
their labels, contain, among other ingredients, natural progesterone. 
According to the FTC complaint, respondents represented that Progesta 
Care Plus, EST, and Restored Balance: (1) Are effective in preventing, 
treating, or curing osteoporosis; (2) are effective in preventing or 
reducing the risk of estrogen-inducted endometrial (uterine) cancer; 
and (3) do not increase the user's risk of developing breast cancer 
and/or are effective in preventing or reducing the user's risk of 
developing breast cancer. The complaint alleges that respondents failed 
to have substantiation for these claims. The proposed consent order 
contains provisions designed to prevent respondents from engaging in 
similar acts and practices in the future.
    Part I of the proposed order requires respondents to have competent 
and reliable scientific evidence substantiating claims that any 
progesterone product or any other dietary supplement, food, drug, 
device or health-related service or program is effective in preventing, 
treating, or curing osteoporosis, in preventing or reducing the risk of 
estrogen-induced endometrial cancer or breast cancer, or in the 
mitigation, treatment, prevention, or cure of any disease, illness, or 
health condition; that it does not increase the user's risk of 
developing breast cancer, is safe for human use, or has no side 
effects; or about its health benefits, performance, efficacy, safety, 
or side effects.
    Part II of the proposed order prevents respondents from 
misrepresenting the existence, contents, validity, results, 
conclusions, or interpretations of any test, study, or research.
    Part III of the proposed order provides that the order does not 
prohibit respondents from making representations for any drug that are 
permitted in labeling for the drug under any tentative final or final 
Food and Drug Administration (``FDA'') standard or under any new drug 
application approved by the FDA; representations for any medical device 
that are permitted in labeling under any new medical device application 
approved by the FDA; and representations for any product that are 
specifically permitted in labeling for that product by regulations 
issued by the FDA under the Nutrition Labeling and Education Act of 
1990.
    Parts IV through VIII require respondents to keep copies of 
relevant advertisements and materials substantiating claims made in the 
advertisements; to provide copies of the order to certain of their 
personnel; to notify the Commission of changes in corporate structure 
and changes in employment that might affect compliance obligations 
under the order; and to file compliance reports with the Commission. 
Part IX provides that the order will terminate after twenty (20) years 
under certain circumstances.
    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 agreement and proposed order or to modify in any 
way their terms.
    By direction of the Commission.

Donald S. Clark,
Secretary.
[FR Doc. E7-20272 Filed 10-12-07: 8:45 am]
[BILLING CODE 6750-01-S]