[Federal Register: October 15, 2007 (Volume 72, Number 198)]
[Notices]
[Page 58304-58305]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15oc07-47]
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FEDERAL TRADE COMMISSION
[File No. 072 3145]
Health Science International, Inc., 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 ``Health Science International, File No. 071
3145,'' 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 mailed or delivered to the following address:
Federal Trade Commission/Office of the Secretary, Room 135-H, 600
Pennsylvania Avenue, NW, Washington, D.C. 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 email box: consentagreement@ftc.gov.
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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).
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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 http://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 website. 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, D.C. 20580.
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, N.W., Washington,
D.C. 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 Health Science International, Inc., a corporation, and David
Martin, individually and as an officer of Health Science International
( 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 Serenity for
Women Natural Progesterone Cream, a transdermal cream that, according
to its label, contains, among other ingredients, natural progesterone.
According to the FTC complaint, respondents represented that Serenity
for Women Natural Progesterone Cream: (1) is effective in preventing,
treating, or curing osteoporosis; (2) is effective in preventing or
reducing the risk of estrogen-inducted endometrial (uterine) cancer;
and (3) does not increase the user's risk of developing breast cancer
and/or is 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 complaint also alleges
that respondents misrepresented that clinical testing proved that
Serenity for Women Natural Progesterone is effective in preventing,
treating, or curing osteoporosis. 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
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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. E7-20277 Filed 10-12-07: 8:45 am]
BILLING CODE 6750-01-S