Professional Documents
Culture Documents
during this period will become part of for any medical device that are in the text and on the envelope, and
the public record. After thirty (30) days, permitted in labeling under any new should be mailed or delivered to the
the Commission will again review the medical device application approved by following address: Federal Trade
agreement and the comments received the FDA; and representations for any Commission/Office of the Secretary,
and will decide whether it should product that are specifically permitted Room 135-H, 600 Pennsylvania Avenue,
withdraw from the agreement or make in labeling for that product by NW, Washington, D.C. 20580.
final the agreement’s proposed order. regulations issued by the FDA under the Comments containing confidential
This matter involves the advertising Nutrition Labeling and Education Act of material must be filed in paper form,
and promotion of ProBalance and 1990. must be clearly labeled ‘‘Confidential,’’
ProBalance Plus, transdermal creams Parts IV through VIII require and must comply with Commission
that, according to their labels, contain, respondents to keep copies of relevant Rule 4.9(c). 16 CFR 4.9(c) (2005).1 The
among other ingredients, natural advertisements and materials FTC is requesting that any comment
progesterone. According to the FTC substantiating claims made in the filed in paper form be sent by courier or
complaint, respondents represented that advertisements; to provide copies of the overnight service, if possible, because
ProBalance and ProBalance Plus: (1) Are order to certain of their personnel; to U.S. postal mail in the Washington area
effective in preventing, treating, or notify the Commission of changes in and at the Commission is subject to
curing osteoporosis; (2) are effective in corporate structure and changes in delay due to heightened security
preventing or reducing the risk of employment that might affect precautions. Comments that do not
estrogen-inducted endometrial (uterine) compliance obligations under the order; contain any nonpublic information may
cancer; and (3) do not increase the and to file compliance reports with the instead be filed in electronic form as
user’s risk of developing breast cancer Commission. Part IX provides that the part of or as an attachment to email
and/or are effective in preventing or order will terminate after twenty (20) messages directed to the following email
reducing the user’s risk of developing years under certain circumstances. box: consentagreement@ftc.gov.
breast cancer. The complaint alleges The purpose of this analysis is to The FTC Act and other laws the
that respondents failed to have facilitate public comment on the Commission administers permit the
substantiation for these claims. The proposed order. It is not intended to collection of public comments to
complaint also alleges that respondents constitute an official interpretation of consider and use in this proceeding as
misrepresented that clinical testing the agreement and proposed order or to appropriate. All timely and responsive
proved that ProBalance and ProBalance modify in any way their terms. public comments, whether filed in
Plus are effective in preventing or By direction of the Commission. paper or electronic form, will be
reducing the risk of estrogen-induced considered by the Commission, and will
Donald S. Clark,
endometrial (uterine) cancer and breast be available to the public on the FTC
cancer. The proposed consent order Secretary. website, to the extent practicable, at
contains provisions designed to prevent [FR Doc. E7–20275 Filed 10–12–07: 8:45 am] www.ftc.gov. As a matter of discretion,
respondents from engaging in similar [BILLING CODE 6750–01–S] the FTC makes every effort to remove
acts and practices in the future. home contact information for
Part I of the proposed order requires individuals from the public comments it
respondents to have competent and FEDERAL TRADE COMMISSION receives before placing those comments
reliable scientific evidence [File No. 072 3143] on the FTC website. More information,
substantiating claims that any including routine uses permitted by the
progesterone product or any other Merilou Barnekow, an individual Privacy Act, may be found in the FTC’s
dietary supplement, food, drug, device trading and doing business as privacy policy, at http://www.ftc.gov/
or health-related service or program is Women’s Menopause Health Center; ftc/privacy.htm.
effective in preventing, treating, or Analysis of Proposed Consent Order FOR FURTHER INFORMATION CONTACT:
curing osteoporosis, in preventing or to Aid Public Comment Laura DeMartino (202) 326-3030,
reducing the risk of estrogen-induced Bureau of Consumer Protection, Room
endometrial cancer or breast cancer, or AGENCY: Federal Trade Commission.
ACTION: Proposed Consent Agreement. NJ-2122, 600 Pennsylvania Avenue,
in the mitigation, treatment, prevention, NW, Washington, D.C. 20580.
or cure of any disease, illness, or health SUMMARY: The consent agreement in this SUPPLEMENTARY INFORMATION: Pursuant
condition; that it does not increase the matter settles alleged violations of to section 6(f) of the Federal Trade
user’s risk of developing breast cancer, federal law prohibiting unfair or Commission Act, 38 Stat. 721, 15 U.S.C.
is safe for human use, or has no side deceptive acts or practices or unfair 46(f), and § 2.34 of the Commission
effects; or about its health benefits, methods of competition. The attached Rules of Practice, 16 CFR 2.34, notice is
performance, efficacy, safety, or side Analysis to Aid Public Comment hereby given that the above-captioned
effects. describes both the allegations in the
Part II of the proposed order prevents consent agreement containing a consent
draft complaint and the terms of the order to cease and desist, having been
respondents from misrepresenting the
consent order—embodied in the consent filed with and accepted, subject to final
existence, contents, validity, results,
agreement—that would settle these approval, by the Commission, has been
conclusions, or interpretations of any
allegations. placed on the public record for a period
test, study, or research.
Part III of the proposed order provides DATES: Comments must be received on of thirty (30) days. The following
that the order does not prohibit or before November 7, 2007.
1 The comment must be accompanied by an
respondents from making ADDRESSES: Interested parties are
explicit request for confidential treatment,
representations for any drug that are invited to submit written comments.
sroberts on PROD1PC70 with NOTICES
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58308 Federal Register / Vol. 72, No. 198 / Monday, October 15, 2007 / Notices
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