Federal Register: October 15, 2007 (Volume 72, Number 198)
DOCID: fr15oc07-48 FR Doc E7-20276
FEDERAL TRADE COMMISSION
Federal Trade Commission
File No. ID: [File No. 072 3146]
ACTION: Prohibited trade practices:
DOCUMENT ACTION: Proposed Consent Agreement.
Shelly Black, individually and doing business as Progesterone Advocates Network; Analysis of Proposed Consent Order to Aid Public Comment
DATES: Comments must be received on or before November 7, 2007.
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 orderembodied in the consent agreementthat would settle these allegations.
Progesterone Advocates Network,
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 abovecaptioned 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 130H, 600 Pennsylvania Avenue, N.W., Washington, D.C. 20580, either in person or by calling (202) 3262222.
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 Shelly Black, an individual trading and doing business as Progesterone Advocates Network (``respondent'').
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 Nature's Precise Cream, a transdermal cream that, according to its label, contains, among other ingredients, natural progesterone. According to the FTC complaint, respondent represented that Nature's Precise Cream: (1) is effective in preventing, treating, or curing osteoporosis; (2) is effective in preventing or reducing the risk of estrogeninducted 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 respondent failed to have substantiation for these claims. The proposed consent order contains provisions designed to prevent respondent 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 healthrelated service or program is effective in preventing, treating, or curing osteoporosis, in preventing or reducing the risk of estrogeninduced 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 respondent 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 respondent 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 respondent to keep copies of relevant advertisements and materials substantiating claims made in the advertisements; to provide copies of the order to certain of her 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,
[FR Doc. E720276 Filed 101207: 8:45 am]
BILLING CODE 675001S
FOR FURTHER INFORMATION CONTACT
Laura DeMartino (202) 326-3030, Bureau of Consumer Protection, Room NJ2122, 600 Pennsylvania Avenue, NW, Washington, D.C. 20580.