Federal Trade Commission.ÿ09ÿ09ÿ09 ÿ09ÿ09ÿ09
Proposed Consent Agreement.ÿ09ÿ09ÿ09
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.ÿ09ÿ09ÿ09 ÿ09ÿ09ÿ09
Comments must be received on or before November 7, 2007.ÿ09ÿ09ÿ09
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).
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
Laura DeMartino (202) 326-3030, Bureau of Consumer Protection, Room NJ-2122, 600 Pennsylvania Avenue, NW, Washington, D.C. 20580.ÿ09ÿ09ÿ09 ÿ09ÿ09 ÿ09ÿ09
Pursuant to section 6(f) of the Federal Trade Commission Act, 38 Stat. 721, 15 U.S.C. 46(f), and § 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
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
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”).ÿ09ÿ09ÿ09
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.ÿ09ÿ09ÿ09
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.ÿ09ÿ09ÿ09
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.ÿ09ÿ09ÿ09
Part II of the proposed order prevents respondents from misrepresenting the existence, contents, validity, results, conclusions, or interpretations of any test, study, or research.ÿ09ÿ09ÿ09
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
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.ÿ09ÿ09ÿ09
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.ÿ09ÿ09ÿ09
By direction of the Commission.ÿ09ÿ09ÿ09