Federal Trade Commission.
Proposed Consent Agreement.
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 complaint and the terms of the consent order—embodied in the consent agreement—that would settle these allegations.
Comments must be received on or before February 19, 2008.
Interested parties are invited to submit written comments. Comments should refer to “Herbs Nutrition, Docket No. 9325,” 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, N.W., 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 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: firstname.lastname@example.org.
FOR FURTHER INFORMATION CONTACT:
Gregory Ashe (202-326-3719) or Janice Frankle (202-326-3022), Bureau of Consumer Protection, 600 Pennsylvania Avenue, NW., Washington, D.C. 20580.End Further Info End Preamble Start Supplemental Information
Pursuant to section 6(f) of the Federal Trade Commission Act, 38 Stat. 721, 15 U.S.C. 46(f), and § 3.25(f) of the Commission Rules of Practice, 16 CFR 3.25(f), 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 January 17, 2008), on the World Wide Web, at http://www.ftc.gov/os/2008/01/index.htm. A paper copy can be obtained from the FTC Public Reference Room, Room 130-H, 600 Pennsylvania Avenue, NW, 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 Herbs Nutrition Corporation, a corporation, and Syed Jafry, individually and as an officer of Herbs Nutrition (together, “respondents”). The proposed order resolves the allegations of the complaint issued against the respondents on September 28, 2007.
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 Eternal Woman Progesterone Cream and Pro-Gest Body Cream, transdermal creams that, according to their respective labels, contain, among other ingredients, Start Printed Page 4231natural progesterone. According to the Commission’s complaint, the respondents represented that Eternal Woman Progesterone Cream and Pro-Gest Body Cream: (1) were effective in preventing, treating, or curing osteoporosis; (2) were effective in preventing or reducing the risk of estrogen-inducted endometrial (uterine) cancer; and (3) did not increase the user’s risk of developing breast cancer and/or were effective in preventing or reducing the user’s risk of developing breast cancer. The complaint alleged that the respondents failed to have substantiation for these claims. The proposed consent order contains provisions designed to prevent the respondents from engaging in similar acts and practices in the future.
Part I of the proposed order requires the 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 the 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 the 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 the 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.Start Signature
Donald S. Clark
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).Back to Citation
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