Herbs Nutrition Corporation

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IN THE MATTER OF HERBS NUTRITION CORPORATION AND SYED M. JAFRY CONSENT ORDER, ETC., IN REGARD TO ALLEGED VIOLATIONS OF SEC. 5 AND 12 OF THE FEDERAL TRADE COMMISSION ACT Docket 9325; File No. 072 3147 Complaint, September 28, 2007 – Decision, February 21, 2008 This consent order addresses the advertising and promotion of Eternal Woman Progesterone Cream and Pro-Gest Body Cream, transdermal creams that respondents claimed were effective in preventing or treating osteoporosis and certain cancers. The Commission’s complaint alleged that the respondents failed to have substantiation for these claims. The 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. The order prevents the respondents from misrepresenting the existence, contents, validity, results, conclusions, or interpretations of any test, study, or research. Respondents are not prohibited from making representations for any drug, medical device, or other product that are permitted in labeling by the Food and Drug Administration. The order requires 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. Participants For the Commission: Gregory A. Ashe, Laura DeMartino, Janice P. Frankle, James A. Kohm, and Michael Ostheimer. For the Respondents: Not represented by counsel. VOLUME 145 Complaint COMPLAINT The Federal Trade Commission, having reason to believe that Herbs Nutrition Corporation, a corporation, and Syed M. Jafry, individually and as an officer of Herbs Nutrition Corporation (“Respondents”), have violated the provisions of the Federal Trade Commission Act, and it appearing to the Commission that this proceeding is in the public interest, alleges: 1. Respondent Herbs Nutrition Corporation is a California corporation with its principal office or place of business at 21712 Hawthorne Blvd #276, Torrance, California 90503. 2. Respondent Syed M. Jafry is an officer of Herbs Nutrition Corporation. Individually, or in concert with others, he formulates, directs, controls, or participates in the policies, acts, or practices of Herbs Nutrition Corporation, including the acts and practices alleged in this complaint. His principal office or place of business is the same as that of Herbs Nutrition Corporation. 3. The acts and practices of Respondents alleged in this complaint have been in or affecting commerce, as “commerce” is defined in Section 4 of the Federal Trade Commission Act. 4. Many women experience symptoms of menopause including hot flashes (also called flushes), night sweats, sleep disturbances, and painful intercourse. To relieve the symptoms of menopause, some doctors prescribe hormone therapy. This typically involves the use of either estrogen alone (for women who have had a hysterectomy) or (for women who have not had a hysterectomy) estrogen with an orally administered progestagen. Progestagen is a general term that includes progesterone (which is the progestagen produced by the human body or which can be synthesized as a drug) and progestins (which are synthetic forms of progestagens). A progestagen is added to estrogen to prevent hyperplasia (cell overgrowth) in the endometrium (lining of the uterus). This overgrowth can lead to endometrial (uterine) cancer. While progestagens decrease a woman’s risk of estrogen-induced HERBS NUTRITION CORPORATION 85 Complaint endometrial cancer, progestins have been found to increase a woman’s risk of developing breast cancer. 5. Respondents have advertised, offered for sale, sold, and distributed products to the public throughout the United States, including Eternal Woman Progesterone Cream and Pro-Gest Body Cream. Respondents advertise and offer the products for sale through the Internet site www.progesterone-cream.net. 6. For the purposes of Section 12 of the FTC Act, 15 U.S.C. § 52, Eternal Woman Progesterone Cream and Pro-Gest Body Cream are “drugs” as defined in Section 15(c) of the FTC Act, 15 U.S.C. § 55(c).

7. Eternal Woman Progesterone Cream is a drug labeled as containing Natural Progesterone USP from soy (500 mg per ounce) and other ingredients. A four ounce jar costs $18.93 plus shipping and handling, and a two ounce tube costs $9.50 plus shipping and handling. Pro-Gest Body Cream is a drug labeled as containing USP Progesterone. A 2-ounce tube costs $18.13 plus shipping and handling. Eternal Woman Progesterone Cream and Pro-Gest Body Cream are applied transdermally.

8. To induce consumers to purchase Eternal Woman Progesterone Cream and Pro-Gest Body Cream, Respondents have disseminated or have caused to be disseminated advertisements, including but not necessarily limited to the attached Exhibit A. These advertisements contain the following statements and depictions, among others, on Respondents’ website: A. Progesterone Cream contains NO synthetic hormones and thus can help you balance your hormones. Progesterone cream eliminates estrogen dominance and relieve your symptoms without dangerous side effects. (Exhibit A at 1.) VOLUME 145 Complaint B. Medical experts believe the out of balance hormones are due to the lack of progesterone in women. Clinical studies show that PMS, menopausal problems, breast cancer and fibrocystic breast have a direct relationship with estrogen dominance. Progesterone is needed for the proper function of the adrenal glands. Stress on the adrenal glands may lead to progesterone deficiency, often causing symptoms of nervous disorders, depression, irritability, fatigue and mood swings. Medical practitioners reports many of these issues are helped through the use of a high quality natural progesterone cream, as Wild Yam & Progesterone+ or Ultra Harmony - a plant estrogen cream. Our creams do not contain estrogen but plant estrogens, which have no side effects.

* * * Millions of women use natural progesterone to reduce monthly PMS symptoms, ease the transitions of menopausal hot flashes, night sweats, mood swings, while others use it as to maintain healthy bones.

Benefits of Progesterone * * * Protects against endometrial cancer Helps protect against breast cancer * * * Natural progesterone is naturally produced in the body. Synthetic progestins can cause side effects. (Exhibit A at 4.) C. Natural Progesterone cream is a safe, natural alternative to HRT because it’s produced by a woman’s body during the second half of each monthly cycle, from ovulation until menses, and is the dominant hormone during this phase. * * * HERBS NUTRITION CORPORATION 87 Complaint Natural Progesterone cream also stimulates bone-building and thus helps protect against osteoporosis. (Exhibit A at 6.) D. Your body needs natural progesterone. . .For women, who suffer from hysterectomy symptoms, menstrual conditions, female health conditions, hormone deficiencies, menopause hot flashes, osteoporosis or thinning bones, pms. Reduces breast cancer risk, hair loss, fat gain from estrogen dominance, menopause acne, migraine headaches, and much more. . .

* * * In the right amount, progesterone can:

* * * Decrease risk of endometrial cancer Help protect against breast cancer, fibrocystic breasts, and osteoporosis (Exhibit A at 12-13.) 9. Through the means described in Paragraphs 7 and 8, Respondents have represented, expressly or by implication, that: A. Eternal Woman Progesterone Cream and Pro-Gest Body Cream are effective in preventing, treating, or curing osteoporosis;

B. Eternal Woman Progesterone Cream and Pro-Gest Body Cream are effective in preventing or reducing the risk of estrogen-induced endometrial (uterine) cancer; and C. Eternal Woman Progesterone Cream and Pro-Gest Body Cream do not increase the user’s risk of developing breast cancer and/or are effective in preventing or reducing the user’s risk of developing breast cancer.

VOLUME 145 Complaint 10. Through the means described in Paragraphs 7 and 8, Respondents have represented, expressly or by implication, that they possessed and relied upon a reasonable basis that substantiated the representations set forth in Paragraph 9, at the time the representations were made.

11. In truth and in fact, Respondents did not possess and rely upon a reasonable basis that substantiated the representations set forth in Paragraph 9 at the time the representations were made. Therefore, the representation set forth in Paragraph 10 was, and is, false or misleading.

12. The acts and practices alleged in this complaint constitute unfair or deceptive acts or practices, and the making of false advertisements, in or affecting commerce in violation of Sections 5(a) and 12 of the Federal Trade Commission Act. NOTICE Proceedings on the charges asserted against the respondents named in this complaint will be held before an Administrative Law Judge (ALJ) of the Federal Trade Commission, under Part 3 of the Commission’s Rules of Practice, 16 C.F.R. Part 3. A copy of Part 3 of the Rules is enclosed with this complaint. You are notified that the opportunity is afforded you to file with the Commission an answer to this complaint on or before the twentieth (20th) day after service of it upon you. An answer in which the allegations of the complaint are contested shall contain a concise statement of the facts constituting each ground of defense; and specific admission, denial, or explanation of each fact alleged in the complaint or, if you are without knowledge thereof, a statement to that effect. Allegations of the complaint not thus answered shall be deemed to have been admitted.

If you elect not to contest the allegations of fact set forth in the complaint, the answer shall consist of a statement that you admit all of the material allegations to be true. Such an answer shall constitute HERBS NUTRITION CORPORATION 89 Complaint a waiver of hearings as to the facts alleged in the complaint, and together with the complaint will provide a record basis on which the ALJ shall file an initial decision containing appropriate findings and conclusions and an appropriate order disposing of the proceeding. In such answer you may, however, reserve the right to submit proposed findings and conclusions and the right to appeal the initial decision to the Commission under Section 3.52 of the Commission’s Rules of Practice for Adjudicative Proceedings.

Failure to answer within the time above provided shall be deemed to constitute a waiver of your right to appear and contest the allegations of the complaint and shall authorize the ALJ, without further notice to you, to find the facts to be as alleged in the complaint and to enter an initial decision containing such findings, appropriate conclusions and order.

The ALJ will schedule an initial prehearing scheduling conference to be held not later than 7 days after the last answer is filed by any party named as a respondent in the complaint. Unless otherwise directed by the ALJ, the scheduling conference and further proceedings will take place at the Federal Trade Commission, 600 Pennsylvania Avenue, N.W., Washington, D.C. 20580. Rule 3.21(a) requires a meeting of the parties’ counsel as early as practicable before the prehearing scheduling conference, and Rule 3.31(b) obligates counsel for each party, within 5 days of receiving a respondent’s answer, to make certain initial disclosures without awaiting a formal discovery request.

Notice is hereby given to each of the respondents named in this complaint that a hearing before the ALJ on the charges set forth in this complaint will begin on January 3, 2008, at 10 a.m., or such other date and time as determined by the ALJ, in Room 532, Federal Trade Commission Building, 600 Pennsylvania Avenue, N.W., Washington, D.C. 20580. At the hearing, you will have the right under the Federal Trade Commission Act to appear and show cause why an order should not be entered requiring you to cease and desist from the violations of law charged in this complaint. VOLUME 145 Complaint The following is the form of order which the Commission has reason to believe should issue if the facts are found to be as alleged in the complaint. If, however, the Commission should conclude from record facts developed in any adjudicative proceedings in this matter that the proposed order provisions might be inadequate to fully protect the consuming public, the Commission may order such other relief as it finds necessary or appropriate. Moreover, the Commission has reason to believe that, if the facts are found as alleged in the complaint, it may be necessary and appropriate for the Commission to seek relief to redress injury to consumers, or other persons, partnerships or corporations, in the form of restitution for past, present, and future consumers and such other types of relief as are set forth in Section 19(b) of the Federal Trade Commission Act. The Commission will determine whether to apply to a court for such relief on the basis of the adjudicative proceedings in this matter and such other factors as are relevant to consider the necessity and appropriateness of such action. ORDER DEFINITIONS For purposes of this order, the following definitions shall apply: 1. Unless otherwise specified, “Respondents” shall mean: a. Herbs Nutrition Corporation, a corporation, and its successors and assigns and its officers; and b. Syed M. Jafry, individually and as an officer of Herbs Nutrition Corporation.

2. “Competent and reliable scientific evidence” shall mean tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area, that has been conducted and evaluated in an objective manner by persons qualified HERBS NUTRITION CORPORATION 91 Complaint to do so, using procedures generally accepted in the profession to yield accurate and reliable results.

3. “Progesterone product” shall mean any product containing or purporting to contain any progestagen (whether natural or synthetic), including but not limited to progesterone (whether produced by the human body or produced outside the human body but having the same chemical structure as the progesterone produced by the human body) or any progestin, including but not limited to Eternal Woman Progesterone Cream and Pro-Gest Body Cream. 4. “Food” shall mean (a) articles used for food or drink for man or other animals, (b) chewing gum, and (c) articles used for components of any such article.

5. “Drug” shall mean (a) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; (b) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; (c) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (d)articles intended for use as a component of any article specified in clause (a), (b), or (c); but does not include devices or their components, parts, or accessories. 6. “Device” shall mean an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is (a) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them; (b) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or (c) intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its principal intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon VOLUME 145 Complaint being metabolized for the achievement of any of its principal intended purposes.

7. “Covered product or service” shall mean any dietary supplement, food, drug, device, or any health-related service or program.

8. “Commerce” shall mean commerce among the several States or with foreign nations, or in any Territory of the United States or in the District of Columbia, or between any such Territory and another, or between any such Territory and any State or foreign nation, or between the District of Columbia and any State or Territory or foreign nation.

9. “Endorsement” shall mean any advertising message (including verbal statements, demonstrations, or depictions of the name, signature, likeness or other identifying personal characteristics of an individual or the name or seal of an organization) which message consumers are likely to believe reflects the opinions, beliefs, findings, or experience of a party other than the sponsoring advertiser. The party whose opinions, beliefs, findings, or experience the message appears to reflect will be called the endorser and may be an individual, group or institution. I.

IT IS THEREFORE ORDERED that Respondents, directly or through any person, partnership, corporation, subsidiary, division, trade name, or other device, in connection with the labeling, advertising, promotion, offering for sale, sale, or distribution of any Progesterone product or any other covered product or service, in or affecting commerce, shall not represent, in any manner, expressly or by implication, including through the use of a product name or endorsement:

A. That such product or service is effective in preventing, treating, or curing osteoporosis;

HERBS NUTRITION CORPORATION 93 Complaint B. That such product or service is effective in preventing or reducing the risk of estrogen-induced endometrial (uterine) cancer;

C. That such product or service does not increase the user’s risk of developing breast cancer;

D. That such product or service is effective in preventing or reducing the user’s risk of developing breast cancer; E. That such product or service is safe for human use or has no side effects;

F. That such product or service is effective in the mitigation, treatment, prevention, or cure of any disease, illness or health conditions; or G. About the health benefits, performance, efficacy, safety, or side effects of such product or service; unless the representation is true, not misleading, and, at the time it is made, Respondents possess and rely upon competent and reliable scientific evidence that substantiates the representation. II.

IT IS FURTHER ORDERED that Respondents, directly or through any person, partnership, corporation, subsidiary, division, trade name, or other device, in connection with the labeling, advertising, promotion, offering for sale, sale, or distribution of any Progesterone product or any other covered product or service in or affecting commerce, shall not misrepresent, in any manner, expressly or by implication, the existence, contents, validity, results, conclusions, or interpretations of any test, study, or research. VOLUME 145 Complaint III.

IT IS FURTHER ORDERED that:

A. Nothing in this order shall prohibit Respondents from making any representation for any drug that is permitted in labeling for such drug under any tentative final or final standard promulgated by the Food and Drug Administration, or under any new drug application approved by the Food and Drug Administration;

B. Nothing in this order shall prohibit Respondents from making any representation for any product that is specifically permitted in labeling for such product by regulations promulgated by the Food and Drug Administration pursuant to the Nutrition Labeling and Education Act of 1990; and C. Nothing in this order shall prohibit Respondents from making any representation for any device that is permitted in labeling for such device under any new medical device application approved by the Food and Drug Administration. IV.

IT IS FURTHER ORDERED that Respondents shall, for five (5) years after the last date of dissemination of any representation covered by this order, maintain and upon reasonable notice make available to the Federal Trade Commission for inspection and copying:

A. All advertisements and promotional materials containing the representation;

B. All materials that were relied upon in disseminating the representation; and HERBS NUTRITION CORPORATION 95 Complaint C. All tests, reports, studies, surveys, demonstrations, or other evidence in their possession or control that contradict, qualify, or call into question the representation or the basis relied upon for the representation, including complaints and other communications with consumers or with governmental or consumer protection organizations.

V.

IT IS FURTHER ORDERED that Respondents shall deliver a copy of this order to all current and future principals, officers, directors, and managers, and to all current and future employees, agents, and representatives having responsibilities with respect to the subject matter of this order, and shall secure from each such person a signed and dated statement acknowledging receipt of the order. Respondents shall deliver this order to current personnel within thirty (30) days after the date of service of the order, and to future personnel within thirty (30) days after the person assumes such position or responsibilities.

VI.

IT IS FURTHER ORDERED that Respondents shall notify the Commission at least thirty (30) days prior to any change with regard to Herbs Nutrition Corporation or any business entity that any Respondent directly or indirectly controls, or has an ownership interest in, that may affect compliance obligations arising under this order, including but not limited to incorporation or other organization; a dissolution, assignment, sale, merger, or other action that would result in the emergence of a successor entity; the creation or dissolution of a subsidiary, parent, or affiliate that engages in any acts or practices subject to this order; the proposed filing of a bankruptcy petition; or a change in the business or corporate name or address. Provided, however, that, with respect to any proposed change about which Respondents learn less than thirty (30) days prior to the date such action is to take place, Respondents shall notify the Commission as soon as is practicable after obtaining such VOLUME 145 Complaint knowledge. All notices required by this Part shall be sent by certified mail to the Associate Director, Division of Enforcement, Bureau of Consumer Protection, Federal Trade Commission, 600 Pennsylvania Avenue, N.W., Washington, D.C. 20580. VII.

IT IS FURTHER ORDERED that Respondents, for a period of seven (7) years after the date of issuance of this order, shall notify the Commission of the discontinuance of their current business or employment; or of their affiliation with any new business or employment. The notice shall include Respondent’s new business address and telephone number, a description of the nature of the business or employment, and their duties and responsibilities. All notices required by this Part shall be sent by certified mail to the Associate Director, Division of Enforcement, Bureau of Consumer Protection, Federal Trade Commission, 600 Pennsylvania Avenue, N.W., Washington, D.C. 20580.

VIII.

IT IS FURTHER ORDERED that Respondents shall, within sixty (60) days after service of this order, and, upon reasonable notice, at such other times as the Federal Trade Commission may require, file with the Commission a report, in writing, setting forth in detail the manner and form in which they have complied with this order.

IX.

This order will terminate twenty (20) years from the date of its issuance, or twenty (20) years from the most recent date that the United States or the Federal Trade Commission files a complaint (with or without an accompanying consent decree) in federal court alleging any violation of the order, whichever comes later; provided, however, that the filing of such a complaint will not affect the duration of:

HERBS NUTRITION CORPORATION 97 Complaint A. Any Part in this order that terminates in less than twenty (20) years;

B. This order’s application to any Respondent that is not named as a Respondent in such complaint; and C. This order if such complaint is filed after the order has terminated pursuant to this Part.

Provided, further, that if such complaint is dismissed or a federal court rules that the Respondent did not violate any provision of the order, and the dismissal or ruling is either not appealed or upheld on appeal, then the order will terminate according to this Part as though the complaint had never been filed, except that this order will not terminate between the date such complaint is filed and the later of the deadline for appealing such dismissal or ruling and the date such dismissal or ruling is upheld on appeal. IN WITNESS WHEREOF, the Federal Trade Commission has caused this complaint to be signed by the Secretary and its official seal to be affixed hereto, at Washington, D.C., this twenty-eighth day of September, 2007.

By the Commission.

VOLUME 145 Complaint EXHIBIT A HERBS NUTRITION CORPORATION Complaint Mula! 4 LUBCOLIUNG iCall dt FLURCOLCLUNS Lcd SLU PMS Forte Futureblotics ™ Size: 50 Tabs Price: $7.94 By PMS:

Hylands Size; 100 Tabs Female Complex Nature's Answer Size: 90 VCaps Price: $5.87 Menopause Formula Natrol Size: 60 Caps Price: $8.68 [een Cran-Aid (CranAld) Tea Traditional Medicinals Teas Size: 16 Bags Price: $4.06 Pregnancy Tea Traditional Medicinals Teas Size: 16 Bags Price: $4.06 PMS Tea Traditional Medicinals Teas Size: 16 Bags Price: $4.06 Women's Liberty Tea Traditional Medicinals Teas Size: 16 Bags Price: $4.06 J = Se Buy® Menopause Tablets Hylands Size: 100 Tabs Royal Ginseng for Women Imperial Elixir/Ginseng Company Size: 45 Caps Price: $9.64 Phyto Estrogen Power Nature's Herbs Size: 150 Caps Price: $24.77 Women's One Multivitamin Rainbow Light Size: 90 Tabs Price: $16.97 Mother's Milk Tea ! Traditional Medicinals Teas Size: 16 Bags Price: $4.06 Organic Raspberry Leaf Tea Traditional Medicinals Teas Size: 16 Bags Price: $4.06 Female Toner Tea = Traditional Medicinals Teas Size: 16 Bags iene Price: $4.06 Womans Moon Cycle Yogi Teas Size: 16 Bags rage 2012 Bitters Doctor's Best Size: 120 VC Price: $13.89 Vagi Gard Moist Again Women's Health Formulas Size: 2.5 Oz Price: $5.31 ic: #5:

MindEase (Mind Ease) Honso USA Size: 180 tabs Price: $18.17 Woman's Nursing Mom Yogi Teas Size: 16 Bags Price: $3.79 Woman's Mother To Be Yogi Teas Size: 16 Bags Price: $3.79 sy ‘Size: 16 Bags Price: $3.79 Complete Menopause Multivitamin Rainbow Light Size: 120 Tabs VOLUME 145 Complaint MULL 2 AU BVO CiCaiil at £LURCOLCAUIUG ULC OLUIG rage 5 Ol > Bs Woman's Dong Quai Tonic Yogi Teas Size: 16 Bags me, Price: $3.79 ) Home | About Us | Shipping | Contact Us | Privacy Policy | Link | Link2 | Resource Link | Online Gift Store | Wholesale Herbs Sponsored Sites: Wellness Formula | Tonalin Cla | AHCC | Lubriflex | Red Marine Algae | Garlique Copyright © 2003 www.progesterone-cream.net, All rights reserved. Statement contained within this web site have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure or prevent any disease. Website Design by LogoOffer.com HERBS NUTRITION CORPORATION 101 Complaint ANMLUL aL FLURCOLCLUUG WHICH al PIUPESICLULIG CACM OLUIC ragoiuse Progesterone Cream - Natural PMS remedy (eee) progesterone Cream - Osteoporosis treatment “ Progesterone Cream preceseron cream -conrol Menopause Soe Progesterone Cream - Hormone Replacement Therapy Home | Add to Favourite | Health Articles | Member Area | Health Froum Progesterone Cream ‘Women need natural progesterone to counter-balance the effects of estrogen dominance. Progesterone therapy is successfully used by health care professionals to relieve symptoms of both PMS, help the transitions of menopause, improve moods, or low libido when progesterone levels are low and/or estrogen is dominant. In menopause, both estrogen and progesterone decrease.

Medical experts believe the out of balance hormones are due to the lack of progesterone in women. Clinical studies show that PMS, menopausal problems, breast cancer and fibrocystic breast have a direct relationship with estrogen dominance. Progesterone is needed for the proper function of the adrenal glands, Stress on the adrenal glands may lead to progesterone deficiency, often causing symptoms of nervous disorders, depression, irritability, fatigue and mood swings.

Medical practitioners reports many of these issues are helped through the use of a high quality natural progesterone cream, as Wild Yam & Progesterone+ or Ultra Harmony -a plant estrogen cream. Our creams do not contain estrogen but plant estrogens, which have no side effects. Blood tests do not show an increase of estrogen with progesterone or plant estrogens. We do know that progesterone and estrogen, like many of the hormones in the body, work synergistically. The presence of progesterone sensitizes estrogen receptors in the body, making circulating estrogen levels work better without changing the actual levels of estrogens. We know that after menopause, many women find that supplementation of progesterone is enough for addressing symptoms. For some women, who are very thin, have had hysterectomies at a younger age, or have high cholesterol or heightened bone loss, some form of estrogen or phytoestrogen may be necessary to completely fulfill and balance the bodies needs. .

Millions of women use natural progesterone to reduce monthly PMS symptoms, ease the transitions of menopausal hot flashes, night sweats, mood swings, while others use it as to maintain healthy bones. ss Benefits of Progesterone * Precursor of other sex hormones, i.e., estrogen and testosterone * Protects against breast fibrocysts * Natural diuretic * Helps use fat for energy + Natural antidepressant * Helps thyroid hormone action * Normalizes blood clotting + Restores libido ¢ Helps normalize blood sugar levels * Restores proper cell oxygen levels * Protects against endometrial cancer * Helps protect against breast cancer * Necessary for survival of embryo and fetus throughout gestation The herbs have been used for medicinal purposes for hundreds of years around the world. Many of these herbs have been clinically documented to have special remedial and therapeutic properties for hormonal balance. Wise Women Essentials creams contain several well-known herbal ingredients. The compound diosgenin from the wild yam or soybean is used to make natural progesterone in a laboratory. Natural progesterone is naturally produced in the body. Synthetic progestins can cause side effects. Often, the cause of distress during changing times is a lack of -4- |

HERBS NUTRITION CORPORATION 103 Complaint rage 1or2 ANMLULa CLUBESICLUUS ULcaL-LOnUU! 1 Our MOTMONEe INeLUTALLY Progesterone Cream - Natural PMS remedy Progesterone Cream - Osteoporosis treatment Progesterone Cream - Control Menopause Progesterone Cream progesterone Cream - Hormone Replacement Therapy Home | Add to Favourite | Health Articles | Member Area | Health Froum Natural Progesterone Cream Natural Progesterone Cream-Control Your Hormone Naturally Natural Progesterone Cream Progesterone derived from plant sources as an alternative to conventional hormone replacement therapy in menopausal women. Progesterone Cream can help address normal menopausal discomforts, such as hot flashes, night sweats, and irritability. Natural Progesterone cream Is a safe, natural alternative to HRT because it's produced by a woman's body during the second half of each monthly cycle, from ovulation until menses, and is the dominant hormone during this phase.

Our leading brands’ Progesterone cream has been clinically formulated to help bring balance to a woman's body throughout change-of-life transitions using herbs, vitamins, and other natural ingredients. Natural Progesterone Cream is comprehensive formula addresses the different changes each woman experiences and may be taken along with other women's health Natural! (Natural Progesterone Cream (4 Oz Tube) Source Naturals Source Naturals ETERNAL WOMAN™ Natural PROGESTERONE CREAM is intended for women of all ages. It features ...

Price = supplements. Natural Progesterone cream also stimulates bone-building and thus helps protect against osteoporosis. Pre Menopausal Woman Need Natural Progesterone Cream Why would a pre menopausal woman need Natural Progesterone Cream? In the ten to fifteen years before menopause, many women regularly have anovulatory cycles in which they make enough estrogen to create menstruation, but they don’t make any progesterone, thus setting the stage for estrogen dominance. Using Natural progesterone cream during anovulatory months can help prevent the symptoms of PMS, PMS We know that PMS can occur despite normal progesterone levels when stress is present. Stress increases cortisol production; cortisol blockades (or competes for) Progesterone receptors. Additional progesterone cream Is required to overcome this blockade, and stress management is important. Source Naturals Price $11.48 Related Products Progestex Menopause Tablets (100 Tabs) by Hylands Nutricology/Allergy Female Toner Tea (16 Bags) by Traditional Medicinals Teas Research Group Related Keyword Searched natural progesterone cream fatigue progesterone effects source natural Price $12.42 VOLUME 145 Complaint ANa@tuna! £LURCOLCIUUC VIG CUUUUL 2 UU CULuUIG IvaLUray rage 2Ol«z estrogen dominance Progesterone menopausal medroxyprogesterone hot flashes hormone Imbalance breast tendemess NOW Foods post menopausal Price $12.66 Home | About Us | Shipping | Contact Us | Privacy Policy | Link | Link2 | Resource Link | Online Gift Store | Wholesale Herbs Sponsored Sites: Andrographis | Red Yeast Rice | Stamina-Rx | Glucomannan | Horny Goat Weed | Resveratrol Copyright © 2003 www.progesterone-cream.net, All rights reserved. Statement contained within this web site have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure or prevent any disease. HERBS NUTRITION CORPORATION 105 Complaint ZAUBLOLCIUNGS Lia VY OUULLS LVaLUIaIS rage 101) Progesterone Cream - Natural PMS remedy Progesterone Cream froicsisone cream - con Menopause progesterone Cream - Hormone Replacement Therapy Home | Add to Favourite | Health Articles | Member Area | Health Froum Progesterone Cream Source Naturals Size 40z Retail Price $2798 Our Price $18.93 fz] i Size Choices ©20z Description of Progesterone Cream Eternal Woman Progesterone Cream features natural progesterone USP from soy. Our Progesterone Cream is guaranteed to contain 500 mg of progesterone per ounce and 22 mg per 1/4 teaspoon. Ingredients of Progesterone Cream Supplement Facts Serving Size: 1/4 teaspoon Amount Per Serving %DV Deionized Water, Aloe Vera Gel, Cetearyl Glucoside, Caprylic/Capric Triglyceride, Cetyl Alcohol, Glycerin, Natural Progesterone USP from soy (500 mg per ounce), Wild Yam Extract, Tocopheryl Acetate (Natural Vitamin E), Lecithin Phospholipid, Glycery! Stearate & Peg-100 Stearate, Jojoba Oil, Squalene, Benzyl Alcohol, Stearic Acid, Grapefruit Seed Extract, Ginseng Root Extract, Methylparaben, Propylparaben, Sorbic Acid, Potassium Benzoate, Xanthan Gum, and Rosemary Oil. Suggested Use for Progesterone Cream Massage 1/4 to 1/2 teaspoon of cream twice daily into smooth skin areas, such as wrists, face, throat, abdomen or chest. Pre-menopausal women use for 14 days prior to the first day of menstruation, discontinue and repeat. Menopausal and postmenopausal women use for 21 days, discontinue for 7 days and repeat. These are general recommendations only and may need to be modified for individual needs. Warning for Progesterone Cream If you are pregnant, nursing, or intending to become pregnant, consult with a health care professional before using this product. If irritation occurs, discontinue use. For external use only. Do not use around eye area. Home | About Us | Shipping | Contact Us | Privacy Policy | Link | Link2 | Resource Link | Online Gift Store | Wholesale Herbs Sponsored Sites: Andrographis | Red Yeast Rice | Stamina-Rx | Glucomannan | Horny Goat Weed | Resveratrol Copyright © 2003 www.progesterone-cream.net, All rights reserved. Statement contained within this web site have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure or prevent any disease. VOLUME 145 Complaint santa 4 LUBLOWAUD KiGalll Uy OUUILE LvaLULas rage 1 Ol. Progesterone Cream - Natural PMS remedy : progesterone Cream - Osteoporosis treatment [iNew Carts] P r ogesterone Cr eam progesterone Cream - Control Menopause fuxcneckouss) Progesterone Cream - Hormone Replacement Therapy Home | Add to Favourite| Health Articles | Member Area] Health Froum Natural Progesterone Cream Source Naturals Size 2 Oz Tube Retail Price $44.98 Our Price $9.50 E Size Choices ©4 07 Tube Description of Natural Progesterone Cream Source Naturals ETERNAL WOMAN™ Natural PROGESTERONE CREAM is intended for women of all ages, It features natural progesterone USP from soy. Our Progesterone Cream is guaranteed to contain 500 mg of progesterone per ounce and 22 mg per 1/4 teaspoon. Ingredients of Natural Progesterone Cream Supplement Facts — Serving Size: 1/4 teaspoon Amount Per Serving %DV Deionized Water, Aloe Vera Gel, Ceteary! Glucoside, Caprylic/Capric Triglyceride, Cetyl Alcohol, Glycerin, Natural Progesterone USP from soy (500 mg per ounce), Tocophery! Acetate (Natural Vitamin E), Wild Yam Extract, Lecithin Phospholipid, Glycery! Stearate & PEG-100 Stearate, Jojoba Oil, Squalene, Benzyl Alcohol, Stearic Acid, Grapefruit Seed Extract, Ginseng Root Extract, Methylparaben, Propylparaben, Sorbic Acid, Xanthan Gum, and Rosemary Oil.

Suggested Use for Natural Progesterone Cream Massage 1/4 to 1/2 teaspoon of cream twice daily into smooth skin areas such as the wrists, inner arms or thighs, throat, abdomen or chest. Premenopausal women use for 14 days prior to the first day of menstruation, discontinue and repeat. Menopausal and postmenopausal women use for 21 days, discontinue for 7 days and repeat. These are general recommendations only and may need to be modified for individual needs. Warning for Natural Progesterone Cream If you are pregnant, nursing, or intending to become pregnant, consult with a health care professional before using this product. If Irritation occurs, discontinue use. For external use only. Do not use around eye area. SSS Home | About Us | Shipping | Contact Us | Privacy Policy | Link | Link2 | Resource Link | Online Gift Store | Wholesale Herbs Sponsored Sites: Andrographis | Red Yeast Rice | Stamina-Rx | Glucomannan | Horny Goat Weed | Resveratrol Copyright © 2003 www.progesterone-cream.net, All rights reserved. _-9-

VOLUME 145 Complaint Ur eok uy Crean Uy Laisa, rage luis Progesterone Cream - Natural PMS remedy ’rogesterone Cream fegeterone cream cone senopouse progesterone Cream - Hormone Replacement Therapy Home | Add to Favourite | Health Articles | Member Area | Health Froum Pro-Gest Body Cream Emerita Size 20z Retall Price $2699 Our Price $18.13 Fy Add to Cart” |] ize Choices ‘4 Oz ‘description of Pro-Gest Body Cream ‘ho knew a little tube of cream could change the world? In 1978 we had a revolutionary idea: that there was ot enough choice when it came to support for perimenopause and menopause. So we created Pro-Gest to give ‘women a much-deserved alternative. It's the only natural progesterone cream that's been clinically tested. It's ye best-selling progesterone cream available anywhere (and has been for many years). USP Progesterone: Pro-Gest cream is manufactured to contain 450 milligrams (mg) of USP Progesterone ®r ounce (900 mg per two-ounce tube). Each % tsp contains approximately 20 mg of USP Progesterone. careful clinical research has shown this to be an effective amount to achieve a natural balance. United States harmacopoeia (USP) denotes a government recognized standard of purity and strength. It is sometimes 2ferred to as "human-identical" or "bio-identical" progesterone, which differentiates it from synthetic rogestins or progestogens. USP classifies the progesterone as the highest quality available 1gredients of Pro-Gest Body Cream tater (Aqua), Aloe Barbadensis Gel, Tocophery! Acetate, Cety! Alcohol, Ethylhexyl Palmitate, Sweet Almond 2runus amygdalus dulcis) Oil, Panthenol, PEG-8 Stearate, Stearic Acid, Glycerin, USP Progesterone, alysorbate 65, Propylene Glycol, Lemon (Citrus medica limonum) Oil, Carbomer, Methylparaben, “opylparaben, Triethanolamine, Diazolidiny! Urea This information is intended for educational purposes only. vese statements have not been evaluated by the Food and Drug Administration. These products are not tended to diagnose, treat, cure or prevent disease. Home | About Us | Shipping | Contact Us | Privacy Policy | Link | Link2 | Resource Link | Online Gift Store | Wholesale Herbs Sponsored Sites: Wellness Formula | Tonalin Cla | AHCC | Lubrifiex | Red Marine Algae | Garlique Copyright © 2003 www.progesterone-cream.net, All rights reserved. Statement contained within this web site have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure or prevent any disease. Website Design by LogoOffer.com -11- HERBS NUTRITION CORPORATION Complaint ogesia Care-rrogestaLare lor women rage 1orZ Progesterone Cream - Natural PMS remedy View Cart > progesterone Cream - Osteoporosis treatment 1 SM 3. Togesterone Crea¥wn srosesterone cream - contro menopause a progesterone Cream - Hormone Replacement Therapy Home | Add to Favourite | Health Articles | Member Area | Health Froum rogesta care rogesta care-ProgestaCare for Women rogestaCare:

yur body needs natural progesterone. ProgestaCare helps women reduce the werity of PMS symptoms lessen the effects of menopause and counter-balance \e effects of estrogen dominance, Infertility, Migraines, Fibrocystic Breast, Skin are, and Acne. For women, who suffer from hysterectomy symptoms, menstrual inditions, female health conditions, hormone deficiencies, menopause hot ashes, osteoporosis or thinning bones, pms. Reduces breast cancer risk, hair loss, t gain from estrogen dominance, menopause acne, migraine headaches, and uch more ProgestaCare is the #1 selling natural progesterone cream trusted by illions of women worldwide. Our superior formula represents the purest gredients you can buy With all its benefits, purity and quality, ProgestaCare is commended by physicians and women more than any other natural ‘ogesterone cream.

rogestaCare for Women Progesterone Cream (2 02) ‘ogesterone Cream Just Got Better, Source Naturals yw 4 oz. size for the price of the old 3 ||Eternal Woman Progesterone u ‘Cream features progesterone ogestaCare is the #1 selling natural from healthful, womanogesterone cream trusted by millions | /friendly soy, enhanced ... women worldwide. Price $7.94 ar superior formula represents the SOLE irest Ingredients you can buy.

ogestaCare helps women reduce the Equi-Gest Progesterone Cream (2 verity of PMS symptoms, lessen the \Oz) fects of menopause and counter- At Last Naturals ilance the effects of estrogen Equigest Natural yminance. Progesterone Cream is the ogestaCare utilizes USP grade perfect solution if you need icronized natural progesterone derived ||Progesterone. Equigest has ... 9m wild yam. The formula contains an ||Price $18.32 ‘erage of 480mg of natural | i} ogesterone per ounce.

ProgestaCare is made entirely from natural ingredients (no fragrances). It is in-oily, does not leave a residue on the skin, and it absorbs quickly. hy Is natural progesterone so important?The fact is, that in industrialized untries, most men and women have out-of-balance hormones. The reason, NOW Foods cording to Dr. John Lee, is there is an over-abundance of estrogen and Price $12.66 trogenic substances in the food we eat and in our modern environment. strogen dominance," as it is sometimes referred to, is a problem in the U.S. and her Industrialized countries. Your body needs natural progesterone to counterjJance the toxic effects of estrogen dominance. rogestaCare - Hormone Balance \e balance of progesterone and estrogen in a woman's body is very important. ogesterone acts to balance excess estrogen thus preventing estrogen from coming harmful to health, a condition known as estrogen dominance, At ferent times in the life of a women, hormonal imbalance can result in symptoms N LP, Cream PMS, perimenopause, or menopause. Symptoms of progesterone imbalance = — = A2- VOLUME 145 Complaint UBSola VULC-FLURSSLaLMIe 101 WULUICH Page Zorz clude moodiness, hot flashes, night sweats, depression, weight gain, bloating, Source Naturals id breast tenderness. Price $14.83 n the right amount, progesterone can:

ave a calming effect qhance moods agulate fluid balance ormalize sleep icrease sex drive alp use fat for energy sabilize blood sugar, thyroid function, and mineral balance acrease risk of endometrial cancer 2lp protect against breast cancer, fibrocystic breasts, and osteoporosis related Products »y¥ 1000 Full Spectrum (1000 mg, 60 Tabs) by Planetary Formulas ogesterone PM (4 Fl Oz) by Kal related Keyword Searched ogesterone cream ogest east assure tyto estrogen ogesterone ee Home | About Us | Shipping | Contact Us | Privacy Policy | Link | Link2 | Resource Link | Online Gift Store | Wholesale Herbs Sponsored Sites: Wellness Formula | Tonalin Cla | AHCC | Lubrifiex | Red Marine Algae | Garlique Copyright © 2003 www.progesterone-cream.net, All rights reserved. Statement contained within this web site have not been evaluated by the Food and Drug Administration. These products are not Intended to diagnose, treat, cure or prevent any disease, Website Design by LogoOffer.com HERBS NUTRITION CORPORATION 111 Decision and Order DECISION AND ORDER The Commission having heretofore issued its Complaint charging the Respondents, Herbs Nutrition Corporation and Syed M. Jafry named in the caption hereof, with violations of Sections 5(a) and 12 of the Federal Trade Commission Act, 15 U.S.C. §§ 45(a) and 52 as amended, and Respondents having been served with a copy of that Complaint, together with a notice of contemplated relief; and The Respondents and counsel for the Commission having thereafter executed an agreement containing a consent order, an admission by the Respondents of all the jurisdictional facts set forth in the aforesaid complaint, a statement that the signing of the agreement is for settlement purposes only and does not constitute an admission by the Respondents that the law has been violated as alleged in such complaint, or that any of the facts as alleged in such complaint, other than jurisdictional facts, are true, and waivers and other provisions as required by the Commission’s Rules; and The Secretary of the Commission having thereafter withdrawn this matter from adjudication in accordance with § 3.25(c) of its Rules; and The Commission having considered the matter and having thereupon accepted the executed Consent Agreement and placed such Agreement on the public record for a period of thirty (30) days, now in further conformity with the procedure prescribed in § 3.25(f) of its Rules, the Commission hereby makes the following jurisdictional findings and enters the following Order: 1. Respondent Herbs Nutrition Corporation is a California corporation with its principal office or place of business at 21712 Hawthorne Blvd #276, Torrance, California 90503. 2. Respondent Syed M. Jafry is an officer of Herbs Nutrition Corporation. Individually, or in concert with others, he formulates, VOLUME 145 Decision and Order directs, controls, or participates in the policies, acts, or practices of Herbs Nutrition Corporation. His principal office or place of business is the same as Herbs Nutrition Corporation. 3. The Federal Trade Commission has jurisdiction of the subject matter of this proceeding and of the Respondents, and the proceeding is in the public interest.

ORDER DEFINITIONS For purposes of this order, the following definitions shall apply: 1. Unless otherwise specified, “Respondents” shall mean: (a) Herbs Nutrition Corporation, a corporation, and its successors and assigns and its officers; and (b) Syed M. Jafry, individually and as an officer of Herbs Nutrition Corporation.

2. “Competent and reliable scientific evidence” shall mean tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area, that has been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results.

3. “Progesterone product” shall mean any product containing or purporting to contain any progestagen (whether natural or synthetic), including but not limited to progesterone (whether produced by the human body or produced outside the human body but having the same chemical structure as the progesterone produced by the human body) or any progestin, including but not limited to Eternal Woman Progesterone Cream and Pro-Gest Body Cream. HERBS NUTRITION CORPORATION 113 Decision and Order 4. “Food” shall mean (a) articles used for food or drink for man or other animals, (b) chewing gum, and (c) articles used for components of any such article.

5. “Drug” shall mean (a) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; (b) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; (c) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (d)articles intended for use as a component of any article specified in clause (a), (b), or (c); but does not include devices or their components, parts, or accessories. 6. “Device” shall mean an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is (a) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them; (b) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or (c) intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its principal intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its principal intended purposes.

7. “Covered product or service” shall mean any dietary supplement, food, drug, device, or any health-related service or program.

8. “Commerce” shall mean commerce among the several States or with foreign nations, or in any Territory of the United States or in the District of Columbia, or between any such Territory and another, or between any such Territory and any State or foreign nation, or VOLUME 145 Decision and Order between the District of Columbia and any State or Territory or foreign nation.

9. “Endorsement” shall mean any advertising message (including verbal statements, demonstrations, or depictions of the name, signature, likeness or other identifying personal characteristics of an individual or the name or seal of an organization) which message consumers are likely to believe reflects the opinions, beliefs, findings, or experience of a party other than the sponsoring advertiser. The party whose opinions, beliefs, findings, or experience the message appears to reflect will be called the endorser and may be an individual, group or institution. I.

IT IS THEREFORE ORDERED that Respondents, directly or through any person, partnership, corporation, subsidiary, division, trade name, or other device, in connection with the labeling, advertising, promotion, offering for sale, sale, or distribution of any Progesterone product or any other covered product or service, in or affecting commerce, shall not represent, in any manner, expressly or by implication, including through the use of a product name or endorsement:

A. That such product or service is effective in preventing, treating, or curing osteoporosis;

B. That such product or service is effective in preventing or reducing the risk of estrogen-induced endometrial (uterine) cancer;

C. That such product or service does not increase the user’s risk of developing breast cancer;

D. That such product or service is effective in preventing or reducing the user’s risk of developing breast cancer; HERBS NUTRITION CORPORATION 115 Decision and Order E. That such product or service is safe for human use or has no side effects;

F. That such product or service is effective in the mitigation, treatment, prevention, or cure of any disease, illness or health conditions; or G. About the health benefits, performance, efficacy, safety, or side effects of such product or service; unless the representation is true, not misleading, and, at the time it is made, Respondents possess and rely upon competent and reliable scientific evidence that substantiates the representation. II.

IT IS FURTHER ORDERED that Respondents, directly or through any person, partnership, corporation, subsidiary, division, trade name, or other device, in connection with the labeling, advertising, promotion, offering for sale, sale, or distribution of any Progesterone product or any other covered product or service in or affecting commerce, shall not misrepresent, in any manner, expressly or by implication, the existence, contents, validity, results, conclusions, or interpretations of any test, study, or research. III.

IT IS FURTHER ORDERED that:

A. Nothing in this order shall prohibit Respondents from making any representation for any drug that is permitted in labeling for such drug under any tentative final or final standard promulgated by the Food and Drug Administration, or under any new drug application approved by the Food and Drug Administration;

VOLUME 145 Decision and Order B. Nothing in this order shall prohibit Respondents from making any representation for any product that is specifically permitted in labeling for such product by regulations promulgated by the Food and Drug Administration pursuant to the Nutrition Labeling and Education Act of 1990; and C. Nothing in this order shall prohibit Respondents from making any representation for any device that is permitted in labeling for such device under any new medical device application approved by the Food and Drug Administration. IV.

IT IS FURTHER ORDERED that Respondents shall, for five (5) years after the last date of dissemination of any representation covered by this order, maintain and upon reasonable notice make available to the Federal Trade Commission for inspection and copying:

A. All advertisements and promotional materials containing the representation;

B. All materials that were relied upon in disseminating the representation; and C. All tests, reports, studies, surveys, demonstrations, or other evidence in their possession or control that contradict, qualify, or call into question the representation or the basis relied upon for the representation, including complaints and other communications with consumers or with governmental or consumer protection organizations.

V.

IT IS FURTHER ORDERED that Respondents shall deliver a copy of this order to all current and future principals, officers, directors, and managers, and to all current and future employees, HERBS NUTRITION CORPORATION 117 Decision and Order agents, and representatives having responsibilities with respect to the subject matter of this order, and shall secure from each such person a signed and dated statement acknowledging receipt of the order. Respondents shall deliver this order to current personnel within thirty (30) days after the date of service of the order, and to future personnel within thirty (30) days after the person assumes such position or responsibilities.

VI.

IT IS FURTHER ORDERED that Respondents shall notify the Commission at least thirty (30) days prior to any change with regard to Herbs Nutrition Corporation or any business entity that any Respondent directly or indirectly controls, or has an ownership interest in, that may affect compliance obligations arising under this order, including but not limited to incorporation or other organization; a dissolution, assignment, sale, merger, or other action that would result in the emergence of a successor entity; the creation or dissolution of a subsidiary, parent, or affiliate that engages in any acts or practices subject to this order; the proposed filing of a bankruptcy petition; or a change in the business or corporate name or address. Provided, however, that, with respect to any proposed change about which Respondents learn less than thirty (30) days prior to the date such action is to take place, Respondents shall notify the Commission as soon as is practicable after obtaining such knowledge. All notices required by this Part shall be sent by certified mail to the Associate Director, Division of Enforcement, Bureau of Consumer Protection, Federal Trade Commission, 600 Pennsylvania Avenue, N.W., Washington, D.C. 20580. VII.

IT IS FURTHER ORDERED that Respondents, for a period of seven (7) years after the date of issuance of this order, shall notify the Commission of the discontinuance of their current business or employment; or of their affiliation with any new business or employment. The notice shall include Respondents’ new business VOLUME 145 Decision and Order address and telephone number, a description of the nature of the business or employment, and their duties and responsibilities. All notices required by this Part shall be sent by certified mail to the Associate Director, Division of Enforcement, Bureau of Consumer Protection, Federal Trade Commission, 600 Pennsylvania Avenue, N.W., Washington, D.C. 20580.

VIII.

IT IS FURTHER ORDERED that Respondents shall, within sixty (60) days after service of this order, and, upon reasonable notice, at such other times as the Federal Trade Commission may require, file with the Commission a report, in writing, setting forth in detail the manner and form in which he has complied with this order. IX.

This order will terminate on February 21, 2028, or twenty (20) years from the most recent date that the United States or the Federal Trade Commission files a complaint (with or without an accompanying consent decree) in federal court alleging any violation of the order, whichever comes later; provided, however, that the filing of such a complaint will not affect the duration of: A. Any Part in this order that terminates in less than twenty (20) years;

B. This order’s application to any Respondent that is not named as a Respondent in such complaint; and C. This order if such complaint is filed after the order has terminated pursuant to this Part.

Provided, further, that if such complaint is dismissed or a federal court rules that the Respondent did not violate any provision of the order, and the dismissal or ruling is either not appealed or upheld on appeal, then the order will terminate according to this Part as though the complaint had never been filed, except that this order will not HERBS NUTRITION CORPORATION 119 Analysis to Aid Public Comment terminate between the date such complaint is filed and the later of the deadline for appealing such dismissal or ruling and the date such dismissal or ruling is upheld on appeal. By the Commission.

ANALYSIS OF 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, natural 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 VOLUME 145 Analysis to Aid Public Comment 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 HERBS NUTRITION CORPORATION 121 Analysis to Aid Public Comment 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.

VOLUME 145 Complaint