Bioque Technologies, Inc.

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IN THE MATTER OF BIOQUE TECHNOLOGIES, INC., VITTORIO A. BONOMO, AND CHRISTINE A. GUILMAN CONSENT ORDER, ETC., IN REGARD TO ALLEGED VIOLATIONS OF SEC. 5 OF THE FEDERAL TRADE COMMISSION ACT Docket No. C-4237; File No. 082 3095 Complaint, October 22, 2008 – Decision, October 22, 2008 This consent order addresses advertising for Serum GV, represented by the respondents to be an effective treatment for skin cancer. The order requires the respondents to have competent and reliable scientific evidence substantiating any claims that a covered product or service is an effective treatment for skin cancer, including melanoma; prevents melanoma; is recognized by the medical profession as an effective treatment for skin cancer; or is clinically proven to prevent or treat melanoma. The order further requires that such claims be true and non-misleading. The order requires the respondents to possess competent and reliable scientific evidence for any claims about the absolute or comparative benefits, performance, efficacy, safety, or side effects of any covered product or service. The claims also must be true and non-misleading. The order prohibits the respondents from making misrepresentations about the existence, contents, validity, results, conclusions, or interpretations of any test or study. The order does not prohibit the respondents from making representations for any drug that are permitted by the Food and Drug Administration. The order requires the respondents to send to the consumers identified in the order a notification letter drafted by the FTC to inform them about the consent agreement. The order provides for the payment of $9,035.85, the full amount of sales of the product, to the Commission. Additional provisions 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 (for the corporate respondent) and changes in employment (for the individual respondents) that might affect compliance obligations under the order; and to file compliance reports with the Commission.

BIOQUE TECHNOLOGIES, INC. 581 Complaint Participants For the Commission: Richard L. Cleland, Mary K. Engle, Diana Finegold, Karen Mandel, and Rosemary Rosso. For the Respondents: Not represented by counsel. COMPLAINT The Federal Trade Commission, having reason to believe that Bioque Technologies, Inc., a corporation, and Vittorio A. Bonomo, individually and as a director of the corporation, and Christine A. Guilman, individually and as an officer of the 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 Bioque Technologies, Inc. (“Bioque”) is a Virginia corporation with its principal office or place of business at 200 Country Club Drive SW, Blacksburg, Virginia 24060. 2. Respondent Vittorio A. Bonomo is a director of Bioque. Individually or in concert with others, he formulates, directs, controls, or participates in the policies, acts, or practices of Bioque, including the acts and practices alleged in this complaint. His principal office or place of business is the same as that of the corporation.

3. Respondent Christine A. Guilman is an officer of Bioque. Individually or in concert with others, she formulates, directs, controls, or participates in the policies, acts, or practices of Bioque, including the acts and practices alleged in this complaint. Her principal office or place of business is the same as that of the corporation.

4. Respondents have labeled, advertised, offered for sale, sold, and distributed Serum GV, a purported cancer treatment, to VOLUME 146 Complaint the public. Serum GV is a topical serum containing annona muricata as the purported active ingredient. Annona muricata, also known as graviola, is an extract from the soursop or guanabana tropical fruit tree. Serum GV is a “drug” within the meaning of Sections 12 and 15 of the Federal Trade Commission Act.

5. 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. 6. Respondents have disseminated or have caused to be disseminated advertisements for Serum GV, including but not necessarily limited to the attached Exhibit A. These advertisements contain the following statements: a. SERUM GV Extraordinarily effective topical skin cancer treatment Clinically proven and professionally endorsed formulation—active ingredient prevents and helps correct melanoma Stamp of approval—The medical profession has recognized Serum GV as the only available and effective topical treatment for skin cancer. Keep the doctor away—Clinical trials and research studies have demonstrated that Serum GV’s active ingredient—a glycol isolate of annona muricata— prevents development of melanoma; it has a natural affinity to cancer cells in their earliest stages and destroys them by cutting off their energy supply. Serves as an excellent non-surgical alternative for abnormal skin conditions—such as moles, lumps and warts.

BIOQUE TECHNOLOGIES, INC. 583 Complaint Support System—In cases where cancer has already appeared in the skin tissue, Serum GV boosts the body’s own defense system to destroy the cancer cells. * * * Gently massage a small amount of Serum GV into and around targeted areas of abnormality — such as moles, lumps, and warts. Apply at least once daily; applying twice will speed up results.

[Exhibit A, Page 1 (bold and italics in original).] 7. Through the means described in Paragraph 6, Respondents have represented, expressly or by implications, that Serum GV: a. is an effective treatment for skin cancer, including melanoma; and b. prevents melanoma.

8. Through the means described in Paragraph 6, Respondents have represented, expressly or by implication, that they possessed and relied upon a reasonable basis that substantiated the representations set forth in Paragraph 7, at the time the representations were made.

9. In truth and in fact, Respondents did not possess and rely upon a reasonable basis that substantiated the representations set forth in Paragraph 7, at the time the representations were made. Therefore, the representation set forth in Paragraph 8 was, and is, false and misleading.

10. Through the means described in Paragraph 6, Respondents have represented, expressly or by implication, that Serum GV: a. is recognized by the medical profession as an effective treatment for skin cancer; and VOLUME 146 Complaint b. is clinically proven to prevent or treat melanoma. 11. In truth and in fact, Serum GV is not recognized by the medical profession as an effective treatment for skin cancer and is not clinically proven to prevent or treat melanoma. Therefore, the representations set forth in Paragraph 10 were, and are, false and misleading.

12. The acts and practices of Respondents as 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.

THEREFORE, the Federal Trade Commission this twentysecond day of October, 2008, has issued this complaint against Respondents.

By the Commission.

BIOQUE TECHNOLOGIES, INC. 585 Complaint EXHIBIT A 1131-2 AM RN Bioque ~ PRODDCY PRIZE-WINNING PRODUCTS SERUM GV Latreoreinarity etlectiow toptes shin cancer treatment Clanreadly prowen ang professcmeliy endoed fermulaton—octive ingredient preverts aad heips correct sneiemoms Stomp of approval The erer:a! Westmeet for nan cancer Keep the oc tor maby Once ("ea fe research shades have OemooLir aed Pat Sores V's acne ny eiert—a hrc emt CF Aon TANKER prevent Sevetbemerl 3f euuarcme thee arated attety 2 cance: cob en her certeat sages anc deabuys wm by Catng ctf fee energy Sod Serves an bm excellent not earl abeenatie abroemal ah conations uct oe motes SDS art warts Support System cases were conc has aPwerty mpowared rhe sion Matem Serum Gv bovuis He body's Ewe detanae ay seme 1 dowry Ihe cance: com ‘olveaon Nae rocognaced Sanam OV an fhe orey aveimet and etinciow hapeoe! Directions for use"

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1. Respondent Bioque Technologies, Inc. (“Bioque”) is a Virginia corporation with its principal office or place of business at 200 Country Club Drive SW, Blacksburg, Virginia 24060. BIOQUE TECHNOLOGIES, INC. 587 Decision and Order 2. Respondent Vittorio A. Bonomo is a director of Bioque. Individually or in concert with others, he formulates, directs, controls, or participates in the policies, acts, or practices of Bioque, including the acts and practices alleged in the complaint. His principal office or place of business is the same as that of the corporation.

3. Respondent Christine A. Guilman is an officer of Bioque. Individually or in concert with others, she formulates, directs, controls, or participates in the policies, acts, or practices of Bioque, including the acts and practices alleged in the complaint. Her principal office or place of business is the same as that of the corporation.

4. 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. Bioque Technologies, Inc. (“Bioque”), a corporation, its successors and assigns and its officers; B. Vittorio A. Bonomo (“Bonomo”), individually, and as a director of Bioque;

C. Christine A. Guilman (“Guilman”), individually, and as an officer of Bioque;

VOLUME 146 Decision and Order and each of the above’s agents, representatives, and employees.

2. “Serum GV” shall mean Serum GV and any other product containing annona muricata, soursop, guanabana, or graviola.

3. “Commerce” shall mean as defined in Section 4 of the FTC Act, 15 U.S.C. § 44.

4. “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.

5. “Covered product or service” shall mean any healthrelated service or program; or any food, dietary supplement, device, or drug, including, but not limited to, Serum GV.

6. “Endorsement” shall mean as defined in 16 C.F.R. § 255.0(b).

7. “Food,” “drug,” and “device” shall mean as defined in Section 15 of the FTC Act, 15 U.S.C. § 55. 8. The term “including” shall mean “without limitation.” 9. The terms “and” and “or” shall be construed conjunctively or disjunctively as necessary, to make the applicable phrase or sentence inclusive rather than exclusive. BIOQUE TECHNOLOGIES, INC. 589 Decision and Order I.

IT IS ORDERED that Respondents, directly or through any corporation, partnership, subsidiary, division, trade name, or other device, in connection with the advertising, promotion, offering for sale, or sale of Serum GV 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, that such product or service: A. is an effective treatment for skin cancer, including melanoma;

B. prevents melanoma;

C. is recognized by the medical profession as an effective treatment for skin cancer; or D. is clinically proven to prevent or treat melanoma, unless the representation is true, non-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 corporation, partnership, subsidiary, division, trade name, or other device, in connection with the advertising, promotion, offering for sale, or sale of any covered product or service, in or affecting commerce, shall not make any representation, in any manner, expressly or by implication, including through the use of a product name or endorsement, about the absolute or comparative benefits, performance, efficacy, safety, or side effects of such covered product or service, unless the representation is true, non-misleading, and, at the time it is VOLUME 146 Decision and Order made, Respondents possess and rely upon competent and reliable scientific evidence that substantiates the representation. III.

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

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 or final standard promulgated by the Food and Drug Administration, or under any new drug application approved by the Food and Drug Administration; and 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 National Labeling and Education Act of 1990.

BIOQUE TECHNOLOGIES, INC. 591 Decision and Order V.

IT IS FURTHER ORDERED that:

A. Respondents shall, within seven (7) days after the date of entry of this Order, deliver to the Commission a list, in the form of a sworn affidavit, of all consumers who purchased Serum GV, on or after January 1, 2003 through the date of entry of this Order, to the extent they have such information in their possession or control. Such list shall include each consumer’s name and address, the product(s) purchased, the total amount of moneys paid less any amount credited for returns or refunds, and, if available, the consumer’s telephone number and email address; and B. Except as provided in this Order, Respondents, and their officers, agents, servants, employees, and attorneys and all other persons or entities who receive actual notice of this Order by personal service or otherwise, are permanently restrained and enjoined from selling, renting, leasing, transferring, or otherwise disclosing the name, address, telephone number, credit card number, bank account number, email address, or other identifying information of any person who paid any money to any Respondent, at any time prior to entry of this Order, in connection with the purchase of Serum GV. Provided, however, that Respondents may disclose such identifying information as required in Subparagraph A above, or to any law enforcement agency, or as required by any law, regulation, or court order.

VI.

IT IS FURTHER ORDERED that within forty-five (45) days after the date of entry of this Order, Respondents shall send by first class mail, postage prepaid, an exact copy of the notice VOLUME 146 Decision and Order attached as Attachment A to all persons identified in Part V(A). The mailing shall not include any other documents. VII.

IT IS FURTHER ORDERED that Respondents shall pay to the Federal Trade Commission the sum of nine thousand, thirtyfive dollars and eighty-five cents ($9,035.85). This payment shall be made in the following manner:

A. The payment shall be made by wire transfer or certified or cashier’s check made payable to the Federal Trade Commission, the payment to be made no later than fifteen (15) days after the date that this order becomes final. B. In the event of any default in payment, which default continues for ten (10) days beyond the due date of payment, the amount due, together with interest, as computed pursuant to 28 U.S.C. § 1961(a), from the date of default to the date of payment, shall immediately become due and payable to the Commission. C. The funds paid by Respondents, together with any accrued interest, shall, in the discretion of the Commission, be used by the Commission to provide direct redress to purchasers of Serum GV in connection with the acts and practices alleged in the complaint, and to pay any attendant costs of administration. If the Commission determines, in its sole discretion, that redress to purchasers of this product is wholly or partially impracticable or is otherwise unwarranted, any funds not so used shall be paid to the United States Treasury. Respondents shall be notified as to how the funds are distributed, but shall have no right to contest the manner of distribution chosen by the Commission. No portion of the payment as herein BIOQUE TECHNOLOGIES, INC. 593 Decision and Order provided shall be deemed a payment of any fine, penalty, or punitive assessment.

D. Respondents relinquish all dominion, control, and title to the funds paid, and all legal and equitable title to the funds vests in the Treasurer of the United States and in the designated consumers. Respondents shall make no claim to or demand for return of the funds, directly or indirectly, through counsel or otherwise; and in the event of bankruptcy of any Respondent, Respondents acknowledge that the funds are not part of the debtor’s estate, nor does the estate have any claim or interest therein. VIII.

IT IS FURTHER ORDERED that Respondent Bioque, and its successors and assigns, and Respondents Bonomo and Guilman 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. IX.

VOLUME 146 Decision and Order IT IS FURTHER ORDERED that Respondent Bioque, and its successors and assigns, and Respondents Bonomo and Guilman shall deliver a copy of this order to all current and future principals, officers, directors, and other employees with managerial authority 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 this order, and to future personnel within thirty (30) days after the person assumes such position or responsibilities. X.

IT IS FURTHER ORDERED that Respondent Bioque, and its successors and assigns, shall notify the Commission at least thirty (30) days prior to any change in the corporation that may affect compliance obligations arising under this order, including, but not limited to, dissolution, assignment, sale, merger, or other action that would result in the emergence of a successor corporation; the creation or dissolution of a subsidiary, parent, or affiliate that engages in any acts or practices subject to this order; the filing of a bankruptcy petition; or a change in the corporate name or address. Provided, however, that, with respect to any proposed change in the corporation about which Respondents learn less than thirty (30) days prior to the date of 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.

XI.

BIOQUE TECHNOLOGIES, INC. 595 Decision and Order IT IS FURTHER ORDERED that Respondents Bonomo and Guilman, for a period of ten (10) years after the date of issuance of this order, shall notify the Commission of the discontinuance of their individual current business or employment, or of their individual affiliation with any new business or employment. The notice shall include the Respondent’s new business address and telephone number and 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. XII.

IT IS FURTHER ORDERED that Respondent Bioque, and its successors and assigns, and Respondents Bonomo and Guilman 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. XIII.

This order will terminate on October 22, 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 defendant in such complaint; and VOLUME 146 Decision and Order 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 the 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. By the Commission.

BIOQUE TECHNOLOGIES, INC. 597 Decision and Order ATTACHMENT A ATTACHMENT A LETTER TO BE SENT BY FIRST CLASS MAIL {on letterhead of Bioque Technologies, Inc.} (Name and address of recipient] [Date] Dear [recipient’s name]:

Our records show that you bought Serum GV from our website, www. bioque.com. We are writing to tell you that the Federal Trade Commission (“FTC”) has alleged that our advertising claims for Serum GV were false or unsubstantiated. To resolve these charges, we have entered into a settlement with the FTC that prohibits us from making misleading claims about Serum GV or any other health-related product. The settlement with the FTC does not constitute an admission that we have violated the law. As part of the settlement, however, we agreed to send you the following information about the scientific evidence on Serum GV. Very little scientific research has been done concerning Serum GV or any other product that contains annona muricata for the prevention, treatment, or cure of skin cancer, including melanoma, in humans. The scientific studies that have been done do not demonstrate that Serum GV or annona muricata effectively prevent or treat melanoma or other forms of skin cancer. It is very important that you talk to your doctor or health care provider before using any alternative or herbal product, including Serum GV or any other product that contains annona muricata. Speaking with your doctor is important to make sure that all aspects of your medical treatment work together. Things that seem safe, such as certain foods, herbs, or pills, may interfere or affect your cancer or other medical treatment, or other medicines you might be taking. Some herbs or other complementary or alternative treatments may keep your medicines from doing what they are supposed to do, or could be harmful when taken with other medicines or in high doses. It also is very important that you talk to your doctor or health care provider before you decide to take any alternative or herbal product, including Serum GV or any other product that contains annona muricata, instead of taking conventional cancer treatments that have been scientifically proven to be safe and effective in humans. If you would like further information about complementary and alternative treatments for cancer, the following Internet web sites may be helpful: 10.The National Cancer Institute: www.cancer.gov/cancertopics/pdq; or 11.The National Center for Complementary and Alternative Medicines: www.nccam.nih.gov.

You also can contact the National Cancer Institute’s Cancer Information Service at 1-800-4~-CANCER or 1-800-422-6237.

Sincerely, Christine Guilman, President Bioque Technologies, Inc.

VOLUME 146 Analysis to Aid Public Comment 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 Bioque Technologies, Inc., Vittorio A. Bonomo, and Christine A. Guilman (together, “Respondents”). The proposed consent order has been placed on the public record for thirty (30) days for receipt 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 Serum GV, a topical serum that, according to its label, contains, among other ingredients, extract of annona muricata, also known as graviola, derived from the soursop or guanabana tree. According to the FTC complaint, Respondents represented that Serum GV is an effective treatment for skin cancer, including melanoma, and that it prevents melanoma. The complaint alleges that Respondents failed to have substantiation for these claims. Also according to the FTC complaint, Respondents represented that Serum GV is recognized by the medical profession as an effective treatment for skin cancer and that it is clinically proven to prevent or treat melanoma. The complaint alleges that these claims are false and misleading because Serum GV is not recognized by the medical profession as an effective treatment for skin cancer and is not clinically proven to prevent or treat melanoma. The proposed consent order contains provisions designed to prevent Respondents from engaging in similar acts and practices in the future.

BIOQUE TECHNOLOGIES, INC. 599 Analysis to Aid Public Comment Part I of the proposed order requires Respondents to have competent and reliable scientific evidence substantiating any claims that a covered product or service is an effective treatment for skin cancer, including melanoma; prevents melanoma; is recognized by the medical profession as an effective treatment for skin cancer; or is clinically proven to prevent or treat melanoma. The provision further requires that such claims be true and nonmisleading. A “covered product or service” is defined in the order as “any health-related service or program; or any food, dietary supplement, device, or drug, including, but not limited to, Serum GV.”

Part II of the proposed order requires the Proposed Respondents to possess competent and reliable scientific evidence for any claims about the absolute or comparative benefits, performance, efficacy, safety, or side effects of any covered product or service. The claims also must be truthful and nonmisleading.

Part III of the proposed order prohibits Respondents from making future misrepresentations about the existence, contents, validity, results, conclusions, or interpretations of any test or study.

Part IV 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 and representations for any product that are specifically permitted in labeling for that product by regulations issues by the FDA under the Nutrition Labeling and Education Act of 1990. Part V of the proposed order requires Respondents to provide the FTC with a list of all consumers that they know purchased Serum GV and prohibits Respondents from using or disclosing the VOLUME 146 Analysis to Aid Public Comment consumer information, except to a law enforcement agency or as required by law.

Part VI of the proposed order requires Respondents to send to the consumers identified in Part V a notification letter drafted by the FTC to inform them about the consent agreement. Part VII of the proposed order provides for the payment of $9,035.85, the full amount of sales of the product, to the Commission.

Parts VIII through XII of the proposed order 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 (for the corporate respondent) and changes in employment (for the individual respondents) that might affect compliance obligations under the order; and to file compliance reports with the Commission. Part XIII 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, and it is not intended to constitute an official interpretation of the agreement and proposed order or to modify in any way their terms.

601 HOLLY A. BACON Complaint