002 3098 UNITED STATES OF AMERICA
In the Matter of MAXCELL BIOSCIENCE, INC., a corporation, and DOCKET NO. C-4017 The Â鶹´«Ã½ Trade Commission having initiated an investigation of certain acts and practices of the respondents named in the caption hereof, and the respondents having been furnished thereafter with a copy of a draft of complaint which the Bureau of Consumer Protection proposed to present to the Commission for its consideration and which, if issued by the Commission, would charge respondents with violation of the Â鶹´«Ã½ Trade Commission Act; and The respondents, their attorney, and counsel for Â鶹´«Ã½ Trade 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 draft of complaint, a statement that the signing of said agreement is for settlement purposes only and does not constitute an admission by respondents that the law has been violated as alleged in such complaint, or that 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 Commission having thereafter considered the matter and having determined that it had reason to believe that the respondents have violated the said Act, and that complaint should issue stating its charges in that respect, 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 § 2.34 of its Rules, the Commission hereby issues its complaint, makes the following jurisdictional findings and enters the following order:
ORDER DEFINITIONS For purposes of this Order, the following definitions shall apply:
I. IT IS ORDERED that respondents, directly or through any corporation, subsidiary, division, or other device, including franchisees, licensees, or distributors, in connection with the manufacturing, labeling, advertising, promotion, offering for sale, sale, or distribution of the Anabolic/Catabolic Index test, or any other substantially similar device, in or affecting commerce, shall not represent, in any manner, expressly or by implication, that such device provides a clinical gauge of an individual's overall healthiness or overall youthfulness. For purposes of this Part, "substantially similar device" shall mean any product that measures the ratio of 17-ketosteroids to creatinine in one urine sample. II. IT IS FURTHER ORDERED that respondents, directly or through any corporation, subsidiary, division, or other device, including franchisees, licensees, or distributors, in connection with the manufacturing, labeling, advertising, promotion, offering for sale, sale, or distribution of any test or other device, in or affecting commerce, shall not represent, in any manner, expressly or by implication, that such device provides a clinical gauge of an individual's overall healthiness or overall youthfulness, unless the representation is true and, at the time it is 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, subsidiary, division, or other device, including franchisees, licensees, or distributors, in connection with the manufacturing, labeling, advertising, promotion, offering for sale, sale, or distribution of Longevity Signal Formula or any other food, drug, device, service, or dietary supplement, in or affecting commerce, shall not make any representation, in any manner, expressly or by implication:
unless, at the time it is made, respondents possess and rely upon competent and reliable scientific evidence that substantiates the representation. IV. IT IS FURTHER ORDERED that respondents shall not provide to any person or entity means and instrumentalities that contain any claim about the effect of any product or service on any disease, or about the effect of any product or service on the structure or function of the human body, or about any other health benefit, or the safety, of any product or service, unless such claim is true, and substantiated by competent and reliable scientific evidence. For purposes of this Part, "means and instrumentalities" shall mean any information, including but not necessarily limited to any advertising, labeling or promotional materials, for use by distributors in their marketing or sale of the Anabolic/Catabolic Index test or Longevity Signal Formula or any other product or service covered under this order, in or affecting commerce. V. IT IS FURTHER ORDERED that respondents, directly or through any corporation, subsidiary, division, or other device, including franchisees, licensees, or distributors, in connection with the manufacturing, labeling, advertising, promotion, offering for sale, sale, or distribution of any food, drug, device, service, or dietary supplement, 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. VI. IT IS FURTHER ORDERED that respondents shall:
VII. IT IS FURTHER ORDERED that respondent MaxCell BioScience, Inc., directly or through any corporation, subsidiary, division, trade name, or other device, shall:
VIII. 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 medical device application approved by the Food and Drug Administration. Nor shall it 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. IX. IT IS FURTHER ORDERED that respondents shall pay the Â鶹´«Ã½ Trade Commission the sum of one hundred fifty thousand dollars ($150,000). This payment shall be made in the following manner:
X. IT IS FURTHER ORDERED that respondent MaxCell BioScience, Inc., and its successors and assigns, and respondent Stephen Cherniske shall, for five (5) years after the last date of dissemination of any representation covered by this order, maintain and upon request make available to the Â鶹´«Ã½ Trade Commission for inspection and copying:
XI. IT IS FURTHER ORDERED that respondent MaxCell BioScience, Inc., and its successors and assigns, and respondent Stephen Cherniske 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 this order, and to future personnel within thirty (30) days after the person assumes such position or responsibilities. XII. IT IS FURTHER ORDERED that respondent MaxCell BioScience, Inc., 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, a 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 proposed 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 respondent learns less than thirty (30) days prior to the date such action is to take place, respondent 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 Â鶹´«Ã½, Bureau of Consumer Protection, Â鶹´«Ã½ Trade Commission, 600 Pennsylvania Avenue, N.W., Washington, D.C. 20580. XIII. IT IS FURTHER ORDERED that respondent Stephen Cherniske, for a period of ten (10) years after the date of issuance of this order, shall notify the Commission of the discontinuance of his current business or employment, or of his affiliation with any new business or employment. The notice shall include respondent's new business address and telephone number and a description of the nature of the business or employment and his duties and responsibilities. All notices required by this Part shall be sent by certified mail to the Associate Director, Division of Â鶹´«Ã½, Bureau of Consumer Protection, Â鶹´«Ã½ Trade Commission, 600 Pennsylvania Avenue, N.W., Washington, D.C. 20580. XIV. IT IS FURTHER ORDERED that respondent MaxCell BioScience, Inc., and its successors and assigns, and respondent Stephen Cherniske shall, within sixty (60) days after service of this order, and at such other times as the Â鶹´«Ã½ 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. XV. This order will terminate on July 30, 2021, or twenty (20) years from the most recent date that the United States or the Â鶹´«Ã½ 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:
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. Benjamin I. Berman ISSUED: July 30, 2001 SEAL ATTACHMENT A LETTER SENT TO DISTRIBUTORS WITH WHOM [To Be Printed on MaxCell BioScience letterhead] [NAME AND ADDRESS OF RECIPIENT] [DATE] Dear [DISTRIBUTOR'S NAME]: This letter is to inform you that MaxCell BioScience, Inc. recently settled a civil dispute with the Â鶹´«Ã½ Trade Commission regarding its advertising for the Anabolic/Catabolic Index test and Longevity Signal Formula. Among other things, we have agreed to notify distributors of the settlement. As a result of its agreement with the FTC, MaxCell BioScience, Inc. has consented to desist from, among other practices, making any claim about the effects on any disease or on the structure or function of the human body, or about any other health benefit, or the safety, of any dietary supplement, food, drug, device, or service, that is not supported by competent and reliable scientific evidence. Competent and reliable scientific evidence is defined as 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. Anecdotal evidence and consumer testimonials are not considered competent and reliable scientific evidence. According the FTC complaint, we did not have a reasonable basis to claim that the ACI test measures a person's overall healthiness or youthfulness or that LSF reduces the risk of atherosclerosis, cures arthritis, lowers blood pressure, lowers cholesterol levels in the bloodstream, strengthens bones, reduces or eliminates the need for corrective lenses, or promotes weight loss and muscle gain without dieting or exercise, increases glucose tolerance, increases Growth Hormone levels in the body, thereby causing positive clinical effects on health, or improves liver function. As always, your responsibility as a distributor is to utilize only claims made directly from corporate communications or to have your advertising approved by the corporation before transmitting it. Failure to comply with these requirements can result in termination. This letter has been provided for your files. If you have any questions or if you want a copy of the FTC order, please contact [insert name and telephone number of respondents' contact]. ___________________________ |