Cytodyne, LLC, Evergood Products Corp., and Melvin L. Rich
Volume 140 · 140 F.T.C. 191
deceptive advertisinghealth claimsendorsements
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Cytodyne, LLC, Evergood Products Corp., and Melvin L. Rich, 140 F.T.C. 191 (2005). Consumer Law Library, https://consumerlawlibrary.org/decisions/v140-0006
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IN THE MATTER OF CYTODYNE, LLC, EVERGOOD PRODUCTS CORP., AND MELVIN L. RICH CONSENT ORDER, ETC., IN REGARD TO ALLEGED VIOLATIONS OF SEC. 5 AND 12 OF THE FEDERAL TRADE COMMISSION ACT Docket C-4146; File No. 0323144 Complaint, August 23, 2005--Decision, August 23, 2005 This consent order, among other things, prohibits Respondents Cytodyne, LLC, Evergood Products Corp., and Melvin Rich, from representing that Xenadrine EFX – a dietary supplement marketed for weight loss – or any other product containing green tea extract, bitter orange, or caffeine causes rapid and substantial weight loss or fat loss, and from representing that any weight loss product causes rapid or substantial weight loss without the need to diet or increase exercise. The consent order also prohibits the respondents from representing that any weight loss product, dietary supplement, food, drug, or device causes weight or fat loss, causes permanent or long-term weight loss – or enables users to lose weight or fat without the need to diet or increase exercise – unless the claim is true and respondents possess competent and reliable scientific evidence that substantiates the claim. In addition, the consent order prohibits the respondents from making any other claims about the health benefits, performance, efficacy, safety, or side effects of any such product unless the claim is true and respondents possess competent and reliable scientific evidence that substantiates the claim. The consent order also prohibits the respondents from misrepresenting the existence, contents, validity, results, conclusions, or interpretations of any test or study – in connection with the marketing or sale of any weight loss product, dietary supplement, food, drug, or device – and from misrepresenting that the experience described in any user testimonial for any weight loss product, dietary supplement, food, drug, or device represents the actual experience of the endorser as a result of using the product under the circumstances depicted in the endorsement. In addition, the consent order requires the respondents to pay $100,000 to the Commission. Participants For the Commission: Rona Kelner, Peter B. Miller, Michael F. Ostheimer, Heather Hippsley, Mary K. Engle, and Susan P. Braman.
For the Respondent: Jay Geller VOLUME 140 Complaint COMPLAINT The Federal Trade Commission, having reason to believe that Cytodyne, LLC, a limited liability company, Evergood Products Corp., a corporation, and Melvin Rich, individually and as a manager of Cytodyne, LLC and an officer of Evergood Products Corp. (“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 Cytodyne, LLC is a New York limited liability company with its principal office or place of business at 200 Adams Boulevard, Farmingdale, NY 11735. Its previous corporate name was Everrich, LLC.
2. Respondent Evergood Products Corp. (“Evergood”) is a Delaware corporation with its principal office or place of business at 200 Adams Boulevard, Farmingdale, NY 11735. Evergood is a holding company and has an eighty-seven and one-half percent ownership interest in Cytodyne, LLC. Evergood has controlled the acts and practices of Cytodyne, LLC with respect to the advertising, marketing, distribution, offering for sale, and sale of Xenadrine EFX.
3. Respondent Melvin L. Rich is a manager of Cytodyne, LLC. He is also President of Evergood and has a forty-five percent ownership interest in the company. Individually or in concert with others, he formulates, directs, or controls the policies, acts, or practices of Cytodyne, LLC and Evergood, including the acts or practices alleged in this complaint. His principal office or place of business is the same as that of Cytodyne, LLC and Evergood. 4. Since May 2003, respondents have advertised, labeled, offered for sale, sold, and distributed the dietary supplement Xenadrine EFX. Xenadrine EFX is a tablet containing, among other ingredients, green tea extract, yerba mate, and bitter orange. A 120-tablet bottle of Xenadrine EFX – a one-month supply – retails VOLUME 140 Complaint for approximately $40. From June 2003 through mid-August 2004, sales of Xenadrine EFX exceeded $61 million. 5. Xenadrine EFX is a “food” or “drug” within the meaning of Sections 12 and 15 of the Federal Trade Commission Act. 6. 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. 7. Respondents have disseminated or have caused to be disseminated advertisements for Xenadrine EFX, including but not limited to the attached Exhibits A through F. These advertisements contain the following statements and depictions: a. Misty Lee Lost 25 Pounds Faster And Easier Than She Ever Dreamed Possible With Xenadrine-EFX! John Murphy lost 37 Pounds in just weeks! Kelly Kinney lost 101 Pounds! Holli Whitacre lost over 100 Pounds! All of these people just discovered the most incredible weight loss product in the world...and it shows! There’s safety in numbers. That’s why it’s nice to know that there are millions of people around the world happily counting the pounds they’ve lost with revolutionary new Xenadrine-EFX.
What makes us different than all the rest? Xenadrine-EFX really works! It’s been clinically proven to help you burn fat safely and effectively, without ephedrine. Our incredibly advanced thermogenic formula literally “revs up” your body’s metabolism for rapid reductions in body-fat and an incredible boost to your energy levels. VOLUME 140 Complaint Amazingly, Xenadrine-EFX’s unique formula of advanced thermogenic compounds actually triggers unprecedented results without the use of ephedrine. In fact, it’s the only product of its kind proven more effective than ephedrinebased fat burners in head-to-head clinical testing. Best of all, you’ll start to see and feel the difference almost overnight and even without strict dieting or exercise! It’s about time you discovered the most incredible weight loss product in the world. Clinically proven Xenadrine-EFX. The Guaranteed Easiest and Fastest Way to Take Off the Weight! Exhibit A (two-page magazine advertisement) b. Video: Claudette Garza with a photograph labeled “Before Claudette Garza lost 22 Pounds!” Announcer 1: “Xenadrine EFX, the world’s number one diet supplement presents swimsuit season.” Video: Joey Anderson with a photograph labeled “Before Joey Anderson lost 55 Pounds!” Announcer 2: “Slip into something sleek and sexy, and start strutting your stuff.”
Video: Hazel Nelson with a photograph labeled “Before Hazel Nelson lost 25 Pounds!”
Announcer 1: “Xenadrine EFX can help make it happen, fast and easy.”
Video: Dan Tedtman with a photograph labeled “Before Dan Tedtman lost 35 pounds!”
Announcer 2: “These real people are living proof of Xenadrine EFX’s unsurpassed thermogenic power.”
Video: Alexis Graham with a photograph labeled “Before Alexis Graham lost 113 pounds!” Announcer 2: “Increase your metabolism and get dramatic results without ephedra.”
Video: Bottle of Xenadrine EFX with “CLINICALLY TESTED” on its label and VOLUME 140 Complaint superscript “FAST! EASY! EPHEDRA- FREE!”
Announcer 1: “So come on, start turning some heads with Xenadrine EFX. Number one in the world because it really works.”
Video: Robert Hale with a photograph labeled “Before Robert Hale lost 85 pounds!”
Exhibit B (thirty-second television advertisement) c. The Shape Of Things To Come . . .With Xenadrine-EFX.
Melissa lost Patrick lost Kelly Lost Jennifer Lost 45 Pounds! 64 Pounds! 110 Pounds! 52 Pounds! Melissa, Patrick, Kelly and Jennifer are happier than ever before –because they all lost incredible amounts of weight, and kept it off, with Xenadrine-EFX. “If it wasn’t for Xenadrine-EFX, I wouldn’t have lost my weight as quickly and as easily as I did.” says Melissa. And Patrick agrees. “I’ve used plenty of products in the past to help with weight loss and improve my energy levels, and Xenadrine-EFX has far surpassed anything I’ve ever used. I’m a new person thanks to Xenadrine-EFX.” These are just a few of the thousands of people who have achieved real weight loss success with Xenadrine-EFX. Its thermogenic, ephedra-free formula increases metabolism and reduces calories which helped them achieve significant decreases in body fat levels. In fact, the Xenadrine-EFX formula was clinically tested against two leading ephedrabased thermogenic supplements and outperformed them both for the boosting of metabolism and resulting caloric expenditure.
. . .
Xenadrine-EFX Real People. Real Science. Real Success. VOLUME 140 Complaint Exhibit C (magazine advertisement) d. Losing Weight Was The Best Thing I Ever Did For Myself! Jennifer Lost An Incredible 52 Pounds And Kept It Off With Xenadrine-EFX! “One day, standing in front of my open closet, I started to cry. None of my clothes fit anymore.” That’s when Jennifer made up her mind to do something about it. She started using Xenadrine-EFX, lost 52 pounds, and has kept off the weight.
“Sure, I’d tried other diets, but with Xenadrine-EFX, it was like the pounds just started disappearing,” she says. “And it didn’t make me feel jittery like the stuff I’d used in the past.”
What makes Xenadrine-EFX so different from other diet supplements is the thermogenic, ephedra-free formula that increases your metabolism and helps control your appetite, which helped Jennifer achieve significant decreases in body fat levels. In fact, the Xenadrine-EFX formula was clinically tested against two leading ephedra-based thermogenic supplements and outperformed them both in boosting metabolism and resulting caloric expenditures. . . .
Xenadrine-EFX Real People.
Real Science.
Real Success.
Exhibit D (magazine advertisement) e. “I lost 100 pounds and I owe it all to Xenadrine-EFX. If I can do it, you can too!”
– Holli Whitacre VOLUME 140 Complaint “I look in the mirror and I still can’t believe that it’s me!” Holli says today. “I'm 100 pounds lighter and I feel 100% healthier! I love what Xenadrine-EFX has done for me.” Xenadrine-EFX worked for Holli and it will work for you. This amazing weight loss technology attacks body fat by increasing your metabolism better than any other product on the market today. Its unique formula combines a new generation of advanced thermogenic components that work together to stimulate significant increases to your metabolism and subsequently burn calories. Simply stated, Xenadrine-EFX helps you to burn fat more quickly. And here's more good news. Xenadrine-EFX doesn’t contain ephedra. In fact, it is the only thermogenic diet product that has been proven in head to head clinical studies to be more effective than ephedra-based fat burners. Scientifically designed to burn fat and maintain muscle, this revolutionary formula has quickly become the #1 diet supplement in America.
Xenadrine-EFX is the fastest and easiest way to dramatic and long term weight loss. Put Xenadrine-EFX to work for you and discover the unprecedented fat burning power of the next generation in weight-loss technology! Xenadrine . . . The #1 Diet Supplement Worldwide . . . because it works! Exhibit E (magazine advertisement translated from the original Spanish to English) f. “It was marvelous to lose 20 lbs. It’s even better not to gain them back with Xenadrine-EFX.”
Over a year ago, Claudette lost more than 20 pounds thanks to Xenadrine-EFX, and she feels happier than ever. As she, herself, says: “In a few weeks, I went down four clothing sizes. It’s a fact: Xenadrine-EFX changed my life forever!” VOLUME 140 Complaint But what really makes Claudette story so incredible is that she has managed to keep the weight off for more than a year... with the help of Xeandrine-EFX, a sensible diet, and regular exercise.
What makes Xenadrine-EFX so effective is its exclusive ephedra-free thermogenic formula, which helps to speed up your metabolism and control your appetite. In fact, the Xenadrine-EFX formula has been clinically proven in comparison with two thermogenic ephedra-based supplements, and in both cases, it had better results in stimulating the metabolism and burning calories. Xenadrine-EFX: The most popular diet supplement worldwide, because it works! Xenadrine-EFX Real People. Real Science. Real Success. Exhibit F (magazine advertisement translated from the original Spanish to English) 8. Through the means described in Paragraph 7, respondents have represented, expressly or by implication, that: a. Xenadrine EFX causes rapid and substantial weight loss; b. Xenadrine EFX causes rapid and substantial fat loss; c. Xenadrine EFX causes rapid and substantial weight loss without the need to reduce caloric intake or increase physical activity; and d. Xenadrine EFX causes permanent or long-term weight loss.
9. In truth and in fact, VOLUME 140 Complaint a. Xenadrine EFX does not cause rapid and substantial weight loss;
b. Xenadrine EFX does not cause rapid and substantial fat loss;
c. Xenadrine EFX does not cause rapid and substantial weight loss without the need to reduce caloric intake or increase physical activity; and d. Xenadrine EFX does not cause permanent or long-term weight loss.
Therefore, the representations set forth in Paragraph 8 were, and are, false or misleading.
10. Through the means described in Paragraph 7, respondents have represented, expressly or by implication, that they possessed and relied upon a reasonable basis that substantiated the representations set forth in Paragraph 8, 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 8, at the time the representations were made. Therefore, the representation set forth in Paragraph 10 was, and is, false or misleading.
12. Through the means described in Paragraph 7, respondents have represented, expressly or by implication, that: a. Xenadrine EFX is clinically proven to cause rapid and substantial weight loss; and b. Xenadrine EFX is clinically proven to be more effective than leading ephedrine-based diet products. 13. In truth and in fact, VOLUME 140 Complaint a. Xenadrine EFX is not clinically proven to cause rapid and substantial weight loss; and b. Xenadrine EFX is not clinically proven to be more effective than leading ephedrine-based diet products. Therefore, the representations set forth in Paragraph 12 were, and are, false or misleading.
14. Through the means described in Paragraph 7, respondents have represented, expressly or by implication, that persons who appeared in Xenadrine EFX advertisements achieved the weight loss reported in those ads solely through the use of Xenadrine EFX.
15. In truth and in fact, persons who appeared in Xenadrine EFX advertisements did not achieve the weight loss reported in those ads solely through the use of Xenadrine EFX. Persons who appeared in the Xenadrine EFX advertisements engaged in rigorous diet and/or exercise programs in order to lose weight, and some were provided with a personal trainer. Therefore, the representation set forth in Paragraph 14 was, and is, false or misleading.
16. Through the means described in Paragraph 7, respondents have presented testimonials for Xenadrine EFX by consumer endorsers who purportedly lost weight in the ordinary course of using the product. Respondents have failed to disclose that the endorsers were paid from $1,000 to $20,000 in connection with their endorsing Xenadrine EFX. This fact would be material to consumers in their purchase or use decisions regarding Xenadrine EFX. The failure to disclose this fact, in light of the representation made, was, and is, a deceptive practice. 17. 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 VOLUME 140 Complaint violation of Sections 5(a) and 12 of the Federal Trade Commission Act.
IN WITNESS WHEREOF, the Federal Trade Commission has caused its complaint to be signed by its Secretary and its official seal to be hereto affixed at Washington, D.C. this 23rd day of August, 2005.
VOLUME 140 Decision and Order DECISION AND ORDER The Federal 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 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 the respondents with violation of the Federal Trade Commission Act; and The respondents, their attorneys, 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 draft 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 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 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: 1. Respondent Cytodyne, LLC is a New York limited liability company with its principal office or place of business at 200 Adams Boulevard, Farmingdale, NY 11735. VOLUME 140 Decision and Order Respondent Evergood Products Corp. (“Evergood”) is a Delaware corporation with its principal office or place of business at 200 Adams Boulevard, Farmingdale, NY 11735. Respondent Melvin L. Rich (“Melvin Rich”) is a manager of respondent Cytodyne, LLC and an officer and director of respondent Evergood. Individually or in concert with others, he formulates, directs, or controls the policies, acts, or practices of Cytodyne, LLC and Evergood, including the acts or practices alleged in this complaint. His principal office or place of business is the same as that of Cytodyne, LLC and Evergood. 2. 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 Cytodyne, LLC, a limited liability company, Evergood Products Corp., a corporation, their successors and assigns, and their officers, members, and managers, and Melvin L. Rich, and each of the above’s agents, representatives, and employees. 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. “Xenadrine EFX” shall mean the Xenadrine EFX dietary supplement.
VOLUME 140 Decision and Order 4. “Substantially similar product” shall mean any product containing one or more of the following ingredients: caffeine, citrus aurantium (bitter orange), or green tea extract. 5. “Weight loss product” shall mean any product, program, or service designed, used, or purported to produce weight loss, reduction or elimination of fat, slimming, or caloric deficit in a user of the product, program, or service. 6. “Food,” “drug,” and “device” shall mean as “food,” “drug,” and “device” are defined in Section 15 of the Federal Trade Commission Act, 15 U.S.C. § 55.
7. “Covered product” shall mean any weight loss product, dietary supplement, food, drug, or device.
8. “Commerce” shall mean as defined in Section 4 of the Federal Trade Commission Act, 15 U.S.C. § 44.
9. “Endorsement” shall mean as defined in 16 C.F.R. § 255.0(b). 10. “Clear(ly) and prominent(ly)” shall mean as follows: a. In an advertisement communicated through an electronic medium (such as television, video, radio, and interactive media such as the Internet, online services and software), the disclosure shall be presented simultaneously in both the audio and visual portions of the advertisement. Provided, however, that in any advertisement presented solely through visual or audio means, the disclosure may be made through the same means in which the ad is presented. The audio disclosure shall be delivered in a volume and cadence sufficient for an ordinary consumer to hear and comprehend it. The visual disclosure shall be of a size and shade, with a degree of contrast to the background against which it appears, and shall appear on the screen for a duration and in a location, sufficiently noticeable for an ordinary consumer to read and comprehend it.
VOLUME 140 Decision and Order b. In a print advertisement, promotional material, or instructional manual, the disclosure shall be in a type size and location sufficiently noticeable for an ordinary consumer to read and comprehend it, in print that contrasts with the background against which it appears. I.
IT IS ORDERED that the respondents, directly or through any corporation, subsidiary, division, trade name, or other device, in connection with the manufacturing, labeling, advertising, promotion, offering for sale, sale, or distribution of Xenadrine EFX or any other weight loss product, in or affecting commerce, shall not represent, in any manner, expressly or by implication, including through the use of a trade name or endorsement, that: A. Such product causes rapid or substantial weight loss without the need to reduce caloric intake or increase physical activity;
B. Xenadrine EFX or any substantially similar product causes rapid and substantial weight loss; or C. Xenadrine EFX or any substantially similar product causes rapid and substantial fat loss. II.
IT IS FURTHER ORDERED that respondents, directly or through any corporation, subsidiary, division, trade name, or other device, in connection with the manufacturing, labeling, advertising, promotion, offering for sale, sale, or distribution of any covered product, in or affecting commerce, shall not make any representation, in any manner, expressly or by implication, including through the use of a trade name or endorsement: A. That such product causes weight loss or fat loss; VOLUME 140 Decision and Order B. That such product enables users to lose weight or fat without the need to increase exercise or reduce caloric intake;
C. That such product causes permanent or long-term weight loss; or D. About the health benefits, performance, efficacy, safety or side effects, of such product;
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, trade name, or other device, in connection with the labeling, advertising, promotion, offering for sale, sale, or distribution of Xenadrine EFX or any other covered product, 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 or study.
IV.
IT IS FURTHER ORDERED that respondents, directly or through any corporation, subsidiary, division, trade name, or other device, in connection with the manufacturing, labeling, advertising, promotion, offering for sale, sale, or distribution of Xenadrine EFX or any other covered product, in or affecting commerce, shall not misrepresent, in any manner, expressly or by implication, that the experience represented by any user testimonial or endorsement of the product represents the actual experience of the endorser as a result of use of the product under the circumstances depicted in the endorsement. VOLUME 140 Decision and Order V.
IT IS FURTHER ORDERED that respondents, directly or through any corporation, subsidiary, division, trade name, or other device, in connection with the manufacturing, labeling, advertising, promotion, offering for sale, sale, or distribution of Xenadrine EFX or any other covered product, in or affecting commerce, shall not make any representation, in any manner, expressly or by implication, about any endorser of such product unless they disclose, clearly and conspicuously, any material connection between such endorser and any respondent or any other individual or entity manufacturing, advertising, promoting, offering for sale, selling, or distributing such product. For purposes of this Paragraph, a “material connection” shall mean any relationship that materially affects the weight or credibility of the endorsement and would not reasonably be expected by consumers, including, but not limited to, monetary payments and the provision of goods, services, or other benefits to any consumer endorser.
VI.
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. VII.
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.
VOLUME 140 Decision and Order VIII.
IT IS FURTHER ORDERED that respondents shall pay to the Federal Trade Commission the sum of one hundred thousand dollars ($100,000). 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 ten (10) 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 from the date of default to the date of payment, shall immediately become due and payable.
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 Xenadrine EFX in connection with the acts or 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 these products 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 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 VOLUME 140 Decision and Order 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. IX.
IT IS FURTHER ORDERED that respondents must, in connection with this action or any subsequent investigations related to or associated with the transactions or the occurrences that are the subject of the Commission’s Complaint, cooperate in good faith with the Commission’s reasonable requests for documents and testimony. Respondents or their representatives shall appear at such places and times as the Commission shall reasonably request for interviews, conferences, pretrial discovery, review of documents, and for such other matters, after written notice to respondents and their counsel of record. Respondents or their representatives shall make themselves available for trial consistent with the Federal Rules of Civil Procedure. Respondents also shall produce such documents and information in a manner as may be reasonably requested by the Commission, after written notice to respondents and to their counsel of record. X.
IT IS FURTHER ORDERED that respondents Cytodyne, LLC, Evergood, and their successors and assigns, and respondent Melvin Rich shall:
A. Within thirty (30) days after the date of service of this order, send by first class mail, postage prepaid and return receipt requested, to each purchaser for resale of Xenadrine EFX with which respondents have done business since May 1, 2003 an exact copy of the notice attached hereto as Attachment A. The mailing shall not include any other document, information, or enclosures. VOLUME 140 Decision and Order B. In the event that respondents receive information that any of respondents’ resellers or distributors are disseminating any advertisement or promotional material that contains any representation prohibited by this order, immediately notify each such reseller or distributor that respondents will stop doing business with that reseller or distributor if it continues to use any advertisement or promotional material that contains any representation prohibited by this order. C. Terminate all sales to any reseller or distributor within twenty (20) days if the reseller or distributor has continued to use any advertisement or promotional material that contains any representation prohibited by this order after receipt of the notice required by Subpart B of this Part. XI.
IT IS FURTHER ORDERED that respondents Cytodyne, LLC, Evergood, and their successors and assigns, and respondent Melvin Rich shall, for five (5) years after the last correspondence to which they pertain, maintain and upon request make available to the Federal Trade Commission for inspection and copying: A. Copies of all notification letters sent to and return receipts from purchasers for resale pursuant to Subpart A of Part X of this order; and B. Copies of all communications with resellers or distributors pursuant to Subpart B and C of Part X of this order. XII.
IT IS FURTHER ORDERED that respondents Cytodyne, LLC, Evergood, and their successors and assigns, and respondent Melvin Rich 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 Federal Trade Commission for inspection and copying: VOLUME 140 Decision and Order A. All advertisements and promotional materials containing the representation including videotape recordings of all such broadcast advertisements;
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. XIII.
IT IS FURTHER ORDERED that respondents Cytodyne, LLC, Evergood, and their successors and assigns, and respondent Melvin Rich, for a period of ten (10) years after the date of issuance of this order, 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.
XIV.
IT IS FURTHER ORDERED that respondents Cytodyne, LLC, Evergood, and their successors and assigns, each shall notify the Commission at least thirty (30) days prior to any proposed change in its corporate structure 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 VOLUME 140 Decision and Order 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 Enforcement, Bureau of Consumer Protection, Federal Trade Commission, 600 Pennsylvania Avenue, NW, Washington, D.C. 20580. XV.
IT IS FURTHER ORDERED that respondent Melvin Rich shall for a period of five (5) years after the date of issuance of this order, notify the Commission of the discontinuance of his current business or employment, or of his affiliation with any new business or employment that may affect his compliance obligations arising out of this order. 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 Enforcement, Bureau of Consumer Protection, Federal Trade Commission, 600 Pennsylvania Avenue, NW, Washington, D.C. 20580.
XVI.
IT IS FURTHER ORDERED that respondents Cytodyne, LLC, Evergood, and their successors and assigns, and respondent Melvin Rich shall, within sixty (60) days from the date of service of this order, and 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.
VOLUME 140 Decision and Order XVII.
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:
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 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. VOLUME 140 Decision and Order ATTACHMENT A GOVERNMENT-ORDERED DISCLOSURE [on Cytodyne, LLC Letterhead] [Insert Date] Dear Xenadrine EFX Reseller or Distributor, This letter is to inform you that Cytodyne, LLC recently settled a dispute with the Federal Trade Commission (“FTC”) regarding its advertising for Xenadrine EFX. Among other things, the settlement requires us to instruct resellers and distributors to stop using advertising or promotional materials that make any of the representations prohibited by the settlement. We will terminate all sales to resellers or distributors that make any of these prohibited representations.
The FTC complaint alleges that Cytodyne, LLC engaged in deceptive advertising of Xenadrine EFX, and the FTC order imposes various requirements on us in connection with its past and future advertising of these and other products. The FTC complaint alleges, among other things, that our advertising materials claimed, expressly or by implication, that Xenadrine EFX causes rapid and substantial weight loss and fat loss; that it does so without the need to reduce caloric intake or increase physical activity; and that it causes permanent or longterm weight loss. The complaint alleges that these claims were false and that the information on which we relied in making these claims was not competent and reliable scientific evidence, as required by law. The FTC order prohibits us from making any claims similar to the challenged claims about any weight loss product unless we have competent and reliable scientific evidence to support them.
In addition, the FTC order provides that we must not make any claim about the health benefits, performance, safety, or efficacy of VOLUME 140 Decision and Order any weight loss product, dietary supplement, food, drug, or device unless we have competent and reliable scientific evidence to support such claims.
The FTC order further provides that we must not misrepresent, in any manner, expressly or by implication, the existence, contents, validity, results, conclusions, or interpretations of any test, study, or scientific research relating to any weight loss product, dietary supplement, food, drug, or device. The FTC complaint also alleges that our Xenadrine EFX ads represented that the featured consumer endorsers achieved the weight loss reported in those ads solely through the use of Xenadrine EFX, but that endorsers had engaged in rigorous diet and/or exercise programs in order to lose weight. The FTC order prohibits us from making similar misrepresentations in the future. The FTC order also requires us to monitor resellers’ and distributors’ advertisements and promotional materials and terminate all sales to resellers and distributors making prohibited claims, whether expressly or by implication, for our products. Resellers and distributors should visit the Xenadrine website, www.Xenadrine.com, for the most up-to-date promotional materials regarding our products.
If you have any questions, please contact [insert name and telephone number of the responsible Cytodyne, LLC Attorney or Officer].
Sincerely, Melvin Rich, Manager Cytodyne, LLC VOLUME 140 Analysis Analysis of Proposed Consent Order to Aid Public Comment The Federal Trade Commission has accepted, subject to final approval, an agreement containing a consent order from Cytodyne, LLC, Evergood Products Corp., and Melvin Rich, individually and as a manager of Cytodyne, LLC and an officer of Evergood Products Corp. (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 practices relating to the advertising and promotion of Xenadrine EFX, a dietary supplement marketed for weight loss. According to the FTC complaint, respondents represented that Xenadrine EFX causes rapid and substantial weight and fat loss, causes permanent or long-term weight loss, and causes rapid and substantial weight loss without the need to diet or increase exercise. The complaint alleges that these claims are false and that the company failed to have substantiation for them. It further alleges that respondents falsely represented that scientific studies prove that Xenadrine EFX causes rapid and substantial weight loss and that it is more effective than leading ephedrine-based diet products.
The FTC complaint also alleges that respondents falsely represented that persons appearing in Xenadrine EFX advertisements achieved the weight loss reported in those ads solely through the use of Xenadrine EFX. According to the FTC complaint, persons who appeared in the Xenadrine EFX advertisements engaged in rigorous diet and/or exercise programs in order to lose weight, and some were provided with a personal trainer. Finally, the complaint alleges that, in presenting testimonials for Xenadrine EFX by consumer endorsers who VOLUME 140 Analysis purportedly lost weight in the ordinary course of using Xenadrine EFX, respondents failed to disclose that the endorsers were paid from $1000 to $20,000 in connection with their endorsement, a fact that would be material to consumers in their decisions about purchasing or using the product.
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 order prohibits representations that Xenadrine EFX or any other product containing green tea extract, bitter orange, or caffeine causes rapid and substantial weight loss or fat loss. It also prohibits representations that any weight loss product causes rapid or substantial weight loss without the need to diet or increase exercise.
Part II prohibits respondents from representing that any weight loss product, dietary supplement, food, drug, or device causes weight or fat loss, causes permanent or long-term weight loss, or enables users to lose weight or fat without the need to diet or increase exercise unless the claim is true and respondents possess competent and reliable scientific evidence that substantiates the claim. It also prohibits respondents from making any other claims about the health benefits, performance, efficacy, safety, or side effects of any such product unless the claim is true and respondents possess competent and reliable scientific evidence that substantiates the claim.
Part III prohibits any misrepresentation of the existence, contents, validity, results, conclusions, or interpretations of any test or study in connection with the marketing or sale of any weight loss product, dietary supplement, food, drug, or device. Part IV prohibits any misrepresentation that the experience described in any user testimonial for any weight loss product, VOLUME 140 Analysis dietary supplement, food, drug, or device represents the actual experience of the endorser as a result of using the product under the circumstances depicted in the endorsement. Part V prohibits any representation about any endorser of any weight loss product, dietary supplement, food, drug, or device unless the respondents disclose any material connection that exists between the endorser and the respondents or any other person or entity involved in manufacturing, marketing, or selling the product.
Part VI of the proposed order allows the respondents to make any 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.
Part VII of the proposed order allows the respondents to make 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. Part VIII provides for the payment of $100,000 to the Commission.
Part IX requires respondents to cooperate in good faith with the Commission’s reasonable requests for documents and testimony in connection with this action or any investigations related to or associated with the transactions or the occurrences that are the subject of the FTC complaint.
Part X requires respondents to send a letter to purchasers for resale of Xenadrine EFX notifying them of the Commission’s order. It also provides that if respondents learn that any of its resellers or distributors are disseminating any advertisement or promotional material containing prohibited representations, they are required to request that the resellers or distributors stop making such representations and to stop doing business with VOLUME 140 Analysis resellers or distributors that do not comply with this request. Part XI requires respondents to keep copies of the communications required by Part X.
Parts XII through XVI 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 respondents) and changes in employment (for the individual respondent) that might affect compliance obligations under the order; and to file compliance reports with the Commission. Part XVII 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.
VOLUME 140 Complaint