Cmo Distribution Centers of America, Inc.
Volume 129 · 129 F.T.C. 1244
deceptive advertisinghealth claimsendorsementsonline internet
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Cmo Distribution Centers of America, Inc., 129 F.T.C. 1244 (2000). Consumer Law Library, https://consumerlawlibrary.org/decisions/v129-0029
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IN THE MATTER OF CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL.
CONSENT ORDER, ETC., IN REGARD TO ALLEGED VIOLATIONS OF SEC. 5 AND 12 OF THE FEDERAL TRADE COMMISSION ACT Docket C-3942; File No. 9823180 Complaint, May 16, 2000--Decision, May 16, 2000 This consent order prohibits Respondents CMO Distribution Centers and Kalon Samluonis from making any representation that CMO or any similar product: (1) is effective in the mitigation, treatment, prevention, or cure of arthritis; (2) provides significant relief from symptoms of arthritis, including pain, swelling, impaired mobility, or deformity; (3) is as effective as, or superior to, prescription medications for the treatment of arthritis or the relief of arthritis symptoms; (4) is effective in the treatment of multiple sclerosis, leukemia, lupus, emphysema, cancer, benign prostate hyperplasia, silicone breast disease, asthma, fibromyalgia, or scleroderma; or (5) is safe or has no adverse side effects, unless, at the time the representation is made, respondents possess and rely upon competent and reliable scientific evidence that substantiates the representation. The order also prohibits proposed respondents from making any representations about the performance, safety, efficacy, or health benefits of CMO or any other food, dietary supplement, or drug, or using the name “cmocure,” using the word “cure”, unless the respondents possess and rely upon competent, reliable scientific evidence substantiating the representation unless the claims are substantiated by competent and reliable scientific evidence. In addition, the order prohibits the proposed respondents from misrepresenting that a product or program is endorsed or approved by any governmental, professional, or private organization or association, or complies with standards or guidelines established by such organization or association, or the existence, contents, validity, results, conclusions, or interpretations of any test, study, or research, or the experience represented by any user testimonial or endorsement of any product or program represents the typical or ordinary experience of members of the public who use the product or program. Participants For the Commission: Judith A. Shepherd, John Hoagland, Mike Eichorn, and BE.
CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. 1245 Complaint For the Respondents: Kirkpatrick Dilling, Dilling and Dilling, and George W. Burditt.
COMPLAINT The Federal Trade Commission, having reason to believe that CMO Distribution Centers of America, Inc. and Kalon Samulonis, individually and as an officer of the corporation, 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 CMO Distribution Centers of America, Inc. is incorporated in the States of Florida and Michigan and maintains its principal place of business at 6479 Parkland Drive, Sarasota, FL 34243.
2. Respondent Kalon Samulonis is the President of the corporate respondent. He formulates, directs, and controls the acts and practices of the corporate respondent, including the acts and practices alleged in this complaint. His principal office or place of business is the same as that of the corporate respondent. 3. Respondents have promoted, offered for sale, sold, and distributed to the public products containing a substance described as cetylmyristoleate, cerasomal-cis-9-cetylmyristoleate, cetyl myristoleate, or CMO, including products identified with the name “CMO™” [hereinafter referred to collectively as “CMO”]. These products are “foods” and/or “drugs” within the meaning of Sections 12 and 15 of the Federal Trade Commission Act. 4. 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. VOLUME 129 Complaint 5. Respondents have disseminated or have caused to be disseminated advertisements or promotional materials for products containing CMO, including but not necessarily limited to the attached Exhibits A and B. Advertisements for respondents’ CMO products have been disseminated through, among other media, a web site on the Internet. These advertisements and promotional materials contain the following statements: * * * A. Arthritis Treatment The purpose of this web site is Breakthrough to give you the opportunity to [Depiction of learn about the arthritis Product treatment breakthrough called Container] CMO™. It is being hailed by doctors, the media and its users as the cure for arthritis. It has taken 26 years to develope CMO™ and make it available to the public. We urge you to explore this site and learn about this revolutionary new substance.
* * * CMO. . . THE DISCOVERY In 1971, the predecessor of CMO™ capsules, was first discovered by a researcher at the National Institutes of Health. . . Eventually he discovered that when this substance was injected near the joints of lab animals it protected them from arthritis. Many years later he contracted arthritis himself. After his doctor could provide no further relief through conventional medicine, he successfully injected himself to permanently reverse his arthritic condition.
* * * CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. 1247 Complaint The San Diego Clinic [Depiction of did the first clinical Scientist] study on CMO™. That study proved CMO™ to be of great benefit to osteo, rheumatoid and reactive arthritis.
Subsequent data proves its value for nearly all other forms of arthritis except gouty arthritis.
* * * HOW IT WORKS In their October 28, 1996 issue, Time magazine reported on the three most promising developments in arthritis research. The scientists participating in all three projects are intensely focused on intervening in the immune system’s involvement in the arthritic process. According to doctors, that is exactly what CMO™ does. It corrects the disease at the source in the immune system. Dr. Len Sands the director of the San Diego Clinic says: “Unlike everything else made for arthritis, you don’t have to take it over and over again. CMO™ is not a pain reliever, antiinflammatory, cortisone or other steroid. CMO™ is an immunomodulator, it regulates your immune system. There’s never been anything like it before for arthritis. Instead of treating the symptoms of pain and inflammation, CMO™ capsules act directly against the VOLUME 129 Complaint cause of arthritis, the memory T-cells in your immune system that create the attacks against your joints. Once the error in your immune system is corrected by CMO™, the attacks on your joints stop and the pain and inflammation should be relieved forever. Once the problems are corrected, they stay corrected and you no longer need CMO™ or other arthritis remedies.”
WHY IT IS DIFFERENT CMO™ is not a conventional product. There’s never been anything like it before. It’s not a pain reliever, herb or anti-inflammatory. CMO™ is a natural immunomodulator. It has the unique ability to normalize the immune system. CMO™ acts directly to regulate and normalize the malfunctioning immune system and stop the arthritic process itself. Once that occurs, the destruction stops, and the pain and inflammation are automatically relieved. Your body then has a chance to heal itself and return to normal.
* * * CMO is:
FAST LASTING RELIEF IS JUST A FEW DAYS AWAY Most users report significant relief in two weeks or less. Even in severe cases it rarely takes longer than 21 days. EASY ONLY ONE SET OF ORAL CAPSULES Take three capsules in the morning and then again at night for 16 days, then say goodbye to the problems of arthritis. Only one bottle is all that is needed in most cases. CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. 1249 Complaint SAFE NO SIDE EFFECTS CMO™ is not like the many medicines for arthritis that are toxic. CMO™ is not even like the several types of vitamins that are toxic at high levels. CMO™ has been tested and shown to have no ill effects whatsoever. To date thousands upon thousands of people have used CMO™ to relieve the symptoms of arthritis and there are no reported ill effects from anyone.
EFFECTIVE IT WORKS FOR ALMOST EVERYONE It works for both osteoarthritis and rheumatoid arthritis. It works for all other types of arthritis except gouty arthritis. CMO™ has been effective on nearly everyone that does not have severe liver damage. CMO™ almost always provides relief of pain, swelling and return of mobility. In the clinical studies they found a few cases that only received 70% to 100% relief. Relief provided by CMO™ was invaluable and the subjects were able to return to a normal life.
NATURAL DRUG FREE PAIN RELIEF CMO™ is the commercial name for cerasomal-cis-9cetylmyristoleate. It is naturally derived from beef. Similar substances have long been used in common foods including cheese and chocolate. This treatment is accepted by the modern medical community. It is natural, drug free and non-toxic.
VOLUME 129 Complaint PERMANENT TAKE CMO™ ONLY ONCE One bottle of capsules is all you should ever need for relief from the symptoms of arthritis for the rest of your life. Most affected persons need to take CMO™ for only a couple of weeks. No further treatment or medicines are needed, not even CMO™. Once CMO™ has done it’s work stopping arthritis the benefits continue for long periods of time as your body repairs and reverses the damage done by arthritis.
* * * What do doctors say about CMO? Dr. Douglas wrote in his newsletter: “A New Miracle Cure for Arthritis ...now we have a new star on the horizon that promises as much (or more) than the old sure-cures.” Dr. Muller of Ferndale, Mich. says there’s a cure. He knows, he’s taken it. Dr. Muller had osteoarthritis for 30 years. Bravely he forged ahead into the naturopathic remedy and tried CMO™. Dr. Muller is no longer troubled by arthritis. Dr. Hunt was so impressed by CMO™ he wrote a book called “Boom, You’re Well”. In that book he says: “...rheumatoid arthritis damages tissues, causes extreme suffering, and premature death. ...If you have rheumatoid arthritis, or you know someone who has it, then you know I am reporting a miracle ... A MIRACLE.”
Dr. Sands the director of the San Diego Clinic knows there’s a cure. He’s taken it and now he says, “I was rescued from arthritis”. In fact that is the name of his forthcoming book about CMO™. In that book he says, “The arthritic process can be halted. Arthritis can be reversed. The pain and inflammation can be relieved. And it’s all been done without any harmful side effects.”
CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. 1251 Complaint What is the media saying about CMO? Books, Television News, Radio Health Talk Shows, Medical Newsletters and Scientific Journals all report CMO™ to be a revolutionary breakthrough! * * * What are people saying about CMO? “It’s a miracle! Ten years with arthritis ... three in a wheelchair ... and now I’ve got a completely normal life again. Just watch me make up for lost time.”
* * * “Even as a doctor, I find CMO™ miraculous. It cured my knee problems, and it’s performing every bit as well for my patients, too. I’ve seen several ‘miracle cures’ already.” “After nine years of crippling pain, I can’t believe I’m actually skiing again. CMO™ is truly incredible.” * * * “Imagine my agony. I was a professional athlete all my life. CMO™ gave me back my life. Even knee surgery didn’t do that for me. It’s amazing how CMO™ ended up fixing all my joints.” FREQUENTLY ASKED QUESTIONS The following questions were answered by the doctors, staff and research associates of the San Diego Clinic: VOLUME 129 Complaint * * * Will it correct deformities? Yes. Deformed fingers and toes are often caused by inflammation which swells joints and pushes the bones out of place. Reduction of the swelling alone improves appearance dramatically and often allows the dislocated bones to return to their normal positions. Extreme cases may require some physical therapy. What about really severe cases? Even most persons previously confined to bed or to wheelchairs have responded dramatically and are now no longer dependent on others for care. A number of these cases received additional benefit from repeating the treatment one more time... * * * Is it expensive? The cost of the treatment is very modest. Most arthritis victims are already spending more on pain and anti-inflammation medications in just a few months. Since you usually need to take only one set of CMO capsules, it actually saves thousands of dollars in the long run.
* * * Is CMO used for any other ailments? Current studies include CMO as a part of therapeutic protocol for other disorders with autoimmune components including multiple sclerosis, leukemia, lupus, emphysema, certain cancers, begin prostrate hyperplasia, silicon breast disease, and especially asthma.
CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. 1253 Complaint * * * ORDERING * * * Toll free in the US: 1-800-909-CURE * * * Manufacturers Statement Modestly speaking, CMO™ is a revolutionary new product. CMO™ is naturally derived, it is sold only as a dietary supplement not intended to treat, cure, or diagnose any disease. [Exhibit A, http://home.earthlink.net/~cmocure /cmocure/] B. Letter of Introduction * * * This site contains exciting information about a naturally [Depiction of Product derived substance called CMO. Container] It is being hailed by it’s users, doctors and the media as the cure for arthritis...
CMO has been clinically tested and found to relieve the symptoms of virtually all forms of arthritis except gouty arthritis. CMO is a one time treatment consisting of 100 capsules taken orally over a period of 16 days. The benefits of CMO should last a lifetime. CMO is reported to be effective on 80% of the people who have used it as a dietary supplement. In clinical studies with a controlled diet, CMO has been reported to be effective on 96% of the people who have used it. CMO can benefit almost everyone who suffers from arthritis with just one treatment. The VOLUME 129 Complaint treatment program is fast, easy, safe and very effective. CMO can halt arthritis and prevent future pain, swelling and stiffness. CMO can rescue someone from the physical damage that a future with arthritis holds.
* * * The History and Discovery of CMO With the research concluded, effectiveness improved, medical community acceptance, imposters and counterfeiters in check, the television commercial finished, the books written, and the distribution arranged, CMO can finally finish it’s 26 year long journey from the point of discovery to benefit the general public. * * * Who says there’s a cure for arthritis? Time Magazine As we mentioned earlier in the CMO Information section, in their October 28, 1996 issue, Time magazine reported on the three most promising developments in arthritis research. The scientists participating in all three projects are intensely focused on intervening in the immune system’s involvement in the arthritic process.
According to doctors that is exactly what CMO does. It corrects the disease at the source in the immune system and doesn’t require a lifetime maintenance program.
* * * What will cure arthritis? Dr. Jason Theodosakis’ book The Arthritis Cure for gives the impression that glucosamine and chondroitin sulfate are the cure for arthritis. In fact neither of those substances have any effect on arthritis...Even the Arthritis Foundation says The Arthritis Cure is CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. 1255 Complaint not recommended and they cannot recommend glucosamine and chondroitin sulfate as a treatment for osteoarthritis or any other form of arthritis.
* * * Speaking of the Arthritis Foundation, they will neither confirm, nor deny that CMO is the cure for arthritis. We are aware of several cases where CMO was presented members of the AF. In turn, they were cured and presented CMO to AF staff. To this day, despite the fact that CMO has cured some of their members, the only official comment the AF has made, was to suggest that when taking CMO, you should consult your physician before reducing steroids or other medications.
According to doctors, clinical studies, users and the media, CMO would certainly seem like the most likely candidate to be given the true title being of a “cure” for arthritis. When asking Dr. Sands if CMO is the only cure for arthritis he replies: “According to the Journal of Rheumatology (1993; 20:137-140) bone marrow transplants seem to have succeeded in curing two cases of arthritis.”
* * * Research CMO Distribution Centers of America in conjunction with the San Diego Clinic act as a clearing house for all the latest information on CMO. With this joint research effort, a network of communication is established between all medical professionals and distributors. This allows for up to the minute information sharing. This will facilitate the application of CMO to uses other than for arthritis. Currently, studies for the use of CMO on other auto-immune diseases are in progress. It is hoped that the Lupus VOLUME 129 Complaint Foundation will conduct one such study. We have offered to fund the protocol.
Current studies of CMO as a part of therapeutic protocol for other diseases include asthma, sclerederma, fibromyalgia, lupus, emphysema, certain cancers, and benign prostrate hyperplasia. * * * Case Histories Condensed Highlights From Case Histories Recorded By The San Diego Clinic * * * From case history #33 Medical Doctor. Auto wreck ten years earlier damaged hip, caused limp and arthritis. CMO relieved pain permanently in one day for the first time after many years. The limp problem is irreparable. Ordered CMO for his patients. * * * From case history #24 Female. Age 50. Family history of arthritis. Pain in shoulders. Severe pain, limited mobility, and gross swelling in hands and fingers. By the third day of CMO, hands were free of pain, mobility had increased immensely, and finger swelling decreased so dramatically she had to have all her rings re-sized. Repeated treatment three weeks later. Totally free of pain and inflammation since. For the first time in many years, she was recently delighted to experience a pain-free skiing holiday. * * * From case history #11 Male. Age 58. Ex football player. Clinically obese. Had knee surgery three times about 15 years ago. Had extreme pain upon lying down. Often slept in a recliner chair instead. With his first evening dose of CMO capsules, he slept soundly and arose the CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. 1257 Complaint next morning completely free of pain. He has enjoyed continuing pain-free remission ever since the first day. * * * From case history #32 Female. Age 66. Rheumatoid arthritis rendered hands useless, gnarled, inflexible, agonizingly painful six years ago. Pain relieved and full use of hands restored after five days of CMO. * * * Suggested Use * * * Methotrxate:
. . .Request that your doctor allow you to discontinue these drugs for at least one week prior to starting CMO. Consult with your physician before making any changes to your current medications. Steroids:
. . .If you are taking cortisone or other steroids, advise your doctor that it would be better to avoid them or reduce their dosage levels. If not ask him about taking half doses. Then as your pain disappears you may request that he discontinue them completely. Consult with your physician before making any changes in your current medications.
* * * Marketing & Sales Market Information * * * Current studies of CMO as a part of therapeutic protocol for other diseases include asthma, sclerederma, fibromyalgia, lupus, VOLUME 129 Complaint emphysema, certain cancers, and benign prostrate hyperplasia. The CMO Distribution Centers and San Diego Clinic team have dedicated themselves to that research and the results will expand the market potential of CMO to other diseases. [Exhibit B, http://home.earthlink.net/~cmocure/cmo/] 6. Through the use of the web site address “cmocure,” the use of the telephone number “1-800-909-CURE,” and the means described in Paragraph 5, respondents have represented, expressly or by implication, that:
A. CMO is effective in the mitigation, treatment, prevention, and cure of all forms of arthritis, except gouty arthritis. B. CMO relieves all symptoms of arthritis, including pain, impaired mobility, swelling, and deformity. C. CMO is as effective as, or superior to, prescription medications for the treatment of arthritis and the relief of arthritis symptoms.
D. CMO is effective in the treatment of multiple sclerosis, leukemia, lupus, emphysema, cancer, benign prostate hyperplasia, silicone breast disease, asthma, fibromyalgia, and scleroderma.
E. CMO is completely safe and without harmful side effects, even at extremely high doses.
7. Through the means described in Paragraph 5, respondents have represented, expressly or by implication, that “case histories” and testimonials from consumers appearing in the advertisements or promotional materials for respondents’ CMO products reflect the typical or ordinary experience of members of the public who use the products.
CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. 1259 Complaint 8. Through the use of the web site address “cmocure,” the use of the telephone number “1-800-909-CURE,” and the means described in Paragraph 5, respondents have represented, expressly or by implication, that they possessed and relied upon a reasonable basis that substantiated the representations set forth in Paragraphs 6 and 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 Paragraphs 6 and 7, at the time the representations were made. For example, studies have not examined the efficacy of the ingredients in respondents’ CMO products in the prevention or cure of arthritis; or in comparison to prescription medications for the treatment of arthritis or the relief of arthritis symptoms; or in the treatment of multiple sclerosis, leukemia, lupus, emphysema, cancer, benign prostate hyperplasia, silicone breast disease, asthma, fibromyalgia, or scleroderma. In addition, there is insufficient information available to determine the reliability of other purported studies or the applicability of such studies to the respondents’ products. Therefore, the representation set forth in Paragraph 8 was, and is, false or misleading. 10. Through the means described in Paragraph 5, respondents have represented, expressly or by implication, that: A. Clinical studies prove that CMO is a safe and effective treatment for virtually all forms of arthritis except gouty arthritis.
B. CMO is accepted by the medical community. C. Time magazine reported in its October 28, 1996 issue that CMO™ is one of the most promising developments in arthritis research.
VOLUME 129 Complaint D. The Arthritis Foundation has not commented on CMO, except to suggest that when taking CMO, patients should consult their physicians before reducing steroids or other medications.
11. In truth and in fact, A. CMO has not been proved in clinical studies to be a safe and effective treatment for virtually all forms of arthritis except gouty arthritis.
B. CMO is not accepted by the medical community. C. Time magazine did not report in its October 28, 1996 issue that CMO™ is one of the most promising developments in arthritis research.
D. The Arthritis Foundation has not refrained from comment on CMO. In its Public Information Memo, P.I. Memo 97- 07 (Oct. 31, 1997), the Arthritis Foundation stated: The Arthritis Foundation cannot recommend cerasomal-cis-9-cetylmyristoleate and related products as a treatment for any form of arthritis. . . Cerasomalcis-9-cetylmyristoleate and related products are an unproven remedy. . . People with arthritis should seek proper medical care from their family physician or a rheumatologist. They should check with their doctor before self-treating with unproven remedies claimed to help arthritis. . . People on medications such as corticosteroids or methotrexate should be especially cautious about using cerasomal-cis-9-cetylmyristoleate and related products and consult their physician. Therefore, the representations set forth in paragraph 10 were, and are, false or misleading.
CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. 1261 Complaint 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 sixteenth day of May, 2000, has issued this complaint against respondents. By the Commission.
VOLUME 129 Complaint Exhibits Complaint Exhibits CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. 1263 Complaint Exhibits see in the clear wrapper. So, if you're new to QVC, if you're new to Cold- Eezers, here's why they're so great. Take it away, Chuck. C. Phillips: Well, it's -- first of all, it's an all-natural, homeopathic product. Show Host: Right.
C. Phillips: It's a unique product here on QVC. It has been clinically proven to reduce the duration and severity of the common cold. And what we're asking people to do is to take a little more aggressive role in caring for their family. Show Host: Right.
C. Phillips: To have a strategy to help fight the common cold. The kids are in school. They are there right now.
Show Host: Um-hum.
C. Phillips: And school is one of the most famous places to have -- Show Host: It's a breeding ground for germs. C. Phillips: It's a breeding ground. Everything they touch -- if the child before had a cold and they touch that spot and they touch their nose, it's off to the races. Show Host: Sure. That's it.
C. Phillips: So, there's a couple of strategies. One is we can take one a day and try to see if you can beat the cold to what they call prophylactic or a preventive medicine. Show Host: Excellent.
C. Phillips: Try taking one a day. Or if the child comes home and you see that it's here -- Show Host: Um-hum.
C. Phillips: -- that they have symptoms, start treating the child. Take one every three hours. But everyone in the family should take a couple to prevent picking up that cold. Show Host: This is safe for kids to take. C. Phillips: Absolutely.
Show Host: _It's certainly safe for adults. It's safe for senior citizens to take. In fact, we gota call the last time I was on the air with Cold-Eezers of a woman whose mom was in a nursing home.
C. Phillips: Yes.
Show Host: And she was taking them one a day as a preventative measure because she was surrounded by lots of other people and lots of other germs. So, it's a great step to take in maintaining your health, and it's also really helpful when you get a cold. In fact, we have someone on the phone who's used Cold-Eezers in the Exhibit A, p.2 VOLUME 129 Complaint Exhibits CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. 1265 Complaint Exhibits C. Phillips: -- and that will help to prevent this from even beginning. There's reports out that tell us that over 55 percent of people who get colds end up at the doctors. Show Host: Ugh.
C. Phillips: So, now you have the doctor's bill -- Show Host: Right.
C. Phillips: -- you have the prescription and you still have the cold and the bronchitis. Show Host: You have time off from work and you have miserable kids if they're sick, too. C. Phillips: Absolutely.
Show Host: Well, Renee, I'm so glad it worked for you and for your granddaughter. Thanks for being a part of our show.
Caller: Thank you.
Show Host: You take care.
Caller: And have a great day, both of you. Show Host: Bye-bye now.
C. Phillips: All right. Thank you, Renee. Caller: Bye-bye.
C. Phillips: Bye-bye. The other thing is allergies. Show Host: Yes.
C. Phillips: We have many, many people who have reported to us that their usual choice is to have antihistamines, which make them dopey -- Show Host: Sure.
C. Phillips: -- which make them incapable of functioning, some of them. Show Host: Right.
C. Phillips: And we suggested they try it. So, we -- they tried it and they take one and they see how long it lasts. It does diminish the symptoms of allergies and -- Show Host: Lots of people have asked exactly how does it work, and we actually have some animation to show you. I'm just showing you, this is what one of the Cold- Eezers looks like up close and personal. Take a look at this. Now -- C. Phillips: Those -- those are purple rhinoviruses. ON SCREEN: Animation Exhibit A, p.4 VOLUME 129 Complaint Exhibits CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. 1267 Complaint Exhibits C. Phillips: Exactly. Exactly.
Show Host: School bus drivers can take this. Teachers can take this. Children can absolutely take this. In fact, I've heard how more people will wrap one of these in cheesecloth and let their toddler suck on it so they can get the benefits from it without actually risking choking or anything. C. Phillips: Um-hum. Yes.
Show Host: Senior citizens can take it. Pregnant ladies can take it. Nursing moms can take it. It's perfectly safe to take. We're going to take a phone call actually. C. Phillips: Excellent.
Show Host: We're going to head right back to the phones and say good morning to Doris. Hi, Doris. Come on in and meet Chuck Phillips. Caller: Good moming.
C. Phillips: Good moming, Doris.
Show Host: How are you? Caller: Just fine. We used these last year. I have a son who goes to college up in Minneapolis.
Show Host: Ah-ha.
Caller: And so, we sent them up there because he has a lot of cold weather and he has allergies.
Show Host: Yeah.
C. Phillips: Uh-huh.
Show Host: Um-hum.
Caller: And I was glad to hear you say something about taking one a day as a preventive. We've never tried that before. C. Phillips: Yes. Well, now's the time to try it. Show Host: Yep.
C. Phillips: This is -- this is a strategy that may pay off big-time because it does help block as you saw in the animation. If we can stop the viruses we pick up over the day, they will not have a chance to even start. Show Host: Perfect.
C. Phillips: Therefore, it will preclude you getting the cold. Caller: Yes.
Exhibit A, p.6 VOLUME 129 Complaint Exhibits CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. 1269 Show Host:
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Complaint Exhibits Take care now. Bye-bye.
Thank you.
So long.
$18.25. Now, you get 60 lozenges. If you want to do it as a preventative measure, that's going to be a two month’supply for you. If you want to stash some in your desk at work, stash some in the glove compartment in your car. Give a couple to your kids at school, because halfway through the day if they Start to get that tickle in their throat, by taking one of these, they're already taking steps ahead to prevent getting sicker and to prevent spreading it to the rest of the family. So, these do last you a good long time. But this is the time of year to stock up. Even if you're not suffering from hay fever and allergies, you know that cold season has pretty much started -- Oh, it's started.
-- or else it's right around the comer.
It's definitely started.
Right back to the phones we go. Chuck ~ Okay.
-- this time we're going to say good morning to Alice. Alice, hello. How are you doing? Well, good moming to both of you.
Good morning.
And I'm doing great, and, of course, ordering more Cold-Eezers. All right.
So, you've tried them in the past, have you? Oh, absolutely. I wouldn't be without them. I've bought some for my sons who are -- they live kind of close by but they're out of the home, and we all swear by them. And I definitely do. You know, I was kind of skeptical in the beginning about colds — Um-hum.
~~ but they really do -- as soon as you feel you've got a cold, you know, you just put one in your mouth and, oh boy, they are just fantastic. They stop it right away. And like that other lady said, I was delighted to hear this morning that you could take one every day to prevent a cold. Sure.
Exhibit A, p.8 VOLUME 129 Complaint Exhibits CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. C. Phillips:
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Complaint Exhibits Hi, Rachel.
I have to tell you a story and this is honest truth. I have two kids in college. Ah-ha.
Ahh.
I gave my son the other flavor, my daughter takes the cherry, and I ran out of it. Uh-oh.
And she already told me, ma, I think I'm catching a cold. Oh, no. Quick, you got to get her more Cold-Eezers. Because -- yeah. Because in college, one person sneezes -- Um-hum.
-- 400, 500 kids, they all catch a cold. Oh, yes.
You're absolutely right.
It goes through like lightning.
It runs through those dorms.
Absolutely.
I wish I had them today. I'm going to go visit her this weekend. Oh.
But I did two orders again.
That is marvelous. And, you know, for you and for everybody else, you can always do our bill to-ship to option. QVC will -- Yes, that's how I sent it today.
Yes. Good for you. We'll do it.
Yes. Yeah, because they have the cleansing for the face, whatever, when I order from you people.
Oh.
Thank you so much. The most wonderful things with the — you know, with the zinc and everything.
Oh, good.
Exhibit A, p.10 VOLUME 129 Complaint Exhibits
VOLUME 129 Complaint Exhibits CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. 1275 Complaint Exhibits Show Host: They sure do.
R. Pollack: They work.
Show Host: We are talking about the Cold-Eezers lozenges, and we have two flavors to choose from, your original, which is sort of a citrusy, kind of an orangy - R. Pollack: Um-hum.
Show Host: -- and the new cherry flavor. The item number is A-36293. $18.25, you get two packages of them, so it's 60 lozenges in all. R. Pollack: Right.
Show Host: And just like Dr. Pollack said, they work. And tell us why they work. R. Pollack: Well, the fact -- very simply, we've treated the zinc in a certain way, which it is zinc, just normal, natural zinc. .
Show Host: Um-hum.
R. Pollack: And it plugs up the viruses, the crevices that attach to the contact points on our cells. There they -- Show Host: Yeah.
ON SCREEN: Animation R. Pollack: There you see the picture of how the viruses are attaching to the cell. Show Host: Um-hum.
R. Pollack: You see those little crevices that are in each side. Show Host: Um-hum.
R. Pollack: They attach onto the cell and that's what causes the cold. They start replicating. Here we have the zinc. Notice how they plug up the crevices and they just can't attach to the cell. It's as simple as that and as effective as that. It's the first nr ee that actually treats -- or is effective against the virus that causes the Show Host: _— Yes.
R. Pollack: -- not the symptoms, the runny nose or the teary eyes. Show Host: Right.
R. Pollack: Here, when we eliminate the virus, you eliminate the symptoms, all of them, not just one, the runny nose that you might buy something for, or the cough. Show Host: Sure, sure.
Exhibit B, p.2 VOLUME 129 Complaint Exhibits CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. 1277 Complaint Exhibits Caller: They help nght away.
Show Host: Yep, they sure do. So, you've made it through this winter season okay, huh? Caller: Yes, we have.
R. Pollack: Good.
Caller: And I'm 83 years old and I'm doing fine. R. Pollack: Bless you.
Show Host: | Wonderful. That's so wonderful to hear. Alice, thank you very much for your phone call. Thanks for being a part of the moming show. Caller: Thank you for talking to me.
Show Host: Our pleasure.
Caller: Okay. Bye-bye.
Show Host: Have a great day.
R. Pollack: Bye.
Show Host: Bye-bye.
You know, my own grandma just got over pneumonia. R. Pollack: Hmm.
Show Host: And I'm sending her these so that she can continue to take them, and as some of the people do, take them on a preventative basis. R. Pollack: Right. Yes.
Show Host: I know that you have women in nursing homes — R. Pollack: Right.
Show Host: -- and gentlemen in retirement communities who are taking these. R. Pollack: Yes. And they find them very effective. Show Host: They sure do. And we've got -- R. Pollack: Because of all the people together and so on. Show Host: Well, that's -- that's where you get germs from -- R. Pollack: Right, right.
Exhibit B, p.4 VOLUME 129 Complaint Exhibits CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. 1279 Complaint Exhibits R. Pollack: When you get just the first sign and you say to yourself, uh-oh, I got that tickle or I have that -- Show Host: Right.
R. Pollack: -- you know, we know when we're going to get it. Show Host: Yeah.
R. Pollack: That's the time to have them ready, pop one in your mouth, and it's going to start like that picture you saw, immediately beginning to get an effect. Caller: Now, what is the action of the zinc? I understand the zinc coats itself to the lining of the nose? R. Pollack: Well, not quite. We feel that -- have you seen the pictures just before that we had on the air? It appears that the zinc -- ON SCREEN: Animation Show Host: There you go. There it is.
R. Pollack: There they go.
Show Host: Yeah, um-hum.
R. Pollack: See, here's a virus with the crevices that you see, and they attach onto positively charged projections that are in our -- that line our nose and mouth and throat. Now, here's the zinc. Notice how they plug up the crevices -- Caller: Oh.
R. Pollack: -- and they can't attach to the cell and there is no way then that they're going to replicate and give us the cold.
Caller: Oh.
R. Pollack: That's the whole key. Now, the point is that we were talking before we came on the program -- Show Host: Right.
R. Pollack: -- there are others that are out there that are trying to imitate this, and they say because Cold-Eezer Plus has zinc and ours has zinc, they must be alike. Show Host: Uh-uh.
R. Pollack: They're not.
Caller: No.
R. Pollack: Because in attempting to flavor them, they tie up the zinc so tightly, they can't Exhibit B, p.6 VOLUME 129 Complaint Exhibits CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. 1281 Complaint Exhibits R. Pollack: It's just that we've treated them so that they're effective against the virus. Here you have a pilot -- or a child that is there. Show Host: Um-hum.
R. Pollack: The mother is putting it in her backpack to take to school. Show Host: Right, sure.
R. Pollack: And they're beginning to recognize when a child is sucking on something, and there are a lot of colds going around, chances are it's a Cold-Eezer and not just some candy.
Show Host: It's safe for your kids, it's safe for your grandkids, it's safe for -- R. Pollack: There's the pilot.
Show Host: __ -- pilots and school bus drivers -- R. Pollack: Right, right.
Show Host: __-- and anyone who is going to be driving a vehicle at all. R. Pollack: Oh, right. They are -- they're prevented by law from taking anything that's -that will sedate them.
Show Host: Absolutely.
R. Pollack: Cold-Eezer Plus is the only thing that they're allowed to take. Show Host: There you go. We're going to head right back to the phones and see who else is taking Cold-Eezers with us.
Hello. You're on the Morning Show. Who's this, please? Caller: This is Margie from Philadelphia, Pennsylvania. Show Host: —__ Hi, Margie. How are you doing? Caller: I'm fine. How are you both? Show Host: Great.
R. Pollack: Okay.
Show Host: Are you taking Cold-Eezers, Margie? Caller: Well, this is the first time we've ever been able to get it. Show Host: Oh.
Caller: And I'm really excited, because as you just showed, I have a four-year old. Exhibit B, p.8 VOLUME 129 Complaint Exhibits CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. 1283 Complaint Exhibits Caller: Yes, they do.
Show Host: It's a good thing you called in this morning. Caller: Yes.
Show Host: Thanks, Margie.
Caller: Thank you.
Show Host: Bye-bye now.
Caller: Bye-bye.
R. Pollack: Bye.
Show Host: You know, this is just about the only place that you can get them. R. Pollack: Yes. It seems that this is true. And it's so wonderful that we have this national ability to get in touch with people and that they can get this, because you alluded to it before, the amount of money spent on just someone getting a cold is really incredible.
Show Host: Oh, it sure is.
R. Pollack: The wages that are concemed, if you can't get into work. Show Host: Sure.
R. Pollack: If a child gets a cold, who's going to stay home with that —- Show Host: Mom's got to stay home.
R. Pollack: Right. It's mom that generally is going to be doing that. Show Host: Sure. And those cold medicines are $6 and $7 a bottle. R. Pollack: Right.
Show Host: And they don't do anything for your cold. They treat your symptoms. R. Pollack: Exactly.
Show Host: They knock you on your butt. You're sleeping. R. Pollack: Right.
Show Host: Sure, you're sleeping 12 hours a day, that's great. But they're doing nothing for the actual cold. This is revolutionary because it's actually doing something to prevent the cold virus from locking on to the respiratory cells. That's how we get sick.
Exhibit B, p.10 VOLUME 129 Complaint Exhibits R. Pollack:
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CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. 1285 Complaint Exhibits Thank you. It's been a pleasure, It's nice to see you again, Dr. Pollack. All right.
The item number is A-36293. You're going to receive 60 of them -- that's two separate bags -- for $18.25.
Right.
What a deal.
(The Cold-Eezers segment was concluded.) Exhibit B, p.12 VOLUME 129 Complaint Exhibits CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. 1287 Complaint Exhibits even if your nose is not itching, pop one of these in your mouth before you get on that airplane. These are preventive measures as well. Let's say hello to Nadine. How are you? Caller: Hi, Lisa.
Show Host: Hi. Nice to have you with us today. Caller: My mother got me started on these -- Show Host: She did? Caller: -- maybe last year.
Show Host: Okay.
Caller: And I was very skeptical about them. Show Host: Right.
Caller: And they looked like candy to me. And -- but I figured, okay, mom uses them, so fine, I'll try it.
Show Host: Sure.
Caller: And then this year, I ordered some myself — Show Host: Okay.
Caller: -- in the cherry. Very good.
Show Host: Yes, they are.
Caller: And I just -- I have not really had a cold this year. Show Host: And what part of the country do you live in? Caller: Towa.
Show Host: Wow. So, you've had your share of tumultuous weather to say the least. Caller: We have. Yes, I - Show Host: _—_You really have.
Caller: Yes, I'm really ready for spring, you know. Show Host: Yes. Well, and this is also going to help -- from what the information has told us and what from viewers tell us, this is going to help during your allergy season, because you guys have a lot of beautiful flowering plants out that way. So, this is going to help if you are ever subject to allergy attacks. Exhibit C, p.2 VOLUME 129 Complaint Exhibits CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. 1289 Complaint Exhibits Show Host: Yeah.
Caller: -- and runny nose and all that — Show Host: Uh-huh.
Caller: -- and start taking them, and by the next evening, we have no signs of it. Show Host: It's amazing, isn't it? Caller: Yes, itis.
Show Host: Well, you know, from what the information tells us, people have known for centuries that zinc. was the way to go. The problem was it was so terrible to Caller: Yeah.
Show Host: So, now -- you know what I'm saying? It just -- it was unpalatable. Caller: I know. We've tried the ones around here. Show Host: Yeah, exactly.
Caller: They're powdery weird stuff.
Show Host: Exactly.
Caller: And taste terrible.
Show Host: They taste horrible.
Caller: Yes, they do. We still have them. Show Host: So, what was -- yeah. What was great about this product is the zinc is in there, but it's just like a little very tasty lozenge. Caller: Yeah.
Show Host: Absolutely. I'm glad it's worked so well for you. I really appreciate you taking a few minutes to call us.
Caller: That's good.
Show Host: And stay well.
Caller: We will. We've ordered more.
Show Host: Good. Thanks now. Take care.
Caller: Uh-huh. Bye-bye.
Show Host: Bye-bye.
Exhibit C, p.4 VOLUME 129 Complaint Exhibits CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. 1291 Complaint Exhibits Show Host: But I'll bet you a dollar they'll say it can't hurt and it may even really help. Caller: I'll certainly do that.
Show Host: Please do. And let us know -- I'd love to know if it works out for his situation as well.
Caller: Okay.
Show Host: — Thank you for calling.
Caller: Thank you.
Show Host: Take care.
Caller: Bye-bye.
Show Host: Bye-bye.
The cold season, the allergy season, for post-nasal drip, for sinusitis, it's zinc. The Cold-Eezers Plus, more zinc, you can only get here. You can't get it anywhere else. Only at QVC.
Hey, it's been fun this Problem Solvers. I'm glad you spent a little bit of time with us. Colors of Gold coming up next and then Collectible Dolls at 5:00. See you right around the corner.
Exhibit C, p.6 VOLUME 129 Complaint Exhibits CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. 1293 Complaint Exhibits Show Host: That's it? R. Pollack: Yeah, that's it. That's it. Nothing else to do. Show Host: What are we looking at here, Dr. Bob? We're going to take a look at a little animation.
ON SCREEN: Animation R. Pollack: Oh. Those are the viruses that are attaching on to the human cell and that's when we get all of the symptoms of the common cold, the sneezing and the sniffling and the coughing and so on. And then, what we're going to see now, there are the zinc ions that are plugging up the virus. They're not able to attach on to the human cell, no cold, and that's what it is. When we get that first feeling, that tickle, that uh-oh, we're headed for it, that's what's going to happen by the next morning, no cold.
Show Host: Hi. You're live on the air. What's your name and where are you calling from? Caller: Hi. My name is Judy and I'm calling from Niceville, Florida. R. Pollack: Yes? Show Host: Judy? Caller: Yes.
Show Host: You got a cold or not? Caller: Not yet.
R. Pollack: Right.
Show Host: Because of the Cold-Eezers? Caller: Yes. I did call about the Cold-Eezers. Show Host: Wow, that's great. You're getting these for yourself? Caller: For me and my husband, I sure am. Show Host: Oh, that's -- Caller: We read about them in the local newspaper. R. Pollack: Um-hum.
Show Host: I'm telling you, you read about them in the newspaper, I've seen articles on ABC News, NBC News, CBS News, articles on, you know, do they really work. R. Pollack: Yeah.
Show Host: — Some of those consumer reporting kind of TV articles. Exhibit D, p.2 VOLUME 129 Complaint Exhibits CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. 1295 R. Pollack:
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Complaint Exhibits For more powerful protection, correct.
(Brief pause) Now, I like the all-natural, Bonnie Johnson likes the cherry. But I'm telling you something, I'm always sick. November of every year, I get strep throat, tonsillitis, I always get some sort of horrible throat ailment. And, you know, this year, I didn't get it and I really am a firm believer in these. I think that they're preventing me from getting sick.
So, there you have it, folks. A-36293. And they must be working because they've sold out before and you can't get them in any stores anymore. So, get them with us. For $18.25, you're getting two bags in your choice of the natural or the cherry, 1-800-345-1331.
(The Cold-Eezers segment was concluded.) Exhibit D, p.4 VOLUME 129 Complaint Exhibits CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. Show Host:
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Complaint Exhibits Um-hum.
And they're hearing that little voice -- Um-hum.
-- mom, I don't feel so good. Well, what we're going to do this year is get more aggressive, we're going to attack the cold. We're suggesting to moms, get Cold- Eezer Plus in the house.
Um-hum.
Have it ready, and at the very first hint of a cold, start applying it. But even before then, try to use it as a preventative measure, so that if you know that the child has had an exposure, whi ich is school, they can take one a day -- Um-hum.
~~ to try to prevent getting a cold.
And you're talking about schools, I mean, everywhere you go, I mean, other children have it, other adults have it, you're just always exposed. Always exposed, exactly. You touch things. Um-hum.
You touch a doorknob and you go up and you touch your nose, you've got the chance to have it.
Right.
So, what we're Saying is, point one, if you don't have it in the house, get some in the house so that you have it to use at the very first sign of a cold. Um-hum.
That's the important thing. This year we're saying, have it around and take one a day. Give your child one before he goes to school, that way, it can possibly Now, what do these contain? How do these work? Well, it contains what we call ZIGG, zinc gluconate glycine. Um-hum.
And it's a patented formula. It is homeopathic, it is all-natural. It's -- Right. That's important I know, especially when we're talking about little ones. Little ones, right. It's non-sedating.
So, anybody -- you're not going to fall asleep on these. Exhibit E, p.2 VOLUME 129 Complaint Exhibits CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. C. Phillips:
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Complaint Exhibits The thing is, we want to be quicker, we want to catch it before it Starts, and we want to even come before that and become preventative -- Right.
-- and try to anticipate things. You know when you've been infected. You've been on an airplane flight. That's recycled air, -- to fill the air.
Um-hum.
And you land, take your Cold-Eeze, Right. Because you have many -- I do that all the time. In fact, when I came back from New York, I was on a train, and I think the trains are similar to the planes with that air.
Sure. It's a contained Space.
And that's where I think I got my cold Saturday moming. Sure. Cold-Eezer Plus should be taken, you know -- Right when I got off the train, I should have taken one. -- aS soon as you're off the train.
Right.
Or in the evening at your home and you've had most of the exposure or you've touched everything you're going to touch, you've washed your hands, take a Cold-Eezer Plus.
Now, with this, you're going to get two bags, each contain 30 lozenges and each have 135 grams of the zinc in it, which — Well, each Cold-Eezer Plus lozenge has -- Right.
~- 14.2 milligrams of zinc gluconate glycine. Um-hum.
And basically one every three hours to treat the cold. Um-hum. | Exhibit E, p.4 VOLUME 129 Complaint Exhibits CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. Caller:
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Complaint Exhibits He says, every time this kid goes to school, I'm sick. Um-hum.
Well, have him take one a day and he will not catch it and have the child, perhaps, take one in the moming before they go to school and -- Oh, that's a good idea.
~- to prevent them from even getting the cold. It's preventive medicine. It's an aggressive family strategy to Stop this spreading of the cold ~ Um-hum.
-- and to help the child out almost instantly. They won't become tired. And rest assured, it's a stocking item here at QVC. You can get Cold-Eezer Plus 24 hours a day. You can't run out. Right.
Well, if they work -- if they work, I guarantee you, you'll have a lifetime member.
Oh, good.
Well, and let us know, Geraldine. Call us back after you try them and let us know how they do work for you. Okay? I certainly will, Thank you so much.
And thank you for talking to me, and you have a real nice day. You, too.
You, too. Bye-bye.
Bye-bye.
I want to let everyone know, too, because a lot of people think zinc, they think bad taste. You've really helped that out a lot. You have two flavors to choose from, original or cherry. I love the cherry. Yes. Well, zinc -- you can take zinc -- Um-hum.
Exhibit E, p.6 VOLUME 129 Complaint Exhibits TAL.
CMO DISTRIBUTION CENTERS OF AMERICA, INC., E Show Host:
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Complaint Exhibits -- the cough and the stuffy nose and the sore throat and the nasal drip and the sneezing, but also the duration.
The duration, which is the most important thing anyway. Because if you're out of work for three or four days, I mean, that's a long time -- Yes.
~- tO not get that paycheck or to just be out of work on your back and miserable. I'd be miserable.
Well, miserable, the agony, the misery is what you want to get rid of. I know, Absolutely.
And as Geraldine said, you know, her husband is moaning. I mean, then the agony for everybody in the family.
Oh, really, everybody is awake.
And the little ones who wake up and, you know, mom, I don't feel good, you know. This is going to ~ And then you're into the whole thing. Mom's got to deal with this. Um-hum.
But we can stop that.
And then she gets the cold, We can stop it ~ Preventative, ~- (inaudible).
Right.
Now, there's a word about business in general, if you own a business, whether it's a single Proprietor or AT&T.
Um-hum.
We suggest they take a good hard look at having Cold-Eezer Plus around for their employees.
Mmm.
Now, the United States last year lost $21 billion from the common cold. We have them here at QVC.
Exhibit E, p.8 VOLUME 129 Complaint Exhibits CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. C. Phillips:
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Complaint Exhibits If you're taking the zinc, it will help aging, it will help immunity, it will help vision. It's good for 26 or 27 conditions of the human body. So, taking one a day, you're getting nearly the daily requirement -- Um-hum.
-- but you're also preventing that cold from getting a foothold on you, Right. :
And it stops the whole process -- Reducing -- -- right in its tracks, You have one right now. There's one working right now. I know. There's one working right now, A-3 6293, and they do taste great. I like the cherry personally, but there are — you know, the other flavor is just as good. Both of those, $18.25.
Thank you so much, Chuck.
Thank you, Bonnie.
Thanks for keeping us healthy.
Oh, I'll be glad to.
I'm sorry that you weren't here Saturday morning. But now my cold will go -- One a day and you won't have this problem. That's right. Thanks so much. A-36293.
(The Cold-Eezers segment was concluded.) Exhibit E, p.10 VOLUME 129 Complaint Exhibits CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. 1307 Complaint Exhibits tte. of Introduction http:/home.earthlink.nev~cmocure/cmo/em00001.htm! CMO Distribution Centers, Letter of Introduction Dear Visitor, Arthritis Treatment This site contains exciting information about a naturally derived substance called CMO. It is being hailed by it’s users, doctors and the media as the cure for arthritis. The discovery that lead to the development of CMO was made by a researcher at the US National Institutes of Health. It was introduced to the medical community in [BR December 1995, at the National Medical Conference on Aging. Now it is available to arthritis sufferers.
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By January 1997, the success of the CMO was so awesome, it had inspired several corporate criminals to market the less effective injectable as an oral liquid. This became quite a problem because they even illegally used trademark name (CMO). Notices of trademark violation were sent out. In February 1997, Dr. Sands began writi his book about CMO called “Rescued From Arthritis”. He says it will be finished by the end of summer. March 1997, marked the first delivery of CMO to the multinational corporation. It will be available as part of a complete care ¢ for arthritis. The official national release of their package will in August 1997. success of CMO in it’s prerelease stage has been outstanding.
eu waa en te eran VOLUME 129 Complaint Exhibits CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. 1311 Complaint Exhibits MO Information http://home.carthlink.net/~cmocure/emo/cm00002.htmi question to view the answer. Use “Back to FAQs” button to return to questions after viewing an answer.
What makes CMO different from all the other remedies?_ Does that mean a person takes CMO only once and that's it? Does it work for both rheumatoid and osteoarthritis? Does CMO improve joint mobility? Does it stop arthritis pain? Does CMO reduce inflammation? How long before it takes effect? Will it correct deformities? What about really severe cases? What about joints where the cartilage is completely worn away? Does it work for everyone? Do Lhaye to go on a special diet? What about exercise? Is it okay to exercise? Is it expensive? Is age a factor? What causes arthritis? How does CMO work? Is itharmful in any way? What is CMO? Where does it come from? Is CMO used for any other ailments? What makes CMO different to other remedies? CMO is not a pain reliever, nor is it a steroid or anti-inflammatory. It is and immunomodulator. There's never been anything like it before for arthritis. Instead of treating the symptoms of pain and inflammation, CMO act against the cause of arthritis — the erroneously programmed Memory T Cells of your own immune system that cause the attacks against your joints. Once the attacks on your joints are halted the symptom of pain and inflammation is promptly remedied.
Back to FAQs Back to Top Does that mean a person takes CMO only once and that's it? Yes. Most afflicted persons need to take the capsules for only a couple of weeks to be free of arthritis symptoms forever. No further medication is ever necessary, not even CMO. Back to FAOs Backto Top Does it work for both rheumatoid and osteoarthritis? Both types respond equally well. It also works for most other types of arthritis such as those ae MPA UTEKAR VOLUME 129 Complaint Exhibits CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. 1313 Complaint Exhibits MO information http://home.earthlink.ne~cmocure/emo/em00002.html! pushes the bones out of place. Reduction of the swelling alone improves appearance dramatically and often allows the dislocated bones to return to their normal positions. Extreme cases may require some physical therapy. Back to FAQs Back to Top What about really severe cases? Even most persons previously confined to bed or to wheelchairs have responded dramatically and are now no longer dependent on others for care. A number of these cases received additional benefit from repeating the treatment one more time. A few others found that physical therapy or exercise programs also helped. Back to FAQs Back to Top What about joints where the cartilage is completely worn away? Unless the bones have fused together, the usual problem is not lack of mobility, but pain. ‘ The majority of such drastic cases have responded favorably resulting in painless movement, even in the knees.
Back to FAQs Back to Top Does it work for every one? No. CMO has been.able to help many individuals, but not everyone will see an i in their arthritic symptoms. We all have different bodies, lifestyles, eating its, etc., therefore the results will vary. Digestive problems or liver function impairment, can sometimes interfere with success.
Back to FAQs BacktoTop _ Can I continue with my usual medications while taking CMO? Yes, but after a few days you probably won't need them. However, it's best to avoid steroids if possible.
Back to FAOs Back to Top aeit AIM AE 17-68 VOLUME 129 Complaint Exhibits CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. 1315 Complaint Exhibits ‘MO Information http:/home.earthlink.net/~cmocure/cmo/cm00002.htm! arin Back to Top What causes arthritis? The numerous theories about what causes arthritis have filled hundreds of volumes. But one thing we do know is that the arthritic process is regulated by Memory T Cells which have been erroneously programmed, causing attacks on your own joints and cartilage. In osteoarthritis, this faulty programming usually results from physical damage (like a fall, sports injury, vehicle accident, repeated operation of vibrating machinery, long-term strenuous physical work or sports activities, and continuous repetitive motions of certain joints) etc. The damage results in an immune mse involving the memory T cells producing attacks against the affected joints. Unfortunately, there's no stop or end command given and the attack continues against healthy cartilage and joints as well. That's why arthritis is called an autoimmune disease, our own body is attacked by our own immune cells, .
Although the various forms of rheumatoid arthritis are usually caused by some ineffective microorganism. Memory T cells is again involved in the same arthritic process. Without CMO it continues to worsen.
Back to FAQs ' Back to Top :
How does CMO work? CMO corrects the root cause of arthritis by erasing the memory of the badly . roy Talis. Once the destruction of your joints is halted, your bod can its repair process without interference, and joints begin to normalize. Although the major benefits come promptly, minor improvements continue even for several months after finishing normally, Despite minor ph eal damage t Sones ao test of sation vecfect . ite minor physi: to asa It of long ly normal joint function usually returns regardless. Back to FAQs Backto Top Is it harmful in any way? {MO studies began at the US National Institutes of Health more than 20 years ago. Recently, clinical applications studies were conducted in San Diego. No harmful short or SNe Ta rr a ae pena, of in laboratory animals even at extremely doses. Similar substances have long been used in common foods including cheese chocolate, and even in medicines and cosmetics. It is a perfectly safe and naturally derived Back to FAQs Backto Top AATPA® ITKEAR VOLUME 129 Complaint Exhibits CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. 1317 Complaint Exhibits MO Information http:/home.carthlink.net/~cmocure/emo/em00002.htm! -oee What is the media saying about CMO? Books, Television News, Radio Health Talk Shows, Medical Newsletters and Scientific Journals all report CMO™ to be a revolutionary breakthrough! Quotes extracted from: The Mark Scot Show, WXYT Radio Detroit, December 1996: “Hang on folks because if you haven’t heard this before, it certainly is going to be an eye opener for you. ...Amazing is not the word for it. ...CMO™ gets to the source of the problem, it actually stops the arthritic process.” Quotes extracted from: The Don Bodenbach Show, KCEO Radio San Diego, August 1996 "...It may be what we consider almost a miracle cure for arthritis, and the form of arthritis doesn’t matter. ...What is more impressive is once you undergo the appropriate treatment -/you are in most cases free from arthritis symptoms forever." Quotes extracted from: The Nature of Health Magazine, Stop Arthritis Now! The Amazing Story of CMO™, September 1996 "CMO™ is a natural substance and is considered an immunomodolator. The reason for the enormous interest is the effect of CMO™ on both theumatoid and osteoarthritis... The results of CMO™ are so impressive that nothing that mainstream or natural medicine has to offer can come close to the dramatic reversals in arthritis that have been observed. The link between CMO™ and arthritis was discovered the National Institutes of Health... Standard medical treatment is aimed at symptomatic ' relief of pain and inflammation and has shown to actually accelerate the disease process... In contrast, the CMO™ protocol works rapidly and does not need to be continued in the vast majority of cases.”
Back to Top What are people saying about CMO? “It’s a miracle! Ten years with arthritis ... three in a wheelchair ... and now I've got a completely normal life again. Just watch me make up for lost time.” “As crippled as I was, I hadn’t worn out a pair of shoes in seven years. Now I’m out shopping for them again all by myself. My whole life has made a complete about face.” “Even as a doctor, I find CMO™ miraculous. It cured my knee problems, and it’s performing every bit as well for my patients, too. I’ve seen several ‘miracle cures” already.” “After nine years of crippling pain, I can’t believe I’m actually skiing again. CMO™ is truly incredible.”
“After two years in a wheelchair, I just can’t believe that I’m taking care of myself and my family again.”
“I am a trophy winning martial arts competitor and I had to quit three years ago because of my arthritis. I'm 100% now that I tried CMO™, I look forward to going to Australia next year to compete again.”
Amn Ce AO VOLUME 129 Complaint Exhibits \rthritis Information aff CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. Complaint Exhibits Arthritis Information Welcome to our Arthritis Information page. Due to the volume of information on this page, we have installed this menu and “Back to Top" buttons to help you navigate this page more effectively.
What is arthritis? Thane (ov fo Tanny Socine of axthriis Chat they cenit ofl be presented here. Acconting to the Arthritis Foundation, arthritis refers to more than 100 different diseases that cause pain, swelling and limited movement in joints and connective tissue throughout the body. It is usually chronic, meaning that it lasts a lifetime. The disease process also varies depending on the form of arthritis.
The three most prevalent forms are osteoarthritis (OA), fibromyalgia and rheumatoid arthritis (RA). Osteoarthritis is a degenerative joint disease in which the cartilage that covers the ends of bones in the joint deteriorates, causing pain and loss of movement as bone begins to rub against bone. In fibromyalgia, widespread pain affects the muscles and attachments to the bone. In rheumatoid arthritis the joint lining becomes inflamed as of the body's immune system activity. The chronic i ion causes deterioration of the joint and the pain and limited movement. You should be aware that osteoarthritis or degenerative joint disease is the most common. CMO is effective on all forms of arthritis except gouty arthritis. The following is what the Arthritis Foundation of New York has to say about osteoarthritis: .
Osteoarthritis or Degenerative Joint Disease Arthritis refers to inflammation of the joint space. Osteoarthritis also known as degenerative joint disease (DID) is « slow and progressive form of degenceative itis that is seen most commonly in the elderly. Joints that have been ously injured (fractured o severely spexined), or subject to chronic strees (obesity or repetitive overuse syndrome) can also lead to premature legenerative changes in the younger patient. The joints are lined with a material known as cartilage, which provides a smooth surface over which the joint can "glide" without ' Degenerative arthritis causes Sastnuction of the cartilage predan oantly in the http:/home.earthlink.net~cmocure/cmo/em00003.htm! MIPANE 17-67-20 VOLUME 129 Complaint Exhibits rthritis Information CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. Complaint Exhibits information about arthritis:
; Arthritis is the #1 crippling disease in the U.S. e Nearly 40 million Americans have arthritis @ One in seven Americans have arthritis e Nearly two-thirds of those with arthritis are women e Nearly 23 million women of all ages have arthritis By the year 2020, 59.6 million Americans will have arthritis unless steps are taken now to limit its impact Arthritis limits everyday activities -- such as dressing, climbing stairs, getting in and out of bed or walking -- for about 7 million Americans $54.6 billion financial impact nationwide each year Arthritis causes $133 billion in lost wages and productivity annually 427 million work days each year are lost to arthritis The number of people with arthritis is staggering and there are 500,000 new cases each year. Take one of our less populated states like Tennessee. The Arthritis Foundation publishes this about their Tennessee chapter:
$ 823,000 people with arthritis @ One in seven people @ 354,589 people with osteoarthritis @ 130,034 people with rheumatoid arthritis 1,481 children with arthritis It is no wonder that arthritis has become one of the top headline news stories in all forms of mass media. The public response to CMO has been overwhelming. News broadcasts and talk shows bring record numbers of callers to sponsoring stations. In San Diego when a local radio station interviewed Dr. Sands they got so many calls their switchboard overloaded! The host of that show wrote in The Nature of Health magazine: "On August 3, 1996, I interviewed Dr. Len Sands on my radio program... Our topic of discussion was cerasomal-cis-9-cytlmyristoleate or CMO. That one hour program generated more calls than any show I've ever done and in fact was the largest response ever for a single show in the history of the radio station." In Detroit the response was so heavy that the show's host canceled all other guests and extended the interview for 2 hours. The traffic on local circuits for that station's exchange were so heavily taxed that callers to that area only get a circuit busy signal. Back to Top What causes arthritis? Dr. Sands the Director of the San Diego Clinic explains it by saying: “The numerous theories about what causes arthritis have filled hundreds of volumes, But one thing we do know is that the arthritic process is regulated by "Memory T-cells" which have been erroneously programmed, causing attacks on your own joints and In osteoarthritis, this faulty programming usually results from ical (like a sports injury, Vehicle accident, long-term strenuous physi work or sports activities, or any frequent jarring or shocking of the joints, etc.). http://home.earthlink.ne’~cmocure/cmo/em00003.htm! MIP 17-67-30 VOLUME 129 Complaint Exhibits CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. 1323 Complaint Exhibits tthritis Information hup:/name.earthlink.nev~cmocure/emo/em00003. htm! time in ten years. As she says, "without any pain or clicking." Second Opinion Second Opinion is a newsletter published by Dr. William Douglass. This newsletter enjoys a readership of over 100,000 informed doctors, health professionals and health conscious readers. Dr. Douglas describes CMO as a “miracle cure. “A New “Miracle Cure" for Arthritis ...now we have a new star on the horizon that promises as much (or more) than the old sure-cures. Again, I'm skeptical _ been through this so many times that I believe in the power of negative thinking _ but it does indeed look promising. ... 40-year employee of the [U.S. Government] National Institutes of Health (NED) reports: “Four years ago, I had arthritis so bad I could hardly walk and it was in my hands, too." He is 84 now and remarkably improved from treating himself with a compound I am still trying to learn to pronounce. It's called Cerasomal-cis-9-Cetyl Myristoleate. The trade name is CMO", so that's what we'll call it.
[One] study involved 48 subjects of both sexes ranging in age from 29 to 82. ...Most patients had a 70 to 100 percent return of joint mobility and a 70 to 100 percent reduction in pain. The initial response time is two to seven days and maximum response time is from seven to 21 days."
Back to Top What will cure arthritis? Dr. Jason Theodosakis' book The Arthritis Cure for gives the impression that glucosamine and chondroitin sulfate are the cure for arthritis. In fact neither of those substances have any effect on arthritis. What glucosamine sulfate and chondroitin sulfate do have an effect on is cartilage growth. To term these compounds as a “cure” is like saying you can cure a disease it continuous treatment of the symptoms and not pemnanentiy treating the cass, Even the Arthritis Foundation says The itis Cure is not recommended and they cannot recommend glucosamine and chondroitin sulfate as a treatment for osteoarthritis or any other form of arthritis.
Glucosamine sulfate, chondroitin sulfate, cartilage, natural unflavored gelatin, or similar compounds are the building blocks for cartilage growth. Once the arthritic process is stopped they are much more beneficial.
Speaking of the Arthritis Foundation, they will neither confirm, nor deny that CMO is the cure for arthritis. We are aware of several cases where CMO was members of the AF. In tum, were cured and presented CMO to AF staff. To this day, despite the fact that CMO has cared Sonne Cf tho rae the oy CE ca in Geeplte the fae was to suggest that when taking CMO, you should consult your physician before reducing steroids or other medications.
According to doctors, clinical studies, users and the media, CMO would certainly seem like the most likely candidate to be given the true title being of a "cure" for arthritis. asking Dr. Sands if CMO is the only cure for arthritis he replies: “According to the Journal of Rheumatology (1993; 20:137-140) bone marrow 6 IMA 17:57:31 VOLUME 129 Complaint Exhibits ‘inicat Information of tt CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. Complaint Exhibits Clinical Information Welcome to our Clinical Information page. Due to the volume of information on this page, we have installed this menu and "Back to Top" buttons to help you navigate this page more effectively.
Research CMO Distribution Centers of America in conjunction with the San Diego Clinic act as a clearing house for all the latest information on CMO, With this joint research effort, a network of communication is established between all medical fessionals and distributors. This allows for up to the minute information s . This facilitate the application of CMO to uses other than for arthritis. Currently, studies for the use of CMO on other auto-immune diseases are in progress. It is hoped that the Lupus Foundation will conduct one such study. We have offered to fund the protocol. Current studies of CMO as a part of therapeutic protocol for other diseases include asthma, sclerederma, fibromyalgia, lupus, emphysema, certain cancers, and prostrate hy lasia. CMO Distribution Centers of America and The San Diego Clinic team have cated themselves to that research and the results will expand the of CMO to other diseases. These CMO pages will reflect any progress we make. In the near future, a user BBS will be added for public access to the data base information posted by medical professionals.
Back to Top http:/mome.earthlink.net/~cmocure/cmo/cm00004.htm! {CMO Distribution Centers 07/2498 17:58:20 VOLUME 129 Complaint Exhibits CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. 1327 Complaint Exhibits linical Information http://name.earthlink.net/~cmocure/emo/cm00004.html rheumatoid arthritis, and other forms of reactive arthritis. Back to Study Back to Top pr SS The Study The study involved 48 subjects. Female subjects (28) ranged from 33 to 82 years of age. Male subjects (20) ranged from 29 to 74 years of age. All races and many ethnic backgrounds were represented. Age, gender, race, and ethnological background appeared to be irrelevant to patient response in this study. Back to Study Back to Top The Protocol ‘ CMO was administered orally in the form of 75mg capsules each morning and evening. The number of capsules and duration of treatment varied for each group of subjects. Subjects were advised to take capsules on an empty stomach with water only; and to avoid tea, chocolate, alcohol, coffee, cola, and other caffeinated drinks for five hours after taking the capsules. Subjects were advised to completely avoid chocolate and alcohol during the entire trial period of two to four weeks duration. With a few exceptions for subjects who could not function without them, steroids were also prohibited. Otherwise diet was not controlled in any wa! . Subjects were permitted to continue taking their customary pain and non- steroidal anti-inflammato ry medications until they were no longer needed. Subjects were asked to visit or call in to report progress at least twice weekly. Back to Study BacktoTop The Results Only two subjects failed to show marked or complete relief of all symptoms of pain and ited mobili normally associated with arthritis. Both of these subjects had suffered prior hepatic problems: one from slochol abuse resulting ia of the liver; the other, a former professional athlete, presented with considerable liver damage from steroid abuse. Further studies are necessary to determine the role of liver function capacity with to this protocol. Liver damage resulting from steroids previously prescribed for itis may prove to be a factor affecting patient response. Two other subjects showed less than a 75% retum of particular mobility. The balance of all oft . A7MANR 17:58:21 VOLUME 129 Complaint Exhibits CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. 1329 Complaint Exhibits inical Information http://home.earthlink.net~cmocure/cmo/cm00004.htm! tit increase in joint mobility. Three subjects reported to be totally free of pain with almost complete return of joint mobility and marked improvement in joint deformation. One patient reported no perceptible change.
On the fourteenth day, at the end of the one week interval without treatment, six subjects reported minor continuing improvement; two reported maintaining their improved status, and one continued to show no improvement. Treatment was resumed on the fifteenth day for 5-1/2 more days.
By the end of the treatment period all but two subjects reported to be 90% free of pain with return of 70% to 100% mobility. The fused hip joint remained fused, of course, but with a return of over 70% mobility in other joints the subject felt hip surgery now to be worth consideration. The one nonresponsive subject proved to have cirrhosis of the liver, which may have been the reason for her inability to respond to treatment. Further investigation is necessary to determine the role of liver function in this protocol. Back to Study Back to Top GROUP #3 Mild to moderately severe rheumatoid arthritis . In Group #3, fourteen subjects presenting with mild to moderately severe rheumatoid arthritis were supplied with 24 capsules, two 75mg capsules to be taken each morning and evening for six days. After three days of treatment eleven reported about 20% to 30% improvement in articulation and inflammation, and about 40% to 50% relief of arthritic pain. In these eleven subjects improvement continued rapidly over the next four days, ing the 80% to 100% level. The remaining three subjects reported similar improvements by the end of the fourth day, with an overall improvement of 70% to 80% after seven days.
Most of the subjects continued to report minor additional improvement for one week or more even though they were no longer under treatment. However, six in this group began to SO ge ne anne or One EE Octo Bye Npaoad Ries abOwe Bae 00 Dee works, (Although not included as part of this study, all of the subjects in this group were treated again and their level of improvement has subsequently stabilized). Back to Study Back to Top GROUP #4 Severe to crippling osteoarthritis In Group #4, fourteen subjects presenting with severe to crippling osteoarthritis were supplied with 50 ca oe aan in two series, tivo 75mg capsules each moming and Sreaing for seven ys, with a seven day interval before repeating the same 5-1/2 more . Three of these subjects were unable to walk and were accustomed to 07/24/98 17:58:21 VOLUME 129 Complaint Exhibits linical Information of 11 CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. Complaint Exhibits Back to Study Back to Top Case Histories Condensed Highlights From Case Histories Recorded By The San Diego Clinic From case history #38:
Medical Doctor. Pain and stiffness in hands for several years. Unable to perform simple office surgery. One day of CMO brought relief. Dexterity and fine surgical ability returned gradually. Ordered CMO for his patients. Male. Medical Doctor lained of his le. i tor/psychiatrist. This physician complained of persistent pains along hi spine and in his feet. He became completely free of pain in both the spine and feet within two days of starting CMO capsules. Remission continues. From case history # 33:
Medical Doctor. Auto wreck ten years earlier damaged hip, caused limp and arthritis. CMO relieved pain permanently in one day for the first time after many years. The limp problem is irreparable. Ordered CMO for his patients. From case history # 06:
Female. Age 45. Arthritis attack worsened rapidly over a period of only seven months. a wheelchair to be moved about. Frequently le to leave bed in mornings because of debilitating pain. Seeking relief, she worked with a personal trainer. She was incapable of holding a five pound weight, unable to make a fist. Saw immediate improvement with CMO in just three days. Two weeks after the first, she took a second course of CMO. She is now able to perform a full workout, has no difficulty making a fist, wakes in the mornings free of pain, and has resumed a normal active life. From case history # 29:
Female. Age 63. Despite devoted adherence to a truly natural diet, suffered severe osteoarthritis in most joints for over ten years. Woke to agonizing pain. Even simple chores were arduous. CMO brought total relief in ten days. From case history #24:
Female. Age 50. Family history of arthritis. Pain in shoulders. Severe pain, limited mobility, and gross swelling in hands and fingers. By the third day of CMO, hands were free of mobility had increased immensely, and finger swelling decreased so dramatically she to have all her rings re-sized. Repeated treatment three weeks later. T free of pain and inflammation since. For the first time in many years, she was recently to experience a pain-free skiing holiday.
From case history # 22:
Female. Clinically obese. Arthritis in neck and spinal column resulting in joint mo limitations. Despite impaired liver function which frequently inhibits the of CMO, her of motion increased by 100% within one week. A repeat course of CMO two weeks has resulted in even greater and continuing improvement. http://home.earthlink.net/~cmocure/emo/cm00004.html 072488 17:5821 VOLUME 129 Complaint Exhibits inical Information of 11 CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. Complaint Exhibits The golden rule while taking CMO:
To improve effectiveness, abstain from the use of alcohol, caffeine and chocolate during the entire period while taking CMO and for two weeks after taking your final capsules. This includes non-alcohol beer, coffee (even decaffeinated), black tea, colas or other caffeine containing substances. Consult your doctor before making radical changes to your diet. Additional hints to improve effectiveness while taking CMO:
Minimize or avoid cating Nightshades (tomatoes, potatoes, green, red and yellow bell pepper and eggplant). Some users find it also helps to reduce the consumption of fats, oils, lentils, and all forms of wheat, rye, corn and barley during the protocol. You should remain on this diet for the entire period of protocol and the following ¢ two weeks for optimum results. Consult your doctor before making radical changes to your diet. A diet for anyone with arthritis:
As with all arthritis sufferers, it is best to avoid the “nightshade” group of vegetables whether you are taking CMO or not. Nightshades have been found to aggravate the arthritic condition. You can check with your local Arthritis Foundation for more information or ask them about the Help Yourself Cookbook, the cookbook for people with arthritis. Cookbook toll-free number: 1-800-454-4662. We are not affiliated with the AF or the makers of the cookbook. We only provide this information in response to the many request we get for type of information. Consult your doctor before making radical changes to your diet. Medications:
CMO does not interfere with any known medications or alter there effects. Medications do not interfere with the effects of MO except in two cases, methotrexate and steroids. Methotrxate:
The presen tion drug methotrexate or (Rheumatrex) will completely block the effects of Methotrexate is an immune suppressant, CMO is a an immune modulator, to two actions are contradictory and the effects of CMO are blocked. Request that your doctor allow you to discontinue these drugs for at least one week prior to starting CMO. Consult with your physician before making any changes in your current medications. Steroids:
In some cases, cortisone or other steroids, have hindered the benefits of CMO. Because your liver is so busy processing them, you can’t absorb the full benefits of CMO. If you are taking cortiaout or other seroids: advise your doctor that it would be better to avoid them or cepa yu my re Tf not ask him about taking half doses. Then as your pain You may request that he discontinue them completely. Consult with your cian before making any changes in your current medications. ss Matias As aeg en nancy tedseane ung ee pla meas http://home.ecarthlink.ney/~cmocure/cmo/cm00004.html O7NANB 17:58:21 VOLUME 129 Complaint Exhibits CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. 1335 Complaint Exhibits inital Information http:/home.carthlink.net/~cmocure/cmo/cm00004.htm! few people with rheumatoid arthritis have felt a short-term, temporary worsening of their symptoms. This has lasted for a few days after which their progress has then continued normally. Sometimes it may appear that the full benefits of CMO have occurred early in the treatment. However it is advised to take all 100 capsules to assure the complete, long lasting benefits of CMO.
Back to Top Last Update: 09/21/97 Copyright ©1997 by CMO Distribution Centers of America Inc. - ALL RIGHTS RESERVED lofil 07/24/98 17:58:21 VOLUME 129 Complaint Exhibits CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. 1337 Complaint Exhibits {manufacturing & Specifications http://home.carthlink.net/~cmocure/emo/cm00005.hum! Quality Control The strictest quality control is maintained. Lots are analyzed and a specifications sheet is generated (see below). Batch records are logged and must be signed by both parties inspecting the run. Should an error in the fill weight be detected, all product since the last check is removed and destroyed. Each capsule of CMO has been checked 3 times. Content, quality and quantity (fill weight) are checked at three different points during the manufacturing process.
Back to Top Specifications This is a copy of one of the specification sheets: Document NO: CMO 863 effective August 3, 1996, the specifications are as follows: $ Product: CMO (cerasomal-cis-9-cetylmyristoleate) Description: Nutritional / dietary supplement consisting of white crystalline powder @ encapsulated in size 00 white capsules. Containers: 125 ml or 225 ml white polypropylene bottle with safety seal, a white plastic screw cap, and a white shrink-wrap seal around top of bottle neck. Packaged twelve (12) per case.
e Fill Weight: 770 mg per capsule, one hundred (100) capsules per bottle. ‘formula:
© CMO cerasomal-cis-9-cetylmyristoleate derived from natural bovine tallow in a mix of related natural tallow-derived waxes. © Calcium Phosphate.
© Silicon Dioxide......
$ Identification: Mixed ester, alcohol, tallow-acid wax. $ Melting Point: 34-39§C Differential Thermal Analysis (DTA): Minimum between 50-608C with therogram ¢ structure depending on scan rate and packing sample tube. standards. ¢ infrared Spectrum: Neat on Nail plates. Matches standards. Microbial Testing: Plate count <1 per gram. E, Coli: Negative. Salmonella: legative.
° Certification: CMO is a substance naturally derived from natural bovine tallow in a mix of naturally derived bovine tallow waxes, containing only naturally derived ingredients.
Back to Top Packaging & Labeling of4 07/24/98 17:58:55 VOLUME 129 Complaint Exhibits CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. 1339 Complaint Exhibits Aanufacturing & Specifications http://home.earthlink.ne’~cmocure/cmo/em00005.htm| Retail orders must be paid in full at time of order. Orders will arrive within 2 weeks from the time we receive payment. Rush orders can be arranged. Wholesale orders of 1,000 units or more require 50% upon order, net upon delivery. Orders of less than 1,000 units must be paid in full at time of order. Orders must be placed at least:
: 10 days prior to FOB pick up from plant in Anaheim, California. ¢ 14 days prior to FOB pick up from our offices in Sarasota, Florida. ¢ 18 days prior to air express shipment. 21 days prior to land carrier shipment.
Back to Top Shipping $ 5 lbs and under: N/C Over 5 lbs: FOB Back to Top ‘ Guarantee CMO Distribution Centers of America Inc. guarantees that the product we ship meets all the above specifications.
Back to Top Last Update: 09/21/97 :
Co; ori rht 51997 by CMO Distribution Centers of America Inc, - ALL RIGHTS of4 07724198 17:58:55 VOLUME 129 Complaint Exhibits CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. 1341 Complaint Exhibits Aarkesing & Sales http://name.earthlink.nev—cmocure/cmo/em00006.hun! International Market CMO has a certificate of Free Trade and is available for export. The full potential of the international market for CMO should be more than double that of the US market. However, a world wide market is impossible to project without first answering these questions: ; What is the true scope of effectiveness for CMO on other autoimmune related diseases? How will price positioning effect foreign markets? Back to Top Current Market Last year independent distributors sales of CMO expanded at a rate of approximately 20% per month. Orders for this coming year exceed 100,000 units.. Back to Top Counterfeit & Inferiort With the success of CMO in the marketplace, counterfeit, inferior and legally questionable products are rapidly appearing. Already two such impostors have been forced to comply with cease and desist orders and a third that refused to comply was sued resulting in a half million dollar judgement. Various col ies are marketing cetylmyristoleate as CMO. This is very deceptive because CMO is not colyhaysistoleete. This is also illegal since a trademark registration for CMO was filed and those rights were assigned to CMO Distribution Centers of America Inc. Our investigations reveal only three manufacturers of cetylmyristoleate. All of their end products can be identified as liquid, 48 capsule or 60 capsule units. Though cetylmyristoleate was effective as an injectable compound, it is not nearly as ive as an orally administered agent. CMO is cerasomal-cis-9-cetyimyristoleate a highly bio-available analogue that is designed to be orally administered and is over 90% effective. Only CMO has been tested clinically. CMO is naturally derived from beef and may be sold directly to the public without regulatory intervention.
Synthetic cetylmyristoleate appears to be in the market without clinical study or the proper regulatory approval. This synthetic version of the original injectable compound is sold as an orally i product. Reports of it's effectiveness have not been favorable. In fact, it has been so ineffective the mere association of this product with CMO is about to inspire legal action. This high failure rate can be explained by the manufacturer's own words. Publi in the Journal of Pharmaceutical Sciences he said that cetylmyristoleate was most effective when injected near the site of the arthritis. We agree with that observation completely. That's why we an orally administered analogue.
There is a very odd collection of characters with uncertain backgrounds that were trying to market cetylmyristoleate and other substances as CMO. They have been forced to comply with a cease and desist order. They are hard to keep track of because they collectively have several corporations that of 07/24/98 17:59:28 VOLUME 129 Complaint Exhibits (marketing & Sales of 8 CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. Complaint Exhibits Promotion Target Market With 85% of Americans over 65 years old and 40% of Americans over 40 years old being afflicted with arthritis, the target market is plain to see. All senior and adult health related media is prime launch ground for any campaign and has brought at least a 2 to 1 return. Detroit metropolitan areas are generating 3 to | returns in senior oriented newspaper print media. Television advertising is untested at this point. Radio advertising response has been varied. Direct mail has been approached with several methods and a variety of results. Mailings to seniors organizations have brought less than a 1% but direct mail test marketing to seniors in Southfield, Michigan brought a staggering 7% return. Back to Top Print This approach to print ads keep any claims about the product itself from falling under regulatory agency scrutiny. Currently all distributors are modifying their approach to parallel this one. Ad placement has proven crucial to the response rate from print advertising. Classified ads barely brought a 1 to 1. Home iving, Senior Living and Health and Fitness magazine inserts proved to be very responsive. Responses of 3 to 1 are achieved through these type of placements as well as standard Placement in news sections carrying health related articles. Display ads have been anywhere from 2 to 5 column inclies on the average. The ad on this page is a typical 4 column inch size. . Currently all advertising is geared to generate a mailing. All product information pamphlets should contain something similar to this statement: "CMO is naturally derived. It is sold only as a pe supplement not intended to treat, cure, or diagnose any disease. Therefore, it is available mail o1 ut prescription." Response to requested mailings are better than 10%. Back to Top Radio Radio health talk shows have proven to generate an overwhelming nse. Both Dr. Sands and Dr. Muller are available for interviews. In Detroit the response to the Scott Show with both Dr. Sands and Dr. Muller generated sales of over 80 bottles per week for over 5 weeks running. Zerbo's Health Foods in Livonia Michigan ran only 2 radio ads during the Mark Scott Show and they are selling about a dozen bottles per week. Their sales have not trickled off as would be expected. . Back to Top Television Being that CMO is a consumable, we feel that the best suggested approach to marketing through television is to promote the product through a mini infomercial. The book by Dr. Sands will be available http://home.carthlink.net/~cmocure/cmo/em00006.html 07/24/98 17:59:28 VOLUME 129 Complaint Exhibits CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. 1345 Complaint Exhibits Marketing & Sales http://home.earthlink.ne~cmocure/emo/em00006.htm! and length of trials and, particularly, more extensive tests of cetyl myristoleate analogues." of 8 Quotes extracted from: The Nature of Health Magazine, September, 1996. “On August 2, 1996, I interviewed Dr. Len Sands on my radio program... Our topic of discussion was cerasomal-cis-9-cetylmyristoleate or CMO. That one hour program generated more calls than any other show I've ever done and in fact was the largest response ever for a single show in the history of the radio station. CMO is a natural substance and is considered an immunomodulator. The reason for the enormous interest is the effect of CMO on both rheumatoid and osteoarthritis. The results of CMO are so impressive that nothing that mainstream or natural medicine has to offer can come close to the dramatic reversals in arthritis that have been observed. The link between CMO and arthritis was discovered at the National Institutes of Health... It is estimated that arthritis affects approximately 50 million people in the United States alone. Standard medical treatment is aimed at symptomatic relief of pain and inflammation and has shown to actually accelerate the disease process... In contrast, the CMO protocol works rapidly and does not need to be continued in the vast majority of cases. The rest of this article is devoted to the most commonly asked questions regarding the potential benefits of CMO ... Does CMO stop arthritis pain? Arthritis pain will disappear completely in almost every instance. In a few extreme cases pain was reduced by only 70% to 90%, which was still of such major benefit that it allowed the persons to function normally again. . Does CMO improve joint mobility? Absolutely! If the joint can be moved just slightly, by the afflicted person or even by someone else, joint mobility can usually be restored. But if the bones have fused and grown together only surgery can help those particular joints. Can it correct deformities? Yes. Deformed fingers and toes are often caused by inflammation which swells joints and pushes the bones out of place. Reduction of the swelling alone improves appearance dramatically and often allows the dislocated bones to return to their normal positions. Extreme cases may require some physical therapy."
Does it work for both rheumatoid and osteoarthritis? Both types of arthritis respond equally well to CMO. It also works for most other types of arthritis such as those associated with ankylosing ylitis, Reiter’s syndrome, Sj”gren's syndrome, Behfet's syndrome, and psoriasis. It has also been found to relieve various types of back pain of undetermined origin, which is more than likely arthritis related.
What about really severe cases? Most people previously confined to bed or to wheelchairs are no longer dependent on others for care. A number of these cases received an additional benefit from i treatment one more time. A few others found that physical therapy or exercise programs also helped. Does it work for everyone? So far CMO has been able to help everyone who has not suffered from dijestive problems or liver function impairment, which usually results from disease, alcohol or steroid Is age a factor? Not really. All ages respond well. Although arthritis becomes far more common with advancing age, even young children are sometimes afflicted." ; RESOURCES Services CMO Distribution Centers's entire staff is at your disposal. There are also ic grtists, copy writers, market analysts and attorneys who are completely familiar with this project ba cre, are available on a free-lance basis. BacktoTop Personnel There are dozens of doctors available to help promote CMO. There is a multitude of 07/24/98 17:59:29 VOLUME 129 Complaint Exhibits CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. 1347 Complaint Exhibits farketing & Sales http://home.earthlink neu~cmocure/cmo/em00006. html communication is established between all medical professionals and distributors. This allows for up to the minute information sharing. This will facilitate the expansion of the market for CMO to uses other than for arthritis.
Back to Top Last Update: 09/21/97 Copyright ©1997 by CMO Distribution Centers of America Inc. - ALL RIGHTS RESERVED of 8 07/24/98 17:59:29 VOLUME 129 Complaint Exhibits CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. 1349 Complaint Exhibits ounterfeit & Inferior Warming help://home.carthlink.ne~cmocure/emo/cm00007.htm! of4 and chondroitin sulfate is that you have to continually take it for the rest of your life to maintain any kind of relief and you have to accompany it with the 9 point program and stringent diet outlined in Dr. Theodosakis' book. It is a similar protocol to pain killers, anti-inflammatory drugs and steroids. While you take them your arthritis will not bother you as much, but once you stop you're soon back to square one again. Even the Arthritis Foundation cannot recommend glucosamine and chondroitin sulfate as a treatment for osteoarthritis or any other form of arthritis. Unique CMO is in a totally different category than the 9 point program, glucosamine sulfate, chondroitin sulfate, cartilage and natural unflavored gelatin. We have always acknowledged the potential benefits of these substances and mention them in our suggested use pamphlets under Nutrients . CMO is in a totally different category than cetylmyristoleate. CMO is: * Naturally derived from beef * Legally sold directly to the public * Backed by clinical study * Supported by ongoing research * Developed for oral administration * Highly effective * Beneficial to all types of arthritis except gouty arthritis * Manufactured by a reliable and reputable company * Protected by trademark registration As you can see, we have a unique product and we have moved swiftly to protect it's reputation from counterfeiters and imitators. We have been working on securing the status of CMO in the market place through a consumer awareness campaign.
MEMORANDUM - CMOTM, CM Pure, CM Plus, Cetylmyristoleate, et al. The marketplace seems to be sprouting new CMO counterfeit impersonators every day. Consumers, , distributors, nutritionists, scientists, physicians, and other health care professionals are confused and dizzy from the spin put on these phony products. We hope to clarify and differentiate between as many of these various fraudulent impostors as best we can. However, we may not be able to keep up with all the new ones as fast as they appear. Still, you should be able to apply many of the points here to other lucts as well. First and foremost, let me emphasize that we are the one and only producer of |OTM. It is strictly our own proprietary product. There is no other. And it is the only naturally derived product of its kind on the market. As such it contains many beneficial closely related trace substances which aid in its effectiveness -- just as the bioflavanoids accompanying vitamin C aid in its fectiveness.
HERE ARE SOME FACTS FOR YOU TO DIGEST:
1. CMOTM is the only naturally derived immunomodulator marketed in the world. There is no other. 2. CMO is the one and only effective orally administered immunomodulator marketed in the world. 3. CMO is the only product of its kind derived from cows. (MOOOve over, impostors.) 4. The biochemical name for CMO is cerasomal-cis-9-cetylmyristoleate. It is not cetylmyristoleate. It is an analog of cetylmyristoleate produced by a complex proprietary process. 5. CMOTM is our proprietary trademarked designation for cerasomal-cis-9-cetylmyristoleate. We are the only manufacturer of CMO. There is no other. Products called CMO by other manufacturers are counterfeits that have virtually no effect on the arthritic process. 6. Cetylmyristoleate is not CMO. Cetylmyristoleate is an injectable. In his own journal article, the discoverer of cetylmyristoleate himself states that it works best when it is injected at or near the site of the arthritic inflammation. It has a very low bioavailability level in oral administration. 7. Myristoleic acid is absolutely essential to make cetylmyristoleate. Myristic acid cannot be used to synthesize cetylmyristoleate or any of its analogs. Any that claim to are phonies. 07/24/98 17:59:57 VOLUME 129 Complaint Exhibits CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. 1351 Complaint Exhibits ounterfeit & Inferior Warning http://home.earthlink.net~cmocure/emo/cm00007 html Last Update: 09/21/97 Copyright ©1997 by CMO Distribution Centers of America Inc. - ALL RIGHTS RESERVED of4 07/24/98 17:59:57 VOLUME 129 Complaint Exhibits CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. 1353 Complaint Exhibits tp//home.earthlink.n...mocure/cmo/emo000" hin http://home.earthlink.net/-cmocure/cmo/em00009 htm! of2 Contact Us To learn more about us or CM(Q, you can call or email us with your questions All of our information services are free of charge. Web sites: Consumer Information (hitp://home.earthlink,net/~cmocure/emocure) Toll Free: (800) 909-CURE (800) 909-2873 Phone: (941) 954- 2100 AOL email: [email protected] (“CMO Center” from within AOL) Internet email: [email protected] Postal: CMO Distribution Centers of America 5726 Cortez Road West # 202 Bradenton, FL Name: CO City/State/Country: [ ~— ~~, ] Ball Address: | [| 7 Guest Book Comments:
“Add Me to the Guest Book ~ | (Start “over | ue —— Order Form To: Gi 5 | Address: oe __ ] Home Phone: [ J 07/24/98 18:01:14 VOLUME 129 Complaint Exhibits CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. 1355 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 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 Federal Trade Commission Act; 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 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 Act, and that a 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:
VOLUME 129 Decision and Order 1. Respondent CMO Distribution Centers of America, Inc., is a Michigan and Florida corporation with its principal office or place of business at 6479 Parkland Drive, Sarasota, FL 34243. 2. Respondent Kalon Samulonis is the President of the corporate respondent. Individually or in concert with others, he formulates, directs, or controls the policies, acts, or practices of the corporation. His principal office or place of business is the same as that of the corporate respondent.
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. "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. 2. "CMO@ shall mean any product or substance that contains or purports to contain cetylmyristoleate (also known as cetyl myristoleate) or ACMO,@ any analogue of cetylmyristoleate, or any formulation of cetyl alcohol and myristoleic acid, including but not limited to CMOJ.
3. Unless otherwise specified, "respondents" shall mean CMO Distribution Centers of America, Inc. (ACDC@), its successors and assigns; Kalon Samulonis, individually and as an officer of the CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. 1357 Decision and Order corporation; and each of their agents, representatives and employees.
4. "Clearly and prominently" 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 and online services), the disclosure shall be presented simultaneously in both the audio and video portions of the advertisement. Provided, however, that in any advertisement presented solely through video 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 video disclosure shall be of a size and shade, and shall appear on the screen for a duration, sufficient for an ordinary consumer to read and comprehend it. In addition to the foregoing, in interactive media the disclosure shall also be unavoidable and shall be presented prior to the consumer incurring any financial obligation.
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. C. On a product label, 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. VOLUME 129 Decision and Order The disclosure shall be in understandable language and syntax. Nothing contrary to, inconsistent with, or in mitigation of the disclosure shall be used in any advertisement or on any label. 5. APurchaser@ shall mean any transferee of any product covered by this order who purchased such product from respondents or any of respondents= distributors for personal use or for the use of a member of the purchaser=s family.
6. ACommerce@ shall mean as defined in Section 4 of the Federal Trade Commission Act, 15 U.S.C. ' 44.
I.
IT IS ORDERED that respondents, directly or through any partnership, 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 CMO or any substantially similar product, in or affecting commerce, shall not represent, in any manner, expressly or by implication, that such product: A. Is effective in the mitigation, treatment, prevention and cure of arthritis;
B. Provides significant relief from symptoms of arthritis, including pain, swelling, impaired mobility, or deformity; C. Is as effective as, or superior to, prescription medications for the treatment of arthritis or the relief of arthritis symptoms;
D. Is effective in the treatment of multiple sclerosis, leukemia, lupus, emphysema, cancer, benign prostate hyperplasia, silicone breast disease, asthma, fibromyalgia, or scleroderma; or E. Is safe or has no harmful side effects; CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. 1359 Decision and Order unless, at the time the representation 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 partnership, 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 CMO products or any other food, dietary supplement or drug, as Afood@ and Adrug@ are defined in Section 15 of the Federal Trade Commission Act, or program, in or affecting commerce, shall not make any representation, in any manner, expressly or by implication, about the performance, safety, efficacy or health benefits of any such product or program, unless, at the time the representation 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 partnership, 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 CMO products or any other food, dietary supplement or drug, as Afood@ and Adrug@ are defined in Section 15 of the Federal Trade Commission Act, or program, in or affecting commerce, shall not use the name Acmocure,@ use the word Acure@ in an address or telephone number, or use any other name, address, or telephone number that represents expressly or by implication, that the VOLUME 129 Decision and Order product will cure any disease or health-related condition, unless, at the time the representation is made, respondents possess and rely upon competent and reliable scientific evidence that substantiates the representation.
IV.
IT IS FURTHER ORDERED that respondents, directly or through any partnership, corporation, subsidiary, division, or other device, including franchisees, licensees, or distributors, in connection with the advertising, promotion, offering for sale, sale, or distribution of any product or program in or affecting commerce, shall not misrepresent, in any manner, expressly or by implication, that such product or program is endorsed or approved by any governmental, professional, or private organization or association, or complies with or meets standards or guidelines for such products or programs established by any such organization or association.
V.
IT IS FURTHER ORDERED that respondents, directly or through any partnership, corporation, subsidiary, division, or other device, including franchisees, licensees, or distributors, in connection with the advertising, promotion, offering for sale, sale, or distribution of any product or program 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, directly or through any partnership, 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 product or program in or affecting commerce, shall not represent, in any CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. 1361 Decision and Order manner, expressly or by implication, that the experience represented by any user testimonial or endorsement of the product or program represents the typical or ordinary experience of members of the public who use the product or program, unless: A. At the time it is made, respondents possess and rely upon competent and reliable scientific evidence that substantiates the representation; or B. Respondents disclose, clearly and prominently, and in close proximity to the endorsement or testimonial, either: 1. What the generally expected results would be for users of the product or program; or 2. The limited applicability of the endorser's experience to what consumers may generally expect to achieve, that is, that consumers should not expect to experience similar results.
For purposes of this Part, "endorsement" shall mean as defined in 16 C.F.R. ' 255.0(b).
VII.
Nothing in this order shall prohibit respondents from making any representation for any product that is specifically permitted in the labeling for such product by regulations promulgated by the Food and Drug Administration pursuant to the Nutrition Labeling and Education Act of 1990.
VOLUME 129 Decision and Order VIII.
Nothing in this order shall prohibit respondents from making any representation for any drug that is permitted in the 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.
IX.
IT IS FURTHER ORDERED that:
A. Respondents shall not disseminate to any distributor any material containing any representations prohibited by this order.
B. Respondents shall not, directly or indirectly, authorize any distributor to make any representations prohibited by this order.
C. Within thirty (30) days after service of this order, respondents shall send by first class mail, with postage prepaid, two exact copies of the notice attached hereto as Attachment A to each distributor with whom respondents have done business between January 1, 1996, and the date of service of this order, to the extent that such distributor is known to respondents through a diligent search of their records, including but not limited to computer files, sales records, and inventory lists. The mailing shall not include any other documents. For purposes of this mailing, respondents shall treat as a distributor any person: 1. Who purchased a CMO product from respondents for resale;
CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. 1363 Decision and Order 2. Who purchased a CMO product from respondents at a discounted or wholesale price unavailable to the general public at the time of the purchase; or 3. Who purchased more than twelve (12) bottles or packages of CMO products from respondents within any twelve (12) month period.
Respondents shall require each distributor with whom they did business between January 1, 1996, and the date of service of this order, to execute and return a copy of Attachment A as a condition of remaining or once again becoming a distributor of CDC.
D. For a period of three (3) years following service of this order, respondents shall provide two exact copies of the notice attached hereto as Attachment B to each new distributor with whom respondents do business after the service of this order. Such notice shall be sent with the first shipment of respondents= products or programs. Respondents shall require each new distributor to execute and return a copy of the letter as a condition of being a distributor of CDC.
E. Respondents shall require distributors to submit to respondents all advertising and promotional materials and claims for any products or programs covered by this order for review prior to their dissemination and publication. Respondents shall not authorize distributors to disseminate these materials and claims unless they are in compliance with this order.
Respondents may also comply with the obligations set forth above in this Subpart by:
VOLUME 129 Decision and Order 1. disseminating to distributors marketing materials that comply with this order; and 2. requiring those distributors to submit for review all advertising and promotional materials for a particular product or program covered by this order that contain representations that are not substantially similar to the representations for the same product or program contained in the advertising and promotional materials most recently forwarded to the distributors by respondents.
F. Respondents shall use reasonable efforts to monitor distributors= advertising and promotional activities. In the event that respondents receive any information that, subsequent to receipt of Attachment A or Attachment B pursuant to Subparts C and D of this Part, any distributor is using or disseminating any advertisement or promotional material or making any oral statement that contains any representation prohibited by this order, respondents shall immediately terminate said distributor=s right to market respondents= products or programs, and immediately provide, by certified mail, all relevant information, including name, address, and telephone number of the company at issue, the nature of the violation, and any relevant materials used or disseminated, to the Associate Director, Division of Enforcement, Federal Trade Commission, Washington, D.C. 20580. X.
IT IS FURTHER ORDERED that respondents shall refund the full purchase price of their CMO products, including shipping and handling and applicable taxes, to each eligible purchaser who requests a refund, under the following terms and conditions: CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. 1365 Decision and Order A. Within thirty (30) days after service of this order, respondents shall send by first class mail, with postage prepaid, an exact copy of the notice attached hereto as Attachment C, showing the date of mailing to each purchaser other than a distributor as defined in Part IX, who purchased respondents= CMO products between January 1, 1996, and the date respondents executed this order, to the extent that such purchaser is known to respondents through a diligent search of their records, including but not limited to computer files, sales records, and inventory lists. The mailing shall not include any other documents.
B. If any purchaser other than a distributor as defined in Part IX, within one hundred and twenty (120) days of the service of this order, makes a request for a refund substantially in the form of the request contained in Attachment C, and respondents= diligent inquiry and examination of the corporate respondent=s books and records reasonably substantiates the purchaser=s claim of purchase or the purchaser provides proof of purchase, including but not limited to any of the following: return of goods or packaging, canceled check(s), credit card invoice(s) or receipt(s), the refund shall be paid within fifteen (15) business days of respondents= receipt of the refund request.
XI.
IT IS FURTHER ORDERED that respondent CDC and its successors and assigns, and respondent Kalon Samulonis shall, no later than one hundred eighty (180) days after the date of service of this order, send by certified mail a monitoring report, in the form of a sworn affidavit executed on behalf of respondents, to the Associate Director, Division of Enforcement, Bureau of VOLUME 129 Decision and Order Consumer Protection, Federal Trade Commission, Washington, D.C. 20580. This report shall specify the steps respondents have taken to comply with the terms of Part X of this order and shall state, without limitation:
A. The name and address of each purchaser from whom respondents received a refund request;
B. The date on which each request was received, the amount of the refund request, and the amount of the refund provided by respondents to each such purchaser; C. The status of any disputed refund request and the identification of each purchaser whose refund request is disputed, by name, address, and amount of the claim; and D. The total amount of refunds paid by respondents. XII.
IT IS FURTHER ORDERED that respondent CDC and its successors and assigns, and respondent Kalon Samulonis 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: Copies of all notification letters sent to distributors, communications between respondents and distributors referring or relating to the requirements of Part IX, and any other materials created pursuant to Parts IX or X of this order.
XIII.
IT IS FURTHER ORDERED that respondent CDC and its successors and assigns, and respondent Kalon Samulonis 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:
CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. 1367 Decision and Order 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 contradicts, qualifies, or calls 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.
XIV.
IT IS FURTHER ORDERED that respondent CDC and its successors and assigns, and respondent Kalon Samulonis 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.
XV.
IT IS FURTHER ORDERED that respondent CDC and its successors and assigns, and respondent Kalon Samulonis shall notify the Commission at least thirty (30) days prior to any change VOLUME 129 Decision and Order in the corporation(s) 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 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 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, Washington, D.C. 20580.
XVI.
IT IS FURTHER ORDERED that respondent CDC and its successors and assigns, and respondent Kalon Samulonis shall, within sixty (60) days after 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.
XVII.
This order will terminate on May 16, 2020, 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;
CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. 1369 Decision and Order 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. By the Commission.
VOLUME 129 Decision and Order ATTACHMENT A LETTER TO DISTRIBUTORS WITH WHOM RESPONDENTS HAVE DONE BUSINESS PRIOR TO SERVICE OF THIS ORDER [To be printed on letterhead of CMO Distribution Centers of America, Inc.] [Name and address of recipient] [Date] Dear [recipient=s name] It is against the law to make false claims about any product or to make any health-related claims about any product of CMO Distribution Centers of America, Inc., which are not substantiated by competent and reliable scientific evidence. Competent and reliable scientific evidence is defined as tests, 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. The Federal Trade Commission has determined that it has reason to believe that claims that CMO Distribution Centers of America, Inc.=s cetyl myristoleate (ACMO@) products are effective in the treatment, relief, mitigation, prevention, or cure of arthritis and other health conditions are not substantiated by competent and reliable scientific evidence. As a result of this determination, CMO Distribution Centers of America, Inc., has agreed to send this letter to its current and former distributors and institute certain procedures, described below.
CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. 1371 Decision and Order CMO Distribution Centers of America, Inc., intends to abide by the law and demands that its distributors do the same. Therefore, as a condition of your future purchase of CMO Distribution Centers of America, Inc.=s products intended for distribution, or resale, or recommendation to others in the context of a professional or commercial relationship, you must agree not to use, rely on, or distribute any advertising or promotional materials containing false or unsubstantiated claims. You must further agree not to make false or unsubstantiated oral representations with regard to any product or program of CMO Distribution Centers of America, Inc. You must also notify your customers who purchase the products for redistribution to do the same. If you or those customers use such materials or make such representations we will stop doing business with you. In order that CMO Distribution Centers of America, Inc., may assure itself that you are in compliance with the aforesaid requirements, you must, as a condition of distributing the Company=s products, agree to submit to CMO Distribution Centers of America, Inc., in advance and prior to use, dissemination, or publication, all advertisements or promotional materials that you intend to use, publish, or disseminate with regard to any CMO Distribution Centers of America, Inc., product or program. In addition, you must furnish us with the URL (Internet address) of any web site you intend to use in connection with the marketing or promotion of our products. You must further agree not to use, disseminate, or publish any such advertisement or promotional materials without our prior approval. We may, in our discretion, send you materials you are authorized to use in your advertising.
Should you fail or refuse to comply with the terms of this letter, we will not do business with you. Furthermore, if CMO Distribution Centers of America, Inc., has reason to believe that you have misrepresented or made claims with respect to any of VOLUME 129 Decision and Order our products that are false or not substantiated by competent and reliable scientific evidence, CMO Distribution Centers of America, Inc., will report your violation to the Federal Trade Commission. Please sign, date, and return the enclosed copy of this letter to CMO Distribution Centers of America, Inc., 6479 Parkland Drive, Sarasota, FL 34243, acknowledging your receipt of this letter and your agreement to the terms set forth herein. Thank you very much for your cooperation. Sincerely, Kalon Samulonis President ACKNOWLEDGMENT AND AGREEMENT The undersigned acknowledges receipt of this letter and hereby agrees to its terms and conditions.
Date Signature Title CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. 1373 Decision and Order ATTACHMENT B LETTER TO DISTRIBUTORS WITH WHOM RESPONDENTS HAVE DONE BUSINESS SINCE RESPONDENTS EXECUTED THIS ORDER [To be printed on letterhead of CMO Distribution Centers of America, Inc.] [Name and address of recipient] [Date] Dear [recipient=s name] It is against the law to make false claims about any product or to make any health-related claims about any product of CMO Distribution Centers of America, Inc., which are not substantiated by competent and reliable scientific evidence. Competent and reliable scientific evidence is defined as tests, 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. The Federal Trade Commission has determined that it has reason to believe that claims made in the past that CMO Distribution Centers of America, Inc.=s CMO products are effective in the treatment, relief, mitigation, prevention, or cure of arthritis and other health conditions are not substantiated by competent and reliable scientific evidence. As a result of this determination, CMO Distribution Centers of America, Inc., has agreed to send this letter to its customers who purchase the Company=s product for distribution or resale.
VOLUME 129 Decision and Order CMO Distribution Centers of America, Inc., intends to abide by the law and demands that its distributors do the same. Therefore, as a condition of your purchase of CMO Distribution Centers of America, Inc.=s products intended for distribution, or resale, or recommendation to others in the context of a professional or commercial relationship, you must agree not to use, rely on, or distribute any advertising or promotional materials containing false or unsubstantiated claims. You must further agree not to make false or unsubstantiated oral representations with regard to any product or program of CMO Distribution Centers of America, Inc. You must also notify your customers who purchase the products for redistribution to do the same. If you or those customers use such materials or make such representations, we will stop doing business with you.
In order that CMO Distribution Centers of America, Inc., may assure itself that you are in compliance with the aforesaid requirements, you must, as a condition of distributing the Company=s products, agree to submit to CMO Distribution Centers of America, Inc., in advance and prior to use, dissemination, or publication, all advertisements or promotional materials that you intend to use, publish, or disseminate with regard to any product of CMO Distribution Centers of America, Inc. In addition, you must furnish us with the URL (Internet address) of any web site you intend to use in connection with the marketing or promotion of our products. You must further agree not to use, disseminate, or publish any such advertisement or promotional materials without our prior approval. We may, in our discretion, send you materials you are authorized to use in your advertising.
Should you fail or refuse to comply with the terms of this letter, we will not do business with you. Furthermore, if CMO Distribution Centers of America, Inc., has reason to believe that you have misrepresented or made claims with respect to any of our products that are false or not substantiated by competent and reliable scientific evidence, CMO Distribution Centers of CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. 1375 Decision and Order America, Inc., will report your violation to the Federal Trade Commission.
Please sign, date, and return the enclosed copy of this letter to CMO Distribution Centers of America, Inc., 6479 Parkland Drive, Sarasota, FL 34243, acknowledging your receipt of this letter and your agreement to the terms set forth herein. Thank you very much for your cooperation. Kalon Samulonis President ACKNOWLEDGMENT AND AGREEMENT The undersigned acknowledges receipt of this letter and hereby agrees to its terms and conditions.
Date Signature Title VOLUME 129 Decision and Order ATTACHMENT C LETTER TO CUSTOMERS (OTHER THAN DISTRIBUTORS) WITH WHOM RESPONDENTS HAVE DONE BUSINESS PRIOR TO EXECUTING THIS ORDER [To be printed on letterhead of CMO Distribution Centers of America, Inc.] [Name and address of recipient] [Date] Dear [recipient=s name] The Federal Trade Commission has determined that it has reason to believe that claims made in the past that CMO Distribution Centers of America, Inc.=s cetyl myristoleate (ACMO@) products are effective in the treatment, relief, mitigation, prevention, or cure of arthritis and other health conditions are not substantiated by competent and reliable scientific evidence. As a result of this determination, CMO Distribution Centers of America, Inc., has agreed to send this letter to its retail customers and former customers and institute the refund program described below. If your purchase of CMO Distribution Centers of America, Inc., CMO products was intended for the personal use of you or your family and not for distribution, or resale, or for recommendation to others in the context of a professional or commercial relationship, you may be entitled to a refund of the purchase price, together with any shipping and handling charges and applicable sales taxes. As part of its agreement with the Federal Trade Commission, CMO Distribution Centers of America, Inc., has agreed to offer refunds to certain customers who verify that they purchased CMO Distribution Centers of America, Inc.=s CMO products for their own use or the use of their families and did not offer the products for resale, and that they are not satisfied with the purchase.
CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. 1377 Decision and Order To claim a refund, please complete the attached form, or a copy of it, and return it to the indicated address within ninety (90) days of the date of this letter. If possible, please indicate on the form the price you paid for the products you purchased, including any shipping or handling charges or sales taxes; and you may submit copies of any documentation substantiating the expense. If you do not supply this information, we will calculate your refund from our records.
We will honor all eligible, undisputed claims within fifteen (15) business days after receiving them.
Sincerely, Kalon Samulonis President VOLUME 129 Decision and Order To apply for a refund:
Complete the form below, or make a copy of it. Please print legibly.
Return the form to CMO Distribution Centers of America, Inc., 6479 Parkland Drive, Sarasota, FL 34243, no later than ninety (90) days after the date of this letter. To: CMO Distribution Centers of America, Inc., 6479 Parkland Drive, Sarasota, FL 34243 From: (Name) (Mailing Address) (City, State, and Zip Code) (Telephone Number) I purchased one or more cetyl myristoleate (CMO) products made or distributed by your company, for my personal use or the use of persons in my family. I am not satisfied with the purchase. Please refund my purchase price of $ (amount, if known), together with the amounts I was charged for shipping and handling $ (amount, if known) and sales tax $ (amount, if known).
Date Signature CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. 1379 Analysis to Aid Public Comment Analysis of Proposed Consent Order to Aid Public Comment The Federal Trade Commission has accepted, subject to final approval, an agreement to a proposed Consent Order (Aproposed order@) from CMO Distribution Centers of America, Inc., and Kalon Samulonis, individually and as an officer of CMO Distribution Centers of America, Inc.
The proposed consent order has been placed on the public record for thirty (30) days for the 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 will decide whether it should withdraw from the agreement or make final the agreement=s proposed order.
This matter concerns advertisements on the Internet for a product called ACMO,@ described as a form of cetylmyristoleate, said to be derived from beef. CMO is purportedly useful in the treatment or cure of arthritis and other diseases. According to the proposed respondents= advertising, CMO affects the human immune system in one or two courses of treatment, each lasting less than three weeks. The proposed respondents claimed their product permanently relieves the symptoms of osteoarthritis and rheumatoid arthritis and reverses the effects of the disease. CMO was also claimed to be useful for the treatment, mitigation, prevention, and cure of most forms of arthritis and a number of other diseases.
The Commission=s complaint charges that the proposed respondents engaged in deceptive advertising in violation of Sections 5 and 12 of the FTC Act by making unsubstantiated claims that their CMO products: (1) are effective in the mitigation, treatment, prevention, and cure of all forms of arthritis, except gouty arthritis; (2) relieve all symptoms of VOLUME 129 Analysis to Aid Public Comment arthritis, including pain, impaired mobility, swelling, and deformity; (3) are as effective as, or superior to, prescription medications for the treatment of arthritis and the relief of arthritis symptoms; (4) are effective in the treatment of multiple sclerosis, leukemia, lupus, emphysema, cancer, benign prostate hyperplasia, silicone breast disease, asthma, fibromyalgia, and scleroderma; and (5) are completely safe and without harmful side effects, even at extremely high doses.
The complaint further alleges that the proposed respondents made false claims that: (1) clinical studies prove that CMO is a safe and effective treatment for virtually all forms of arthritis except gouty arthritis; (2) CMO is accepted by the medical community; (3) Time magazine reported in its October 28, 1996 issue that CMOJ is one of the most promising developments in arthritis research; and (4) the Arthritis Foundation has not commented on CMO, except to suggest that when taking CMO, patients should consult their physicians before reducing steroids or other medications.
The proposed order contains provisions designed to remedy the violations charged and to prevent proposed respondents from engaging in similar acts in the future.
Paragraph I of the proposed order prohibits proposed respondents from making any representation that CMO or any similar product: (1) is effective in the mitigation, treatment, prevention, or cure of arthritis; (2) provides significant relief from symptoms of arthritis, including pain, swelling, impaired mobility, or deformity; (3) is as effective as, or superior to, prescription medications for the treatment of arthritis or the relief of arthritis symptoms; (4) is effective in the treatment of multiple sclerosis, leukemia, lupus, emphysema, cancer, benign prostate hyperplasia, silicone breast disease, asthma, fibromyalgia, or scleroderma; or (5) is safe or has no adverse side effects, unless, at the time the representation is made, respondents possess and rely upon competent and reliable scientific evidence that substantiates the representation.
CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. 1381 Analysis to Aid Public Comment Paragraph II of the proposed order prohibits proposed respondents from making any representations about the performance, safety, efficacy, or health benefits of CMO or any other food, dietary supplement, or drug, unless the claims are substantiated by competent and reliable scientific evidence. Paragraph III of the proposed order prohibits proposed respondents from using the name Acmocure,@ using the word Acure@ in an address or telephone number, or using any other name, address, or telephone number in marketing a food, dietary supplement, drug, or program, to represent a cure for any disease or health-related condition, unless the respondents possess and rely upon competent, reliable scientific evidence substantiating the representation.
Paragraph IV of the proposed order prohibits the proposed respondents from misrepresenting that a product or program is endorsed or approved by any governmental, professional, or private organization or association, or complies with standards or guidelines established by such organization or association. Paragraph V of the proposed order prohibits proposed respondents from misrepresenting the existence, contents, validity, results, conclusions, or interpretations of any test, study, or research.
Paragraph VI of the proposed order prohibits proposed respondents from representing that the experience represented by any user testimonial or endorsement of any product or program represents the typical or ordinary experience of members of the public who use the product or program, unless the representation is true, and competent and reliable scientific evidence substantiates that claim, or respondents clearly and prominently disclose either: (1) what the generally expected results would be VOLUME 129 Analysis to Aid Public Comment for users or the product or program; or (2) the limited applicability of the endorser=s experience to what consumers may generally expect to achieve, that is, that consumers should not expect to experience similar results.
Paragraph VII of the proposed order provides that proposed respondents are not prohibited from making representations which are specifically permitted by regulations of the Food and Drug Administration pursuant to the Nutrition Labeling and Education Act of 1990. Paragraph VIII of the proposed order provides that proposed respondents are not prohibited from making representations for a drug that are permitted under tentative final or final standards issued by the Food and Drug Administration or under any new drug application approved by that agency. Paragraph IX of the proposed order requires that proposed respondents: (1) not disseminate to any distributor any material containing any representations prohibited by the order; (2) not authorize any distributor to make any representations prohibited by the order; (3) send a required notice to each distributor with whom proposed respondents have done business since January 1, 1996, requesting that the distributor cease using any advertising or promotional materials containing unsubstantiated claims for CMO, requesting distributors not to make unsubstantiated oral representations, informing the distributor of this settlement, and not including any other documents in the mailing; (4) for a period of three (3) years following service of the order, send the required notice to each distributor who has not previously received the notice; the notices shall be sent with the first shipment of respondents= products to the distributor; (5) require distributors to submit to proposed respondents all advertising and promotional materials and claims for any products or programs covered by the order for review prior to their dissemination and publication, and not authorize distributors to disseminate materials and claims unless they comply with the order; alternatively, proposed respondents must furnish to distributors marketing materials that comply with the order and require the distributors to submit for review all advertising and promotional materials for a particular CMO DISTRIBUTION CENTERS OF AMERICA, INC., ET AL. 1383 Analysis to Aid Public Comment product covered by the order that contain representations that are not substantially similar to the representations for the same product or program contained in the marketing materials most recently provided to the distributors by proposed respondents; and (6) use reasonable efforts to monitor distributors= advertising and promotional activities, immediately terminate the right of any distributor who disseminates advertisements or marketing material or makes oral representations prohibited by the order, and immediately provide information to the Federal Trade Commission about any such distributor and the materials used. ADistributor@ is defined in the proposed order to mean any person who purchased a product covered by the order from the respondents for resale or at a discounted or wholesale price unavailable to the general public at the time of the purchase, or who has purchased more than twelve bottles or packages of a covered product from respondents within a twelve-month period. Paragraph X of the proposed order requires the proposed respondents to send a prescribed notice to each person, other than a distributor, who purchased respondents= CMO products and can be identified through a diligent search of respondents= records. The notice offers a refund of the purchase price and any shipping or handling charges to customers who purchased respondents= CMO product for personal use or the use of a family member and who make a request for a refund within ninety days of the date of the notice. Paragraph XI of the proposed order requires the proposed respondents to submit a report to the Federal Trade Commission specifying the actions they have taken to comply with the provisions of Paragraph X. Paragraph XII of the proposed order requires proposed respondents to retain for five years after the last correspondence to which they pertain and to make available to the Federal Trade Commission on request, copies of notification letters, communications with distributors, and other materials relating to the requirements of Paragraph IX and Paragraph X.
VOLUME 129 Analysis to Aid Public Comment Paragraph XIII of the proposed order contains record keeping requirements for materials that substantiate, qualify, or contradict covered claims and requires proposed respondents to keep and maintain all advertisements and promotional materials containing any representation covered by the proposed order. In addition, Paragraph XIV requires distribution of a copy of the consent decree to current and future officers and agents. Further, Paragraph XV requires the filing of a compliance report. Paragraph XVI of the proposed order requires the respondents to notify the Federal Trade Commission in advance of any change in the corporation that may affect compliance obligations arising under the order.
Finally, Paragraph XVII of the proposed order provides for the termination of the order after twenty 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.
EHP PRODUCTS, INC., ET AL. 1385 Complaint