James, Max F
Volume 127 · 127 F.T.C. 324
deceptive advertisinghealth claimsendorsements
Cite this decision
James, Max F, 127 F.T.C. 324 (1999). Consumer Law Library, https://consumerlawlibrary.org/decisions/v127-0018
Report an error in this record (decision id v127-0018)
Cited by 0 later FTC decisions
Cites
- 127 F.T.C. 4 — BOZELL WORLDWIDE, lNC cited_neutral
Text (OCR of the scan at left; may contain errors)
IN THE MA ITER OF MAXF.JAMES CONSENT ORDER, ETC., IN REGARD TO ALLEGED VIOLATION OF SECS. 5 AND 12 OF THE FEDERAL TRADE COMMISSION ACT Docket C-3857. Complaint, March 3, 1999--Decision, March 3, 1999 This consent order, among other things, prohibits Max F. James, a distributor for New Vision International, Inc., (a multi-level marketing company that advertises and sells a combination of supplements called "God's Recipe") from making unsubstantiated advertising claims that the supplements can prevent, treat, cure or mitigate Attention Deficit Disorder and Attention Deficit Hyperactivity Disorder or their symptoms. Also, the consent order prohibits the misrepresentation of . testimonials or endorsements for the product.
Participants For the Commission: Matthew Gold, Sylvia Kundig, and Jeffrey Klurfeld.
For the respondent: Claude Wild, III and James Prochnow, Patton Boggs, Denver, CO.
COMPLAINT The Federal Trade Commission, having reason to believe that Max F. James ("respondent'') has violated the provisions of the Federal Trade Commission Act, and it appearing to the Commission that a proceeding by it in respect thereof would be in the public interest, alleges:
1. Max F. James resides at 1857 Ridgeview Drive, Roseville, CA. 2. Respondent is an "Executive Diamond Team Leader" distributor for New Vision International, Inc. ("New Vision"). Respondent has advertised, labeled, offered for sale, sold, and distributed nutritional supplement products, and audiotapes and other promotional materials for these products, and has engaged in the recruitment of distributors for the products. The respondent has furnished the means, instrumentalities, services and facilities for and/or condoned or approved the acts and practices referred to below.
3. Respondent has been a distributor in a multilevel marketing plan to sell New Vision products to consumers. The marketing plan allows distributors to earn money by selling the products at a suggested mark-up to consumers. Respondent has also recruited and MAX F. JAMES 325 . 324 Complaint : trained other individuals to be distributors in the multilevel marketing plan. Respondent earned additional money based on purchases from. New Vision made by these recruits and others who they, in tum, recruit to be distributors.
4. Respondent has advertised, promoted, offered for sale, sold, and distributed various nutritional supplements, including: (a) "PC Grape Seed Extract with an Herbal Blend;" (b) "Essential Minerals;" and (c) "Multi-Enzymes with Alfalfa/Barley Sprouts." In some ofhis promotional materials, respondent collectively referred to these products as "God's Recipe," and touted them as a natural alternative to the prescription drug Ritalin for children suffering from Attention Deficit Disorder or Attention Deficit/Hyperactivity Disorder . ("ADD/ADHD"). These products are '"foods' and/or 'drugs'," within the meaning of Sections 12 and 15 of the Federal Trade Commission Act. 5. The acts and practices of respondent alleged in this complaint have been in or affecting commerce, as "commerce" is defined in 'Section 4 of the Federal Trade Commission Act.
6. Respondent has disseminated or has caused to be disseminated advertisements for God's Recipe, including but not necessarily limited to the attached Exhibits A through D. These advertisements contain the following statements:
I A. "The problem: Johnny isn't staying up with the rest of the children, he's I I getting into fights at recess and he's just not listening. The teacher has seen it hundreds oftimes: ADD (Attention Deficit Disorder)- the most common form of I treatment: Ritalin. Parents trusting the advice of well-meaning professionals are unknowingly starting their children on a cycle of chemical dependency. Is there an alternative? The good news is yes, and this tape will outline what has become known as 'Gog's recipe' as well as letting you hear from some doctors on this very subject. God's recipe is made up of three very exciting, natural health products. The three products you'll hear about on this tape are colloidal minerals, OPC grape seed extract containing ginkgo biloba, and a multi-enzyme product. This combination is making a huge difference in the lives of thousands of children and is a natural approach that works ....
One out of every three is going to drop out of school and if they carry this into adulthood, the nationaTstatistics are that one out of every ten will attempt suicide, so my recommendation is a couple of ounces of colloidal minerals each day for these children. We believe that the anti-oxidant is very important to help clean up the free radical damage that is going on inside their little brains and we combine that with ginkgo biloba and then we think that the multi-enzymes to help them metabolize that sugar that they're going to get -- we just can't seem to eliminate enough of it -- is very important.. ..
Complaint 127 F.T.C.
I've learned a lot tonight and I very much appreciate your being willing to share all of this. I think one of the things that I'd like to kind of end with here is as Zoanne said, "Thank God." And it seems to me that we have properly titled what we're doing and the success of this fotmulation, this combination of natural nutritional supplements with eight, 10, 15 calls I get a day and the hundreds and hundreds of parents and children now that are benefitting from this, we really can, I think, in good consciousness call it God's recipe. And what most of us are. doing is two ounces of these colloidal minerals spread during the day, maybe first thing in the morning and then sometime mid to late afternoon, 40 milligrams of this Proanthocyanidin, preferably one that comes from grape seed extract in combination with Ginkgo Biloba and we think that you should take those toughly at the same time that you take the mineral supplementation and then lastly, because there is no question that sugar is a major culprit in ADHD and ADD, we need to eliminate sugar as much as possible from all of our diets, but particularly from the diets ofthose that are very sensitive and impacted negatively by sugar and in order to help ease the problem of the sugar that we are unable to eliminate, these multienzyme capsules are phenomenal because as Dr. Chris has told us tonight, they assist mightily in metabolizing the sugar and getting that whole digestive process and the reaction of digesting sugar under control so that we don't get the mood swings and the metabolic swings. So we call that God's recipe. Hopefully, with the information that you have been kind enough to share with us tonight, the recipe will spread and the resultant blessing will occur to as many people as possible. So, I would just say, again, thank you."
(Exhibit A, Transcript of tape entitled "God's Recipe - The Natural Alternative to Ritalin.") B. "[Maxi. James] Former Executive VP with Days Inn of America wants to rid the world of Ritalin, substitute good nutrition and dietary supplements in its place ...
I attended a lecture by Dr. Kris Van Oeveren last year, at which time he stated that in his practice, he often dealt with children who were ADHD. In many cases (but not all), it was his opinion that these children were unable to adequately process sugar or glucose, and if you added a good multi-enzyme supplement (one containing sufficient gluco-amylase) to their diets, that the problems would disappear, or as a minimum. be greatly reduced ....
Having watched my son suffer through the anguish and destruction of being on Ritalin for six years of his life, I was absolutely dumbstruck! I thought, "Are you trying to tell me that I could have avoided putting my son (and my family) through that nightmare from hell by simply giving him a 100% natural supplement? I don't believe it!" But the guilt and sadness of those memories with my son and the family during his formative years-of ages six through twelve would not let this stunning disclosure subside from my consciousness. I decided to test this idea with friends from Memphis, who had a son, on Ritalin, and not doing well at all. In fact, he was the same age as my son when our drug odyssey began .... Back to my friends in Tennessee. They agreed to have their son's pediatrician monitor the reduction of Ritalin over a 30 day period, combined with the addition of certain natural nutritional supplements. At the end of this· test period, they us MAX F. JAMES 327 324 Complaint reported that the Ritalin was no longer being taken and that there had been no negative changes in behavior.... · Now, hundreds and perhaps many thousands of cases later,parents are hearing glowing reports of their children' outstanding ·performances in the academic environment as well as the social environments in which they are asked to participate. In fact, while I have no certified statistical evidence to support this conclusion other than anecdotal, I have not had a single report back to me that even one single chi!~ has had to return to Ritalin after trying a combination of three natural nutritional supplements which I eaii 'God's Recipe."' (Exhibit B, "Well Being Journal," Vol V, No. 4, July/August 1996 (Included in "Attention Deficit Hyperactivity Disorder" pamphlet.)) C. "God's Recipe 1.) 2 ounces of Colloidal Minerals.
2.) 40 milligrams ofhighly effective antioxidant- OPC capsule combined with Ginkgo Biloba.
3 .) Multi-enzyme capsule with every meal and with every significant snack, as well as the elimination of as much sugar as possible from the diet. * See back page for more information [B.ack Page] Information on our "God's Recipe" Products 1~) Colloidal Minerals These are minerals in a delicious liquid form that children of all ages really enjoy. The minerals are extremely easy for the body to absorb as they are extracted from plant source deposits of vegetation origin. In fact, the absorption rate in the body ofthese minerals is much greater than elemental minerals taken in tablet form. There are over 60 minerals in every 32.ounce bottle.
2.) Antioxidant with Ginkgo Biloba:
This antioxidant is OPC and is derived from the original patented grape seed extract. It has 50 times more antioxidant potency than vitamin E, and 20 times more than vitamin C. In combination with Ginkgo Biloba and other herbs, it can have a very positive impact on one's health.
3.) Multi-Enzymes · As the basis of all metabolic activity, enzymes are the driving force of. our body's more than 150,000 biochemical reactions. Enzymes are very important for effectively metabolizing sugars, an activity of critical importance to ADHD control. A balanced blend of enzymes and minerals maximizes the assimilation of nutrients. WHEN TO TAKE GOD'S.RECIPE Take one· ounce of Colloidal Minerals and 1 capsule (20 JDilligrams) of the Antioxidant with Ginkgo Biloba first thing in the morning, and both again mid-tolate afternoon. Take 1 capsule of Multi-Enzymes with each meal and with each significant snack. Eliminate sugar throughout the day and evening. We wish you and your family the best. If you have any questions, or would like to place an order, please call us at: ... "
- - -- ·--- -- - - Complaint 127 F.T.C.
(Exhibit C, Excerpted from 11Attention Deficit Hyperactivity Disorder" pamphlet.) D. "GOD'S RECIPE TESTIMONIALS 'Good evening Mr. James: This is Shondra W. I had talked to you about a month ago to get information from you about how I could get my son off ofRitalin. And I just wanted you to know that I have had him completely offRitalin for the past five days and I couldn't be more pleased with the way he is doing, he is doing so well. He is such a pleasure to be with now. And he is feeling better himself, he· doesn't even want foods with sugar. And I just wanted to tell you 'Thank You and I really appreciate all ofyour help.' (Shondra W, Texas) 'Dear Max: We started about four and a half months ago and this has been the greatest four and a halfmonths.my son and I have ever had, ever. My son is 6 ~ years old. He was being brought to my work by the school principle because he was such a severe discipline problem that he was under consideration to be 'kicked out' of first grade. I was accused by the school of not being strict enough with my son, not disciplining him enough. It was right after that meeting with the school teachers and counselors that I started him on the program (God's Recipe) and we have had perfect behavior since then. He won an award pin for his perfect behavior and he won an all expense paid vacation from the principle for perfect behavior for four straight months. His teacher says that she wishes that she could get this (God's Recipe) for every kid in class. This is the best thing that has ever happened to us. I thank God that we have this. I really, really do!' (Zoanne, California)" (Exhibit D, Excerpted from 11Attention Deficit Hyperactivity Disorder" pamphlet.) . ! 7. Through the means described in paragraph six, respondent has represented, expressly or by implication, that:
A. God's Recipe can cure, prevent, treat or mitigate Attention Deficit Disorder or its symptoms.
B. God's Recipe can cure, prevent, treat or mitigate Attention Deficit Hyperactivity Disorder or its symptoms·.
C. God's Recipe is an effective alternative treatment to the prescription drug Ritalin for Attention Deficit Disorder and Attention Deficit Hyperactivity Disorder.
D. Testimonials from consumers appearing in the advertisements for God's Recipe reflect the typical or ordinary experience ~f members of the public whose children have used the product. 8. Through the means ·described in paragraph six, respondent has represented, expressly or by implication, that he possessed and relied upon a reasonable basis that substantiated the representations set forth in paragraph seven, at the time the representations were made . ..........-----·- - - -- - MAX F. JAMES 329 324 Complaint 9. In truth and in fact, respondent did not possess and rely upon a reasonable basis that substantiated the representations set forth in paragraph seven, at the time the representations were made. Therefore, the representation set forth in paragraph eight was, and is, false or misleading.
10. The acts and practices of respondent as alleged in this complaint constitute unfair or deceptive acts or practices, and the making of false advertisements, in or affecting commerce in villlation of Section 5(a) and 12 ofthe Federal Trade Commission Act. Complaint 127 F.T.C.
EXHIBIT A TAPE: 'GOD'S RECIPE- THE NATu,RAL ALTERNATIVE TO RITALIN- [ music] Parents across America are receiving phone calls from their children's teachers not to praise their progress in class, but to inform them there is a problem~ with Johnny. The problem? Johnny isn't staying up with the rest of the children_. he's getting into fights at recess and he's just not listening. The teacher has seen it hun~eds of times: ADD (Attention Deficit Disorder)- the most common form of treatment: Ritalin. Parents trusting the advice of well-meaning professionals are unknowingly starting their children on a cycle of chemical depende~cy. Is there an alternative? The good news is yes, and this tape will-outline what has become known as God's Recipe, as well as letting you hear from some doctors on this very subject. God's Recipe is made up of three very exciting, natural health products. The three products you'll hear about on this tape are ~olloidal minerals, OPC grape seed extract containing ginkgo biloba, and a multienzyme product. This combination is making a huge difference in the lives of thousands of children and is a natural approach that works. Let us start this learning adventure with a wellknown radio show broadcasted weekly, hosted by Dr. Joel Wallach. [music] Thank you and welcome to the Wellness Hour. This is Dr. Joel Wallach, your host, a physician and a veterinarian. I can tell you a lot of my patients say I treat them like dogs, but they seem to get better. We're going to talk about ADD/ADHD, hyperactivity, learning · disabilities and all kinds of related disorders. I would be famous for this up in Portland, Oregon where I practiced for 12 years. I used to see literally hundreds and hundreds; maybe as many as thousands of parents who'd bring their children to me who had these problems and, of course, this was in the '?_O's and early '80's. People were just learning about Rital.in and all the teachers A-1 MAXF. JAMES 331 324 Complaint EXHIBIT A would like to put the students on Ritalin- we're talking about 6, 7, 8, 9 and 10-year olds- they would want to put them on Ritalin. I think a psychiatrist gave lectures to the teachers so they were very aware of Ritalin and, when a child was disruptive in the class, the first thing they would do is say to the parent, "Put the kid on Ritalin." And if the parent refused, the teachers would tum the parents over to the social services in Oregon, which were really hot to do something and they would then take on the parents and they'd say look, if you don't tum the kid over to be put on Ritalin, the first thu:tg that's going to happen is we're going to make the child a ward of the state and the state will make sure that the kid gets Ritalin because it is good for the kid. And this is all based on the teachers' assessment of what. wa5 going on in the classroom. Well, what I got famous for was taking these kids and having them draw their favorite animal or plane or flower or house or whatever it might be prior to having breakfast in the morning. Then having whatever usual breakfast they would have; it could be sugar frosted flakes,.something like Pop Tarts, syrup on their Eggos, apple juice, grape juice, Sunny Delight, these kinds of things. Then go to school and about an hour and a half later do their same drawing again and then compare the two. And what we found out was that a six-year-old who could draw a giraffe that looked obviously like a giraffe after an hour and half following a high-sugar breakfast would draw a giraffe that would look much like a schmoo. For those of you who are old enough to remember what a schmoo looked like, it was a pillowcase with eyes on it. So, we would recognize that this kid was sensitive to sugar and, of course, we have talked about this many times on this show, there are people who are sensitive to sugar in all fonns, whether it is natural, processed, corn syrup, honey, molasses, and people are sensitive to sugar-just like they are to alcohol. There are good alcoholics-people who, for instance, if they have a drink, they might go to sleep. This is at one extreme end, they go to sleep, there's people in the middle, who drink A-2 --~.......,~-"-..--,... ---·~--.......--··- .,- -- - - ·-- - . ----... .-- Complaint 127 F.T.C.
EXHIBIT A alcohol and just kinda get giddy and loud and boisterous and, at the other end of the scale, they become violent The same thing is true with sugar. Some people when they take in sugar get sleepy a..Gd drowsy. Some people when they take in sugar get agitated and boisterous and then some people when they take in sugar get violent. And ADD/ADHD is somewhere in between those two extremes because these kids or adults even get disruptive, irritable and they can be involved in domestic violence; certaiiUy, they are not going to learn how to read, write and do math, they are going to experiment with cigarettes, alcohol and drugs as they get !)lder trying to find something to satisfy their cravings to be successful at, because when you have AJ?DIADHD it's very difficult to be a positive performer. And so what we-did was take these kids'and young adults totally off of all sugar, natural and processed, supplement them with three trace minerals preferably in the colloidal form. This was lithi_um, chromium and vanadium and low and behold, usually within 24 to 72 hours, the~ was a significant benefit The parents and teachers inunediately recognized this and then, within weeks, the kid would go from the bottom of the class to the top of the cla.Ss. It has nothing to do with_intelligence and we actually saved thousands of kids from being put on Ritalin and today's- welcome, Max James! Max James: Thank you, sir, good morning.
Dr. Wallach: Good morning. And obviously, you've had a lot of personal experience. I was reading your materials. Why don't you share with our listeners how you got involved, a real estate agent basically and somebody with a military background. How did you get involved within ADD? Max James: Yes, I have a wonderful son and when he reached the age of six years and headed off to the first grade after about two weeks in school, we got what turned out to be a perennial call from the school teacher saying we have a major probl~m with your son disrupting A-3 I Jl l MAXF. JAMES 333 324 Complaint EXHIBIT A the class. He's two weeks behind academically, got quite a problem. He's the playground bully and you need to come talk with him. We were absolutely stunned. Our son had no behavioral problems at home, was the nicest little guy you ever want to meet in your life so we thought perhaps there was an error, that maybe it was the wrong child. In any event, fortunately we had a very bright and progressive first grade teacher who suggested that if that were the ~e. what she'd like to do is have the school psychologist test him and they did so and a couple of weeks .later called us and said they believed that he had a learning disability at that time. This was in the late sixties. They called it hyperkinesis or hyperkinetic behavior and suggested th~t we go to Stanford University and have further psychological tests done. We did so and they determined that indeed he was ADHD and was going to be incapable of getting a normal education if we didn't do something to render him some assistance. The intelligence exams that they gave him indicated that he had an extremely high IQ but simply was not able to utilize it and produce the results. So we were given three choiees, Dr. Wallach. They said number one, you can '·.
institutionalize him and - Dr. WaUacb: 11Us is a six-year old? Max, James: This is a six-year old. I said, well, that's interesting. I mean. what kind of institution you're talking about and having seen the Jack Nichols-movie "One Flew Over The Cuckoos Nest" - Dr. WaUach: E~tly.
Max James: I had visions of horror and they said, well, he'll be in with quite a variety. of children with learning disabilities up to the medical level of moron and that just didn't seem appropriate for my son, given that we had no problems with his social behavior in the home setting, in the family setting. I said, what's my next choice? And they said, well, you could try A-4 Complaint 127 F.T.C.
EXHIBIT A nutrition and I said great, fantastic. What. do we do? And their response was you've got to remove all sugar. You've got to remove red food dye. No more peanuts. No more this, no more that, no more - - Dr. Wallach: Wait a minute. You said this is in the 1960's? Max James: Yes, late sixties. Probably '68, '69.
Dr. Wallach: Okay.
Max James: I said, well, you know, I - I think that we might be able to do that at home. It sounds like quite a challenge, but what do I do about his meals at school and what do I do about vacation and camp and visits and friend's home and bi.r:thday parties. What's the third choice? Anyway, they said, well we highly recommend the third choice. It's the drug of choice. It's Ritalin and Ritalin is safe, it's a mild drug and they explained it and so that was the recommendation and that's what we did. The results were immediate and wonderful. Suddenly the handwriting which had been virtually illegible became not only legible but quite artistic, and I had thought that the handwriting problem was probably genetic. I couldn't write. My handwriting was terrible.
Dr. Wallach: Uh-huh.
Max James: So in any event, he suddenly started using three syllable words which his older sister had difficulty at that point understanding and then the body made the adjustment and a lot of that went away and constant battles with the appropriate dosage finally settled in and we proceeded on a six-year odyssey of my son on the drug_that is more popularly called speed. The problem in my mind with Ritalin is that it works. He certainly was able to get an education, but the problem with Ritalin also is the side effects and in this case were, in my mind, devastating. Dr. Wallach: Parents who are just exhausted with a hyperkinetic child or one with ADD A-5 MAXF. JAMES 335 324 Complaint EXHIBIT A or ADHD, they get this relief from this drug Ritalin. Suddenly, they can all go to sleep and suddenly they can go on with Jheir lives because the kid's under control and things seem to be going well and the education's going good. And they think they've solved the problem. 1bis is why the medical profession and teachers can get parents kind of coerced into this because suddenly the major portions of the problems go away and they can say~ phew, fmally,' we get some relief here and we can go on with everybody's lives. Let me ask you something. Did they tell you to still with the child on Ritalin to take him off of sugar and supplement him with some trace minerals? Max James: There's certainly no suggestion of trace-minerals, no. Dr. Walla~b: But they did say it would help to get him off of sugar? Max James: Yes, they did. Yes, they did. The benefits of the Ritalin of course were ,that he became perfectly adjusted in the classroom, but the side effects, Dr. Wallach, are what have created my passion to see ifl can find a better alternative. Dr. Wallach: Sure. Well, what were the side effects that you saw in your son? Max James: For six years my son was on Ritalin and they required a drug holiday which .,j is we took him off on the weekends and obviously during holidays and' the summers. And when ~ I he came off the drug there were withdrawals. The symptoms of drug withdrawal, as well as . I what's now popularly called "Ritalin rebound," so that about late Sunday afternoon behavioral problems really were abundant Huge blue circles under the eyes from the abuse of this drug. Lips that were constantly chapped and bleeding because he was so dehydrated from this drug that he was constantly licking the lips and that created problems. Dr. Wallach: Uh-huh.
Max James: Depression, moodiness and withdrawal - A-6 Complaint 127 F.T.C.
EXHIBIT A Dr. Wallach: Well, these blue circles under the.eyes. We call them allergic shiners. Max James: Okay.
Dr. WaUach: You know, allergic shiners, and invariably there's something that they're eating either sugar in one form or another or maybe even dairy can cause that on occasion and it's one of the signals that the child's in trouble when you see these blue, purply marks under the eyes that we call allergic shiners.
Ma.x James: Well, it was clear to us that he was in trouble from a growth potential physically at the age of 12, he weighed 50 pounds.
Dr. Wallach: My goodness.
Max James: And when he finished the sixth grade at 50 pounds, we sent him back to the farm in Tennessee back to my parents. And, of course, went off the Ritalin and he got on those good natural foods back there at my dad's ·farm and garden, and then an environment that was · free without the pressures of the school room and the classroom, and Dr. Wallach, he had a sixty percent weight gain in 30 days. Went from 50 pounds to 80 pounds and never went back on Ritalin.
Dr. Wallach: lsn't that amazing? Max James: Absolutely amazing. He was able to go through the rest of his secondary education and in fact had an opportunity to redevelop and rebuild his self-esteem with a special program that at one time was provided by the University of the Pacific here to help children with these problems and he went on and got a college education and is a well-adjusted young adult today. But never back on RitaliiL I would hope that no one would ever have to go through that with their son.
Dr• Wallach: Okay. So what have you been doing all these years siflce your son has A-7 I ( MAXF. JAMES 337 324 Complaint EXHIDIT A gotten off of Ritalin? It says here that you're a tireless worker. in helping people and going into the media an~ making sure that people know about this problem. Tell us some of your experiences.
Max James: Well, a little over a year ago, I was sitting in a lecture on nutrition and a Dr. Kris Van Oeveren indicated that in his practice he dealt with a lot of children that were diagnosed ·as ADHD. And his experience was that many of them, not all, were unable to process or metabolize sugar and that if you gave them a good multi-enzyme the problem would often disappear. Well, I sat in this audience in total shock., I mean, I was stunned that I could have perhaps avoided putting my son through all of that pain and agony, as well as the family, by simply treating it with a nutritional supplement and so I determined right then that evening that I was going to test it because quite honestly, I didn't believe it The route.that we took in experimenting with nutritional supplements was to go with colloidal minerals, to go with a good, strong anti-oxidant combined with ginkgo biloba, and to go with a multi-enzyme and the I I elimination of as much sugar as possible out of these children's diets. Well, the word just kind of ; ! i spread, word of mouth, and the results have been over a period of 10 or 12 months now, Dr. l Wallach, that I receive phone calls every day,letters,.people c_alling me, psychiatrists, medical doctors, neurologists, pediatricians, all wondering what we're doing. rm not even sure I believe.I these statistics myself. I feel blessed by them, but I have not had one single case reported to me, not one, that a child has had to go back on Ritalin after going on to these nutritional supplements. Dr. Wallach: What a blessing that is. You can take comfort in knowing that I had the ·same results. Never had to hav~ a child go back on Ritalin. The caveat here again, the thing that . you have to have everybody agree on that the whole family has to be aware, have to educate the child that there is a connection between sugar and their negative behavior. Kids don't like to be A-8 - --- ---- --·--- --·-·- -- ---- - ------------- Complaint 127 F.T.C.
EXHffiiT A different. As you know, kids don't like to be behind in class and kids don't like to be a nonteamer and so once they really get down deep inside of them this knowledge that sugar is a very negative thing for them, when you get them at a young age and the whole fami~y does the same thing, it is very, very easy to get them on the rignt road and stay on the right road. My own son who was, I guess, about six years old when we figured this out for him, we started looking at health food stores and were able to get hot dogs for instance without com syrup in it and get pure beef, pure chicken, pure turkey, pure lamb hot dogs. When he got to be nine years old, he'd go -out with the Cub Scouts and [ used to make brownies out of the roasted carob and out of rice flour and so forth and he could take his brownies that had a nice pecan half on the top of each brownie and his hot dogs and go and do his thing with the Cub Scouts and know that he couldn't eat anybody else's hot dogs. He couldn't trade. He couldn't eat their Twinkies, but he could eat their brownies and because they were so special, [ had to start making more of these things so that the whole Cub Scout troop wanted them. [t was fascinating to see the change in the whole troop.
Max James: We have a problem in the United States with prescribed drugs and children. Right now, it's reported and [ can believe it that ADI·ID is America'~ number one childhood psychiatric disorder. And in some_areas of the country, the percentage of children that are taking Ritalin has reached 7-8%. Over two million children ~nit. I am absolutely convinced by the hundreds and hundreds of people that I've talked to that it is not necessary. Dr. WaUacb: Oh, absolutely. And of course, the reason, Max, is that per person in America, now this does not exclude children, it doesn't say per adults, it says per person, there's 148 pounds of sugar per year consumed per person. Now there's some poor kid out there eating 300 pounds because I don't eat any.
A-9 MAX F. JAMES 339 324 Complaint EXHIBIT A Max James: Right.
Dr. Wallach: And my son doesn't eat any. I'm assuming yours doesn't, so there's, you know, there'; six people out there who are ~ating 300 pounds of sugar per person and it's pretty scary and another fact which is even scarier to me - according to experts, juveruTe and childhood experts, one-third of American children are going to be in a juvenile court this year, 1996, because of behavioral problems because of some kind of criminal behavior whether it is burglarizing neighborhood houses or assaults or murder or manslaughter. These kinds of things -destructive behavior ~d. you can attribute most of this really to this 148 pounds of sugar per kid and the fact that our foods are totally deficient in minerals and that if you don't supplement these kids with lithium, chromium and vanadiwn, zinc, sulphur, things Like copper, magnesium, manganese and so forth, they get all kinds of physical problems, as well as mental ones and I have to ask you, have you had any rebellion from parents who say well, gosh, this is so expensive our insurance will pay for the Ritalin and we have to pay for the vitamins and minerals.
Max James: I really have not. I found that parents really are anti-drug for children. They don't want the kids on drugs and you're exactly right. These children do not want to take Ritalin. In fact I am working with one school nurse whose job it is every day to stand at the head of this queue of children all lined up to take their "Meds" as they're called, and they have to be supervised of course because it's a controlled substance. She says now that she actually has to put her fingers into their mouth to ensure that they are in fact taking Ritalin because they don't J want the drug.
Dr. Wallach: You know, I hope she's washing her fingers between each child. Max James: [inaudible)· A-10 ....--- - ---- ----- ----·-- Complaint 127 F.T.C.
EXHIBIT A Dr. Wallach: Okay, Max, hang on. This is Dr. Joel Wallach, your host of the Wellness HOIJl' and we're going to be right back after this message. Voice: Jerry, you're on live with Dr. Joel Wallach and Max James. Your question please, Jerry? Jerry: rm a Judo coach and I have several students that are obviously suffering from ADD. What kind of information can you give me on that? Max James: As you know, Dr. Wallach, an awful lot of these children that are ADHD become great athletes because of the frustration and the energy that builds up inside t11em, the anger of having to deal with their problem on a daily basis. This certainly was the case with my son and so we find a lot of ADHD children in Judo classes and they also become great entertainers, again, because of this energy, but one out of every three is going to drop out of school, and if they carry this into adulthood, the national statistics are that one out of every l 0 will attempt suicide, so my recommendation is a couple of ounces of colloidal minerals each day for these children. We believe that the anti-oxidant is very important to help clean up the free radical damage that is going on inside their little brains and we combine that with ginkgo biloba and then we think that the multi-enzymes to help them metabolize that sugar that they're going to get - we just can't seem to eliminate enough of it -- is very important Jerry: Okay.
Dr. Wallach: Okay. Thank you. Does that help you out, Jerry? Jerry: Yeah, that helps me quite a bit and I'm going to try it out with a couple of the students that I have in mind and I will definitely let you know how it went Dr. Wallach: Yeah, great, and of course you want to have the parents go through those boxes of all the items that have sugar in it or give them ten cents for every different can, box, A-ll ' r MAXF. JAMES 341 324 Complaint EXIDBIT A bottle, or bag that bas sugar in it, you know, something, some incentive and you'll be amazed, it'll be a lot of fun_ Jerry: Great Great. I appreciate it Dr. Wallach: Okay, Jeny.
Jerry: Thanks.
Dr. Wallach: Okay, thank you. Yeah, Max, if you had to have one recommendation for parents when they discover- usually parents discover on their own that there's a problem or a teacher tells them. Personally, I like to keep them away from counselors and shrinks because they invariably direct them and convince the parent it's the-right tliing to do to get them on Ritalin and I feel if the parents are really interested in the child, I give them the advice without suggesting that they go to a counselor or a shri.nk. How about yourself? Max James: A major concern here over this child self-esteem and it's a problem that can be dealt with and it's going to require a great deal of patience and a tremendous amount of love for that child, but that I believe that the problem can be overcome without drugs and that the problem can be overcome with nutrition and number one, you must reduce th~ amount of sugar. Number two, because you cannot reduce all the sugar, you've got to do something about the negative impact of the sugar and so we start just with that recommendation. Diet, diet, diet Dr. Wallach: And as you point out, it's a life-long process and some get it and some don't. It's really a sad thing. And again, I attribute the kids who don't get it is because the family is not willing to give up sugar in their own lives and give the support that's totally necessary for the kid and do the education that's necessary to have the child make the association between sugar and the negative behavior.
Max James: We've also had great experience, by the way, in going to the doctors. Not A-12 T------ - Complaint 127 F.T.C.
EXHIBIT A being a medical practitioner myself, I'm vecy careful of course when children are on prescribed drugs and I suggest to the parents that they go to their doctor and tell the doctor what they want to do. Tell the doctor that they want to lfY an alternative and Dr. Wallach, I simply have to say this that there have been no long-term studies on the negative effects of Ritalin or Zyler or some of the others that are used and it seems to me that there is something wrong with the picture that says we put adults in jail for possessing this drug and yet we're forcing our children to take it on a daily basis. You know, there weren't any pharmacies in the Garden of Eden and I've just got to believe that this can be handled using natural supplementation. Dr. Wallach: You're absolutely right and it's a matter-of giving up that sugar, 148 pounds of sugar per kid per year and supplementing them properly and the best way to get their minerals is in the colloidal form, of course, 98% available to them. And I've just seen such wonderful results with pills. It used to take me, oh, somewhere around, oh anywhere from four to six weeks _to see some real progress because you can't absorb the elemental forms of minerals vecy well. Even children only would get 8-12%, but with the colloidal minerals, I've had so many parents come back to me and say, hey, in 72 bows this kid is just a different child. The teacher asked if this was the good twin.
Max James: Right.
Dr. Wallach: And I'm sure you've seen the same thing.
Max James: I have indeed. My brother is a doctor back in Memphis, "' Tennessee, and his children suffer from this malady and they have seen results overnight Often I hear by the next morning a perceptible change in behavior. It's truly a blessing, Dr. Wallach.
Dr. Wallach: So people nave everything to gain and nothing to lose by doing this. A-13 MAXF.JAMES 343 324 Complaint EXHIBIT A Max James: Amen.
Dr. WaUach: Absolutely. And we just want to thank you a lot, Max. Max James: Well, thank you for sharing this time with me. Dr. WaUach: Yes, and I appreciate all your experience and hope that this works and-· [music] Voice: Max James has taken this mission upon himself to educate as many parents as he can. Please turn to Side 2 to hear more about God's Recipe. [END OF TAPE SIDE A. START OF TAPE SIDE B.] [music] Voice: .During a recent phone session, parents of ADD children met with Dr. Kris Van Oeveren and Max James.
Max James: Bobbie, would you mind leading us off? Bobbie: Oh. not a bit.
Max James: Oh, fantastic.
Bobbie: I am so excited to be able to share the wonderful things that have happened to my daughter. She. started showing signs of ADD when she was in first gnide and in second grade she started out above level in reading and ended up with below level at the end of the year. There were a couple of other children in her classroom that also had the same problem as Katie and between all of them mixed together, it was a pretty hectic classroom for the poor teacher and by the end of-the year she was doing cartwheels in the back room and the whole nine yards and not really learning anything and she was also having social problems. She was having these fits of rage. She couldn't hold friends' because of the rage that she was showing and the rage was· A-14 Complaint 127 F.T.C.
EXHIBIT A coming out at the family and on her sister and she was just, poor thing was in trouble all of the time. You'd ask her to do a specific task and go and check on her in about 10 or 15 minutes and the poor little thing was in a trance, I mean, it was like she was staring off into space and it's like, honey, why haven't you done what we asked you to do, you know, you've been here for 15 minutes. No, Mom, [just walked in the room. And she was very honest You know, you can tell when kids are fibbing and she was very, very honest with the fact that she felt that she had just walked into the room. So, this was long before [ found these wonderful products --the multi-enzymes and such. We started working with a naturopath and she did help us. ~he said that, you !mow, a lot oftimes with food allergies that these things· occur and so we did change her diet and so on and so forth, ~ut when we started on the colloidal minerals and the enzymes and the Proanthocyanidin product that has the ginkgo biloba for the brain, etc., my daughter just came up I 00% better than just with changing her diet and in two weeks her teacher called me at home during the day. It scared me because I thought something had happened and she said, Mrs. McKuen, [ would like to know what it is that you're doing different with Katie and I said, well, in what regard, you know, after having so many bad phone calls, you know, with a child with ADD, you kind of don't want to volunteer too much. Oh, gee, what have we done now. She was wonderful. She says, I don't know what you're doing with her and for her but whatever it is, please don't stop. She says please do ~ore. She said Katie is focusing in the classroom and she is; her attitude towards the other children is changing and she's calming down and she's actually grasping onto concepts now. And I said, well, gosh, it's only been a couple of weeks since we started her on these new products, these natural health care products and she said, wow, I don't care what it is that you've done. I am just so excited. She said, I'm really beginning to see what a wonderful child Katie is and you told me that at the beginning of the year that she was really a A-15 MAX F. JAMES 345 324 Complaint EXHIBIT A wonderful child, but because of the these problems and stuff with her ADD, it's hard to get to know the real Katie like you have the chance to at home and she says, I'm just so excited that I've had the chance to get to know the real Katie underneath the problem. She said this is just wonderful and the year has continued to progress and she is just doing~ absolutely wonderful. She has several friends now. She's become quite popular in school and she's doing much better on her homework and we're still working with some of the backlashes of the ADD, but Katie is definitely a success story and we just started her on these products and so we haven't had her on · them for an extreme amount of time before, you know, we're very pleased thinking th~t she's just about cured from the ADD symptoms.
Dr. Van Oeveren: Oh, that's a fantastic story. Fantastic. Max James: Jackie, why don't you do the same. Just tell us what's happened in your special family with AD lid and nutritional supplements. Jackie: Okay. I have a son who is 14 right now and he has had ADD since he was teenie. He was one of those kids that was hyperactive and couldn't sit still and loved to experiment and was always breaking everything in the house. We had trouble with the frustration mainly. Everything he tried to do was so hard for him and he would get terribly frustrated. When he was learning to read, he would read a word fine one day and then he wouldn't remember it the next He couldn't remember the multiplication tables. When he was spelling, he'd drill and drill and drill and then he wouldn't remember it the next day and it made I him so frustrated, and so, usually with his schooling, he would do 10 or 15 minutes and get so frustrated he would go out and jump on the trampoline. He's very good at that Also, another thing he used to do is when he got really frustrated, he'd kind of almost roll up in a ball and say I'm so dumb, I'm so dumb, I can't; I can't. How come I'm not like anybody else? And it was A-16 Complaint . 127 F.T.C.
EXHlBIT A driving me crazy and I felt like I needed to put him on some kind of drugs just because his life seemed so miserable. And we really didn't want to go to Ritalin and so we kind of worked with him and worked with him until we found these products and it was amazing. We gave him the first dose at night and the next morning when we sat down to do, we do scripture reading first and when we sat down to do our scripture reading," he took his tum and he read fluently. Not one word at a time, not sort of sounding them out and looking at them as if he'd never seen them before. He read fluently, just as fluently as could be. And we were just shocked because this is - he'd only had two doses, you know, night and morning. And then he sat down at.the computer and typed a story. And the story ended up being.--be tjped that day for like six or seven hours with a little while off for lunch. Straight through. When he came across a word he couldn't spell, he'd always just fly into a rage. This time if he came across a word he didn't know, he'd either spell it the best he could and then use the spell checker or he'd ask somebody and go right on. No rage, no frustration. And his story is absolutely amazing. He sent it in to the contest right now. He won fust place in the local contest and it's in the state-wide contest right now. It's an amazirig story. He did a fantastic job. And I can always tell if he has remembered to take it or not because if he hasn't taken it, then little things bother him, like he can't fmd his shoes and he'll, he just gets so frustrated and so angry and all you need to say is hey, did you take your stuff? Did you take your pills? Nope. It's just really easy to tell. It's made a huge difference in his life.
Max James: Oh. what a fantastic story.
Dr. Van Oeveren: lllat's great.
Max James: Great, great story. Thanks, Jackie, I really appreciate you sharing that with us.
A-17 MAX F. JAMES 347 324 Complaint EXHIBIT A Dr. Van Oeveren: That's great.
Max James: Dr. K.ris.
Dr. Van Oeveren: Yeah.
Max James: Any particular thing you'd want to add into that? That's classic or that you've observed? Dr. .Van Oeveren: Well, I'm not exactly sure why sugar is the main problem. There are a few concepts that we're fairly sure of and that is that refined sugar is the main culprit because it gets metabolized in the digestive system much quicker, basically raises havoc with th~ rest of the metabolism of the sugar. And it causes a very high influx of.instil. in to regulate this immense absorption rate of the refined sugars. Thats basically the mechanism involved there is that we're just in- primarily, we're just taking in the incorrect form of sugar which we were never intended to receive that way. We were intended to receive sugar in a natural form like from fruit or vegetables and so now what's happened is through that violation, the digestive system is imbalanced, you might say. Its ability to tolerate these sugars has decreased and then of course that leads in to dysfunction. Where the enzymes come in is twofold. One is to try to help the body recover from this dysfunction by providing enzymatic action with the sugar that is inevitably going to be a part of our diet and thus helping to regulate the metabolism better. That's the primary function of how that does that. The second deal is, what it also does is it sort of gives the body an opportunity then to heal up certain aspects of the digestibility of these sugars by providing its o\vn enzymes. When you have a dysfunctional system, it takes time for the body to heal and in getting this extra help from the enzymes is, it gives you this extra time and ability for the body to heal it up. So, it's a twofold situation and it's in conjunction with a person having to reduce the amount of these refined sugars in their diet and ·then supplementing A-18 ~-- --- Complaint 127 F.T.C.
EXHIBIT A in the enzymes to help the body recover and bring it back into balance and also help regulate normal metabolic process of the sugar.
Max James: Fantastic, Kris. Thanks. You related that to the co-factors. Dr. Van Oeveren: Because it is required to be metabolized so much it depletes the body of the co-factors and co-enzymes or co-enzymes are vitamins and co-factors are minerals. So that's why the minerals fit into this program is that you end up depleting or utilizing the minerals available_in the body just to try to maintain as long as it can while the person is taking in these processed sugars or violating natural digestive processes, so if you're depleting your vitamins and your minerals and your enzymes, it's somewhere along the li~. it's just going to raise havoc and something's going to give. ~d in this case it's ADD. So the remedy nutritionally would be to supplement back in the vitamins and the minerals or the enzyme co-factors and co-enzymes, along with the food enzymes to bring the body back into balance. Max James: Dr. Kris, what about the anti-<>xidants and what benefit we may be receiving by the people that are ADD? Dr. Van Oeveren: Well, the anti-oxidants-- of course, anytime that you're goirig to have tissue dysfunction, you're going to have inflammatory processes going .on more than likely and, of course, the anti-<>xidants do have an effect on inflammation in attempting to reduce it, thereby also trying to bring back into balance normal' function. Things like ginkgo have elements of them that get into the brain to help in the tissue in that particular organ. So there's a relationship th~re, [ think, between utilizing antioxidants and also getting into specific regions of the body or specific organs, for example, ·the brain with ginkgo and this helps then to bring back. into balance the normal function of specific tissues or organs. Max James: Okay. Super. I've got one last one for you, ·Kris. Children are getting the A-19 MAX F. JAMES 349 324 Complaint EXHIBIT A attention here for ADHD. What about taking this malady into adulthood? What's the story there? Is it curable? Do'we just learn to deal with it? What's the situation? · Dr. Van Oeveren: The basic premise is the body's a self-healing organism and in order . for it to continue to maintain its natural processes of self-healing, it needs to be fed. And if we continue to feed it appropriately, it has its best opportunity then to maintain proper health. That transcends all age. It doesn't matter how old you are. I think that the answer is basically the same thing.
Max James: Right. Fantastic, Kris. Thanks very much. Sure appreciate you_r time. i>r. Van Oevereo: Okay. Thank you very much. · Dr. Van Oeveren: Okay. Bye-bye.
Max James: Well, let's see. Mike Hart.
Mike: Hi, Max.
Max James: How about telling us what's going on in your family? Mike: Travis is a five-year old young man. Great personality. We have managed to keep him away from the thought of having to take Ritalin by natural means. First, we took sugar out of his life. At about three years old. Travis had some challenges and when ever he bad sugar, he became a totally different person. Everybody out there listening, if you're listening to this because you have a challenge, you already know all the stories. You know what happens. You know what happens in school. You know what happens at home. You know what happens to the character of the persons we're talking about. It's not just Travis. This is happening to children all over America. With sugar, we control their lot. We changed his life a lot.· Only half as much as his life changed when we were able to give him minerals, enzymes and· OPC'S. The group together really made some tnajor changes. And I want to say when we first started giving A-20 Complaint 127 F.T.C.
EXHIBIT A him the products, we halfheartedly gave him the products and we've seen minimal change. It wasn't until we got really regiment about giving him these products all day, every day and what 1 mean by that is by giving Travis·these products three times a day, or if it took four times a day, you could tell when there's a mood swing and there's a change has started to come on. We made sure that he had an enzyme whenever he ate anything. If it was a piece of toast, he had an enzyme. He had minerals at least twice a·<Jay and OPC's at least twice a day. What a difference. He's a little gentleman. All of the things that we were experiencing that could have led us to other means of, you know, what a lot of other lcids have to take. I know some other programs that are trying to get all lcinds of other types of programs going, but we combated it naturally, not even knowing that we had the major problem. So, we're like so many others out there. We think: that our child is just maybe a little more excited, a little more o·rnery than others and that's normal. We think it's normal because there's so many other children out there that we can compare him to. So we think that's normal and what we have to learn is it's not normal, it's common. There's a lot of other people out there, a lot of other children or even adults that we can compare it to that makes it common, but not normal, so if you keep that in mind, there is a problem that needs to be addressed and there are ways to address it naturally. It's really wonderful.
Max James: Oh, that's a fantastic story. Zoanne? Zoanne: Yes.
Max James: We understand that you've got a wonderful story to share with us about nutrition in your family and ADHD.
Zoanne: We started about four and a half months ago and this has been the greatest four and a half months we've ever had; ever. My son is six and a half years old. In fact I had talked A-21 I• II I• I MAX F. JAMES 351 I' 324 Complaint EXHIBIT A to Jackie Ruland about natural things to help for the ADD and this is what she told me ~about. And at that point, my son, he's in first grade, the principal was bringing him to my work to get him out of the school. He was running away from school. He was talking back to the teachers. He was a severe discipline problem .almost to the point of being kicked out of school in ftrst grade. That was the main thing. We had just taken the written test through the school for ADD. The teacher made it out that he was an extreme discipline problem and that he must, we had this meeting. They said I must not discipline him enough. I must not be structured enough with him. All these things that were my fault that were his fault And right after that meeting w~ when I started the pills. And [ started with one a day. And I didn't see much difference for about a week and so Jackie told me to IIy two. And so [tried two pills.a day over the weekend and then that Monday, from that time period on, we have had perfect behavior all the way through. He won. a little pin from the principal for his outstanding work. He got a trip to Sam's Town all paid for by the principal because.he has done so fantastically. Th~y're on a green card, yellow card, red card system, green card being the best. He used to be getting he was getting two to three red cards and a yellow card every week which was bad, bad. And he's gotten one red card in four and a half months. His teacher says that she wishes that she could get the stuff for every kid in her class. Just everybody comes into my work. Every day. I. hear it. [ hear feedback of how great he's doing. What is he doing, what are we doing. It's fantastic. Max James: Oh, that's a fantastic story: ... a fantastic story. Let's just take a moment here and let me see if [ can't get John to join us. John! John: Hello! Max James: Hello, John! John: How are you? A-22 Complaint 127 F.T.C.
EXHIBIT A Max James: Good, thank you for taking.time to join us. Really do appreciate it. John: Oh, you're welcome. I'd always suffered from -- which I didn't know what it was; I found out later it was ADD. I suffered from a real attention problem, and I'd get focused on certain things that w~re very confusing to me and it caused me a lot of problems. It caused me all kinds of problems in school. I remember the first time in second grade they were trying to figure out whether or not to let me go into third grade. And I was very distracted. Reading was a real challenge for me. Concentrating on the teacher, or even anyone in just a single conversation was a real challenge. And it turned out that obviously it was not personality. I thought it was just my personality, and I used to get into all kinds of predicaments because of it Create a lot of tension with my family and with learning in general. And to make a long story short, when I originally ~ed ·supplementary minerals, with the colloidal minerals, I started regaining control. Control that I had never really had before. And looking back, having dropped out of high school in the loth grade, looking back at all this, just all the unnecessary trauma.due to somethipg that was preventable, it is just neat -- it's neat to see that all these kids that I'd been around, and all these people I'd seen had similar disorders, .that they could have avoided it, and avoided the grief due to it, just from supplementing minerals. And I hear you guys have some other remedies for the disorder, and that's really exciting to me. I found that I really do -- I really do love enzymes, and I recently heard that the enzymes are helping the ADD cases, and I think that's pretty exciting too. I notice that when I get on any kind of sugars, or I eat thirigs that are not really good for me, I turn into a completely different person. And all of a sudden some of the prior problems and disorders and different symptoms set in pretty heavy. And it does take quite a bit of minerals, and enzymes really do help too, in breaking down the sugars for me. That's my little story. I tell you, when I got on minerals, the control that I had back when my life A-23 MAXF. JAMES 353 .f I 324 Complaint EXIDBIT A . I was very exciting. I started reading, and I'd get up and I just wanted to read. And just started feeding myself. Feeding myself all kinds of things that I didn't get before. Started having relationships that I hadn't had before with my mom and with my brother. With some friends that I used to - just not get along with real well. I think it was really due to deficiencies and the ~isorder. · It really was challenging for me to keep a relationship of any kind. And it's just really been a blessing to me.
Max James: John, would you say that it's had a significant effect on your business career? John: Oh, there's no question. You cannot be in business for any length of time successfully with the type of symptoms that ADD causes. I was always in business; I never did have a job. I've never had a job in my life, with the exception of a paper route. And I've always, I've always had some kind of business of some kind, and the reason I never had a job is because I could never keep any kind of job, or take any kind of orders, or concentrate on any one task for any length of tude. So I had to choose employment that was-- oh that would work around my . crazy schedule and habits and things. And so I had all kinds of different businesses, like I'd mow lawns, and I used to paint fences. And I got into automotive and painting things; things that were . craft oriented. And that was about all I could do. It definitely enabled me to do things that involved a lot of multi-tasking and concentrating on many different things versus just one singleminded thing. I was always good at what I did before, but I was just good at one single minded task at a time. And now I'm finding I'm able to do many things at once. And it definitely has impacted mY. business. No question about it.
Max James: John, thank you very, very much.
John: You're very welcome! A-24 Complaint 127 F.T.C.
EXHIBIT A Max James: For taking the time out, and joining us.
John: Bye-bye.
Max James: Uh-huh. Now I've learned a lot tonight And I very much appreciate your being willing to share all ofthis. I think one of the things that I'd like to end with here is Zoanne said, "Thank God." And it seems to me that we have properly titled what we're doing and the success of this formulation, this combination of natural nutritional supplements with eight, ten, fifteen calls I get a day and the hundreds and hundreds of parents and children now that are benefitting from this, we really can, I think, in good consciousness call it God's Recipe. And what most of us are doing Is two ounces of these colloidal minerals spread during the day, maybe first thing in the morning-and then sometime mid to late afternoon, 40 milligrams of this Proanthocyanidin, preferably one that comes from grape seed extract in combination with Ginkgo Biloba and we think that you should take those roughly at the same time that you take the mineral supplementation and then lastly, because there is no question that sugar is a major culprit in ADHD and ADD, we need to elinpnate sugar as much as possible from aji of our diets, but particularly from the diets of those that are very sensitive and impacted negatively by sugar and in order to help ease the problem of the sugar that we are unable to eliminate, these multienzyme capsules are phenomenal because as Dr. Kris has told us tonight, they assist mightily in metabolizing the sugar and getting that whole digestive process and the reaction of digesting sugar wider control.so that we don't get the mood swings and the metabolic swings. So we call that God's Recipe. Hopefully, with the information that you have been kind enough to share with us tonight, the recipe will spread and the resultant blessing will occur to as many people as possible. So, I would just say, again, thank you.
[music] A-25 ·' MAX F. JAMES II 355 'II 324 Complaint EXHIBIT A Voice: To discover how you can start your children on God's Recipe, contact the person who thought enough to give you this tape. All proceeds from this tape are donated to ADD -research.
[END OF TAPE SIDE B.] A-26 ~-----· ··--------L- --~- -- WELL BEING Journal VOL. VN0. 4 JULY/AUGUST 1996 Attention Deficit Disorder Reversed·ByMwdames Former Executive VP with Days Inn of America wants to rid the world of Ritalin, substitute.good nutrition and dietary supplements In Its place I au-lo4 t.lcc:lwc by Dr. Kri1 Van o..a.... lut )at, at ..t.ich time be llokd d..r in his pnclico, Nlli:nd ducup lbo -"-1 t.Dd pb)'lical paiAs ofwilh<!ra..al AJ acbool. lie wu IOU<d add be oft.cD dct.h wid> childrca wbo wcte ADHD. 1D maay c:uc:o (but - all), i1 wu his opiaiao d..r lawltcd ba:aauo be bod 10 S0 10 lbo ocboaJ Olficc 10 lb.t bot could 'pt bi.o 'Mcd'IM, Jie WU lbooe c:hildn:a wcte uabLc to Jidaqualdy p-.111p1 or si...,_,IDII if you oddcd a saod multi· allowecl10 lab ..WU in a.....,_ """"t.Dd oftm uoo u opm bock, t.Dd his claumau:a acauod CDZ)'III8 ..pplancm (0110 CiCIIIIa.IDina Nfliciall siUCCH~D)'Iue) 110 m.ir ctids, tballbc problcml bim o! dlolaliiJa. His clyd\ml::liclla lal"' his - bcUia ablo 10 rocalllhooc lbiap - cbildtalwould dit.t.ppoar, or as a miaimwn, be pally Rlllu<ed. · ouily COIIliDiiiO role """""'Y lUCio u 1bo ABC'1, mullipliCIIillllablcl, 1J1011iae WOlds, c:opilcll of lho-. cc.:., all oflllil l&oodioc to aio&al lou of 101f cst.oc:zil, add Ibis lou loa.dine 10 anaer, 1011Ha\'iq my for -.bid Ri1a1iD o! ~.., aix fnaiUalica, oociallllilbobavior, t.Dd allimol violoaoo, tbo ..,...W. t.Dd dootni<:lioa ll1ffi:t dlrouab absoluldyyean of cbnbsi:Ndtl llbauabl. "AR youlr)'iaa 10 ldlmc !ball CQU!d was 0n his life, I have awidod plllliD& my loll (add my lilmily) lhn>olaJ> d..r oigbmwe fn:al boll by Jimply ginia Upac pldualioa fn:allbc 6ch Jlf.do, lie was liOilliO T.......... IO vilil his ~ Cor •looa 3 bim t. I 00% Dt.lwaloupplaa:m? I dall'l bcliG¥e ill' But lbc pill add MdDcu o!lbooc IIICIIKiri<a stay Clllbo farm, a fll- of p'CIIl rr...laa! add aood Dlllrilico. lA 30 dt.ys, be oxporioaood a 60"-' '0with my SOD add lbc &mily durias his formoriw yean o! aaea aix dlrouab twclw would - 14 lbiJ wda~Jlplo, fn:also to 10 pouadt. AND HE NEVER WENT BACK ON RITALIN. 'IbaDb 10 s ltWIIIiaa disclooure IUbti4c fn:al myn¥1ecjoe•mre•. I docid<d 10 lalllbiJ idot.'with friends fn:al bani"""" ... his p&rt. 1101110 waodorNl, porio::al. t.Dd IU>domaod.iaa cducal.on, be IIUCOO:Ufiilly ~· M~, wbo bad a 1011, Ill RMiill, add- doille well at all. ID faa, be was !be aamc ap u my camcd a hi8b ICboal t.Dd a colkeo rGicaliCII.. He wu aJii>nlc:d lho oppoltWiily u a 11CDio< iA high ..., wbm cur drua odyucy bcpa. It was, Jimply put, a saod..acwslbad..,.,.. jowncy. ocbooiiO allcDd t. opocial ocbool, tpODIOftld by lbc Uai-.ity ollbc PaciJ!c, in which tho principal objOCiiYO WU to roalablilb lbo lllldoala' odf - · 0Do c:uOIIIy c:cali.auo 10 WOIIdcr wbol The diocovory of !be problem add !be dilploia u Sca..ford University ....-110 be bad II<WIIaood pormaDall damaae baa bem wrouabl upon his body add apiril, by i drva !hi! ws put advJu Ia DCWI. "He bas a "lc:anlioa disability" add be ia "bypc:rltiDctic' (IIOW <alloocl ADHD), however, be il jail Cor poypaiac yd yet. n foac oyr dliJdBA to tMc og 1 4aity byjt. SOindhiD.! ia CXU'Cmdy briabl add c:u be ucatcd 10 tbal be will be able 10 adoqlwcly Nlldioo in a aormal oocia1 terribly - wilb lbiJ pi<:lwc. a>vitmmoa:t add obtain AD. llf'Proprial.c educ:llicD..
Back 10 my fiioDda ill 1'- Tbcy .....,.S to baw tboir tDA'a pcdialridaA liiOIIilor tho 1bc tolulica ..u 0110 ofdwc choicco: We could~ bim in t.Jn<dical Dcility d..r bod l'lllb:liCil o! RilaliD.,.... t. 30 dly period. <XIIIIbiDod owilb tbo addiliCil of ccnaiD DIIUral ~ cCildtal wbo ......., ~ will> moalal diaabililica llf' to lbc modicallo\'CI o! •mcrao.•; Or we tupplaDaall. JU lbo cod a(lbia IDil poriod, lboy roponaflb.t lbo RilaJiD WU DO loll8ct beicc could allcmpl • IIUiritialal di.ollb.t ralricl.od - lioodo lb.t wcte .,.;,. ~ "' bim - CDiy al t&k.ca ud.lholldfcn b8d bciCID • ....m tb " bstaulor.borne, but at .ocbao1 ....t all ccber paa::o ""-be wu Rd. iDcludina ~ 11¥1 Clllet1ailomaJICWIIU. Or M c;cukl PVC him OQ tho ·n ofcbojcc• Riaalio . Now, lwDdnda t.Dd porlaapt maay lbowaDdl of cuoa Iaior, pu-. arc beariajJ jlowina rcpocU of lbcir cbildtooa'.........,. j>cillxo • ill lbo IIQdoalic a>Yiraamaoc u wo1l u !be JOCial For six yean, lbiJ dtut. wbida ia maro pcpuluty called "SPEED', d<:bydrucd my ICG't body 10 oovirmmada iD ..tW:b !bey ano ubolto pllticipaiiO. ID faa, wbilo I baw 1110 OMifi.od otariatical aw:b ao ex1a>1 tbal be CXlDO!aotly lid<.ed his dty lipo cauaial COIIIIIIDI choppiaa iDd bla::dilla· He evidoDoo 10 auppart lbiJ .....:lllliaa. alba lbao aaoodotal, lloo.w-bad t. aiDalo report back 10 JDO bad huge blue cirdco ,UDdor his cyco fn:allbo dna abuoe. He bad ao ~ becama !bat- -liaslo child baa bad 10 .-m to Rilalin a&r uyia& t. ~ ofdllao I>IIWal lll&ioouriSb<d add at tbo 111• of 12, wcigbat llllly 50 J>Oilllds. E"!''}' wockt:al add Ill bolidays, be DLilriboaal IIUpplommlt ..tW:b I ot.ll "God'all<dpe". MAX F. JAMES 357 3.24 Complaint EXHIBIT C God's Recipe - 1.) . 2 ·ounces of Colloidal Minerals.
2.) 40 milligrams of highly effective antioxidant- OPC capsule combined with Ginkgo Biloba:.
3.) ·Multi-enzyme capsule with every meal and with every significant snack, well as.
. i the elimination of as much I sugar as possible from the I i diet. . II * See back page for more I information EXHIBIT C Complaint 121 F.T.c. EXHIBIT C . I Information on our "God's Recipe" Products 1.) Colloidal Minenlls These are minerals in a·delicious liquid form that children of all ages really et:Yoy. The minerals are extremely easy forth~body to absorb as they are extracted from plant source deposits of vegetation origin. In fact, the absorption rate in the body of these minerals is much greater than elemental minerals taken in tablet fonn. There are over 60 minerals in every 32 ounce bottle.
l .) Antioxidant with Ginkgo Biloba:
This antioxidant is OPC and is.derived from the original patented grape seed extract. It has 50 times more antioxidant potency than vitamin E, and 20 times more than vitamin C. In combination with Ginkgo Biloba and other herbs, it can have a very positive impact_on one's health. 3.) Multi-Enzymes As the basis of all metabolic activity, enzymes are the driving force of our body's more than lso,ooo biochemical reactions. Enzymes are very important for effectiveiy metabolizing sugars, an activity of critical importance to ADIID·control. A-balanced blend of enzyuies and minerals maximizes the assimilation of nutrients.
WHEN TO TAKE GOD'S RECIPE Take one ounce of Colloidal Minerals and 1 capsule (20 milligrams) of the Antioxidant with Ginko Biloba first thing in the morning, and both ~ mid-t~late afternoon. Take 1 capsule ·of Multi-Enzymes with. each meal and with each significant snack. Eliminate sugar throughout the day and evening. . · We wish you and your tamily the best. If you have any questions, or would like to place an order, please call us at:
C- 2 i I I . .. <;c ....;....
MAXF. JAMES 359 324 Complaint EXHIBIT D GOD'S RECIPE TESTIMONIALS ."Good evening Mr. James: This is Shondra W. I bad talked to you about a ~oath ago to get information from you about how I could get 'my son off of Ritalin. And I just wanted you to know that I have had him completely off Ritalin for the past five days and I couldn't be more pleased with the way be is doing, be is doing so wdl He is such a pleasw-e to be with now. And he is feeling better bimself; be doesn't even want foods with sugar. And I just W1lllted to teu you~ You and I ready appreciate all of your help.' • (Shondra W., Texas) "De.r Mu: Your letter regarding your personal experience with ADliD was absolutely fabulous! It moved me to tears, because I could really relate to it with the problems I have been having with my own son with ADliD. He is now 16 years old, has been on Dexedrine for 2 years, and has lost 30 potmdsl He is developing a tolerance to the drug and his doctor has had to keep increasing his dosage from S mg to the current 20 mg. He is ltilliO!ing weight and I am very coricemed. He has just recently begtm using your 'God's Recipe' with (the doctor's) blessing. I have permission from my son's pediatric neurologist to distribute ('God's Recipe') product literature and tapes to other parents of children with ADD/ADliD.• (Chetyl G., Micbi· gao) "Dear Mu:: I am looking forward to hearing your presentation at the conference. I will be sending my first mailing to over 200 teachers and to approximately 150 homeschooling fami. lies, many of whom were motivated to homescbool because ofleaming difficulties which include ADD or ADHD. I know inaDy families who have mem~ who are also struggling with the symptoms shared by those diagnosed with Attmtion Deficit Disorder, as w-ell as the devastlting side effects they experience as a result of Ritalin. This article (My Experience... ") had such. an impact on me that I want to tell everyone about the news and encourage them to tell other - they deserve to be aware that olher choices are available!" (Tma M, Washington) "Dear Mu:: We started about four and a half months ago and this has been ihe greatest four and a half months my son and I have ever had, ever. My son is 6 1/2 years old. He was being brought to my world by the school principle because he was such a severe discipline problem that he was tmder consideration to be "lcick:ed out" of lim grade. I was accused by the school of not being strict eno~ with my son, not disciplining him enough. It was right after that meeting with the school teachers and counselors that I started him on the program (God's Recipe) and we have had perfect behavior since then. He woo an award pin fur his perfect behavior and he woo an all expense paid vacation from the principle for perfect behavior for four straight months. His teacher says that she wishes that she could get this (God's Recipe) for eve!}' lcid in class. This is the best 1hing that bas ever happened to us. I thank God that we have this. [ really, really dol (Zoanne, California) .( EXHIBIT D Decision and Order 127 F.T.C.
DECISION AND ORDER The Federal Trade Commission having initiated an investigation of certain acts and practices of the respondent named in the caption hereof, and the respondent having been. fuinished 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 respondent with violation of the Federal Trade Commission Act; and The respondent and counsel for the Commission having thereafter executed an agreement containing a consent order, an admission by· the respondent 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 respondent 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 respondent has violated the said 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 sixty ( 60) days, now in further conformity with the procedure prescribed in Section 2.34 of its Rules, the Commission hereby issues its complaint, makes the following jurisdictional findings and enters the following order:
1. Respondent Max F. James resides at 1857 Ridgeview Prive, Roseville, CA.
2. The Federal Trade Commission has jurisdiction of the subject matter of this proceeding and of the respondent, and the proceeding is in the public interest.
ORDER DEFINITIONS For the purposes of this order, the following definitions shall apply:
' $2- '4. ·' --~-,.........-- MAX F. JAMES 361 324 Decision and Order 1. "God's Recipe" shall mean the following New Vision products, either collectively or individually: "OPC Grape Seed Extract with an Herbal Blend," "Essential Minerals," and "Multi-Enzymes with Alfalfa/Barley Sprouts."
2. "Competent and reliable scientific evidence" shall mean tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area, that have been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in theprofession to yield accurate and reliable results.
3. "Clearly and prominently" shall mean as follows:
A. In an advertisement communicated through an electronic medium {such as television, video, radio, and interactive t:nedia 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. If1 addition to the foregoing, in interactive media the di~closure 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. In multipage documents, the disclosure shall appe~r on the cover or first page.
C. On a product label, the disclosure shall be in a type size and location on the principal display panel sufficiently noticeable for an ordinary consumer to read and comprehend it, in print that contrasts with the background against which it appears.
The disclosure shall be in u~derstandable language and syntax. Nothing contrary to, inconsistent with, or in mitigation of the disclosure shall be used in any advertisement or on any label. Decision and Order 127 F.T.C.
4. Unless otherwise specified, "respondent" shall mean Max F. James, and his agents, representatives and employees. · 5. "Drug" shall mean as defined in Section 15 of the Federal Trade Commission Act, 15 U.S.C. 55.
6. "Fo9d'' shall mean as defined in Section 15 of the Federal Trade Commission Act, 15 U.S.C. 55.
7. "Commerce" shall mean as defined in Section 4 of the Federal Trade Commission J\ct, 1.5 U.S.C. 44.
I.
It is ordered, That respondent, directly or through any corporation, partnership, subsidiary, division, or other device, in connection with the manufactur~ng, labeling, advertising, promotion, offering for sale, sale, or distribution of"God's Recipe," or any food, drug or dietary supplement, in or affecting commerce, shall not make any representation, in any manner, expressly or by. implication, that: A. Such products can cure, prevent, treat or mitigate Attention Deficit Disorder or its symptoms;
B. Such products can cure, prevent, treat or mitigate Attention Deficit Hyperactivity Disorder or its symptoms; or C. Such products are an effective alternative treatment to the prescription drug Ritalin for Attention Deficit Disorder and Attention Deficit Hyperactivity Disorder;
unless, at the time the representation is made, respondent possesses and relies upon competent and reliable scientific evidence that substaptiates the representation.
II.
It is further ordered, That respondent, directly or through any corporation, subsidiary, division, or other device, in connection with the manufacturing, labeling, advertising, promotion, offering for sale, sale, or distribution of any product in or affecting commerce, shall not represent, in any manner, expressly or by implication, that the experience represented by any user testimonial or endorsement of the product represents the typical or ordinary experience of members of the public who use the product, unless: .
A. At the time the representation is made, respondent possesses and relies upon competent and reliable evidence, which when MAXF.JAMES 363 ·i I 324 Decision and Order appropriate must be competent and reliable scientific evidence, that substantiates the representation; or B. Respondent discloses, clearly and prominently, and in close proximity to the endorsement or testimonial, either:
I ~ 1. What the generally expected results would be for users of the product, 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 CFR 25~ .0(b) .
III.
It is further ordered, That respondent, directly or through any corporation, partnership, subsidiary, division, or other device, in connection with the manufacturing, labeling, advertising, promotion, ·offering for sale, sale, or distribution of any food, drug or dietary supplement, in or affecting comme~ce, shall not make· any representation, in any manner, expressly or by implication, regarding: A. The safety of such product; or ,·'•i . B. The ability of such product to treat, cure, alleviate the symptoms of, prevent, or reduce the risk of developing any disease or. disorder; unless, at the time the representation is n1ade, respondent possesses ,.. and relies upon competent and reliable scientific evidence that substantiates the representation.
IV.
Nothing in this order shall pr?hibit respondent from making any representation for any drug .that is permitted in .labeling for such drug under any tentative final or final standard promulgated by the Food and Drug Administration, or under any new drug ·application approved by the Food and Drug Administration.
v.
Nothing in this order shall prohibit respondents from making any representation for any product that is specifically permitted in labeling for such product by regulations promulgated by the Food and - --- ~ ·- - ... - -- ··--- ·- Decision and Order 127 F.T.C. . Drug Administration pursuant to the Nutrition Labeling and Education Act of 1990.
VI.
It is further ord_ered, That respondent, and his successors and assigns 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 copymg:
A. All advertisements and promotional materials containing the · representation;
B. All materials that came into his possession from a distributor or any other source that were relied upon in disseminating the representation; and C. All tests, reports, studies, surveys, demonstrations, or other evidence in his possession or control that contradict, qualify, or call into question the representation, or the basis relied upon for the representation, including complaints and other communications with consumers or with governmental or con~umer protection organizations. ' VII.
It is further ordered, That respondent shall deliver a copy of this I order, or a summary in the form set forth as Appendix A to this order, to all current and future employees, agents, and representatives having responsibilities with respect to the subject matter of this order, .I and shall se~ure from each such person a signed and dated statement acknowledging receipt of the order. Respondent shall deliver this order, or a summary in the form set forth as Appendix A to this order, to current personnel within thirty (30) days after the date of service of this order, and to future personriel within thirty (30) days after the person assumes such position or responsibilities.
VIII.
It is further ordered, That respondent, for a period of ten ( 10) years after the date of issuance of this order, shall notify the Commission of the discontinuance ofhis current business or employment, or of his affiliation with any new business or employment. The notice shall include respondent's new business address and telephone ' - ~1 ..,..___ MAXF.JAMES 365 324 Decision and Order number and a description of the nature ofthe business or employment and his duties and responsibilities. All notices required by this Part shall be sent by certified mail to the Associate Director, Division of Enforcement, Bureau of Consumer Protection, Federal Trade Commission, Washington, D.C.
IX.
It is further ordered,. That respondent, and his successors and assigns, 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 he has complied with this order. X.
This order will terminate on March 3, 2019, 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:
• I A. Any Part in this order that terminates in less than twenty (20) years;
B. This order's application to any respondent that is not named as a defendant in such complaint; and C. Thi~ 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 b~tween the date suclLc.complaint is filed and the later of the deadline for appealing such dismissal or ruling arid the date such dismissal or ruling is upheld on appeal.
~---·- · ·- - Decision and Order 127 F.T.C.
APPENDIX A Dear Agent, ~epresentative, or Employee:
The Federal Trade Commission ("FTC") has conducted an investigation to determine whether Max James may have engaged in acts or practices which violate Section 5 of the Federal Trade Commission Act, 15 U.S.C. § 45, as amended, including,"but not limited to, false and unsubstantiated product claims for New Vision products. As a result of its investigation, the FTC has alleged that Mr. James (herein referred to as "respondent"), has made false and unsubstantiated representations in connection with the advertising, promotion, offering for sale, sale and distribution of a combination of three New Vision products known as "God's Recipe."
As a result of recent negotiations with the FTC, the respondent has agreed to a consent order ("order") with the FTC. The order is for settlement purposes only and does not constitute an admission of violations of law by Mr. James. Pursuant to the order, the respondent has agreed not to make certain claims for God's Recipe, or any other food, drug or dietary supplement, unless he can substantiate those claims.
Specifically, the order prohibits respondent from representing that God's Recipe, or any other food, drug or dietary supplement: 1. Can cure, prevent, treat or mitigate Attention Deficit Disorder or its symptoms;
2. Can cure, prevent, treat or mitigate Attertion Deficit Hyp~ractivity Disorder or its symptoms; or 3. Is an effective alternative treatment to the prescription drug Ritalin for Attention Deficit Disorder and Attention Deficit Hyperactivity Disorder;
unless respondent possesses and relies upon competent and reliable scientific evidence that substantiates the representation. The order also prohibits respondent, when advertising any food, drug or dietary supplement, from making any representation regarding the safety of such a product, or the ability of such product to treat, cure, alleviate the symptoms of, prevent, or reduce the risk of developing any disease or disorder, unless respondent possesses and relies upon competent and reliable scientific evidence that substantiates the representation.
MAX F. JAiviES 367 324 Decision and Order The order also prohibits respondent from claiming that user testimonials or endorsements represent the typical or ordinary experience of members of the public who use the product, unless respondent possesses and relies upon competent and reliable evidence · that substantiates the representation, or respondent discloses either (1) what the generally expected results would be for users of the product; 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.
The order specifies that respondent may make any representation for any drug that is permitted in labeling for such drug under any tentative final or final . standard promulgated by the Food and Drug Administration, .or under any new drug application approved by the· Food and Drug Administration. The order further specifies that respondent may make any representation for ·any product that is specifically permitted in labeling for such product by regulations , promulgated by the Food and Drug Administration pursuant to the Nutrition Labeling and Education Act of 1990.
- In addition. to the above provisions, the order requires that respondent provide a copy ofthis notice to each of his current and future agents, representatives and employees who have responsibilities with regard to the order's requirements.
If you have any questions or would like a copy of the order, you can contact me at f ] .
Very truly yours, [respondent's name] Complaint 121 F.r.c .