In the Matter of the Complaint Against COSVETIC LABS, or any variation thereof at P. O. Boxes 49024, 49087, 49303 and 49425, Atlanta, GA 30329 and at P. O. Box 10064, Atlanta, GA 30319 and at P. O. Box 11627, Atlanta, GA 30305 and at P. O. Box 52977, Atlanta, GA 30355 and at P. O. Box 95543, Atlanta, GA 30347 and at P. O. Boxes 20190, 20429 and 20499, Atlanta, GA 30325 and at P. O. Box 14048, Atlanta, GA 30324, BRASWELL, INCORPORATED, or any variation thereof at P. O. Box 10064, Atlanta, GA 30319, QUEST RESEARCH, or any variation thereof at P. O. Box 14009, Atlanta, GA 30324, COSVETIC LABS, or any variation thereof at P. O. Box 1097, Deerfield Beach, FL 33441 P.S. Docket Nos. 9/121, 9/122, 9/123 and 10/39 May 12, 1981 Quentin E. Grant Administrative Law Judge APPEARANCES FOR COMPLAINANT: Daniel S. Greenberg, Esq. Consumer Protection Division Law Department United States Postal Service Washington, DC 20260 APPEARANCES FOR RESPONDENT: John M. Creger, Esq. H. Robert Ronick, Esq. Katz, Paller & Land 470 E. Paces Ferry Road Suite 2000 Atlanta, GA 30363
These proceedings were initiated by Complaints filed on October 21 and December 19, 1980, alleging that Respondent is in violation of 39 U.S.C. 3005 by engaging in schemes or devices for obtaining money or property through the mails by means of false representa- tions concerning a product called APPETITE ELIMINATOR.
The specific false representations alleged to be made in Respondent's advertisements are as follows:
(1) That ingestion of the "Appetite Eliminator" will eliminate the sensation of hunger for most people;
(2) That ingestion of the "Appetite Eliminator" will eliminate the desire for food for most people;
(3) That ingestion of the "Appetite Eliminator" will prevent most people from overeating;
(4) That ingestion of the "Appetite Eliminator" will cause most people to lose weight;
(5) That ingestion of the "Appetite Eliminator" will cause the body to eliminate fat more rapidly than it would have if said product had not been ingested;
(6) That ingestion of "Appetite Eliminator" will cause the body to eliminate more fat than it would have if said product had not been ingested;
(7) That ingestion of "Appetite Eliminator" will cause most people to lose weight at the fastest rate possible for that person.
Respondent filed answers to the Complaints, denying the making and the material falsity of the alleged representations and being engaged in violation of 39 U.S.C. 3005.
To obviate the necessity for repetition of the testimony and pleadings, these cases were consolidated by Order dated January 22, 1981.
On motion of Respondent the location of the hearing was changed from Washington, D.C. to Atlanta, GA, where it was held from January 26 through 30, 1981.
The parties have filed written argument and proposed findings of fact and conclusions of law all of which have been fully considered and, to the extent indicated, have been adopted. Otherwise, they have been rejected as unsupported by or contrary to the evidence or because of their irrelevance or immateriality.
1. Respondent, under the names and using the addresses shown in the captions of these proceedings, is engaged in selling a product called APPETITE ELIMINATOR and obtaining money or property therefor through the mails. (CX-1 through CX-16; CX-189; CX-300; Tr. 188-213)
Attached hereto as Exhibits A through D are typical examples of Respondent's advertisements for APPETITE ELIMINATOR.
3. Respondent's answers in these proceedings denied the making of the representations alleged in the Complaints. At the hearing Complainant placed in evidence Respondent's advertisements for the product. Complainant's proposed findings of fact set forth in detail the language therein which it claims makes the representa- tions alleged. Respondent has not offered evidence, argument, or proposed findings of fact and conclusions of law that its advertising does not make such representations. On this issue its defense is confined to the argument that the representations made are either not false or, if false, are not materially so. On this state of the record the making of the representations as alleged in the Complaints is treated as admitted.
4. Complainant called as an expert witness Dr. William Ayers, a medical doctor, board certified in the field of internal medicine. At the time of the hearing he was Assistant Dean for Curriculum and Associate Professor, Departments of Medicine and Pediatrics at the Georgetown University School of Medicine, Washington, D.C. Of particular significance in these proceedings, Dr. Ayers has been since 1978 Medical Director of the Georgetown Diet Management Program. He spends about 20% of his time on the Diet Program, establishing procedures to be followed and furnishing direct medical care to about 100 patients, mostly obese. Additionally, Dr. Ayers has been, since 1977, Director of the Introduction to Clinical Science course for freshman and sophomore medical students. In this capacity he has overall planning responsibility for the clinical nutrition segment of the course and, additionally, lectures on the medical management of obesity. Dr. Ayers has not used in the treatment of obesity any of the products involved in these proceedings.
5. Respondent called as an expert witness Dr. J. T. Cooper, a medical doctor. He does not have a specialty but limits his practice almost 100% to the treatment of obesity. His experience consists of approximately 14 years of treatment, either short-term or long-term, of about 9000 obese patients. Dr. Cooper is a member and past-president of the American Society of Bariatrics, a group of physicians interested in the treatment of obesity. He annually gives a one-hour lecture on obesity to sophomore medical students at Emory University. He has written three lay books on obesity and has published for physicians a seven-volume set of cassette tapes on the subject of obesity.
6. Drs. Ayers and Cooper were in general agreement that most obesity is caused by consumption of more calories than the person needs to maintain daily activities, the excess calories being stored in the body as fat (Tr. 20, 21, 337, 338).
Dr. Ayers testified that people overeat for a variety of overlapping reasons:
". . . People can be conditioned by their upbringing, by their families. In many families in this country vigorous eating is considered to be a healthy sign. People are encouraged to clean their plates. Various social functions are centered around eating. People work diligently at the preparation of food that tastes good, smells good, looks good. And for a variety of these and other reasons, bombardment by advertising, social requirements, business lunches, et cetera, people are constantly in a situation where it is easy to overeat." (Tr. 21).
He testified that frustration, pressures of various kinds from business, home, school, etc., can also cause overeating (Tr. 21, 22).
Dr. Cooper traced the onset of overeating and resultant obesity in most overweight people to particularly stressful times such as pregnancy, surgery, a severe illness, or severe emotional shock. During these stressful periods something, at present not understood, happens to the body to destroy or change the delicate and intricate mechanism by which body weight is maintained. From that point on, probably for the rest of their lives, they must pay attention to their diets (Tr. 338).
7. Dr. Ayers and Dr. Cooper were in essential agreement that there is a difference between hunger and appetite as causes of eating. Hunger is basically physiological and refers to the body's physiological need for food manifested in the stomach's contractions known as hunger pangs. Appetite is a psychological desire for food as distinguished from the body's actual physiological need. Overeating and resultant obesity are generally the result of psychological factors manifested in appetite (Ayers CX-274; Cooper T. 339, 340, 347). In this connection Dr. Ayers said in his affidavit (CX-274) as follows:
"It is important, in evaluating any weight loss regimen, to bear in mind that overeating is generally due to factors other than actual hunger pangs. The psychological aspects of overeating are extremely important. Many people will overeat out of frustration in regard to work, family problems, or any of the other myriad situations that can cause frustration. Others may overeat in response to visual or olfactory stimulation, or merely in response to spoken suggestions. Yet others may overeat because of their upbringing, which may have taught them to always 'clean the plat,' and still others may have been brought up to think of food as a 'reward' and thus overeat when they are particularly happy about something. Complicating treatment of such overeating is the fact that many of these causes overlap, i.e., a person may well overeat for more than one of the above reasons. The instances of obesity due to overeating for psychological reasons greatly outweigh those instances due to actual physiological hunger."
8. Dr. Cooper testified as follows concerning appetite:
"The appetite is a very complex behavior pattern, and it's different with everybody. The appetite is subject to mood; it's subject to external influences. *** The most important things that we notice [with obese patients] --they are very vulnerable to depression, and very vulnerable to fatigue. They're very vulnerable to boredom, and they are very vulnerable to any sort of external cue. It can be visual; it can be olfactory; it can be tactile, even" (Tr. 342, 343).
Dr. Cooper's opinion was that depression and fatigue are the principal causes of overeating due to appetite.
9. Dr. Ayers and Dr. Cooper were in agreement that, excluding the rare cases of obesity due to illness, obesity is treated by getting the patient to reduce caloric intake below the body's needs thus forcing the body to resort to stored fat as its energy source, thus diminishing the fat stores and thereby producing loss of weight (Ayers Tr. 22; Cooper Tr. 341).
10. In the Georgetown Diet Management Program Dr. Ayers employs various diets having different caloric contents, works "Verh hard" with psychological counseling to modify patient behavior with respect to eating habits, and encourages mild forms of exercise. The psychological counseling is emphasized because it helps to identify the cues or situation which lead to overeating, enhancing the achievement of weight loss and, most important, keeping the weight off once it has been lost. Counseling involves suggesting alterations for individual patients to employ in their effort to modify their behavior with respect to eating patterns (Tr. 18, 19, 22, 23).
11. Dr. Ayers regards appetite suppression as relatively unimportant to a successful diet management program. In his program reliance is placed mainly on establishment of appropriate caloric intake levels and behavior modification through counseling (Tr. 114, 115).
12. Dr. Cooper placed much emphasis on the necessity of "intervention" in order to achieve success in weight loss. he described intervention as follows:
"Intervention to me can be anything from going to a meeting, as Weight Watchers does, to actually using a product or a medication with a patient, or to changing anything to do with their behavior pattern. It can be very minor, or it can be extremely involved, such as a daily diary, and two or three times a week checking that diary and the weight. But whatever is used, even the placebos that are used in a lot of studies, are effective in part" (Tr. 351).
13. Dr. Cooper also places each patient on one of about seven different diets (Tr. 349, 350). But he said that a diet by itself is almost never enough; some form of intervention is also required. The different types of intervention help patients to deal, to one degree or another, with the difficulty or remaining on diets (Tr. 351, 352).
14. He stated that a physician or other monitor of a dieting patient provides a benefit in the behavioral aspects of obesity. The training and monitoring of the patient is important and desirable because of human nature and the need for some sort of intervening ritual in weight reduction, whether the ritual be going to a doctor, getting on the scale, going to a meeting, or taking a product. He attributes more than half of his success in treating obesity to the fact that he acts as an intervening agent. Even with his intervention there is a hard core group of about 20% of his patients who do not stay on their diets (Tr. 475, 476). According to Dr. Cooper, his success rate in treatment, including drop-outs, is better than 50%. Not counting drop-outs it is better than 80%. Dr. Cooper defined success as a sustained weight loss of more than 20 pounds.
15. According to Dr. Cooper there is a "honeymoon" period that lasts 4 to 6 weeks in most weight patients produced by the novelty of the new program or treatment. Long term management requires getting away from the "magic" of medicine or weight loss and "getting down to the basic adult-type relation to reality." (Tr. 477, 478)
16. In addition to a diet, Dr. Cooper gives some sort of nutritional therapy to all patients, usually a multi-vitamin tablet, a calcium and Vitamin D2 tablet, a magnesium luconate tablet, and a capsule containing choline, methionine, and inisotol. He gives these both to prevent nutritional deficiencies and to "probably *** help speed up the enzyme reactions that are necessary for fat burning." Dr. Cooper identified the vitamin B and C groups as that part of diet supplementation necessary to speed up the fat burning process (Tr. 486-489, 490).
17. Dr. Cooper uses in treatment of obesity certain products similar to some of those sold by Respondent, including APPETITE ELIMINATOR, but at the same time uses additional nutritional supplements or other forms of treatment. He acknowledged that he is unable to differentiate results, if any, attributable to use of products similar to Respondent's from those that might be attributable in whole or in part to other treatment given his patients (Tr. 506, 507).
18. Dr. Cooper testified on cross-examination that the actual cause or loss of fat is caloric deficit and that the mere ingestion of one of Respondent's products is not going to cause the burning of fat or to eliminate more fat than would have occurred without it (Tr. 509, 514).
19. Following are pertinent portions of the label appearing on the container of APPETITE ELIMINATOR (CX-17):
Directions: As a dietary supplement, one teaspoonful in 1/2 glass of water one to three times daily. Contents: Contains dietary fiber derived from the refined husk of the psyllium seed, a natural grain material, Fructose, a natural fruit sugar, methylcellulose, gelatin, natural orange juice flavor and color.
20. Dr. Ayers testified as to the ingredients in Appetite Eliminator with regard to weight loss as follows:
(a) Dietary fiber is a non-absorbable fiber which adds bulk to the stool (but not to the stomach), and is considered to be a mild cathartic. Short of extreme overuse, it would have only a "very negligible, it any, effect on body weight loss." Moreover, even if it did cause a weight loss, said loss would be regained absent the patient's following a diet. He explained that the increased bulk in the stool is due to the fiber's absorption of water, and that this would have no effect on mobilizing the fat and reducing weight. Nor will it cause a feeling of fullness, inasmuch as the increased bulk is in the stool, rather than in the stomach. (Tr. 29-31)
(b) Fructose is a carbohydrate, a sugar. Dr. Ayers read into the record the following portion of his affidavit (CX-274 pertaining to fructose:
"For the purposes of this discussion, it is important to understand two aspects of blood sugar (glucose) metabolism: (1) the importance of glucose in the production of energy and (2) the role of glucose in the production of gastric contractions and as a regulator of food intake.
Energy for the essential functions of the body is derived from the metabolism of glucose, which is carried by the blood to the vital organs. Insulin, which is constantly being secreted by the pancreas, is required for glucose to enter the cells. Insulin is secreted, and enters the bloodstream in response to the presence and the rate of utilization of glucose.
Additional insulin is produced after eating, in response ti the increased presence of glucose in the blood. The glucose required for energy enters the cells of the appropriate organs, and the blood sugar level drops. Enzyme systems within the cells break down the glucose to produce energy. Glucose not required for near-term energy is stored as fat.
A drop in the blood sugar level below the normal circulating blood sugar level of 60-100 mg. percent stimulates specialized cells in the brain to initiate a sequence resulting in stomach wall contractions, which are recognized by the brain as hunger pangs, and which signal the body's need for food.
When the food is ingested, the blood sugar level rises, and the receptors in the brain signal the person to stop eating. The increased blood sugar level also stimulates the secretion of additional insulin which, as indicated above, is required in order to permit the glucose to enter the appropriate cells for the production of energy or for the storage of fat.
[Respondent] suggests that, because fructose does not stimulate the production of the insulin which is responsible for the lowering of the blood sugar level, substitution of fructose for glucose would avoid the hunger and lack of energy accompanying insulin production. [Respondent] suggests that this substitution will cause the body to maintain a steady blood sugar level, thereby preventing the effects associated with the glucose and insulin cycle, and will also keep the person from overeating.
The use of fructose will not have the desired effect. Firstly, fructose does not remain in the blood for long. It is rapidly removed from the blood and converted into glucose. This occurs within about 18 minutes of ingestion. 1 /
Secondly, the cells cannot
1 / Subsequent testimony indicated that this sentence should read:
"The half-life of fructose after absorption is approximately 18 minutes, i.e., half of the fructose absorbed into the blood is converted into glucose within 18 minutes, half of the remainder within the next 18 minutes, etc." (Tr. 45-47).
use fructose to produce energy. It must first be converted into glucose. Glucose derived from fructose is treated in the same manner as is ingested glucose. As such, it enters into the same metabolic reactions, including the stimulation of insulin production, with its subsequent lowering of the blood sugar level.
Thirdly, the receptors in the brain which signal that an adequate blood sugar level has been achieved are not responsive to fructose. Hence, a blood sugar level raised by fructose would not cause the person to stop eating." (CX-274, pp. 4-6)
Additionally, Dr. Ayers testified that a report provided by Respondent, received in evidence as CX-273 (Tr. 32, 51), supported his testimony. The report, "Dietary Sugars in Health and Disease, I Fructose," by Kimura, K.K. and Carr, C.J., dated October, 1976 (Tr. 33), stated at page 16 that fructose (along with xylitol and sorbitol) are rapidly converted to glucose by the liver (Tr. 43).
He further testified that the following portion of the Kimura report negated the common misconception that use of fructose by the body does not require insulin, and supported his conclusion that glucose derived from fructose requires insulin for its use:
"It should be reemphasized that while the glycolytic pathway of dietary fructose in the liver may be independent of insulin, the fact remains that much of the ultimate tissue utilization is via glucose and requires insulin." (CX-273, p. 17, Tr. 44)
Dr. Ayers testified that the Kimura article, at page 19, confirmed his opinion that fructose as such is not utilized by the muscle, heart, or brain, and must first be converted to glucose, as he had earlier testified (Tr. 48). 2 /
Additionally, the Kimura article noted that results in other species of animals are not necessarily applicable to man. Dr. Ayers explained that many of the original fructose studies had been done with rats, where results could be expected to be different from man (Tr. 48, 49).
Lastly, he testified that stores of fructose are minimal in the body. It is stored either as triglyceride, which is a fatty acid (a fat), or, after conversion to glucose, it may be stored as glycogen (Tr. 121; Tr. 53-59).
(c) Methylcellulose is a non-absorbably fiber which passes through the body without being broken down and absorbed. It absorbs water, and then swells, adding a sense of bulk in the stomach. It forms a mass, or "bolus," which then stimulates the intestine to pass it out of the system. The larger the bulk, the faster it will be expelled. Thus methylcellulose is used as a laxative because it increases intestinal motility, or intestinal movement (Tr. 54, 55).
Dr. Ayers testified that, despite claims that the resulting bulk could eliminate the desire to eat, people eat for a wide variety of overlapping reasons and that this bulk would touch only one of the "many, many overlapping causes" of overeating. Moreover, he noted, the larger the bolus, the more rapidly it would be expelled (Tr. 55, 56).
2 / Respondent's Dr. Wittman took issue with Dr. Ayers on the question of the body's use of fructose, stating that the human liver can use fructose without first converting it to glucose. However, Dr. Ayers was discussion the use of fructose in regard to the body's requirements for energy, both of which require that fructose be broken down into glucose. Dr. Wittman then conceded that Dr. Ayers' testimony was correct in regard to those points.
Dr. Ayers testified that his opinion was supported by an article entitled "The Effects of Bulk-Producing Tablets on Hunger Intensity in Dieting Patients," by Robin S. Shearer. That article, which appeared in Current Therapeutics , Vol. 19, stated, in pertinent part:
"Reduction in hunger intensity, not weight loss, is the only criterion by which bulking agents can be judged, for a successful weight reduction program is dependent on far more variables than hunger. Appetite, for example . . . . (Tr. 57)
Appetite, for example, is a sensation not necessarily related to hunger in all individuals, not even always related to hunger in any one individual.
Appetite is defined as a complex of pleasant sensations by which a person is aware of the desire for and anticipation of ingestion of palatable food; whereas hunger is defined as the complex of unpleasant sensations felt during deprivation, which impels a person to seek immediate relief by ingesting something.
Thus, appetite for foods may cause a person to continue eating at mealtimes even after hunger has been relieved. (Tr. 59)
Dr. Ayers explained that the significance of the article lay in the fact that it confirmed his testimony to the effect that, even if there were a reduction in the sensation of hunger, people would nevertheless continue to eat because of the many factors that contribute to appetite (Tr. 59, 60).
He testified that the remaining ingredients, gelatin and orange flavor and color, would have no effect in any weight loss regimen (Tr. 60).
21. When asked about the specific charges in the Complaint, Dr. Ayers testified that ingestion of Appetite Eliminator will not eliminate the sensation of hunger for most people, will not eliminate the desire for food for most people, will not prevent most people from overeating, will not cause most people to lose weight, will not cause the body to eliminate fat more rapidly than it would have if the product had not been ingested, will not cause the body to eliminate more fat than it would have if said product had not been ingested, and, lastly, that it will not cause most people to lose weight at the fastest rate possible for that person (Tr. 60, 61).
22. Dr. Ayers stated that his testimony represents the informed medical consensus (Tr. 102).
23. Dr. Cooper's testimony as to the effectiveness of the ingredients in APPETITE ELIMINATOR may be summarized as follows:
(a) Dietary fiber is an "interventionary thing" with a small satiety factor resulting from bulking in the stomach lasting maybe half an hour, "maybe enough time to modify the food intake pattern." (Tr. 417, 418)
(b) Dr. Cooper did not testify as to the effect, if any, of methylcellulose on appetite or hunger.
(c) Dr. Cooper has used fructose in his practice on more patients, according to him, than any other physician in the country. On the basis of theoretical considerations and his own clinical observations he is of the opinion that used in amounts less than 50 grams per day, fructose is a valuable adjunct in the treatment of obesity, both from a hunger-prevention standpoint and, in many cases, from an interventionary standpoint where the amount of fructose is relatively unimportant (Tr. 440).
Dr. Cooper's theoretical considerations underlying the foregoing opinion were found by him in four articles received in evidence (RX-9, 10, 11, 13). He stated that these articles "in one way or another show the desirable aspects of fructose, namely that it is absorbed slower than glucose, and even absorbed slower if it is combined with another sugar as it is in sucrose. And the desirability of the non-stimulation of insulin until after absorption and utilization [of fructose] in the liver." (Tr. 432) Respondent, through Dr. Wittman, introduced RX-3, a diagram illustrating Respondent's point that the metabolic pathway of fructose differs from that of glucose. The difference in metabolism of fructose and glucose is not disputed by Complainant. Drs. Cooper and Wittman theorize that while most of the glucose ingested passes swiftly through the liver immediately increasing the blood sugar level and stimulating through, 85% being metabolized in the liver and trapped in the liver cells where it is used to provide energy for the liver's metabolic activities and in the formation and storage of glycogen. The greater amount of glycogen in the liver resulting from ingestion of fructose, rather than glucose, would supply the blood sugar for the maintenance thereof as required by the body for its other activities. The substitution of fructose for glucose would result in a more steady blood sugar level over a longer period and minimal releases of insulin in response thereto avoiding the possibility of low blood sugar, and resultant hunger, resulting from secretion of excessive amounts of insulin sometimes caused by high blood sugar levels (Dr. Cooper Tr. 425-437; Dr. Wittman Tr. 243-256, 307-319).
24. There was received in evidence the report of a study made by Dr. Cooper, entitled "The Efficacy of Fructose, Fiber and High Quality Protein Supplementation on Dietary Compliance in an Outpatient Weight Reduction Program." (RX-2) The report of the study concludes as follows:
"This study demonstrates that patients on a 1,000 calorie diet which includes a dietary supplementation composed of protein, fiber, and fructose, can have a greater weight loss than patients who are put on a standard 1,000 calorie diet alone. These results support the hypothesis that specific types of dietary materials, particularly high quality protein, fiber, and fructose, can act as an aid to the motivated dieter and result in better dietary compliance on a reduced calorie regimen."
Dr. Cooper testified that he thought the study could assist in proving that fructose plays a part in a person's desire to eat but that he was not trying to prove, in that study, that fructose kills appetite. Instead, he said he was trying to show, and believed the study showed, that an intervening type of influence such as protein, fiber, and fructose would be effective in gaining patient compliance in a weight reduction program (Tr. 494).
The study involved two groups of 19 patients each, selected randomly from Dr. Cooper's new patients and assigned alternately to the two groups. Patients with illnesses were excluded. Partici- pants were not compensated. They were told that during the first three weeks of their diet program they would be studied to determine how their bodies reacted to different diets and then a decision would be made as to which diet they would continue with until reaching ideal weight.
The first week each of the two groups was placed on a different diet, one a standard 1,000 calorie diabetic diet (the S-diet), the other a standard 1,000 calorie diet modified to include two Diet Bullets (packet of fructose, fiber and high quality protein), and five 2-gram fructose tablets per day (the DB-diet). A cross-over design was used. Group 1 had the DB-diet the first week, the S-diet the second week, and the DB-diet the third. Group 2 had the S-diet the first week, the DB-diet the second week, and the S-diet the third week. During each of the three weeks the group on the supplemental diet (DB-diet) lost more weight than the group on the standard diet. Weight loss for all patient-weeks on the DB-diet was 2.9 + .6 lbs., versus .5 + 0.3 lbs. for all patient-weeks on the S-diet.
Patients were evaluated at weekly intervals. Each patient was questioned and instructed on each visit to increase their understanding of the importance of nutrition knowledge and other influences on eating behavior. Compliance was determined only as it could be inferred from weight change. They were asked to keep diaries on their food intake, noting reasons for deviation from diet.
Dr. Cooper approached the study with the opinion that the Diet Bullet was a useful way to intervene in a diet program (Tr. 421). Most of the patients were women. The average age of both groups was 39. Dr. Cooper thought the randomness of selection would take care of any menstrual effect on weight loss (Tr. 422, 423) but he admitted that he did not know what effect the menstrual cycle might have played and that randomization did not assure an equal balance of menstrual impact between the two groups (Tr. 503). Dr. Cooper acknowledged that with regard to the study he could not separate the effect of fructose from that of intervention and could not deny the possibility that the same results might have been achieved with a placebo (Tr. 505).
25. Dr. James S. Wittman testified for Respondent on the metabolism of fructose and on the scientific validity of Dr. Cooper's study employing the Diet Bullet. Dr. Wittman's doctorate is in biochemistry, received in 1970 from Tulane University. He is technical director for Batter-Lite Foods, Inc., a distributor of fructose products, in charge of quality control, new products, and liaison with the research community. Batter-Lite is a pioneer company in the use of fructose as a food product. Wittman's job also involves public relations activities because fructose has been on the market for only a few years, requiring a great deal of education in connection with its marketing. Prior to his employment by Batter-Lite, Wittman worked for Hoffman-LaRoche, Inc., for about 8 years as a research scientist and two years in an administrative capacity. His work for Hoffman-LaRoche included participation in the evaluation of scientific studies and review for appropriateness of the design of studies to test the particular thing that was being tested (Tr. 266).
26. Dr. Wittman testified as an expert in the evaluation of scientific studies and the design of clinical studies. It turned out that his first-hand experience in design of clinical studies was quite limited, the largest part of such experience having been in review of protocols prepared by others (Tr. 264-266). Wittman testified that the Cooper study is suggestive of supporting Cooper's theoretical argument that the ingredients of the Diet Bullet can play a role in satiety. However, he pointed out that the study was deficient in that it did not rule out the possibility of placebo effect, in that a week was probably too short for a change in diet to be fully adapted, and that some of the weight changes could be due to changes in water retention. Even if the study overcame these deficiencies, Wittman would want to see it replicated one or more times (Tr. 234, 235). Dr. Wittman testified that a double blind study is not necessary where a claim is made that a food product used in conjunction with an appropriate diet is useful in dietary management of obesity because weight loss measurement is objective. But he acknowledged that certainty as to the results of the Cooper study is lacking because of the variables present such as menstrual cycle, possible bias on the part of doctor and patients, possible placebo effect (Tr. 282-287) and because of the absence of a placebo (Tr. 287).
27. Following is a summary of Dr. Cooper's answers to questions concerning the specific allegations of misrepresentation:
Appetite Eliminator will not eliminate hunger (Tr. 510, 511).
Appetite Eliminator will not eliminate the desire for food for most people, although he thought it would modify it by eliminating "part" of it (Tr. 512). He testified on both cross-examination and on direct-examination that many people eat for psychological reasons (Tr. 512).
When asked about the representation that ingestion of Appetite Eliminator will prevent most people from overeating, Dr. Cooper stated that it "could." However, when asked whether it in fact would , he could not answer that question (Tr. 512, 513).
When asked whether ingestion of Appetite Eliminator would cause most people to lose weight, Dr. Cooper said that he thought it would do so by modifying the food intake pattern, and that the modification itself can cause weight loss. However, he stated that it did not necessarily mean that it would, in fact, do so (Tr. 513).
Dr. Cooper testified that ingestion of the Appetite Eliminator might cause the body to eliminate fat more rapidly than it would have if this product had not been ingested because of the possibility that it might modify the food intake. However, he admitted that it would not directly cause the body to eliminate fat. He emphasized again that the real cause of fat reduction is the caloric restriction, and that he was suggesting that the product would have the desired effect only through a chain of events. He was assuming for the purpose of his answer that the product would cause the person to eat less, which would cause a caloric deficit (Tr. 513, 514).
Similarly, he stated that ingestion of the Appetite Eliminator will not directly cause the body to eliminate more fat than it would have if the product had not been ingested (Tr. 514) and that ingestion of Appetite Eliminator will not cause most people to lose weight at the fastest rate possible for that person (Tr. 514, 515).
28. Dr. Cooper testified that his testimony represented the consensus of enlightened medical opinion in the field of bariatrics (Tr. 450).
Doctors Ayers and Cooper were in essential agreement that the dietary fiber in Appetite Eliminator would have little, if any, direct effect on body weight loss. Dr. Cooper's emphasis was on the interventionary value of the fiber. He gave only a "maybe" to the likelihood of the fiber's capacity to modify the food intake pattern as a result of bulking in the stomach.
Dr. Cooper did not express an opinion as to the effect of methylcellulose. Dr. Ayers concluded that any reduction in hunger sensation produced by bulking of this ingredient in the stomach would not likely prevent overeating which has "many, many overlapping causes."
As to the ingredient fructose, Respondent's evidence was insufficient to overcome the informed medical consensus expressed by Dr. Ayers that substitution of fructose for glucose will not avoid the hunger and lack of energy accompanying reduced blood sugar level resulting from insulin production. The journal articles introduced by Respondent to support Dr. Cooper's contrary opinion do not support to deal with the effect of ingestion of fructose on hunger. Rather, they report findings as to the relative insulin-independence of the metabolism of fructose versus glucose, the relatively slow absorption of fructose from the alimentary canal without causing abrupt changes in blood sugar levels, and its value as a sweetening agent in the diet of diabetics.
Dr. Cooper's opinion is based on purely theoretical conclusions drawn from those articles and on the results of his study of the effect of the use of a fructose, fiber and protein supplementation on dietary compliance in a weight reduction program (RX-2). This study has little, if any, scientific value for the following reasons, developed in large part in the testimony of Respondent's witness, Dr. Wittman: the study did not rule out the possibility of placebo effect; the study covered too short a period for a change in diet to be fully adapted; some of the weight changes could have been due to changes in water retention; the study has not been replicated; the procedure employed permitted possible bias on the part of doctor and patients.
Dr. Cooper's bias was evident in his testimony that he approached the study with the opinion that the Diet Bullet was a useful way to intervene in a diet. Bias on the part of patients could have been produced by the fact that they were told that they were being studied to determine how their bodies reacted to various diets to aid in a decision as to the diet with which they would continue.
Lack of adequate control is manifest in the facts that most participants were women under the age of 39 and that random selection did not assure an equal balance of menstrual impact between the two groups. Dr. Cooper admitted that he did not know what effect the menstrual cycle might have played.
1. Respondent solicits remittances of money through the mails to the names and addresses shown in the caption hereof for its product APPETITE ELIMINATOR.
2. The meaning of advertising representations is to be judged from a consideration of an advertisement in its totality and the impression it would most probably create in ordinary minds. Donaldson v. Read Magazine , 333 U.S. 178 (1948); Vibra-Brush Corp. v. Schaffer , 152 F. Supp. 461 (S.D.N.Y., 1957); Borg-Johnson Electronics v. Christenberry , 169 F. Supp. 746 (S.D.N.Y., 1959).
Express representations are not required. It is the net impression which the advertisement is likely to make upon purchasers to whom it is directed which is important, and even if an advertisement is so worded as not to make an express representation, if it is artfully designed to mislead those responding to it the mail fraud statutes are applicable. G. J. Howard v. Cassidy , 162 F. Supp. 568. See, also, Virginia State Board of Pharmacy v. Virginia Citizens Council , 425 U.S. 748 (1976).
3. Applying the foregoing standards, I find that Respondent's advertisements make the representations alleged in the Complaints.
4. Testing of the product is not required to sustain a complaint under 39 U.S.C. 3005. Without it, the opinion of a medical expert is sufficient evidence of falsity of advertising claims. Original Cosmetic Products, Inc. v. John Strachan and United States Postal Service , 459 F. Supp. 496 (S.D.N.Y., 1978) aff'd w/o Op. 2d Cir., 78-6165, 4/30/79.
5. The offering of a product for use with a given condition implies that it will cure or effectively treat that condition. Aronberg v. F.T.C. , 132 F.2d 165, 167 (7th Cir., 1942). See, also, Rhodes Pharmacal Co., Inc. v. F.T.C. , 208 F.2d 382, 386 (7th Cir. 1953), modified on other grounds , 348 U.S. 940 (1954).
Even where statements as to the necessity of vitamins or other nutrients may be literally true, Respondent's failure to disclose that there are other, more common causes of the condition in question, misrepresents the likelihood of successful treatment. S.S.S. Co. v. F.T.C. , 416 F.2d 226, 228 (6th Cir. 1969). See, also, U. S. v. Vitasafe Formula M , 226 F. Supp. 266, 277 (D.N.J. 1964), modified on other grounds , 345 F.2d 864 (3d Cir. 1965), cert. denied , 382 U.S. 918. Of course, the question to be decided is not whether the product is worthless, but whether it will do what is promised. Borg-Johnson Electronics v. Christenberry , supra . The fact that a product may put the purchaser in the proper frame of mind to diet is no defense to a charge of misrepresentation where the advertising implies that the promised result will be due to the product itself, rather than to the diet. Stauffer Labs, Inc. v. F.T.C. , 343 F.2d 75, 82-83 (9th Cir. 1965).
6. Based on the testimony of Dr. Ayers, representing the informed medical consensus, I conclude that the representations made by Respondent as to the product APPETITE ELIMINATOR are false in fact. To the extent that Dr. Cooper did not concur in Dr. Ayers' opinions as to the lack of efficacy of the product, I reject his opinions as not being supported by valid scientific proof. In finding falsity I do not find that the product is not, or may not be, useful as an interventionary, psychological, ritual in weight reduction as described by Dr. Cooper. But I do not read Respondent's representations as going to the interventionary value of the product. Rather, they represent that the product will directly effect the results claimed.
7. The representations made by Respondent, as found, are material in that their natural tendency is to induce readers to purchase the product.
8. Complainant has established its cases by a preponderance of the reliable and probative evidence of record.
9. Respondent is engaged in the conduct of schemes for obtaining remittances of money through the mails by means of materially false representations in violation of 39 U.S.C. 3005.
10. An order pursuant to that statute in the form attached should be issued against Respondent.