May 05, 1988
In the Matter of the Complaint Against
HEALTH CARE PRODUCTS, INC.,
P. O. Box 271448,
Tampa, FL 33688-1448
HEALTH CARE PRODUCTS, INC.
d/b/a ANDERSON PHARMACALS,
P. O. Box 271344,
Tampa, FL 33688-1344
P. O. Box 150,
Tampa, FL 33601-0150
BARBARA W. LARKINS,
P. O. Box 271344,
Tampa, FL 33688-1344
15414 E. Burrell Drive,
Lutz, FL 33549-9999
P. O. Box 271448,
Tampa, FL 33688-1448
P.S. Docket No. 28/90
Quentin E. Grant Chief Administrative Law Judge
APPEARANCE FOR COMPLAINANT:
Jerry Belenker, Esq.
Alan B. Ostroff, Esq.
Consumer Protection Division
Washington, DC 20260-1100
APPEARANCE FOR RESPONDENT:
Marion E. Harrison, Esq.
840 The Watergate
2600 Virginia Avenue, N.W.
Washington, DC 20037-1905
The complaint filed in this matter charges Respondents with violation of 39 U.S.C. 3005. It alleges they are engaged in a scheme or device to obtain money or property through the mails by means of the following materially false representations as to their weight-loss product Cal-Ban 3000 (Cplt., parag. 8).
(a) Ingestion of Cal-Ban 3000 will cause signi- ficant weight loss in virtually all users.
(b) Ingestion of Cal-Ban 3000 will cause signi- ficant weight loss without discipline, calorie restricted diets, or exercise.
(c) Cal-Ban 3000 prevents foods from being converted into stored fat.
(d) The weight loss claims for Cal-Ban 3000 are supported by the results of scientifically sound clinical studies.
(e) An obese person who takes Cal-Ban 3000 may reasonably expect to lose a significant amount of weight while continuing to eat all he or she wants.
Respondents' answer to the complaint admits that Health Care Products, Inc. (Health Care), doing business as Anderson Pharmacals (Anderson) and Cal-Ban 3000, markets Cal-Ban 3000 by means of adver- tisements typified by Exhibit 1 to the complaint and solicits remittances of money through the mails to Anderson Pharmacals, P. O. Box 271344, Tampa, FL 33688 and Cal-Ban, P. O. Box 150, Tampa, FL 33601; admits that Barbara W. Larkins is president of Health Care, Anderson, and Cal-Ban 3000; denies that Respondent Carl Anderson is an individual active in the conduct of Respondents' business and that Ronald Anderson is a director of Health Care; states that claims made for Cal-Ban 3000 in Respondents' advertisements cannot be summarized as alleged in paragraph 8 of the complaint; and denies the falsity of the representations alleged in paragraph 8. The answer asserts as affirmative defenses the money back guarantee contained in Respondents' ads and the unconstitutionality of 39 U.S.C. 3005.
A hearing at which both sides presented evidence was held in Washington, DC on December 15, 16, and 17, l987. Complainant's witnesses were Dr. William D. Ayers, a physician, and Postal Inspector James Lowe. Respondent's witnesses were three physicians, Dr. Jaakko Tuomilehto, Dr. Anthony R. Leeds, and Dr. Alban Comeau; biochemist Dr. Jack Hegenauer; and marketing professor Dr. Lynda Maddox.
The parties have filed proposed findings of fact, conclusions of law and written argument all of which have been fully considered. To the extent indicated they have been adopted. Otherwise, they have been rejected as irrelevant or contrary to the evidence.
Respondent's Motion to Dismiss for Denial
of Due Process
From page 4 through page 14 of their brief, Respondents argue for dismissal of the complaint based on denial of due process. Essentially, their argument is that they were irreparably prejudiced in preparation for the hearing by denial of their discovery requests.
The Complaint was filed on September 3, l987. The original hearing date was October 5. Respondents' answer was filed on September 23 and on their accompanying motion, based on schedule conflicts of their counsel, the hearing was continued to October 23. As the result of another motion for continuance by Respondents, based on unavailability of a witness, the hearing was continued to November 6. On November 4, Marion R. Harrison, Esq., first appeared in the matter and requested a further continuance, stating that he had been retained on November 2, would have an initial meeting with his clients on November 10, and could not possibly prepare for a November 6 hearing or engage in settlement negotiations prior to that date. His motion was granted. The hearing was continued for the third time at Respondents' request to December 15.
On December 3, three months after filing of the complaint, Respondents made their first discovery request, to take discovery depositions of Complainant's expert witness, Dr. William R. Ayers, and any other expert witnesses to be called by Complainant and for production by Dr. Ayers, at his deposition, of various categories of documents (statements, sources consulted, contracts or other agreements with United States Postal Service, etc.). The motion was denied on December 7 on the ground that the applicable Postal Service rules do not provide for discovery depositions and, further, that Respondents had not shown good cause in view of the fact that much of the information they sought was contained in the affidavit of Dr. Ayers filed in the related U. S. District Court proceeding under 39 U.S.C. 3007. The motion could also have been denied, properly, for untimeliness since, under 952.21 of the rules, discovery must be initiated not later than 5 days after filing of the answer.
On December 14, the day before the hearing, Respondents filed another production request relating to Dr. Ayers, covering the same documents requested in the December 3 motion and adding the Jencks Act (18 U.S.C. 3500) as authority for compelling production of Dr. Ayers' prior statements. Although this motion was also extremely untimely, it was partially granted.
The circumstances outlined above make it abundantly clear that any failure to obtain discovery was due to Respondents' failure to make appropriate and timely requests therefor and that there has been no denial of due process to them. Respondents' request for dismissal of the complaint on due process grounds is denied.
FINDINGS OF FACT
1. Respondent Health Care Products, Inc., does business as Anderson Pharmacals and Cal-Ban 3000 (Stip. filed 12/15/87, 6, 7; Tr. 5).
2. Respondent Barbara W. Larkins is president and owner of Health Care (Stip. 8).
3. Respondent Ronald Anderson is vice president and director of Health Care (CX-3).
4. Respondent Carl Anderson is manager of Health Care and active in its promotion of Cal-Ban 3000 (CX-4, 5; Tr. 406-408).
5. Respondents market a weight-loss product called Cal-Ban 3000 by means of television advertisements and advertisements appearing in publications of general circulation. The advertisement attached to the Complaint as Exhibit 1 is typical of those recently employed by Respondents (Cplt. 6; Ans. 6). A copy of this advertisement is attached hereto as Exhibit A.
6. Respondents' advertisements solicit the public to order Cal-Ban 3000 by sending money or credit card information through the mails to Anderson Pharmacals, P. O. Box 271344, Department M31, Tampa, Florida 33688. They have also rented P. O. Box 150, Tampa, Florida 33601 for receipt of money through the mails for sales of Cal-Ban 3000 (Stip. 3, 4, 5). Respondents receive remittances of money for Cal-Ban 3000 at these addresses (Ans. 7).
7. At the hearing, on motion of Complainant, without objection by Respondent, post office boxes 273477, Tampa, FL 33688-3477 and 271266, Tampa, FL 33688-1266 were added to the complaint. Complainant introduced in evidence as to these boxes applications therefor signed by Barbara W. Larkins (CX-6, 7). Only as to box 271266 does the evidence indicate that it was used to receive remittances, or credit card information, or orders for Cal-Ban 3000.
Expert Testimony on Interpretation
8. Lynda M. Maddox, Ph.D., testified for Respondents as an expert witness on advertising interpretation (Tr. 574, 575). Dr. Maddox has B.A. and M.A. degrees in advertising from The Pennsylvania State University, and a Ph.D. degree in communications (advertising major) from Southern Illinois University. She is an associate professor of business administration at George Washington University, currently on sabbatical leave and teaching at the University of Goteborg in Sweden. Her particular area of expertise is deceptive advertising. She maintains a consulting practice in which she helps clients prepare advertising and analyzes the effectiveness of advertising they use. A significant amount of this practice involves advertising copy related to drugs or medically- related items (Tr. 571-575; RX-52).
9. On direct examination, Dr. Maddox's attention was confined by counsel to the words "WITHOUT DIETING .. at the top of the ad (Tr. 576) and to the words "GUARANTEED 100%" in the upper right hand corner, the words "unconditional 100% money back GUARANTEE" in the lower left corner, and the words "We guarantee it]" at the end of the first paragraph of text at the top of the ad (Tr. 578-579). Within that restriction, she testified that the ad says basically, "you can lose weight without dieting, but if you do not, for whatever reason, you have the opportunity to receive a full refund on the product" (Tr. 579, 580). Dr. Maddox treated the word guarantee as the "red flag" of advertising, i.e., "[the product] may not work for you" (Tr. 579).
10. On cross-examination, Dr. Maddox refused to interpret the word guarantee, no matter where it appears in the ad, as anything more than a "frequency repetition" of the money back promise should the product not work (Tr. 592, 593). At one point, she even appeared to say that the average reader would pay little, if any, attention to the words "GUARANTEED 100%" in the upper right corner and would notice first, the illustration of the young lady, second, the headline "NEW MEDICAL BREAKTHROUGH] LOSE UP TO 50 POUNDS WITHOUT DIETING" and third, because of the attraction of the word FREE, in the bottom middle of the ad, the money back guarantee and the order form in the bottom corners (Tr. 597-601). She said the graphic outline of the money-back guarantee makes it stand out (Tr. 598). She conjectured that if the ad were subjected to copy testing it might be found that the word FREE at the bottom stands out more than anything else in the ad because it is the most read word in advertising (Tr. 599, 600). Dr. Maddox agreed, however, that the overall conspicuousness of the the portions of the ad containing the word guarantee without reference to money back was greater than the portions in which the word is used in conjunction with a refund (Tr. 597).
11. On cross-examination, Dr. Maddox's attention was directed to certain portions of the ad not touched on in direct examination. These were, among others, portions of the ad that say "eat all you want and still lose weight," you can eat all your favorite foods and still lose weight," "your weight loss in automatic," and "a clinical study of the Cal-Ban 3000 formulation showed 100% success] Everyone lost weight." She was asked, repeatedly, if it is a fair conclusion, considering the totality of the quotes, that the average reader of the ad would interpret it to mean that simply taking the product, without doing anything more, will cause automatic weight loss. Her answers were always qualified, based on apparent reluctance to go beyond her original interpretation, on direct examination, that the ad simply says that taking the product, without following a diet, will cause weight loss (Tr. 605-610). She would not attach importance to the quotes because the question called for a word for word reading of the ad which, she said, would not be done by the average consumer who would read the ad in terms of total import, rather than line-by-line, and would remember only two things: "They're going to lose weight without following a diet, and if they don't, they get their money back" (Tr. 611, 615).
The Alleged Representations
12. Rejecting as unrealistic Dr. Maddox's opinion that the average consumer would, in effect, merely skim the ad, noting only illustrations, headline, the word "FREE," and the money-back guarantee (see "DISCUSSION," below), I find that the ordinary reader interested in losing weight, would read most of the ad, almost certainly those portions quoted below, found to make the represen- tations alleged in paragraph 8 of the complaint (underscored below).
"(a) Ingestion of Cal-Ban 3000 will cause signi- ficant weight loss in virtually all users
This representation is made in the following portions of the ad and the illustrations:
"LOSE UP TO TO POUNDS . . . powerful, fast acting weight-loss compound . . . powerful bio-active ingredient . . . 'short circuiting' the fat-building process . . . you will reach your weight-loss goal this time ... FACT: A clinical study of the Cal-Ban 3000 formulation showed 100% success] Everyone lost weight . . . everyone lost a substantial amount of weight"
"(b) Ingestion of Cal-Ban 3000 will cause significant weight loss without discipline, calorie restricted diets, or exercise ."
This representation is made in the portions of the ad quoted under representation (a), supra , and the illustrations, coupled with the following:
"...virtually eliminates dieting, eliminates strenuous exercise . . . FACT:
You can eat all your favorite foods and still lose weight] . . .you will automa- tically lose weight. There is no calorie counting, no tortuous exercises ... Eat all you want and still lose weight * * * Lose weight whether you exercise or not ... (Most diets fail because they require ongoing discipline and will-power. This formula doesn't.)"
"(c) Cal-Ban 3000 prevents foods from being converted into stored fat ."
This representation is made in the following portions of the ad:
"The powerful bio-active ingredient in Cal-Ban 3000 . . . works by 'short circuiting' the fat-building process before your body can turn excess calories into figure-destroying fat . . . . Cal-Ban 3000 bonds with the food you eat and prevents absorption of a substantial portion of the calories forcing your body to burn fat, flab and cellulite for energy. ... (The formula 'bonds' with food preventing absorption of much of your caloric intake)"
"(d) The weight loss claims for Cal-Ban 3000 are supported by the results of scientifically sound clinical studies .
This representation is found in the following portions of the ad:
"In a major medical breakthrough, the scientific community has at last developed a powerful, fast-acting weight-loss compound that virtually eliminates dieting, eliminates strenuous exercise and most importantly eliminates fat, flab and cellulite] . . .
Fact: A clinical study of the Cal-Ban 3000 formulation showed 100% success. Everyone lost weight. A team of European doctors tested a number of overweight women. In the group that took the Cal-Ban 3000 formulation, everyone lost a substantial amount of weight. The amazing results of this study published in The British Journal of Nutrition , Vol. 52,
pp. 97-105, stated:
Bodyweight was significantly reduced during the study even though the patients were specifically asked not to alter their dietary habits."
"(e) An obese person who takes Cal-Ban 3000 may reasonably expect to lose a significant amount of weight while continuing to eat all he or she wants ."
This representation is found in the photographs of David Gaudet and the text of his testimonial together with the following portions of the ad:
"LOSE UP TO 50 POUNDS WITHOUT DIETING] . . .
Fact: You can eat all your favorite foods and still lose weight. . . Fact: Your weight is automatic] Just take your Cal-Ban 3000 every day and you will automatically lose weight. There is no calorie counting . . . A team of European doctors tested a number of overweight women. Body weight was significantly reduced during the study even though the patients were specifically asked not to alter their dietary habits. . . Cal-Ban 3000 lets you eat all you want and still lose weight]
13. The representations found to be made by Respondents' ad are material because their tendency is to persuade readers to purchase Cal-Ban 3000.
The Product, Definition of Terms,
14. Cal-Ban 3000 consists of 1,000 mg. (1g.) tablets of "Cyamopsis Tetragonolobus", commonly known as guar gum. The directions on the label call for the ingestion of 15g. per day as follows:
4 TABLETS 20 to 30 minutes before breakfast with 8 oz. glass of water, coffee or tea.
5 TABLETS 20 to 30 minutes before lunch with 8 oz. glass of water, coffee or tea.
6 TABLETS 20 to 30 minutes before dinner with 8 oz. glass of water, coffee or tea. (CX-1; Tr. 47, 48).
15. Guar gum is a water soluble gel-forming fiber indigestible in the human gastrointestinal tract (Tr. 50).
16. Guar gum is a very important product having several well-accepted medical uses, e.g., as a bulk-laxative, a cholesterol lowering agent in patients with high blood lipids, and in retarding the absorption of sugar and blunting the peak and valley relation- ship between sugar and insulin in insulin-dependent diabetics (Tr. 51, 52; CX-2, p. 4).
17. Guar gum, along with other fibers, is the subject of intense scrutiny in the management of obesity (Tr. 51).
18. It is very difficult to study guar gum in the precise setting of human weight loss in carefully controlled, double blind clinical studies because there is no acceptable placebo having the same physical characteristics (Tr. 54) and monitored control of food intake of subjects is difficult, if not impossible, to achieve (Tr. 208).
19. Obesity is weight above a certain standard due to accumulation of stored energy in the form of fat in cells (Tr. 49, 50, 84). Clinical obesity is weight 15 to 20 percent above an accepted standard (Tr. 84, 85).
20. Obesity is a very complex clinical problem to manage. It has many facets, among them dietary, psychological, physiological, environmental, and genetic (Tr. 49).
21. To lose weight, an obese person must create a negative energy balance, that is, fewer calories must be taken in, more must be used, or both (CX-2, p. 2). The usual approach to bringing about weight loss in an obese person is to use some method to reduce energy intake or increase energy expenditure or both (Tr. 68).
22. Many obese people continue eating even after they would be expected to feel full. There is evidence that their eating behavior is different from non-obese people (Tr. 567).
Qualifications of Expert Witnesses on Falsity Issues
Dr. William R. Ayers
23. Complainant's expert witness, William R. Ayers, is a physician. He received his B.S. and M.D. degrees at Georgetown University and is board-certified in internal medicine. He is Associate Dean for Undergraduate Medical Education and Associate Professor in the Departments of Medicine and Pediatrics in the Georgetown University School of Medicine. He is a co-founder, and was for five years (1978-1983) medical director, of the Georgetown Diet Management Program (now the Georgetown University Diet Management and Eating Disorders Program), a center for treatment and research in weight control and eating disorders. In this program, he designed and participated in clinical studies for the evaluation of innovative approaches to the control of obesity. He has a special interest in weight control and has published articles in that field. Dr. Ayers directs and teaches a course in clinical nutrition required of all medical students at Georgetown. He keeps current in medicine, including weight control, by regularly reading respected medical journals.
Dr. Ayers is familiar with literature on guar gum and has used guar gum in his own practice in treating insulin-dependent diabetics and as a lipid lowering agent (Tr. 51, 52). Articles relied on by Dr. Ayers for most of his opinions as to the current status of the use of guar gum in weight reduction programs were introduced as CX-10; Tr. 110, 111).
Dr. Jaako Tuomilehto
24. Dr. Jaako Tuomilehto is a citizen of Finland. He is a professor and director of the Department of Epidemiology of the National Health Institute in Helsinki. He has an M.D. degree and a Ph.D. degree in community health. The Department of Epidemiology deals mainly with population-based national and public health problems, investigating major diseases with a view to prevention and effective treatment. Dr. Tuomilehto is an experienced researcher, obesity being one of his main research areas as a result of his involvement in a national program to find strategies for prevention of diabetes and coronary heart disease. Obesity is one of the risk factors in these diseases, along with high cholesterol and glucose levels. He became interested in finding ways to reduce these factors. While reviewing relevant world literature he became aware of dietary fibers, particularly guar gum, as having properties which can prevent, simultaneously, cholesterol and blood glucose (Tr. 162, 163). Interest in guar gum has resulted in a series of scientific pieces of work and publications, major medical and clinical break- throughs. Dr. Tuomilehto is an expert in the field of guar gum, its properties and the effects of its ingestion on the various risk factors, including obesity (Tr. 167).
Dr. Jack Hegenauer
25. Dr. Jack Hegenauer has been a research biologist in the biology department of the University of California, San Diego, since 1972. He has an M.S. degree in zoology and biochemistry and a Ph.D degree in biochemistry and biophysics from the University of Michigan. He did post graduate study in the fields of biochemistry and nutrition at the University of California, San Diego (Tr. 245-247; RX-9). Dr. Hegenauer has been the lead investigator on two projects involving human nutrition and human populations. He is a member of a team studying and treating human subjects for nutritional disorders and is doing dietary and nutritional counseling for weight control in the metabolic unit at the University of California, San Diego Medical Center. He has conducted clinical experiments on humans. Most of his nutritional research has pertained to trace elements (Tr. 253). He has been involved in some unreported laboratory studies evaluating the role of fiber in malabsorption of trace elements (Tr. 256, 257).
Dr. Hegenauer has been actively following the literature on fiber and biochemistry and the clinical application of fibers since 1984 in connection with teaching fiber nutrition to medical students and investigations he has conducted. He has reviewed literature on fiber for many different applications, from food technology to use of fibers in weight control (Tr. 272, 273).
Dr. Hegenauer was offered and received as an expert witness on nutrition (Tr. 246, 270).
Dr. Anthony Richard Leeds
26. Dr. Anthony Richard Leeds is a British citizen. He received his medical degree in 1971 from the Middlesex Hospital Medical School. He received a master of science degree in biochemistry in 1977 from Chelsea College, University of London.
In l974, Dr. Leeds began research on dietary fiber. Since then, most of his work has been in that area. Since 1979, Dr. Leeds has been a lecturer in the Department of Food & Nutritional Science at King's College of the University of London. During this period he has continued a clinical practice, particularly in areas of metabolic medicine related to fiber, obesity management, hyperlipidemia, and diabetes. He continues to run research programs investigating questions related to dietary fiber, among them the question of satiety, metabolism and hyperlipidemia (Tr. 522).
Dr. Leeds is a member of the Association for the Study of Obesity, the Nutrition Society, and the Forum on Food and Health of the Royal Society of Medicine. He is also a member of the European Association of Scientific Editors having been co-editor of the Journal of Plant Medicine from 1981 to 1986.
Dr. Leeds has edited a book entitled "Dietary Fiber Perspec- tives: Reviews and Bibliography One" (John Libbey and Company Ltd: London 1985) and is preparing for publication a second volume with the same title to be published in 1988. He has, by special invitation, delivered numerous addresses on various aspects of dietary fibers, including treatment of obesity, to scientific gatherings in the United States, Canada, and other countries. He has published a large number of full papers, reviews, leading articles, and abstracts on the medical uses of fibers, including guar gum (RX-10).
Dr. Leeds was offered and accepted as an expert in nutrition and, more particularly, on the use of fibers in weight control (Tr. 525, 530).
Opinions of the Expert Witnesses on Falsity Issues
Dr. William P. Ayers
27. The literature relied on by Dr. Ayers for his opinions as to the current status of the use of guar gum in weight reduction programs was introduced as CX-10 (Tr. 110-111). He believes that from 75 to 90 percent of the world's experts on the use of guar gum and other fibers for weight reduction are named in this literature (Tr. 123-127). They include Dr. Tuomileheto and Dr. Leeds who testified for Respondent.
Dr. Ayers believes that none of the studies which he located, and none of those introduced in evidence by Respondent to which he was referred on cross-examination, provides valid scientific substantiation for the claim that ingestion of Cal-Ban 3000 will, by itself, bring about significant weight loss. He also believes there is no support for the claim that the product short circuits fat building.
28. Dr. Ayers was critical on several grounds of the study mentioned in Respondents' ad. This study was done by Dr. Marcin Krotkiewski of the Department of Rehabilitation Medicine, Sahlgren's Hospital, University of Goteborg, Goteborg, Sweden. It was published in the British Journal of Nutrition (1984), Vol 52, pages 97-105, and was introduced in evidence as part of CX-10 and also, by Respondent, as RX-46. The study involved 9 obese individuals who were asked not to change their dietary habits and were given guar gum treatment (10g twice daily before two main meals) over an eight-week period. Mean body weight before treatment was 95.6 ( + .31 SEM). Mean body weight after 8 weeks of guar gum treatment was 91.3 ( + 2.1 SEM). Converted to pounds, the mean weight reduction was approximately 8. On page 103, the study refers to the weight loss as slight. However, on page 104 it is described as a significant weight reduction suggesting a reduced energy intake. The study concludes with the statement that guar gum reduces appetite when taken with meals and may thus be an important adjunct to other treatments of obesity.
Dr. Ayers' principal criticisms of the Krotkiewski study were (a) that it was not a placebo controlled or double-blind study, (b) that the small number of subjects created the risk that reported mean weight losses were dominated by the results of 1 or 2 subjects, and (c) that while subjects were instructed to maintain their normal dietary habits, their food intake during the study was not adequately controlled or monitored (Tr. 58-60). Near the time of publication of this study, Dr. Ayers talked with Dr. Krotkiewski on the telephone about it. Dr. Krotkiewski told him that at that point in his use of guar gum he was only willing to say that as an adjunct to other treatments of obesity, specifically diets, this fiber may have a role in aiding weight loss, but not when used alone (Tr. 79, 80).
29. In support of his opinion, Dr. Ayers referred to the reports of three other studies included in CX-10. One of these, referred to as the Aro study (Diabetologia (1981) 21:22-33), reported no change in mean body weight of nine patients in a 3-month double-blind, cross-over study in which the patients were told not to change their dietary habits during the study and to take 7 g of guar gum with each of the three main meals. The study was designed to elucidate the long-term effects of guar gum on diabetes rather than the body weight impact of guar gum. Another Aro report included in CX-10 (American Journal of Clinical Nutrition, 39:911-16, 1984) involved a double-blind, cross-over experiment conducted over two 12-week periods during which the normal diet of 14 male subjects with hypercholesterolemia was supplemented either with 15g. of guar gum or a placebo to study the effects of guar gum on lipoprotein and minerals. The study revealed no statistically significant changes in mean body weight during the trial.
A third report, this one principally authored by Respondents' expert, Dr. Jaako Tuomilehto, is of a double-blind cross-over study of the effect of ingested guar gum granules (15 g. per day for three months) on blood lipids in twelve obese hypercholesterolemia patients. It was reported in Human Nutrition: Clinical Nutrition (1983) 37c, pages 109-116. One of the findings of the study was a mean body weight increase during both guar gum and placebo treatment. The report noted that the results of this study as to body weight differed from those of an earlier similar study by Dr. Tuomilehto (and others) reported in Acta Med Scan 208:45-18 1980. The earlier study, RX-49, reported a decrease (approx. 6 pounds) in mean body weight of patients treated with guar gum over a period of four months. With respect to the difference in body weight changes between the 1980 (RX-49) and 1983 studies the later report states:
"In the beginning of the  study all patients received similar dietary advice and later on, no additional advice was given, and this may explain the difference in the body weight changes in our present and a previous study (Tuomilehto et al., 1980). Another possi- bility could be the influence of the season. During the autumn body weight tends to increase spontaneously and therefore weight reduction has been found more difficult in the autumn than in the spring time (Zahorska-Markiewicz, 1980), at which time our previous work was done (Tuomilehto et al., 1980). On the other hand, it seems to us that guar gum alone cannot control body weight, but could probably be of importance as a part of more comprehensive weight-control programme ." (emphasis supplied)
Dr. Ayers noted on cross-examination that the subjects in the earlier Tuomilehto study, having been advised to reduce the use of saturated fats and simple carbohydrates and to avoid excessive alcohol consumption, probably took in less energy (Tr. 98).
30. Dr. Ayers, in forming his opinion, also relied on a series of statements and position papers (included in CX-10) presented at a 1986 European Congress (Tr. 77), sometimes referred to as the Swedish Symposium (Tr. 13), on the subject of dietary fiber and obesity. Nowhere in these papers did he find a claim for fiber in general, or guar gum in particular, that it brings about significant weight loss when used alone. These papers include the comments of Dr. Per Bjorntrup, the moderator of the symposium, that the treatment of obesity, simple in theory, is very difficult in practice and that evidence for decrease in body fat through ingestion of dietary fiber is fairly weak at this time and that, although there are promising observations, much more work remains to be done (p. 150, 160).
31. Dr. Ayers does not believe that cause and effect has been established between the use of guar and weight loss in studies where weight loss has been reported. In his opinion such losses could be a placebo effect (Tr. 81, 82).
32. Based on his research, discussion with colleagues at Georgetown Medical School, and his telephone conversation with Dr. Krotkiewski, supra , Dr. Ayers' opinion is that guar gum may be an important adjunct to diet or other treatment of obesity, but will not, by itself, effect weight reduction (Tr. 51, 52, 60, 79). He believes that his opinion conforms with his understanding of informed medical and scientific opinion (Tr. 70, 71).
Dr. Jaako Tuomilehto
33. Respondent's expert, Dr. Jaako Tuomilehto, has had a great interest in dietary fibers in connection with obesity, and has engaged in clinical studies using guar gum which have included body weight observations. Two of these studies have been noted in connection with the testimony of Dr. Ayers, supra . For convenience, they are referred in herein as the 1980 (RX-49) and 1983 studies
In testimony Dr. Tuomilehto listed several properties of guar gum when ingested (Tr. 168-172). They are (a) binding of considerable amounts of water with potential for caloric dilution which can reduce caloric intake, (b) production of greater satiety through increased volume in the intestinal tract and slowing the gastric emptying rate, (c) reduction of appetite through prevention of hypoglycemia, (d) malabsorption, or slowing the absorption, of several nutrients, particularly fatty acids, (e) normalizing hunger through improved glucose tolerance, and (f) laxative properties. He indicated that these properties make guar gum one of the most promising agents for weight control as described in the literature (Tr. 172, 173) and can lead to weight reduction without any significant calorie restriction or increased exercise (Tr. 194).
34. Dr. Tuomilehto testified that his 1980 study showed a statistically significant reduction in body weight in women who ingested guar gum, leading to the conclusion that guar gum had a significant impact on weight reduction (Tr. 174). As found supra , FOF 29, his 1983 study (CX-10) resulted in the contrary conclusion, that guar gum alone cannot control body weight, but could probably be of importance as part of a more comprehensive weight control program. At the hearing Dr. Tuomileheto, on the primary basis that the lifestyle and environment of the patients changed greatly during the study, testified that the weight loss conclusions reached in the 1983 study are meaningless and that no conclusions regarding weight loss are allowed on the basis of that study (Tr. 176, 177). I note, however, that these same factors were specifically mentioned in the 1983 study as possibly explaining the results contradictory to the 1980 study but did not, at that time, prevent the conclusion that guar gum alone cannot control body weight.
35. Dr. Tuomilehto testified that there is a consensus among medical professionals and scientists dealing with weight reduction that there are two ways to control obesity: (a) to restrict caloric intake and (b) without specific reduction of caloric intake to manipulate the diet or circumstances of eating, as by increase of dietary fiber intake, so as to induce spontaneous decrease of energy intake (Tr. 175). He stated that Dr. Ayers' opinion as to lack of guar gum efficacy in weight reduction is not a general opinion among scientists working in the field of dietary fibers and guar (Tr. 184, 185).
36. Since 1983 Dr. Tuomilehto has done further study of the effects of guar gum on weight control. Included is a formal study in the process of publication. It involved 23 hypercholesterolemia patients who were treated with guar gum for one year. A 2 kilogram (4.4 lb.) weight loss was observed (Tr. 180). Another study, also submitted for publication, involving the same type of patient, conducted over a 12-week period, also showed what he described as a significant weight reduction, approximately 2.2 pounds (Tr. 181, 210). Dr. Tuomilehto testified that on the basis of the evidence now available, including the studies described in this finding, and his treatment of hundreds of patients with guar gum, he is of the opinion that it is almost automatic that the majority of patients taking guar gum in their treatment will have a weight reduction (Tr. 181, 192-194).
37. Dr. Tuomilehto expressed the opinion that, in general, Respondents' advertisement is supported by the scientific evidence reviewed in his testimony (Tr. 184). He stated that such evidence makes it quite clear that guar gum per se has properties which can lead to weight reduction without any significant calorie restrictions or increased exercise (Tr. 194).
38. On cross-examination, Dr. Tuomilehto was asked to identify any study made by anyone which concludes that irrespective of any other variables, such as lifestyle, eating habits, and physical exercise, simply taking guar gum will cause a significant reduction in weight. His answer was that such a study would be practically impossible to carry out on human beings but has been done with chickens (Tr. 194-196). Also during cross-examination, Dr. Tuomilehto stated that his opinion as to the efficacy of guar gum, alone, in weight reduction, is necessarily based on the assumptions that a person taking guar gum wants to lose weight, will continue the normal pattern of life, and will not decrease physical activity or significantly increase food intake (Tr. 198, 199).
39. Asked whether an obese person will lose weight by taking Cal-Ban 3000 if his habit is to eat all his favorite foods to excess, Dr. Tuomilehto's answer was that it is possible (Tr. 216, 217) and that it is probable (Tr. 218). His native language is Finnish and he demonstrated some difficulty in distinguishing any difference between the meanings of the words possible and probable (Tr. 217, 218). However, it is reasonably clear that he really had in mind the concept of possibility, rather than probability, in answering this questions. This is evident in his use of the word possibility in a similar context at page 221 of the transcript.
Dr. Anthony R. Leeds
40. Based on his extensive experience with guar gum, Dr. Leeds expressed the opinion that a weight loss would, in most cases, result from the ingestion of Cal-Ban 3000 by obese patients according to instructions (CX-1) over a substantial period of time without medical supervision (Tr. 537). The phenomena related to guar gum which would cause weight reduction he placed under three headings: (a) decreased energy absorption, (b) metabolic effects related to insulin, carbohydrates and fat, and (c) reduced energy intake (Tr. 537-539).
41. Dr. Leeds had examined Respondents' advertisement. He expressed the opinion that, taking the ad as a whole, the claims made therein are scientifically supportable (Tr. 542).
42. Dr. Leeds testified that there is no consensus of informed scientific opinion that guar gum, ingested alone, does not facilitate weight reduction (Tr. 561).
43. Dr. Leeds presented at the Swedish Symposium in 1986 a paper entitled "Treatment of Obesity with dietary fibre: Present position and potential development" (pages 156-158, CX-10). In that paper he stated "while there is little evidence for a role for fibre in weight reduction there is no evidence for its role in weight maintenance *** Evidence for a possible role for dietary fibre in the management of obesity and overweight is gradually accumulating." In testimony, Dr. Leeds agreed that the general thrust of that paper with regard to the effect of fiber on obesity is that the present findings and conclusions remain highly tentative and suggest the need for additional research before conclusive statements can be made (Tr. 558, 559). That constitutes his present view of the subject (Tr. 559, 560).
Jack Hegenauer, Ph.D.
44. Dr. Hegenauer thinks there is clear evidence in the reports of the following four studies in evidence that individuals to whom guar is administered, and who consume the same foods as before taking guar, are able to lose a significant amount of weight (Tr. 396):
(a) "Bulking Agents in the Treatment of Obesity," Evans/Miller, 1975 (RX-12)
(b) "Dietary fiber and blood lipids: treatment of hypercholesterolemia with guar crispbread," Jenkins et al. 1980 (RX-16)
(c) "Effect of Guar Gum on Body Weight and Serum Lipids in Hypercholesterolemic Females," Tuomilehto, et al., 1980 (RX-49)
(d) "Effect of guar gum on bodyweight, hunger ratings and metabolism in obese subjects," Krotkiewski, 1984 (RX-46)
Study (a) (RX-12), the oldest of these four studies, involved 11 subjects, 3 of whom were obese. It was conducted to compare the efficacy of guar gum and methylcellulose as appetite depressants. It ran over a period of 4 weeks and was designed to measure food intake during two baseline periods with no medication alternating with experimental weeks during which either guar gum or methylcellulose was ingested before meals. Individual weighed food intakes were measured for each subject and each subject was weighed daily. The mean weight loss for the 3 obese subjects during the week they took guar gum was 1.5 kg. + 0.4 (SE) (approx. 3.3 lbs.) Mean weight loss for non-obese subjects during that week was .24 kg. + 0.24 (SE) (approx. 1/2 lb.). The study found a 10% reduction in food intake using either agent and concluded that they are effective as a means of reducing appetite. No placebo was used and it is quite obvious that the subjects had to be aware of the purpose of the study because of the weighed food intakes and daily body weight measurements.
Study (b) (RX-16), was a study of the effectiveness of guar gum (13g. of guar per day) in reducing cholesterol levels in 11 hyperlipidemic patients. The study was conducted over an 8-week period. The patients had previously been encouraged to lose weight. A significant reduction in cholesterol was reported over the 8-week period. An incidental finding was a "small but significant" weight loss. Dr. Leeds, one of Respondents' expert witnesses, was involved in the conduct of the study. In his testimony, he made only passing reference to the study as one in which he had been involved. The study was introduced through Dr. Hegenauer who acknowledged, on cross-examination, that encouragement of the patients to lose weight could have had an impact on the reported weight loss (Tr. 445). Studies (c) and (d), above, are the subject of findings in FOF's 29 and 34, supra .
45. The bulk of Dr. Hegenauer's testimony was devoted to identification and discussion of studies, introduced in evidence by Respondent, supporting the various mechanisms, or properties, of guar gum to which the studies listed above attributed the weight losses observed therein, i.e., delayed gastric emptying; increased fecal energy loss; reducing, or flattening, of insulin response to carbohydrates; glucose lowering; diminished hunger or increased satiety; cholesterol lowering; bile acid sequestration; malabsorption of nutrients (Tr. 281-391). Dr. Hegenauer testified that is clear to him that a combination of these mechanisms quite nicely accounts for the attributed effects of guar on weight loss in both normal and obese individuals (Tr. 397).
46. According to Dr. Hegenauer, there is no consensus of informed scientific opinion that guar gum taken alone is inefficacious for weight reduction; there is no evidence in the literature that anybody doubts that water soluble dietary fibers have important effects in weight reduction; and there is no convincing evidence that water soluble fibers do not cause weight reduction (Tr. 397).
47. Dr. Hegenauer's conclusions were heavily influenced by the results of the Krotkiewski study, RX-46 (Tr. 396) and a statistical analysis which he made of that study (CX-8). Among Dr. Hegenauer's conclusions from that analysis are the following:
"Rate of weight loss over the 8-10 week study periods averaged 0.45 - 0.55 kg per week. Rate of weight loss was significantly greater than zero and was not due to chance alone. Rate of weight loss obtained with guar supplementation was not significantly different from the weight loss obtained by dieting alone in the two different studies considered separately or as combined populations.
From statistical tests and inductive reasoning, we conclude that guar supplementation without dieting is as effective as dieting alone under medical supervision in producing signifi- cant weight loss in middle-aged, extremely obese women.
48. On December 14, l987, Dr. Hegenauer spoke on the telephone with Professor Krotkiewski in order to clarify some of the issues raised by criticisms of design, procedures, and controls of his study (Tr. 377-8). With regard to the quantitative food intake of patients during the study, Krotkiewski stated that food intake records (commonly kept in the form of diaries (Tr. 383)) are notoriously subjective, underreported and inaccurate; that it is difficult to accurately quantitate caloric content of diets; that there are large daily, and within - individual, fluctuations in intake; that he could only say that the composition of their diets didn't change and he merely assumed that they ate less of the same foods but cannot pin it down quantitatively (RX-47; Tr. 382-384).
In the same conversation, Professor Krotkiewski told Dr. Hegenauer that in his own practice the administration of guar alone will cause only the slightest degree of weight loss that he is able to justify in terms of patient management and that he is not satisfied with the slow, conservative weight loss obtainable with guar supplementation alone. He prefers to administer guar in addition to as many other regimens for weight loss as will allow the patient to come down from a high weight to a non-life threatening low weight (Tr. 386-7).
Testimony of Dr. Alban Comeau
49. Respondents also presented that testimony of Dr. Alban Comeau, a practicing medical doctor not offered as an expert but, rather, as the personal physician of David Gaudet, the man pictured in Respondents' ad. He began treating Mr. Gaudet in 1981 for medical problems, including obesity. Dr. Comeau did not prescribe any medicine for Mr. Gaudet's obesity but imposed a dietary regimen which resulted in depression, causing eventual acceptance of obesity to counteract the mental health problem (Tr. 639, 640). Between 1981 and 1986, Mr. Gaudet's weight fluctuated from a high of 325 to a low of 293 pounds (Tr. 638). According to Dr. Comeau, Mr. Gaudet began taking Cal-Ban 3000 on his own in February 1986 and had been using it for some time before he told Dr. Comeau about it. At that time, Dr. Comeau noticed that he had lost significant amount of weight. As of December 9, l987, Dr. Comeau reported that Mr. Gaudet had lost 84 pounds as a result of using Cal-Ban 3000 (RX-1). As a result of his evaluation of Mr. Gaudet, Dr. Comeau has prescribed the product for a dozen other patients. At the time he testified, he had no solid information on the results experienced by such patients (Tr. 644, 645).
According to Dr. Comeau, the photographs of Mr. Gaudet appearing in Respondent's ad accurately portray him and the statements about him in the ad are accurate (Tr. 623).
Interpretation of the Advertisement
The credentials of Respondents' expert, Dr. Lynda Maddox, are impressive. However, I found much of her testimony unpersuasive. By restrictions on the portions of the ad she was asked to consider on direct examination, her opinion as to the representations which might be found therein by the average consumer was unrealistically limited. By taking the position that such a consumer would read but little of the ad, she concluded that the total import of the ad, its "net effect," would be only two representations: (a) that users of Cal-Ban 3000 are going to lose weight without following a diet and (b) if they don't, they will get their money back (Tr. 611, 612). Unyielding in this narrow view, she evaded and, admittedly, fudged and hedged (Tr. 597, 598) answers as to representations an average reader might find in other parts of the advertisements which I find important. These parts are set forth in FOF 12, supra . I believe the average reader interested in losing weight would, despite the money-back guarantee, read and consider them before paying $22.00 to $42.00 (including postage) for the product. Dr. Maddox did not expressly deny that a consumer reading the entire ad would find the other representations alleged in the complaint. In fact, at pages 611 through 618 she made some limited concessions as to other representations made by the ad in the unlikely event, as she maintained, those portions of the ad were read.
The Falsity Issues
(a) Three of the representations alleged in the complaint and found to be made, supra , employ the word significant with relation to weight loss. The ad uses that word, as well as the word substantial, with respect to the promised weight loss. The magnitude of loss assured in the ad is "UP TO 50 POUNDS" (in the headline), although the David Gaudet testimonial states that his loss was 74 pounds "so far." The ad does not tie any particular amount, or range, of weight loss to a specific time frame, but the assurance of the loss of a large number of pounds in a short time is conveyed by the bold mention of "50 POUNDS" together with the description of Cal-Ban 3000 as "powerful, fast-acting," "short- circuiting the fat-building process," beginning to shrink millions of fat cells ... within 24 hours as your body goes on a fat-burning spree," "Melt[ing] away flab." Also David Gaudet's testimonial that he recently weighed 298 pounds and, since using the product, has lost 74 pounds, convey the assurance of the loss of large number of pounds in a relatively short time.
The expert witnesses, in describing weight losses as signi- ficant, referred to clinical and/or statistical significance, in most cases a more conservative, limited significance than the large, rapid weight losses represented in the ad.
(b) Dr. Ayers' impression of the informed medical and scientific consensus as being guar gum's lack of efficacy, used alone, to produce weight loss was disputed by Respondent's experts who stated there is no such consensus, at least among scientists working in the field of dietary fibers and guar as are two of these experts, Drs. Tuomilehto and Leeds. Their opinions effectively offset that of Dr. Ayers as to the existence of such a consensus. However, the evidence does not support a finding that there is a contrary consensus.
(c) Dr. Ayers stated that the literature contains no conclusive evidence that guar gum taken alone causes an obese individual to lose weight and, further, that any claims that ingestion of guar gum will assure weight loss without dieting or exercising is not supported by the medical evidence (CX-2, p. 4). The preponderance of the relevant evidence in this case supports Dr. Ayers' view.
Some of the studies in evidence report a weight loss with the ingestion of guar gum (RX-12, 16, 46, and 49). Other studies show no weight loss or no statistically significant changes in weight (CX-10; the 1981 and 1984 Aro studies and the 1983 Tuomilehto study). The only study reporting a large weight loss (over 3 lbs. per week) was the oldest, the Evans/Milton study of 1975 (RX-12), which was so lacking in control and so far out of line with losses reported in later more carefully controlled studies that little importance can be attached to it. RX-16, the Jenkins (Leeds, et al.) study, reporting "small but significant" weight loss, is of minimal importance because the subjects had been encouraged to lose weight. The Krotkiewski study reported a mean weight loss of approximately one pound per week but refers to the loss as "slight." Moreover, in a telephone conversation with Dr. Ayers about the time the study was published, Dr. Krotkiewski said that, at that point in his use of guar gum, he was only willing to say that it may have a role in aiding weight loss when used as an adjunct to diet, or other treatments of obesity, but not when used alone. In the telephone conversation with Dr. Hegenauer just before the hearing (FOF 48, RX-47) Dr. Krotkiewski stated dissatisfaction with the slow, conservative, slight degree of weight loss obtainable with guar gum alone. While RX-49, the 1980 Tuomilehto study, reported mean body weight reduction of approximately 6 pounds in four months, his 1983 study (CX-10) reported a mean body weight increase leading to the conclusion stated therein that guar gum alone cannot control body weight. Doubt is also cast on the importance of the 1980 study because the subjects had been advised to reduce the use of saturated fats and simple carbohydrates and to avoid excessive alcohol consumption with the probable consequence that they reduced their energy intake.
The inconclusiveness of the studies, taken together, as to the efficacy of guar gum, alone, to produce significant weight reduction is substantiated by the reports of the 1986 European Congress on the subject of dietary fiber and obesity (CX-10) including the statement of the moderator, at p. 150, that the evidence for decrease in body fat through ingestion of dietary fibers is fairly weak at present and the paper presented by Respondent's expert, Dr. Leeds, that there is little evidence for the role for fiber in weight reduction (p. 157).
Of Respondents' expert witnesses, only Dr. Hegenauer stated that there is clear evidence that guar gum, alone, will cause significant weight reduction. This opinion was based on the studies introduced as RX-12, 16, 46 and 49, discussed and discounted above. Drs. Tuomilehto and Leeds, leading researchers in the field, were more guarded in the opinions they gave at the hearing in that they did not use the word significant with respect to the weight reduction obtainable through guar gum, alone (Tuomilehto, Tr. 194; Leeds, Tr. 537-539). Their opinions spoke merely to weight loss, not to the significance of the amount thereof. Further Dr. Leeds acknowledged that present findings and conclusions with respect to the effect of fiber on obesity remain highly tentative and that more work needs to be done (Tr. 558, 559). Dr. Tuomilehto stated that it is practically impossible to carry out a study on humans which would conclude that irrespective of any other variables, such as life- style, eating habits, and physical exercise, simply taking guar gum will cause a significant reduction in weight. His opinions as to the efficacy of guar gum alone were necessarily based on the assumption that a person who wants to lose weight will not make any significant changes in these areas (FOF 34). Dr. Tuomilehto's view as to the great difficulty of conducting conclusive tests with guar gum for weight loss in human beings was corroborated by Dr. Ayers (Tr. 54) and Dr. Leeds (Tr. 545).
The opinions of Drs. Tuomilehto and Leeds as to the existence of scientific support for Respondents' ad (FOF 37, 41) were in response to a vague, general question by Respondents' counsel which did not include, specifically, the representations alleged in the complaint and did not call for a clear answer as to the truth thereof. Therefore, I give little weight to those opinions as evidence of such truth.
Lacking conclusive evidence by way of weight loss studies for the efficacy of guar gum, the numerous studies introduced by Respondents suggesting mechanisms by which guar gum may cause weight loss are merely interesting. They do not fill the gap left by the weight loss studies.
Dr. Comeau's testimony with respect to the weight loss experienced by David Gaudet is anecdotal, based on information supplied by Mr. Gaudet, a lay person. I, therefore, give it no weight.
CONCLUSIONS OF LAW
1. An advertisement must be considered as a whole and its meaning determined in the light of its probable effect on persons of ordinary minds. Donaldson v. Read Magazine, Inc. , 333 U. S. 178 (1948); Vibra-Brush Corp. v. Schaffer , 152 F. Supp. 461 (S.D.N.Y 1957), rev'd on other grounds , 256 F.2d 681 (2nd Cir. l958).
Express misrepresentations are not required. It is the net impression that the advertisement as a whole is likely to make upon individuals to whom it is directed that is important. Even if a solicitation is so worded as to not make an express representation, but is artfully designed to mislead those responding to it, the false representation statute is applicable. G. J. Howard Co. v. Cassidy , 162 F. Supp. 568 (E.D.N.Y. 1958); See also, Virginia State Board of Pharmacy v. Virginia Citizens Consumer Council , 425 U. S. 748 (1976).
Where an advertisement is ambiguous or capable of more than one meaning, if one of those meanings is false, the advertisement will be held to be misleading. Rhodes Pharmacal Co., Inc. v. F.T.C. , 209 F.2d 382, 387 (7th Cir. l953); Ralph J. Galliano , P.S. Docket No. 19/15 (P.S.D. May 2, l985).
2. Applying the foregoing principles, I conclude, for the reasons stated in FOF 12, that Respondent's advertisements make the representations as to Cal-Ban 3000 alleged in paragraph 8 of the complaint. For the reasons given in the Discussion, supra , I reject the much narrower interpretation which Dr. Maddox placed on the ad, exercising my authority to interpret the ad based solely on my reading thereof, having found the extrinsic evidence unpersuasive. World Communications, Inc. , P.S. Docket No. 19/33 (P.S.D. on Motion for Reconsideration, 11/1/85); see also Vibra-Brush v. Schaffer , supra ; Quest Research , P.S. 7/163 (P.S.D. July 31, l981).
3. These representations are material because they have the effect of inducing individuals to purchase the product.
4. A promise to refund payment if a customer is dissatisfied does not dispel the effect of false advertisements. Farley v. Henninger , 105 F.2d 79, 84 (D.C. Cir. 1939); Borg-Johnson Electronics, Inc. v. Christenberry , 169 F. Supp. 746, 761 (S.D.N.Y. 1959).
5. Complainant has established by a preponderance of the reliable and probative evidence that Respondents' claims for the product, as found to be represented in the advertisement, have not been accepted by the medical or scientific community, thereby making a prima facie case of falsity of those claims. Cosvetic Laboratories , P.S. Docket No. 8/160, P.S.D. July 22, l982. Respondent failed to sustain its burden of rebutting this case with persuasive evidence of the truth of those claims. Cosvetic Laboratories , supra ; Kingsbridge Media & Marketing, Inc. , P.S. 20/17 (P.S.D. June 13, l986); Peak Laboratories, Inc. v. U.S.P.S. , 556 F.2d 1387, 1390 (CA 5 1977).
6. Complainant has made a prima facie showing that Ronald Anderson, by virtue of his capacity as vice-president and director of Health Care Products, Inc., and Carl Anderson, as manager of that corporation, are actively engaged in the scheme involved in this proceeding. Respondents have stipulated the active involvement therein of Respondent Barbara W. Larkins. I conclude, therefore, that the individual Respondents are properly included in the proposed cease and desist order.
7. Complainant has failed to prove that post office box 273477, Tampa, FL 33688-3477 was used by Respondents to receive remittances, or credit card information, or orders for Cal-Ban 3000. Therefore, it will not be included in the proposed false representation order.
8. Respondents are engaged in the conduct of a scheme for obtaining money or property through the mails by means of materially false representations in violation of 39 U.S.C. 3005. Complainant has not offered evidence of past conduct of Respondents showing a likelihood that they will perpetrate additional violations of this statute with respect to weight loss products. Accordingly, false representation and cease and desist orders in the forms attached hereto, without the "fencing in" provisions requested by Complainant, should be issued against Respondents.