In the Matter of the Complaint Against COSVETIC LABS, or any variation thereof, at P. O. Boxes 14092, 49024, 49087, 49303, and 49425, Atlanta, GA 30329 and at P. O. Box 81345, Atlanta, GA 30366, P. O. Boxes 10064 and 10101, Atlanta, GA 30319 and at P. O. Box 14048, Atlanta, GA 30324, and at P. O. Boxes 20190, 20429 and 20499, Atlanta, GA 30325 and at P. O. Boxes 95542 and 95545, Atlanta, GA 30347 and at P. O. Box 53098, Atlanta, GA 30305, BRASWELL, INC. at P. O. Boxes 10064 and 10101, Atlanta, GA 30319 and at P. O. Box 81345, Atlanta, GA 30366 and at P. O. Box 95544, Atlanta, GA 30347, COSVETIC LABS, or any variation thereof at P. O. Box 1097, Deerfield Beach, FL 33441 P.S. Docket Nos. 9/124 and at 9/125 and 10/38 May 19, 1981 Quentin E. Grant Administrative Law Judge APPEARANCE 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 WILLPOWER.
The specific false representations alleged to be made in Respondent's advertisements are as follows:
That by means of said advertisements, and in similar matter, Respondent represents, directly or indirectly, by means of affirmative statement, implication, or omission, in substance and effect:
(1) That ingestion of "Willpower" will make most people "feel full;"
(2) That ingestion of "Willpower" halts your hunger;"
(3) That ingestion of "Willpower" will cause most people to eat less than they had previously;
(4) That ingestion of "Willpower" will cause most people to lose weight;
(5) That ingestion of "Willpower" will improve the body's ability to burn fat for most people;
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 WILLPOWER and obtaining money or property therefor through the mails. (CX-41 through CX-60; CX-171, 189, 302; Tr. 188-213)
2. Attached hereto as Exhibits A through D are typical examples of Respondent's advertisements for WILLPOWER.
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 representations 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 freshmen 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 900 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. Over- eating and resultant obesity are generally the result of psychologi- cal factors manifested in appetite (Ayers CX-274; Cooper Tr. 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 plate,' 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 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 "very 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 of 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 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 WILLPOWER 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 of 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. The label for the product WILLPOWER reads as follows (CX-59):
THIS BOTTLE CONTAINS 200 TABLETS OR
WILL POWER BRAND
Dietary Supplement Tablets - A Vitamin B6 & B12 Dietary
Supplement
Each Tablet Contains: % MDR
Vitamin B6 (Pyridoxine Hcl.) .... 5mg. *
Vitamin B12 (Cyanocobalamin) .... 5mcg. *
Desiccated Liver ................ 300mg. **
Brewers Yeast ................... 100mg. **
The tablet also contains 30 mg. of Methylcellulose
for which no claims are made.
*The MDR has not been established, but the need in
human nutrition is established.
**The need in human nutrition has not been established
and no nutritional claims are made.
Suggested use:
About 30 minutes before each meal and at bedtime, take 3-4 tablets with a full glass of water or low calorie beverage as a Vitamin B6 and Vitamin B12 dietary supplement.
DISTRIBUTED BY EARTHQUEST, LTD. ATLANTA, GA 30305 A SUBSIDIARY OF BRASWELL, INC.
20. Dr. Ayers stated that his testimony relating to the methylcellulose in WILLPOWER would not be different from his testimony regarding the same ingredient in APPETITE ELIMINATOR (PS 9/121, et al.). That testimony is summarized as follows:
(a) Methycellulose is a non-absorbable 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, 73).
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).
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).
(b) Vitamin B-6 is essential for blood formation, but plays no part in the metabolism of fat (Tr. 74).
(c) Vitamin B-12 is essential for the normal formation of red blood cells, but plays no part in the metabolism of fat (Tr. 74).
(d) Desiccated Liver and Brewer's Yeast are sources of Vitamin B-12, but neither plays a part in the metabolism of fat (Tr. 74).
In regard to the specific charges of the Complaint, Dr. Ayers testified that ingestion of Willpower will not make most people feel full, will not halt the user's hunger, will not cause most people to eat less than they had previously, will not cause most people to lose weight, and will not improve the body's ability to burn fat for most people (Tr. 74, 75).
21. Dr. Ayers stated that his testimony represents the informed medical consensus (Tr. 102).
22. Dr. Cooper's testimony relating to WILLPOWER may be summarized as follows:
Brewer's yeast and desiccated liver are very rich in B-complex and B-12. The B-complex is involved as a co-factor in the intermediate metabolism of proteins, carbohydrates, and fat. Dr. Cooper has not used Respondent's product in tablet form but has used, as an intervening method to prevent uncontrollable appetite, a milkshake containing, among other things, brewer's yeast and desiccated liver. He believes that the milkshake, taken twice a day, contributes to control of appetite in that it modifies the patient's food intake pattern. He acknowledged that it doesn't have much effect on satiety. Dr. Cooper stressed that it doesn't have much effect on satiety. Dr. Cooper stressed the interventionary, or ritual, effect of the milkshake (Tr. 393-397).
Dr. Cooper stated a belief that the WILLPOWER tablets would have the same intervening, or ritual, effect as the milkshakes he uses. He said that the satiety value would not be very much (Tr. 396, 397).
On direct examination Dr. Cooper said that ingestion of WILLPOWER could make most people feel full, mainly through the power of suggestion (Tr. 397-399). On cross-examination he said that it would not make most people feel full (Tr. 526).
He stated that ingestion of WILLPOWER will not halt hunger (Tr. 398).
He stated that ingestion of WILLPOWER as an intervention factor very well could cause most people to eat less than they had previously but could only speculate that it would (Tr. 526).
Dr. Cooper testified on direct examination that ingestion of WILLPOWER will, as a focusing aid (intervening aid) in combination with a diet, cause most people to lose weight (Tr. 398). He also stated that the B-complex of vitamins could contribute to weight loss as co-factors in fat burning but acknowledged that not all people are deficient in B-complex (Tr. 526, 527).
He testified that ingestion of WILLPOWER will improve the body's ability to burn fat for most people "if they are on a thousand calorie diet, or less" (Tr. 527) and if they are lacking the B-complex factors (Tr. 398-400).
On cross-examination Dr. Cooper acknowledged that the mere ingestion of any product is not going to cause the burning of fat (Tr. 509).
23. Dr. Cooper stated that his testimony represents the consensus of informed medical opinion in the bariatric field.
Drs. Ayers and Cooper agreed that ingestion of WILLPOWER will not make most people feel full and will not halt the user's hunger. As to the product's efficacy to cause most people to eat less and to cause most people to lose weight, Dr. Cooper's affirmative answer was based mainly on his opinion of its interventionary (ritual or psychological) influence and as to weight loss, also on the simultaneous use of a diet. Dr. Cooper's affirmative opinion as to the fat-burning efficacy of the product was confined to persons deficient in B-complex factors following a 1000, or fewer, calorie diet. This is a very limited group, certainly one to which a majority of users would not likely belong. Further, Dr. Cooper testified that mere ingestion of any product is not going to cause fat to burn.
An interventionary influence as described by Dr. Cooper is not a direct effect on the body of the ingestion of the product but rather a psychological effect altering behavior, specifically in this case, eating patterns.
In support of Dr. Cooper's opinion as to the fat-burning efficacy of the product Respondent has not shown that most users would be suffering from a B-complex deficiency or would be following a 1000, or fewer, calorie diet.
Insofar as the medical expert testimony is in conflict as to the efficacy of the product, Dr. Ayers' testimony is more persuasive and in accord with the informed medical consensus.
1. Respondent solicits remittances of money through the mails to the names and addresses shown in the caption hereof for its product WILLPOWER.
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. Based on the opinions expressed by Complainant's witness Dr. Ayers, conforming to the informed medical consensus, I find that the representations alleged and found to be made by Respondent are false in fact. They are material in that their natural tendency is to induce readers of Respondent's advertising to purchase the product.
6. A fair reading of Respondent's advertising discloses that it does not make claims for the product based on its possible interven tionary effect, the principle mode of effect attributed to the product by Dr. Cooper. Rather, the representations involved direct effect of the product on the user.
7. 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).
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.