In the Matter of the Complaint Against COSVETIC LABS, or any variation thereof at P. O. Boxes 11627 and 53098, Atlanta, GA 30305 and at P. O. Boxes 95543 and 95545, Atlanta, GA 30347 and at P. O. Box 10064, Atlanta, GA 30319 and at P. O. Box 20429, Atlanta, GA 30325 and at P. O. Box 14048, Atlanta, GA 30324 and at P. O. Boxes 14092 and 49425, Atlanta, GA 30329, BRASWELL, INC. at P. O. Boxes 10101 and 10064, Atlanta, GA 30319 and at P O. Box 81345, Atlanta, GA 30366 and at P. O. Box 14092, Atlanta, GA 30324 and at P. O. Box 11627, Atlanta, GA 30305, WILLPOWER at P. O. Boxes 49024, 49087 and 49303, Atlanta, GA 30329 P.S. Docket Nos. 9/118, 9/119, 9/120 May 18, 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, 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 representations concerning a product called "DIGESTAID."
The specific false representations alleged to be made in Respondent's advertisements are as follows:
(1) That ingestion of "Digestaid" will enable most users to diet without hunger;
(2) That ingestion of "Digestaid" will prevent most dieters from overeating;
(3) That ingestion of "Digestaid" by dieters will elevate the energy level of most users;
(4) That ingestion of "Digestaid" by dieters will assure that most users maintain a high energy level;
(5) That ingestion of "Digestaid" will cause most dieters to lose weight more quickly and more easily than they would have if they had not taken "Digestaid;"
(6) That ingestion of "Digestaid" will effectively treat most cases of the following conditions for most dieters:
(i) night blindness;
(ii) chronic gas problems;
(iii) joint pain;
(iv) eczema;
(v) vision problems;
(vi) excessive bleeding from small cuts;
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 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 DIGESTAID and obtaining money or property therefor through the mails. (CX-21 through CX-38; CX-189; CX-301; Tr. 188-213)
2. Attached hereto as Exhibits A through D are typical examples of Respondent's advertisements for DIGESTAID.
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 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 speciality 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 toe 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 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 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 of obesity 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 ot nutritional therapy to all patients, usually a multi-vitamin 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 DIGESTAID, 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 DIGESTAID reads as follows (CX-37):
Digestaid
Contains All Pancreatic Enzymes
60 Tablets
CONTAINS:
Protease . . . . . . . . . . . . Protein digesting enzyme
Lipase . . . . . . . . . . . . . Fat digesting enzyme
Amylase . . . . . . . . . . . . Starch digesting enzyme
derived from Pancreatin 387 mg. (4xNF) special high
lipase formula in a specially constructed natural base
containing Zinc, Calcium, Glycine, Herbal Mints, Raw
Duodenum Concentrate.
DIRECTIONS:
As a dietary supplement, One or Two Tablets after each meal.
20. Dr. Ayers' testimony relating to DIGESTAID is summarized as follows:
Dr. Ayers testified that the ingredients -- protease, lipase, and amylase --are derived from pancreatin, which is pancreatic enzyme. The proteases (there is more than one type of protease) are used in the digestion of protein; lipase is used in the breaking down of ingested fat; and amylase is used for the breakdown of starch products. They are found in the pancrease and, absent serious medical illness, there are no deficiencies of them. The addition of these enzymes to the diet of a person who is not deficient in them will not improve digestion, suppress hunger or overeating, play any part in determining their energy level, or in weight loss (Tr. 63-65).
Referring to the alleged representations in Respondent's advertising, supra , Dr. Ayers testified that ingestion of Digestaid will not enable most users from overeating, will not elevate the energy level of most dieters, will not assure that most dieters attain a high energy level, and will not cause most dieters to lose weight more quickly and more easily than they would have if they had not taken the product (Tr. 65, 66).
In addition to the aforementioned claims relating to weight loss, Respondent claims that Digestaid will treat certain conditions, as charged in subparagraph II(6) of the complaint. Dr. Ayers' testimony as to the remaining claims made for the product is summarized as follows:
(1) Night blindness is most commonly due to a deficiency of Vitamin A. There is no Vitamin A in the product, and ingestion of Digestaid will not effectively treat most cases of night blindness for dieters (Tr. 66, 67).
(ii) Chronic gas problems are most commonly caused by swallowing air, which is itself gas. This can happen during periods of anxiety, running, or exercise. Gas can also be formed from the breakdown of certain foods such as starches and legumes (beans). Additionally, certain diseases which require specific diagnosis and treatment can cause gas problems. Ingestion of Digestaid will not treat most cases of chronic gas problems for most dieters (Tr. 67, 68).
(iii) Joint pains are most commonly caused, depending upon the age of the person, by traumatic accidents, sprains, and bruises. Additionally, the family of diseases that causes inflammatory arthritis, such as rheumatoid arthritis, are specific illnesses requiring specific treatment. None of the ingredients of the product are a treatment for any of the common causes of joint pain. Accordingly, he concluded that ingestion of Digestaid will not effectively treat most cases of joint pain for most dieters (Tr. 68, 70).
(iv) Eczema is a skin condition related to allergic disease and manifested in the skin. It is not due to lack of any of the ingredients in the product except for relatively uncommon disease states which require specific treatment.
Ingestion of Digestaid will not effectively treat most cases of eczema for most dieters (Tr. 70).
(v) Vision problems . other than night blindness, if due to nutritional problems, would be caused by "severe protein deficiency, malnutrition, starvation, concentration camp, in that order of magnitude, of protein deficiency." Inflammatory reactions can also cause vision problems. All of these conditions require medical care, and Digestaid will not effectively treat them, or any other, vision problem (Tr. 70, 71).
(vi) Excessive bleeding from small cuts is caused by poor coagulation (clotting of the blood). A listing of its causes would "fill a textbook." However, the only possible relation- ship of Digestaid to this condition would be a situation where the person had severe pancreatic disease and a deficiency of lipase, which would result in reduced Vitamin K absorption (Vitamin K is required for blood clothing). However, pancreatic disease is an illness requiring specific medical treatment in addition to the administration of lipase. Moreover, it cannot be self-diagnosed by the lay person, and is not a common cause of such bleeding. The most common causes are hereditary and familial, e.g., hemophilia. There are also many clotting problems unrelated to Vitamin K. In sum, Dr. Ayers testified that ingestion of Digestaid will not effectively treat ingestion of Digestaid will not effectively treat most cases of excessive bleeding from small cuts (Tr. 71-73).
21. Dr. Ayers stated that his testimony represents the informed medical consensus (Tr. 102).
22. Dr. Cooper's testimony relating to DIGESTAID is summarized as follows:
Dr. Cooper testified that Digestaid will not enable most users to diet without hunger, will not prevent most dieters from overeating, will not elevate the energy level of most users, will not assure that most users maintain a high energy level, will not cause most dieters to lose weight more quickly and more easily than they would have if they had not taken Digestaid, will not effectively treat most cases of night blindness (Tr. 515, 516).
Dr. Cooper said that ingestion of Digestaid will help effectively treat most cases of chronic gas problems. However, his testimony was contradictory on this point. He testified that gas could be due to many things, the most common being air swallowing (Tr. 516, 517). He then said that the product would be useful when the person can't digest his food properly because of a relative or absolute lack of pancreatic enzymes, but acknowledged that such lack could be due to a serious disease. However, he insisted that there are instances in which a person with this symptom is helped clinically, i.e., that they come in with the problem, get treatment, and associate elimination of the problem with the taking of the preparation (Tr. 517, 518).
He further testified that ingestion of Digestaid will not effectively treat most cases of joint pain, will not effectively treat most cases of eczema, will not effectively treat most vision problems, will not effectively treat most cases of excessive bleeding from small cuts (Tr. 518, 519).
23. Dr. Cooper testified that his testimony represented the consensus of enlightened medical opinion in the field of bariatrics (Tr. 450).
The medical expert witnesses were in agreement that DIGESTAID will not produce the results claimed in 10 of the 11 representations alleged in the Complaint. Their only disagreement involved the representation that the product will for most dieters effectively treat chronic gas problems. Dr. Ayers' testimony in this connection was more credible than that of Dr. Cooper. Ayers testified that DIGESTAID will not effectively treat the two most common causes of gas problems, i.e., air swallowing and digestion of starches and legumes. Cooper agreed that the product will not help chronic gas resulting from air swallowing. But he felt that it would be useful in cases of improper digestion of food due to lack of pancreatic enzymes. He admitted that lack of such enzymes could be due to a serious disease. But he stated that there are "instances" of patients who have a "relative" lack of such enzymes symptomized by chronic gas who associate relief of the gas with taking a product similar to DIGESTAID.
I am unable to conclude from Dr. Cooper's testimony that the "instances" he refers to reflect a common cause of gas problems. Dr. Cooper's rationale falls far short of adequate support for his opinion that the product will effectively treat most cases of chronic gas problems for dieters.
1. Respondent solicits remittances of money through the mails to the names and addresses shown in the caption hereof for its product DIGESTAID.
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 representations substantially as characterized 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 evident 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 expert testimony of both medical doctors, I conclude that the representations alleged and found to be made by Respondent are false in fact. They are material representations because their natural tendency is to induce readers to purchase the product.
7. Complainant has established its cases by a preponderance of the reliable and probative evidence of record.
8. 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.
9. An order pursuant to that statute in the form attached should be issued against Respondent.