In the Matter of the Complaint Against COSVETIC LABS, or any variation thereof at P. O. Boxes 49024, 49087, 49303 and 49425, Atlanta, GA 30329 and at P. O. Box 10064, Atlanta, GA 30319 and at P. O. Box 14048, Atlanta, GA 30324 and at P. O. Boxes 20190, 20429 and 20499, Atlanta, Ga 30325 and at P. O. Box 52977, Atlanta, Ga 30355 and at P. O. Boxes 95544 and 95545, Atlanta, GA 30347, COSVETIC LABS, or any variation thereof at P. O. Box 1097, Deerfield Beach, FL 33441 P.S. Docket No. 9/139; P.S. Docket No. 10/42 May 29, 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 made in advertisements concerning a product called "SOUTH AMERICAN DIET."
The specific allegations concerning false representations alleged to be made in Respondent's advertisements are as follows:
A. 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 Respondent will supply purchasers of the "South American Diet" package with a list of foods from which to select meals, in addition to the other items which are part of the package;
(2) That ingestion of the "Fat Emulsifier" portion of the "South American Diet" package will, for most people, cause the body to make more efficient use of fat than it would have if the user had merely followed the diet described in subparagraph (1), supra ;
(3) That ingestion of the "Fat Emulsifier" portion of the "South American Diet" package will, for most people, cause the body to burn fat more rapidly than it would have if the user had merely followed the diet described in subparagraph (1), supra ;
(4) That ingestion of the "Fat Emulsifier" portion of the "South American Diet" package will, for most people, cause "localized" weight loss, while maintaining weight in desired areas, and will do so to a greater degree than if the user had merely followed the diet described in subparagraph (1), supra ;
(5) That ingestion of the "Multi-Vitamin" portion of the "South American Diet" package will, for most people, cause the body to burn fat more rapidly than if the user had merely followed the diet described in subparagraph (1), supra ;
(6) That the products accompanying the diet described in subparagraph (1), supra , when taken in conjunction with said diet will, for most people, improve the body's metabolism of fat;
(7) That the effect described in subparagraph (6), supra , will create "metabolic perfection" for most users;
(8) That most users of the "South American Diet" package "will not be hungry," i.e., will not have the desire to eat more than is permitted by the diet described in subparagraph (1), supra ;
B. That, alternatively, the making of said claims, coupled with the failure to supply the promised list of foods, leads the purchaser to retain the package in the belief that:
(1) the results enumerated in subparagraphs II A(2) through (7), supra , will be achieved by ingestion of the products sent by Respondent in conjunction with whatever dietary restrictions the user may follow;
(2) most people ingesting the products sent by Respondent, in conjunction with whatever dietary restrictions they are following, "will not be hungry,"
i.e., will not have the desire to eat more than they should in order to achieve a reasonable weight loss; 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 SOUTH AMERICAN DIET and obtaining money or property therefor through the mails. (CX-89-92, 101-113; CX-175, 189, 305; Tr. 188-213)
2. Attached hereto as Exhibits A through D are typical examples of Respondent's advertisements for SOUTH AMERICAN DIET.
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 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 argeement that most obesity is caused by consumption of more calories than the person needs to maintain daily activities, the excess calories being stored in the body as fat (Tr. 20, 21, 337, 338).
Dr. Ayers testified that people overeat for a variety of overlapping reasons:
". . . People can be conditioned by their upbringing, by their families. In many families in this country vigorous eating is considered to be a healthy sign. People are encouraged to clean their plates. Various social functions are centered around eating. People work diligently at the preparation of food that tastes good, smells good, looks good. And for a variety of these and other reasons, bombardment by advertising, social requirements, business lunches, et cetera, people are constantly in a situation where it is easy to overeat." (Tr. 21)
He testified that frustration, pressures of various kinds from business, home, school, etc., can also cause overeating (Tr. 21, 22).
Dr. Cooper traced the onset of overeating and resultant obesity in most overweight people to particularly stressful times such as pregnancy, surgery, a severe illness, or severe emotional shock. During these stressful periods something, at present not understood, happens to the body to destroy or change the delicate and intricate mechanism by which body weight is maintained. From that point on, probably for the rest of their lives, they must pay attention to their diets (Tr. 338).
7. Dr. Ayers and Dr. Cooper were in essential agreement that there is a difference between hunger and appetite as causes of eating. Hunger is basically physiological and refers to the body's physiological need for food manifested in the stomach's contractions known as hunger pangs. Appetite is a psychological desire for food as distinguished from the body's actual physiological need. Overeating and resultant obesity are generally the result of psychological factors manifested in appetite (Ayers CX-274; Cooper 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 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 olfactor; 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 hels 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 inositol. 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 sole by Respondent, including SOUTH AMERICAN DIET, 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 SOUTH AMERICAN DIET consists of three parts, called Steps 1, 2, and 3 and a food list. The labels of the three steps read as follows (CX-112(a), 112(b), and 112(c)):
STEP 1
SOUTH AMERICAN DIET
30 TABLETS
Each tablet contains: *U.S. RDA
Vitamin A (Acetate) 10,000 I.U. 200%
Vitamin D (Ergocalciferol) 400 I.U. 100%
Vitamin E (d1 alpha)
tocopheryl acetate) 15 I.U. 50%
Vitamin B1 (Thiamine
Mononitrate) 10 mg 660%
Vitamin B2 (Riboflavin) 10 mg 580%
Vitamin B6 (Pyridoxine Hcl) 5 mg 250%
Vitamin B12 (Cyanocobalamin) 5 mcg 82%
Vitamin C 200 mg. 333%
Niacinamide 100 mg. 500%
d-Calcium Pantothenate 20 mg. 200%
Copper 2 mg. 100%
Iodine (Potassium Iodide) 150 mcg. 100%
Iron 12 mg. 67%
Magnesium (oxide) 65 mg. 16.3%
Manganese 1 mg. **
Zinc 1.5 mg. 10%
*U.S. RDA - U.S. Recommended Daily Allowance
**No U.S. RDA has been established
Suggested use: Take one tablet daily
STEP 2
SOUTH AMERICAN DIET
60 TABLETS
Each tablet contains:
Juniper Berry Powder 16.2 mg.
Cornsilk Powder 32.4 mg.
Buchu Leaf Powder 32.4 mg.
Uva Ursi Powder 32.4 mg.
Caffeine 50 mg.
Potassium Gluconate 300 mg.
Suggested Use: 2 tablets daily.
STEP 3
SOUTH AMERICAN DIET
90 TABLETS
Each tablet contains:
Choline Bitartrate 240 mg.
Methionine 110 mg.
Inositol 83 mg.
Suggested Use: 3 tablets daily.
20. Dr. Ayers' testimony concerning the SOUTH AMERICAN DIET is summarized as follows:
Dr. Ayers estimated that the food list (CX-175(q) and (r) was the equivalent of a 1,000-calorie diet. he testified that this diet would result in a significant reduction in calories for most people, and would thereby cause a loss of weight (Tr. 84, 85).
"Step 1" of the South American Diet is essentially a multi-vitamin tablet, with minerals (copper, iron, zinc, manganese, and magnesium). It has been claimed that vitamins D and E and zinc play a part in fat metabolism (Tr. 85, 86).
Dr. Ayers testified that the most common symptom of Vitamin D deficiency is bone pain. He further stated that the bones are soft because of poor calcification, and they may even crack or break. Such a person should be under medical care. He also stated that a deficiency of Vitamin D has been reported to cause increase of fat in the liver.
He testified that a person deficient in Vitamin D would likely be deficient in other vitamins and minerals, and would suffer from a wide variety of symptoms, including extreme weakness, in addition to the bone pain. Such a person would be "very sick," and a person who is merely obese, without other problems, would be unlikely Vitamin D by a person who is not deficient would not increase fat mobilization (Tr. 87, 88).
Vitamin E has been claimed to play a part in fat mobilization but there is no reason to believe that it in fact does so (Tr. 88, 89).
Although zinc plays a part in fat mobilization, there is no known deficiency of zinc such as would prevent the body from mobilizing fat at its normal rate, except in cases of serious disease (e.g., alcoholics with extensive liver disease) (Tr. 89).
Specifically, in regard to subparagraph II A(5) of the Complaint, Dr. Ayers testified that ingestion of the multi- vitamin tablet for most people will not cause the body to burn fat more rapidly than if the user had merely followed the diet supplied by Respondent (Tr. 90).
In his affidavit Dr. Ayers stated that while certain of the ingredients of Step 1 may be necessary for proper fat metabolism there is no deficiency of any of the ingredients such as would result in a lessened rate of fat metabolism except in very rare instances of serious metabolic disease (CX-274, p. 11).
He further testified that none of the ingredients in "Step 2" (the diuretic, according to Respondent's advertisements) directly play a part in fat metabolism (Tr. 90). He stated that caffeine might have an indirect effect on weight loss for some depressed persons by causing them to feel more alert and possibly to reduce food intake. He did not think this would happen for many people (Tr. 91, 92).
"Step 3" of the South American Diet contains the lipotropic agents, choline, methionine, and inositol --and Dr. Ayers stated that his testimony would be no different in regard to those ingredients as contained in this product, from what he had previously testified in connection with Respondent's product, FAT OFF (P.S. Docket No. 9/126), et al., Init. Dec. May 18, 1981) (Tr. 92). In that case he stated that they are related to metabolism of fat; that they are normally manufactured in the body; that there are no known deficiencies thereof in humans; that ingestion of these agents by a person not deficient therein will not cause the body to burn fat at a greater rate than it had previously (Tr. 75-77).
In regard to the specific charges of the Complaint, Dr. Ayers testified that ingestion of the fat emulsifier portion of the South American Diet (Step 3) will not, for most people, cause the body to make more efficient use of fat than it would have if the user had merely followed the diet accompanying same (Tr. 93); will not for most people cause the body to burn fat more rapidly than it would have if the user had merely followed the diet (Tr. 93); will not for most people cause a localized weight loss while maintaining weight in the desired areas (Tr. 93).
Dr. Ayers further testified that the taking of the products (Steps 1, 2, and 3) in conjunction with the diet will not improve the body's metabolism of fat for most people (Tr. 93), will not create "metabolic perfection" for most users (Tr. 94), and will not assure that the user will not have the desire to eat more than is permitted by the diet (Tr. 94).
21. Dr. Ayers stated that his testimony represents the informed medical consensus (Tr. 102).
22. Respondent's medical witness, Dr. Cooper, developed the South American Diet from specifications of a doctor in Caracas, Venezuela. The diet and the products comprising it are referred to in his book, Dr. Cooper's South American Diet (RX-5).
Dr. Cooper receives royalties from sales of the book and the products involved in this case (Tr. 355).
Dr. Cooper uses the products in connection with a diet he employs in his practice (Tr. 355).
23. Dr. Cooper testified that the caloric content of the diet ranges from 930 to 980 per day.
He uses Step 1 of the product, a multi-vitamin-mineral tablet, as a "prudent gesture" to assure that patients on diets of less than 1000 calories get all the RDA (Recommended Dietary Allowances) of the ingredients of the tablet, there being the possibility that such a diet may not provide the RDA. He stated that persons on diets of 1500 calories or more would not require such a product (Tr. 359, 360).
Step 2 is a diuretic, the main purpose of which is to "cut down on the triggering of water retention," a secondary function being the relief of discomfort from water retention which can trigger eating for some people (Tr. 364).
Step 3 contains choline, methionine, and inositol which are called lipotropics (related to the metabolism of fat). Dr. Cooper described this as a controversial area, many people believing that these factors have absolutely nothing to do with overweight and others, including himself, having clinically observed the effects of these materials (Tr. 365).
24. Dr. Cooper briefly described his experience with lipotropic agents as follows: Based on an article he read in the mid-60's on use of lecithin in lowering cholesterol, he tried lecithin for that purpose on his patients in conjunction with a diet. He noticed an effect not related to cholesterol. This was that "a lot of times their [patients'] shape appeared to change out of proportion to their weight loss, and I could not figure that out.: Thereafter, on the recommendation of other physicians, he tried giving patients just the choline fraction of lecithin and, later, inositol. He observed a smoother loss of fat, less loss of fat in the facial area, loss of "ugly" fat around the abdomen. Later he put some patients on a preparation containing choline, methionine, and inositol and another group on a preparation lacking those ingredients. He "could see a difference," in quicker loss of "ugly" fat by those on choline (Tr. 367, 368).
In support of his opinion as to effectiveness of lipotropic agents in removing fat, Dr. Cooper pointed to an article entitled "Dose Response Curves in the Estimation of Potency of Lipotropic Agents" appearing in the Journal of Biological Chemistry (Sept. 1950) (RX-6). One of the quotes read by Dr. Cooper from this article stated, in substance, that in the 18 years since the discovery of the lipotropic activity of choline four other substances, among them inositol, have been shown "to inhibit the deposition or to hasten the removal of excessive amounts of liver fat ***." Examination of the article reveals that it was based on studies conducted on rats and mice and that it concerned only the accumulation of fat in the liver, not in other parts of the body.
Dr. Cooper acknowledged that a deficiency of choline and inositol in man is not known but that there could be such a deficiency. He stated that he did not know whether correction of a choline deficiency occurs in patients being given choline causing them to "change their shape better, " or whether "we're doing something else; but the fact remains that, with clinical observations (uncontrolled Tr. 368), you see this (removal of "ugly" fat)" (Tr. 368-372).
Dr. Cooper stated that a person eating a normal diet probably has adequate choline. But, he speculated that on a 1500 calorie diet there is a significant increased need for lipotropic substances (Tr. 375).
25. Dr. Cooper testified that in significantly overweight people, particularly females, there is a pattern of fat deposition, the first fat depositions being on the inner part of the knees, then on the lateral thighs, next on the buttocks and abdomen, then on up to the upper arms, shoulders, and finally the so-called dowager's hump (an area between the shoulder blades up into the neck area) (Tr. 273). Dr. Cooper stated that the pattern of fat loss "seems" to be the reverse of the deposition pattern, the dowager hump coming off first, etc. (Tr. 373, 374).
26. Dr. Cooper expressed the opinion that Steps 1, 2, and 3 of the South American Diet, if used as directed on the labels, are of benefit in accomplishing weight reduction when used in conjunction with a properly designed calorie-reduced dietary regimen (Tr. 375).
27. Dr. Cooper also stated opinions that ingestion of Step 3 (the so-called fat emulsifier) of the product would for most people cause the body to make more efficient use of fat than if the user simply followed the diet accompanying the plan (Tr. 376, 377); that ingestion of Step 3 will for most people cause the body to make more efficient use of fat than if the user simply follows the furnished diet (Tr. 378); that based on his clinical experience and observation ingestion of Step 3 will for most people caused localized weight loss while maintaining weight in desired areas and to a greater degree than if the user had merely followed the diet furnished (Tr. 379).
28. Dr. Cooper stated that he didn't think that ingestion of Step 3 (fat emulsifier) would for most people cause the body to burn fat more rapidly than merely following the diet (Tr. 378, 379). Further, he stated that in the absence of a vitamin deficiency ingestion of Step 1 (multi-vitamin tablet) would not for most persons cause the body to burn fat more rapidly than if the user merely followed the diet (Tr. 379, 380). He assumes that a person on a diet of less than 1000 calories per day has a "relative deficiency" of elements needed for fat metabolism and, therefore, will burn fat more rapidly with ingestion of Step 1 (Tr. 379, 380).
29. With respect to the importance of the vitamin supplements in the South American Diet Dr. Cooper referred to a statement in Nutrition in Health and Disease (Mitchell, Rynberger, Anderson and Dibble, RX-7) that the recommendations in the RDA are designed for the maintenance of good nutrition of the most healthy persons in the United States and Canada and that some healthy persons require less and some apparently healthy persons require more than the recommended allowances (Tr. 381, 382).
30. Dr. Cooper testified that his testimony relative to the product represents the consensus of enlightened medical opinion in the field of bariatrics (Tr. 450).
31. On cross-examination Dr. Cooper said that if a person does not have a deficiency of choline, inositol, and methionine, additional amounts will not increase the rate of fat burning (Tr. 491, 492). As to deficiency of these substances in a person on a 1000 calorie diet, Dr. Cooper said "it's possible." (Tr. 493)
32. On cross-examination Dr. Cooper testified that there is no product the ingestion of which will cause the body to burn more fat than it would have otherwise (Tr. 514).
33. Dr. Cooper placed great weight on his clinical observations in stating his opinion as to efficacy of the product. He admitted on cross-examination that such observations, while possibly being the "foundation" of discovery, are not definite proof of the accuracy of the observer's conclusions as to cause, and that clinical studies are necessary for confirmation thereof (Tr. 539-542).
34. Dr. Cooper testified that aside from helping with possible vitamin deficiencies, only one of the causes of metabolic problems, ingestion of the product would not cure metabolic problems.
Dr. Cooper uses Step 1 of the product, the multi-vitamin-mineral tablet, simply as a "prudent gesture," a form of insurance against the "possibility" that diets of less than 1000 calories may not provide the RDA of the ingredients thereof. he seemed careful in placing the likelihood of deficiencies in terms of possibility rather than probability or certainty. Dr. Ayers' view of Step 1 was summarized in his affidavit, i.e., is that it will not cause the body to burn fat more rapidly than mere following of the diet alone because in the absence of rare instances of serious metabolic disease there is not such a deficiency of the fat metabolic ingredients such as would result in a lessened rate of fat metabolism.
The record does not disclose that users of the South American Diet are told that they must adhere to a 1000, or fewer, calorie diet to realize the results promised in Respondent's advertising. Therefore, there is no assurance, and probably little likelihood, that most users will follow such a stringent regimen. Dr. Cooper testified that persons ingesting 1500 or more calories daily would have no need to use Step 1.
On this record Dr. Ayers' opinion as to the efficacy of Step 1 to achieve the promised more rapid fat burning is more persuasive than that of Dr. Cooper.
Step 2 of the product, is a diuretic. Respondent does not seriously argue, and the record discloses no reason to believe, that it would play any part in fat metabolism.
With respect to Step 3 of the product, both doctors recognized the three ingredients thereof as lipotropic agents. Dr. Cooper was in agreement with Dr. Ayers that there are no known deficiencies of these agents in humans but speculated (to use his term) that there could be a deficiency in persons following a 1000 to 1500 calorie diet. Dr. Cooper acknowledged on cross-examination that if there is no deficiency ingestion of additional amounts of these ingredients will not increase the rate of fat burning.
Dr. Cooper's clinical observations of localized fat loss among patients using the lipotropics in Step 3 are interesting but, as he admitted on cross-examination, fall short of constituting proof that such losses were attributable to the lipotropic factors. Dr. Cooper's testimony as to clinical observations of localized fat loss showed minimal controls, no method of measurement of relative fat losses between "valuable" and "ugly" fat areas other than gross visual estimation having subjective elements, and no means of eliminating bias on the part of Dr. Cooper and his patients.
Dr. Cooper's observations are not of sufficient scientific validity to overcome the informed medical consensus as expressed by Dr. Ayers that just as the body metabolizes fat at a given rate, it draws from the same stores when insufficient calories are ingested, the fat mobilization occurring evenly from the storage sites (CX-274, p. 13).
Dr. Ayers' opinion that the product will not create metabolic perfection for most users was not refuted by Dr. Cooper.
1. Respondent solicits remittances of money through the mails to the names and addresses shown in the caption hereof for its product SOUTH AMERICAN DIET.
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-JohnsonElectronics 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. 428 (1976).
3. Applying the foregoing standards, I find that Respondent's advertisements make the representations alleged in the Complaints except for those alleged in paragraph II B of the Complaint based on the alleged failure of Respondent to furnish a list of foods with the package. Complainant acknowledged at the hearing that Respondent in fact furnished such a list. Accordingly, the representation alleged in paragraph II A(1) of the Complaint is found not to be false and paragraph II B of the Complaint is dismissed in its entirety.
4. Testing of the product is not required to sustain a Complaint under 39 U.S.C. 3005. Without it, the opinion of a medical expert is sufficient evidence of falsity of advertising claims. Original Cosmetic Products, Inc. v. John Strachan and United States Postal Service , 459 F. Supp. 496 (S.D.N.Y., 1978) aff'd w/o Op. 2d Cir., 78-6165, 4/30/79.
5. The offering of a product for use with a given condition implies that it will cure or effectively treat that condition. Aronberg v. F.T.C. , 132 F.2d 165, 167 (7th Cir., 1942). See, also, Rhodes Pharmacal Co., Inc. v. F.T.C. , 108 F.2d 382, 386 (7th Cir. 1953), modified on other grounds , 348 U.S. 940 (1954).
Even where statements as to the necessity of vitamins or other nutrients may be literally true, Respondent's failure to disclose that there are other, more common causes of the condition in question, misrepresents the likelihood of successful treatment. S.S.S. Co. v. F.T.C. , 416 F.2d 226, 228 (6th Cir. 1969). See, also, U. S. v. Vitasafe Formula M , 226 F. Supp. 266, 277 (D.N.J. 1964), modified on other grounds , 345 F.2d 864 (3d Cir. 1965), cert . denied , 382 U.S. 918.
Of course, the question to be decided is not whether the product is worthless, but whether it will do what is promised. Borg-Johnson Electronics v. Christenberry, supra . The fact that a product may put the purchaser in the proper frame of mind to diet is no defense to a charge of misrepresentation where the advertising implies that the promised result will be due to the product itself, rather than to the diet. Stauffer Labs, Inc. v. F.T.C. , 343 F.2d 75, 82-83 (9th Cir. 1965).
6. Based on the testimony of Dr. Ayers, representing the informed medical consensus, I conclude that the representations as found, supra , made by Respondent as to the product SOUTH AMERICAN DIET are false in fact. To the extent that Dr. Cooper did not concur with Dr. Ayers' opinions as to lack of efficacy of the product to produce the promised results, I reject Dr. Cooper's contrary opinions as not being supported by valid scientific proof.
7. The representations made by Respondent, as found, are material in that their natural tendency is to induce readers to purchase the product.
8. Complainant has established its cases by a preponderance of the reliable and probative evidence of record.
9. Respondent is engaged in the conduct of schemes for obtaining remittances of money through the mails by means of materially false representations in violation of 39 U.S.C. 3005.
10. An order pursuant to that statute in the form attached should be issued against Respondent.