In the Matter of the Complaint Against COSVETIC LABS, or any variation thereof at P. O. Boxes 14092, 49303, 49087, 49024, and 49425, Atlanta, GA 30329 and at P. O. Box 10064, Atlanta, GA 30319 and at 9/127, 9/128, 10/40, P. O. Box 81345, Atlanta, GA 30366 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 95543 and 95545, Atlanta, GA 30347 and at P. O. Box 53098, Atlanta, GA 30305, BRASWELL, INC. at P. O. Boxes 10101 and 10064, Atlanta, GA 30319 and at P. O. Box 81345, Atlanta, GA 30366, FAT OFF at P. O. Box 9669, Atlanta, GA 30319, COSVETIC LABS, or any variation thereof at P. O. Box 1097, Deerfield Beach, FL 33441 P.S. Docket Nos. 9/126 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 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 representations concerning a product called "FAT OFF."
The specific false representation alleged to be made in Respondent's advertisements is that ingestion of "Fat Off" while dieting will, for most people, cause the body to burn fat more rapidly than it would have if "Fat Off" had not been ingested.
Respondent filed answers to the Complaints, denying the making and the material falsity of the alleged representation 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 FAT OFF and obtaining money or property therefor through the mails. (CX-61 through CX-79; CX-189; CX-303; Tr. 188-213)
2. Attached hereto as Exhibits A through C are typical examples of Respondent's advertisements for FAT OFF.
3. Respondent's answers in these proceedings denied the making of the representation 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 representation alleged. Respondent has not offered evidence, argument, or proposed findings of fact and conclusions of law that its advertising does not make such representation. On this issue its defense is confined to the argument that the representation made is either not false or, if false, is not materially so. On this state of the record the making of the representation as alleged in the Complaints is treated as not contested.
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 agreement that most obesity is caused by consumption of more calories than the person needs to maintain daily activities, the excess calories being stored in the body as fat (Tr. 20, 21, 337, 338).
Dr. Ayers testified that people overeat for a variety of overlapping reasons:
". . . People can be conditioned by their upbringing, by their families. In many families in this country vigorous eating is considered to be a healthy sign. People are encouraged to clean their plates. Various social functions are centered around eating. People work diligently at the preparation of food that tastes good, smells good, looks good. And for a variety of these and other reasons, bombardment by advertising, social requirements, business lunches, et cetera, people are constantly in a situation where it is easy to overeat." (Tr. 21)
He testified that frustration, pressures of various kinds from business, home, school, etc., can also cause overeating (Tr. 21, 22).
Dr. Cooper traced the onset of overeating and resultant obesity in most overweight people to particularly stressful times such as pregnancy, surgery, a severe illness, or severe emotional shock. During these stressful periods something, at present not understood, happens to the body to destroy or change the delicate and intricate mechanism by which body weight is maintained. From that point on, probably for the rest of their lives, they must pay attention to their diets (Tr. 338).
7. Dr. Ayers and Dr. Cooper were in essential agreement that there is a difference between hunger and appetite as causes of eating. Hunger is basically physiological and refers to the body's physiological need for food manifested in the stomach's contractions known as hunger pangs. Appetite is a psychological desire for food as distinguished from the body's actual physiological need. Overeating and resultant obesity are generally the result of psychological factors manifested in appetite (Ayers CX-274; Cooper 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 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 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 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 sold by Respondent, including FAT OFF, 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. Following are the pertinent portions of the label appearing on the container of FAT OFF 9CX-78):
fat Vitamin
off] Formulated
Contents: 120 Tablets
4 TABLETS CONTAIN: % U.S. RDA*
LECITHIN........................1000 mg.........................-
VITAMIN B6 (PYRIDOXINE HCI)......50 mg......................2500
MAGNESIUM
(as MAGNESIUM OXIDE).........74 mg........................16
VITAMIN B12
(CYANOCOBALAMIN)..............5 mcg.......................80
FOLIC ACID.......................200 mcg.......................48
VITAMIN C........................100 mg.......................164
VITAMIN E.........................50 I.U......................164
CALCIUM..........................200 mg........................20
PHOSPHOROUS.......................80 mg.........................8
CHOLINE BITARTRATE...............500 mg.........................-
INOSITOL.........................250 mg.........................-
IN A BASE CONTAINING: CIDER VINEGAR AND KELP
AND SODIUM CARBOXYMETHYL CELLULOSE
*PERCENTAGE OF THE U.S. GOVERNMENT
RECOMMENDED DAILY ALLOWANCE FOR ADULTS.
**U.S. RDA HAS NOT BEEN ESTABLISHED.
DIRECTIONS: ADULTS - FOUR
(4) TABLETS DAILY
AS A DIETARY SUPPLEMENT.
20. The testimony of Dr. Ayers as to the ingredients of FAT OFF in relation to fat metabolism is summarized as follows:
Dr. Ayers stated that of the ingredients in the product only lecithin, choline, and inositol are lipotropic agents (related to metabolism of fat). They are normally manufactured in the body. There are no known deficiencies of these agents in humans. The body normally has a sufficient supply of them. They are used as needed. 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.
Dr. Ayers expressed the opinion, stated by him to represent the informed medical consensus, that ingestion of FAT OFF, while dieting, will not, for most people, cause the body to burn fat more rapidly than it would have if FAT OFF had not been ingested (Tr. 75-77, 102).
21. On direct examination Dr. Cooper stated that the ingredients in FAT OFF are of benefit "in one way or another" in helping a person lose weight. He stressed particularly the interventionary (psychological) effect of the product to change eating patterns by affecting appetite. He also mentioned that when he had taken a similar tablet with coffee he noticed that his hunger, after not eating for 8 hours, went away (Tr. 383-385).
Dr. Cooper pointed out that the tablet contains a substantial amount of choline and inositol and said that his testimony with respect to these two ingredients in relation to another product (South American Diet) would be relevant to FAT OFF. The relevant parts of that testimony may be summarized 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).
Dr. Cooper expressed the opinion that ingestion of FAT OFF while dieting will cause most people to burn fat more rapidly than if FAT OFF has not been ingested (Tr. 387, 388).
22. Dr. Cooper testified that his testimony relative to the product represents the consensus of enlightened medical opinion in the field of bariatrics (Tr. 450).
23. 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)
24. 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).
25. 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).
The opinion of Dr. Ayers that ingestion of FAT OFF will not, for most dieters, cause the body to burn fat more rapidly stands, unimpaired by the contrary opinion of Dr. Cooper, as representing the informed medical consensus.
Both doctors recognized three ingredients of the product -- lecithin, choline, and inositol --as lipotropic agents. As to Dr. Ayers' statement that there are no known deficiencies of these agents in humans, Dr. Cooper agreed, but speculated that there could be a deficiency of these agents ingestion of additional amounts will not increase the rate of fat burning.
Dr. Cooper saw its interventionary effect on eating patterns as the principal value of the product in connection with weight loss. This is consistent with the view of both doctors that weight loss occurs only as a result of reduction in calories consumed.
Although interesting, Dr. Cooper's clinical observations as to loss of more "ugly" fat than the "valuable" or facial fat in patients treated with choline (or other lipotropic agents) they fall far short of proving that ingestion of additional amounts of lipotropic agents cause fat to burn faster than without such ingestion. Subjected to analysis, Dr. Cooper's observations if accurate --accuracy in such loosely controlled observations obviously having such a large subjective component --show at most a possible contribution of such agents to selective fat loss in terms of areas affected. They do not establish, by any stretch of the imagination, a faster fat loss, or great over-all fat loss, as the result of ingestion of a product such as FAT OFF than the reduced calorie intake of his dieting patients, alone, would have produced.
1. Respondent solicits remittances of money through the mails to the names and addresses shown in the caption hereof for its product FAT OFF.
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 statutesare 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 representation alleged in the Complaints.
4. Testing of the product is not required to sustain a complaint under 39 U.S.C. 3005. Without it, the opinion of a medical expert is sufficient evidence of falsity of advertising claims. Original Cosmetic Products, Inc. v. John Strachan and United States Postal Service , 459 F. Supp. 496 (S.D.N.Y., 1978) aff'd w/o Op. 2d Cir., 78-6165, 4/30/79.
5. The offering of a product for use with a given condition implies that it will cure or effectively treat that condition. Aronberg v. F.T.C. , 132 F.2d 165, 167 (7th Cir., 1942). See, also, Rhodes Pharmacal Co., Inc. v. F.T.C. , 208 F.2d 382, 386 (7th Cir. 1953), modified on other grounds , 348 U.S. 940 (1954).
Even where statements as to the necessity of vitamins or other nutrients may be literally true, Respondent's failure to disclose that there are other, more common causes of the condition in question, misrepresents the likelihood of successful treatment. S.S.S. Co. v. F.T.C. , 416 F.2d 226, 228 (6th Cir. 1969). See, also, U.S. v. Vitasafe Formula M , 226 F. Supp. 266, 277 (D.N.J. 1964), modified on other grounds , 345 F.2d 864 (3d Cir. 1965), cert . denied , 382 U.S. 918).
Of course, the question to be decided is not whether the product is worthless, but whether it will do what is promised. Borg-Johnson Electronics v. Christenberry , supra . The fact that a product may put the purchaser in the proper frame of mind to diet is no defense to a charge of misrepresentation where the advertising implies that the promised result will be due to the product itself, rather than to the diet. Stauffer Labs, Inc. v. F.T.C. , 343 F.2d 75, 82-83 (9th Cir. 1965).
6. Based on the testimony of Dr. Ayers, representing the informed medical consensus, I conclude that the representation made by Respondent as to the product FAT OFF is false in fact. I reject Dr. Cooper's contrary opinion as not being supported by valid and persuasive evidence. In finding falsity I do not find that the product is not, or may not be, useful as an interventionary, psychological, ritual in weight reduction as described by Dr. Cooper. But I do not read Respondent's representation as going to the interventionary value of the product. Rather, it represents that the product will directly effect the results claimed.
7. The representation made by Respondent, as found, is material in that its natural tendency is to induce readers to purchase the product. See Standard Research Labs , P.S. Docket Nos. 7/78, 7/86 (P.S. Decision 1980) re authority of administrative law judge to determine materiality of representations without testimony on that issue.
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.