In the Matter of the Complaint Against

PEAK LABORATORIES 1937 Briarwood Court, at
Atlanta, Georgia 30329 and
6 Commercial Street
Hicksville, New York 11801

P.S. Docket No. 3/124

04/09/75

Lussier, Edward F.

APPEARANCES:
Lee H. Harter, Esq.;
Law Department, U. S. Postal Service
Washington, D.C. 20260 for Complainant

Jack Paller, Esq.;
400 Colony Square, 16th Floor,
1201 Peachtree Street, N.W.,
Atlanta, Georgia 30361 for Respondent

POSTAL SERVICE DECISION

The complaint in this case alleges that the Respondent, in the sale and promotion of the product "Fat Off", "is engaged in conducting a scheme or device for obtaining money or property through the mail by means of false representations" in violation of 39 U.S. Code § 3005. Each bottle of "Fat Off" contains 80 capsules and sells for $7.95 plus 75c / postage and handling. The reorder form offers a base price of $5.95 for one bottle and $15.90 for three bottles. On March 3, 1975, Respondent filed a motion pursuant to § 952.17 of the Rules of Practice asking that the Judicial Officer of the Postal Service preside at the hearing and render a final agency decision rather than proceed through the normal intermediate step of having the case first heard and decided by an administrative law judge. The basis for this request was the issuance of a court order by The Honorable Newell Edenfield, United States District Judge for the Northern District of Georgia, on February 18, 1975, which detained all Respondent's mail under 39 U.S.C. § 3007 pending the outcome of the administrative proceeding and contained the suggestion that such proceeding should be accelerated. The case was heard by the undersigned in a trial in Atlanta, Georgia; briefs have been submitted and the case is ready for decision.

The specific false representations which Complainant charges Respondent is making to the public are:

"A. That use of the product will cause a loss of fat;

B. That the effective cause of fat loss is the capsule and not caloric restriction (dieting) and/or caloric expenditure (exercising);

C. That the product will dissolve fat; e.g., "THE FAT DISSOLVER"

D. That the lecithin in the product, in the doses provided therein, will cause a decrease of 30% in the cholesterol level of the average person;

E. That use of the product will cause fat to be redistributed. F. That the capsule will significantly contribute to the effectiveness of a conscientious diet program."

Attached hereto as an exhibit is a copy of the advertising material in question. ^1/ The representation in subparagraph F above was added by amendment to the complaint based upon a February 3, 1975, advertisement identical to the exhibit except for the addition of the underlined phrase--

"A special blend that in conjunction with a conscientious diet program shows results almost immediately."

In its Brief (pp. 2-5) Respondent states that its answer denied that the advertisements contained the alleged misrepresentations. However, a review of the record reveals that its answer, filed on January 30, 1975, contained the following:

"Respondent admits sub-section A. of paragraph III.

"Respondent admits sub-section B. of paragraph III that 'Fat Off' is the effective cause of fat loss, but suggests that the results achieved through the use of the product can be enhanced even more through the use of a 'conscientious diet program'.

"Respondent admits sub-section C. of paragraph III.

"Respondent denies sub-section D. of paragraph III and states that the advertisement attached as Exhibit 1 states:

'Dr. Lester L. Morrison in a recent project, found that Lecithin produced a decrease of as much as 30% in cholesterol in the body.'

"Respondent admits sub-section E. of paragraph III."

Respondent's answer, filed the same date, to the amended Complaint, contains the following pleading:

"Respondent admits amended sub-section F. of paragraph III of the complaint."

Thus, on the basis of the pleadings Respondent has admitted making all of the alleged representations except charge "D". Respondent goes into some depth with respect to why its advertising cannot be said to make the representation alleged in III D. of the complaint. Its statement that "Similar in-depth analyses of the other five representations as to whether or not they were made in fact ^2/ would be repetitious and superfluous" is not helpful under the circumstances. Even if the alleged representations had been denied, instead of admitted in the pleadings, the advertising material leaves no doubt whatsoever that these five representations were made. With respect to alleged representation "D" which is "Tht the lecithin in the product, in the doses provided therein, will cause a decrease of 30% in the cholesterol level of the average person", a more difficult question is presented. The statement in the advertisement directly bearing upon the point is the statement that "Dr. Lester L. Morrison, in a recent project, found that Lecithin produced a decrease of as much as 30% in cholesterol in the body". Respondent contends that the ordinary reader would not conclude that he or she would enjoy a 30% decrease in cholesterol and points to its cross-examination of Complainant's expert witness, Dr. Jack L. Segal, a medical doctor, who testified that he would not expect to experience a 30% reduction of the cholesterol level of his body if he read an advertisement that a doctor in a recent project had found that lecithin produced a decrease of as much as 30% in cholesterol (Tr. 50). However, Dr. Segal's answer is conditioned by the explanation that he would want to check the references of the individual and his qualifications and then to look further into the literature regarding the subject (Tr. 50). It must also be weighed in the light of his earlier testimony that a 30% reduction in total body cholesterol, as distinguished from serum cholesterol, might well be fatal to a human and his further opinion that lecithin does not reduce total body store of cholesterol or the serum level of cholesterol by any significant extent (Tr. 11-12). The average reader would not have Dr. Segal's technical background, the advertisement being directed to members of the public at large and not to the medical community.

The above-referenced statement in the advertisement regarding lecithin producing a reduction of "as much as 30% in cholesterol in the body" is obviously intended to have some influence on the prospective purchaser of "Fat Off". I believe it apparent that the reader is supposed to conclude that this statement has some reference to what is being sold. It would be in keeping with reason to conclude that the lecithin in "Fat Off" can produce a decrease in cholesterol as great as 30%. It doesn't have to be phrased in terms of a guarantee in each individual case to impress upon the average reader that significant reductions in the magnitude mentioned are in store for him. One must also take into account the immediately preceding and following paragraphs between which this statement is sandwiched which read:

"Ms.Davis in Let's Get Well says lecithin is an emulsifier, meaning it keeps things moving. And that's what it'll do to your fat--move it right off your body.

* * * * *

"But it isn't that Lecithin reduces you. It just shifts the weight around to where you'd want it. Trim and slim? No lumps? So who could ask for more?" taking with the glaring bold print headline at the top of the advertisement "THE FAT DISSOLVER" and the promise at the end of the advertisement that the user will "see" the results in 10 days the 30% decrease stands out with more prominence than any qualification intended to convey the meaning that this was one result obtained in an unrelated study. It is well established that "the meaning and impression upon the mind of the reader arises from the sum total of not only what is said but also of all that is reasonably implied". Spiegel, Inc. v. FTC, 411 F.2d 481, 483 (7th Cir. 1969). In citing this case the court in Baslee Products Corp. v. United States Postal Service, 356 F.Supp. 841 (1973) went on to state "After all, as I have already stressed, to hold that the law is otherwise would be to provide immunity to the master of the artful phrase who was able to convey a subtle but penetrating message by seemingly innocuous but carefully contrived verbalisms". Applying this test I find that the allegation made in compliant paragraph "D" was in substance made by Respondent. It now becomes necessary to examine the representations found as having been made by Respondent to determine whether they are materially and substantially false in the light of the evidence in this record. Complainant presented as an expert witness,Dr. Jack L. Segal, a medical doctor currently employed as a fellow in medicine in the division of clinical pharmacology at Emory University School of Medicine. He is board certified in internal medicine. As a general practitioner in Los Angeles in 1967-1969 he had occasion to treat large numbers of patients for obesity. Respondent presented as its first witness, Dr. John Ellis, M.D., a medical doctor in family practice with emphasis on surgery and nutrition. For the past thirteen years Dr. Ellis has done extensive work with Vitamin B-6. He is the author of two books and a number of papers on his experiences in treating patients with Vitamin B-6. Judge Edenfield's description of Dr. Ellis, who also appeared as a witness in the 39 U.S.C. § 3007 injunction proceeding, as "the personified troubadour of pyridoxine, or Vitamin B-6" is further borne out by his testimony in the administrative hearing. Dr. Ellis' testimony was in the main related to Vitamin B-6. Respondent's second expert witness was John Rudolph, Jr., who holds a Ph.D. in biochemistry at the College of Osteopathic Medicine in Fort Worth, Texas. His testimony was primarily related to the component lecithin. Respondent's third expert witness was Dr. James Cooper, M.D., a medical doctor, board certified in bariatrics, who is engaged in family practice with emphasis upon the treatment of obese patients. At the present time he has between 400-500 patients under some form of routine for weight control. Dr. Cooper's testimony touched on all the ingredients in "Fat Off" as did Dr. Segal's testimony.

Current medical knowledge, according to Dr. Segal, indicates that the primary cause of obesity is the ingestion of excess amounts of calories over and above those which are required to maintain day-to-day living. Reduction requires a deficit in caloric intake which is accomplished by eating less, or by burning more calories, or by a combination of both (Tr. 9).

Respondent contends that the evidence shows that "Fat Off" will in fact cause a loss of fat and that it does dissolve fat and cause it to be redistributed. In considering this defense on the truth or falsity of the representation it is necessary to view the advertisement as a whole to glean the impression upon the average reader. When so read it is readily seen that the whole thrust of the advertisement holds out the promise of quick and measurable results for the user of "Fat Off". I have underlined words in certain portions of the advertisement which emphasize this, for example:

"But now Mary Crenshaw says these four named substance will get your body in shape safely and (best of all) quickly"--"FAT-OFF MOVES THE FAT OFF YOUR BODY"--"It's practically a miracle for dieters"--"and that's what it'll do to your fat--move it right off your body."--"But it isn't that Lecithin reduces you. It just shifts the weight around to where you'd want it. Trim and slim? No lumps? So who could ask for more?"--"A special blend that shows results almost immediately"--"We're so sure it works (and works fast) we'll unconditionally guarantee it. Order Fat-Off now and use as described for just 10 days. You'll see the results".

There are four ingredients in "Fat Off": Kelp, Cider Vinegar, Lecithin and Vitamin B-6. It is Dr. Segal's testimony that the use of the product will not cause a loss of fat, dissolve fat or redistribute fat. The medical testimony of both parties centered principally on the two ingredients, Vitamin B-6 and lecithin.

The labels from two separate purchases of "Fat Off" are in evidence as CX-8 and CX-13 and show different quantities of these ingredients in each bottle. The label on CX-8 shows that each capsule contains 100 milligrams of lecithin and 3.5 milligrams of Vitamin B-6. The label directions state "Take after each meal. Four to six daily". Thus the daily intake, if four capsules are taken, would be 400 milligrams of lecithin and 14 milligrams of

Vitamin B-6. If six capsules are taken, the daily intake would be 600 milligrams of lecithin and 21 milligrams of Vitamin b-6. The label on CX-13 shows that each capsule contains 200 milligrams of "Soya Lecithin and Soya Oil" and 5.0 milligrams of Vitamin B-6. This label contains the statement "Suggested use: As a food supplement take 1 or 2 capsules daily". Thus, if one capsule is taken, the daily intake would be as listed above or, if two capsules are taken, the daily intake would be 400 milligrams of lecithin and 10 milligrams of Vitamin B-6.

Dr. Ellis who has used Vitamin B-6 for a number of years in his practice testified that his experience indicates a definite beneficial effect in the use of Vitamin B-6 in treating edema (Tr. 64). Much of his testimony related to his clinical experience in treating women on birth control pills and he normally gives a daily dosage of 50 milligrams of Vitamin B-6 to his patients (Tr. 84). He nevertheless was of the opinion that the 21 milligrams quantity of Vitamin B-6 in CX-8, if six tablets are taken, would be sufficient to control edema in most cases (Tr. 67).

Dr. Ellis testified that it is still one of his life's dreams to have his findings reported in the medical literature (Tr. 81). He has tried unsuccessfully to get his findings reported but the reason they have not been published is that "This kind of data is not accepted from country doctors in country towns. And they always ask for control studies". His personal conviction in the value of Vitamin B-6 is evident from his testimony but it does not equate to a consensus of accepted medical opinion on the matter. In response to a question of whether 25 milligrams of

Vitamin B-6 would cause loss of weight in an individual 10 to 15 pounds overweigh who did not have edema Dr. Ellis said he would not expect so (Tr. 86). Moreover, it is to be noted that "Fat Off", taken as directed, provides a range of Vitamin B-6 from as small as 5 milligrams to a maximum of 21 milligrams daily.

Dr. Rudolph was of the opinion that Vitamin B-6 would reduce edema, or water weight (Tr. 153) but he based this principally upon Dr. Ellis' testimony. Dr. Cooper uses Vitamin B-6 in treating edema in his women patients (Tr. 173). The daily dosage he uses which could be as little as 4 milligrams, and go to 50 milligrams or more, is decided upon only after a comprehensive physical examination to determine the cause of the edema (Tr. 202, 204). All of his patients are placed on a reduced calorie diet which produces a deficit of 1,000-2,500 calories a day and is the standard method of taking off one to two pounds a week (Tr. 189). While he believes that Vitamin B-6 has a stimulatory effect in the burning of at he primarily uses it for fluid reduction in patients with edema (Tr. 205). Dr. Cooper (Tr. 177) was not aware of any medical literature on the effectiveness of Vitamin B-6 in the treatment of edema but remembered presiding over a medical meeting of the Bariatric Society at which the use of Vitamin B-6 was discussed and almost uniformly the physicians were able to get some response to edema using Vitamin B-6 (Tr. 177). The details are not in evidence.

Dr. Segal's testimony was that Vitamin B-6 given in the quantities in "Fat Off" would not cause a reduction of excess water in the average person (Tr. 15) and that Vitamin B-6 is of no therapeutic value in the reduction of edema (Tr. 16, 41, 42).

He further testified that at the present time the use of Vitamin B-6 to treat edema is not commonly medically accepted in any of the texts that are considered to be standard reference sources (Tr. 47). The labels in CX-8 and CX-13 state that the minimum daily requirement for Vitamin B-6 "has not been established".

Before going on to the evidence on lecithin it is appropriate here to note with all due respect to the credentials and experience of the medical experts that the testimony with respect to the value of Vitamin B-6 in the treatment of edema does not really come to grips with the charges in the complaint which relate to fat, not fluids. In fact Respondent's advertisement in reference to Vitamin B-6 mentions the regulation of "body fluids" and prevention of "bloat", and these references are not made on the basis of a false representation charge, as such, by Complainant. Dr. Cooper pointed out in his testimony the depressing effect of excess body fluids on the dieter who might lose fat on a reduced caloric intake but be discouraged by an offsetting increase in fluid weight (Tr. 205). Respondent is not, of course, selling the ingredients separately. It is selling a product which emphasizes immediate and visible results in moving the "fat off".

The evidence with respect to the need for and value of a lecithin supplement also presented some contradictions in the expert testimony. It may be noted here also that, with respect to lecithin, the label which is CX-8 reads "Need in human nutrition has not been established" and the label which is CX-13 reads "200 mg of Soya lecithin and Soya oil plus 50 mg of Cider Viengar, for which no special dietary values are claimed because their presence is without nutritional significance". The testimony on lecithin dealt with all of the representations involved in this case. Again, although necessarily technical in nature, it must be viewed in the light of the overall impression upon the ordinary reader of Respondent's advertising. It might be best at this point to take up the issue of what the evidence reveals with respect to the cholesterol reduction capabilities of "Fat Off". Dr. Segal's testimony on this point has been referred to in discussion at the beginning of this decision on the issue of whether the representation charged in complaint paragraph III D was made in Respondent's advertising. He testified that total body cholesterol is much greater than that which is circulating in the blood; that a decrease in total body cholesterol of 30% might well be a terminal event in a human being; and that lecithin would not reduce blood cholesterol by 30% (Tr. 11, 12). Dr. Rudolph's testimony as a biochemist was with respect to serum cholesterol (Tr. 104). He was aware of studies that had been conducted in the late 1950's wherein lecithin had reduced cholesterol levels in patients with high blood cholesterol up to 30% and more recently by intravenous injection up to 40% (Tr. 103, 135). The earlier studies used about 8 tablespoons of lecithin (Tr. 128). Dr. Rudolph's work with physicians using lecithin for patients with high blood cholesterol presently involves the use of two to three grams ^3/ daily (Tr. 127, 128). He has not seen any studies using daily quantities of 400 to 600 milligrams but was of the opinion that it would have some eventual cumulative effect in the reduction of cholesterol (Tr. 129-130). The patients he works with were on other medical supplements and a diet excluding beef because of its high fat content (Tr. 131). Dr. Cooper has used lecithin in cholesterol control (Tr. 165) and considered that there was "possibly" enough in "Fat Off" to effect a lessening of the cholesterol level although he gives his patients doses of two to four 1-1/4 gram tablets daily (Tr. 180, 181), which would be 2-1/2 to 5 grams daily. Even on that dosage he did not expect a 30% drop in serum cholesterol in a person who was within the range of normalcy for cholesterol (Tr. 194). Understandably he also would not expect a decrease of 30% in cholesterol level for persons within the range of normalcy taking a maximum of 600 milligrams a day (Tr. 194).

There is not an iota of doubt that "Fat Off" will not reduce total body cholesterol by as much as 30%. Moreover, the evidence compels the conclusion that it will not reduce blood serum cholesterol in the average person by 30% or anything like that. The average reader of Respondent's advertising who feels a need for the product "Fat Off" whether he associates the cholesterol reduction with serum cholesterol, or fat as he might think of it, is being seriously misled quantitatively. Dr. Rudolf testified that lecithin has a normalizing effect on lipid metabolism. Without it there would be a backup of fatty products in the liver and the liver would not be able to handle these products (Tr. 102-103). In a biochemical sense it is a fat distributor or mobilizer (Tr. 105) but this has relation to its importance to the normal functioning of the liver rather than to a weight loss (Tr. 111, 112). He also distinguished this form of redistribution from any external redistribution of fat (Tr. 111, 154). While he testified that in his opinion people today probably do not get enough lecithin in their diets (Tr. 113) he further testified on cross-examination that the average American diet would probably not be so deficient in lecithin as to cause this fatty liver condition (Tr 156) and that the body manufactures its own lecithin (Tr. 139). He also testified that lecithin contains polyunsaturated fatty acids which would increase oxidative phosphorylation and in effect burn more calories (Tr. 115-118, RX-1). He could not say what the effect would be in terms of weight loss except probably a very small amount (Tr. 145). Dr. Cooper thought there might be a relative deficiency, in a lot of diets, of choline, one of the constituent parts necessary for the body to manufacture lecithin (Tr. 200) but knew of no reports in medical literature confirming this (Tr. 202). In this connection, and as pointed out earlier in this decision, the labels on "Fat Off" are explicit in disclaiming any established need for lecithin in human nutrition. Dr. Cooper shares Dr. Rudolph's opinion that the unsaturated fatty acids in lecithin produce an increased expenditure of body energy in the form of heat (Tr. 168-169, 196). He said that "Fat Off" could help dissolve fat (Tr. 163, 164, 180) speaking in terms of the breakdown of the tryglyceride into its components, the transport of these components to various organs of the body and the conversion of these products into energy. Regarding fat redistribution Dr. Cooper pointed out that while treating patients with lecithin in 1967 for high cholesterol he observed a change in shape, or body contour, of a lot of these patients (Tr. 165, 166, 181). However, these patients were on a dosage of several tablespoons of lecithin and some of them "took much more" (Tr. 193) although some may have taken less (Tr. 194). Dr.Cooper did not hold out this observation as any more than an observation. Without a great deal more in the way of specifics it cannot be considered, and it was not held out as, a controlled study. Nor does the entire testimony support a conclusion that the consensus of medical opinion would be that such an effect would be produced by a supplement of lecithin in any dosage much less the dosage in "Fat Off".

The remaining two ingredients are kelp and apple cider vinegar. Dr. Segal testified that there is no need for the average individual to supplement his diet with additional sources of iodine, the ingredient of kelp advertised here (Tr. 13) and that in fact any supplementation of iodine over the daily requirement could suppress the thyroid function and trigger an allergic reaction in a significant part of the population (Tr. 14, 43). Apple cider vinegar, he said, has no recognized medicinal use (Tr. 16).

Dr. Rudolf testified that if a person had a normal thyroid adding the iodine in the amounts contained in "Fat Off" would have no effect one way or the other (Tr. 144). Kelp also has other minerals and trace elements helpful in stabilizing metabolism (Tr. 99). It and apple cider vinegar are a good source of potassium and a lot of people do not eat enough of the proper foods to get potassium according to Dr.Cooper although he doesn't use either in his practice (Tr. 178). Respondent's advertisement references the main assistance of the cider vinegar as being its source of potassium as a preventative of water retention. It is necessary at this point to evaluate the opinions of the expert witnesses with respect to their conclusions as to the probable effect upon the average person of using the product "Fat Off". Dr. Segal's conclusions stated in part earlier, are that all of the representations are unfounded based upon his experience and knowledge of the consensus of current medical thinking which he bases upon accepted medical reference sources (Tr. 12, 15, 16, 18, 48). The opinions of Respondent's experts and the bases therefore, have been gone into in some detail already but their ultimate conclusions are more essential from the standpoint of the issues in this case.

Dr. Ellis' testimony relates to edema rather than a loss of fat as indicated in greater detail above. Although he stated that to the patients the swelling looked like fat and he didn't know whether the loss was coming out of fat cells (Tr. 93) he earlier defined the loss as a fluid loss (Tr. 65) and Dr. Rudolph's testimony regarding this being a water weight loss (Tr. 153) is consistent with that. Moreover, Dr. Ellis' opinion (Tr. 86) that the ingestion of 25 milligrams a day of Vitamin B-6 would not cause a loss of weight in an overweight person who did not have edema is also significant. Whatever the merits of Vitamin B-6 as may someday be established, Dr. Ellis' conclusions insofar as the issues in this case are concerned support if anything the Complainant's view rather than the Respondent's view of the case. Dr. Rudolph and Dr. Cooper both attribute to "Fat Off" the potential for achieving, in some degree, the results claimed in the alleged representations. The problem to a large extent is the degree. For example, while both claim lecithin reduces blood serum cholesterol their testimony, as earlier discussed, regarding the degree of reduction supports the falsity rather than the truth of the cholesterol representation.

Dr. Rudolph's testimony regarding the introduction of the polyunsaturated fatty acids through the lecithin ingredient having the effect of converting calories to heat, as well as his testimony regarding the biochemical process of a lecithin supplement in normalizing liver function in cases where the body may have a lecithin deficiency, never reaches the level of the representations which hold out the immediate results the user is told he will "see" in himself, such as the "So who could ask for more?" claim of shifting the weight around "to where you'd want it. Trim and slim? No lumps? He could offer no opinion on how much fat would be lost due to the polyunsaturates other than the opinion that it would "probably be a very small amount" because he has seen no quantitative data (Tr. 145-146). Dr. Cooper was of the opinion that "Fat Off" could cause a loss of fat (Tr. 179). He would expect some weight loss but "How much I have no idea" (Tr. 179). In conjunction with a conscientious diet program he would expect it to be greater because of the sheer placebo effect of having to take the capsules every day (Tr. 179-180). On cross-examination Dr. Cooper was pressed to quantify his opinion. He did so by giving what he term was a "wild ball park figure" that approximately 30 to 60% of the people taking "Fat Off" and not on any diet would lose a pound a month (Tr. 212). This estimate must be closely examined in light of the remainder of Dr. Cooper's testimony on this point.

Dr. Cooper's initial response to the question whether "Fat Off" would produce a weight loss without a reduced caloric intake was that it would for a certain percentage of people and he considered it possible for everyone to lose "a little bit" based purely on the lecithin and Vitamin B-6 (Tr. 209, 210). When asked whether anybody would lose a pound a month he answered:

"A. It's possible. That represents a little bit--a little bit more than a hundred calories a day. It's possible. Of course, nobody who buys this product, at least nobody with any insight is not going to diet. Most people who take this product are going to try to at least modify their diet a little bit. So I think your question in a sense is fallacious. But I think the very act of taking the pill is going to make you conscious of the food intake.

"For instance, I've used placebos in my office. I've got a placebo that looks just like a dexedrine capsule. It's nothing in the world but an inert capsule with little inert

beads in it. And I've gotten results from that just purely from placebo effect.

"Q. Well, would the loss of the weight of this percentage of people you say will lose weight, will that be due to any placebo effect or the ingredients themselves?

"A. I don't think you can totally separate them. This is the big problem with any product that you give a person for weight. It's been proven that the external influences on any weight patient as far as hunger will far outweight the internal influences." (Tr. 210, 211).

The very next question asked whether the placebo effect entered into his answer on the one pound loss and Dr. Cooper answered that it did not (Tr. 211). However, he also volunteered that a sustained one pound a month weight loss is "fantastic" for patients in clinics such as the Mayo Clinic where they are on a diet and under professional supervision (Tr. 212, 213). In explanation he said that the clinic patients do not comply with the diet program (Tr. 214) wherein his 100 calorie a day loss was based on heat loss "from the specific action of the unsaturated fatty acids in the lecithin" and added "It may only be a half pound a month. This is the unlikely event they do not diet" (Tr. 215). He has no knowledge of any reports in the medical literature that ingestion of lecithin up to 600 milligrams a day will cause increased caloric heat loss of 100 calories a day (Tr. 215). When his testimony is viewed in its entirety the estimate of 30 to 60% of the people losing a pound a month without being on a diet does not stand up. Respondent's other expert witness on lecithin, Dr. Rudolph, could not attribute any significant fat loss to the lecithin in "Fat Off". In light of all the evidence and Dr. Segal's testimony regarding the consensus of medical opinion, Dr. Cooper's estimate cannot be accepted as controlling. Moreover, even if 30 to 60% could lose one-half pound a month without dieting this would still be a far cry from the significant losses promised both explicitly and implicitly in Respondent's advertising. On the basis of the foregoing I find that the representations made in Complaint paragraphs A. (loss of fat), C. (fat dissolver), D. (30% cholesterol reduction) and E. (fat redistribution) are materially and substantially false when viewed in the perspective of the entire advertisement's impact upon the ordinary reader. It necessarily follows, and I so find, that the representation made in Complaint paragraph B. that the effective cause of the promised fat loss is the capsule and not diet or exercise is also materially and substantially false. By the same token, I find that the representation made in Complaint paragraph F. that the capsule will contribute significantly to the effectiveness of a conscientious diet program is also materially and substantially false. The only evidence warranting such a conclusion relates to the placebo effect which any capsule will have on approximately 30% of the population of mentally stimulating the belief that they are receiving some additional help beyond their own control (Tr. 30). Any placebo effect would by its terms be unrelated to the ingredients of the placebo and quite obviously Respondent's product is not being advertised as a placebo. If Respondent must rely on the placebo effect it relies upon what is inherently a false representation.

The difference between permissible puffing and false representation is very often a matter of degree. In the case of diet plans where a good segment of the population stands anxiously awaiting the solution which permits them to achieve a slim figure without giving up eating, a ready market exists for purveyors of new products holding out this hope. More often than not, as here, the product is promoted with a fanfare far exceeding its worth. Of course if the truth is told in its simplicity the buyers would be less willing, if at all, to part with their cash, but therein lies the basis for enactment of 39 U.S.C. § 3005. In conclusion I find that Respondent is, as charged, engaged in a scheme or device for obtaining money through the mails by means of false representations in violation of 39 U.S. Code § 3005. Accordingly, I am issuing an appropriate order under that statute contemporaneously with this decision. In this connection Complainant has filed a motion to stay implementation of any such order insofar as it requires return of mail to senders. The motion is based upon the preliminary injunction order in the District Court directing the Postal Service to detain mail during the pendency of the administrative proceedings "and any appeal therefrom". Complainant's motion represents that Respondent has advised that it intends to seek judicial review of any adverse administrative decision. Accordingly, by supplement to the order issued under 39 U.S.C. § 3005 I am staying full execution of that order pending appeal, if taken within 30 days, and action thereon, so that mail will be detained temporarily, rather than returned to senders, pending court action on this case.

                                                                                       04/09/75
                                                                                       Lussier, Edward F.

____________________

1/ This exhibit was originally attached to the complaint as CX-2.

2/ On the merits Respondent contends in fact that they are all true.

3/ This would be 2,000 to 3,000 milligrams since one gram is 1,000 milligrams. As indicated earlier the range of ingestion for "Fat Off" would be from 200 to 400 milligrams if the particular purchaser received CX-13 and 400 to 600 milligrams if the purchaser received CX-8.