In the Matter of the Complaints Against HANOVER HOUSE at Hanover, Pennsylvania 17331 and ROMAR SALES CORP., 227 East 45th Street at New York, New York 10017 P.S. Docket No. 2/143; P.S. Docket No. 2/149 February 14, 1975 William A. Duvall Chief Administrative Law Judge Thomas A. Ziebarth, Esq., Law Department, United States Postal Service, Washington, D. C., for Complainant Jerold W. Dorfman, Esq., Friend & Dorfman, 747 Third Avenue, New York, New York for Respondent
This consolidated proceeding is brought under 39 U. S. Code 3005. The General Counsel for the United States Postal Service (Complainant) charged Hanover House and Romar Sales (hereinafter referred to collectively, except as otherwise indicated, as "Respondent") with conducting a scheme or device for obtaining money or property through the mail by means of false representations.
The scheme in which Respondent is alleged to engage is the sale of pills called "Hungrex" or "Hungrex with PPA"1/ (hereinafter sometimes referred to as the "product") by falsely representing in advertising matter, directly or indirectly, in substance and effect as follows:
1. The Hanover House charges:
"(a) That HUNGREX tablets help the user to start losing weight the first day;
"(b) That the use of HUNGREX tablets will banish hunger pangs;
"(c) That HUNGREX has been proved safe by laboratory tests to effectively reduce excess food craving;
"(d) That the use of HUNGREX tablets will cause calorie intake to go down; and
"(e) That HUNGREX is the most powerful reducing aid ever released for public use without prescription."
2. The Romar Sales charges:
"(a) That HUNGREX tablets will cause the user to lose weight the first day;
"(b) That the use of HUNGREX tablets will banish hunger by limiting the ability of the body to produce hunger sensations;
"(c) That the use of HUNGREX will cause calorie intake to go down;
"(d) That HUNGREX with PPA is the most powerful reducing aid ever released for public use without prescription."
In its Answer to the Complaint Respondent denied all allegations of the Complaint. In addition, Respondent asserted that (1) the Postal Service is barred from proceeding with this case by reason of a finding Respondent claims was made by the Federal Trade Commission (In re Allegheny Pharmacal , FTC Docket #7176) "***that the advertising attached to the complaint is not false or misleading and may be used in interstate commerce and the mails"; (2) the Postal Service is barred from proceeding with this case because the advertising complained of "*** complies with a consent agreement entered into between the Post Office Department and Allegheny [sic] Pharmacal, in In re Fisk Research, Inc., H.E. Docket 5/67 and/or In re Allegheny [sic] Pharmacal Corp., H.E. Docket 5/68, one of the terms of which was that no action would be brought by the Post Office Department against the advertising for Hungrex unless it violated that agreement"; (3) this proceeding is "barred by collateral estoppel in that the complainant may not relitigate the issues determined by the Federal Trade Commission in Allegheny [sic] (supra), in which it was found that the advertisement, herein alleged to be false, was in fact not false or misleading"; (4) although Respondent is not Allegheny , Respondent, "***as a customer of Allegheny [sic] for Hungrex is in privity with Allegheny [sic] for the purpose of obtaining the benefit of the prior decision, and is entitled to assert the defense of res judicata and collateral estoppel"; and (5) the Postal Service "***is bound by final decisions on the merits rendered by the Post Office Department, the FTC, and other federal administrative agencies to to those issues actually decided, or which could have been raised in the above mentioned prior proceedings involving the same parties or their privies." (Amended Answer filed Dec. 4, 1973) In support of its defense of res judicata and collateral estoppel Respondent cited and relied upon United States v. Willard Tablet Co ., 141 F.2d 141; United States v. 14 Cartons, etc. Ayds Candy , D.C. Mo. (1946) (not officially reported, by a copy of which was submitted with Respondent's proposed findings and conclusions); United States v. Federal Trade Commission , 113 F.2d 583; United States v. Hindman , 179 F. Supp. 926; and Sunshine Anthracite Coal Co. v. Adkins , 310 U.S. 381, 402-403.
Respondent's position with regard to res judicata and collateral estoppel is untenable for a number of reasons.
In the first place, contrary to the assertion in Respondent's Answer, there has been no "finding by the Federal Trade Commission, in a final agency decision on the merits, that the advertising attached to the complaint is not false or misleading and may be used in interstate commerce and the mails" (Amended Answer, first affirmative defense). Assuming, arguendo , that the advertising matter and the charges in the complaint under consideration in the Federal Trade Commission (hereinafter, Commission) proceeding (In re Allegheny Pharmacal , FTC Docket #7176) were identical to the advertisements and charges in the instant proceeding, neither the finding of the Hearing Examiner nor the order of the Commission operates as a bar to this proceeding. The Hearing Examiner stated:
"Considering all of the evidence of record, it is found that the allegations of the complaint have not been established by a preponderance of the evidence." (75 F.T.C. 1034)
This finding is a far cry from a declaration that the representations complained of are not false.
Based upon the Hearing Examiner's finding, above, the Commission, on June 17, 1969, ordered:
"That the amended complaint *** be dismissed as to all respondents without prejudice to the right of the Commission to take such further action as may appear to be appropriate."
The Commission then ordered that there remain in effect a previous order requiring all respondents named therein, including Allegheny Pharmacal, to cease and desist representing that Hungrex with PPA is safe for use by all obese persons or that any predetermined weight reduction can be achieved by the taking or use of the product for a prescribed period of time.
In the case of Federal Trade Commission v. Raladam Co ., 316 U.S. 149 (1942) in a closely analogous situation it was held that a prior proceeding in which "the reasons for refusing to enforce the Commission's order are grounded upon the inadequacy of the findings and proof" is not controlling in a subsequent case in which, although the allegations of the complaint were substantially the same, there were different proceedings, different facts and a different record. ( id ., pp. 150-151, 152)
If the Federal Trade Commission is not precluded from re- instituting proceedings and presenting different evidence, then, clearly, the Postal Service, with different allegations and after the passage of more than 30 years, would not be foreclosed from bringing a proceeding based upon allegedly misleading advertising.
Respondent next asserts that this action is barred by the Existence of a "consent agreement entered into between the then Post Office Department and Allegheny Pharmacal, in In re Fisk Research, Inc. , H.E. Docket No. 5/67 and/or In re Allegheny Pharmacal Corp. , H.E. Docket No. 5/68, one of the terms of which was that no action would be brought by the Post Office against the advertising for Hungrex unless it violated that agreement."
A number of reasons exist why this assertion by Respondent lacks validity. One of the principal reasons why the Postal Service is not now precluded from bringing this proceeding was stated by Professor Davis in 18.04 of his Treatise as follows:
"Probably the best answer is that the question of the legality of the company's 1929 practices is not necessarily the same as the question of the legality of the company's 1935 practices, even if the practices remained the same. Otherwise the opportunity for development of law and policy by processes of administrative and judicial interpretation would be duty off. *** But it [the doctrine of res judicata ]
should not prevent an agency, after a decent interval, from testing the question whether or not law or policy concerning continuing practices may have changed."
The admonition of the foregoing quotation should be especially heeded in the area of the sale of products claimed to have a capability to produce certain results on the human body. Medical progress is so rapid, and unanticipated adverse side effects are so frequently encountered, that it would be a grave mistake to prevent an inquiry about a product simply because at some earlier time there was available insufficient evidence to show precisely what its effects were.
Another reason why the claim that the former Post Office Department proceedings bar the present one is invalid is the difference between the statutes under which the former and the instant proceedings were brought. When the earlier proceeding was initiated, before a remedial order could issue it was necessary that the complainant establish the existence on the part of the respondent of an intent to deceive. By Public Law 90-590, approved October 17, 1968 (82 Stat. 1153), former 39 U. S. Code 4005 (now 43005) was amended so that it no longer is necessary to establish that a respondent intends to deceive persons who read this advertisement. This amendment so changed the character and quality of proof necessary to justify the issuance of a remedial order that it could warrant the institution of proceedings under the new statute.
Other objections to the prosecution of this proceeding involving the principles of res judicata and collateral estoppel were made by Respondent in its Amended Answer but, in view of what has heretofore been said, those objections are not persuasive. The cases cited by Respondent in support of its position on this point are clearly distinguishable. For example, in the Willard case, the issues and the parties were the same and no new facts or information were alleged. In George H. Lee , there had been a final decree by a court which was pleaded, and of course recognized, as a bar to a later proceeding. In Sunshine Anthracite Coal Co. , Congress had enacted legislation vesting the Bituminous coal Commission with authority to make final determinations whether producers' coal was "bituminous."
If the coal was bituminous, then the Commissioner of Internal Revenue (C.I.R.) was authorized to collect a particular tax. When C.I.R. attempted to collect the tax, Sunshine attempted to re-litigate the question of the classification of its coal. The Supreme Court held that the final determination of this question by the Bituminous Coal Commission was res judicata of the matter.
The other cases cited by Respondent on the questions of res judicata and collateral estoppel are not controlling in this proceeding. Each of them is similarly distinguishable and lacking in persuasiveness.
It is now the time to consider the charges in the Complaint in this case. Since these charges previously have been stated, attention must be directed to the proof, or lack thereof, in regard to them.
Although in the first paragraph of the Answer to the Complaint Respondent denied all of the allegations in the Complaint, at the hearing Respondent's Counsel stipulated that CX-1 2/ and CX-4 (Appendices A and B, respectively, to this decision) are advertisements used, respectively, contain shipments of Hungrex and Hungrex with PPA sent through the mails by Hanover House and Romar Sales, respectively, in response to remittances made pursuant to the solicitations of CX-1 and CX-4. (Tr. 11-17)
From the foregoing recitation, it is shown that in the conduct of business Respondent advertises the product in publications of wide distribution and that by means of these advertisements Respondent solicits remittances of money through the mails for the product.
Comparison of the charges set forth in paragraph (3) of the Complaint with the language of the Respondent's advertisements demonstrates that the charges are comprised largely of the language appearing in the advertisements, clearly establishing that Respondent does make the representations set forth in the Complaint.
The next question to be resolved is whether Respondent's product will produce for its users the results represented by Respondent. The resolution of this question makes it necessary to weigh the testimony of the expert witnesses who testified on behalf of each party.
Complainant's first witness was Vincent F. Cordaro, M.D., who is employed in the Bureau of Drugs of the United States Food and Drug Administration. Dr. Cordaro identified letters dated July 5, 1957, Oct. 23, 1957 and May 6, 1959 (CX-7, 8 and 6, respectively) in which medical officers of the New Drug Branch of the Bureau of Medicine of the Food and Drug Administration advised either manufacturers or distributors of a product containing PPA that its label must contain the following language:
"Phenyl Propanolamine Hydrochloride is useful as an appetite suppressant in the dietary management [or control] of obesity." (CX-7A and 8A)
The product then under consideration contained 75 milligrams of PPA and the product was described as a "Timed-Disintegration Capsule."
In Exhibit CX-8A the addressee of the letter was told that the last sentence in the first paragraph of the label should, in the opinion of the writer of the letter, be revised to read:
"This capsule is equivalent to one tablet of 25 mgm. potency taken three times daily".
On cross-examination information was elicited about a technique employed by the Food and Drug Administration which is used to assist that agency in making a determination as to whether a particular product is safe and effective and whether it is truthfully labeled. The procedure is put in motion by the publication in the Federal Register, and perhaps in other appropriate places, of a notice that is called a request for data. The request for data invites interested parties to submit data, published and unpublished, and other information pertinent to all active ingredients utilized in the product. Information is also requested as to statements made on the labeling of the product, the effects of the use of the product as shown by tests, it any, the comments about the product made in the pertinent medical and scientific literature, and any other information that may have a bearing upon the determination sought to be made by the Food and Drug Administration.
After all of the foregoing information has been received, it is delivered to a panel of experts which previously has been appointed and these experts review all the data. In the usual course of events the panel will make their findings and reduce them to writing in a monograph in which they state their conclusions in regard to the safety, efficacy and truthful branding of the product. This monograph is used for its guidance by the Food and Drug Administration, but that agency is not obligated to adopt the findings stated by the panel in its monograph.
It was established through Dr. Cordaro that such a procedure as has been described above is now being followed in respect to non-prescription or over-the-counter reducing aids. It is likely, therefore, that some determination will be made by a panel as to the safety and effectiveness of the use of PPA when used as an appetite suppressant.
Dr. Heinz Sorer was next called as a witness by the Complainant. Dr. Sorer received his Bachelor's degree in biological sciences from Western Reserve University in Cleveland, Ohio; a Bachelor's degree with distinction in pharmacy from Ohio State University; a Master's degree from Ohio State University in pharmacology, and a Ph.D. in pharmacology from the same educational institution. For some time in 1965 Dr. Sorer was in charge of acute toxicity testing at the Food and Drug Administration and since 1965 he has been with that agency as a pharmacologist. His duties include the function of reviewing preclinical data for investigation of new drug applications. In 1966 Dr. Sorer was assigned to the Division of Neuropharmacological Drugs where he has been ever since. He has additional duties as a member of the Food and Drug Administration's drug abuse staff. In his present position he has reviewed a wide variety of drugs affecting the central nervous system and, in particular reference to this proceeding, he reviewed virtually every appetite suppressant that was submitted to the Food and Drug Administration from 1965 to 1970.
Dr. Sorer conducted a study in 1972 for the purpose of assisting in developing a Food and Drug Administration policy on appetite sup- pressants and to determine the abuse potential of amphetamines. Incidentally, in his search of the literature on the subject, Dr. Sorer found no evidence of abuse potential in regard to PPA. The amphetamines and PPA are members of the same family of sumpathomi- metic agents. They are synthetic derivatives of ephedrine and, therefore, they are pharmacologically related and can be expected to have similar characteristics. The similar characteristics of the two agents are qualitative rather than quantitative. Some of the qualitative similarities of amphetamines and PPA are (1) both are central nervous system (CNS) stimulants; (2) both reduce food consumption in animals and in man; (3) they will produce tolerance to the stimulating effects to the central nervous system; (4) both will depress the appetite but tolerance to this effect does occur (in general tolerance to anorexigenic agents will occur in from one to four weeks); (5) both agents will elevate the blood pressure in anesthetized animals, but repeated dosage produce tachyphylaxis; (6) both agents will dilate the eyes and both will elevate the blood pressure in both man and animals.
Despite the foregoing qualitative similarities between amphetamines and PPA, there are quantitative differences between these agents. For example, dextro-amphitamine,3/ which generally is used as the yardstick for measuring anorexiant effect, is approximately 10 to 20 times as potent as PPA and this relationship would hold true in regard to all pharmacological effects (Tr. 42-48). Dr. Sorer expressed the view that the development of tolerance to PPA would occur in about the same amount of time as it would take for tolerance to develop in regard to amphetamines. Dr. Sorer stated that prescription anorectic agents produce an average weight loss produces an average weekly weight loss of from about .625 pounds per week to .75 pounds per week.
On cross-examination, it was pointed out that the validity of one of the studies cited in Dr. Sorer's report had been brought into serious question in a proceeding before another agency. Dr. Sorer agreed that he would question the validity of a study if certain deficiencies suggested by Respondent's Counsel existed in the conditions under which the study was conducted. Dr. Sorer stated, however, that in the preparation of his study and in the report thereon he did not rely on the study referred to by Respondent's Counsel. He stated, further, that even if the question study did not exist, that fact would not cause him to make any change in the report of his study. (Tr. 76, 77)
Thaddeus Edmond Prout, M.D., Associate Professor of Medicine, Johns Hopkins University; Physician, Johns Hopkins Hospital, Baltimore; Chief of Medicine, Greater Baltimore Medical Center, was called next as a witness by Complainant. Dr. Prout has a large number of professional appointments, affiliations and memberships in professional groups. He is Board certified in Internal Medicine, and he has written at least 78 papers for publication on professional journals or for delivery to professional symposia. Dr. Prout was appointed by the Federal Food and Drug Administration as Chairman of a Board of Evaluation of prescription anorectic agents.
Dr. Prout defined obesity as the condition of being 25-30% over an ideal body weight. In the treatment of obesity Dr. Prouty has tried amphetamines in the past, but he is generally convinced on clinical grounds that they are not very useful. It is impossible to separate their side effects from usefulness.
As Chairman of the FDA Board of Evaluation mentioned above, Dr. Prout studied data submitted by large groups of pharmaceutical experts, amounting to several thousands of volumes of data, to determine the usefulness over a period of time of agents generically referred to as prescription anorexigenic agents (Tr. 81). In that study, the Board of Evaluation found that the use of the most powerful anorectics in terms of CNS stimulation over a period of 12-16 weeks did not lead to weight reduction or more than 1/4 to 1/2 pound a week over and above that attributable to diet alone (Tr. 92); that the major part of this weight reduction occurred in the early part of the study; that this kind of treatment for what is really a life-time disease does not produce significant results. (Tr. 83) Tolerance to an anorectic effect of amphetamines can be referred from the fact that weight reduction is lessened with time, and the tolerance usually results in a few weeks. (Tr. 88) A dosage of 25 milligrams of PPA does not cause much CNS effect. (Tr. 85) The generally accepted anorectic dose of dextro-amphetamine is 5 mg., three times a day, and that is the dosage that produced the clinically trivial results shown in his review of pertinent data. Eighty-five percent of the people taking 5 mg. of dextro-amphetamine are aware of a slight increase in heart rate or slight sleeplessness or difficulty in sleeping. It would take several hundred milligrams of PPA to get the relative stimulation of 5 mg. of dextro-amphetamine. (Tr. 86) Such a dosage of PPA might well be a toxic dose. PPA is only about 1/20 as effective as dextro- amphetamine when used as an anorexiant. When tolerance occurs, the dosage should not be increased to overcome it. Amphetamines may mask extreme fatigue and they have a potential for abuse, therefore their use for treatment of obesity should be as a short term (a few weeks) adjunct in a weight reduction regime. Amphetamines should be (and now are) available only by prescription.
The tests studied by the panel of which Dr. Prout was the Chairman had been funded, or had in some way been supported, by the pharmaceutical manufacturers and they had been conducted by reliable investigators. (Tr. 94) Since publication of the report of the panel, there has been a remarkable decrease in the use of amphetamines as anorectic agents. (Tr. 97)
There is no rationale at all in the statement that taking 25 mg. of PPA before meals would cause the user to lose weight the first day he used them. (Tr. 98) To lose one pound one must have a deficiency of 3600 calories, which would mean that a patient could not eat at all on the first day of use of such a product and, in addition to such starvation, he would have to engage in unusual physical activity to achieve a significant weight loss - which Dr. Prout defines as a loss of one pound.
The use of 25 mg. of PPA, three times a day, would not limit the body's ability to produce hunger sensations.
The use as directed of the product under consideration in this case would not necessarily cause one's caloric intake to decrease. Since there are no real generic differences between Hungrex and a number of products being sold as nasa decongestants, there would be as much justification for claiming some of the other products are anorectic agents as there is for making that claim about the product involved in this case. (Tr. 101).
At the dosage in which it is found in Respondent's product, the only possible adverse effect would be its capacity to increase blood pressure. The likelihood that this result would occur (less than one per cent with the most unusual sensitivity to this agent) is so slight that it would not be considered a hazard at all. (Tr. 102)
On cross-examination, Dr. Prout stated that the Food and Drug Administration group of which he was the Chairman did not review data on PPA because it was obtainable without prescription, while his study group considered only prescription anorectic agents. Based upon his knowledge of pharmacology and his knowledge of the usefulness of such agents in general, however, Dr. Prout stated that PPA has no anorectic effect. (Tr. 105) He has seen but little data in respect to the usefulness of PPA in helping a susceptible individual who is motivated to lose weight, and one of the studies he has seen was the Fazekas report which was not accepted as credible by the Federal Trade Commission. (Tr. 106) There may be a small percentage of people who might respond psychologically to the ingestion of PPA and lose weight. (Tr. 108) It is Dr. Prout's opinion that to achieve a significant weight loss means to lose at least one pound and that "physiologically, to relate that to the first day does not make sense. It's a dream." (Tr. 118)
In connection with the study review conducted by the panel of which he was Chairman, Dr. Prout stated that over a 12-16 weeks period, the subjects following a reduced calorie diet supplemented with amphetamines lost only 3 to 4 pounds more than the subjects who were following a reduced calorie diet supplemented with a placebo. (Tr. 122) It would be safe to assume that persons taking Respondent's products as directed would receive considerably less effect in terms of weight loss than would persons taking 5 mg. tablets of d-amphetamine, three times a day. (Tr. 124).
A person taking Respondent's products as directed for a period of 21 days would be likely to lose little, if any, weight. This fact would cause the user's motivation to remain on the program to disappear rapidly, since it is more difficult for unsupervised individuals to stay on a weight reduction program than it is for persons who are participating in a controlled study or persons who are under the care of a physician. In any event, most physicians are successful in treating persons for obesity in less than 1 out of 10 cases. (Tr. 124-127)
Dr. Prout agreed that there are statements in medical books and treatises that PPA has been, and is, used to control the appetite, but he said that these statements do not mean that the substance is efficacious when used for that purpose. (Tr. 129)
With the conclusion of Dr. Prout's testimony the Complainant completed its case-in-chief. The Respondent called as its first witness Bartley G. Hoebel, Ph.D. Dr. Hoebel received an A.B. degree from Harvard College in 1957, majoring in psychology; he did graduate studies at rockefeller Institute, Woods Hole Marine Biological Laboratories and the University of Pennsylvania, by which latter institution he was awarded a Ph.D. degree in the field of physiological psychology in 1962. Dr. Hoebel has occupied a number or research and professional positions and he has received a number of academic honors, fellowships and awards. He is a member of numerous professional societies and at the time fo the hearing he had authored or co-authored at least 21 articles in various scientific and professional publications, and at least 4 abstracts on scientific subjects.
Dr. Hoebel conducted three studies that are of particular interest in connection with this proceeding. (RX-9, 10 and 11) Prior to the first study, it was known that by stimulation of a certain area of the brain an animal can be made to eat or drink. Dr. Hoebel and his associates were interested in knowing whether one system in the brain controls both eating and drinking or whether each function has a separate control system. Propadrine was given to test rats and it was found that eating decreased but drinking continued. This finding suggested that there is separate neurological, and therefore pharmacological, control of these two behaviors on the part of the brain. The neurochemicals affecting eating are apparently different than those which affect drinking, and propadrine appeared to affect the difference between the two functions in the test animals. (Tr. 152)
During the course of the study just discussed Dr. Hoebel saw Hungrex in a drug store and was surprised to see that it contained PPA, the substance with which he had been working. He contacted the manufacturer, who later asked if he would be interested in conducting studies using propadrine. Pursuant to this request, Dr. Hoebel conducted three studies. Two studies were on the effect of PPA on food intake of humans and the other study dealt with the effect of PPA on body weight in humans.
In the first food intake study, there were 16 subjects. Each person was asked to sit in a small cubicle, with walls much higher than their heads, where they were faced with a straw coming of a table. The straw led out the back of the partition to a reservoir of liquid metrecal which the subject could not see. The subject then drank as much as he wanted.
The subjects were given a pill one half-hour before lunch and the pill would be either PPA, 25 mg., or a placebo. The test lasted 10 days and on five of those days the subjects would get Hungrex while on the other five days they were given the placebo. The five Hungrex days and the five placebo days were intermixed in random order and neither the subjects nor the experimenter knew which subject received which pill on any day.
In the report of this study, Dr. Hoebel stated the following conclusions:
"The principle [sic] finding is that Hungrex reduced meal size. In addition, the questionnaire data suggests that Hungrex does not affect the taste of food, nor does it distort a person's perception of amount eaten. Apparently, the subjective feeling of satiety induced with Hungrex is similar to the satiety produced by eating a greater amount of food without Hungrex." (RX-9)
In the report of a replication of the first study, it is stated that there were 13 female and 19 male subjects who participated. The conclusions drawn by Dr. Hoebel from the replication are as follows:
"The principle [sic] finding is that Hungrex reduced meal size. In addition, the questionnaire data suffests that Hungrex makes food less palatable, although the test was not designed to distinguish between changing the taste of the food and the shift to unpalatability that occurs during satiety. Clearly the drug does not distort a person's perception of amount eaten. They consumed less on Hungrex administration days and they accurately estimated that they had indeed eaten less than on prior days with the placebo. Therefore, in humans, Hungrex reduces lunchtime meal size and people accurately perceive this.
"This replication of the prior study now giving a total of 48 subjects firmly establishes that Hungrex is effective in suppressing appetite." (RX-11)
The third test about which Dr. Hoebel testified was said to be designed to determine whether periodic administration of propadrine would, in fact, cause a loss of body weight in humans. There were 30 subjects in this test. The subjects arrived at the experimental room at noon every day at which time they would be weighed and they would receive three pills -- either Hungrex or a placebo. The pills were to be taken one half-hour before breakfast, lunch and dinner, and neither the subject more the person dispensing the pills knew which type of pill the various subjects were given. The subjects were required, also, to complete a questionnaire each day on which they recorded (1) the amount eaten at each of three previous meals, (2) their perceptions as to whether their meals were larger, smaller or the same as usual, and (3) whether they experienced any side effects after taking the drug. This test continued for 12 days.
In the report of this test, Dr. Hoebel stated, in part:
"***the initial mean weight of subjects in the Hungrex condition was 156.53 pounds while on the final day it was 152.71 pounds. The initial weight of the control subjects was 150.5 pounds; on the twelfth day it was 150.88 pounds. Therefore, the average weight loss for Hungrex subjects was 3,82 pounds compared to a slight weight gain of 0.38 pounds on the part of the control subjects.***
"The questionnaire data indicated that neither subjects in the Hungrex condition not the control condition reported any perceived side effects from the drug. However, Hungrex subjects did report eating less meals than did the control subjects. From the description of their meals each day, no discernable differences between the two groups were reported. Consequently, it is more probably the case that Hungrex subjects consumed smaller portions of food than did the control subjects.
"In summary, the data indicate a strong reliable effect from the drug, Hungrex, as a pill capable of causing individuals to lose weight over a twelve day period." (RX-10)
Dr. Hoebel testified that the first few days of a reduced caloric intake diet are the most difficult for the dieter. Since PPA has been shown to curb appetite in a 10-day period, it will help people to lose weight and, therefore, it will help them to live longer. (Tr. 308, 309)
According to Dr. Hoebel, the fact that studies have shown amphetamines to have certain effects as anorexiant agents would not allow one to conclude with certainty that PPA will or will not produce the same effects. The scientific way to make such a determination is to have clinical tests of each substance. (Tr. 164-165) Even clinical tests may produce varying results if the tests are conducted by different investigators, at different times and under different conditions. (Tr. 166) If the subjects decreased their caloric intake at each of the three meals on the first day of the test, Dr. Hoebel would assume that they would have a small decrease in weight on that day. (Tr. 166)
In connection with his studies of the effect of PPA on food intake of rats, Dr. Hoebel found that there was a discernible elevation in tolerance measurable in days. (Tr. 169) His weight- loss study with humans was not designed to analyze or measure tolerance to PPA, but he did not doubt that a tolerance to PPA is built up on repeated administration. The literature in the field would indicate that this is also true of dextro-amphetamine. (Tr. 169, 170) After a person has been on a reduced caloric diet induced by taking PPA for an extended period he gets hungrier. He is likely to eat more and, thus, to slow down his rate of weight loss. It is difficult to tell whether his decreased rate of weight loss is due to tolerance to PPA or to increased hunger due to deprivation. (Tr. 325)
Dr. Hoebel suspects that both the amphetamines and PPA depend for their anorectic effect, at least in part, upon the norepinephrine stores of the brain. To this extent the two substances are probably very similar in the manner in which they exert their effects. (Tr. 171, 172)
Concerning the subjects who took part in the weight-loss test, participants were not necessarily overweight, nor, in the case of females, was account taken of the fact that some women tend to develop anemia during their menstrual cycles. (Tr. 173) In preparation for weekends, subjects were given 9 pills, and "once in a while" some subjects would bring back a vial with a pill in it. (Tr. 175) PPA does have certain physiological effects which possibly could be subjectively determined, but it was not certain that the subjects could tell what pill they were taking (Tr. 177).
Dr. Hoebel had completed, but had compiled the data from, another test with human subjects to determine the effect of taking PPA in 25 mg. dosages three times per day, one half-hour before meals. This second study extended over 14 days and the first study (RX-10) was run for 12 days. Since the subjects would be given PPA for only 7 and 6 days in the two tests, respectively, question was raised as to whether these periods of time were sufficient for the subjects to develop a tolerance to PPA. The tests were not designed to measure tolerance, but in the tests using rats as subjects it was noted that tolerance began to develop after 10 days, with the result that either increased dosage would be required or there would be reduced efficacy. (Tr. 178-180)
It is of interest to note that prospective subjects for the studies conducted by Dr. Hoebel were not permitted to participate if they had histories of high blood pressure, heart disease or diabetes. It is not unreasonable to conclude that the reason for this exclusion is the pressor effect of PPA, to which allusion previously has been made.
Dr. Hoebel's first test related to food intake by humans, the gross results were that those subjects taking Hungrex consumed 160 milliliters less than those subjects taking placebos consumed. In the second test, the Hungrex subjects consumed .18 of an eight-ounce can of Metrecal less than did the placebo subjects. (Tr. 178) This means that the Hungrex subjects consumed slightly in excess of 5.4 ounces and 1.4 ounces, respectively, less Metrecal over the courses of two tests than did the placebo subjects.
Respondent's next witness was H. I. Silverman, Pharmacologist, who was awarded the degrees of B.Sc. in 1951, M.Sc. in 1952 and D.Sc. in 1956 from the Philadelphia College of Pharmacy and Science. Dr. Silverman has done postgraduate work at New York University, Columbia University, Rutgers, Harvard and Boston Universities. He has taught at a number of educational institutions, including the Philadelphia College of Pharmacy and Science, Long Island University and Brooklyn College of Pharmacy; he has served as consultant to a number of pharmaceutical companies; he belongs to numerous professional and scientific societies; and he has contributed papers and notes to many professional journals. (RX-17) At present he holds teaching positions at the Massachusetts Collegs of Pharmacy, the Massachusetts College of Optometry, and Boston University School of Medicine.
Dr. Silverman identified PPA as a recognized and potent nasal constrictor and as an anorexiant in wide use by Laymen. (Tr. 198) He said that ephedrine is the substance which represents the "grandfather" of this class of substances and that PPA and dextro-amphetamine represent synthetic compounds which are related to ephedrine. Individual dosage of PPA would range from 25 to 50 mg., while daily dosage might be 75 mg. (Tr. 199, 203)
According to Dr. Silverman, PPA is about one-tenth as effective an anorexiant as dextro-amphetamine, which is the standard drug to which all other anorexiants are compared. Referring to an article written by him in 1963 (RX-18), Dr. Silverman pointed out that it would require 50 mg. of PPA to equal the anorexiant effect of 5 mg. of d-amphetamine. Daily dosage of d-amphetamine ranges from 5 to 15 milligrams. PPA as recommended by Respondent is to be taken at the rate of 75 mg. per day, but Dr. Silverman said this is ten times the 7 1/2 mg. of d-amphetamine which is within the established normal daily dosage range of this substance for use asn an anorexiant in the treatment of obesity.
Dr. Silverman then told of two tests he had conducted during 1973, in one of which tests volunteers in his laboratory were given d-amphetamine and PPA with the result that their taste acuity for saccharin decreased. In the other test, some first- and second-year medical students were given either 5 mg. of de-amphetamine or 50 mg. of PPA once a day, usually in the evening, and they were asked to consume pizza pies until they reached a state of satiety. The students' consumption was less when they were taking drugs than it was when they were not taking drugs. (Tr. 206, 207) Dr. Silverman had no figures showing the difference, if any, in intake of food by persons who were given placebos as compared with persons who were given PPA and compared with persons who were given dextro- amphetamine. (Tr. 295-296) The fact that the rate of weight loss slows down after the first week is due to fact that the initial weight loss is accountable for in large measure by a loss of water, whereas later weight loss occurs more in the area of body tissue. (Tr. 297) No conditions or criteria applied in these two studies were stated by Dr. Silverman.
It is Dr. Silverman's opinion that conscious dietary restriction by one who takes PPA will assist the person to lose weight, but it is not essential because with PPA, dextro-amphetamines, or the other drugs in this class, the individuals will, by virtue of the effect of these drugs, diminish their food intake. (Tr. 207, 208) A "susceptible person" in terms of one who would purchase PPA is a person who is overweight, needs to lose weight, is anxious to lose weight, has a conscientious desire to lose weight and seeks some aid or crutch to assist in the loss of weight. Such a person, if he took 75 mg. of PPA per day, would eat less and would thereby lose weight. (Tr. 208)
Dr. Silverman said that it is not scientifically valid to apply to PPA the conclusions reached by Dr. Prout's panel on the subject of the effectiveness of prescription drugs used as appetite suppressants. (Tr. 219, 222) Despite the act that certain drugs may belong to the same broad category, the effects they will produce will differ. Some illustrations of this statement given by Dr. Silverman are: dextro-amphetamine, which is recognized as a potent anorexigenic agent, is very weak as a nasal decongestant (Tr. 221); PPA and d-amphetamine have some degree of effectiveness in preventing enuresis, but d-amphetamine is not particularly effective for this purpose; narcolepsy, which is a valid indication for dextro- amphetamine, is not necessarily benefited at all by PPA; Parkinson's disease is treated with d-amphetamine, but PPA has, if any, a trivial effect on it. While there may be a general idea of what a drug will do, the actual value of the drug for treatment of a particular condition must be determined by testing the drug itself. (Tr. 222)
Dr. Silverman stated that PPA has been used as an anorexiant for approximately 25 years; it has been established as being effective in assisting in appetite suppression; the average person should be able to buy such a product over the counter without a doctor's prescription. (Tr. 224-226) PPA is the most pharmacologically powerful reducing aid sold over-the-counter in this country, according to Dr. Silverman (Tr. 229)
"In all probability" a person taking PPA as directed by Respondent will begin losing weight on the first day of its use, but Dr. Silverman would not hesitate the amount of such weight loss. (Tr. 289-294) Furthermore, taking PPA in daily dosages of 75 mg. per day would cause the user to reduce caloric intake and, thus, to lose weight. (Tr. 232) Dr. Silverman knows of no studies which show that users develop a tolerance to PPA in daily dosage of 75 mg. (Tr. 233-234)
Dr. Silverman said that although the Food and Drug Administration is demanding in the quality of the protocols used in testing drugs with a view to assuring validity in the results of the tests, the Food and Drug Administration will reject the reported results of such tests if the conclusions reached differ from the preconceived conclusions held by that agency. (Tr. 238-239)
The witness conceded on cross-examination that in an article he wrote in 1963 he stated that the anorexiants d-amphetamine and PPA are in the same pharmacological class; that they all have some degree of anorectic effect; and that d-amphetamine has 10 times the anorectic potency as has PPA. (Tr. 240-241) The most commonly used dosage of d-amphetamine is 5 mg., three times a day, while the product in this proceeding is to be taken in doses of 25 mg., three times per day. (It would follow, therefore, that taking into consideration normal dosages, the person taking PPA would receive only half of the anorectic effect as would the person taking d-amphetamine.) The witness then said that he intended to indicate that the normal dosage of d-amphetamine ranges between 5 and 15 mg. per day, with some people requiring only 5 mg. and some 10 mg. per day. (Tr. 242-245) The witness declined to answer the question whether, if there is a person whom a doctor feels should have a 10 mg. dose of amphetamine, that person would require a 100 mg. dose of PPA to have the same anorectic effect. (Tr. 244-245) Dr. Silverman agreed, however, that insofar as they both produce anorexiant effects, they are of the same family and are properly comparable. (Tr. 247)
In one of the studies quoted in Dr. Silverman's 1963 report, it was stated that rats given both benzedrine and PPA showed reduced intake and weight, but that they developed a tolerance for the substances in a week. Dr. Silverman asserted that it is not fair to extrapolate to human beings the results of a test on rats. (RX-20; Tr. 250-252)
Referring to a recent unreported study he made, Dr. Silverman said the human subjects were given 4 weeks on dextro-amphetamine. At the end of four weeks on each drug, there was a weight loss of approximately 2 pounds per week. (Tr. 255) As is usually the case, there was a greater weight loss in the first test the dosages used were d-amphetamine - 5 mg., three times per day; and PPA - 50 mg., three times per day. (Thus, in this test the 10 - 1 ratio was maintained, which is not the case if Respondent's products are taken as directed.)
Drugs should be administered, according to the witness, on the basis of their half-lives. A person must take a drug for approxi- mately 5 or 6 half-lives in most cases to achieve a therapeutic level or steady state of that drug, and in order quickly to achieve such a state or level larger doses must initially be given. PPA has a half-life of approximately 3 to 4 hours, which means that the Respondent's recommendation that the drug be taken three times a day represents a logical type of dosage. This dosage would also mean, however, that it would be probably the end of the second day before the PPA would reach its maximum pharmacological effect - whatever that might be. (Tr. 260-262)
Dr. Silverman was aware that the Federal Food and Drug Administration requires that prescription anorectics be labeled to indicate that they are recognized as being effective for the short term (which he defined as six weeks) treatment of obesity. He did not know of any studies conducted specifically to establish the rates at which tolerance to amphetamines or PPA occurs in humans, but there are studies which point in that direction for the dextro- amphetamine prescription type of preparation. He did not know whether these studies produced the same indications for PPA. The witness stated that the pharmacological profile of PPA leads him to believe that the possibility of the incidence of tolerance to PPA does exist, but whether it does, in certainty, develop he does not know. A type of tolerance may result from use of PPA as a nasal decongestant, but he repeated that he did not know whether the same situation holds true for PPA's anorectic properties or qualities. If such a tolerance should develop at all, he said, it would be a very, very mild one. This statement is based on Dr. Silverman's view that the tolerance to dextro-amphetamine, if it occurs at all, is a very mild one, which is overcome by titering the dosage. (Tr. 265-269)
Dr. Silverman places a great deal of reliance on the fact that certain pharmacological texts indicate the usage of PPA as an anorexiant. He recognizes the possibility that this occurs because of duplication of other material, but he stated that in more recent years doctors who write articles for publication in professional journals have, themselves, significant familiarity with the subjects about which they write. The fact that statements are made that a drug is used for a particular purpose does not necessarily mean that it is efficacious when used for that purpose, but it is a rather strong indication that the author believes it to be so efficacious, according to Dr. Silverman. Nevertheless, he rejected out of hand a statement from a book by a recognized author, read to him on cross- examination, in which it was indicated that 25 mg. of PPA as contained in Respondent's products is too small to exert any pharmacological effect. (Tr. 271-276)
Dr. Silverman adamantly declined to give any estimate as to how much, if any, weight persons taking Respondent's products would lose on the first day of use of such product, but he said that there would be some weight loss. (Tr. 277, 289-294) Certain studies introduced into evidence by Respondent (RX-19 through 22) and on which, in part, Dr. Silverman relied in the preparation of his article published in the February 1943, American Journal of Pharmacy (RX-18) were reports of tests which were recognized by him as being in conformity with standards existing at the time the studies were made, but he stated that the criteria then followed are not the correct way to conduct a test today. (Tr. 278-284)
The testimony by Dr. Silverman completed the calling of witnesses by the parties to this proceeding. It now must be determined what the evidence reveals in regard to the truth or falsity of the Respondent's representations heretofore found to have been made.
This case has been marked by testimony of well qualified experts in medicine and in pharmacology. The background of education, training and experience of these experts and their testimony has been presented or summarized at length in order to disclose their very considerable expertise.
As the result of careful and lengthy presentation of the evidence adduced herein, certain conclusions are warranted. Using these conclusions as criteria, the proof of the truth or falsity of Respondent's representations must be gauged.
The principal witness for the Complainant was Dr. Prout who stated that PPA is only about 1/10 to 1/20 as potent an anorexiant as d-amphetamine and that, therefore, it would take a far larger daily dosage of PPA than is present in Respondent's product to produce the anorexiant effect of 5 mg. of d-amphetamine taken three times a day. Dr. Prout testified, also, that tolerance to both d-amphetamine and PPA will develop in a matter of a few weeks. Dr. Prout's testimony was based upon his study of prescription anorectics containing amphetamines and his knowledge of the pharmacological relationship between those substances and PPA. Dr. Prout conducted no studies with, and did not search the literature regarding, PPA when used in the amounts and for the purposes intended with Respondent's product. Dr. Prout's testimony was supported by that of Dr. Sorer, the Complainant's expert in pharmacology.
Respondent presented testimony contrary to that of Dr. Prout. As a starting point, Drs. Hoebel and Silverman said that it is not valid to conclude that the results of tests of the effects of d-amphetamine are applicable, without testing, to PPA. Each of these witnesses for Respondent had conducted studies to determine the anorexiant effect of PPA, and both of them concluded that PPA does cause a decrease in appetite and that it does cause a reduction in caloric intake which, in turn, will produce some loss of weight.
Dr. Hoebel said that he does not doubt that tolerance to PPA does develop on repeated administration. Dr. Silverman said that his studies showing the development of tolerance will occur in humans, but that he believes the possibility of the incidence of tolerance in humans to PPA does exist. The development of such tolerance would produce a decrease in the appetite-suppressant properties of the drug.
The fact that Dr. Hoebel reached certain conclusions upon the basis of actual tests of PPA conducted by him does not necessarily establish the validity of these conclusions. For example, certain of his tests were conducted for two 5-day periods - one period each on d-amphetamine and on PPA. These tests were too short in duration, and they were not designed, to determine the incidence of tolerance to PPA in the test subjects. Other questions as to the validity of the conclusions Dr. Hoebel reached based on these and other studies referred to herein legitimately could be raised.
The foregoing points are mentioned to show that there are competent, qualified men of medicine and other sciences whose opinions on some of the crucial questions of another group of competent, qualified experts. Support for each group's views can be found in the evidence and there are discoverable, also, weaknesses in the positions of the adherents to both sides of the controversy. The result of this situation is that the question of the efficacy of PPA, in the quantity in which it appears in Respondent's product, when taken as directed as an aid to achieving a loss of weight, is a question that has not been satisfactorily resolved. In part, the matter is, insofar as this record shows, still a question that has not been "reduced to one of fact as distinguished from mere opinion". American School of Magnetic Healing v. McAnnulty , 187 U.S. 94, 106 (1902) On the other hand, the record in regard to certain aspects of this case does not present the situation in which "medical witnesses can be produced who blindly adhere to a curative technique thoroughly discredited by reliable scientific experiments." Reilly v. Pinkus , 338 U.S. 269, 274 (1949) What are presented concerning portions of this case are questions upon which experts differ -- and widely differ.
That certain medical questions presented in this case are unsettled is further suggested by the fact that as of the time this decision is being written a Panel of Evaluation has been appointed by the Food and Drug Administration to consider the safety, efficacy and truthful labeling of over-the-counter reducing aids containing various drugs, including PPA. It is not known when this panel will submit its monograph, nor can it be predicted what will be its findings and recommendations in regard to the efficacy of PPA when taken to achieve the loss of weight. Ultimately, if there is sufficient evidence presented, the Panel probably will state its views as to whether the various over-the-counter reducing aids, including those containing PPA, are safe and efficacious and it will also report its views as to the reasonable requirements for labeling relating to such products.
In view of all of the foregoing considerations, I find that there is not sufficient evidence in this record to establish the falsity of the following representations made by Respondent:
1. The Hanover House charges:
"(b) That the use of HUNGREX tablets will banish hunger pangs;
"(d) That the use of Hungrex tablets will cause calorie intake to go down; and
"(e) That HUNGREX is the most powerful reducing aid ever released for public use without prescription."
2. The Romar Sales charges:
"(b) That the use of HUNGREX tablets will banish hunger by limiting the ability of the body to produce hunger sensations;
"(c) That the use of HUNGREX tablets will cause calorie intake and weight to go down;
"(d) That HUNGREX with P.P.A. is the most powerful reducing aid ever released for public use without prescription."
One of the two remaining representations relates to the safety of the use of Hungrex to reduce hunger. There is a peculiar, but interesting, conflict in the evidence on the question of safety.
Complainant's witness, Dr. Sorer, in his 1972 study found no evidence of abuse potential in regard to PPA. (Tr. 42) Another of Complainant's witnesses, Dr. Prout, testified that taking 25 mg. of PPA three times per day would have some tendency to increase the user's blood pressure, but that the likelihood of the occurrence of this result is so slight as to produce no hazard. (Tr. 102)
On the other hand, in every test conducted by experts called to testify by Respondent, prospective test subjects who had high blood pressure, heart disease or diabetes were uniformly excluded from participating in the tests. This exclusionary policy suggests, at the very least, that the experts conducting the tests with products containing PPA entertained some doubt as to the universal safety of the taking of Respondent's product as directed.
Because of these conflicting attitudes and opinions of the experts appearing on behalf of the parties, it is concluded, again, that the evidence of record in this proceeding is insufficient to establish the falsity of the representation set forth as paragraph (3) (c) of the Hanover House complaint, as follows:
"(c) That HUNGREX has been proved safe by laboratory tests to effectively reduce excess food craving."
One representation in each complaint in this consolidated proceeding remains as being alleged to be false. These charges are:
1. The Hanover House complaint:
"(a) That Hungrex tablets help the user to start losing weight the first day."
2. The Romar Sales complaint:
"(a) That HUNGREX tablets will cause the user to lose weight the first day."
Respondent's witness, Dr. Silverman, gave the following definition, which I accept and adopt, of a member of the "'susceptible population' in terms of a product like PPA that is sold over-the-counter as a weight reducing aid":
"Susceptible? There must really be a conscientious desire to lose weight. I would make the assumption that the person who would take a product like this is certainly overweight, needs to lose weight, is anxious to lose weight, and seeks some aid or crutch to assist in the loss of weight." (Tr. 208)
Thus, there is a ready-made market comprised of customers avidly seeking some "aid or crutch" to help them achieve a longed-for loss of weight. When the members of the audience to which Respondent's advertisements and representations are directed see Appendices A and B hereto, they will believe that: since Hungrex is said to be the most powerful over-the-counter reducing aid ever made available; since it is represented as being capable of reducing calorie intake while at the same time banishing hunger pangs; the weight which they will lose or start to lose the first day will be a significant, perceptible amount. This view was expressed by Dr. Prout and it is adopted as being reasonable, as is, also, his statement that to be significant a weight loss must be at least one pound. (Tr. 117, 118)
When the audience Respondent seeks to attract sees Respondent's advertising material and considers it as a whole, the impression most likely to be created in the mind of the ordinary reader of those advertisements is that after taking Hungrex for one day, he will experience a weight loss of at least one pound. (Donaldson v. Read Magazine , 333 U.S. 178, 189; Gottlieb v. Schaffer , 141 F. SUpp. 7, 16; F.T.C. v. Standard Education Society , 302 U.S. 112, 116; FLorence Mfg. Co. v. J. C. Dowd & Co ., 178 F. 73; Charles of the Ritz Distributors Corp., v. F.T.C. , 143 F.2d 676, 679; Stein v. Pilling , 256 F. Supp. 238, 243, aff'd. 379 F.2d 554.)
There is no uncertainty in this record as to whether a person will achieve a weight loss of approximately one pound after a day's use of Hungrex. The overwhelming preponderance of the evidence is to the effect that nothing approaching such a weight loss will occur.
The following excerpts or summaries support this conclusion:
1. Dr. Prout --
a. A significant weight loss [1 pound] in one day is "physiologically untenable." (Tr. 117)
b. "There would be no rationale in such a statement [weight loss of one pound after one day's use] at all, none whatever." (Tr. 98)
c. "And physiologically, to relate that [loss of one pound] to the first day does not make sense. It's a dream." (Tr. 118)
2. Dr. Hoebel --
a. Dr. Hoebel would go no further than to make the following unenlightening statement: "I would assume that if they did that [decreased their intake of Metrecal] at each of the 3 meals that day, they would have some small decrease in their food intake, they would lose weight that first day, fewer calories in, it's a loss of weight." (Tr. 166)
3. Dr. Silverman --
a. Note has been made of the fact that Dr. Silverman said that "in all probability" a person would begin to lose weight on the first day of taking PPA as Respondent directs, but Dr. Silverman steadfastly declined to estimate the amount of any such loss. (Tr. 289-294)
b. In an unreported test he conducted, Dr. Silverman found that persons taking 50 mg. of PPA three times per day [as opposed to 25 mg. in Hungrex] lost approximately "2 pounds per week." (Tr. 255)
Comment: If the taking of 50 mg. of PPA, three times per day, for four weeks produced a loss of only approximately 2 pounds per week, the likelihood that the first day of ingestion of only 25 mg., three times per day, would produce a loss of one pound is so remote as to be negligible.
c. According to a study of the literature performed by Dr. Silverman in 1963 (RX-18, p. 49) PPA is one-tenth as effective an anorexiant as is de-amphetamine. To reach the maximum degree of its effectiveness however, PPA probably would have to be taken as directed by Respondent for two days. (Tr. 261-262)
Comment: The validity of the comment stated above under "b.", is particularly striking when cognizance is taken fo the fact that two days of use of Respondent's products are required to achieve the maximum of their limited anorexiant effect.
The foregoing quotations and summaries lead inevitably to the following conclusions:
1. Respondent represents in its advertising matter that persons taking Hungrex as directed will lose a significant amount of weight on the first day of such use of the product;
2. Respondent's aforesaid representation is an unequivocal representation of a material fact.
3. The overwhelming preponderance of the evidence of record in this proceeding demonstrates that Respondent's aforesaid representation is false as a matter of medical fact.4/
Careful study of the entire record in this proceeding, including the exhibits of both parties, the testimony of all witnesses, and the briefs of Counsel, leads to the following --
In the sale of Hungrex and Hungrex with PPA in the manner herein described, Respondent is engaged in conducting a scheme or device for obtaining money or property through the mail by means of false representation within the meaning of the provisions of 39 U. S. Code 3005.
It is emphasized that with respect to those charges in the Complaint found not to have been made out by the proof in this case, the representations embodied therein are not found to be true. Those findings are only what they purport to be, namely, that, while Respondent's representations may well be false, the state of medical and scientific opinion as reflected in this record is so divided as to preclude a determination that Complainant sustained its burden of proof with respect to those charges.
Proposed findings of fact and conclusions of law submitted by the parties have been considered and they are adopted to the extent herein indicated. Otherwise, such proposed findings and conclusions are rejected for the reasons stated or because they are contrary to, or unsupported by, the evidence or because they are immaterial.
An order of the type provided for in 39 U. S. Code 3005, and substantially in the form attached, should be issued against Hanover House, at Hanover, Pennsylvania, and Romar Sales Corp., at New York, New York.
____________________
1/ PPA is an abbreviation for phenylpropanolamine hydrochloride.
2/ Abbreviations used herein include the following: CX-1 or
C-1 for Complainant's Exhibit No. 1; RX-1 or R-1 for Respondent's Exhibit 1;
Tr.-- for Transcript, page--.