In the Matter of the Complaint That                         )
                                                                               )
THE CARDIAC SOCIETY                                         )
                                                                               )
at                                                                            )
                                                                               )
Detroit, Michigan                                                     ) P.O.D. Docket No. 1/187
                                                                               )
(hereinafter called Respondent), is                       )
engaged in conducting a scheme for                    )
obtaining money through the mails                         )
in violation of 39 U.S. Code 259 and                      )
732.                                                                        )

APPEARANCES:
Robert M. Ague, Esq.
Office of the General Counsel
Post Office Department
for the Complainant

Arthur B. Carton, Esq. and
Wilbert McInerney, Esq.
Washington, D.C.
Peter E. Bradt (post-hearing appearance)
Port Huron, Michigan
for the Respondent

Kelly, Raymond J.

DEPARTMENTAL DECISION

This matter comes before the Judicial Officer upon an appeal and exceptions filed herein on October 31, 1960, from the Initial Decision of the Hearing Examiner entered on September 19, 1960.

In this matter complaint was filed on October 26, 1959, charging the Respondent with the operation of a scheme or device for obtaining money through the mails by means of false and fraudulent pretenses, representations or promises in violation of 39 U.S.C., Sections 259 and 732. A hearing was held before the Hearing Examiner March 14 through 17, 1960. Proposed findings of fact and conclusions of law were filed by the parties on May 31, 1960.

The complaint filed herein by the Acting General Counsel of the Post Office Department alleges that public attention is attracted to Respondent's scheme by means of advertising matter which is widely distributed and is calculated to induce readers to submit money through the mails to Respondent. Copies of such advertising matter are attached to the complaint as exhibits therein. The complaint further charges that by means of such advertising matter and in similar matter Respondent makes certain representations to the public which are false and fraudulent. That these representations are in substance and effect as follows:

"(a) That Respondent's product 'E-FEROL 30 I.U.' (containing vitamin E) is therapeutically effective and beneficial in the treatment of heart and cardiovascular diseases for any person so afflicted;

(b) That Respondent's said product will prevent heart disease;

(c) That 'It vitamin E is the key both to the prevention and treatment of all those conditions in which a lack of blood supply due to thickened or blocked blood vessels or a lack of oxygen is a part or the whole story of the disease';

(d) That 'Vitamin E seems to be a natural anti-thrombin in the human blood stream. It has been found by Zierler of Johns Hopkins and the U.S. Navy Research Department and Kay of Tulane to be a substance normally circulating in the blood which prevents clots occurring inside vessels. It is the only substance preventing the clotting of blood which is not dangerous';

(e) That 'Indeed it vitamin E actually accelerates the healing of burns and wounds';

(f) That 'The third major function of Vitamin E is the prevention of excessive scar tissue product and even, in some instances, the ability to melt away unwanted scar';

(g) That 'It vitamin E is a dilator of blood vessels';

(h) That vitamin E is therapeutically effective in the treatment of X-ray burns in humans;

(i) That 'It has been established by many clinicians, particularly the Shute Institute Staff, that if you stop taking it vitamin E even for three days you may suffer a set-back';

(j) That vitamin E is therapeutically effective in the treatment of sunburn;

(k) That vitamin E is therapeutically effective in the treatment of, or is a cure for, sugar diabetes;

(l) That the book 'Your Heart and Vitamin E' tells you:

'What Vitamin E is and Does

How It Treats Heart Disease

Its Success In Circulatory Diseases

Your Foods' Deficiency in Vitamin E'

and that the information in the book and the claims for vitamin E set forth therein are true and in conformity with established medical and scientific evidence;

(m) That 'It the book explains medical facts in every-day language concerning the help that is available for sufferers from diseases of the heart and blood vessels such as Coronary Heart Disease, Angina Pectoris, Phlebitis, Buerger's Disease, Diabetes, Strokes, etc.'; i.e., that the information contained in the book is true and in conformity with established medical and scientific evidence regarding diseases and conditions above-mentioned."

The answer filed by the Respondent through his attorney admits that Respondent uses the mails in its enterprise and that the exhibits attached to the complaint are true copies of advertising material employed by Respondent in its enterprise. The answer denies the other allegations of the complaint.

At the four-day hearing before the Hearing Examiner in Washington, D.C. the Complainant produced the following witnesses:

Postal Inspector W. J. Hegarty, Dr. Leo Friedman, Dr. John F. Finnegan, Dr. James E. Chapman and Dr. Kenneth D. Campbell. Witnesses for the Respondent were: Mrs. Lillian M. Henderson, Mr. Charles R. Zepp, Mr. Carl E. Muir, Secretary-Treasurer of The Cardiac Society, and Dr. Evan V. Shute. The transcript of this testimony is contained in four volumes totaling 856 pages. Seventy-six exhibits were received in evidence - both parties submitted findings of fact and conclusions of law for the consideration of the Hearing Examiner. His Initial Decision covers forty-two pages.

The Hearing Examiner in the Initial Decision correctly found from the undisputed evidence that public attention is attracted to Respondent's enterprise by means of advertising matter calculated and intended to induce the recipients and others to remit money through the United States mail to Respondent.

The Hearing Examiner found that all thirteen of the allegedly false representations were published and sent through the mails.

He held that the record failed to show that five of the charges; namely, those contained in Complainant's paragraphs (3)(e), (f), (h), (i) and (j) (Initial Decision, pages 28-33) had been proven materially false within the meaning of applicable law. These five paragraphs will not be considered in this decision.

The Hearing Examiner found that Respondent's representations were made as charged in paragraphs (3)(a) and (b) of the complaint and according to universal scientific belief were wholly unsupportable - that not even Respondent's own medical adviser would support those representations. These relate to Respondent's claim for E-Ferol 30 I.U. containing Vitamin E as effective therapy for heart and cardiovascular disease, or as a means of preventing heart disease.

He found in respect Respondent's charges as set forth in paragraphs (3)(c), (d) and (g) of the complaint that the Respondent deliberately concealed adverse scientific reports in respect to these matters and the lack of efficacy of Vitamin E in the treatment of coronary, hypertensive or rheumatic heart disease and held that this deliberate concealment of well known and highly significant scientific evidence is indicative of an intent to deceive.

The representations set forth in paragraphs (3)(c), (d) and (g) of the complaint were quotations from the so-called "New Members' Issue" of Respondent's publication, "the Cardiac" (Government Exhibit No. 4, page 2). Under the caption of "Heart Disease" and the sub-caption "Excerpts from Addresses by Dr. W. E. Shute." Dr. W. E. Shute is a brother of Dr. Evan Shute. He severed connections with the Shute Foundation and the Shute Clinic several years ago in order to go elsewhere to practice medicine.

He likewise found that in respect to Respondent's charge in paragraph (3)(k) of the complaint that the Respondent deliberately withheld reports of controlled scientific tests on Vitamin E used with diabetics showing Respondent's claim as to the therapeutic efficacy of Vitamin E for diabetes to be unsubstantiated and that this constituted evidence of intent to deceive.

He further found in respect to the charges set forth in paragraphs (3)(l) and (m) of the complaint, that the Respondent uses the words contained in these paragraphs in a special advertisement order form (Government Exhibit 16) for the book "Your Heart and Vitamin E", copyrighted 1956 by Respondent (Government Exhibit 41). He points out that in the advertisement and in the publication "The Cardiac", which frequently urges people to buy the book, Respondent conveys the impression that information contained therein is reliable and accurate in the sense that it is in conformity with established medical and scientific practices.

He determined that on the basis of the entire record, including particularly the expert testimony of the cardiologists, Drs. Finnegan and Chapman corroborated by controlled tests and the leading text on cardiology, that established medical and scientific practice does not substantiate the conclusions in "Your Heart and Vitamin E" that Vitamin E has therapeutic efficacy for heart diseases such as coronary heart disease, hypertensive heart disease and rheumatic heart disease. He, therefore, determined that the representations made by the Respondent in advertising the book as charged in paragraphs (3)(l) and (m) of the complaint are materially false.

Although Respondent after the hearing selected a new lawyer to substitute for the two lawyers who represented Respondent at the hearing, the Respondent is of course bound by the actions of his attorneys at the hearing. The record, moreover, indicates diligent representation by Respondent's attorneys at the hearing.

Respondent's present Counsel is in error in asserting that the Hearing Examiner made no findings in respect to the alleged false representations described in paragraphs (3)(l) and (m) of the complaint. The Initial Decision finds (1) Respondent makes the representations described in paragraphs 3(l) and (m) of the complaint; (2) in respect to Respondent's representations that established medical and scientific evidence is in conformity with the claims and conclusions in the book "Your Heart and Vitamin E" concerning Vitamin E having therapeutic efficacy for heart diseases, such as coronary heart disease, hypertensive heart disease and rheumatic heart disease, the representations are materially false. Intent to deceive is found by the Hearing Examiner to permeate all of Respondent's materially false representations, including certain of those embodied in paragraphs (3)(l) and (m) of the complaint.

The Respondent also filed, in connection with its appeal, various motions or petitions (including those filed December 1, 1960, February 6, 1961 and March 2, 1961). The Complainant filed motions in 1960 on November 8, 17, 29 and December 15. The motions or petitions of the parties have already been disposed of by specific orders issued by the Judicial Officer and, therefore, they need not be considered further at this time.

The issues herein as outlined in the Initial Decision as well as in the pleadings can be stated generally to be whether or not the Respondent makes the representations alleged in the complaint and whether or not such representations are material misrepresentations made with an intent to deceive.

The Vitamin E Society was incorporated in Ontario, Canada about 1950 by Campbell C. Calder and others. In September 1952 Mr. Calder and Dr. Evan Shute persuaded Carl E. Muir to work for the Vitamin E Society of Ontario. He is not a doctor and has no medical training but claims to be an authority on Vitamin E. Later Muir and Calder tried to change the name of The Vitamin E Society, the Ontario Corporation, to The Heart Foundation or The Cardiac Society but the Minister of Health in Canada rejected the proposed change on the ground that Vitamin E was more descriptive of the work of Mr. Muir and his organization than "Heart" or "Cardiac" would be. At the present time the Ontario Corporation Vitamin E Society is either defunct or dormant.

The American Medical Association Journal issue of February 18, 1950 referring to Dr. Evan Shute and his associates in an article highly critical of their activities referred among other things to (1) the Public Relations Office of The Shute Foundation for medical research; (2) the fact that The Shute Institute for clinical and laboratory medicine "solicits patients in the same brochure that it uses to solicit funds" and (3) the fact that the Foundation and The Institute issue pamphlets and booklets addressed apparently to sufferers from heart disease and other cardiovascular conditions as well as diabetic persons promoting an alleged Vitamin E therapy and particularly promoting The Shute Institute because of its unique use of Vitamin E.

In April 1955, the Respondent was organized under the name "The Heart Foundation" as a non-profit corporation under the laws of the State of Michigan. The purpose of the corporation as stated in the articles of incorporation was:

"Exclusively *** to aid and engage in research and study of the cause, means of preventing, and methods of treating and relieving heart and circulatory diseases; to aid in educating the general public in regard to the results of such research and study; ***; and for the foregoing purposes to receive and distribute donations of supplies, provisions and money, and to raise money by contributions from the general public; ***." Carl E. Muir was an incorporator and member of the original Board of Directors; so also was Campbell C. Calder, of London, Ontario, who was the personal attorney for Dr. Evan Shute, of London, Ontario.

Respondent's amended articles of incorporation in May, 1955, changed its name to "The Cardiac Society" and specifically provided:

"Members of the Vitamin E Society, a non-profit Ontario Corporation, in good standing and residing in the United States or its possessions are members of The Cardiac Society.***"

Mr. Muir is the resident agent and manager of The Cardiac Society, the Michigan Corporation, and does whatever is necessary in the conduct of its affairs including the handling of the orders from members of the Society for Vitamin E. The Shute Foundation was formed in May 1947 by Dr. Evan Shute, Mr. Calder and others to receive donations from the public and patient's fees. Its information followed the alleged discoveries by Dr. Shute and his associates of the therapeutic efficacy of Vitamin E in heart disease.

The Foundation received contributions and cash from the Respondent in 1959 and Respondent expected to contribute again in 1960.

The Shute Institute as a part of the foundation's activities operated a clinic in London, Ontario beginning in October 1948. The Clinic was headed by Dr. Evan Shute and the Respondent refers patients to the Shute Institute for medical treatment.

The existence of Vitamin E was announced first in 1922 and in the past fifteen years this Vitamin has been investigated quite extensively. In animals, symptoms resulting from deficiency in Vitamin E are widespread and have included structural and functional abnormalities of the reproductive system, the nervous system, skeletal muscle and cardiac muscle. Many symptoms of Vitamin E deficiency in animals resemble superficially disease conditions in humans, but in 1955 it was stated in a standard reference book: "There is no unequivocal evidence that Vitamin E *** is of any value in therapy" for man.

The Respondent excepts to the finding of the Hearing Examiner that Respondent sells Vitamin E products. Respondent, thus, now denies it "sells" Vitamin E products and says it merely takes orders for such products and makes a service charge for "handling the orders". Highly technical refinements concerning the passage of title and the law of sales are of no avail, under the postal laws (39 U.S.C. 259 and 732) to one proven to be receiving money by mail on the basis of false representations, concerning the efficacy of Vitamin E for serious diseases, made with the intent to deceive. In any event, the evidence in the record is ample to support a finding that the Respondent sells Vitamin E products.

Certain color slides purporting to show some pathological conditions in various states of response to medical care including the alleged use of Vitamin E, the Respondent now says should have been somehow more freely usable by Respondent's witness, Dr. Evan Shute, in his description of results in administering Vitamin E. The color slides were never offered in evidence. It was stipulated by Counsel for the respective parties at the hearing that the slides might be used to refresh the recollection of Dr. Evan Shute, who thereafter if he wished could supply for the record additional testimony concerning his use of Vitamin E. Respondent has failed to show any prejudicial error by the Hearing Examiner in the limited use of the slides at the hearing - with the full consent of all parties.

There was no prejudicial error in the Hearing Examiner limiting Dr. Evan Shute to his three strongest authorities (book or articles) in support of each of those representations concerning Vitamin E (listed in the complaint) which he testified were true representations. Reasonable limits in the scope and duration of administrative proceedings necessitate steps such as the Hearing Examiner took here to avoid excessive repetition of data of doubtful relevance or significance. Furthermore, Respondent's Counsel at the hearing did not object to the procedure thus limiting Dr. Shute and he did not suggest that such procedure was in any way unfair.

Respondent likewise takes exception to the finding by the Hearing Examiner that Respondent's representation about Vitamin E and disease fail to state that they are inapplicable to E-FEROL 30 I.U As the Hearing Examiner pointed out there is no doubt as to the fact that Respondent takes orders for E-FEROL 30 I.U. This product is listed in their order blanks and it is also the product which was sold through test correspondence and is part of the evidence in the record. The Respondent's advertisements in connection with Vitamin E and heart or other cardiovascular diseases do not say they are inapplicable to E-FEROL 30 I.U. and the impression given to credulous persons eager to prevent or treat heart conditions is that they are applicable. His finding is fully supported by the record.

The important thing in the consideration of the issues here involved is that Respondent is selling Vitamin E preparations through the mails for the prevention and cure of heart and cardiovascular diseases and labelling requirements which are referred to by Respondent have nothing to do with a particular finding by the Hearing Examiner. The record clearly shows the successful attempt by Respondent to solicit money through the mails by distributing advertising matter containing the representation that Vitamin E (30 I.U.) is therapeutically effective in the treatment and prevention of heart and cardiovascular diseases. (See Government Exhibits No. 3-5, 9-14, 16-21, 23, 24, 26-29, 31-33, 36, 38 and 41-42.) Complainant's interpretation in connection with this advertisement is reasonable, Donaldson v. Read Magazine, 333 U.S. 178. This interpretation likewise is in conformity with the effect such advertisements would produce on ordinary minds - Durland v. U.S., 61 U.S. 306, 313, 314.

Respondent likewise excepts to the findings of the Hearing Examiner pertaining to the charge in paragraph (3)(a) that the Respondent had represented to the public in substance and effect:

"That Respondent's product 'E-FEROL 30 I.U.' (containing vitamin E) is therapeutically effective and beneficial in the treatment of heart and cardiovascular diseases for any person so afflicted."

Respondent likewise excepts to the finding by the Hearing Examiner that Respondent's representation as charged in paragraph (3) (b) of the complaint "that Respondent's said product will prevent heart disease" was false. These paragraphs (3)(a) and (b) charge that the Respondent claims his said product will prevent heart disease. Respondent contends that the Government produced no proof that Respondent had unconditionally represented that alpha tocopherol would prevent heart disease and in connection with exceptions 3, 4 and 5 covering paragraph (3) (b) they contend the Hearing Examiner's findings are in error - first, because Respondent made no such unconditional representation and secondly, because the representation which was made was true. The record does not substantiate these contentions. The record clearly discloses facts which within themselves or from reasonable inferences which may be drawn from them fully support the finding.

Respondent likewise excepts to the finding by the Hearing Examiner that the Respondent was guilty of fraud because its alleged representations did not accord with "universality of scientific belief" and that the truth of Respondent's representation must be determined by whether they have general scientific acceptance.

Respondent excepts to the finding of the Hearing Examiner that Respondent's representations as alleged in paragraphs (3)(c), (d) and (g) of the complaint are untrue. These refer to Respondent's claims that Vitamin E is the key both to the prevention and treatment of all those conditions in which a lack of blood supply or lack of oxygen is involved, that it seems to be a natural anti-thrombin in the human blood stream and is a dilator of blood vessels. These claims admittedly were made by the Respondent who contends, however, that these statements are true.

The Respondent also excepts to the findings of the Hearing Examiner that there is ample medical and scientific authority for the proposition that Vitamin E has not been shown to have any value in the prevention or treatment of coronary heart disease, hypertensive heart disease or rheumatic heart disease, and that Respondent's evidence shows no adequate scientific or medical basis for Respondent's Vitamin E representations and to the Hearing Examiner's findings that scientific evidence fails to establish unequivocally or with anything approaching reasonable certainty that Vitamin E is therapeutically effective in the treatment of sugar diabetes. Respondent also excepts to Hearing Examiner's findings that the truth of Respondent's representation (3)(k) is not substantiated by reliable evidence, that there is no significant scientific evidence that Respondent's representation (3)(k) is true and that said representation is materially false.

He excepts to the Hearing Examiner's findings that Respondent is engaged in a scheme or device for obtaining money through the mails by false or fraudulent representations; that Respondent has violated 39 U.S.C. 259 and 732; and that the Judicial Officer should issue a fraud order.

The "universality of scientific opinion" test was laid down in the Supreme Court in Reilly v. Pinkus, 338 U.S. 269, 267 as a test for inferring intent. Courts have discussed the acceptable methods of proving falsity as (1) the testimony of experts based upon tests of drugs; (2) the testimony of experts as to the consensus of scientific medical opinion with respect to the effectiveness of the drug; (3) expert testimony of the therapeutic value of a drug even though the expert has neither tested it nor purports to represent the consensus of opinion, Research Laboratory, Inc. v. U.S. 167 F.2d 410. The expert witnesses produced by the Complainant stated that their testimony in effect was in conformity with the consensus of medical opinion on the subject. The record here shows that the consensus of medical opinion is that Respondent's claims are false and that this is the universality of medical opinion on the subject. Numerous tests and experiments have been conducted to attempt to substantiate the claims made by Respondent that Vitamin E is efficacious for treatment of a number of conditions but these have failed to substantiate the claims.

It appears perfectly clear from the testimony of the expert witnesses that Respondent's claims and representations are devoid of scientific support. Dr. Finnegan testified that as a cardiologist he treats patients suffering from cardiovascular diseases and that the complicated method of diagnosis could not be accomplished by a layman either in himself or others. A proper diagnosis consists of a careful physical examination and history by indicated laboratory studies such as the electrocardiogram, x-rays and other diagnostic procedures as the individual case requires and that the method of treating these diseases is complicated and involved; that he tried Vitamin E in the treatment of heart diseases for approximately a year and observed no clinical changes in the patients and no beneficial results could be attributable to Vitamin E and that based upon his study, work, reading and practice there is no evidence that Vitamin E deficiency either causes or its administration prevents or cures any form of heart disease regardless of how many international units are used.

Dr. Chapman testified that as a cardiologist he routinely treats patients suffering from cardiovascular diseases and that he has treated thousands of these patients - that the diagnosis of these diseases and conditions is quite involved by includes the taking of a very thorough inventory of the patient's complaints, medical history and a thorough physical examination with particular reference to the cardiovascular system or the heart and circulatory apparatus and the use of certain other diagnostic aides which may help in the physician's qualifying or lending precision to the diagnosis which may include x-rays, floroscopic examinations of the heart, electrocardiograph studies, blood studies, exercise tests in response to treatment. That the treatment of heart conditions is as much individualized as any other disease process, each patient being different. Such treatment is very complicated and varies from one condition to another as well as patient to patient. That Vitamin E in any strength dose would not be an effective agent in treating parasitic heart disease and that it would not be of therapeutic value in the treatment of coronary thrombosis - that he knows of no study or clinical reports that are accurate, thorough and reliable and would indicate that Vitamin E would be beneficial or of therapeutic value to patients with heart conditions with or without accompanying mild cardiac contraction. That Vitamin E in any strength would be ineffective in the treatment of hypertensive heart disease - that the literature on the subject supports his opinion that Vitamin E is worthless in the treatment of heart disease and disorders and there is no evidence to support any such claims regardless of how many units of Vitamin E are administered. He testified that there is no evidence that Vitamin E will prevent heart disease and that he knows of no cardiologist who would state that Vitamin E is of any value in the treatment of heart disease. That sugar diabetes is a metabolic disorder associated with the deficiency of insulin which is treated by diet, regulation of activity and insulin supplementation if necessary and that Vitamin E has no action of an insulin like type as it does not tend to lower elevated blood sugar and does not provide calories and does not assist the patient in controlling his physical activities and the witness therefore could see no valid reason to use Vitamin E to treat diabetes.

Similarly Dr. Campbell testified that he is familiar with sugar diabetes in its treatment and that Vitamin E in any strength would not be therapeutically effective in the treatment thereof. That he has read Dr. Shute's book "Your Heart and Vitamin E" (Government Exhibit 41) and in his private practice he treats cardiovascular patients. He deplores the use of Vitamin E by laymen without medical consultation because he may fail to obtain proper and necessary treatment thereby threatening the patient's life span and exposing him to a lot of suffering. That vascular degenerations in a diabetic are not effectively treated in the use of Vitamin E in any dosage and that he knows of no informed physician who would testify to the contrary. That Vitamin E has been thoroughly studied and that there is no doubt whatsoever as to its lack of utility.

Dr. Friedman testified that the amount of the daily need of Vitamin E in the human diet remains unestablished although in October 1959 need for Vitamin E in human nutrition was formally established and that the average daily intake of Vitamin E in the ordinary diet of people in the United States is considered to be possibly 15 miligrams or international units and that although some questionable estimates of the need run as high as 30 miligrams a day he believes that the ingestion of 5 miligrams a day would be sufficient to prevent any alleged deficiency and that there is no need for supplementing the human diet with Vitamin E and that there is no deficiency of Vitamin E in the diet of the average person in the United States and that to his knowledge there has been no scientific demonstration of the existence of any Vitamin E deficiency or of any correlation between cardiovascular diseases and Vitamin E intake.

Dr. Evan V. Shute who was Respondent's expert testified he has a specialty in obstetrics and gynecology and not cardiology nor internal medicine. He spent a great deal of time in his testimony berating other doctors and medical associations none of which agreed with him and uses ridicule and invectives to characterize their stand in regard to the claims of the Respondent which are involved in this matter. He treats patients through the mail diagnosing and prescribing to them based entirely upon the layman patient's statements in letters without the advantage of a medical history, physical examination or usual diagnostic technique but nowhere in his testimony does Dr. Shute fully support Respondent's claims and representations.

In October 1959, the Food and Drug Administration formally determined (a) the need for Vitamin E in the physiological processes of the human body has been established (b) but the difficulty of producing experimental dietary deficiency of Vitamin E emphasizes that the diets used in this country are amply supplied with this vitamin, and (c) any claim in the labeling of drugs or of foods offered for special dietary use by reason of Vitamin E that there is need for dietary supplementation with Vitamin E will be considered false. Mr. Muir admitted he was aware of this but does not agree with the Food and Drug Administration.

He testified that he has made no attempt to corroborate the advice received from Dr. Shute regarding the efficacy of Vitamin E but has accepted it without reservation and he has rejected all adverse reports or comments and has concealed their existence from the members of the society. He testified that the society spreads good news to the public but never mentions any adverse report even though he is aware of the reports which are contrary to the society's claims.

The findings of the Hering Examiner in his Initial Decision are supported completely by an overwhelming preponderance of reliable testimony. In the record as pointed out by the Hearing Examiner all the scientific evidence establishes that Respondent's representations, as described in paragraphs (3)(a) and (b) of the complaint, are untrue. Their falsity is material because it is likely to induce credulous people, eager to treat or prevent heart disease, to part with their money for a product which will surely not do what they are led to believe by Respondent it will do.

The record likewise supports his finding that there is a universality of scientific belief that Respondent's product "E-FEROL 30 I.U." containing Vitamin E is not therapeutically effective and beneficial in the treatment of heart and cardiovascular disease for all persons so afflicted. That this product will not prevent heart disease and in the dosage prescribed by Respondent, one or two capsules a day, would be useless in the treatment of heart and cardiovascular disease or in the prevention of heart disease.

The Hearing Examiner's determination as to paragraphs (3)(c), (d) and (g) is amply supported in the record. As he points out Respondent's representations conveyed the impression to credulous readers that the statements of medical fact and theory contained therein have general scientific acceptance and constitutes valid evidence or proof of the efficacy of Vitamin E in the treatment and prevention of coronary heart disease, hypertensive heart disease or rheumatic heart disease and other heart diseases. The preponderance of reliable evidence in the record clearly shows that such an impression is contrary to the truth and therefore those representations are false. They do not have general scientific acceptance and they do not constitute valid evidence or proof of the efficacy of Vitamin E in the treatment or prevention of heart disease. There is ample medical and scientific authority for the proposition that Vitamin E has not been shown to have any value in the prevention or treatment of these heart ailments. I completely agree with the Hearing Examiner's findings that the Respondent's representations as alleged in paragraphs (3)(c), (d) and (g) of the complaint are materially false.

The Hearing Examiner's findings in reference to paragraph (3)(k) of the complaint is likewise amply supported in the record. The Respondent in his publication "The Cardiac" represents that Vitamin E is therapeutically effective in the treatment of sugar diabetes. They also in their publication urge the use of Vitamin E in the treatment of diabetes. The record reveals that investigation of the effects of Vitamin E on juvenile diabetes patients disclosed no beneficial effects and that a carefully controlled study led to the conclusion that evidence was lacking to support the view that Vitamin E is of value in the treatment of diabetes mellitus. The scientific evidence fails to establish Respondent's claim that Vitamin E is therapeutically effective in the treatment of sugar diabetes and the Hearing Examiner's finding that the Respondent's representation that Vitamin E is effective in such treatment is materially false is overwhelmingly supported in the record.

The quotes from Respondent's book "Your Heart and Vitamin E" as set forth in paragraphs (3) (l) and (m) supra, are used by Respondent in its special advertisement and order form (Government Exhibit 16), for this book authored by Dr. Evan V. Shute and Dr. Wilfred E. Shute and copyrighted by Respondent in 1956 (Government Exhibit 41). In both these exhibits the impression is conveyed that the information contained therein is in conformity with established medical and scientific practices and so is reliable and accurate. The record does not support the claims in the book that Vitamin E has therapeutic efficacy for heart diseases such as coronary heart disease, hypertensive heart disease and rheumatic heart disease. The record fully supports the Hearing Examiner's finding that the representations of Respondent, in advertising the book, as charged in paragraphs (3) (l) and (m) are materially false.

In reference to the showing of intent to deceive, the Hearing Examiner correctly points out that Respondent's representations as charged in paragraphs (3) (a) and (b) of the complaint according to universal scientific belief are wholly unsupportable. In reference to those representations as charged in paragraphs (3) (c), (d) and (g) of the complaint that the Respondent deliberately concealed adverse scientific reports in respect to these matters and the lack of efficacy of Vitamin E in the treatment of coronary hypertensive or rheumatic heart disease and this deliberate concealment of well-known highly significant scientific evidence is indicative of an intent to deceive. In respect to Respondent's representation as charged in paragraph (3)(k) of the complaint, the Hearing Examiner points out that the Respondent deliberately withheld reports of controlled scientific tests on Vitamin E used with diabetics showing Respondent's claim as to the therapeutic efficacy of Vitamin E for diabetes to be unsubstantiated. The Hearing Examiner further points out that in several instances the Respondent by placing alleged summaries of articles from the American Medical Association or the American Heart Association in juxtaposition or in context with Respondent's promotion for the use of Vitamin E for diabetes or heart impairments, has done that which subtly but skillfully was designed to create the false impression in credulous readers that these Associations support the use of Vitamin E for these diseases and that this conduct is further evidence of an intent to deceive.

An intent to deceive may be inferred from the universality of scientific belief that advertising representations are wholly unsupportable, Reilly v. Pinkus, supra. The Hearing Examiner correctly found that the Respondent intends to deceive by its false representation and that actual fraud under established law is proven.

I therefore affirm the Hearing Examiner's findings that Respondent is engaged in a scheme or device for obtaining money through the mails by means of false or fraudulent pretenses, representations or promises and that as a matter of law Respondent is engaged in a scheme or device to obtain money through the mails by means of false or fraudulent pretenses, representations or promises within the meaning of 39 U.S.C. 259 and 732.

The proposed findings of fact and conclusions of law as submitted by the parties hereto or the substance thereof have been fully considered and they are adopted to the extent herein indicated otherwise such proposals are rejected for reasons stated herein or because they are neither relevant or material.

The Judicial Officer is quite convinced that Respondent has had a full and fair hearing. Because the record establishes that Respondent is engaged in a scheme or device for obtaining money through the mails by means of false or fraudulent pretenses, representations or promises, a fraud order shall issue forthwith forbidding the delivery of mail and the payment of money orders incident to such scheme, to the Respondent, its agents and representatives, all in accordance with 39 U.S.C. 259 and 732.