P.S. Docket No. 2/151


April 19, 1974 


In the Matter of the Complaint Against

MIDWEST HEALTH AIDS at
154 East Erie Street,
Chicago, Illinois 60611

P.S. Docket No. 2/151

Rudolf Sobernheim Administrative Law Judge

APPEARANCES:
James J. Robertson, Esq.
Law Department U.S. Postal Service
Washington, D.C. 20260 for Complainant

Charles Rowan, Esq.
Rowan, Slaby, Mueller & Ilse
324 East Wisconsin Avenue
Milwaukee, Wisconsin 53202 for Respondent

INITIAL DECISION

This is a proceeding by Complainant against Respondent under 39 U.S.C. 3005 which authorizes action against Respondent upon evidence satisfactory to the Postal Service that Respondent "is engaged in conducting a scheme or device for obtaining money or property through the mails by means of false representations."

Complainant alleged that Respondent is engaged in such a scheme in the sale of a remedy for drunkenness, called "ALCOREM," and of vitamin B pills, called "PINKLES":

"(a) by the use of an advertisement (Compl., Ex. A) through which Respondent, directly or indirectly, in substance and effect represents:

(1) That use of Respondent's product will break the drinking cycle;

(2) That use of Respondent's product promotes an aversion to all alcoholic drinks;

(3) That use of Respondent's product will interrupt the drinking cycle;

(4) That Respondent's product may be taken secretly;

(5) That use of Respondent's product eliminates the desire for alcohol;

(6) That the use of the product supplied by Respondent for $11.75, in the quantity provided with such a purchase, will promote an aversion to all alcoholic beverages;

(7) That use of its product is safe;

(8) That Respondent's product is new."

(b) by the use of promotional material (Compl., Ex. B to F), seeking refill orders from purchasers of Respondent's products in response to the first advertisement (Compl., Ex. A), through which Respondent represents, directly or indirectly, in substance or effect:

"(1) That is product may be administered to a noncooperative drinker, in secret, and be efficacious as a means of breaking the drinking cycle, creating an aversion to all alcoholic beverages and be safe;

(2) That use of Respondent's product causes sudden and complete abstinence from all drinks;

(3) That is product will create a permanent aversion to all alcoholic beverages;

(4) That Respondent's product will have an emetic action when placed in alcoholic beverages;

(5) That use of Respondent's product will effect relief from alcoholism;

(6) That use of Respondent's product will cause the person upon whom it is used to believe he has developed an allergy or sensitivity to alcoholic beverages."

(c) by the use of promotional material (Compl., Ex. D), promoting the sale of PINKIES, through which Respondent represents, directly or indirectly, in substance and effect:

"(1) That a vitamin deficiency of the vitamin B-complex is frequently found in excessive drinkers for long periods after they have ceased consuming alcoholic beverages;

(2) That the use of 'Pinkies' is necessary for many months after the use of Respondent's product."

Respondent in its answer admitted the use of the materials attached to the complaint as Exhibits A to F but denied that any of its representations were false and that it represented that its product was safe or that any aversion to alcohol resulting from its use was either permanent or of definite duration.

Respondent also asserted as separate defense: (1) that Complainant was bound by the decision in a Post Office Department misrepresentation proceeding against Respondent, conducted in 1948 (F & L Docket No. 16/235) in which aversion therapy was found to be a recognized treatment of alcoholics and Respondent's product not unsafe; (2) that determination of the safety of Respondent's product should be left to the Food and Drug Administration; (3) that the Postal Service should not prevent the sale of an inexpensive remedy to interrupt the drinking cycle of alcoholics and should not destroy the social value of such a product; (4) that the complaint did not charge Respondent with intent, nor had Respondent intended to deceive, that Respondent, on the contrary, had in 1948 obtained approval for its currently-used advertising material from the Post Office lawyer and hearing examiner who had presented and heard, respectively, the 1948 case against Respondent, and that the instant proceeding was brought only to meet the charge of Soberin Aids Company (P.S. Docket No. 2/36) that it was singled out for action under 39 U.S.C. 3005.

At the end of the hearings Complainant's motion for oral decision was denied. Thereafter, both parties presented in writing proposed findings and argument.

FINDINGS OF FACT

1. At all relevant times Milton Hecker was doing business at 151 East Erie Street, Chicago, Illinois 60611 under the trade name and style of Midwest Health Aids, Respondent herein.

2. At all relevant times Respondent was engaged in the purchase and repacking of syrup of ipecac and its sale under the name of ALCOREM as well as in the sale of PINKIES, receiving money, representing the purchase price therefor, through the mails. ALCOREM together with 21 PINKIES is offered for sale at $11.95 and a bottle of 100 PINKIES is offered for sale at $3.00.

3. Purchases are solicited by means of the material attached to the complaint as Exhibits A to F.

4. ALCOREM is an emetic brand of syrup of ipecac with 2% alcohol by volume (Compl. Ex. C-4) which Respondent advertises as GUARANTEED PURE (Compl., Ex. A). The label (Comp. Ex. C-4) bears the warning:

"CAUTION: Do not use in heart, liver, kidney, circulatory diseases, pregnancy, stomach ulcers, high blood pressure or serious organic disorder without consulting your physician."

5. The advertisement used by Respondent to attract buyers of its products (Compl., Ex. A) carries the word "DRUNKENNESS" in bold letters as a headline above a picture of a man drinking in seeming desperation and advises that the ruinous drinking cycle can be broken quickly and inexpensively by the new ALCOREM which promotes aversion to ALL intoxicating drinks. The reader is told that ALCOREM method of alcohol withdrawal which interrupts the drinking cycle, turns many from liquor, and eliminates the desire for alcohol for varying periods. The aversion treatment is again described as recognized by medical authority. The reader is further told that ALCOREM may be taken in secret and comes ready to use with simple instructions.

A quotation from a purported testimonial is followed by a plug for PINKIES to help "Prevent Vitamin-B Complex Deficiency," 21 of which are advertised to come "FREE" with the order for ALCOREM.

In the final paragraph the reader is urged now to order for $11.95 NEW ALCOREM which, he is told, is known world wide since 1948.

6. With the order, the buyer receives several flyers (Compl., Ex. B to F).

a. Exhibit B is entitled "READ WHAT SATISFIED USERS SAY ABOUT ALCOREM". It contains numerous excerpts from purported testimonials with comments thereon in between which there is inserted a section styled "EXPLANATION OF METHOD". Among other things the purchaser is told that ALCOREM can be given secretly to non-cooperative drinkers, that just a few teaspoons of ALCOREM eliminate the desire for more alcohol and that thereafter PINKIES can be given to the "reformed" drinker. The flyer describes the "New Alcorem Method" as exerting a physiological effect in helping to break the drinking cycle, states that "there exists a difference of opinion among experts qualified by scientific training and experience as to the efficacy and rationale of the use of an emetic or nauseant to help break the drinking cycle and produce an aversion or conditioned reflex to excessive drinking" but, nevertheless, claims that the effect of the use of ALCOREM may be "even forever."

b. Exhibits C and D are mail order forms for PINKIES, which are described as an important part of the NEW ALCOREM METHOD and the use of which should be continued for a period of many months following the use of ALCOREM to supply an deficiency of Vitamin B-complex frequently found in excessive drinkers (Compl., Ex. D). The prospective purchaser is told that their content may be put into the food of a non-cooperative drinker apparently without his knowledge.

c. Exhibit E is a two-page advertising flyer not too dissimilar in content from Exhibit B. It also contains the assertion that the effectiveness of taking ALCOREM may last forever (Compl., Ex. E-1).

d. Exhibit F repeats on one side (Compl., Ex. F-1) the explanation of method and other promotional assertions also found in Exhibits B and E, including the claim that the effect of taking ALCOREM may be "even forever" (Compl., Ex. F-1). On the back page (Compl., F-2), this flyer sets forth the instructions for the five day regimen of taking ALCOREM, at the end of which total dislike for liquor and complete aversion and abhorrence to alcohol are claimed to be achieved except in stubborn cases where the five-day ALCOREM regimen must be repeated to insure continued abhorrence of alcoholic beverages. Secret administration of ALCOREM to unknowing or unwilling victims is again advised.

e. Only this last piece of sales promotion material incorporates the caution on the label of the ALCOREM bottle (Compl., Ex. F-2):

"WARNING Do not use NEW ALCOREM in heart, liver, kidney, circulatory disease, stomach ulcers, pregnancy, high blood pressure, or any organic disorder without consulting your physician. This method is intended only for those who are otherwise normal and healthy but victims of alcohol." and further adds in a final paragraph:

"The medical profession should be consulted in each and every case involving personality problems or mal- adjustment resulting in excessive drinking. The New Alcorem Method is especially designed to break the alcohol cycle by establishing an aversion to drink. If the victim is otherwise healthy and normal but merely drinks too much alcohol then the New Alcorem Method may be of invaluable help. It is specifically designed to be of help in those cases of common or ordinary addiction and not where maladjustment, psychosis, neurosis or other psychological causes for drink exists."

7. Ipecac syrup is commonly used as an emetic in cases of, and is permitted to be sold without prescription because of its importance in treating emergencies caused by, acute poisoning. See 21 CFR sec. 3.30.

8. It has also been used to combat alcoholism through aversion therapy since the Thirties (T II 71)* or early Forties (T I 35) and apparently is still so used occasionally (see GOODMAN & GILMAN, THE PHARMACOLOGICAL BASIS OF THE THERAPEUTICS (8th ptg, 1964), s . v. Ipecac), especially in Europe (T I 35). At the present time other agents are used in the United States in aversion therapy for alcoholics which produce a faster reaction than syrup of ipecac (T I 32).

9. Syrup of ipecac in the dosages recommended by Respondent produces vomiting within 10 to 30 minutes after it is taken (T I 22, I TT 19) in all but 10 to 15 or 20 percent of those to whom it is given (T I 22, T II 43). The evidence is in conflict whether nausea occurs where the patient does not vomit (Compare T I 63, 90 [negative] with T II 20 [possible]).

10. PINKIES are vitamin B capsules each of which contains according to their label (Compl. Ex. C-5) 1 mg. vitamin B1 (thiamine mononitrate), 3 mg. vitamin B-2 (riboflavin), 0.1 mg. vitamin B-6 (pyridoxine h. cl.), 3 mg. calcium pantothenate and 10 mg. niacinamide.

* T I refers to the transcript of the testimony of Complainant's medical witness, T II to that of Respondent's.

11. Vitamin B-1 deficiency is common in chronic drinkers but rapidly overcome once the drinker again eats adequately. Hence, PINKIES would not be needed for a long time (T I 71, 72). If a drinker has, however, a real vitamin B deficiency, doses of vitamin B greatly in excess of those contained in PINKIES would be needed (T I 71, T II 68-69).

12. Findings No. 7 through 11 are essentially undisputed. In order to establish other facts relevant to the truth or falsity of the challenged representations, each party introduced expert medical testimony.

13. a. The physician called as an expert witness by Complainant was certified as an internist in 1971, had spent his residency in a naval hospital and was employed by the Navy at the time of his appearance as a witness. While a student at the University of Utah, he had come in contact with alcoholic patients at a rehabilitation center and he had also treated alcoholic patients since graduation (T I 12-13, 76-77).

b. He testified that in treating an alcoholic patient the most important point was to obtain a complete medical history of the patient, establishing the physical or psychological causes of his or her alcoholic addiction, to determine whether the patient had any illness, such as cirrhosis of the liver, and to ascertain whether the patient was motivated to change. If so, various modes of treatment exist, including medication ( T I 14-15).

c. Aversion therapy by means of syrup of ipecac, intramuscular injection of its chief alkaloid emetine (T I 32), or other substances, such as antabuse, causes violent vomiting and the patient expels alcohol consumed after the syrup of ipecac or other medication is administered. This treatment repeated over five days results in aversion to alcohol lasting from days to weeks. In order to establish aversion more firmly, repetition of aversion treatment once weekly for six weeks and then at quarterly intervals for an indefinite period is required (T I 33-34). If such extended treatment is followed, it was the Postal Service Medical expert's view, long-lasting results could follow (T I 34). The witness was strongly opposed to secret administration of ALCOREM since one not knowing that it was being administered would connect in his or her mind vomiting with consumption of alcohol (T I 82). He emphasized that cooperation of a motivated, knowing patient was most important for successful application of aversion therapy (T I 38-39). He furthermore considered secret administration of ALCOREM unsafe, victimization of the patient and malpractice (T I 36, 38, 40) and strongly opposed even self-administration as dangerous because of the propensity for diseases among alcoholics (T I 39).

d. The Postal Service medical expert further testified that, if vomiting did not occur and the emetine was not eliminated from the body, it might because of its toxicity cause arrhythmia of the heart and heart failure even in the dosage prescribed by Respondent (T I 26) and that syrup of ipecac could cause medical complications for drinkers with hernias of the diaphragm, especially could cause hemorrhages in drinkers with esophageal varices (T I 57-60), and result in other adverse effects upon drinkers suffering, as they frequently do, from cirrhosis of the liver, gastritis or ulcers (T I 48-50) or cardiomyopy (T I 83).

e. Finally, the Postal Service medical expert testified that to the extent that Respondent's interruption of the drinking cycle was attained, this effect would be achieved only as to the type of liquor, e.g. bourbon, scotch, wine, beer, in which ALCOREM was administered (T I 66, 92), that Respondent's four-ounce bottle of ALCOREM was not enough effectively to be used for more than one class of alcoholic beverages (see T I 67-69), and that conditioning for all major types of drinks was likely to be necessary to break the drinking cycle of an alcoholic (T I 95).

14. a. Respondent's medical expert witness was a Chicago dermatologist with an impressive record of teaching and writing experience as well as longstanding practice in that special field (T II 12-14) but who had treated alcoholism in patients only incidentally so that he could treat other diseases from which they suffered (T II 15) and not in recent years (T II 74).

b. This witness expressed the belief that administration of syrup of ipecac, if successful, would create a permanent aversion to alcohol (T II 21). He subsequently stated, however, that he presumed the effect of using syrup of ipecac to break the drinking cycle would vary (T II 28) and, again, that the effect could last for days or be permanent (T II 30).

c. He considered it probably that taking syrup of ipecac in one kind of liquor would extent the effect to all (T II 31, 58-59), since the odor of alcohol was the decisive aversion factor. If aversion to alcoholic smells was successful aversion to one kind of alcoholic smell should extend to all (T II 71). While whiskey, beer, wine and other liquors all smell differently, the smell of alcohol was noticeable in all of them (T II 70).

d. In regard to the effect which vomiting, induced by taking syrup of ipecac, would have on persons suffering from various illnesses, Respondent's medical expert considered the various dangers outlined by the Postal Service medical expert or the danger from toxic effect of emetine, ingested but not subsequently expelled by vomiting, as not likely (T II 32). He did not think that absorption of emetine was very likely to bring on arrhythmia (T II 33), that the existence of a hernia of the diaphragm would bring about aspiration of stomach contents and attendant medical complications (T II 34), such as pneumonitis (T II 56), and he considered the hemorrhaging from vomiting by drinkers with esophageal varices uncommon though he conceded that the varices might break open more easily under the strain of violent vomiting (T II 35, 51). He saw no harmful effect from violent vomiting on drinkers with ulcers or liver diseases (T II 36-37). He did not think that in such cases ulcer perforation would occur but considered that it could occur in a rare case (T II 44-45). His overall approach to this aspect of the use of syrup of ipecac as a vomiting agent is best known in his statements that in his experimental work he had "maybe *** been guilty of doing things with subjects, human subjects, that is frowned upon today" (T II 65), that in giving emetine to persons with heart disease one must constantly balance risks and benefits (T II 46-47) and that he would give people a chance to use syrup of ipecac even if it worked only in 5% of the users (T II 61).

15. Respondent has denied that it represented its product as "safe" either expressly or by implication and introduced in evidence (Resp. Ex. R-4) the transcript of the hearing held in 1948 in a proceeding against Health-Aids Research (F & L Docket No. 16/235) - a trade name under which Milton Hecker was then doing business. Respondent's counsel then as now objected to a question relating to the safety of the product ( id ., p. 73) and was plainly overruled ( id ., p. 75). The Chief Trial Examiner of the Post Office Department held that a false representation of product safety provided a basis for action under 39 U.S.C. 3005 (then 39 U.S.C. 259) and that to that extent at least product safety was an issue in false representation proceedings.

16. Respondent's counsel advised Postal Service counsel in 1971 that he lost Respondent's 1948 case but worked out the form of advertising since used by his client with the Chief Trial Examiner and showed it to the attorney who had represented the Post Office Department in the proceeding and who "at least did not object to it." Respondent also made an offer of proof that Milton Hecker, if not prevented from testifying by illness and called as a witness, would testify to like effect (T II 9-10). No documentation of this alleged agreement or any formal departmental order in respect thereof has been produced and I find that none exists. At most there can have been only informal dealings which did not rise to the dignity of a binding agreement.

17. Under date of 11 January 1971 the Assistant General Counsel of the Post Office Department in charge of the Mailability Division advised Respondent that it considered that it falsely represented NEW ALCOREM as a scientifically recognized and effective means of overcoming alcoholism and that, moreover, its sole constituent (syrup of ipecac) was obsolete as well as highly toxic and superseded by more effective drugs (Resp. Ex. R-5). Hence, he requested that Respondent sign a Compromise Agreement (P.O.D. Form 2157) providing for discontinuance of the criticized advertising (Encl. to Resp. Ex. R-5). After correspondence and conferences (Resp. Ex. R-2 to R-4) Postal Service counsel advised Respondent that the Service was closing its file on the matter, at least temporarily, in the light of certain changes made by Respondent in its advertising, but reserving the right to reopen the matter in the future (Resp. Ex. R-1).

18. Respondent has adduced no evidence to establish its charge that the instant proceeding was filed "unreasonably, capriciously and in bad faith" for the "sole" purpose of supporting the Postal Service position in the Soberin Aids case, discussed infra (answ., 5th Def., par. 3). On review of the record I find that the record is bare of any proof whatever of such charge.

19. Neither of the two experts was a specialist in the treatment of alcoholic addiction, had substantial experience in using aversion therapy to this end or used syrup of ipecac in the aversion treatment of alcoholics. Both testified primarily on the basis of general medical knowledge and study of the medical literature on aversion treatment of alcoholism.

20. Careful scrutiny of the testimony, however, leads to the conclusions that the physician who testified on behalf of the Postal Service has had presently far closer contact with the treatment of alcoholics for their addiction than the eminent dermatologist, called as a witness by Respondent. Hence, I accept his testimony over that of Respondent's witness.

21. Moreover, it appears that the conflict between the two expert witnesses is largely one of attitude. Respondent's witness does not really deny the risks pointed out by Complainant's medical expert but merely low-rates them and is willing to accept them even for very small success. In such a situation where orders for a potentially dangerous product, to be physically ingested, are solicited through the mails, proper caution commands that the conclusions of Respondent's medical witness be rejected. The issue is not here posited squarely, for on its label (Compl. Ex. C-4) and in its instructions for use (Compl., Ex. F) Respondent has of its own accord adopted the view that the dangers, pointed out by Complainant's medical witness, are real enough to be brought to the purchaser's attention.

22. Based on the foregoing detailed findings of fact and the record as a whole I find:

a. Respondent falsely represents, as alleged in paragraph V(2) and (6) of the Complaint that Respondent's product promotes an aversion to all alcoholic drinks. Its advertisement (Compl., Ex. A) expressly so states and clearly conveys the impression that, when used as directed, one order of ALCOREM is sufficient to give the user aversion against "ALL" alcoholic beverages. To the contrary, the testimony which I accept establishes that ALCOREM creates aversion, while it lasts, only against the kind or class or alcoholic beverage in which it is taken. If smell is the sense on which aversion therapy plays, then it would seem logical that the different odors overlaying the basic alcohol odor of beverages such as whiskey, beer, wine or liquiurs, would require separate courses of ALCOREM use so as to create complete aversion against alcoholic beverages. Hence, Respondent's representation is false in that it fails to inform the user that ALCOREM must be separately taken in each kind or class of alcoholic beverages to be effective against all, and I so find.

b.(1) Respondent, without using the word, nevertheless falsely represents that its product is safe, as charged in paragraph V(7) of the Complaint. Addressing himself to the general public, Respondent in his advertisement (Compl., Ex. A) informs the reader and prospective purchaser that quick and inexpensive relief from drunkenness is available through use of ALCOREM which comes ready to use and represents a form of treatment recognized by medical authority. An ordinary member of the public may well form the belief that Respondent offers a product which can be used by anyone without restriction or collateral expense, such as the cost of medical advise or supervision. The facts impose the conclusion that by the language of the challenged advertisement Respondent effectively communicates to the public that ALCOREM is broadly useful for the purpose for which it is sold, i . e . that its product can be safely used by all in need of it.

(2) Such representation in Respondent's advertisement (Comp., Ex. A) is plainly false since the label and the instructions for the use of ALCOREM openly state that Respondent's product cannot be safely used by every purchaser, and Respondent knows it. Moreover, ALCOREM is effective only for 80% to 90% of those not afflicted with the diseases recited in Respondent's warnings, since from 10% to 20% of the users of ALCOREM will not experience vomiting and the aversion effect which it induces. All this the prospective purchaser learns only, if at all, after he has purchased ALCOREM. To reveal these facts only after purchase is to have represented to the potential purchasers that no limitations exist, i . e . that the product is safe For all to use.

c. Respondent falsely alleges as charged in paragraph V(8) of the complaint that its product is new. In fact its basic component is a product used in alcohol aversion therapy since the Thirties and ALCOREM itself, under whatever name, has been sold unchanged by Respondent and other enterprises of Milton Hecker since before 1948. A product 25 or more years old is not new. Respondent's contrary allegation is not only false but materially so since the claim that a product, particularly one with some kind of curative effect, is new inevitably attracts purchasers and enhances Respondent's receipt of money from them through the mails.

d. The representations charged to Respondent in paragraph V(1), (3) and (5) of the complaint have not been shown to be false when read in the context of Respondent's advertisement (Compl., Ex. A).

e. The representations charged to Respondent in paragraph VIII of the complaint, as being made in promotional materials and instructions sent to purchasers of ALCOREM (Compl., Ex. B to F), repeat to some extent those charged to Respondent in paragraph V of the complaint.

(1) It follows that Complainant's complaint is upheld as to the charges made in paragraph VIII(2) of the complaint and rejected as to the charges made in paragraph VIII(1), (5) and (6) of the complaint.

(2) The representation charged in paragraph VIII(3) of the complaint that ALCOREM may have permanent effect is false. The overwhelming weight of the evidence indicates that no permanent effect is obtained from a single 5-day course of using ALCOREM as instructed by Respondent. On this point the testimony of Respondent's medical witness was so ambivalent as to be devoid of value.

(3) The representation, charged in paragraph VIII(4) of the complaint, is false in that, as the record shows, a substantial portion of potential users of syrup of ipecac will not experience the emetic reaction necessary to any effectiveness of ALCOREM. An outfall of perhaps 1 in 5 or 6 is too large to be disregarded and renders materially false a general statement of emetic action.

f. The representations charged to Respondent in paragraph XI of the complaint in respect of PINKIES (Compl., Ex. D) are false. The record shows that lack of vitamin B complex, frequently resulting from the drinker's failure to eat properly, is rapidly overcome as soon as the former drinker again partakes of regular nourishment. Not all drinkers, however, cease to do so during their drinking period and are, therefore, in need of vitamin B pills. In either event use of vitamin-B complex capsules, such as PINKIES, over any length of time is unnecessary. On the other hand, if the former drinker has reached the point of a true vitamin B deficiency, large doses of vitamin B, vastly in excess of those provided in PINKIES, are needed to bring the former drinker back to health.

CONCLUSIONS OF LAW

1. Respondent is engaged in a scheme or device for obtaining money or property through the mails by means of false representations within the meaning of 39 U.S.C. 3005, as alleged in paragraphs V(2), (6), (7) and (8), VIII(2), (3) and (4) and XI of the complaint.

2. Scienter or intent to defraud is not required as a condition to the application of the present statute and its proof is immaterial. See National Opportunity Research Service, P.S. Docket No. 2/125 (1974); U.S. Zip Code Service , P.S. Docket No. 2/171 (1974). Hence, Respondent's contrary contention (Answer, Fifth Defense) cannot prevail. As indicated in Finding of Fact No. 22 b. (2), Respondent here acted with knowledge of the falsity of some of its representations.

3. Neither the Post Office Department nor the United States Postal Service entered into a binding agreement with Respondent either in 1948 or in 1971 which would preclude Complainant from pursuing the present proceeding.

In respect of the 1948 dealings the only witness who could have testified as to what actually transpired is Respondent's present counsel. He did not take the stand to testify as to these dealings and to permit his recollection to be explored further through cross-examination. His only statement about his dealings with the Post Office Department in 1948 (Resp. Ex. R-4) indicates clearly that anything then done was informal and off the record. Such informal arrangements off the record do not rise to the level of an administrative determination setting a precedent, whether otherwise binding or not.

The 1971 investigation of Respondent did not involve all of the issues now raised or central. In any event the letter closing that investigation (Resp. Ex R-1) expressly left the door open to further review and forewarned Respondent of a possible further investigation and complaint.

4. However, Complainant would not, as a matter of law, be estopped from presently enforcing section 3005 against Respondent if Respondent in fact violates its prohibitions. Institute for Weight Control, Inc. v. Klassen , 348 F. Supp. 1304 (D.N.J., 1972), aff'd w.o. op. 474 F.2d 1338 (ed Cir., 1973). For further discussion of the applicable decisions and principles of law see Shepard's Citations, Inc. , P.S. Docket No. 1/88(1974).

5. Respondent's defense of bad faith in bringing this proceeding completely fails for lack of proof. If the proceeding in Soberin Aids Company , P.S. Docket No. 2/36(1973), P.S. decision upheld in N. Van Dyne Advertising Agency, Inc. v. United States Postal Service , 73 Civil 4584 (S.D.N.Y., 1974), led to the renewed investigation of and this proceeding against Respondent, as claimed by him, the U.S. Postal Service authorities in charge merely carried out their official duties and no blame whatever attached to their action.

6. Contrary to Respondent's assertion, a false representation of product safety may properly serve as the basis for an order against Respondent under 39 U.S.C. 3005. Even though other Government agencies may take action where product safety is involved that fact does not bar action by Complainant. Reilly v. Pinkus , 338 U.S. 269, 277 (1949). Nor need the representation of safety be made directly. It suffices that it is implied in the advertising material addressed to the public. See Donaldson v. Read Magazine , 333 U.S. 178 (1948). Thus in Sauna Belt, Inc., P.O.D. Docket No. 3/43 (1972), the Acting Judicial Officer of the Postal Service held that reference to ease of use and the entire wording of the advertisement would lead many readers to believe that the exercises involved in Sauna Belt were capable of being safely performed irrespective of the age or state of health of the person involved (Jud. Off. Dec., p. 31), contrary to the testimony accepted by him (see ibid ., pp. 63-64). In Slimtyme Co. , P.S. Docket No. 2/11(1973) the Judicial Officer described the implied representation of safety as essentially the implied common-law warranty of merchantability (Jud. Off. Dec., p. 6). Clearly, such a warranty is present here. Without restrictive caveats, the need for which was known to Respondent and which he incorporated in his product label and instructions for use, Respondent made an appeal to all concerned with a drinking problem to use his product, advertised as representing a medically approved method of combatting excessive drinking, a quick and inexpensive way of breaking the drinking cycle and providing relief from drunkenness.

Indeed, though the point is not directly involved, it is most questionable whether, as Respondent says, any person can properly be described as healthy (Compl., Ex. F-2) if he has a serious drinking problem. See Easter v. District of Columbia, 361 F.2d 50 (D.C. Cir., 1966).

7. The result here reached is in accord with the Postal Service decision in Soberlin Aids Company , P.S. Docket No. 2/36(1973) where The Judicial Officer held that Soberin Aids Company in an advertisement for a syrup of ipecac preparation, in terms (ALJ dec., 2/36, App. A) essentially identical with those employed in Respondent's advertisement (Compl., Ex. A), represented by implication that its product was safe and effectively created an aversion against all kinds of alcoholic beverages when used only in one.

8. Affirming this decision, the Federal District Judge stated in his opinion ( supra , No. 5) in respect of the issue of product safety:

"Considering that the advertisement is directed to alcoholics and members of their families, and viewing its contents in totality, the administrative finding that it represents the product may be safely used is fully warranted.(9) To find otherwise one must be blind to reality. The thrust of the advertisement, directed as it was to alcoholics, with its emphasis that it was a 'Doctor's Marvelous Medical Discovery' and a 'Doctor's Marvelous Medical Discovery' and a 'Doctor's recognized method for interrupting the drinking cycle,' carried with it a representation that plaintiff's product, to be ingested internally, could be used without unexpected or untoward hazards to health.

The issue next to be considered is whether the administrative finding that the representation is materially false is supported by substantial evidence. (10)

(9) Cf . Donaldson v. Read Magazine, Inc., 333 U.S. 178 (1948); P. Lorillard Co. v. FTC, 186 F.2d 52 (4th Cir. 1950); Vibra Brush Corp. v. Schaffer, 152 F. Supp. 461 (S.D.N.Y. 1957), order vacated on other grounds, 256 F.2d 681 (2d Cir. 1958); Gottlieb v. Schaffer, 141 F. Supp. 7 (S.D.N.Y. 1956).

(10) See Leach v. Carlile, 258 U.S. 138, 139-140 (1922); Stein's v. Pilling, 256 F. Supp. 238, 243 (D.N.J. 1966), aff'd. 379 F.2d 554 (3d Cir. 1967); Vibra Brush Corp. v. Schaffer, 152 F. Supp. 461, 467 (S.D.N.Y. 1957), order vacated on other grounds , 256 F.2d 681 (2d Cir. 1958)."

After summarizing the medical testimony in that case, including the testimony on behalf of the Postal Service by the same physician who testified on its behalf here in substantially the same manner, he continued:

"The administrative law officer found that the taking of plaintiff's product, without medical supervision, presented an appreciable medical risk. He accepted the substance of the testimony of the Postal Service's witness, which as noted in some measure was concurred in by the plaintiff's witness.

Plaintiff challenges acceptance of the testimony of the Postal Service's medical expert, but upon a review of the testimony it cannot be said that the administrative law judge's acceptance of it was erroneous. The evaluation of the testimony of the medical experts based upon their experience, their knowledge of the subject matter as to which opinions were offered, and their demeanor, was for the trier of the fact. (12) Indeed, a reading of the record leaves no room to doubt there was substantial evidence to support the finding that plaintiff's representation that its product could be used safely was false.

(12) WEBR, Inc. v. FCC, 420 F.2d 158, 162-63 (D.C. Cir. 1969); Coscia v. Willard, 257 F.2d 105, 107 (2d Cir.), cert. denied, 358 U.S. 885 (1958); Benton v. FTC, 130 F.2d 254 (2d Cir. 1942); O'Kon v. Roland, 247 F. Supp. 743, 747 (S.D.N.Y. 1965)."

And he concluded:

"***if the product should be taken only under medical supervision to assure that it will not be hazardous to such persons, the representation that it can be used safely is materially false. (13)

(13) The materiality of plaintiff's false represen- tation of the safety of its product is emphasized by its omission to state in the advertisement the essential ingredient of the product and that its effect is to induce nausea and vomiting. Thus, potential users are kept in the dark as to the contents of what they are ordering and are prevented from deciding before purchasing the product whether it provides a type of treatment that they wish to use, and whether its effects could be hazardous to them depending upon their physical condition or particular ailments. A purchaser of plaintiff's product learns for the first time its ingredient and the nature of the treatment after he has parted with his money and received the product."

9. Accordingly, an order under 39 U.S.C. 3005 should be issued against Respondent.