In the Matter of the Complaint Against

THE DOCTOR'S DIET PLAN,
Box 1344 at
Hallandale, FL 33009

P.S. Docket No. 6/77

August 4, 1978

Quentin E. Grant Administrative Law Judge

APPEARANCE FOR COMPLAINANT:
H. Richard Hefner, Esq.
Consumer Protection Office
Law Department U. S. Postal Service
Washington, D.C. 20260

APPEARANCE FOR RESPONDENT:
Marvin I. Moss, Esq.
12550 Biscayne Boulevard North
Miami, FL 33181

INITIAL DECISION

In a complaint filed March 7, 1978, complainant alleged that respondent is engaged in the conduct of a scheme or device for obtaining money through the mail by means of false representations in violation of 39 U.S.C., 3005. Specifically, the complaint (para. III) alleged that by means of advertisements intended to induce readers thereof to remit money through the mails for its product, "The Doctor's Diet Reducing Tablets" (hereinafter sometimes called the product), respondent expressly or impliedly represents to the public in substance and effect that:

"(a) 'The Doctor's Diet Reducing Tablets' are an effective remedy for obesity.

"(b) 'The Doctor's Diet Reducing Tablets' contain a recently developed ingredient not previously available to the public as a means of controlling obesity.

"(c) 'The Doctor's Diet Reducing Tablets' are a scientifically tested and proven remedy for obesity.

"(d) 'The Doctor's Diet Reducing Tablets' are a medically recognized and accepted remedy for obesity.

"(e) 'The Doctor's Diet Reducing Tablets' will burn fat stored on the body.

"(f) 'The Doctor's Diet Reducing Tablets' will convert food into energy rather than fat.

"(g) 'The Doctor's Diet Reducing Tablets' will effectively overcome obesity without requiring the exercise of will-power or determination," and that such representations are materially false in fact.

At the request of respondent the hearing location was changed from Washington, D.C. to Miami, Florida, and the hearing was continued from April 10 to April 27, 1978. At a hearing held on April 27 both parties presented evidence. A time extension granted at the request of respondent's counsel delayed the filing of proposed findings of fact and conclusions of law for approximately 30 days. The matter is now ready for decision.

FINDINGS OF FACT

1. Exhibits CX-1 and CX-2, advertisements for "The Doctor's Diet Reducing Tablets" published by respondent in nationally circulated magazines and newspapers, together with the testimony of Postal Inspector Olin J. Broadwater concerning a test purchase from respondent (Tr. 10-52) support a finding, which I make, that respondent is engaged in a scheme or device for obtaining money through the mails. In making this finding, I recognize the fact that there was some confusion in Inspector Broadwater's testimony concerning the publication from which he extracted the advertisement and the accompanying coupon with which he initiated the test purchase. But this does not vitiate the unrebutted fact that using an advertisement published by respondent and found by the Inspector in one of the magazines he regularly reviews (Tr. 26, 27), whatever the source of such advertisement, Inspector Broadwater caused a test purchase to be made. In making this finding I also recognize the fact that the chain of evidence proving the making of the test purchase includes copies of certain documents, not the originals thereof. However, being satisfied by the unrebutted testimony of Inspector Broadwater as to the reliability of such secondary evidence, it was within my discretion to receive it. Further, common sense validated such evidence upon complainant's production, through Inspector Broadwater, of the product (CX-5) whose test purchase he had initiated contained in a mailing envelope bearing respondent's return address (CX-4). This evidence constituted, at least, prima facie evidence of the initiation and consummation of the test purchase the Inspector testified that he made following procedures routinely used in making such purchases (Tr. 14). This evidence was not rebutted by respondent.

2. A fair reading of respondent's advertisements (Exhibits A and B attached hereto) discloses that they make representations substantially as characterized in paragraph III of the complaint.

3. Complainant in response to its test purchase order addressed to respondent received a plastic container with 60 tablets bearing a label headed, "DR. SCHWEITZER'S Plan for Effective Appetite Control to Aid Weight Reduction" and stating as the contents, "Each tablet contains 25 mg. Dr. Schweitzer's Special Formula Phenylpropanolamine Hydrochloride" (CX-5). I find that these tablets are the product, or for all practical purposes identical to the product, as to which the representations involved in this case are made. This finding is supported by the fact that the product, presumably "The Doctor's Diet Reducing Tablets," furnished by respondent to its expert medical witness for his examination preparatory to testifying were similar in appearance to those in CX-5, contained the same amount of PPA and directions for a dosage of one tablet per day, and were accompanied by a diet similar to the one furnished with CX-5 (CX-6) (Tr. 208, 209, 212). Respondent offered no testimony tending to invalidate this finding.

4. Phenylpropanolamine hydrochloride is commonly referred to as PPA (Tr. 63). PPA has a basic chemical structure similar to that of amphetamine and other drugs used as anorectic agents (Tr. 132, 133; RX-8). It has been used in medicinal products for many years (Tr. 68, 189, 190).

5. Complainant called as its expert witness, Vincent F. Cordaro, M.D., an employee of the Food and Drug Administration (FDA) assigned as Medical Liaison with the U. S. Postal Service (Tr. 58). Over his years of various kinds of experience in the medical profession, Dr. Cordaro may have treated 100 or fewer patients for obesity problems (Tr. 83).

6. According to Dr. Cordaro the basic cause of exogenous obesity is overeating. The standard medical treatment is a diet reducing the number of calories consumed by the patient (Tr. 61, 62). Apparently, Dr. Cordaro has never used PPA in the treatment of obesity but has used a related drug, Dexamyl, an ephedrine derivative of amphetamine. He prefers non-drug therapy for obesity because he doesn't like the side effects of the ephedrine derivatives (Tr. 86).

7. Dr. Cordaro testified that he believes PPA does not have an anorectic (appetite suppressant) effect. This belief, according to Dr. Cordaro, is based on a text called the "Pharmacology of Therapeutics" by Goodman and Gilman, several unidentified articles in British publications, articles by Hoeble at Princeton and Stillman in New York (Tr. 87, 88, 90, 91), a certain Fazeka study and a clinical evaluation by Griboff and Silverman of PPA in the treatment of exogenous obesity (Tr. 104, 105; RX-4). Dr. Cordaro did not testify specifically as to the views expressed in the articles mentioned or the result in the Fazeka study. He stated that Goodman and Gilman, in the text cited above, note the use of PPA in treatment of obesity but "doubt its effectiveness" (Tr. 88). Dr. Cordaro labeled as defective the Griboff and Silverman test as to which the testers concluded that a PPA-caffeine-vitamin preparation can be helpful to an exogenously obese individual who wants to lose weight (Tr. 107).

8. Dr. Cordaro was not aware of any study made by the FDA of PPA as an appetite suppressant (Tr. 101). According to Dr. Cordaro PPA is not recognized by FDA as a safe and effective over-the-counter appetite suppressant (Tr. 102) but did not know if FDA had approved the labeling of a product containing PPA for use in the management of obesity (Tr. 103).

9. Dr. Cordaro expressed the opinion that the product would not do any of the things represented by respondent as alleged in the complaint and believes that his views and opinions accord with the consensus of informed medical opinion (Tr. 75-78).

10. Respondent's expert witness was Leonard Haimes, a doctor of medicine, and a diplomate of the American Board of Bariatric (weight control) Medicine. He is a past-president, and currently chairman of the board, of the American Society of Bariatric Medicine. Since 1968, Dr. Haimes has limited his practice to treatment of obesity and nutritional disorders. He has written several published articles on obesity problems. He is Director of Nutrition and Bariatric Medicine at Cedars of Lebanon Hospital in Miami, Florida. In his 25 years of clinical experience he has treated over 100,000 patients for obesity problems (Tr. 117-121).

11. According to Dr. Haimes the treatment of obesity requires a multi-disciplinary approach including diet, possible use of a drug, psychological support such as behavior modification, nutritional education, and an exercise program. He said that effective treatment is directed at development of a change of lifestyle for each individual (Tr. 172, 173). He prescribes PPA for 30 to 40 percent of his patients (Tr. 187). Most of his peers with whom he has discussed the matter at meetings and conferences have also found PPA to be an effective anorectic agent (Tr. 122). The terms anorexant, anorexiant, and anorexogenic agent are used at places in the record. All three terms mean appetite suppressant.

12. Through Dr. Haimes respondent introduced several documents offered as proof that PPA is an effective appetite suppressant. Careful examination of these documents reveals that three of them, RX-5, 6 and 7, identified as the Asher, Kalb, and Hirsh papers, respectively, do not mention phenylpropanolamine hydrochloride. They deal with other so-called appetite depressants. One page of RX-7 mentions PPA but it is not part of the Hirsh paper and is not otherwise identified.

13. RX-10 is the so-called Biometric Report which involved a study conducted with a combination of PPA and caffeine. This report concludes that this combination given to subjects placed on a strict low calorie diet (60% of calories required to maintain ideal weight) is an effective adjunct in a total therapeutic program for weight reduction. Such a program is outlined as including a formal weight reduction program conducted by a forceful expert.

14. RX-11 and 12, a text and a pharmacopoeia, respectively, very briefly mention PPA as being used as a decongestant and to depress appetite in obesity but make no assertions as to its efficacy.

15. RX-4, an excerpt from a paper by Griboff, German and Silverman, reports on a double-blind study on 77 adult males and females. The test involved the use of a combination tablet containing 25 mg. of PPA, 100 mg. of caffeine, and multi-vitamins and a 1,200 calorie per day diet plan with personally delivered instructions for use and weekly visits by participants over a 5-week period. The conclusion reached in this paper is that in this clinical study employing a well-motivated group of exogenously obese people, PPA was found to be both safe and effective as an anorexiant. Unlike the directions for use of the product involved in this matter (one per day), the subjects in the Griboff et al . study were given three tablets (75 mg.) per day.

16. RX-13 is an excerpt from the Handbook of Non-Prescription Drugs (5th Ed., 1977, American Pharmaceutical Assn., Wash., D.C.). It states that a controversy has existed over the effectiveness of PPA as an anorexogenic agent and that all authorities do not agree on its effectiveness as such an agent. This publication further states, significantly, as follows:

"The AMA Drug Evaluations states that 'This agent is probably ineffective in the dose provided (25 mg.)' [citing "AMA Drug Evaluations," 2d ed., Publishing Sciences Group, Acton, Mass., 1973, p. 370]. A basic pharmacology textbook states that the drug is ineffective as an appetite suppressant. [citing A. Goth, "Medical Pharmacology," 7th ed., Mosby, St. Louis, MO, 1974, p. 110]. In addition, no mention of its use in obesity is made in a standard pharmacy reference."

17. A collection of purported quotations from various texts and other sources was introduced in evidence through Dr. Haimes (RX-8). The sources of these quotations date, in time of publication, from 1944 to 1960. Without expansion to indicate the circumstances of use (with or without rigid diet, frequent visits to doctor, dosage, etc.), these sources all indicate the effectiveness, in unspecified degree, of PPA as an appetite suppressant. The only quotation mentioning a dosage states the quantity as 50 mg., twice the specified dosage of the product involved in this proceeding.

18. Dr. Haimes testified that the AMA Drug Evaluation Journal lists PPA as an effective anorectic agent (Tr. 134). In view of the statement in the Handbook of Non-Prescription Drugs (RX-13) that the " AMA Drug Evaluations states that 'This agent is probably ineffective in the dose provided (25 mg.),'" I must conclude that Dr. Haimes' testimony as to the AMA Drug Evaluation Journal relates to dosages of PPA greater than 25 mg. Respondent did not produce the AMA Drug Evaluation Journal or excerpts therefrom to support Dr. Haimes' testimony. Dr. Haimes, however, claimed to have used PPA effectively in a daily dosage of 25 mg. (Tr. 139).

19. Dr. Haimes testified that it has been established in the medical community that PPA is an accepted anorectic agent and that it has been thoroughly scientifically tested (Tr. 153). He further testified that the great majority of bariatric physicians use PPA and that the consensus of such physicians is that PPA is an effective anorectic agent (Tr. 166, 167). However, the purported corroboration for Dr. Haimes' views placed in evidence by respondent (RX-10 through 13) does not support the conclusion that PPA without caffeine and in dosages as small as 25 mg. per day and without a strict and rigidly controlled very low-calorie diet, significant will-power or determination is an effective remedy for obesity, is a scientifically tested and proven, and a medically recognized and accepted, remedy for obesity.

20. I find that for PPA in a dosage as small as 25 mg. per day to make any contribution to weight loss it must be used with a strictly controlled, calorie deficient diet, tailormade to the weight loss goal and activities of each individual (Tr. 191-193, 202-203).

21. I find that the diet furnished by respondent with the PPA tablets (CX-6), except for breakfast and the quantity of meat in one supper, leaves open the quantities of food allowed. Consequently, I find that the diet is not a strict, calorie deficient diet for all, or even most, users.

22. PPA has been available to the public at least since 1939 in medicinal products and, specifically, as a purported anorectic agent (Tr. 68, 179, 180).

23. Dr. Haimes testified that the diet pills involved here will "burn fat stored in the body" in the sense that by suppressing appetite and thereby decreasing the number of calories consumed the user of PPA will reach into the body stores of fat for energy in order to survive (Tr. 174-177). Obviously, the pills do not operate directly on fat to "burn" it off.

24. Dr. Haimes testified that the diet pills will "convert food into energy rather than fat" in the same sense that they "burn fat stored in the body" (Tr. 178, 179). Again, the pills do not perform a direct conversion of food into energy.

25. Dr. Haimes' testimony (Tr. 172, 219) and the diet furnished with the tablets (CX-6) show that loss of weight using PPA requires a large amount of will-power and determination.

CONCLUSIONS OF LAW

1. Respondent is engaged in a scheme for obtaining money or property through the mails by means of representations substantially as characterized in the complaint.

2. The product advertised by respondent as "The Doctor's Diet Reducing Tablets" is sometimes, if not always, furnished to purchasers under the label "Dr. Schweitzer's Special Formula Phenylpropanolamine Hydrochloride." For the purposes of the decision I conclude that the tablets in evidence as CX-5 are, or are identical to, the product advertised by respondent as alleged in the complaint.

3. The weight of the evidence is close as to whether the product in the directed dosage of 25 mg. per day is an effective remedy for obesity. Dr. Cordaro testified that it is not. Dr. Haimes, whose credentials in the field of bariatrics are significantly greater than those of Dr. Cordaro, stated that it is an effective remedy based on his use thereof in his practice. However, much of respondent's other evidence casts serious doubt on the validity of Dr. Haimes' opinions. First, there is RX-13, the Handbook of Non-Prescription Drugs which quotes "The AMA Drug Evaluations" as stating that PPA in a dosage of 25 mg. is probably ineffective as an appetite suppressant. The same exhibit quotes a basic pharmocology textbook as stating that PPA is ineffective as an appetite suppressant. Second, Dr. Haimes' other testimony and other exhibits introduced by respondent indicate that PPA in dosages as high as 75 mg. per day is effective, if at all, only as an adjunct to a total therapeutic program for weight reduction including a strict low calorie diet, psychological support such as behavior modification, nutritional education, and exercise (Tr. 172, 173; RX-4, 10). None of respondent's exhibits reports affirmatively on the effectiveness of PPA as an appetite suppressant in dosage less than 50 mg. per day. Respondent's advertising barely mentions a "correct eating plan" as an adjunct of the use of the product. The diet plan furnished with the tablets is open-ended as to the amount of calories allowed. It is clearly not a strict low calorie diet. It is not the kind of diet that respondent's authorities have found essential to the effective use of PPA.

On the entire record I conclude that the product used as directed is not an effective remedy for obesity.

4. PPA, the only active ingredient in the product, as a purported appetite suppressant, has been available to the public for forty years or more. Consequently, I conclude that the product does not contain a recently developed ingredient not previously available to the public as a means of controlling obesity.

5. I further conclude that the product in a 25 mg. per day dosage is not a scientifically tested and proven remedy for obesity and is not a medically recognized and accepted remedy for obesity.

6. PPA does not burn fat stored in the body and does not convert food into energy rather than fat.

7. The product will not effectively overcome obesity without requiring the exercise of will-power or determination. The evidence is clear that a large amount of will-power and determination is required for PPA to have any beneficial effect on obesity even in dosages as high as 75 mg. per day.

8. The representations made by respondent are materially false in fact.

9. An order pursuant to 39 U.S.C. 3005, in the form attached, should be issued.