In the Matter of the Complaint Against

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

P.S. Docket No. 6/77;

04/18/79

Cohen, James A.

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

APPEARANCE FOR RESPONDENT:
Mr. Joel Heim
1420 Diplomat Parkway
Hollywood, Florida 33019

POSTAL SERVICE DECISION
ON MOTION FOR RECONSIDERATION

By Order and Postal Service Decision dated October 23, 1978, Respondent's request for an additional extension of the period in which to file an appeal from the Initial Decision of Administrative Law Judge Quentin E. Grant was denied, and a final decision and remedial order were issued. The return portion of the remedial order was thereafter stayed during the pendency of various motions filed by Respondent.

Respondent has filed a motion in which it requests reconsideration of the Order and Decision of October 23, 1978. Subsequently Respondent filed various other motions which essentially seek reversal of the Initial Decision.

The Order and Postal Service Decision to which Respondent's various motions are directed concludes that Respondent did not file its appeal within the appeal period as extended on three occasions and that good cause had not been shown for a further extension. Accordingly, it was held that the Initial Decision became the final agency decision in accordance with 39 CFR § 952.24(a).

Since the Order and Postal Service Decision relate to the failure of Respondent to file a timely appeal, the only issues which should properly be considered on reconsideration are whether the appeal period had expired, and whether the decision denying Respondent's requested extension was erroneous as a matter of fact or law. Nonetheless, Respondent also raises issues which go to the merits of the controversy and which should have been the subject of a timely appeal. In view of the state of the record these issues, although untimely and not ordinarily proper for consideration at this stage of the proceeding, will be decided in this decision.

Certain of the motions filed by Respondent were filed as joint motions in this case and in the Matter of the Complaint Against Vitahair, P.S. Docket No. 6/76. A Postal Service Decision on Motion for Reconsideration in the Matter of the Complaint Against Vitahair was issued on January 26, 1979. In that decision many of the issues raised by Respondent in this proceeding were considered and decided. Liberal reference has been made to the Vitahair decision and to the extent the issues are common to both proceedings the decision in Vitahair is considered a part of this decision.

Respondent's piecemeal, repetitious, and often unsupported allegations on appeal do not lend themselves to orderly consideration of its claims. However an attempt has been made to address each of the issues raised.

MOTION FOR RECONSIDERATION

Respondent, in its Motion for Reconsideration, alleges that the Judicial Officer has taken inconsistent portions in both this case and the Vitahair case. The inconsistent actions referred to by Respondent are the several extensions of the appeal period which were granted to Respondent and the subsequent denial of additional extensions. Respondent was granted three extensions in this case and warned that additional extensions could not be expected. These extensions were granted until it became obvious that Respondent was seeking to delay the proceeding and that it did not have a bona fide need for additional time in which to prepare its appeal papers. The consideration and leniency shown to Respondent in connection with its initial requests for extensions are not precedent for allowing further extensions. Thus Respondent's complaint of inconsistent actions does not merit any further relief.

Respondent also complains that it was not furnished Complainant's Exhibits 4 and 5 and that Complainant's Exhibits 5 and 6 are titled "Dr. Schweitzers" Plan. The general availability of exhibits to Respondent was discussed in an Order dated October 13, 1978, in this case, in the Vitahair decision, and elsewhere in this decision and will not be repeated here. Respondent's further assertion that a photograph of Complainant's Exhibits 4 and 5, was an insufficient reproduction to allow it to prepare its appeal is not persuasive. The photographic reproduction was an accommodation to Respondent even though its request for the exhibits was not filed in a timely manner. If Respondent needed to view the originals of the exhibits, a matter of which I am not persuaded, it could have done so at the hearing, or subsequently at the office of the Docket Clerk.

Respondent's challenge of the exhibits which carry the title "Dr. Schweitzers" Plan is also without merit. This issue was addressed in Finding of Fact 3 of the Initial Decision. That Finding is supported by the evidence in the record. The evidence establishes that the Postal Inspector responded to an advertisement for the Doctor's Diet Plan and received in the mail a pill vial and diet plan called "Dr. Schweitzers" Plan. In the absence of contrary evidence this evidence is sufficient to establish that the plan advertised by Respondent as "The Doctor's Diet Plan" is the plan received by the Inspector called "Dr. Schweitzers" Plan. Thus regardless of what name appears on the pill vial and diet plan, it is the product Respondent sends through the mail in response to its advertising material. Respondent's Exhibits 5 and 6 were, therefore, properly received in evidence.

Respondent, in addition, alleges that it was deprived of a fair trial by the conduct of Judge Grant. A review of the record does not persuade me that Judge Grant acted improperly or that Respondent was deprived of a fair hearing. More specific allegations in this regard are discussed elsewhere in this opinion.

Respondent's brief supporting its Motion for Reconsideration discusses 7 contentions. These contentions are:

1. "Our right to the exhibits."

2. "Diligent pursuit of information under FOIA."

3. "The denial of information before and at trial and later giving information is prejudicial to defense and solid grounds for reversal."

4. "Interpretation of two law cases cited in order."

5. "Our right to review complaints of complaining persons."

6. "Denial of expert witness to defense."

7. "Failure of Postal Service to prove complaint."

These contentions are considered in the order presented.

1. "OUR RIGHT TO THE EXHIBITS."

Respondent alleges it has been deprived of the exhibits. This contention was previously addressed in an order dated October 13, 1978, denying Respondent's request for a fourth extension of the appeal period. In that Order it was stated:

"Respondent's allegations with respect to the exhibits provide no basis for granting the extension. The exhibits were available at the hearing and copies could have been obtained at that time. There is no basis for Respondent to assume the exhibits would be furnished to it with the transcript. Also Respondent had since April 27, 1978, when the hearing was held, or since approximately June 1, 1978, when the transcript became available, to request the exhibits. No good reason has been shown for Respondent's failure to have requested the exhibits previously. Finally copies of the exhibits were furnished to Respondent in accordance with the agreement reached during the conference call of September 25, 1978. Accordingly no extension is granted on this basis."

Respondent's motion does not present any basis to alter the ruling made in the Order of October 13, 1978. However it should be reiterated that the exhibits were at all times available to Respondent, even though it did not seek to obtain the exhibits until shortly before the appeal period was to expire. At that time copies of all exhibits which could reasonably be reproduced were furnished to Respondent. If the copies were not adequate reproductions for Respondent's purposes, it was a risk assumed by Respondent by its failure to have requested the exhibits in sufficient time to allow it to obtain additional or more legible copies, or for it to personally examine the exhibits before the expiration of the appeal period.

Respondent has not been deprived of the exhibits and its contentions concerning the exhibits do not now or did not previously support a further extension of the appeal period. Moreover they do not now serve as a basis to grant its Motion for Reconsideration. See Vitahair, supra, pp. 4 and 5.

2. "DILIGENT PURSUIT OF INFORMATION UNDER FOIA."

This issue was also considered in the Order of October 13, 1978. Respondent now alleges the Order erred in concluding that Respondent did not diligently pursue its Freedom of Information Act (FOIA) requests. Diligent pursuit of the FOIA requests would have included resort to the remedies provided by the statute when the information sought was not produced. Respondent did not resort to its statutory remedies. Rather it sought extensions in this proceeding which is not the proper forum for granting remedial action for FOIA violations. Furthermore Respondent's lack of diligent pursuit was not the only reason for the denial of Respondent's request for an extension of the appeal period. As stated in the Order of October 13, 1978:

"Respondent's arguments relating to pending Freedom of Information Act requests are also not persuasive that an extension of the appeal period should be granted. Even if the previous extension had been granted, in part, on this basis, I am not persuaded that further extensions should also be granted. The Freedom of Information Act is designed to inform the public about agency action rather than to benefit private litigants and should not be used to delay administrative proceedings. NLRB v. Sears Roebuck & Co., 421 U.S. 132 (1974); Renegotiation Board v. Bannercraft Co., 415 U.S. 1 (1973). Moreover the Freedom of Information Act specifies remedies for violations of its disclosure requirements, and Respondent has not established that it has made any diligent effort to obtain enforcement of the provisions of the Act. This office is not authorized to enforce the Act and will not permit further delay of this proceeding because a Freedom of Information Act request of Respondent is pending. Further Respondent has not persuaded me that the information it seeks is relevant and material to this proceeding or that it has been deprived of a fair trial because it has not obtained the information it seeks."

Accordingly Respondent's FOIA request did not previously and does not now support a further extension of the appeal period. In addition it does not now serve as a basis to grant Respondent's Motion for Reconsideration. See Vitahair, supra, p. 5.

3. "THE DENIAL OF INFORMATION BEFORE AND AT TRIAL AND LATER GIVING INFORMATION IS PREJUDICIAL TO DEFENSE AND SOLID GROUNDS FOR REVERSAL."

Respondent's argument here is principally a rehash of its position that the appeal period should have been extended until the FOIA requests had been resolved. I am not persuaded that the failure of Respondent to have obtained the information it sought under the FOIA hampered it in its defense or deprived it of a fair hearing. Therefore this contention did not previously and does not now support a further extension of the appeal period. Neither does it serve as a basis to grant Respondent's Motion for Reconsideration. See Vitahair, supra, p. 6.

4. "INTERPRETATION OF TWO LAW CASES CITED IN ORDER."

Respondent points out factual differences between the cases cited in the Postal Service Decision, NLRB v. Sears Roebuck & Co., 421 U.S. 132 (1974); Renegotiation Board v. Bannercraft Co., 415 U.S. 1 (1973), and this case. Certainly there are factual distinctions but these distinctions are not legally meaningful. The principle stated in the cited cases is equally applicable to this case, and probably more so, since in this case Respondent's interests must be balanced against the interests of the public.

Accordingly I find no improper interpretation of the cited cases. See Vitahair, supra, p. 6.

5. "OUR RIGHT TO REVIEW COMPLAINTS OF COMPLAINING PERSONS."

Respondent claims it has been deprived of a constitutional right to confront its accusers. Complainant clearly and correctly points out that this is not a criminal proceeding and there are no accusers within the meaning of the Sixth Amendment to the Constitution. The complaining party in this proceeding is the Postal Service and its evidence was presented at the hearing before Administrative Law Judge Grant. Respondent was given full opportunity to cross examine the Postal Service witnesses and to present its own evidence. If complaining persons do exist their testimony was not presented at the hearing and Respondent has not been prejudiced by the failure of the Postal Service to release their names. Further the propriety of releasing the names of complaining persons in response to a Freedom of Information Act request is not a matter for determination by the Judicial Officer. Neither does it serve as a basis for extending the time periods in this proceeding or for granting Respondent's Motion for Reconsideration. See Vitahair, supra, pp. 6, 7.

6. "DENIAL OF EXPERT WITNESS TO DEFENSE."

Respondent contends the Initial Decision should be reversed because it was not granted a postponement of the hearing due to the illness of an expert witness. The expert witness referred to by Respondent is identified as a Mr. Seymour Rosen. Mr. Rosen was not included in the list of 58 witnesses which was submitted to support Respondent's request for a change of place of hearing. Had Respondent intended to call Mr. Rosen as a witness it seems reasonable Mr. Rosen's name would have been included among the list of 58 potential witnesses. Accordingly I am not persuaded Respondent intended to call Mr. Rosen as a witness. Moreover, Respondent has not shown the testimony it intended to elicit from Mr. Rosen was essential to its defense and that the same testimony could not have been obtained from other witnesses. On these facts I cannot conclude that Respondent was prejudiced in the presentation of its case. Therefore this contention presents no basis for granting Respondent's Motion for Reconsideration. See Vitahair, supra, pp. 7, 8.

7. "FAILURE OF POSTAL SERVICE TO PROVE COMPLAINT."

Respondent argues that the complainant has not proved its case because it has not established that (1) Respondent wilfully misrepresented its product, (2) that the product is harmful, or that any real person has been injured as the result of the use of the product. In a proceeding under 39 U.S.C. § 3005 it is not necessary to establish that the misrepresentation is wilful. Lynch v. Blount, 330 F.Supp. 689 at 693 (S.D. N.Y. 1971). That a Postal Service Inspector's manual may appear to require intent to deceive is not determinative, since the manual does not modify the statute nor in any other way control this proceeding. Therefore the absence of intent to deceive by Respondent does not alter the finding that a violation of the statute has occurred. Neither is it necessary to show that the product is harmful or that any real person has been injured as the result of the use of the product. Under the statute it is necessary for Complainant to establish that Respondent is engaged in conducting a scheme for obtaining money or property through the mails by means of materially false representations. Based on my independent review of the entire record Complainant has sustained its burden of proof.

Accordingly Respondent's contentions under this issue do not serve as a basis for granting its Motion for Reconsideration. See Vitahair, supra, pp. 8, 9.

CONCLUSION ON ORIGINAL
MOTION FOR RECONSIDERATION

Respondent's Motion for Reconsideration does not establish that it was improperly denied an extension of the appeal period or that the result reached in the Initial Decision was erroneous. Accordingly Respondent's Motion for Reconsideration is denied.

II

MOTION TO MAKE ORAL ARGUMENT BEFORE THE
JUDICIAL OFFICER IN WASHINGTON, D.C.
AND AMENDED MOTION FOR RECONSIDERATION

These motions were received on November 22, 1978, and were jointly filed in this and the Vitahair proceeding. By these motions Respondent has added 37 numbered allegations plus additional unnumbered allegations which it claims support reversal of the Initial Decision. These allegations are essentially a list of assertions providing little or no support for each allegation. The numbered allegations will be addressed by the number and in the order presented.

8. "THE GOVERNMENT EXPERT WITNESS DR. VINCENT CORDARO PROVIDED FALSE INFORMATION TO JUDGE GRANT. THIS FALSE INFORMATION LED JUDGE GRANT TO MAKE A FAULTY DECISION WHICH IS GROUNDS FOR REVERSAL. THIS WITNESS'S CREDENTIALS ARE INSUFFICIENT TO MAKE HIM AN EXPERT ON WEIGHT LOSS."

This contention is considered later in this opinion in connection with another motion filed by Respondent.

9. "JUDGE GRANT'S CONDUCT OF THE CASE BEFORE AND DURING TRIAL INTIMIDATED AND CUT SHORT DEFENSE. THEREBY DEPRIVING US OF A FAIR TRIAL."

Both parties had an opportunity to present relevant and material evidence. Judge Grant did limit the presentation of evidence at various times during the course of the hearing but the limitations were a proper attempt to exclude irrelevant, immaterial or repetitious evidence in accordance with 39 C.F.R. § 952.18. Respondent did not show at the hearing nor has it shown in its various motions that it was prevented from introducing relevant and material evidence. Based on a review of the record it is concluded there was no improper limitation on the presentation of evidence or any other improper conduct on the part of the presiding officer. Therefore Respondent was not deprived of a fair trial.

10. "JUDGE GRANT GAVE THE DEFENSE INSUFFICIENT TIME TO PREPARE THESE CASES FOR TRIAL."

In accordance with 39 C.F.R. § 952.7, the complaint and notice of hearing were served on Respondent on March 13, 1978, and the hearing was scheduled to commence on April 10, 1978. The place of hearing was changed from Washington, D.C. to Miami, Florida, at Respondent's request. Respondent requested a 30 day continuance of the hearing date but a continuance of only 17 days was granted. The hearing was held on April 27, 1978, at which Respondent appeared and presented the testimony of one witness.

Respondent's request for continuance did not justify a continuance for a period in excess of that granted. Respondent had approximately 44 days in which to prepare for the hearing. Since the representations being questioned in this proceeding were those made by Respondent, Respondent should have had no difficulty in obtaining supporting evidence for its product. In fact Respondent did present the testimony of one witness. Respondent listed 58 persons as potential witnesses but did not attempt to show that any of those persons had been contacted and were unavailable to testify at the hearing.

Under the circumstances of this case I cannot conclude that the continuance allowed was inadequate or that a longer continuance should have been granted. With the continuance granted Respondent had sufficient time to prepare for the hearing. Thus this contention does not provide a basis to grant the relief requested by Respondent. See Vitahair, supra, pp. 11-13.

11. "THESE CASES CONTAIN THE WRONG HEADING."

Respondent alleges that because the complaint was filed against the trade name Doctor's Diet as opposed to the corporation marketing the product, Diet Lake, Inc., it was improperly filed. This contention was addressed in connection with a petition for supplemental order in the Matter of the Complaint Against Vitahair, P.S. No. 6/76. In an Order dated January 16, 1979, in that case it was stated:

"The Complaint was filed against the trade name or trade style Vitahair. A trade name is a commercial signature applying to a business and its good will. Cf. Southwestern Bell Telephone Co. v. Nationwide Independent Directory Service, Inc., 371 F.Supp. 900 (W.D. Ark. 1974); Chayt v. Darling Retail Shops Corp., 175 F.Supp. 462 (D. Md. 1959) (which discuss the use of trade names). The use of the trade name was sufficient to place Diet Lake, Inc., through its president, Joel Heim, on notice of the filing of the Complaint and subsequent proceedings. Diet Lake, Inc., identified through its trade name, Vitahair, is a person within the meaning of 39 C.F.R. § 932.5 and the mail stop order as issued applies to the corporation and its principals."

The rationale applied in the Vitahair proceeding is equally applicable here. The complaint filed against the trade name Doctor's Diet was sufficient to place Diet Lake, Inc., through its president, Joel Heim, on notice of the filing of the complaint and subsequent proceedings. Diet Lake, Inc., identified through its trade name, Doctor's Diet, is a person within the meaning of 39 C.F.R. § 932.5. Accordingly this allegation provides no basis for granting the relief requested.

12. "INSPECTOR BROADWATER'S TESTIMONY CONTAINS MANY ERRORS. HIS TESTIMONY FAILS TO SHOW A TEST PURCHASE HAS BEEN COMPLETED WHICH IS REQUIRED TO MAKE CHARGES STICK."

The issue raised here was addressed in Finding of Fact 1 of the Initial Decision which is supported by the evidence in the record. Inspector Broadwater incorrectly testified that the advertisement which was the subject of the test purchase was found in the December 1977 issue of True Story magazine. Despite this error, the evidence establishes that Respondent advertised its product in nationally circulated magazines, and that such advertisements made certain representations concerning the product it called the Doctor's Diet Plan (Tr. 11, 18-21, 38, 45, 50). The advertisements sought remittances through the mail for the product (Compl. Exhibits 1, 2). In addition the evidence establishes that Inspector Broadwater set in motion a test purchase which resulted in his obtaining through the mail Complainant's Exhibits 4, 5 and 6 (Tr. 19-21, 38, 45). The return address which appears on

Complainant's Exhibit 4 is Respondent's address (Compl. Ex. 4). Thus, in the absence of any contrary evidence, the evidence in the record is sufficient to establish that a proper test purchase was made and that Respondent is engaged in a scheme or device for obtaining money or property through the mail.

13. "THE POSTAL SERVICE HAS FAILED TO PROVE THESE CASES BY SUBSTANTIAL EVIDENCE - THE TRUE TEST SINCE THE BURDEN OF PROOF IS ON THE POSTAL SERVICE SINCE A GENERAL DENIAL WAS MADE."

Based on a review of the entire record I am persuaded that the charges contained in the complaint have been proven by the Complainant and are supported by substantial evidence.

14. "THE POSTAL SERVICE HAS MADE THE DEFENSE RESORT TO ORGANIZATION WHICH IS GROUNDS FOR A SUMMARY JUDGMENT."

The record reveals no grounds for a summary judgment in Respondent's favor.

15. "BOTH ADJUDICATING POWER AND PROSECUTING POWER LIE IN THE HANDS OF THE GENERAL COUNSEL. THE LACK OF SEPARATION HAS BEEN HELD AS GROUNDS FOR SUMMARY JUDGMENT."

In connection with cases alleging violations of 39 U.S.C. § 3005, the prosecuting power lies with the General Counsel and the adjudicating power lies with the Administrative Law Judges and the Judicial Officer. There is a distinct separation of functions which is detailed in 39 C.F.R. Part 952. See Vitahair, supra, p. 15.

16. "OUR 4TH, 5TH, 6TH, 7TH, 8TH, and 9TH AMENDMENT RIGHTS HAVE BEEN VIOLATED."

The record does not reveal a violation of Respondent's Constitutional rights.

17. "THE POSTAL SERVICE IS ATTEMPTING TO BREAK A CONTRACT BETWEEN TWO PARTIES WITHOUT DUE PROCESS."

The Postal Service is not attempting to break a contract between two parties without due process of law. The Postal Service is charged with the responsibility for enforcing the requirements of 39 U.S.C. § 3005. Under the cited statute the Postal Service is authorized to issue a mail stop order when it finds a violation of the statutory requirements.

18. "WHAT ABOUT THE RIGHT OF A LADY WHO SAYS SHE LOST 57 LBS. AND WANTS TO ORDER PRODUCT FOR A RELATIVE AND REORDER FOR HERSELF? IS THE POSTAL SERVICE GOING TO TELL HER THE PRODUCT IS INEFFECTIVE?"

The Postal Service is directed by 39 U.S.C. § 3005 to issue appropriate orders when there is satisfactory evidence of a violation of the statute. The determination of a statutory violation is based on the evidence presented in the record. If a statutory violation is found, an appropriate order under 39 U.S.C. § 3005 will prevent potential customers, including satisfied customers, if they exist, from ordering the product through the mail.

19. "DENIAL OF INFORMATION REQUESTED UNDER THE FREEDOM OF INFORMATION ACT BEFORE TRIAL."

This matter has been previously addressed. The Judicial Officer has no authority under the Freedom of Information Act.

20. "DENIAL OF INFORMATION REQUESTED UNDER THE FREEDOM OF INFORMATION ACT AFTER TRIAL BUT BEFORE DECISION."

This matter has been previously addressed. The Judicial Officer has no authority under the Freedom of Information Act.

21. "THE BEST EVIDENCE RULE WAS NOT FOLLOWED."

From a reading of the transcript it appears that Appellant's contention in this regard relates to the evidence pertaining to the test purchase procedures. The evidence relating to the test purchase procedures has been previously discussed.

22. "HAD THE POSTAL SERVICE PROVIDED US ALL INFORMATION REQUESTED UNDER FREEDOM OF INFORMATION ACT, WE WOULD HAVE BEEN ABLE TO IMPEACH THE TESTIMONY OF DR. CORDARO AND INSPECTOR BROADWATER AT TRIAL. THIS OPPORTUNITY WAS DENIED."

Contentions relating to the Freedom of Information Act have already been discussed. Moreover, Respondent has made no showing that the information it sought under the Freedom of Information Act would have provided it with information needed to impeach the testimony of Inspector Broadwater or Dr. Cordaro.

23. "THERE HAS BEEN NO TYING IN BETWEEN DR. SCHWEITZER PILLS AND THE DR. DIET PLAN."

This contention has been previously discussed.

24. "POSTAL SERVICE DENIED INDEXES TO CASES-CONTRARY TO PROVISIONS IN FOIA ACT WHICH SAY THEY MUST BE MADE AVAILABLE."

Contentions relating to the Freedom of Information Act have already been discussed.

25. MAIL STOP CAUSES SEVERE MONETARY DAMAGE."

A mail stop order can certainly cause severe monetary losses however it is a remedy provided by statute. As stated by the Court in Lynch v. Blount, 330 F.Supp. 689 at 693 (S.D. N.Y. 1971):

"If in a given case such as the one now before us, the selling of some particular nostrum is the sole business in which plaintiff is engaged and the stop order will put him out of business, so much the better, if the proofs substantially support the finding that the false statements were made as a part of a scheme to defraud."

Accordingly, because a mail stop order causes severe monetary damage is not a basis to grant Respondent's Motion for Reconsideration. See Vitahair, supra, p. 17.

26. "BENEFICIAL LAW CASES."

This contention is unclear.

27. "ALLEGED AD NEVER MENTIONS OBESITY, YET WORD OBESITY IS CONTAINED IN FIVE CHARGES. DR. HAIMES SITES DIFFERENCE BETWEEN OBESITY AND OVERWEIGHT."

According to the testimony of Dr. Haimes the definition of obesity is somewhat controversial among experts in the field. Dr. Haimes testified that for the purposes of definition and understanding, persons are considered obese if they are approximately 20 percent above their ideal weight (Tr. 145). On the other hand he testified that obesity relates to the percentage of fat in the body, and although a person may be overweight he might not have an excessive amount of fat and therefore might not be obese (Tr. 150). It makes no difference in terms of this case whether the term obesity as used in the complaint means excess weight or excess body fat. Respondent's advertisements, reasonably construed, are directed to both conditions and the results represented by Respondent's advertisement will not be achieved regardless of which condition exists. Accordingly, this argument presents no basis to grant Respondent the relief requested.

28. "FDA APPROVED OF P.P.A. FOR WEIGHT LOSS."

There is no persuasive evidence in the record that the Food and Drug Administration approved the use of P.P.A. for weight loss.

29. "EXHIBITS RX5, 6 and 7 DO REFER TO P.P.A. JUDGE GRANT ERRORED."

In finding number 12 of the Initial Decision, Judge Grant found that Respondent's Exhibits 5, 6 and 7 do not mention phenylpropanolamine hydrochloride (P.P.A.). Exhibit 6 refers to propadrine hydrochloride which is the same as P.P.A. (Tr. 137 and 138). Respondent's Exhibit 7 also discusses the use of propadrine hydrochloride which again is the same as P.P.A. (Tr. 158-160). Finding 12 is therefore incorrect insofar as it relates to Respondent's Exhibits 6 and 7. This error is not grounds for reversal. Even though Respondent's Exhibits 6 and 7 do refer to P.P.A., on the basis of my independent review of the record the evidence establishes that Respondent's product will not achieve the results represented in its advertisements.

30. "DR. EVANS, A GOVERNMENT WITNESS IN THE EVERYWOMANS WATER PILL CASE P.S. DOCKET NO. 6/133, SAID DIET PLAN VERY GOOD LOW CALORIE DIET THEREBY DIRECTLY CONTRADICTING DR. CORDARO GOVERNMENT WITNESS IN THIS CASE."

Without further explanation I am unable to perceive any contradiction of the testimony of Dr. Cordaro by the alleged statement of Dr. Evans.

31. "THE SCARSDALE DIET WHICH IS EXTREMELY POPULAR AND EFFECTIVE, DOES NOT GIVE SPECIFIC AMOUNTS OF FOOD. THIS DIET WAS DEVISED BY A QUALIFIED DOCTOR."

The Scarsdale diet was not the subject of testimony in this proceeding. Respondent's contention with respect to the Scarsdale diet does not provide a basis for overturning the Initial Decision.

32. "JUDGE GRANT'S FINDINGS OF FACT ARE ERRONEOUS."

Respondent has previously challenged Finding of Fact 12 which has been found to be partially in error. Respondent has pointed out no other error in the Findings. The entire record has been reviewed and no other Findings have been found to be in error.

33. "JUDGE GRANT'S CONCLUSIONS OF LAW ARE INCORRECT."

Respondent has not specifically identified the Conclusions of Law, or portions thereof, which it considers to be erroneous. Based on a review of the entire record it is concluded that the Conclusions of Law are correct. However, a slight clarification of Conclusion of Law 3 is in order. That Conclusion contains the statement: "However, much of respondent's other evidence casts serious doubt on the validity of Dr. Haimes' opinions." To the extent Dr. Haimes' testimony is understood to mean that a dosage of 25 mg. of P.P.A. alone is effective to control weight, I agree with the Conclusion of Law that this opinion is not supported by Respondent's other evidence. However, I do not find that Dr. Haimes' opinion was based on the use of 25 mg. of P.P.A. alone.

Rather Dr. Haimes' testimony establishes that in his hands and as part of a total weight control program including a calorie reduced diet, P.P.A. in quantities as small as 25 mg. per day can be an effective anorectic agent. Viewed in this way Dr. Haimes' testimony is not inconsistent with Respondent's other exhibits inasmuch as those exhibits do not take into consideration the other facets of Dr. Haimes' total weight control treatment.

I can find no other respect in which the evidence of record casts serious doubt on the validity of the opinions expressed by Dr. Haimes. In reaching the conclusion which I do later in this decision that Respondent's product will not achieve the results advertised, I have relied heavily on Dr. Haimes' testimony. Considered in total Dr. Haimes' testimony establishes that, in his hands and as part of a complete weight program, P.P.A. in proper dosages is effective for weight control. His testimony does not substantiate the efficacy of Respondent's pills when used as directed, or that they will achieve the results advertised.

34. "WEIGHT OF EVIDENCE IS CLOSE."

The fact that Judge Grant found the weight of evidence to be close does not mean that in his weighing the evidence that he must find for the Appellant. Although he concluded that the weight of the evidence was close, he also concluded that based upon a preponderance of the evidence the charges of the Complaint had been proved. An independent review of the evidence substantiates this conclusion.

35. "IN THE HANOVER HOUSE-ROMAR SALES CASE EVIDENCE A STANDOFF - ISSUE CLOUDY OPPOSITE VIEW POINTS." In the Matter of the Complaint Against Hanover House and Romar Sales Corporation, P.S. Docket Nos. 2/143 and 2/149 it was held that Complainant had not proved the allegations of the Complaint by a preponderance of the evidence. This conclusion was reached after an evaluation of the evidence of record. In the present case although the presiding Administrative Law Judge considered the weight of the evidence to be close he nonetheless concluded that by a preponderance of evidence the allegations of the Complaint had been proved. Whether his conclusion would have been different had he viewed Respondent's Exhibits 6 and 7 as referring to P.P.A. is not clear. However, since it is my independent conclusion that Complainant has proven its case, there is no reason to remand this case to Judge Grant for further findings and conclusions.

36. "REQUEST TO SUPPLEMENT THE RECORD DENIED."

At the outset it should be pointed out that the proper time to offer evidence is at the hearing when the witnesses are available to testify and to have their direct testimony subjected to cross examination. To allow the record to be supplemented at a later time deprives the opposing party of its right to cross examine with respect to that evidence and to present contrary evidence. A request to keep the record open to supplement the record after the conclusion of the hearing should be granted only on a showing of extreme good cause and with opportunity for the opposing party to obtain a further hearing.

At the hearing Respondent sought to keep the record open for the submission of additional data it had requested from FDA (Tr. 4-6, 223). Respondent did not show that it could not have obtained the data earlier or that the data was likely to have an effect on the outcome of the case. Moreover, it did not represent that data it sought would be expeditiously produced so that there would be no delay to the final disposition of the case. Absent such a showing Respondent's request was properly denied and such denial does not show a bias against Respondent.

In connection with this appeal proceeding Respondent has submitted a report of an FDA Advisory Review Panel which it seeks to have considered. The report has been received and will be considered in determining the efficacy of Respondent's product. Thus any prejudice which may have accrued to Respondent as a result of the denial of its request to keep the record open is cured in this proceeding.

37. "QUALIFICATION OF DR. HAIMES

HIS VIEWS SUPPORTED BY 12 ARTICLES PUBLISHED IN LEADING MEDICAL JOURNALS PLUS 6 REFERENCES DR. HAIMES INTRODUCED WITH CHEMICAL STRUCTURE OF P.P.A. 2 CLINICAL LABORATORY TESTS SHOW P.P.A. EFFECTIVE IN WEIGHT LOSS."

Dr. Haimes' testimony was considered in connection with the issuance of the Initial Decision and has been considered in connection with Respondent's allegations in its various motions. The testimony although establishing that P.P.A. is effective as an appetite suppressant does not establish that Respondent's diet pills, containing 25 mg. of P.P.A., will achieve the results represented in Respondent's advertisements.

38. "DR. HAIMES USES P.P.A. ON 40% OF PATIENTS OR A TOTAL OF OVER 40,000 PATIENTS. HE CAN USE ANYTHING - PRESCRIPTION OR NON-PRESCRIPTION DRUG BUT USES P.P.A. - 40% OF TIME."

Dr. Haimes has treated over 100,000 patients in his 25 years of practice for obesity problems (Tr. 121). In his judgment and in the judgment of other medical doctors, P.P.A. is an effective anorectic agent (Tr. 122-124, 130, 131, 134).

Dr. Haimes testified he uses P.P.A. on approximately 30-40% of his patients and has found it effective in his hands (Tr. 187).

However, the use of P.P.A. is only one component of a complete program (Tr. 181). Part of any complete diet program is some vehicle for decreasing appetite which is to be used in conjunction with a calorie restricted diet (Tr. 196, 197). Dr. Haimes does not prescribe P.P.A. without a calorie restricted diet (Tr. 197).

According to Dr. Haimes the treatment of obesity requires a multi-disciplinary approach rather than merely the administration of an appetite suppressant (Tr. 172, 173). He also testified that the treatment of obesity has to be individualized and a program of treatment always involves a calorie restricted diet (Tr. 191, 192). Dr. Haimes would not prescribe a dietary regimen without knowing the patient (Tr. 193, 194). The treatment of obesity, in addition to an appetite suppressant and a calorie reduced diet, includes psychological support, nutritional education and exercise (Tr. 172).

Dr. Haimes uses the least amount of a drug that he finds effective. He has prescribed as little as 12.5 mg. of P.P.A. per day and as much as 300 mg. per day depending on the individual (Tr. 195). Dosages are an individualized matter but Dr. Haimes has effectively used 25 mg. of P.P.A. on a daily basis as part of a total program (Tr. 124, 125, 139).

Dr. Haimes further testified that P.P.A. alone, without a restriction of calories, will not burn off fat. With a reduction of calorie intake, fat will be burned off and with an appetite suppressant an individual will have less intake of calories and more fat will be burned (Tr. 202-204). The increased burning of fat is due to the lowering of calorie intake (Tr. 203). All of the studies using P.P.A. as an anorectic agent involved restricted diets (Tr. 206).

Dr. Haimes' testimony persuades me that P.P.A. is an effective anorectic agent when prescribed by him and used as part of a total weight reduction program. However, I am not persuaded by his testimony that Respondent's product will achieve the results represented in its advertisements.

39. "DR. HAIMES STATES QUANTITY OF 25MG. P.P.A. EFFECTIVE ON DAILY BASIS. HE IS EMINENTLY QUALIFIED TO KNOW."

Dr. Haimes did not testify that 25 mg. of P.P.A. taken on a daily basis alone is effective to achieve weight loss. Dr. Haimes' testimony in this regard is summarized in connection with previous allegations. In effect Dr. Haimes testified that 25 mg. of P.P.A. on a daily basis has been effective to achieve weight loss when used as part of a total weight loss program.

40. "DIFFERENCE BETWEEN OVERWEIGHT & OBESITY."

This contention has been discussed in connection with contention 27.

41. "ARTICLES AND LABORATORY TESTS INTRODUCED BY DR. HAIMES."

The articles and the laboratory tests admitted as Respondent's exhibits have been discussed in the Initial Decision and, except for Finding of Fact 12, have been properly evaluated. The basis on which Appellant seeks to have the Initial Decision reversed because of these articles and laboratory tests is not clear. However, a review of Respondent's exhibits is not persuasive that the result reached in the Initial Decision was in error.

42. "MOTION TO SUPPLEMENT RECORD TO OBTAIN MATERIAL REQUESTED FROM F.D.A. DENIED. SHOWS BIAS TO DEFENSE."

Respondent's motion to supplement the record was properly denied and shows no bias against Respondent.

43. "ADMINISTRATIVE PROCEDURES ACT SECTION 7(D) STATES 'THE TRANSCRIPT OF TESTIMONY AND EXHIBITS ... SHALL BE MADE AVAILABLE TO THE PARTIES.'"

This contention has been previously addressed.

44. "IT IS LOGICAL TO ASSUME ANYONE SENDING FOR A DIET PROGRAM IS MOTIVATED TO LOSE WEIGHT."

This contention is true but is irrelevant to the determination of this case.

CONCLUSION ON MOTION FOR ORAL ARGUMENT
AND AMENDED MOTION FOR RECONSIDERATION

The entire record has been carefully reviewed and Respondent's numbered arguments as well as it's unnumbered arguments have been carefully considered. With the exception noted herein the evidence supports the findings and conclusions of the Initial Decision. Accordingly, Respondent's motion to allow oral argument and its amended motion for reconsideration are denied.

III

RESPONSE TO COMPLAINANT'S REPLY TO RESPONDENT'S
MOTION FOR RECONSIDERATION AND MOTION TO REVERSE
INITIAL DECISION, TO GRANT DEFENSE SUMMARY JUDG-
MENT AND TO ISSUE PERMANENT INJUNCTION AGAINST MAIL
STOPS ISSUED IN DOCTOR'S DIET AND VITAHAIR CASES

These motions were filed jointly in this case and in the Matter of the Complaint Against Vitahair, supra. Respondent has divided its argument into 13 points or sections and then "added several other points at the end." According to Respondent "each point in itself is sufficient to overturn the Initial Decision but when taken together their sheer weight and preponderance demolish any possible opposing position." The 13 sections are:

1. "DID NOT RECEIVE EXHIBITS."

2. "POSTAL SERVICE REPLY TO INFORMATION REQUESTED UNDER F.O.I.A. WAS TOO LATE TO BE OF ANY USE IN FILING APPEAL."

3. "FAILURE TO MAINTAIN PROPER INDEXES ARE REQUIRED BY LAW UNDER F.O.I.A."

4. "CONDITION EXIST THAT ARE HIGHLY PREJUDICIAL TO DEFENSE."

5. "NAMES OF COMPLAINING PERSONS."

6. "THE DEFENSES' INHERENT RIGHT TO ALL CONSTITUTIONAL SAFEGUARDS.

7. "RESTRICTION OF DEFENSE AND INTIMIDATION OF DEFENSE BY JUDGE GRANT."

8. "DENIAL OF EXPERT WITNESS SEYMOUR ROSEN."

9. "VIOLATIONS UNDER F.O.I.A.

(A) ADJUDICATING AND PROSECUTING POWER REST IN SAME PERSON

(B) THE DEFENSE HAS BEEN FORCED TO RESORT TO ORGANIZATION.."

10. "POSTAL SERVICE FAILED TO PROVE COMPLAINT FALSE MIS-REPRESENTATION AS A GENERAL DENIAL WAS MADE & BURDEN OF PROOF IS ON POSTAL SERVICE"

11. "DENIAL OF INFORMATION AT TRIAL."

12. "DR. CORDARO GAVE FALSE INFORMATION TO JUDGE GRANT. BASED ON FALSE INFORMATION JUDGE GRANT MADE FAULTY DECISION."

13. "INSPECTOR BROADWATER'S TESTIMONY CONTAINS MANY ERRORS. HIS TESTIMONY FAILS TO SHOW ELEMENTS NECESSARY TO PROVE TEST PURCHASE MADE."

Each of these contentions has been considered in Vitahair, supra, and the discussion of each contention in that case is for the most part equally applicable here. Also most of the contentions have been previously considered in this decision. Only contention 12 requires further discussion.

12. "DR. CORDARO GAVE FALSE INFORMATION TO JUDGE GRANT. BASED ON FALSE INFORMATION JUDGE GRANT MADE FAULTY DECISION."

It is clear from the record that Dr. Cordaro was not fully aware of studies relating to P.P.A. Also reasonable men could disagree on the opinions expressed by Dr. Cordaro. However, Dr. Cordaro did not, as alleged by Respondent, give "false information" at the hearing. Respondent's principal argument in this connection is that Dr. Cordaro, the Government expert witness, lacked experience in dealing with weight problems, and his qualifications when matched against the qualifications of Respondent's expert entitle his testimony to little weight. Certain of Respondent's arguments in this regard are based on information which should have been the subject of questioning during cross-examination, but were not and are matters which have no evidentiary basis in the record. Accordingly, to the extent they were not made the subject of cross-examination or are not otherwise in the record they will not be considered on appeal.

Based on the evidence of record, Dr. Cordaro was properly qualified to testify with regard to the use of P.P.A. and there is no basis for the assertion that his testimony contains false information. With regard to the weight to be accorded to Dr. Cordaro's testimony, however, it is agreed that Dr. Haimes' experience in the treatment of patients with weight problems entitles his testimony to greater weight than than accorded the testimony of Dr. Cordaro. Even though greater weight is placed on the testimony of Dr. Haimes, the allegations of the complaint have been proven.

MISCELLANEOUS CONTENTIONS

Respondent follows his thirteen numbered arguments with additional arguments and citations of cases which it claims support its motion for reconsideration. These additional arguments are essentially a repeat of its prior arguments which have been previously considered and will not be considered again. The cases relied on by Respondent recite various general principles, but none of the cited cases serves as precedent to reverse the Initial Decision on the facts presented in this case.

CONCLUSION

Respondent's arguments in connection with its response to Complainant's reply to Respondent's Motion for Reconsideration and

Motion to Reverse Initial Decision have been considered but have not been found to provide a basis for relief.

IV

FDA ADVISORY PANEL REPORT

By letter of November 28, 1978, Respondent, inter alia, notified the Judicial Officer that an advisory review panel for the Food & Drug Administration recently "recommended P.P.A. as safe and effective for use in weight reduction." On December 7, 1978, a copy of the report was submitted to the Judicial Officer by Mr. Ross Ladderman, Chief, Advisory Opinions Branch, Bureau of Drugs. Mr. Ladderman's letter and the report were considered as an exhibit to Respondent's letter of November 28, 1978, and Complainant was granted an opportunity to file a reply which it did on December 7, 1978. On December 20, 1978, Respondent filed an additional package of materials. In these materials Respondent reiterates arguments previously made. These arguments were previously considered and will not be addressed again. However, Respondent also relies upon the advisory committee study of the FDA to support the contention that P.P.A. is safe and effective for use in weight loss. The question of the proper dosage of P.P.A. to be used has also been raised. These issues will be considered.

It is clear from the text of the report itself, as well as the letter of transmittal that the report contains only the tentative findings of the Advisory Review Panel. It does not purport to be the final report of the panel and even if it was the final report of the panel it has not been adopted by the FDA.

The report concludes that:

"A single dose of phenylpropanolamine of 25 to 50 mg. and a daily dose of not more than 100 mg. given in divided doses 30 minutes before meals is generally recognized as safe and effective for weight control."

This conclusion lends some support to Respondent's argument relating to the efficacy of P.P.A. It does not, however, support the efficacy of Respondent's product. The pills distributed by Respondent contain a dosage of 25 mg. and, according to the directions, only one is to be taken each day. The report does not conclude that a single daily dose of 25 mg. of P.P.A. is effective for weight control. Therefore, there is no basis in the report to conclude that the pills distributed by Respondent are effective for weight control when taken as directed.

CONCLUSION

Having considered Respondent's various motions and arguments, it is my conclusion that the result reached in the Initial Decision is correct. Although a portion of Finding of Fact 12 is incorrect and I have found clarification of Conclusion of Law 3 to be appropriate, the remainder of the Findings and Conclusions are correct, supported by the record, and support the result reached. Thus, on the basis of the evidence presented, I conclude that Respondent's diet pills alone will not achieve the results advertised. Neither will the pills and the diet accompanying the pills (Compl. Exhibit 6) achieve the results advertised (see Initial Decision, Findings of Fact 20-25).

Accordingly, Respondent's motions are denied. Having upheld the Initial Decision it would normally be appropriate to place a mail stop order in full force and effect. The parties have stipulated, however, that mail addressed to Respondent should continue to be detained in accordance with previous orders but not returned to senders. Therefore, since the mail is being detained but not returned, no further instructions need be sent to the Postmaster at Hallandale, Florida, at this time.