United States Postal Service(TM)


 In the Matter of the Complaint Against

 G. H. P. LABORATORIES, INC.
 at 1551 Dunwoody Village Parkway
 P. O. Box 888651
 Atlanta, GA 30338

 5999 New Peachtree Road
 P. O. Box 47154
 Doraville, GA 30362

 6094 Boylston Drive, N.E.
 P. O. Box 28453
 Atlanta, GA 30328

 3545 Broad Street
 P. O. Box 80501
 Atlanta, GA 30366

 3104 Briarcliff Road, N.E.
 P. O. Box 29452
 Atlanta, GA 30359

 and

 P. O. Box 1324
 Norcross, GA 30091

 P.S. Docket No. 10/149;
 
 11/30/81
 
 Cohen, James A.

 APPEARANCE FOR COMPLAINANT:
 DanielE. Lewis, Esq.
 James F. McMullin, Esq.

 Consumer Protection Division
 Law Department
 U.S. Postal Service
 Washington, DC 20260

 APPEARANCE FOR RESPONDENT:
 Tom B. Benham, Esq.
 Benham & Cohen Suite 210
 6600 Powers Ferry Road, N.W.
 Atlanta, GA 30339


POSTAL SERVICE DECISION

Respondent has appealed from an Initial Decision of an Administrative Law Judge which holds that with regard to the advertising and sale of the products GEROVITAL HP and GEROVITAL HP CREAM Respondent is in violation of 39 U.S.C. § 3005.

BACKGROUND

On March 3, 1981, the Consumer Protection Division, Law Department, United States Postal Service, filed a Complaint alleging that Respondent is engaged in a scheme or device to obtain money or property through the mail by means of false representations in violation of 39 U.S.C. § 3005. The Complaint alleges that advertisements similar to an advertisement attached to the Complaint as Exhibit 1 makes the following materially false representations:

"3. ...

a. Gerovital HP will retard aging.

b. Gerovital HP is an effective remedy for such maladies as:

1. depression

2. hypertension

3. arthritis

4. heart problems

5. impotency

6. stress

c. PABA (para amino benzoic acid) is a necessary human vitamin.

d. Gerovital HP has the same metabolic effects as procaine ingestion.

e. Gerovital HP Cream will retard the aging process of skin.

f. Gerovital HP Cream contains absorbable protein that passes directly through the skin and into cells.

g. Gerovital HP Cream is an effective remedy for skin that is dull, wrinkled and blemished with age spots.

h. RNA Supplement is capable of altering the cell's genetic make-up."

Respondent filed an Answer in which it denied the charges of the Complaint and attacked the constitutionality of the proceeding. At a hearing held before an Administrative Law Judge to take evidence on the allegations of the Complaint, Complainant presented the testimony of Michael P. Flynn, a Postal Service Inspector; Sorell L. Schwartz, Ph.D, a pharmacologist; and Karl J. Kramer, M.D., who is board certified in dermatology and internal medicine. Complainant also introduced into evidence various documents in support of its position. Respondent called as witnesses William C. Douglas, M.D., formerly a specialist in emergency medicine and most recently a practitioner in preventive medicine and nutrition, and Morton Walker, a doctor of podiatry who, for the past fifteen years has been a free lance medical journalist specializing in writing about matters of nutrition. Both parties participated in the examination and cross-examination of the witnesses.

On the basis of the record presented, the Administrative Law Judge concluded in the Initial Decision that, except for the representation alleged in paragraph 3(h) of the Complaint, Respondent's advertisements make the representations alleged in the Complaint and that the representations made are materially false.

The conclusion that the representations are materially false was based primarily on the expert opinions of Drs. Schwartz and Kramer as to the consensus of medical and scientific opinion with regard to the ingredients in the products. The Administrative Law Judge found that Dr. Douglas' testimony did not contradict the views of Drs. Schwartz and Kramer and that, while Dr. Walker's opinions were to the contrary, they were not credible.

The ingredients and directions for use of the two products which are the subject of this proceeding, Gerovital HP and Gerovital HP Cream, are accurately described in the Initial Decision (ID, FOF 2 and 3). Gerovital HP is sold by Respondent in the form of a capsule, one or two of which are to be taken daily as a dietary supplement. The testimony relating to the efficacy of this capsule focused primarily on the ingredient para-amino benzoic acid (PABA). The testimony relating to Gerovital HP Cream, which is to be applied externally, dealt primarily with two ingredients, soluble collagen and soluble ribo nucleic acid (RNA).

RESPONDENT'S EXCEPTIONS

Respondent has enumerated 29 specific exceptions to the Initial Decision. Each of Respondent's exceptions is addressed below.

"1. The Administrative Law Judge erred in finding that 39 U.S.C. § 3005 is constitutional (Opinion, p. 25)."

In Conclusion of Law 3 the Administrative Law Judge, citing Original Cosmetics Products, Inc. v. Strachan, 459 F.Supp. 496 (S.D. N.Y., 1978), aff'd without opinion, 603 F.2d 214 (2d Cir. 1979), cert. denied, 444 U.S. 915, and Hollywood House International, Inc. v. Klassen, 508 F.2d 1276 (9th Cir. 1974), stated that 39 U.S.C. § 3005 has been repeatedly held by the courts to be constitutional under first and fourteenth amendment attack. Respondent takes issue with this proposition and argues at some length that 39 U.S.C. § 3005 is unconstitutional. It contends that § 3005 ineffectively and only indirectly promotes the Government's interest, restrains speech clearly protected as well as that found to be false, and could better achieve the Government's objective by less restrictive means. In support of its position Respondent cites first amendment decisions pertaining principally to commercial speech and obscenity, and attempts to distinguish the cases relied on by the Administrative Law Judge.

Neither the Administrative Law Judges nor the Judicial Officer determine the constitutionality of statutes. 39 C.F.R. § 224.1 (c)(4)(iii) and (iv)(B). If authorized to make such a determination, however, the constitutionality of § 3005 would be upheld based on persuasive court precedent. The most recent first amendment attack on the constitutionality of § 3005 was considered in United States Postal Service v. Athena Products, Ltd., 654 F.2d 362 (5th Cir. 1981). The Court, relying on what it considered to be a considerable body of precedent, distinguished the obscenity cases from those brought under 39 U.S.C. 3005 and 3007. It recognized, however, that the precedent relied on predated Virginia State Board of Pharmacy v. Virginia Citizens Consumer Council, Inc., 425 U.S. 748 (1976), which held that unwarranted governmental regulation of commercial speech infringes upon the first amendment rights of both speaker and listener. In concluding that the constitutionality of § 3005 and 3007 was unaffected by Virginia, the Court stated:

"The care with which the Court has distinguished commercial from noncommercial speech indicates that its decisions upholding the constitutionality of sections 3005 and 3007 retain their vitality. The Court's Supreme Court clear concern to permit effective regulation of deceptive advertising and its suggestion that the prohibition against prior restraints may be inapplicable where commercial speech is concerned, Virginia Board, 425 U.S. at 771 n. 24, 96 S.Ct. at 1830, negate any suggestion that prompt judicial review initiated by the censor is required whenever the government undertakes to regulate misleading advertising. This judgment reflects not only the 'subordinate position in the scale of First Amendment values' allotted to commercial speech, Ohralik, 436 U.S. at 456, 98 S.Ct. at 1918, but the comparative difficulties inherent in determining obscenity and misleading advertisement noted by the court in Lynch v. Blount. We conclude therefore that the decision in Lynch v. Blount upholding section 3005 remains good law. Accord, Original Cosmetics Products, Inc. v. Strachan, 459 F.Supp. 496 (S.D.N.Y. 1978), aff'd 603 F.2d 214 (2d Cir), cert. denied 444 U.S. 915, 100 S.Ct. 229, 62 L.Ed.2d 170 (1979)." (654 F.2d at 367)

The Court also addressed the breadth of an order issued under § 3007. The Court concluded that the injunctive relief provided in § 3007 was not overly broad and that the probable cause standard of that section did not deprive an advertiser of due process of law (ibid at 368-69). The Court's reasoning applies equally to an order issued under § 3005.

The Court's conclusions on the constitutionality of § 3005 and 3007 and the implementing orders are persuasive and dispositive of the constitutional aspects of the issues raised by Respondent. Respondent's additional argument that there may be a more effective means for promoting the Government's interest is also unavailing. The means for enforcing the Government's interest is a matter for Congress to decide.

Accordingly, Respondent's Exception 1 is without merit.

"2. The United States Postal Service has not proffered the required substantial evidence necessary to sustain its burden of proof in demonstrating the representations contained in the advertisements for Gerovital HP and Gerovital HP Cream are materially false as a matter of law, and the Administrative Law Judge has erred in failing to properly impose the required burden of proof upon the Complainant."

Respondent contends that it was improper for the Administrative Law Judge to rely on the "mere opinion of an alleged expert witness" to establish the falsity of Respondent's representations. It further contends that Complainant has the burden of proving its case by substantial evidence,e but in this proceeding, by relying on the testimony of Complainant's experts, the Administrative Law Judge shifted this burden to Respondent. According to Respondent this shift in the burden of proof occurred because Complainant's experts failed to set forth a standard for their opinion which is consistent with applicable law.

It is true that Complainant, as the proponent of an order under 39 U.S.C. § 3005, has the burden of establishing a prima facie case and the ultimate burden of persuasion. In order to satisfy its burden of persuasion Complainant must prove the allegations of the Complaint by a preponderance of the evidence. See Kimberly Jewels, Inc., P.S. Docket No. 9/65 (P.S.D. July 23, 1981), and cases cited therein. The substantial evidence test is the test used by a court in reviewing an administrative decision, e.g., M.K.S. Enterprises, Inc. v. United States Postal Service, 459 F.Supp. 1180 (E.D.N.Y. 1978), and requires something less than a preponderance of the evidence. See Kimberly Jewels, Inc., supra.

Respondent cites American School of Magnetic Healing v. McAnnulty, 187 U.S. 94 (1902); Reilly v. Pinkus, 338 U.S. 269 (1949), and U. S. Health Club, Inc. v. Major, 182 F.Supp. 759 (D.N.J. 1960), to support its argument that opinion evidence is insufficient to establish falsity. All of the cited cases involved the predecessor statute to § 3005 which required evidence of intent to deceive, an element of proof not required under the present statute. Furthermore, the Supreme Court, in Reilly, while defining its holding in McAnnulty to make it clear that reliance upon medical experts is not barred where some disagreement exists, accepted the opinion of medical experts to support the conclusion that misrepresentation had occurred. Thus, the holding in Reilly does not support Respondent's position.

Respondent's reliance on U.S. Health Club Inc. v. Major, 182 F.Supp. 759 (D.N.J. 1960), is also misplaced. That case was reversed on appeal, 292 F.2d 665 (3d Cir. 1961), cert. denied, 368 U.S. 896, with the Court finding that the testimony of one medical expert was sufficient to show the state of medical opinion and to establish the falsity of an advertiser's representations.

Respondent's final argument relates to the basis for the opinion of Complainant's experts. Both experts testified that they would not consider a claim of efficacy to be valid unless accompanied by a validly controlled clinical study (Tr. 28-29, 92-93). Respondent has not made such a study and contends that it would be a time-consuming and expensive procedure which is not required by law and, in effect, shifts the burden of persuasion from Complainant to Respondent.

The opinions of Complainant's witnesses were based on the consensus of scientific and medical opinion with regard to the effectiveness of the ingredients of Respondent's products and were not contradicted by any credible evidence (Tr. 25-27, 82). The testimony of the experts on the studies necessary to support a claim of efficacy was based on the accepted procedure within the scientific community for establishing the consensus of informed medical and scientific opinion (Tr. 28). Complainant, by proving that the consensus of medical and scientific opinion supports its position, has established a prima facie case and shifted the burden of going forward with evidence to Respondent. While it may be difficult to controvert the consensus of informed medical and scientific opinion, it is, nonetheless, a burden Respondent, as an advertiser making claims of efficacy, must bear. It does not serve to improperly shift the ultimate burden of persuasion to Respondent. If Respondent's position were accepted Complainant would be required to prove the negative, i.e., that there is no possible way by which the products could meet the representations for which they are advertised. Such a burden is not normally imposed on a litigant in general civil litigation and has been rejected as a burden of the Complainant in a proceeding under 39 U.S.C. § 3005. See Athena Products Limited, P.S. Docket No. 7/99 (P.S.D. June 26, 1981); Project Prayer, P.S. Docket No. 8/68 (P.S.D. May 29, 1981); Standard Research Laboratories, P.S. Docket No. 7/48 (P.S.D. April 4, 1980).

Complainant has presented a preponderance of the credible evidence to support the falsity of the representations alleged in the Complaint as found by the Administrative Law Judge. It has, therefore, sustained its burden of proof. Accordingly, this exception has no merit.

"3. The Administrative Law Judge erred in finding of fact number 4 by concluding that Exhibit A is a typical example of advertising matter used by Respondent in promoting the sale of the subject products."

Respondent contends the Administrative Law Judge's finding is an overstatement which is not supported by the record. It points out that there is evidence that one particular advertisement was received at several test addresses (Tr. 102, 106), but there is no evidence of the use of other advertisements.

It is not clear from the Initial Decision whether the use of the word "typical" was intended to indicate that other advertisements were being used by Respondent or to imply that the advertisement in evidence was the same as those advertisements received at several other test addresses. Neither does it make any difference. The findings and conclusions of the Initial Decision are based on the advertisement in the record. Therefore, this exception, even if valid, offers Respondent no basis for relief.

"4. The Administrative Law Judge erred in determining the applicable rules of interpretation of advertising in paragraph 4 of the findings of fact."

Respondent contends that interpretations of law should have been set forth as Conclusions of Law rather than as Findings of Fact. Following finding of fact 4, the Administrative Law Judge set forth the applicable and correct rules, with supporting citations, for interpreting advertisements. In finding of fact 5, he applied those rules to determine whether Respondent made the representations alleged in the Complaint. While the applicable rules if interpretation are legal standards, nonetheless, for purpose of clarity and continuity it was not improper, or a basis for finding error, for the Administrative Law Judge to have set out the standards prior to making his findings concerning Respondent's advertising. Accordingly, there is no merit to this exception.

Exceptions 5 - 10

"5. The Administrative Law Judge erred in concluding that Respondent advertised that Gerovital HP is an effective remedy for such maldies as depression, hypertension, arthritis, heart problems, impotency, and stress, as set forth in finding of fact 5(b)."

"6. The Administrative Law Judge erred in finding that Respondent advertised PABA is a necessary human vitamin, as set forth in finding of fact 5(c)."

"7. The Administrative Law Judge erred in finding of fact 5(d) by concluding that Respondent's advertising represents": 'Gerovital HP has the same metabolic effects as procaine ingestion.'"

"8. The Administrative Law Judge erred in finding of fact 5(e) by concluding that Respondent's advertising represents: 'Gerovital HP Cream will retard the aging process of skin.'"

"9. The Administrative Law Judge erred in concluding in finding of fact 5(f) that Respondent's advertising represents that: 'Gerovital HP Cream contains absorbable protein that passes directly through the skin and into cells.'"

"10. The Administrative Law Judge erred in concluding in finding of fact 5(g) that Respondent's advertising represents that: 'Gerovital HP Cream is an effective remedy for skin that is dull, wrinkled and blemished with age spots.'"

Generally, in connection with these six exceptions Respondent contends that the portions of the advertisement relied on by the Administrative Law Judge to support his findings do not support or justify the findings that the representations are in fact made by Respondent. A review of the language quoted by the Administrative Law Judge and the remaining language in the advertisement supports the findings. An ordinary reader would conclude that the representations are either expressly or impliedly made in the advertisements. Accordingly, these exceptions have no merit.

Exceptions 11, 12, 17 and 27

"11. The Administrative Law Judge erred in finding of fact 7 by concluding that Dr. Kramer was involved in an ongoing study of human aging."

"12. The Administrative Law Judge erred in finding of fact 7 by concluding that the curriculum vitae sic of Drs. Schwartz and Kramer show that they were well qualified to testify in this matter."

"17. The Administrative Law Judge erred on page 22 of its sic decision by concluding that Complainant's expert witnesses were well qualified by education, experience and familiarity with literature, etc."

"27. The Administrative Law Judge erred in admitting into evidence the curriculum vitaes sic of Complainant's witnesses."

At the hearing Respondent objected to the admission of the curricula vitae of Complainant's expert witnesses, contending that summaries of testimony are not admissible and, therefore, should have been excluded (Tr. 13, 73). The documents were admitted into evidence over Respondent's objections. Respondent continues to object to the admission of the curricula vitae, but cites no rule of evidence which supports its position. Neither has it shown that it was prejudiced by the admission of the documents. Respondent was furnished copies of the documents prior to the hearing and was afforded an opportunity to cross-examine the witnesses with regard to the qualifications shown on the curricula vitae. Respondent has, therefore, not shown that it was in any way prejudiced by the admission of the curricula vitae into the record Moreover, the interests of efficiency and economy of trial time justified the admission of the documents into the record. Cf., Oriental Nurseries, P.S. Docket No. 8/24 (P.S.D., March 31, 1981). Thus, exception 27 has no merit.

Exceptions 11, 12 and 17 relate to the qualifications of Complainant's expert witnesses. In Exception 11, Respondent contends that finding of fact 17 characterizes Dr. Kramer as engaged in an ongoing study of human aging and that such a characterization is misleading. The finding, however, referred to Dr. Kramer's work from 1971 to 1973 when he was a clinical associate to the Gerontology Research Center (now the National Institute of Aging) in the National Institutes of Health. In his work there he was part of a program involved in an ongoing study of human aging. The finding was not misleading and this exception has no merit.

In Exceptions 12 and 17 Respondent contends that Drs. Schwartz and Kramer are not well qualified experts as they admitted they had no expertise in nutrition, their curricula vitae show no such expertise, and there is nothing in the evidence that shows they have had any education, experience or familiarity with the products involved in this proceeding.

Although neither of these witnesses had actually used or prescribed the two products, they were both familiar with their ingredients and well qualified to testify concerning them. Dr. Schwartz is a professor of pharmacology at Georgetown University School of Medicine and Dentistry. He received his bachelor's degree in pharmacy from the University of Maryland in 1959 and his Ph.D in pharmacology from the Medical College of Virginia (now Virginia Commonwealth University) in 1963. Dr. Kramer received a BA degree in chemistry from Cornell University in 1965, his M.D. from Johns Hopkins School of Medicine in 1969. He is board certified in dermatology and internal medicine and has been in the private practice of dermatology since 1976. Both witnesses have authored publications in their fields and have varied experience and professional affiliations. Both witnesses relied on medical or scientific literature and discussions with colleagues in the field and although neither is a nutritionist (Tr. 30, 87), they were, nonetheless, well qualified by their training, profession and experience to testify about the matters considered in this proceeding.

A review of the entire testimony of Complainant's witnesses, as well as the testimony of Respondent's witnesses, supports the Administrative Law Judge's reliance on the opinion of Complainant's experts. Accordingly, these exceptions have no merit.

"13. The Administrative Law Judge erred in finding of fact 8 by concluding that Respondent's advertising concentrates on PABA as the most important ingredient in the Gerovital HP capsule."

Respondent contends that finding of fact 8 is erroneous because the advertisement mentions PABA only twice and indicates it is "a high potency adult vitamin-mineral supplement." However, the advertising equates the product with the European treatment by Dr. Aslan stressing her use of procaine. It refers to PABA as the active ingredient in the procaine treatment. Therefore, the finding is correct and this exception has no merit.

"14. The Administrative Law Judge erred in finding of fact 9 by characterizing Dr. Schwartz' s testimony in regard to PABA as an inactive chemical substance."

Respondent contends it would have been more accurate to include other aspects of Dr. Schwartz's testimony such as "It is a chemical substance which is an essential vitamin in bacteria." The thrust of finding of fact 9 related to Dr. Schwartz's testimony that there was no scientific proof PABA is an essential vitamin for humans. Omitting his testimony that PABA was an essential vitamin in bacteria is not material and is no basis for demonstrating error in the Initial Decision. Therefore, this exception has no merit.

Exceptions 15, 16 and 18

"15. The Administrative Law Judge erred in finding of fact 14 by concluding that Dr. Schwartz' s opinions are consistent with the informed pharmacological and scientific consensus."

"16. The Administrative Law Judge erred in finding of fact 20 by considering Dr. Kramer's opinions are consistent with the informed medical and scientific consensus."

"18. The Administrative Law Judge erred on page 22 of its sic decision by concluding that the review article, The Journal of American Geriatric Society, supports Complainant's experts."

These three exceptions relate to the consensus of scientific and medical opinion concerning the claims made for Respondent's products, especially as to the internal use of PABA. Respondent questions whether there is any informed pharmacological and scientific consensus about nutritional matters generally and asserts that the opinions of Drs. Schwartz and Kramer do not reflect an informed medical and scientific consensus. Specifically, as to PABA, it contends that its position rather than that of Complainant is supported by Complainant's Exhibit 3, an article titled, "The Systemic Use of Procaine in the Treatment of the Elderly: A Review," published in vol. XXV, no. 1, January 1977, The Journal of the American Geriatric Society. Respondent argues that because a majority of the publications reviewed in the article claimed some benefit from the use of procaine in the treatment of the aging process, there is no consensus of opinion and the opinion of Drs. Schwartz and Kramer side with a minority view.

With respect to this argument, it must first be pointed out that PABA is a metabolite, a breakdown product of procaine in the body, and the two substances have different pharmacological effects (Tr. 18, 69, 76). Thus, even if the article could be construed as supporting the efficacy of procaine, it would not support the efficacy of Respondent's products.

The review article evaluated the medical and scientific literature on procaine and the aging process and concluded that the claims for procaine in the favorable articles were not substantiated by acceptable scientific studies. Except for a possible anti-depressant effect, it concluded there was no evidence that procaine has any value in the treatment of disease in older patients. Only those studies which meet accepted scientific and medical standard represent an informed scientific or medical viewpoint. The evaluation and conclusion reached by the review article represents the informed opinion, rather than the views of those not following such standards. In any event, in addition to the review article, the testimony of Drs. Schwartz and Kramer as to the consensus of medical and scientific opinion with respect to PABA was supported by Respondent's witness, Dr. Douglas. Despite his own personal belief that PABA is an essential human nutrient, he testified that it has not been established as an essential nutrient (Tr. 130), and the consensus today is that it is not (Tr. 138, 151). Therefore, the preponderance of the credible evidence supports the Administrative Law Judge's findings as to the consensus of informed scientific and medical opinion.

Respondent also contends that a statement on page 5 of the review article supports its position. It states:

"Moreover, if PABA is the active ingredient, then a far more rational approach to therapy would be its direct administration rather than via the complicated administration of procaine."

This hypothetical statement taken out of context from the remainder of the article does not represent a view that PABA has the therapeutic benefit which Respondent's advertisements represent. Furthermore, Dr. Schwartz indicated that Dr. Aslan's view of the particular benefits of her product (Gerovital H.3) was that she had stabilized the procaine to prevent it from being broken down into its metabolic parts, one of which is PABA (Tr. 69). If this is so, any claimed benefit would not be for PABA. Thus, considering the entire article and the testimony of the expert witnesses concerning it, there is no error in the Administrative Law Judge's findings.

Accordingly, Exceptions 15, 16 and 18 have no merit.

Exceptions 19 and 20

"19. The Administrative Law Judge erred on page 23 of its sic opinion by concluding that Dr. Walker's testimony was at variance with uncontroverted facts and common sense."

"20. The Administrative Law Judge erred on page 24 of its sic decision by concluding that Dr. Walker's support for PABA can be explained by his authorship of a book presumably yielding him income containing a chapter involving Gerovital."

Basically in these two exceptions Respondent objects to the Administrative Law Judge's analysis of Dr. Walker's qualifications and his testimony. The Administrative Law Judge offered a number of different reasons why he would give little, if any weight, to Dr. Walker's opinions. He indicated that certain testimony of Dr. Walker was "...so at variance with uncontroverted fact and common sense, or so careless, as to cast doubt on the validity of most opinions." The Administrative Law Judge then gave three examples to support this conclusion. Respondent refers to one of these examples, the Administrative Law Judge's reference to the testimony of Dr. Walker that PABA taken internally acts as a sun screen, and contends that there is no support for the criticism of that testimony.

Both Dr. Kramer and Dr. Schwartz testified that there would be no therapeutic benefit from the internal use of PABA (Tr. 17, 75). Dr. Schwartz testified that the only known pharmacological effect of PABA would be as a sun screen applied topically (externally) (Tr. 18). Thus, it was not improper for the Administrative Law Judge to be critical of Dr. Walker's testimony relating to the internal use of PABA as a sun screen. Moreover, a review of Dr. Walker's testimony supports the analysis of the Administrative Law Judge. As the initial trier of fact, the Administrative Law Judge had the best opportunity to observe the demeanor of the witness and otherwise to weight his credibility. The Administrative Law Judge found the witness to lack credibility with respect to the products in issue and, on the basis of the record, we would reach the same conclusion. The Administrative Law Judge's referral to Dr. Walker's co-authorship of a book as a possible explanation for his "unrestrained enthusiasm for PABA" does not demonstrate prejudice, as Respondent contends. However, even if the comment were improper, it would be a harmless error. Accordingly, these exceptions have no merit.

Exceptions 21 through 25

" 21-25 The Administrative Law Judge erred in Conclusion of Law 1 2, 3, 4 and 5, respectively ."

In conclusion of law 1 the Administrative Law Judge found that, with one exception, Respondent is engaged in a scheme or device to obtain money or property through the mail with regard to its advertisements for Gerovital HP and Gerovital HP Cream. This conclusion is supported by the record. Respondent's contention that there is no evidence to show that Respondent is engaged in such a scheme or device is without merit.

In conclusion of law 2 the Administrative Law Judge found that, with one exception, the representations are false in fact and that they were material in that their natural tendency is to induce readers to purchase the products. Respondent contends that there is no evidence to substantiate these conclusions. A review of the record supports the Administrative Law Judge's determination.

Respondent's contentions regarding conclusions of law 3, 4 and 5 refer only to its arguments made with respect to exceptions 1, 21 and 22. For the reasons stated regarding those exceptions, these contentions have no merit.

"26. The Administrative Law Judge erred by not disqualifying himself from hearing the issues in the within case."

Respondent contends that the presiding Administrative Law Judge could not be objective in deciding this case because in a previous case involving a similar product he decided against the advertiser of the product. Respondent goes on to point out that the testimony relied on by the Administrative Law Judge in connection with the similar product was given by one of the same experts called by Complainant in this case.

At the commencement of the hearing Respondent made a motion to have the Administrative law Judge recuse himself from hearing this case because of his participation in the prior case (Tr. 6-8).

Respondent's counsel stated that he was making the motion for the record and that he would research the issue and "...if I feel there's law to substantiate it, then I would pursue it, and if not, I would not." (Tr. 9) In its brief on appeal, Respondent has cited no case law to supports its exception.

The presiding Administrative Law Judge properly denied Respondent's motion stating he would decide the case on the basis of the evidence presented at the hearing. Respondent has not established that the Administrative Law Judge did not decide this case on the evidence produced at the hearing. Moreover, Respondent has failed to make the requisite "substantial showing of bias" to disqualify an Administrative Law Judge or to justify a ruling that the hearing was unfair. See United States v. O'Rourke, 213 F.2d 759, 763 (8th Cir. 1954). Such bias must be a personal bias. Marquette Cement Manufacturing Co. v. F.T.C., 147 F.2d 589 (7th Cir. 1945); Converse v. Udall, 262 F.Supp. 583, 590 (D. Ore. 1966), aff'd., 399 F.2d 616 (9th Cir. 1968), cert. denied, 393 U.S. 1025. The fact the Administrative Law Judge had recently heard a case involving a similar product and ruled in favor of the Complainant in that case does not establish bias. See N.L.R.B. v. Anthony Co., 577 F.2d 692, 695 (9th Cir. 1977).

Accordingly, Respondent's position is without merit.

Exceptions 28 and 29

"28. The Administrative Law Judge erred by not allowing Respondent to cross-examine Dr. Kramer in regard to previous inconsistent testimony."

"29. The Administrative Law Judge erred by overruling the objection of Respondent set forth on page 99 of the transcript at line 6."

Like Exception 26, Respondent's contentions with regard to these exceptions raise issues concerning the impartiality and fairness of the presiding Administrative Law Judge.

With regard to Exception 28 Respondent contends that the following statement by the presiding Administrative Law Judge indicates extreme bias in favor of the Postal Service and against Respondent:

"I'll be glad to read that transcript in full if you want me to, and I dare say that I will not find any major inconsistency, but if you want me to do that, I'll be glad to do that."

As to Exception 29, Respondent contends the Administrative Law Judge erred in overruling an objection to a leading question propounded by Complainant's counsel by stating that the evidence would get in one way or another.

Both exceptions are without merit. The Administrative Law Judge permitted cross-examination of Dr. Kramer on prior statements when Respondent was attempting to impeach his testimony. He drew the line on matters which he felt were immaterial (Tr. 89). Respondent has made no offer of proof of anything in the earlier transcript which would demonstrate that the Administrative Law Judge's skepticism about finding inconsistencies in the witness' testimony was not justified and was prejudicial to its case. Such an offer is necessary to demonstrate error. Cf. FED. R. EVID. 103(a); Mills v. Levy, 537 F.2d 1331 (5th Cir. 1976).

The Administrative Law Judge's ruling on Respondent's objection to a leading question does not show bias or constitute reversible error. The Administrative Law Judge ruled exactly the same way on Complainant's objection to a leading question posed by Respondent (Tr. 200). While in both cases a preferable ruling might have been to have the questions rephrased, nonetheless, there is no showing that either party was prejudiced by the rulings.

CONCLUSION

After consideration of the entire record and Respondent's exceptions to the Initial Decision, it is concluded that Respondent is engaged in a scheme to obtain money through the mail by means of materially false representations. Accordingly, Respondent's appeal is denied and a remedial order under 39 U.S.C. § 3005 is being issued contemporaneously with this decision.