P.S. Docket No. 11/107


August 31, 1982 


In the Matter of the Complaint Against

ATHENA PRODUCTS, LTD.
at 780 Morosgo Dr., N.E.
P. O. Box 14152
Atlanta, GA 30324 etc.

P.S. Docket No. 11/107;

08/31/82

Cohen, James A.

APPEARANCE FOR COMPLAINANT:
James F. M S C L U WcMullin, Esq.
Sandra C. McFeeley, Esq.
Consumer Protection Division
Law Department
United States Postal Service
Washington, DC 20260

APPEARANCE FOR RESPONDENT:
T T B 6 A om Benham, Esq.
odd K. Maziar, Esq.
enham and Cohen
600 Powers Ferry Road, N.W.,
Suite 210 Atlanta, GA 30339

POSTAL SERVICE DECISION

Respondent has appealed from the Initial Decision of an Administrative Law Judge which holds that, with regard to the advertising and sale of the product "Super RNA Complex," Respondent is engaged in a scheme for obtaining money or property through the mail by means of materially false representations in violation of 39 U.S.C. § 3005.

BACKGROUND

On June 8, 1981, the Consumer Protection Division, Law Department, U.S. Postal Service (Complainant), filed a Complaint alleging that by means of direct mail solicitations and advertisements Respondent makes the following materially false representations:

"a. Super RNA Complex retards the aging process.

b. Super RNA Complex effectively replaces worn out and deteriorated human RNA.

c. Super RNA Complex is capable of altering the cell's genetic makeup.

d. Exogenously administered RNA will effectively:

1. curb senility;

2. restore vitality and sexual vigor;

3. improve eyesight and hearing; and

4. bring back a more youthful look to lined and wrinkled faces.

e. Large doses of supplemental RNA and DNA will increase the chances for absorption.

f. Super RNA Complex contains ingredients that heighten the anti-aging effects of ribonucleic acid."

In its Answer Respondent denied all of the allegations of the Complaint and affirmatively challenged the jurisdiction of this agency to conduct these proceedings. A hearing was held before an Administrative Law Judge at which Complainant presented the testimony of Postal Inspector Michael Flynn and Nancy Jo Balter, B.A. in biology, Ph.D. in pharmacology, assistant research professor in biology at Georgetown University. Respondent presented the testimony of William Saunders, M.D., a private practitioner of medicine specializing in nutrition, exercise and promotion of good health habits, and Richard Lord, B.S. in chemistry and Ph.D. in bio-chemistry, professor of chemistry at Life Chiropractic College, Marietta, Georgia. Both parties also introduced documentary evidence.

Based on the evidence in the record the Administrative Law Judge found that Respondent's advertisements made all of the representations alleged in the Complaint, except the representation alleged in subparagraph C. He found that the representations which were made were false, and therefore concluded that Respondent is engaged in a scheme or device in violation of 39 U.S.C. § 3005.

RESPONDENT'S EXCEPTIONS TO THE INITIAL DECISION

Respondent has stated 20 exceptions to the Initial Decision which are hereafter addressed.

Exceptions 1 - 3

"1. The Administrative Law Judge erred in failing to grant the Respondent's Motion to Dismiss Order dated July 17, 1981. Such Motion took exception to said ALJ taking official notice of a particular publication as well as unilaterally ordering discovery to take place between the parties.

"2. The ALJ erred in failing to grant the Respondent's Motion to Recuse Administrative Law Judge dated July 17, 1981. Said Motion excepted to a clear predisposition of the ALJ against Respondent manifested in the ALJ's Order of July 15, 1981.

"3. The ALJ's Order of July 15, 1981, was in error. Said Order erroneously directed that discovery take place between the parties, and manifested the erroneous action of the ALJ in taking judicial notice of a publication clearly opposed to Respondent's position."

These three exceptions object to the Administrative Law Judge's prehearing Order of July 15, 1981, and denial of Respondent's motions based on that Order. The Order stated:

"I

The parties are directed to exchange not later than July 22, 1981, the following:

a. Lists of witnesses who will testify at the hearing, including a curriculum vitae for each expert witness.

b. Copies of all documents to be offered in evidence or used in cross-examination at the hearing. If either party intends to offer only selected portions of a document the complete document must be available at the hearing for inspection by opposing counsel and the presiding officer.

II

The parties are advised that the presiding officer intends to take official notice of the publication entitled 'Recommended Dietary Allowances, Ninth Edition 1980' published by The National Research Council and may consider any relevant portions thereof in conjunction with other evidence received at the hearing."

Respondent contends that paragraph I of the quoted Order "is clearly discovery" which was advantageous to Complainant, but not timely filed.

Respondent's contention that the Administrative Law Judge improperly ordered discovery which benefits Complainant has no merit. The prehearing Order did not constitute discovery by or for either party. Rather, it was a reasonable prehearing requirement to help expedite and simplify the hearing proceedings (39 C.F.R. § 952.17; 5 U.S.C. § 556). Thus, the Order in this regard was not improper or untimely. Moreover, Respondent has not shown that compliance with the Order was harmful or prejudicial, nor do we believe such a showing could be made. Full disclosure prior to hearing rather than surprise at the hearing is good judicial practice.

Respondent next contends the Administrative Law Judge should have recused himself in response to its motion. Respondent asserts that the publication of which the Administrative Law Judge advised in paragraph II of the July 15 Order that he would tak official notice does not contain any recommended dietary allowance for ribonucleic acid, the primary ingredient of Respondent's product. Respondent argues that taking notice of the publication constituted a "strong predisposition of thought in regard to the subject matter of the litigation" which was prejudicial to Respondent.

To disqualify an Administrative Law Judge there must be a "substantial showing of bias" which was prejudicial to a party to the proceeding. G.H.P. Laboratories, Inc., P.S. Docket No. 10/149 (P.S.D. Nov. 30, 1981, at 21), and cases cited therein. Notice by the Administrative Law Judge that he would take official notice of the publication does not establish a predisposition or bias against Respondent. Furthermore, it was proper to take official notice of the publication. Cosvetic Laboratories, P.S. Docket No. 7/38 (P.S.D. Jan. 29, 1980 at p. 10). In addition there was testimony at the hearing by witnesses for both parties that there was no established recommended dietary allowance for ribonucleic acid (Tr. 44, 96, 97). Respondent had ample opportunity at the hearing to present its case as to the efficacy of the product in relation to its advertised claims, including showing a need for supplemental ribonucleic acid. Its evidence in this regard was not persuasive.

Accordingly, there is no merit to these exceptions.

Exception 4

"The ALJ erred in Finding of Fact number 1 on page 3 of the Initial Decision by holding that Respondent solicits remittances of monies through the mails to the addresses appearing in CX19 and 20."

Respondent contends that the Administrative Law Judge improperly admitted into evidence three exhibits (CX 19, 20 & 21) which were not furnished to Respondent until the day of the hearing rather than "not later than July 22, 1981" as directed by the Administrative Law Judge's Order of July 15, 1981. The exhibits were introduced through the testimony of the Postal Inspector who testified the exhibits were advertisements included in the July/August 1981 issue of Respondent's magazine which he had only become aware of on Monday, August 24, 1981, two days before the hearing (Tr. 23, 25). Complainant's exhibits 19 and 20 were introduced to show that Respondent solicits remittances of money through the mails to: Box 8384, Coral Springs, Florida 33065, and 250 Corey Avenue, P.O. Box 67112, St. Petersburg Beach, Florida 33736. Respondent contends it was improper to receive these exhibits over its objection and to include the addresses in the caption and findings of the Initial Decision.

The Administrative Law Judge did not err in admitting the exhibits into evidence. The exhibits were not required to have been exchanged by July 22, 1981, since Complainant was unaware of their existence, and there is no showing that it should have known of their existence on that date. Furthermore, Respondent has not shown that it was prejudiced by the admission of the advertisements into evidence. Respondent does not contend nor did it make any offer of proof that the advertisements were not for its product or that it does not receive the remittances which are directed to the addresses used in the exhibits. Accordingly, the admission of the exhibits and the inclusion of the addresses in the caption of the case was proper.

Exception 5

"The ALJ erred in Finding of Fact No. 4 on page 5 of the Initial Decision by holding that Respondent makes the representation alleged in Paragraph 3(d) reference should be to paragraph 3(b) of the Complaint."

Paragraph 3(b) of the Complaint alleges that Respondent falsely represents that: "Super RNA Complex effectively replaces worn out and deteriorated human RNA." In Finding of Fact 4 the Administrative Law Judge found this representation was made in the following language from one of Respondent's advertisements (CX 1):

" . . . the problem for RNA users and advocates alike has been how to get more working RNA, as a replacement for worn out and deteriorated RNA, into the cells to have a more dramatic anti-aging impact. But, now we have finally developed Super RNA Complex (etc.) . . ." (I.D. p. 5)

Respondent contends that this language has been taken out of context and that an examination of the entirety of Respondent's advertisements shows that they "would not 'most probably' impress upon ordinary minds that Super RNA Complex effectively replaces worn-out and deteriorated human RNA." The quoted language clearly makes the representation alleged in the Complaint. A consideration of the advertisements in their entirety would lead the ordinary reader to conclude that this representation was being made. Accordingly, this exception has no merit.

Exceptions 6 and 18

"6. The ALJ erred in Finding of Fact number 9 on page 6 of the Initial Decision by holding (a) that the education of Complainant's witness, Dr. Nancy J. Balter, qualified her to evaluate the efficacy of Respondent's product, Super RNA Complex; (b) that Dr. Balter's research qualified her to testify with respect to claims made by Respondent for Super RNA Complex; and (c) that Dr. Balter's opinions are based upon a scientific viewpoint and are consistent with informed scientific consensus."

"18. The ALJ erred in Conclusion of Law Number 3 on pages 12 and 13 of the Initial Decision by stating the conclusion of law found therein."

In these exceptions Respondent attacks Dr. Balter's testimony and the Administrative Law Judge's reliance thereon. Respondent contends that Dr. Balter was not qualified by education or research to evaluate the efficacy of its product and should not be relied on to express the scientific viewpoint and the informed scientific consensus. Further, Respondent argues that the Administrative Law Judge improperly ignored the testimony of its two experts.

The testimony of Respondent's experts was not ignored by the Administrative Law Judge. However, he found Dr. Balter's testimony to be persuasive. Some of his reasons are set forth in his third conclusion of law in which he stated:

"I am deciding the falsity issues in this matter based on the testimony of Dr. Balter. The conformity of her opinions with the informed scientific consensus stands unrefuted by Respondent's evidence which, at best, might lead to the conclusion that future scientific investigations may disclose that this, or a similar, product is efficacious to produce one or more of the results represented by Respondent. The opinions of Respondent's experts and the reports of studies received in evidence fall far short of establishing such efficacy. Doctor Balter's testimony made a prima facie case for Complainant on the falsity issues not overcome by a preponderance of reliable and probative evidence on Respondent's part." (I.D. at 12.)

The conclusion that Dr. Balter's testimony made a prima facie case which was not overcome by a preponderance of reliable and probative evidence is correct and supported by a review of all the evidence in the record. Respondent's witnesses' testimony is discussed, infra, under other exceptions.

To discredit Dr. Balter's testimony Respondent contends that she was not qualified to evaluate the therapeutic benefit of the Super RNA Complex. Its reasons are that most of her research has been in the field of immunology and she conceded that oral supplementation has not been a major part of her research work. However, Dr. Balter did testify that she had some experience with oral supplementation (Tr. 46). Her Ph.D. is in pharmacology, which is the study of drugs, their inter-actions, and their effects on biological systems (Tr. 32; CX 17). A review of the record shows that her testimony was direct and impressive. She is well-qualified to testify as an expert in this matter.

Respondent further contends that Dr. Balter did not adequately research the issues. It cites testimony that she read materials which had been supplied by a student and had been collected by Dr. Schwartz of Georgetown University. However, her testimony was that she used those materials "as a starting base (Tr. 47) and "went from one paper to another based on what was published" (Tr. 35, 47). She also used the Index Medicus, a computerized index of articles "in thousands of medical journals," to research more recent publications (Tr. 35). Respondent contends Dr. Balter's statement that she "saw no studies which directly addressed therapeutic benefits that were listed in the Complaint" (Tr. 53) is an example of her deficient research. This response was in answer to a question whether she saw anything "of a scientific nature" which satisfied her about the claims made. Thus, her response was limited to studies considered to meet scientific criteria.

Respondent asserts that the Administrative Law Judge erred in finding that Dr. Balter's opinions are based on a scientific viewpoint and are consistent with the informed scientific consensus. Nothing that Respondent has argued establishes that this finding is in error. Dr. Balter's entire testimony has been reviewed. This testimony establishes she properly researched the medical and scientific literature, and that her opinions are based on a scientific viewpoint and are consistent with the informed scientific consensus (Tr. 44, 51). Dr. Balter's unwillingness to state that it will never be proven that RNA supplements are not beneficial (Tr. 51, 52) was consistent with the scientific approach and does not detract from her opinion. Also, it does not support a proposition that the supplement is beneficial. Respondent's Exceptions 6 and 18 have no merit.

Exception 7

"The ALJ erred in Finding of Fact number 10 on page 7 of the Initial Decision by holding (a) that the record fails to indicate that Respondent's expert witness, Dr. William Henry Saunders, has done any research concerning RNA prior to his testimony, or that Dr. Saunders has any special knowledge concerning RNA; and (b) that Dr. Saunders expressed guarded opinions as to the efficacy of RNA to provide some of the benefits promised in Respondent's advertising."

Respondent contends the Administrative Law Judge properly disregarded certain testimony of Dr. Saunders in making his findings. It cites Dr. Saunders' statement that except for Dr. Benjamin Frank and other individuals who have specialized in the area, he probably knows as much as anyone on the potential use of RNA on a clinical level (Tr. 79). Respondent also quotes in part Dr. Saunders' response to a question as to the effect of exogenously administered RNA in eliminating or reducing aging. The entire response is quoted with those portions quoted in Respondent's brief underlined:

"A. Yes. I think they have every possibility of doing so in that much work has been done to support that. Now there's a difference in clinical work and double blind absolute tests according to some people's opinions. Now not everyone shares in the opinion that double blind studies are necessarily the best proof in any one particular case. Sometimes it's impossible to do a double blind study but clinical evidence seems to indicate that many people will benefit from the administration of exogenous RNA." (Tr. 68; Resp's. Brief at 14.)

Respondent contends that this testimony and Dr. Saunders' reference to Dr. Frank adequately demonstrates his knowledge and research. Respondent also contends that Dr. Saunders' opinion concerning the benefits of supplemental RNA was not guarded as demonstrated by his testimony at Tr. 67 to the effect that RNA could be beneficial if a deficiency existed. It is evident from Dr. Saunders' entire testimony, especially that quoted above, that his opinion is based on clinical observations by persons such as Dr. Frank and not on any scientifically accepted double blind studies. Therefore, his opinion as to the possible efficacy of RNA supplements does not rest on scientifically accepted proof of the efficacy of RNA. See discussion, infra, under Exception 14. Despite his asserted knowledge and opinion of possible benefits, Dr. Saunders does not use RNA supplements in his own clinical practice (Tr. 78).

The Administrative Law Judge's characterization of Dr. Saunders' opinions as "guarded" is supported by the record. A review of his entire testimony compels the conclusion that it is not persuasive as to the efficacy of Respondent's product in relation to the charges in the Complaint. It was proper for the Administrative Law Judge to give little or no weight to Dr. Saunders' opinions.

Accordingly, this exception is without merit.

Exceptions 8 and 9

"8. The ALJ erred in Finding of Fact number 11 on pages 7 and 8 of the Initial Decision in not fully stating the educational and medical background of the other expert witness used by Respondent, Dr. Richard Lord, as established in the record."

"9. The ALJ erred in Finding of Fact number 12 on page 8 of the Initial Decision by holding that Dr. Lord's opinions regarding RNA were based solely on two specific magazine articles."

In these exceptions Respondent attempts to discredit the Administrative Law Judge's evaluation of Dr. Lord's testimony. In Exception 8 it asserts he failed to list the 3 1/2 years Dr. Lord worked as a Post-Doctoral Fellow which should have been disclosed in the Initial Decision. A summary of all of the qualifications of a witness is not required to be included in the Initial Decision. Furthermore, even if this omission is assumed as an error, it is, at most, a harmless error. Respondent has not shown that the omission of that fact would warrant any change in the result of the decision.

In Exception 9 Respondent has misstated the Administrative Law Judge's Finding of Fact 12. The Administrative Law Judge did not state that Dr. Lord's opinions about RNA "were based solely on two specific magazine articles," as asserted by Respondent. Instead, he stated:

"Doctor Lord's only specific references to such evidence the beneficial effect of RNA on degenerative conditions were the observations of Dr. Benjamin Frank, referred to in a review article in Geriatrics (October 1977) by Saul Kent, entitled 'Can Nucleic Acid Therapy Reverse the Degenerative Process of Aging?' (RX-2; CX-18) and a 1961 article in Geriatrics entitled "Effects of Ribonucleic Acid on Memory." (I.D. at 8.)

Respondent's citation of certain testimony of Dr. Lord and arguments therefrom are irrelevant to its basic contention. Exception 9 has no validity as it is based on a faulty premise and Respondent, otherwise, has shown no error.

Exception 10

"The ALJ erred in Finding of Fact number 14 on page 9 of the Initial Decision by holding that Dr. Lord agreed that the Kent article introduced into evidence by Complainant (RX-2, CX-18) cast doubt on the validity of Dr. Frank's findings."

Respondent asserts that Dr. Lord did not agree that the article written by Saul Kent (RX-2, CX-18) casts doubt on the validity of findings by Dr. Frank.

Although not referred to in the Initial Decision, Dr. Lord's answer to the following question supports the finding:

"Q. In the Saul Kent article that you referred to earlier it states that many of Dr. Frank's findings are based on the subjective evaluations and none of the clinical studies are free from potential bias or placebo effects. Do you think if that's true that would cast some doubt on the authenticity of Dr. Frank's findings?"

"A. I think I can cast some doubt on the authenticity of almost anyone's findings. Yes, it casts doubt."

(Tr. 96.)

Accordingly, this exception has no merit.

Exception 11

"The ALJ erred in Finding of Fact number 16 on page 9 of the Initial Decision by holding that there is no established need in human nutrition for supplemental RNA."

Respondent contends that certain testimony of Dr. Lord at Tr. 97 was not taken into consideration by the Administrative Law Judge in making this finding. Dr. Lord stated RNA is not considered an essential nutrient (Tr. 96, 97). Although he suggested there is some evidence of an indication of a need, he stated it is an unknown area in nutrition. His testimony cannot be viewed as stating there is an "established" need in human nutrition for supplemental RNA. Rather, all of his testimony at Tr. 96 and 97 supports the finding that there is no "established" need, and does not contradict testimony of Dr. Balter to that effect.

This exception has no merit.

Exception 12

The ALJ erred in Finding of Fact number 18 on page 10 of the Initial Decision by holding that the source of RNA in Respondent's product is probably yeast."

Respondent contends this finding is erroneous because it was based on a guess by Dr. Balter that yeast is the source of the RNA in Respondent's product. Dr. Balter's suggestion was based on information she had of use of yeast RNA in some studies and in other products (Tr. 39). Because there was no evidence by Respondent contradicting her stated assumption, the Administrative Law Judge could properly infer that the source is "probably" yeast.

Respondent objects to the further finding under Finding of Fact 18 in which the Administrative Law Judge stated:

"Yeast RNA will code for protein of yeast and presumably has little, if any, effect on the human cell and cannot enter the human cell as RNA (Tr. 39, 40)." (I.D. at 10.)

This finding is based on Dr. Balter's testimony at Tr. 39 and 40 that RNA is:

". . . cell specific. It codes for the synthesis of protein which are specifically needed by a given cell. The RNA in one cell is different from the RNA in another cell in terms of the proteins that it makes. If you carried this a step further and talk about yeast RNA, yeast RNA is going to code for protein of the yeast and would presumably have little effect on a human cell at all. You can carry it a step further though. Even if it could code the proteins which are of use to the cell it would never be able to get into the cell and actually perform as such. The regulation on cell metabolism in protein synthesis is so finely tuned that it wouldn't be able to perform that function."

Respondent contends in making this finding that the Administrative Law Judge ignored Dr. Lord's testimony at Tr. 83, 84. There he stated, inter alia, that the source of the RNA did not matter because it is broken down into nucleosides and nucleotides where it is absorbed into the bloodstream with other nutrients as compounds available to the cells to build their own RNA and DNA.

Nothing in Dr. Lord's entire testimony specifically contradicts Dr. Balter's testimony that RNA is cell specific. Further, his other testimony supports Dr. Balter's testimony that an RNA supplement cannot be absorbed into a cell or that it has not been proven that it can be absorbed intact (Tr. 95, 106).

This exception has no merit.

Exception 13

"The ALJ erred in Finding of Fact number 20 on page 10 of the Initial Decision by holding that there is no known beneficial effect on humans of exogenously administered allantoin or collagen."

Respondent has pointed to no error in the finding as to allantoin. Its own witness, Dr. Lord, could not testify that allantoin had any beneficial effects (Tr. 107, 108). As to collagen, Dr. Lord testified it could "possibly" have benefit retarding the aging process because it is a protein consisting of a number of amino acids and it could supplement those. However, he also stated these are not essential amino acids (Tr. 108).

The record supports the finding. This exception is without merit.

Exception 14

"The ALJ erred in Finding of Fact number 21 on page 10 of the Initial Decision by holding that there are no reported, valid, controlled clinical studies supporting Respondent's advertised claims for Super RNA Complex."

Respondent contends that the Administrative Law Judge's reliance on testimony by Dr. Balter for this fiding is in error because it is based on the lack of double blind studies proving the benefit of exogenously administered RNA to humans. It contends testimony of Dr. Saunders (previously quoted, supra, under Exception 7) about double blind studies was ignored.

Dr. Saunders' testimony does not contradict the Administrative Law Judge's finding that " t here are o reported valid controlled clinical studies supporting Respondent's advertised claims." While Dr. Saunders did testify that double blind studies are not necessarily the best proof, Dr. Balter testified that controlled clinical double blind studies are the accepted procedure within the medical and scientific community to eliminate the placebo effect and bias (Tr. 33-35, 51-53). The Administrative Law Judge properly accepted her testimony concerning the studies. It was in accord with the consensus of informed medical and scientific opinion as to acceptable proof of the efficacy of a product. See G.H.P. Laboratories, Inc., supra, at 9.

This exception has no merit.

Exceptions 15, 19 and 20

"15. The ALJ erred in Finding of Fact number 22 on pages 10 and 11 of the Initial Decision by holding that the ingestion of Super RNA Complex will not provide any of the benefits promised in the representations made by Respondent for its product alleged in the Complaint and found in the ALJ's Finding of Fact numbers 3 and 4, and 6 thru 8."

"19. 20. The ALJ erred in Conclusion of Law number 4 and 5 on page 13 of the Initial Decision by stating the conclusion of law found therein."

Conclusion of Law 4 states:

"Respondent is engaged in a scheme or device to obtain money or property through the mails for its product, Super RNA Complex, by means of false representations substantially as characterized in the Complaint with the exception that no representation is made that the product is capable of altering the cell's genetic makeup. Such representations are material in that their natural tendency is to induce readers to purchase the product."

Conclusion of Law 5 states that Respondent's "scheme or device is in violation of 39 U.S.C. § 3005" and an order under that statute should be issued against Respondent.

Basically, in these exceptions Respondent contends that the Administrative Law Judge erred in finding that Complainant met its burden of proving the falsity of the representations alleged in the Complaint (except that in paragraph 3 (c) relating to alteration of the cell's genetic makeup). Respondent contends Complainant produced no evidence to show that RNA's breakdown products could not benefit humans in combating the effects of aging. Specifically, it contends in Exception 15 that the Administrative Law Judge unjustifiedly based his conclusion on Dr. Balter's opinion. It contends her opinion testimony is not sufficient to establish a prima facie case and was directly refuted by testimony of Respondent's expert witnesses.

Respondent objects to Dr. Balter's testimony that she believed her opinion represents a consensus of informed scientific opinion. As previously discussed, Dr. Balter was qualified to testify as an expert as to the therapeutic benefits of the ingredients of Respondent's product and her opinion was based on the consensus of scientific and medical proof (see Exceptions 6 and 14). Complainant's burden of making a prima facie case on the falsity of representations of therapeutic benefits for a product is satisfied by evidence of the consensus of the informed scientific and medical community that there are no such known therapeutic benefits. Respondent, not Complainant, then has the burden to show such benefits by a preponderance of the evidence. G.H.P. Laboratories, Inc., supra, at 7-9. Similar arguments of Respondent concerning court cases on an expert's opinion and burden of proof were addressed and found wanting in G.H.P. Laboratories, Inc.

Despite Respondent's arguments to the contrary, Dr. Balter's testimony established a prima facie case as to the falsity of the representations found by the Administrative Law Judge. Neither of

Respondent's experts contradicted her statements and opinions as to the consensus of the scientific and medical community. Many of Respondent's additional arguments under these exceptions have been answered and found to be without merit in the prior discussion under other exceptions. Furthermore, Respondent takes certain testimony out of context and gives it attributions which are not supported by the record. Respondent's witnesses did not directly refute Dr. Balter's testimony. In many respects their testimony supports her opinions. Their opinions of possible therapeutic benefits were not based on scientific studies, but primarily on reports of some clinical experience of others and mere conjecture. This is not reliable or persuasive evidence.

It suffices to conclude that Respondent did not overcome Complainant's prima facie case by a preponderance of the evidence. Therefore, these exceptions have no merit.

Exceptions 16 and 17

" 17 The ALJ erred in Conclusion of Law number 1 and 2 on page 11 and 12 of the Initial Decision by stating the conclusion of law found therein."

Both of these Conclusions of Law addressed Respondent's contentions that the administrative proceedings under 39 U.S.C. § 3005 are unconstitutional and the governmental objective could be better achieved by less restrictive means. Similar contentions to those made by Respondent in Exception 16 that the statute constitutes an unconstitutional prior restraint of speech were answered in G.H.P. Laboratories, Inc., supra, at 4-7. See also United States Postal Service v. Athena Products, Ltd., 654 F.2d 362 (5th Cir. 1981).

In Exception 17, Respondent contends that 39 U.S.C. § 3005 violates the right of privacy of members of the public. It contends the right of privacy has been recognized as within the "penumbra of the Bill of Rights" and within the language of the First, Fourth, Fifth, Ninth and Fourteenth Amendments, citing Roe v. Wade, 410 U.S. 113, 152 (1973). It also cites a companion case, Doe v. Bolton, 410 U.S. 179 (1973), for the right of freedom of an individual to choose one's own health care. Respondent contends that the government cannot act to protect the general welfare unless there is a threat to the welfare, and it has failed to show such a threat here. Respondent concludes that "Complainant has unconstitutionally trampled upon the guaranteed right to privacy" by "detaining mails of citizens voluntarily choosing to purchase Respondent's product, on a mere suspicion that Respondent may be guilty of a violation of the United States Code." (Resp's. Brief at 28.)

Unless Complainant obtains a court injunction under 39 U.S.C. § 3007, no mail is detained until after the conclusion of the entire administrative proceeding provided by 39 U.S.C. § 3005 and 39 C.F.R., Part 952. These require first a final administrative determination that the Respondent is in violation of 39 U.S.C. § 3005. This determination is much more than a mere "suspicion." Thus, there is no validity to Respondent's argument that mail is detained on the basis of a "mere suspicion" of a violation of the United States Code.

As to Respondent's constitutionality argument, it is first noted that this administrative proceeding is not a proper forum for determining the constitutionality of the statute. G.H.P. Laboratories, Inc., supra. Furthermore, Respondent is not a proper party to assert a violation of privacy rights in unidentified members of the public. However, assuming there were no bars to considering the alleged statutory violation of constitutional privacy rights, Respondent's arguments under Exception 17, as well as 16, would be deemed without merit and the constitutionality of the statute upheld.

The companion Supreme Court cases of Roe v. Wade, supra, and Doe v. Bolton, supra, involve state regulation of abortion of human fetuses. The limited right of privacy of a woman seeking an abortion recognized in those cases is not analagous to the circumstances here. As the Administrative Law Judge correctly concluded, 39 U.S.C. § 3005 does not interfere with the right of an individual to pick and choose medical remedies. Its purpose is to protect the public:

"from being duped by means of false representations concerning this product . . . It is only Respondent's fault, the making of false representations, which should lead to inability of the public to purchase the product from Respondent through use of the mail ." (I.D. at 12)

The legitimate public policy and procedures of 39 U.S.C. § 3005 to protect the public from false advertising have been recognized by the Federal courts as constitutional. See cases cited in G.H.P. Laboratories, Inc., supra, at 4-7. Inherent in those rulings, even though not expressly stated, is recognition that no constitutional rights are violated, including any right of privacy by members of the public.

Exceptions 16 and 17 are without merit.

CONCLUSION

After consideration of the entire record and Respondent's exceptions, 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. A remedial order under 39 U.S.C. § 3005 is being issued with this decision.