October 10, 1984
In the Matter of the Complaint Against
WALTER HEAD FRANK E. BUSH, INC.
P. O. Box 361
East Rockaway, NY 11518-0361
and at P. O. Box 362
East Rockaway, NY 11518-0362
and at P. O. Box 121
Hewlett, NY 11557-0121
and at P. O. Box 538
Rockville Centre, NY 11571-0538
and at P. O. Box 549
Rockville Centre, NY 11571-0549
P.S. Docket No. 15/123;
Dicus, Carroll C. Jr.
APPEARANCES FOR COMPLAINANT:
Thomas A. Ziebarth, Esq.
Consumer Protection Division
U.S. Postal Service
Washington, DC 20260-1112
APPEARANCE FOR RESPONDENT:
Anne C. Vladeck, Esq.
Vladeck, Waldman, Elias & Engelhard, P.C.
1501 Broadway, Suite 800
New York, NY 10036-5560
POSTAL SERVICE DECISION
Respondent has appealed from the Initial Decision of an Administrative Law Judge which holds that Respondent is engaged in conducting a scheme or device to obtain money through the mail by means of materially false representations in violation of 39 U.S.C. § 3005.
On December 22, 1982, the Consumer Protection Division, Law Department, United States Postal Service (Complainant), filed a Complaint alleging that Respondent, by means of materially false direct mail circulars and advertisements, expressly or impliedly represents to the public, directly or indirectly, in substance and effect, whether by affirmative statements, omissions or implications, that:
"3. . . .
(a) U.S. Government research has recently discovered that the average man is significantly deficient in a 'sex nutrient' critical for maximum sexual performance;
(b) Otherwise healthy males who are low in the 'sex nutrient' critical for maximum sexual performance will be materially aided in their sexual abilities by ingesting NSP-270;
(c) The efficacy of NSP-270 in improving sexual performance in men has been established by competent scientific tests and studies;
(d) The ingestion of NSP-270 will improve the sexual performance of any man who is low in the 'sex nutrient';
(e) Deficiencies in the 'sex nutrient' serious enough to cause a substantial diminution in sexual performance by males are relatively common in the United States;
(f) A man with a deficiency in the 'sex nutrient' serious enough to cause a substantial diminution in his sexual abilities may otherwise be in good health;
(g) The amount of the 'sex nutrient' contained in NSP-270 is adequate to reverse a deficiency in this nutrient serious enough to cause diminished sexual performance in males;
(h) A U.S. Navy medical research unit successfully conducted a 'penis enlargement and erection improvement program' using the 'sex nutrient' contained in NSP-270;
(i) Tests conducted by the USDA at Beltsville, Maryland on its own employees revealed that 2 out of 3 were significantly short of the recommended levels of the 'sex nutrient' contained in NSP-270;
(j) The graph set forth in Respondent's advertising material represents actual increases in penis size that may be achieved through the use of NSP-270;
(k) The efficacy of NSP-270 has been established by experiments conducted by the Veterans Administration in Washington, DC".
Two additional false representations alleged in subparagraphs (1) and (m) of Paragraph 3 of the Complaint were dismissed pursuant to Complainant's motion. In a timely filed Answer, Respondent admitted making the representations alleged in subparagraphs (h) and (i) and denied the allegations set forth in subparagraphs (a)-(g) and (j)-(k). A hearing was held before an Administrative Law Judge at which both parties presented documentary and testimonial evidence. Harold H. Sandstead, M.D., and James Cecil Smith, Jr., Ph.D, testified for Complainant; Loretta M. McQuillan, M.Sc., M.D., and Kasja M. Suljaga-Petchel, M.D., testified for the Respondent. Following the hearing, Respondent took Dr. Sandstead's deposition, which was subsequently admitted into evidence. In addition, Dr. Sandstead's
"Affirmation" with attached data from the Health and Nutrition Examination Survey II ("HANES-2") was admitted into evidence.
Following the hearing and the parties' submission of proposed findings of fact and conclusions of law and reply briefs, the Administrative Law Judge issued an Initial Decision in which he found that Respondent makes the representations alleged in the Complaint and that they are materially false in violation of 39 U.S.C. § 3005. On the basis of these findings, the Administrative Law Judge recommended the issuance of a False Representation Order against Respondent.
Following the issuance of the Initial Decision, Complainant filed a motion to amend the Complaint to include two additional addresses in the caption. Since Respondent did not interpose any objection, Complainant's motion was granted and the caption now includes the additional addresses of the Respondent.
Respondent's Exceptions to the Initial Decision
In its appeal Respondent presents ten exceptions to the findings and conclusions of the Initial Decision. Each exception is hereafter addressed.
"1. The Administrative Law Judge erred in finding that Respondent's advertisement made the representations alleged in paragraphs 3(a), (b), (c), (d), (e), (f), (g), and (j) of the Complaint."
Whether Respondent's advertisements make the representations alleged in the Complaint must be "...determined in the light of the effect the advertisements ... would probably produce on ordinary minds." Donaldson v. Read Magazine, Inc., 333 U.S. 178, 189 (1948); Peak Laboratories, Inc. v. United States Postal Service, 556 F.2d 1387, 1389-90 (5th Cir. 1977). In this regard, both the advertisement's express and implied representations must be considered. N. Van Dyne Advertising Agency, Inc. v. United States Postal Service, 371 F.Supp. 1373 (S.D.N.Y. 1974); Vibra-Brush Corp. v. Schaffer, 152 F.Supp. 461 (S.D.N.Y. 1957), rev'd on other grounds, 256 F.2d 681 (2d Cir. 1958). The Administrative Law Judge properly applied the above standards when he found that Respondent made the representations alleged in Paragraphs 3(a)-(k) of the Complaint. The portions of Respondent's advertisements quoted in the Initial Decision (I.D. at 3-12), when read in context, fully support the finding that the alleged representations are made.
Since Respondent failed to specify any reasons why the representations set forth in Paragraphs 3(b), (d), (f), and (g) were not made, no further discussion of those subparagraphs is necessary. Respondent's arguments concerning the remaining contested representations are addressed below under the quoted subparagraphs of Paragraph 3 of the Complaint.
"(a) U.S. Government research has recently discovered that the average man is significantly deficient in a 'sex nutrient' critical for maximum sexual performance."
Respondent first argues that it does not represent that the average man is "significantly deficient" in the nutrient (zinc) because the advertisements merely state that average men are "low" in this nutrient. This argument is rejected. The advertisements state that average males are "surprisingly low" in the nutrient and "lower than they should be" (CX 1-3), which indicates to the ordinary reader that the deficiency is significant.
"(c) The efficacy of NSP-270 in improving sexual performance in men has been established by competent scientific tests and studies."
Respondent argues that no representation is made that the product in issue, NSP-270, has been proven efficacious by competent scientific tests. Respondent maintains that it merely makes this representation with respect to the "sex nutrient" contained in NSP-270, but not the product itself. This argument is rejected. Respondent's advertisements (CX 1 & 2) refer to the product in large lettering occupying about one-third of a page as "a Tested 'Sex Pill' For Men." Other statements in the advertisements to the effect that the "sex nutrient" found in this product has been studied in scientific tests do not detract from the impression given that NSP-270, itself, has also been tested.
"(e) Deficiencies in the 'sex nutrient' serious enough to cause a substantial diminution in sexual performance by males are relatively common in the United States."
Respondent argues that the advertisements do not represent that these deficiencies are "relatively common." Respondent points to several instances in which the deficiency is described as "rare." However, the Administrative Law Judge correctly found that other language in the advertisements gives the overall impression that the deficiency is relatively common (I.D. at 8).
In this regard, the advertisements state in large type that the product is for "average" men. This statement is repeated several times.
"(j) The graph set forth in Respondent's advertising material represents actual increases in penis size that may be achieved through the use of NSP-270."
Respondent argues that the graph does ot measure increase in penis size, but merely demonstrates the amount of zinc that individuals with varying levels of zinc deficiency would receive by ingesting one NSP-270 tablet. Although a sophisticated reader might come to this conclusion after a careful analysis of the graph, a person of ordinary mind would interpret the graph as representing increases in penis size that may be achieved through the use of NSP-270. In this regard, the headline on pages 2 and 3 of the advertisement (CX 1, 2) announces in large, bold type a "Revolutionary Medical Discovery For Better Erections." The advertisement then states "See For Yourself What Extra Strength NSP-270 Can Do." A vertical bar graph then portrays a series of erections which increase in size depending on the amount of zinc deficiency. The ordinary reader would receive the overall impression as set forth in subparagraphs (j). Donaldson v. Read Magazine, Inc., 333 U.S. 178, 189 (1948). Moreover, even if the graph is ambiguous in this regard, it is still misleading. Rhodes Pharmacal Co. v. F.T.C., 208 F.2d 387 (7th Cir. 1953). Respondent's exception has no merit.
Respondent admitted in its Answer that it made the representations set forth in subparagraphs (h) and (i). Also, Respondent did not take exception to the finding that the representation set forth in subparagraph (k) was made. Accordingly, it is concluded that the Administrative Law Judge properly found that the representations were made as alleged in subparagraphs (a) through (k) of Paragraph 3 of the Complaint.
"2. The Administrative Law Judge erred in finding that all of the alleged representations are materially false."
Respondent's arguments concerning the truth or falsity of the representations are addressed following each of the subparagraphs quoted below from Paragraph 3 of the Complaint.
"(a) U.S. Government research has recently discovered that the average man is significantly deficient in a 'sex nutrient' critical for maximum sexual performance.
. . .
(e) Deficiencies in the 'sex nutrient' serious enough to cause a substantial diminution in sexual performance by males are relatively common in the United States."
In an effort to prove the truth of these representations, Respondent relies on two facts which are essentially undisputed. First, Respondent points to the fact that it has been established by scientific studies that zinc is a critical nutrient for sexual development and abilities. Second, the average human ingests less zinc than the Recommended Dietary Allowance (RDA) of 15 mg. per day advocated by the National Academy of Sciences. However, these facts do not establish the truth of the representations in question.
In finding these representations to be false, the Administrative Law Judge relied on the testimony of the Complainant's expert witnesses whom he found "more impressive and persuasive" than Respondent's witnesses. As found by the Administrative Law Judge (I.D. at 20-21), Complainant established through the testimony of Dr. Sandstead that the usual American diet provides 7 to 8 mg. of zinc daily and that this amount is adequate to maintain homeostasis (Tr. 21-22). He also testified that the fact that the average man consumes less zinc than the RDA of 15 mg. per day does not mean that he is deficient in zinc. He noted that there is nothing i the medical literature which would indicate that the average man has such a deficiency (Tr. 34). He characterized the likelihood of impaired male sexual function due to zinc deficiency as "rare as hen's teeth" (Sandstead Deposition Sandstead Depo. at 50).
Dr. Sandstead also based his conclusions, in part, on some raw data that he had obtained from the Health and Nutrition Examination Survey-II (HANES-2) conducted by the Department of Health, Education, and Welfare. HANES-2 is the largest survey that has been conducted to assess zinc levels in humans (Sandstead Depo. at 9). At the time of the hearing, Dr. Sandstead was a member of the group of scientists who were interpreting the raw data of HANES-2 (Id. at 21, 45). After Respondent objected to Dr. Sandstead's testimony regarding HANES-2, Dr. Sandstead submitted an "Affirmation" after the hearing and attached the raw data relating to zinc obtained by the survey. These were admitted into evidence. He also testified by deposition that there is little possibility of zinc deficiency unless the level of zinc in the blood is below 70 micrograms per deciliter (Id. at 23, 42-43). According to Dr. Sandstead and the HANES-2 data, only about five to ten percent of the population have serum zinc levels below that level (Id. at 42-44). These findings demonstrate the falsity of Respondent's representations that the average man is deficient in zinc.
In addition to the above, Complainant introduced the testimony of Dr. Smith to the effect that the RDA for zinc is too high and that the National Academy of Science is considering whether it should be lowered. He predicted that it would be (Tr. 133, 149-50). Respondent complains that the Administrative Law Judge should not have relied on this "prediction" in making his findings. This contention is also rejected. This evidence is merely additional support for the finding of falsity which is fully supported by other evidence of record.
Finally, Respondent attacks the credibility of Dr. Sandstead. Respondent contends that a prior written statement made by Dr. Sandstead is inconsistent with his testimony at the hearing. He previously stated in a published article that " c current data suggest that mild zinc deficiency is not a rare phenomenon" (RX 12 at 117). He testified at the hearing that zinc deficiency in the United States is "probably more widespread than most people preach" (Tr. 56). However, these statements are not necessarily inconsistent with Dr. Sandstead's other testimony. Regarding the publication, the context of the statement included other countries and addressed diseases affecting zinc absorption. Moreover, the fact that something is
"not rare" does not meant that it is common. As to his comment during cross-examination it is not known what "most people preach," so the statement by itself does not indicate an incidence of zinc deficiency in conflict with his other testimony. In any event, Dr. Sandstead's testimony at the hearing was based significantly on the HANES-2 data, which clearly demonstrates that the average man is not deficient in zinc.
Respondent also contends that another statement, made by Dr. Sandstead in a 1982 article, is inconsistent with his reliance on the plasma zinc data from HANES-2 in this proceeding. He had previously stated:
"At present, there is no single, unequivocal index for measurement of zinc status of humans. Plasma zinc represents the most readily available and easily analyzed zinc pool. However, under circumstances of deficiency, plasma zinc may not reliably reflect depletion. A finding of low plasma zinc is presumptive evidence of impaired zinc nutriture, if a redistribution of zinc caused by an acute stimulus can be ruled out. On the other hand, normal plasma levels may be found even though the patient is zinc depleted." footnotes omitted . (RX 12 at 101)
The above statement is not inconsistent with Dr. Sandstead's testimony in the instant case. In reaching his conclusion that zinc deficiency is not widespread (Sandstead Depo., at 44), he relied in part on plasma zinc levels in the population obtained from HANES-2. However, he admitted:
"...having a plasma zinc of 70 or 72 in and of itself does not diagnose zinc deficiency. There is a lot more to it than simply a blood level. You can't prove that somebody is deficient on the basis of that." (Id. at 42).
His use of the HANES-2 plasma zinc data as reliable "presumptive evidence" for the purpose of proving that the average man is not deficient in zinc is not inconsistent with his previous statement.
Respondent also disputes the credibility of Dr. Sandstead in light of his statement at trial characterizing Respondent's advertising as a "gross, sleazy fraud" (Tr. 41). He made that comment while describing the portion of the advertisement concerning the "Tennessee man." He first testified that it was a "fraud" for Respondent to have stated that the man's penis began to grow "almost immediately" after taking zinc. Dr. Sandstead noted that he himself had treated this man with zinc for an entire year and that he had showed "small changes." It was only after quadrupling the amount of zinc and removing part of his small bowel that he subsequently began to mature over a 6-month period. While Dr. Sandstead's characterization of this and other misrepresentations as a "gross, sleazy fraud" may have been intemperate, the Administrative Law Judge had an opportunity to observe the demeanor of Dr. Sandstead and determined he was a credible witness. Respondent has failed to give any valid reason why the determination by the Administrative Law Judge should not be sustained.
"(b) Otherwise healthy males who are low in the 'sex nutrient' critical for maximum sexual performance will be materially aided in their sexual abilities by ingesting NSP-270."
"(f) A man with a deficiency in the 'sex nutrient' serious enough to cause a substantial diminution in his sex abilities may otherwise be in good health."
The Administrative Law Judge found these representations false on the ground that a person with a zinc deficiency severe enough to diminish sexual abilities would not be "otherwise healthy" (I.D. at 25-26). This finding was fully supported by the testimony of Complainant's experts. They established that impairment of sexual abilities due to zinc deficiency would be accompanied by other problems such as dermatitis, impaired night vision, and loss of taste acuity (Tr. 161; Sandstead Depo. at 49). It was also established that impairment of sexual abilities would usually be accompanied by such illnesses as malnutrition, intestinal malabsorption, renal failure, alcoholism, and cirrhosis (Tr. 31-34, 126-27).
There is no credible evidence of record that rebuts the above testimony by Complainant's experts. The studies Respondent relies on do not involve impairment of "sexual abilities" as that term is used in Respondent's advertisements. The latter define "weak sexual abilities" as "poor erections ...low sex drives ... inability to satisfy a woman in bed" (CX 1, 2 at 2). In contrast, various studies in the record address zinc as a treatment for subjects suffering dwarfism, renal malfunction and Crohn's Disease. Even the studies indicating that zinc deficiency causes a reduction in sperm count and testosterone levels (RX 6-8) do not address impaired sexual functioning. Therefore, these studies do not tend to prove the truth of Respondent's representations with respect to impairment of "sexual abilities" as defined by the advertisements.
In addition to improving "sexual ability," the advertisement also claims that NSP-270 will restore "reproductive functioning." It is noted that the zinc deficiency was artificially induced by dietary means in one of the studies relied on by Respondent, and it does not appear that the authors attempted to measure any effects of zinc deficiency other than gonadal function (RX 6, 7). Also, the Netter study (RX 8) found that oral administration of zinc increased the testosterone and sperm count levels of infertile males. However, these patients were given about four times the amount of zinc contained in Respondent's tablets, and the authors characterized their findings as "preliminary data."
Accordingly, Respondent's exception to these findings has no merit.
"(b) The ingestion of NSP-270 will improve the sexual performance of any man who is low in the 'sex nutrient'.
(g) The amount of the 'sex nutrient' contained in NSP-270 is adequate to reverse a deficiency in this nutrient serious enough to cause diminished sexual performance in males."
NSP-270 tablets contain either 15 or 20 milligrams of zinc. The Administrative Law Judge found that the ingestion of 15 or 20 mg. of zinc has not been shown to improve sexual function (I.D. at 27-28). This finding is based on the testimony of Dr. Sandstead who has been an expert in zinc nutrition for about 20 years (Tr. 21, 34). He also testified that there is no evidence that the ingestion of zinc, in any amount, would improve the sexual performance of a person who does not manifest any of the other symptoms of zinc deficiency (Tr. 34-35). Complainant established that Dr. Sandstead's views are consistent with the informed medical and scientific consensus (Tr. 52). By establishing that this consensus exists, Complainant made a prima facie case as to the falsity of the above representations. The burden of going forward with evidence thus shifted to Respondent, who was required to show either that the consensus does not exist or that the claims are true despite the lack of acceptance by the medical community. Cosvetic Labs., et al., P.S. Docket Nos. 8/160 and cases consolidated therewith (P.S.D. July 22, 1982, at 14); Standard Research Laboratories, P.S. Docket No. 7/48 (P.S.D. April 4, 1980) and cases cited therein; cf., Texas Dept. of Community Affairs v. Burdine, 450 U.S. 248 (1981).
Respondent's evidence is not persuasive to prove that the scientific and medical consensus is in error. Respondent points to Dr. Sandstead's own study with dwarfed, sexually retarded adolescent boys in Egypt (CX 13) to prove that small amounts of zinc can reverse a zinc deficiency. However, the patients in that study were extreme cases. Moreover, they were treated with one and a half to two times the amount of zinc contained in Respondent's product. This evidence fails to rebut the informed consensus.
"(c) The efficacy of NSP-270 in improving sexual performance in men has been established by competent, scientific tests and studies.
. . .
"(k) The efficacy of NSP-270 has been established by experiments conducted by the Veterans Administrative in Washington, DC."
Since Respondent admits that NSP-270, itself, has never been tested, the above representations are false. Moreover, as indicated in the discussion of subparagraphs (b) and (g), above, no competent, scientific tests and studies have been performed which prove that 15 or 20 mg. of zinc, the amount contained in NSP-270, improves sexual performance in males (Tr. 34).
In addition, the study performed at the Veterans Administration Hospital in Washington, DC, (CX 19) fails to prove the efficacy of Respondent's product. The study indicted that zinc deficiency is a major, reversible cause of impotence in some hemodialysed men. However, the zinc deficiency resulted from renal failure, so the implications of the test results are severely limited. In addition, substantially larger amounts of zinc were administered to these patients than the amount contained in Respondent's product. Further, although these patients took 100 to 150 mg. of oral zinc a day during the initial stages of the study, oral administration was discontinued because it raised plasma-zinc levels only slightly over a period of six months. Thereafter, the zinc was added directly to the dialysis bath. Although the latter means of administration appeared to be successful, this study fails to prove the efficacy of oral zinc products such as NSP-270.
Finally, the Administrative Law Judge found that the conclusion of the VA study was cast in doubt by a subsequent study (I.D. at 23; CX 25; Tr. 152-54), and noted Dr. Smith's testimony that the question is "still up in the air." Thus the Administrative Law Judge found representation (k) to be false, in part, because the conclusions of the VA study cannot properly be characterized as scientifically "established" in view of the later, contrary study. The finding of falsity is supported by this rationale. However, falsity is more clearly demonstrated by the fact that the VA study fails to establish the efficacy of NSP-270 since the latter contains much less zinc and is administered orally.
"(h) A. U.S. Naval Medical Research Unit successfully conducted a 'penis enlargement and erection improvement program' using the 'sex nutrient' contained in NSP-270."
The record fully supports the finding of falsity made by the Administrative Law Judge with respect to this representation. Respondent's advertisements make it appear that the primary goal of the U.S. Naval Medical Research Unit was "penis enlargement and erection improvement." However, growth of the male genitalia was only one aspect of the study and "erection improvement" was not even considered. In contrast to the impression created by Respondent's advertisements, the study made a wide variety of clinical and biochemical findings on a group of economically deprived Egyptian adolescents with growth retardation and associated zinc deficiency (CX 13).
"(i) Tests conducted by the USDA at Beltsville, MD on its own employees revealed that two out of three were significantly short of the recommended levels of the 'sex nutrient' contained in NSP-270."
As found by the Administrative Law Judge, Respondent's advertisements give the impression that the USDA study found that two out of three subjects had a significant zinc deficiency. This representation is false. The USDA study merely found that two- thirds of the subjects consumed less than the RDA for zinc in their self-selected diets. As discussed previously with respect to subparagraphs (a) and (e), the fact that the average man consumes less than the RDA for zinc does not mean that he has a zinc deficiency. Moreover, even if the advertisements is susceptible of two meanings, it is still ambiguous. Rhodes Pharmacal Co. v. F.T.C., supra. Accordingly, this exception has no merit.
"(j) The graph set forth in Respondent's advertising material represents actual increases in penis size that may be achieved through the use of NSP-270."
As previously indicated, the Administrative Law Judge properly held that a person of ordinary mind would have read the graph in Respondent's advertisements as set forth in subparagraph (j). The "before and after" pictures contained in the graph indicate that a man who takes NSP-270 will triple the size of his penis. Respondent does not seriously contend that the product will actually increase penis size as indicated on the graph, but simply argues that the graph does not make the alleged representation.
Dr. Sandstead testified that NSP-270 would not cause enlargement of the type indicated on the graph (Tr. 49) and there is no persuasive evidence of record that NSP-270 would result in enlargement of the magnitude depicted in the graph. Accordingly, the finding of falsity by the Administrative Law Judge is sustained.
Exceptions 3 - 9
"3. The Administrative Law Judge erred by wholesale rejection of expert medical testimony which supports Respondent's representations."
. . .
4. The Administrative Law Judge erred in crediting Complainant's witness' at-trial statements that were inconsistent with the witness' prior statements which supported Respondents."
In making his findings regarding the truth or falsity of the representations, the Administrative Law Judge set forth the qualifications and experience of all expert witnesses who testified in this proceeding (I.D. at 13, 16). He found Complainant's witnesses to be "more impressive and persuasive" than Respondent's witnesses. He also found that Complainant's witnesses were at "the forefront of research and personal involvement regarding zinc." On the other hand, he found that Respondent's witnesses did not have any special expertise in the field of nutrition and their testimony was primarily based on their review of the published literature on zinc nutrition (I.D. at 13, 16).
The record fully supports the conclusion by the Administrative Law Judge that the testimony of Complainant's witnesses was more reliable in view of their superior qualifications. Under the circumstances, it was appropriate for the Administrative Law Judge to rely on this testimony in making his findings of fact. Accordingly, Exception 3 has no merit.
In Exception 4 Respondent attacks the credibility of Complainant's expert witnesses by alleging that prior inconsistencies have been found, Exception 4 has not merit. These alleged inconsistencies have been previously discussed, to the extent necessary, under Exception 2 with regard to subparagraphs (a) and (e).
"5. The Administrative Law Judge erred in adopting virtually verbatim, Complainant's post-hearing submissions without a full and independent review of the record as a whole.
. . .
6. The Administrative Law Judge erred in relying on a publication not in evidence."
Respondent contends that the Administrative Law Judge failed to examine all of the evidence of record. In support of this position he points to the fact that the Administrative Law Judge adopted verbatim many of the proposed findings of fact submitted by Complainant. Then Respondent notes that the citation to "HANES-2" in the Initial Decision (I.D. at 22, 28) demonstrates that he failed to examine the record "since the HANES survey was not in evidence." However, it is clear that the Administrative Law Judge was not relying on any document not in evidence, but was merely relying on the data from HANES-2, which was attached as an exhibit to Dr. Sandstead's "Affirmation" dated March 21, 1983, and subsequently made a part of the record by order of the Administrative Law Judge dated May 2, 1983. Therefore, it was appropriate for the Administrative Law Judge to rely on this data in making his findings of fact, and his citation to that data does not indicate a failure to review the evidence of record.
In addition, all of the evidence of record has been carefully reviewed on appeal and it is concluded that the findings of the Administrative Law Judge are supported by a preponderance of the evidence. Accordingly, these exceptions have no merit.
"7. The Administrative Law Judge erred by shifting the burden of proof to Respondent to prove efficacy rather than properly placing it on Complainant to prove falsity."
As previously indicated, Complainant established through its expert witnesses that the informed medical and scientific consensus is that the representations set forth in the Complaint are false (Tr. 52, 139). By establishing that this consensus exists, Complainant made a prima facie case as to the falsity of these representations. The burden of going forward with evidence thus shifted to Respondents, who were required to show either that the consensus does not exist or that the claim of effectiveness is true despite the lack of acceptance by the medical community. Cosvetic Labs., et al., supra. Although the Administrative Law Judge placed the burden of going forward on Respondents, he did not shift the burden of proof. Therefore, this exception has no merit.
"8. The Administrative Law Judge erred in finding that lack of medical consensus, or issues 'still up in the air,' support a finding of falsity."
Respondent argues, in effect, that there is consensus that zinc is necessary to male sexual development and that the consensus is not affected by the inconclusiveness of certain tests. While it is not in dispute that zinc is an essential nutrient affecting sexual development, Respondent's advertisement makes representations about "maximum sexual performance" and organ growth in average American men. As Dr. Sandstead testified, impaired sexual functioning in American males due to zinc deficiency is essentially non-existent (Sandstead Depo. at 50). Thus, while the zinc in Respondent's product can reverse some zinc deficiencies, it has not been shown that small organ size or poor sexual performance in American males is attributable to zinc deficiency. As to the specific test at a Veterans Hospital which Respondent cites, zinc was not administered orally and the does was much larger than contained in NSP-270. See Exception 2(k). Not only was the test inconclusive, as the Administrative Law Judge found, but the nature of the patients (men with severe renal failure on dialysis) and the method and quantity of zinc administered render the test ineffective as support for Respondent's position. Respondent's exception is without merit.
"9. The Administrative Law Judge erred in relying on a non-medical doctor's 'prediction' which is totally contrary to all the evidence of record."
This issue was previously addressed under Exception 2 in the discussion of subparagraphs (a) and (e). For the reasons previously stated, this exception has no merit.
"10. The Administrative Law Judge erred in finding that a False Representation Order should be issued."
As addressed throughout this decision, the record amply supports the Administrative Law Judge's conclusion that a False Representation Order should be issued.
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 issued herewith.