In the Matter of the Complaint Against WALTER HEAD FRANK E. BUSH, INC. P. O. Box 361 at East Rockaway, NY 11518-0361 Post Office Box 362 at East Rockaway, NY 11518-0362 Post Office Box 0121 at Hewlett, NY 11557-0121 P.S. Docket No. 15/123; 01/27/84 Bernstein, Edwin S. APPEARANCE FOR COMPLAINANT: Thomas A. Ziebarth, Esq. Consumer Protection Division Law Department United States Postal Service Washington, DC 20260-1100 APPEARANCE FOR RESPONDENT: Anne C. Vladeck, Esq. Vladeck, Waldman, Elias & Engelhard 1501 Broadway New York, NY 10036-5560 BEFORE: Judge Edwin S. Bernstein
Complainant alleged and Respondent denied that Respondent was engaged in conducting a scheme or device for obtaining money or property through the mails by means of false representations in violation of 39 United States Code § 3005. By Order dated February 25, 1983, Complainant's unopposed motion to add Paragraph 4 to the Complaint was granted and by Order dated June 2, 1983, Complainant's unopposed motion to dismiss subparagraphs 3(l) and 3(m) of the Complaint was granted. At the hearing, Dr. Harold H. Sandstead and Dr. James C. Smith, Jr., testified for Complainant while Dr. Loretta M. McQuillan and Dr. Kasja Suljaga-Petchel testified for Respondent. Dr. Sandstead also testified by post-hearing deposition. The parties filed proposed findings of fact, proposed conclusions of law and memoranda. These have been considered. To the extent indicated, they have been adopted. Otherwise, they have been rejected as irrelevant or not supported by the evidence.
I. The Use of the Mails
Respondent's advertising materials solicit remittances of money through the mail in connection with the sale of Respondent's product NSP-270. In its Answer, Respondent admits an allegation to this effect which was made in Paragraph 1 of the Complaint. Additionally, Respondent's advertising materials (CX-1, 2 and 3) substantiate the allegation. A copy of CX-1 is attached as Exhibit 1 to this Decision.
II. The Advertising Representations
I further find that Respondent's advertisements make all the representations alleged in Paragraph 3 of the Complaint which are listed below, based upon the following language in Respondent's advertisements and rationale.
(a) U. S. Government Research has recently discovered that the average man is significantly deficient in a "sex nutrient" critical for maximum sexual performance.
New Medical Discovery] U. S. Government Research Team Finds Average Men Low in Nutrient Critical For Maximum Sexual Performance]
(CX-1 & 2, p. 1, CX-3)
Latest Findings Show Many Average Men Are Lower Than
They Should Be]
. . . .
In Denver, Colorado, an accidental discovery suddenly rocked the medical world back on its heels. Surprisingly low sex nutrient levels were discovered in "average" males who, up until then, had been thought to be normal. (Even though their girlfriends had always known they were "short"])
(CX-1 & 2, p. 2, CX-3)
U. S. Government Research Team Finds Average Men Low In Nutrient Critical For Sex]
(CX-1 & 2, p. 7, CX-3)
At page 12 of its proposed findings, Respondent argues that it does not expressly represent that the average man is "significantly deficient" in zinc and the use of the words "low" and "lower" in advertisements should not be interpreted to mean "significantly deficient". While "low" and "lower" by themselves can mean less than "significantly deficient", in the context of other dramatic language surrounding these words, I find that the advertisements' language impliedly represents that the average man is "significantly deficient" in zinc, the sex nutrient referred to in this matter. Such language, which includes "New Medical Discovery", "rocked the medical world back on its heels", "surprisingly low sex nutrient levels", conveys the impression that "low" means significantly low or significantly deficient.
(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.
If your level is low in the micro nutrient critical for maximum sexual performance, NSP-270 is guaranteed to help you get it up...and keep it up...to where experts say it should be] Yes, now--if you are in good health otherwise--and your sexual problems are a result of this rare deficiency--you can be sure that your erection is getting a FULL CHARGE of this vital sex nutrient, so it will always be "up to the mark" for maximum sexual performance]
(CX-1 & 2, p. 1, CX-3)
Cure For Weak Sexual Powers Discovered]
(CX-1 & 2, p. 2, CX-3)
See For Yourself What Extra Strength NSP-270 Can Do]
Perks Up The Sex Lives of World War II Vets]
(CX-1 & 2, p. 3, CX-3)
Revolutionary Medical Discovery For Better Erections]
(CX-1 & 2, pp. 2-3)
(c) The efficacy of NSP-270 in improving sexual performance in men has been established by competent scientific tests and studies.
Now]
A Tested "Sex Pill" For Men]
(CX-1 & 2, p. 1)
New Findings from medical research] Doctors have discovered that, in amazing but true cases, weak sexual ability--poor erections...low sex drive...inability to satisfy a woman in bed--can stem from a very rare sexual nutrition deficiency that has been treated in almost every case through the use of an amazing "sex nutrient" found in NSP-270]
(CX-1 & 2, p. 2, CX-3)
NOW] A GUARANTEED "SEX PILL" FOR MEN]
(CX-3)
Cure for Weak Sexual Powers Discovered]
The first breakthrough came in animal research at leading universities. Scientists traced weak sexual ability and reproductive failures to a micro mineral deficiency--then cured that deficiency and restored normal, healthy sex drive...erections...and reproductive functioning...using the amazing sex nutrient found in NSP-270]
(CX-1 & 2, p. 2, CX-3)
Because, in our files, we have actual proof and medical photographs that show
. Dramatic new erection power]
. New ability to satisfy a woman in bed]
. Amazing spurts of penis growth]
. Sensational ejaculations]
...all thanks to the use of the amazing sex nutrient in NSP-270] ACT NOW]
(CX-1 & 2, p. 4, CX-3)
(d) The ingestion of NSP-270 will improve the sexual performance of any man who is low in the "sex nutrient."
Revolutionary Medical Discovery For Better Erections]
(CX-1 & 2, pp. 2-3)
NSP-270 is now being released to adult men, for your private and personal use. If your "sex nutrient" level is low, NSP-270 is guaranteed to help you get it up...keep it up...and keep your organ growing] Yes, if you are in good health otherwise, in this respect we guaranteed that when you have an erection--now your erection will always be "up to the mark" for maximum sexual performance]
Yes, if you want to be sure that your erection has the sex nutrients it needs to do the best job possible...if you want to be sure that your sperk is getting what it needs to "keep it perking"...if you want to be absolutely certain that your sex life won't "die young" due to sex nutrient depletion...NSP-270 is guaranteed to give you the full daily sex nutrient charge--and more--that experts say you need to keep your organ standing "ready and able"]
(CX-1 & 2, p. 4, CX-3)
(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.
U. S. Government Research Team Finds Average Men Low in Nutrient Critical For Sex]
Vital Announcement For Men]
(CX-1 & 2, Envelope)
Latest Findings Show Many Average Men Are Lower Than They Should Be]
(CX-1 & 2, p. 2)
Then came the most amazing sex discovery of the century-:
In Denver, Colorado, an accidental discovery suddenly rocked the medical world back on its heels, Surprisingly low sex nutrient levels were discovered in "average" males who, up until then, had been thought to be normal. (Even though their girlfriends had always known they were "short"])
So important were these findings that the U. S.Department of Agriculture at Beltsville, Maryland, repeated the Colorado research using their own methods. Any they encouraged their own employees to take part in this revolutionary program] The result? Two out of three so-called "average" subjects in the program were proven short of the recommended level that has been established by the National Research Council of the National Academy of Sciences. Yet, NSP-270 was all they needed to bring them "up to the mark"...and beyond]
(CX-1 & 2, p. 2, CX-3)
Although the advertisements refer to "this rare deficiency", the other language refutes such an impression. Such references as "average men low" in the heading, "if you are in good health otherwise," "average men are lower than they should be", "two out of three so-called 'average' subjects ... were proven short of the recommended level", effectively contradict the word "rare" and represent that deficiencies in NSP-270's sex nutrient or zinc are relatively common.
(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.
If your "sex nutrient" level is low, NSP-270 is guaranteed to help you get it up...keep it up...and keep your organ growing] Yes, if you are in good health otherwise, in this respect we guarantee that when you have an erection--now your erection will always be "up to the mark" for maximum sexual performance] (underscoring supplied)
CX-1 & 2, p. 4)
Now NSP-270 is guaranteed to help keep your daily sex nutrient intake level up to and above where experts say it belongs, so that now, when you have an erection--if you are in good health otherwise--and if your sexual problems are a result of this rare deficiency--you can be sure that your erection is getting all the sex nutrient it needs to be "up to the mark" for maximum sexual performance]
(CX-1 & 2, p. 1)
(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.
If your level is low in the micro nutrient critical for maximum sexual performance, NSP-270 is guaranteed to help you get it up...and keep it up...to where experts sayit should be] Yes, now--if you are in good health otherwise--and your sexual problems are a result of this rare deficiency--you can be sure that your erection is getting a FULL CHARGE of this vital sex nutrient, so it will always be "up to the mark" for maximum sexual performance]
(CX-1 & 2, p. 1, CX-3)
(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.
Thus, allegation was admitted in Respondent's Answer and is supported by the following language in Respondent's advertising:
U. S. Navy Uses This Discovery To Give Men Dramatic Increase In Penis Size
Among the official U. S. Government agencies that quickly took an interest in this astonishing sex discovery was the U. S. Navy's Medical Research Unit #3. Boys who couldn't measure up to the Navy's proud standards of manhood...who would never be able to satisfy a "woman in every port"...who would disgrace the uniform if they were ever allowed to wear it...were given massive dosages of this amazing sex nutrient found in NSP-270. And, the results of this U. S. Navy penis enlargement and erection improvement program have been hailed by the medical press throughout the world]
Fellows who were totally impotent...who couldn't ejaculate...who suffered from embarrassingly small penis dimensions--suddenly and dramatically experience--
. Proud Erections]
. Dramatic New Ability In Intercourse]
. Supercharged Sperm That Now Can "Do The Job]"
...And, most amazing of all, fantastic growth in penis size]
(CX-1 & 2, p. 2, CX-3)
(i) Tests conducted by the USDA at Beltsville, Maryland on its own employees revealed that 2 our of 3 were significantly short of the recommended levels of the "sex nutrient" contained in NSP-270.
This allegation was admitted in Respondent's Answer and is supported by the following language in Respondent's advertising:
So important were these findings that the U. S. Department of Agriculture at Beltsville, Maryland repeated the Colorado research using their own methods. And they encouraged their own employees to take part in this revolutionary program] The result? Two out of three so-called "average" subjects in the program were proven short of the recommended level that has been established by the National Research Council of the National Academy of Sciences. Yet, NSP-270 was all they needed to bring them "up to the mark"...and beyond]
(CX-1 & 2, p. 2, CX-3)
(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.
The graph found on page 3 of Respondent's advertising brochure invites the reader to "See for yourself what extra strength NSP-270 can do]" A series of before and after entries on the graph strongly imply to the average male reader that the ingestion of extra strength NSP-270 will cause a substantial increase in the size of his penis.
(k) The efficacy of NSP-270 has been established by experiments conducted by the Veterans Administration in Washington, D.C.
Perks Up The Sex Lives Of World
War II Vets]]
After reviewing the wonderful results that were now being achieved with this amazing sex discovery by medical teams around the world--in England...Iran...New York...and Tennessee--whose work was giving men, good, healthy erections...sperm that could do the job...increased sex drive...sensational spurts of penis growth--the Veteran's Administration in Washington, DC, began conducting sex nutrient experiments of its own, on older men--haemodialysed World War II vets--who had totally lost their ability to have sex.
The result] In just two weeks, men whose sex lives had been down to rock bottom zero...men who couldn't get an erection no matter how hard they tried...men whose organs were absolutely limp--suddenly found themselves getting erections with ease]
(CX-1 & 2, p. 3, CX-3)
Here Are Some Of The Actual Results Doctors Have Achieved
In Part By Using The Amazing "Sex Nutrient" Found in NSP-270]
* * * *
True Case History #782
Restores The Sexual Potency Of Haemodialysised World War II Vets]]
(CX-1 & 2, p. 6)
III. The Truth or Falsity of The Representations
Before discussing the truth or falsity of each allegation in Paragraph 3, I make the following preliminary findings:
A. Respondent's Products
NSP-270 is a multi-vitamin-mineral preparation furnished in tablet form. Each tablet contains, among other things, 100% (or more) of the RDA of vitamins A, C, D and E, as well as a number of vitamins in the B complex. Also included are true minerals, iodine, iron and zine.
NSP-270 comes in two strengths, regular strength (CX-5) and extra strength (CX-5a). The formulations are identical except that regular strength NSP-270 contains 12.5 mg. of B-6 (625% of the RDA) and 15.0 mg. of zinc (100% of the RDA). Extra strength NSP-270 contains 25 mg. of B-6 (1,250% of the RDA) and 20.0 mg. of zinc (133% of the RDA).
All of the evidence in this proceeding relates to the role of zinc as a supposed sex nutrient. The essential difference between regular strength NSP-270 and extra strength NSP-270 is that regular strength NSP-270 provides 100% of the RDA of zine while extra strength NSP-270 provides 133% of the RDA of zinc.
B. The Witnesses
I found that Complainant's witnesses, Doctors Sandstead and Smith, were more impressive and persuasive than Respondent's witnesses, Doctors McQuillan and Petchel. Complainant's witnesses, were at the forefront of research and personal involvement regarding zinc. Respondent's witnesses, while qualified medical doctors, had no personal involvement with zinc and, in essence, read and analyzed research reports of others.
Dr. Harold H. Sandstead received his medical degree from Vanderbilt University School of Medicine in 1958. His post-graduate work includes an internship and residency at Barnes Hospital in St. Louis, Missouri and a further residency at Vanderbilt University School of Medicine. His academic appointments include Assistant Professor of Biochemistry and Medicine as well as Associate Professor Nutrition all at Vanderbilt University School of Medicine. He is currently an adjunct professor of Biochemistry and Medicine at the University of North Dakota School of Medicine and is Director of the Nutrition Division of the Department of Internal Medicine at that institution.
Since 1971 Dr. Sandstead has been Director of the Human Nutrition Research Center of the United States Department of Agriculture Research Service at Grand Forks, North Dakota. He is board certified in Internal Medicine as well as in Nutrition. He is on a large number of committees dealing primarily with problems of nutrition, especially those involving trace minerals. He has served or is currently serving on the editorial boards of a number of prestigious medical journals. (CX-10)
Dr. Sandstead's area of specialization is the role of trace minerals--especially zinc--in human nutrition. He has published widely in this field. (CX-10, Tr. 21) There are a total of 19 articles from peer-review medical journals in this record. Dr. Sandstead is the author or co-author of eight of them including two introduced by Respondent. (CX-11-13, 15-17; RX-9, 12) Dr. Sandstead is a recognized leading expert in zinc nutrition. Dr. McQuillan who testified for Respondent, acknowledged that Dr. Sandstead is one of the outstanding researches in the field. (Tr. 213)
Dr. James Cecil Smith, Jr. is Laboratory Chief of the Vitamin and Mineral Nutrition Laboratory, Nutrition Institute, United States Department of Agriculture, Beltsville, Maryland. He is also a Professional Lecturer in Biochemistry at George Washington University School of Medicine, in Washington, DC. Dr. Smith's research activities are outlined in his Curriculum Vitae. (CX-20) He has over 71 abstracts and 78 articles in the peer-reviewed medical or scientific literature in which he is either the lead author or co-author. (CX-21, 22)
Dr. Smith's particular area of interest and expertise is trace element nutrition, especially zinc. (CX-20, 21, 22; Tr. 113) He is one of the co-authors of CX-19 and CX-26.
Dr. Loretta M. McQuillan received her M. Sc. and M.D. degrees from the University of British Columbia, Vancouver, Canada. She did her internship at the Cooper Hospital, New Jersey, which is affiliated with the University of Pennsylvania. She has done a residency in both Internal Medicine and Neurology at New York Medical College and is specialty board eligible. She is licensed to practice medicine in Canada and New York.
Dr. McQuillan's research activities since receiving her M.D. degree are in the field of Neurology including the use of L-Dopa in the treatment of Parkinson's Disease and studies of chronic brain disease. (RX-2) Her Curriculum Vitae lists no publications. There is nothing to indicate that she has any special expertise in the field of nutrition. Her testimony in this proceeding was based on her review of the published medical literature. (Tr. 183, 186, 190, 213, 229)
Dr. Kasja M. Suljaga-Petchel (Hereafter Dr. Petchel) received her medical degree from the University of Zagreb School of Medicine in Yugoslavia. She did post-graduate work in public health at the University of Zagreb and further studies at the Harvard University, School of Public Health where she received her M.Sc. degree in 1976. Her field of specialization is Epidemiology of Noncommunicable Diseases. (RX-3, 5; Tr. 247-9)
Dr. Petchel's published materials are all in the Croatian language (with English abstracts available). She has several additional articles in preparation. (RX-3) She was recently advised that she had been certified by the American Board of Preventive Medicine as a specialist in Public Health and General Preventive Medicine. (RX-4)
Like Dr. McQuillan, Dr. Petchel has no particular expertise in nutrition or trace element nutrients. She relied primarily on the published literature on zinc nutrition in preparing for her testimony. (Tr. 251-253, 265, 272-3, 277-85)
I further find that, except for subparagraphs l and m, the representations set forth in Paragraph 3 of the Complaint are materially false. The representations, but not necessarily in the order alleged, together with the basis of my findings follow:
(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.
Respondent's advertising labels the research program conducted by the U. S. Navy's Medical Research Unit No. 3 as a "penis enlargement and erection imporvement program." What the advertisements did not disclose is that the subjects of this research were Egyptian boys suffering from malnutrition so acute that their growth was severely stunted. Moreover, the advertisements implied that the subjects were potential Navy recruits: "Boys who couldn't measure up to the Navy's proud standards of manhood ... who would never be able to satisfy a woman in every port ... who would disgrace the uniform if they were ever allowed to wear it." The facts relating to the research activities of the U. S. Navy's Medical Research Unit No. 3 were set forth in Exhibits CX-12, 13 and 14. (Also Tr. 42-48, 95-96)
Dr. Sandstead, who was personally involved in this study, pointed out:
That work was done on Egyptian adolescent boys. It was not done on U. S. Naval personnel. It was done at the U. S. Naval Medical Research Unit No. 3. The persons involved were on the faculty of Vanderbilt who were working there on a N.I.H. grant. There were some U. S. Naval personnel who participated. August Miale, Jr. was a U. S. Naval medical officer. I was a U. S. Public Health Service officer, at that time. Dr. Prasad was there and Arthur Shulert was there as Vanderbilt staff.Dr. Soheir Farid an Egyptian was director of clinical investigation of NAMRU. Dr. Bassilly was an Egyptian physician employed to manage the ward on a day-to-day basis. (Tr. 43-44)
Dr. Sandstead emphasized that, it was not a study to measure enlargement of the male genitalia.
* * * *
We were interested in their dwarfism, growth failure, a severe dwarfism, similar to hypopituitism, a depression of the function of the pituitary gland. There is a dwarfism associated with failure to produce growth hormone. These people had impaired growth. Many of them were iron deficient. One of the manifestations in association with their dwarfism was a failure of sexual maturation. They appeared to have an arrested development. A person of 16 years of age would appear to be 9. (Tr. 44)
Biologically, these young men were actually children and the fact that they may not have had a sex life was "not a part of the issue". (Tr. 45-46) Dr. Sandstead explained,
That wasn't the reason we were studying them. We studied them because their overall development was arrested. It was a very unusual type of dwarfism. (Tr. 46)
Dr. Sandstead noted that even without therapy, people similar to the subjects eventually matured sexually.
Prasad also studied some subjects at an oasis in upper Egypt, and I believe that was Kharga Oasis, who had zinc deficiency and growth failure and delayed sexual maturation. They received no therapy at all. They were studied again several years later, the same subjects by Dr. Yankovel, and over time, they had gradually matured, much later than most people in this country. They had eventually matured. They were small in stature, but had matured sexually. I suspect this is what happens to many of these people in the villages. I might point out that they have lots of children. (Tr. 46)
(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.
Respondent's advertisement contains a paragraph that states: "Surprisingly low sex nutrient levels were discovered in 'average' males who, up until then, had been thought to be normal." Respondent adds parenthetically, "(Even though their girl friends had always known they were 'short'])". Immediately following this paragraph Respondent's advertisement refers to the self-selected diet study conducted by the U. S. Department of Agriculture's Nutrient Composition Laboratory at Beltsville, MD. (CX-1, 2, para. 2) The implication is that the subjects of the Beltsville study were sexually deficient. The Beltsville experiment is described in detail by Holden, et al., in the article, Zinc and Copper in Self-Selected Diets. (CX-23) This study found that the subjects' average intake of zinc was 8.6 mg. per day. While this is below the RDA for zinc of 15 mg. per day, there was no indication that any of the subjects manifested symptoms of zinc deficiency. Moreover, this intake level is in line with many of the zinc intake levels reported in the literature. (CX-23, pp. 25-26 and table 5)
Dr. Sandstead testified that the usual American diet provides between 7 and 8 mg. of zinc daily and that this is adequate to maintain homeostasis. (Tr. 21-22)
The record contains aevidence that many average people consume less zinc daily than the recommended daily allowances (RDS's) established by the National Academy of Science. (Tr. 53, 57-58, 258-259, CX-23) However, this does not establish that the average person is significantly deficient in zinc critical for his maximum sexual performance. When the RDA for zinc was first established in 1974 there was very little information available and the 15 mg. level was based on very limited observations. (Tr. 28) That number probably came from the data of a Dr. Spencer who found her subjects in equilibrium at 12.5 mg. A few more milligrams were added empirically. Fifteen seemed like a good number. (Tr. 29)
It is not correct to say that a person getting less than the RDA is deficient. Deficiency is another issue. As Dr. Sandstead noted, "Most of us consume less than the RDA. Obviously, we are not in bad health." (Tr. 29)
Dr. Sandstead testified that he follows all research done in zinc and that this research is massive. He is not aware of any research that would suggest that the average man in the United States is significantly deficient in zinc. (Tr. 30) Very few cases of zinc deficiency are seen in the United States. Dr. Sandstead concluded that since there is no clinical evidence that many people are deficient in zinc, he must assume that they are not deficient. (Tr. 31)
In establishing recommended dietary allowances the National Academy of Science attempts to set the levels high enough to insure that virtually all persons will receive enough of the nutrient to insure against any possibility of deficiency. (Tr. 28)
Since the RDA was established at 15 mg./day there have been important advances in knowledge about the actual requirements for zinc by humans. It now appears that the RDA for zinc as established by the National Acadmey of Science is excessive. Dr. Smith predicted that the RDA for zinc will be substantially lowered as a result of recently discovered data. Such a change is under consideration by the National Academy of Science. (Tr. 133, 149-50) Among these recently discovered data is the fact that the overwhelming majority of the population of the United States were found to have serum zinc levels sufficiently high to virtually guarantee that they are not deficient notwithstanding the fact that their zinc intake levels are well below the RDA--typically in the range of 8 to 12 mg. per day. (HANES-2)
(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's advertising represents that NSP-270 is effective in increasing the size of the male user's penis. This implication is made in the "before and after" illustrations contained in the bar graph. A similar representation is made in the paragraph headed, "Tennessee Man Doubles the Size of His Penis." This section is meant to imply and does imply that ingestion of NSP-270 will do the same thing for other "average men" who "are lower ahn they should be". The young man in question was Dr. Sandstead's patient. A detailed account of the case is given in Zinc Deficiency in Crohn's Disease. (RX-9) Before treatment the subject had the appearance of a 12 year old child. In some respects his problem was similar to the adolescents in Egypt and Iran in that his growth generally was severely retarded. While the size of his genitalia doubled, this most probably was because he was biologically a child before treatment. The Nashville case was very unusual. The patient suffered from a significant intestinal malabsorption problem. The treatment involved not only surgery to remove part of his small bowel but massive doses of zinc--up to 400 mg./day. This is 26 times the RDA and the equivalent of 20 extra strength NSP-270 tablets] (Tr. 40)
(k) The efficacy of NSP-270 has been established by experiments conducted by the Veterans Administration in Washington, D.C.
An article entitled, Reversal of Uraemic Impotence by Zinc (CX-19) describes an experiment conducted at the Veterans Administration Hospital in Washington, D.C. It involved eight men who had been on haemodialysis for a number of years. They all had low plasma-zinc levels and suffered some degree of impotence although libido was normal.
Initially the patients were given large doses of zinc orally. (150 mg. per day) Because of gastric disturbances, that was later reduced to 100 mg. per day. This increased their plasma-zinc levels only slightly over a period of six months. The oral zinc was discontinued and, instead, zinc chloride was added directly to the dialysis bath. This resulted in an increase in plasma-zinc from an average of 63 micrograms/deciliter to a range of 100 to 150 micrograms/deciliter. It was accompanied by a striking improvement in potency. The study concluded that zinc deficiency is a major, reversible cause of impotence in some haemodialysed men.
The findings of the Veterans' Administration Hospital, however, were case in doubt by an experiment conducted by Brook, et al in England. (CX-25) Using essentially the same technique of adding zinc chloride to the dialysis bath, Brook found that the administration of zinc had no significant effect on any aspect of sexual functions whether measured by subjective or objective criteria.
Dr. Smith, one of the co-authors of CX-19 who personally participated in the VA study emphasized that it is by no means established that zinc deficiency is a reversible cause of gonadal dysfunction. While Prasad, another authority on zinc, was of the opinion that oral zinc may have some impact, Brook and his colleagues found no effect. Dr. Smith concluded that question is "still up in the air." (Tr. 152-3)
(a) U. S. Government Research has recently discovered that the average man is significantly deficient in a "sex nutrient" critical for maximum sexual performance.
Respondent's advertising refers to four U. S. Government related activities. These are (1) the research of Naval Medical Unit No. 3; (2) the USDA Self-Selected Diet Experiment; (3) the Nashville Case, and (4) the Veterans Administration Study. For the reasons already discussed none of these activities substantiates the representation and there is no other evidence of record of any other U. S. Government research discovery that substantiates the representation.
(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 sexual abilities may otherwise be in good health.
Although Respondent's advertising repeatedly suggests that a person might be otherwise healthy and still be so deficient in zinc as to impair sexual function, there is nothing in the record to support such a position. On the contrary the "case histories" cited by Respondent all involve persons who were far from "otherwise healthy." The adolescent boys and young men in Egypt and Iran were so malnourished that they suffered a severe dwarfism. (CX-14) The young man in Nashville had Crohn's disease which, in addition to zinc therapy, required numerous hospitalizations and surgical intervention. (RX-9) A person requiring haemodialysis would hardly be called "otherwise healthy." (CX-23, 26)
Dr. Smith testified that persons who have clinically definable features of zinc deficiency would be malnourished in general. If a person had sexual dysfunction as a result of malnutrition, it would be part of a complicabed condition. (Tr. 126-27) In any event, if a person had a serious zinc deficiency merely taking the RDA would not reverse the condition. (Tr. 128-29) He pointed out that administering the RDA brought about no improvement in the Iranian subjects. Six to ten times the RDA is required in the dialysis subjects and then it is not even administered orally. (Tr. 130-31)
On cross-examination, Dr. Smith noted that sexual dysfunction is not the first sign of a zinc deficiency. One would first see dermatitis, impaired night vision and other problems. (Tr. 161)
Dr. Sandstead testified that persons with a serious zinc deficiency will suffer from dermatitis. They will usually have some other underlying disease and zinc deficiency is just one of a host of things related to that. Several examples he gave are: intestinal malabsorption, renal failure, alcoholism and cirrhosis. He concluded that then the ingestion of the RDA would not be sufficient to reverse the condition. (Tr. 122)
(c) The efficacy of NSP-270 in improving sexual performance in men has been established by competent scientific tests and studies.
The record contains absolutely no evidence that NSP-270 (either regular strength or extra-strength) has been tested in any way. Moreover, there is no evidence of any clinical study or test involving the administration of zinc in doses of 15 or 20 mg. per day.
The record does contain medical articles about the use of zinc therapy in treating various forms of sexual dysfunction. However, these studies involve much larger doses, different modes of administration, and frequently other modes of treatment in which zinc therapy is only a part. There is no reason to conclude that NSP-270 would not have been useful in treating the subjects of the articles in this record. (CX-11-14, RX-9, 12)
Dr. Sandstead testified that he knows of nothing in the literature that would tend to show that the ingestion of the RDA of zinc would improve sexual performance. (Tr. 34) There is no evidence that a zinc supplement taken by a person with no deficiency symptoms would improve his sexual function except, possibly, a placebo effect which, he added, is not a pharmacological phenomenon. (Tr. 35)
(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.
The HANES-2 data show that zinc deficiencies are uncommon in the United States. Over 90% of the population have serum zinc levels of 81 or better. Seventy is considered the threshold level at which zinc deficiency might occur and Dr. Sandstead has never seen an individual with a zinc deficiency with a serum zinc level above 60. (Deposition 49) There is no data on the record to contradict these reliable findings.
The HANES-2 survey is a comprehensive study that was undertaken to determine the nutritional status of the American population as a whole. (Tr. 105) The study showed that over 90 percent of the population have serum zinc levels above 81 micrograms per deciliter. (Tr. 109) Moreover, Dr. Sandstead testified, "we don't become suspicious...until plasma zinc is less than 70". (Tr. 110) Although Dr. Sandstead did state that "zinc deficiency is probably more widespread than people preach" (Tr. 56), other statements by Dr. Sandstead (Tr. 31, 34, 100) and the HANES-2 data do not support a finding that zinc deficiency is particularly common in the United States.
(d) 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.
As indicated by the evidence, although the average American ingests less than the RDA, he is not deficient in zinc. As I have previously found, the ingestion of 15 or 20 mg. of zinc has not been shown to improve sexual function. Sexual function was only improved through zinc in persons suffering from other problems who ingested doses of zinc much larger than found in NSP-270.
1. The meaning of an advertising representation is to be judged from a consideration of the advertisement in its totality and the impression it would most probably create in ordinary minds. Donaldson v. Read Magazine, 333 U. S. 178 (1948); Vibra-Brush Corp. v. Schaffer, 152 F. Supp. 461 (S.D.N.Y. 1957); Borg-Johnson Electronics v. Christenberry, 169 F. Supp. 746 (S.D.N.Y. 1959).
2. An advertisement as a whole may be completely misleading although every sentence separately considered is literally true. This may be because things are omitted that should be said, or because advertisements are composed or purposefully printed in such a way as to mislead. Donaldson v. Read Magazine, supra.
3. The average person reading Respondent's advertisements would interpret them substantially as characterized in Paragraph 3, subparagraphs (a) through (k) of the Complaint.
4. The effect of false representations is not dispelled by a money-back guarantee. Borg-Johnson Electronics v. Christenberry, supra.
5. Complainant has established its case by means of reliable, probative and substantial evidence of record. Leach v. Carlile, 258 U. S. 138 (1922); Donaldson v. Read Magazine, supra.
6. The Postal Service need not show actual victims in a proceeding of this type. See: Norton v. U. S., 92 F.2d 753 (9th Cir. 1937).
7. In the context of Respondent's other advertising language the use of the word "rare" in various phrases does not serve to erase or outweigh the claims represented. A disclaimer will not necessarily refute otherwise emphatic representations. See: Gottlieb v. Schaffer, 141 F. Supp. 7 (S.D.N.Y. 1956); Vibra-Brush v. Schaffer, supra; Black Magic Shop Astral Co., P.O.D. No. 2/210 (1965); Virtu Imports, Inc., P.O.D. 3/2 (1968); Manuel Garcia Imports, P.S. 5/127 (1977).
8. Therefore Respondent is engaged in the conduct of a scheme for obtaining money through the mails by means of materially false representations in violation of 39 U.S.C. § 3005 and a False Representation Order in the form attached should be issued against Respondent.