In the Matter of the Complaint Against: SCHIFFAHRTS LABORATORIES, Box 2954 at Van Nuys, California 91408 P.S. Docket No. 3/193 04/26/76 Grant, Quentin E., Administrative Law Judge Daniel S. Greenberg, Esq. Law Department United States Postal Service Washington, D.C., for Complainant Fleishman, McDaniel, Brown & Weston by Barry A. Fisher, Esq. Los Angeles, California for Respondent Before: Quentin E. Grant, Administrative Law Judge
Complainant initiated this proceeding on April 15, 1975, by filing a complaint alleging that respondent is engaged in conducting a scheme or device for obtaining money or property through the mails by false representations in violation of 39 U.S.C. § 3005.
The product involved is called "Schiffahrts Laboratories Ginseng" (hereinafter sometimes referred to as the "product"). The complaint alleges that respondent attracts attention to the product by means of advertising matter containing false representations calculated and intended to induce readers thereof to remit to respondent money or property through the mails for the product.
The complaint specifically alleges that by means of said advertisements respondent falsely represents, directly or indirectly, by means of affirmative statement, implication, or omission, in substance and effect as follows:
"(a) That, as advertised in Exhibit A attached hereto, respondent's 'GINSENG' (not identified by name in advertisement):
1. will enable the user to overcome partial impotence and premature ejaculation;
2. will effect the results described in subparagraph 1, supra, irrespective of the cause of the user's condition;
(b) That, as advertised in Exhibit B n1 attached hereto, respondent's 'GINSENG':
n1 Exhibits A and B referred in the quoted allegations were received in evidence as exhibits C-4 and C-5, respectively.
1. will increase the size of the penis;
2. will, irrespective of the user's present state of sexual desire or ability, restore lost, and increase present:
a. desire;
b. ability to attain and retain an erection;
c. ability to attain and prolong orgasm;
3. will enable the user to overcome impotence;
4. will rebuild the cells of the gonads;
5. will cause an increase in, or resumption of, production of male sex hormones;
6. will, by means of the effects described in subparagraphs 4 and 5, supra, rejuvenate the entire body;
7. will strengthen the heart and nervous system;
8. will effect the results enumerated in subparagraphs 1-7, supra, irrespective of the cause of the user's present condition;
9. will effect the results enumerated in subparagraphs 1-8, supra, permanently for most users, even after the taking of 'GINSENG' is discontinued.
Finally, the complaint alleges that the representations alleged are materially false as a matter of fact.
Respondent's answer denies each allegation of the complaint and alleges the unconstitutionality of 39 U.S.C. § 3005 on numerous grounds. n2
n2 Essentially, the constitutional grounds urged are violations of respondent's rights of free speech, free press, due process, and equal protection and rights to compulsory process and jury trial under the First, Fifth, Sixth and Seventh amendments of the Constitution of the United States.
A hearing was held in Los Angeles, California, at which both parties introduced evidence. Both parties have submitted written argument, proposed findings of fact and conclusions of law.
1. Respondent uses the mails in advertising the product and in mail order sales thereof, including receipt of remittances for the product (Tr. 65, 66; Exhs. C-4, C-5, C-6).
2. The product (Ex. C-6) consists of filled capsules in a plastic bottle bearing a label containing the words "SCHIFFAHRTS LABORATORIES GINSENG" and directions for use thereon.
3. Exhibit C-5, an advertisement with mail order blank included, identifies the product as "the more potent and difficult to secure wild Manchurian ginseng which grows only in the Sikhote-Alin Mountains of Eastern Manchuria." Recent atlases reveal that said mountains are located not in Manchuria, but along the Pacific Coast of the U.S.S.R., northwest of Vladivostok in what is called the Maritime Province of South Siberia. Brittanica Atlas (1974) p. 79; National Geographic Atlas of the World (1975) p. 133.
4. Complainant conducted no chemical analysis or tests of the product. Neither of the medical experts who testified in the hearing had conducted analyses or tests of the product. Complainant's expert, Dr. Jack L. Segal, assumed, in expressing his opinions, that the product is Manchurian ginseng as identified in respondent's advertisement, Ex. C-2 (Tr. 75, 76). The answer filed in the proceeding by respondent, signed by James E. Poston, presumably the owner of respondent, who was present at the hearing but did not testify as to the ingredients of the product, identifies the product simply as ginseng. According to Dr. Segal the folklore is that the ginseng from Manchuria is more potent than that from Korea and western countries (Tr. 76).
5. Respondent's medical expert, Dr. Bruce W. Halstead, assumed, in expressing his opinions, that the product is Siberian or Russian ginseng having the scientific name eleutherococcus senticosus (Tr. 223). According to Dr. Halstead, Siberian (or Russian) ginseng is the more correct popular name for Manchurian ginseng (Tr. 114, 115). Dr. Segal was not familiar with the scientific name eleutherococcus senticosus (Tr. 81).
6. Dr. Halstead based his opinion on the efficacy of the product almost entirely on tests and studies made in Russia, papers written by Russian doctors and scientists and conversations with Russian scientists on a trip made by Dr. Halstead to Vladivostok in 1969 or 1970. Respondent put in evidence a paper (Ex. R-13) written by I.I. Brekhman who, according to Dr. Halstead, is the world's leading authority on a group of drugs, given the name "adaptogens" by the Russians, which includes eleutherococcus senticosus and ginseng. Exhibit R-13 creates a serious question as to what, if any, weight should be given to the testimony of Dr. Halstead insofar as his opinions were based on the assumption that the product involved in this proceeding is eleutherococcus senticosus. This is because the paper draws a definite distinction between ginseng and eleutherococcus senticosus. On pages 3 and 4 of this exhibit, Brekhman makes the following statements:
"One of the most important consequences in the study of ginseng was the increased interest toward other Aralia plants. Ginseng was always expensive and not readily available to people, who were always looking for a plant that could replace ginseng. However, more often, this gave rise to poor substitutes and falsifications. Only eleutherococcus (eleutherococcus senticosus Maxim.), a wild shrub that grows abundantly in the Soviet Far East, not only resembles ginseng, but, in some respects, is superior to it (8). In summer, eleutherococcus does not seem very ornamental (Fib. 8); in winter, it is conspicuous for its fruit (Fig. 9). Unlike the triterpene glycosides in ginseng, its active substances are ligmno glycosides (Fig. 10). Not only tinctures and extracts, but also individual glycosides act almost in the same way. Differences exist too, but they are less substantial.
Unlike ginseng, eleutherococcus acts even more universally. It is absolutely harmless even in very large doses and acts more reliably without any seasonal variations."
A distinction between ginseng and eleutherococcus senticosus is also made in other Russian literature placed in evidence by respondent (Dardymov paper, pp. 3, 9). Further, Dr. Halstead testified that he did not know and could not prove that the product involved in this proceeding is eleutherococcus senticosus.
7. Because those identified by Dr. Halstead as the world's leading authorities draw a clear distinction between ginseng and eleutherococcus senticosus and because respondent identifies its product as ginseng on the label thereon and in its advertising, I find that the product is ginseng, not eleutherococcus senticosus. Consequently, I place little weight on the testimony of Dr. Halstead insofar as such testimony is based on his assumption that the product is eleutherococcus senticosus.
8. I find that the respondent's advertisements make the representations that the product (a) will enable the user to overcome partial impotence and premature ejaculation (Ex. C-4; Ex. C-5, p. 1, 1st parag., lines 5, 6, 7; (b) will increase the size of the penis of the average user (Ex. C-4; Ex. C-5, p. 1, 1st parag., lines 6, 10; p. 2, 5th parag.); (c) will, irrespective of the user's present state of sexual desire or ability, restore lost and increase present: (1) desire (Ex. C-5, 1st p., 2nd parag., line 6); (2) ability to attain and retain an erection (Ex. C-4, Ex. C-5, 1st p., 1st parag., lines 5 and 6); (d) will enable the user to overcome impotence (Ex. C-4; Ex. C-5, 1st p., 2nd parag., lines 6, 7, 4th parag.); (e) will rebuild the cells of the gonads (Ex. C-5, 1st p., 1st parag., line 4); (f) will cause an increase in, or resumption of, production of male sex hormones (Ex. C-5, 1st p., 1st. parag., line 5; 4th parag., lines 16 and 17); (g) will, by means of the effects described in (e) and (f) above, rejuvenate the entire system (1st p., 1st parag., lines 4 and 5; 2nd p., 5th parag., lines 4 and 5); (h) will strengthen the heart and nervous system (1st p., 4th parag., lines 16 and 17) (i) will restore lost, and increase present ability to attain orgasm (Ex. C-5, 1st p., 2nd parag.); that the product will effect the results described in (a) through (i), above, irrespective of the cause of the user's present condition.
9. I do not find that respondent represents, as alleged in the complaint, that the product will effect the results described in (a) through (i) of Finding No. 8, above, permanently for most users, even after ingestion of the product is discontinued; or that respondent represents that the product will restore lost, and increase present, ability to prolong orgasm.
10. Complainant's medical expert, Dr. Jack L. Segal, was qualified to testify as to the history and folklore of ginseng and as to its efficacy or lack thereof. Pertinent to this matter among his qualifications are a B.S. degree in biochemistry, a medical doctorate, fellowships in clinical pharmacology, an instructorship in pharmacology, board certification in internal medicine, specialization in clinical pharmacology and search of the literature relating to ginseng (Ex. C-3; Tr. 5-7). Dr. Segal's testimony assumed that the principal constituent of the product is Manchurian ginseng (Tr. 74, 76). He testified that ginseng is, primarily, the root of a plant known as panex, the word panex being the Latin word for cure-all; that this root has a long and interesting history, having been described in Chinese and other oriental literature for many thousands of years. According to this history, or folklore, the most active form of ginseng is a wild, or uncultivated root, the Manchurian root being said to be the most potent, the Korean root the next most potent, with the wester product, grown in the United States, being considered to have little, if any, medicinal value although 100,000 pounds thereof were exported to the Orient in 1963. According to Dr. Segal, ginseng has not been listed as a drug of efficacy or interest in the National Formulary or the U.S. Dispensatory since 1882. He testified that there is no real pharmacology known about the product involved here (Tr. 72-74); that there are no studies of which he is aware, objective, controlled, or otherwise, to show that the various kinds of ginseng, including Manchurian, have any active effect whatsoever (Tr. 76).
11. Dr. Segal testified that the size of the penis is genetically predetermined, although certain diseases or trauma may affect penis size after birth; that such diseases may be treated with hormonal therapy and traumatic injury may sometimes be treated surgically; but that enlargement of the penis beyond the size genetically predetermined cannot be achieved either medically or surgically. Dr. Segal was of the opinion that nothing in ginseng will increase the size of the penis (Tr. 69). Respondent's medical expert, Dr. Halstead, testified that ingestion of respondent's product will not increase the size of the penis (Tr. 226, 227). Accordingly, I find that ingestion of respondent's product will not increase the size of the penis.
12. Dr. Segal testified that the principal factors influencing the male desire for sex, the ability to attain and retain erection of the penis, and the ability to achieve orgasm are the psychological state of the individual and his general physical health. He further testified that in some rare instances hormonal deficiencies could also be a factor in such desire and abilities (Tr. 10, 11). According to Dr. Segal there is no single treatment for problems in the area of such desire and abilities, each treatment depending on the cause of the problem. When the problem is due to psychological causes, treatment by a psychiatrist or psychologist is indicated. Organic problems call for medical treatment. Dr. Segal testified, and I so find, that there is nothing in respondent's product which will restore lost, or increase present, sexual desire, ability to attain or retain erection, ability to attain orgasm, enable the user to overcome impotence, or which will prevent premature ejaculation (Tr. 68-70).
13. Dr. Segal testified, and I so find, that there is nothing in respondent's product (a) which will rebuild the cells of the gonads; (b) which will cause an increase in or resumption of, production of male sex hormones; or (c) which will rejuvenate the entire body.
14. Dr. Segal testified that the terms strengthening of the heart and strengthening of the nervous system, as used in respondent's advertisement (Ex. C-5). are general lay terms and were, to him, very vague, the latter term having no analogous concept in medicine. He testified that certain diseases and heart attacks can damage the heart muscle and that there are drugs available for treatment of such damage which can increase the strength of the heart muscle and make it more efficient. In his opinion, however, and I so find, there is nothing in respondent's product which will strengthen the heart and nervous system (Tr. 77-79).
15. Based on Dr. Segal's testimony I find that his answers and opinions expressed therein are in conformity with the consensus of medical opinion (Tr. 79).
16. With respect to the testimony and opinions of respondent's medical expert, Dr. Halstead, I give it little, if any weight, as against that of Dr. Segal not only because there is serious doubt that the plant (eleutherococcus senticosus) on whose properties he based his opinions is present in respondent's product (see Finding Nos. 5 and 6, above), but also for the following reasons:
(a) Dr. Halstead is a biotoxicologist whose main professional concern has been with the toxicity, efficacy and development of poisons that might serve as components in the development of new drugs (Tr. 110) and with the location of drugs or crude drug products which he has turned over to the Department of Defense, the Central Intelligence Agency, or pharmaceutical companies for study, testing and evaluation (Tr. 147, 148). He has not been involved in or concerned with the final determinations as to efficacy of the drugs or crude drug products he has located (Tr. 149).
(b) Dr. Halstead's testimony as to incidental success in helping approximately four out of six patients, being treated for general debilitation, with complaints concerning loss of sexual desire or ability, was based on the use of eleutherococcus senticosus which, as found above, is distinguished from ginseng by the world's leading authorities. Further, in connection with these patients, Dr. Halstead testified that such success might have been due to a placebo effect of the drug (Tr. 153).
(c) The Russian studies and reports relied on by Dr. Halstead were based primarily on tests and experiments conducted on sexually immature white mice (Tr. 128, 129) and other animals (chickens, bulls, cows, etc.). In cross-examination Dr. Halstead indicated doubts as to whether, or the degree to which, results obtained in tests on animals can be extrapolated to humans (Tr. 196). Also, the Russian studies and reports give scant attention to the gonadotropic effect of adaptogens on animals, the primary emphasis being placed on the total "normalizing" or "tonic" effect of eleutherococcus senticosus on numerous organs and functions of the body. The only statement Dr. Halstead could point to concerning the gonadotropic effect of ginseng on the human male in the mass of Russian literature he had available was one appearing in the Brekhman paper at p. 6 in which the author compares seasonal variations in the effects of ginseng with absence of such variations in eleutherococcus. This statement reads in translation as follows: "The gonadotropic effect of ginseng (increased weight of seminal vesicles and prostatic gland) was observed only in winter; in summer, there was no effect, while in spring ginseng even had a reverse effect."
(d) There is other testimony of Dr. Halstead which seriously detracts from the weight which I give to opinions expressed by him as to the efficacy of respondent's product to produce the results represented in its advertising. For instance, at page 135 of the transcript, he testified that if you are a normal, healthy individual and if you are operating under optimum conditions, you will receive only minimal benefits or essentially no benefit at all from an adaptogen. Then at page 170 he testified that even if something has a gonadotropic effect on a human male, the ultimate result may not necessarily be an increase in sexual desire or ability to attain an erection.
17. Based on the foregoing findings of fact, I find that the representations made by respondent as set forth in Finding No. 8, above, are materially false in fact.
1. Respondent is engaged in conducting a scheme or device for obtaining money or property through the mails by means of false representations within the meaning of 39 U.S.C. § 3005.
2. Respondent's advertisements make the materially false representations found above and will be so understood by the average reader. See Donaldson v. Read Magazine, 333 U.S. 178, 179 (1948).
3. Respondent's argument that complainant was required to make a chemical analysis and test of the product involved on which to base its medical evidence is not well taken. See Skinny Suit, P.S. Docket No. 3/44, Postal Service Decision, February 19, 1976; Rogers Laboratories, Inc., P.S. Docket No. 4/123, Postal Service Decision, April 14, 1976. Complainant was at liberty to assume that the contents of the capsules were as stated on the label which respondent affixed to the container. It did so and its medical testimony, as found above, was based on that assumption. If the product contained something other than stated on the label, respondent had the opportunity to show that. Respondent did not do so.
4. The United States Circuit Court of Appeals for the 9th Circuit has recently upheld the constitutionality of 39 U.S.C. § 3005 under attack apparently identical with that set forth in respondent's answer and brief herein. Hollywood House International, Inc. v. Klassen, 508 F.2d 1276 (1974). See also Lynch v. Blount, 330 F. Supp. 689 (U.S.D.C., S.D.N.Y., 1971) aff'd 404 U.S. 1007 (1972).
5. Accordingly, an order pursuant to 39 U.S.C. § 3005 in the form attached should be issued against respondent.