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Author Topic: Eine massive Klage gegen etliche Täter, absolut lesenswichtig  (Read 2779 times)

pordi

  • Jr. Member
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  • Posts: 173

Ein Blick hinter die Kulissen der Mafia:

http://www.usps.com/judicial/1981deci/9-173d.htm
[*quote*]
United States Postal Service(TM)

 In the Matter of the Complaint Against

 COSVETIC LABORATORIES
 P. O. Box 53098
 at Atlanta, GA 30305
 P. O. Box 10101
 at Atlanta, GA 30319
 P. O. Box 14048
 at Atlanta, GA 30324
 P. O. Box 49024, 49303, 39087 and 49425
 at Atlanta, GA 30329
 P. O. Boxes 95544 and 95545
 at Atlanta, GA 30347
 P. O. Boxes 20190, 20429 & 20499
 at Atlanta, GA 30325

 BRASWELL, INC.
 P. O. Box 11527
 at Atlanta, GA 30305
 P. O. Box 14092
 at Atlanta, GA 30324

 BRASWELL, INC.
 470 East Paces Ferry Road
 at Atlanta, GA 30305
 P. O. Box 11627
 at Atlanta, GA 30305
 P. O. Boxes 9953, 10064 and 10101
 at Atlanta, GA 30319
 P. O. Boxes 14009 and 14092
 at Atlanta, GA 30324
 P. O. Box 81345
 at Atlanta, GA 30366

 COSVETIC LABORATORIES
 P. O. Box 53098
 at Atlanta, GA 30305
 P. O. Box 10064
 at Atlanta, GA 30319
 P. O. Boxes 14048 and 14092
 at Atlanta, GA 30324
 P. O. Boxes 20190, 20429 and 20499
 at Atlanta, GA 30325
 P. O. Boxes 49024, 49087, 49303 and 494
 at Atlanta, GA 30329
 P. O. Boxes 95543, 95544 and 95545
 at Atlanta, GA 30347

 EARTHQUEST, LTD.
 P. O. Box 49024
 P. O. Box 49087
 P. O. Box 49303
 at Atlanta, GA 30329

 COSVETIC LABORATORIES
 P. O. Box 53098
 at Atlanta, GA 30305
 P. O. Box 10064
 at Atlanta, GA 30319
 P. O. Box 14048
 at Atlanta, GA 30324
 P. O. Boxes 20190, 20429 and 20499
 at Atlanta, GA 30325
 P. O. Boxes 14092 and 49425
 at Atlanta, GA 30329
 P. O. Boxes 95543 and 05545
 at Atlanta, GA 30347

 COSVETIC LABORATORIES
 P. O. Box 53098
 at Atlanta, GA 30305
 P. O. Boxes 14048 and 14092
 at Atlanta, GA 30324
 P. O. Box 49425
 at Atlanta, GA 30325
 P. O. Boxes 95544 and 95545
 at Atlanta, GA 30347
 P. O. Boxes 20190, 20429 and 20499
 at Atlanta, GA 30325

 BRASWELL, INC.
 470 E. Paces Ferry Road
 at Atlanta, GA 30305
 P. O. Box 11627
 at Atlanta, GA 30305
 P. O. Box 11627
 at Atlanta, GA 30305
 P. O. BOxes 9953, 10064 and 10101
 at Atlanta, GA 30319
 P. O. Boxes 14009 and 14092
 at Atlanta, GA 30324
 P. O. Box 95544
 at Atlanta, GA 30347
 P. O. Box 81345
 at Atlanta, GA 30366

 COSVETIC LABORATORIES
 P. O. Box 14048
 at Atlanta, GA 30324
 P. O. Box 49087
 P. O. Box 49303
 at Atlanta, GA 30329

 LA FLEUR NATURAL
 P. O. Box 14048
 at Atlanta, GA 30324
 P. O. Box 49087
 P. O. Box 49303
 at Atlanta, GA 30329

 COSVETIC LABORATORIES
 P. O, Box 20190
 P. O. Box 20429
 P. O. Box 20499
 at Atlanta, GA 30325
 P. O. Box 49425
 at Atlanta, GA 30329

 BRASWELL, INC., HOME SALES
 DIVISION, HEAD START, INC.
 470 E. Paces Ferry Road
 at Atlanta, GA 30305
 P. O. Box 14052
 at Atlanta, GA 30324
 P. O. Box 10064
 at Atlanta, GA 30319
 P. O. Box 53141
 at Atlanta, GA 30355

 P.S. Docket No. 9/173;
 P.S. Docket No. 9/174;
 P.S. Docket No. 9/175;
 P.S. Docket No. 9/176;
 P.S. Docket No. 9/177;
 P.S. Docket No. 9/178;
 P.S. Docket No. 9/180;
 P.S. Docket No. 9/181;
 P.S. Docket No. 9/182;
 P.S. Docket No. 9/183;
 P.S. Docket No. 9/184;
 P.S. Docket No. 9/189;

 07/20/81
 
 Bernstein, Edwin S.

 APPEARANCE FOR COMPLAINANT:
 Thom as A. Ziebarth, Esq.
 Law Department
 United States Postal Service
 Washington, D.C.  20260

 APPEARANCE FOR RESPONDENTS:
 John M. Creger, Esq.
 Katz, Paller & Land
 470 E. Paces Ferry Road
 Suite 2000
 Atlanta, Georgia 30363

 BEFORE: Judge Edwin S. Bernstein



INITIAL DECISION

Complainant alleged and Respondents denied that Respondents are engaged in conducting schemes or devices to obtain money or property through the mail by means of false representations in violation of 39 U.S. Code § 3005.

The November 13, 1980 Complaints alleged that by means of materially false representations in direct mail solicitations as well as advertisements and promotion articles appearing in Body Forum magazine, Respondents attempted to induce readers to remit money through the mails.

These 13 consolidated cases cite several Respondents for claims in connection with various products. Docket Nos. 9/173 and 9/174 name Cosvetic Laboratories (Cosvetic) and Braswell, Inc. (Braswell), respectively for the NEOCEL system. Docket Nos. 9/175 and 9/176 name Braswell and Cosvetic, respectively for SUPEROXIDE DISMUTASE ("DISMUTASE" or "SOD"). Docket Nos. 9/177 and 9/178 name Earthquest, Ltd. (Earthquest) and Cosvetic, respectively for RNA Tablets and Creme. Docket Nos. 9/179, 9/180 and 9/181 name Earthquest, Cosvetic and Braswell, respectively for GLUCOSE TOLERANCE FACTOR ("GTF"). Docket No. 9/182 names Cosvetic for YOUTH EXTENSION SYSTEM, a regimen that combines the use of NEOCEL Tablets and Creme, SOD, RNA Tablets and Creme and GTF. Docket Nos. 9/183 and 9/184 name La Fleur Natural and Cosvetic, respectively for BRAINPOWER. Docket No. 9/185 names Braswell, Home Sales Division and Head Start, Inc. for a sales recruiting program. The hearing was held in Washington, D.C. on February 19 and 20, 1981 and in Atlanta, Georgia on February 25 and 26, 1981.

FINDINGS OF FACT

Complainant's witnesses were Sorell L. Schwartz, PH.D., Jerry R. Williams, D.SC., and Victor Herbert, M.D., J.D., Respondents' witnesses were Hans J. Kugler, Ph.D., Richard Peter Huemer, M.D., and John Paul Reeve.

Dr. Schwartz is a full professor in Pharmacology at Georgetown University Medical and Dental Schools and has impressive creden tials. He has published more than 50 articles in Pharmacology. He also has designed clinical pharmacological studies.

Dr. Schwartz defined anecdotal information as uncontrolled observations (Tr. 11). In contrast, a controlled study attempts to minimize bias, even unconscious bias. In drugs, bias or the placebo effect means that when one expects somethings to happen, it often happens. Thus, a patient who is given a drug and told that the drug will benefit him may feel that the drug benefits him although it does not in fact (Tr. 12). Dr. Schwartz believes that this effect can account for up to 35 percent of reactions. In a controlled study, one group is given a placebo, an innocuous, similar-appearing preparation. In a double-blind study, both the observers and the patients are unaware which patients get the placebo. Dr. Schwartz called tests not conducted in that way quackery (Tr. 16). He stated that the most that can be said for anecdotal studies is that they serve as a stimulus for controlled studies (Tr. 19).

When Dr. Schwartz was asked if Neocel would improve skin tone, he testified that Neocel creme, similar to other hand creams, has demulcents or soothing agents and these, tougher with the water and mineral oil in Neocel creme, counteract dryness (Tr. 19). He stated that Neocel Tablets are a multiple vitamin preparation similar to others sold in drug and health food stores. He testified that, based upon current knowledge, Neocel Tablets will only help persons who suffer from vitamin deficiencies. He stated that vitamin deficiencies, which primarily are due to malnutrition, are rare in the United States (Tr. 20).

Dr. Schwartz testified that Neocel will not lessen the severity of wrinkles (Tr. 20). He also stated that there is nothing in either Neocel Tablets or Creme which will decrease graying in hair or make individuals feel younger (Tr. 21, 22). He stated that Neocel contains nothing known to retard the aging process (Tr. 22). Dr. Schwartz also denied that Neocel will increase stamina or energy in the absence of a vitamin deficiency. However, he stated that in times of great stress, vitamins may help, although he doubts that vitamins will help during moderate stress (Tr. 22, 23). He also stated that Neocel contains nothing which will prevent or reverse cell degeneration or make oxygen available for use by cells (Tr. 23).

Dr. Schwartz stated that, according to GTF's label, chromium is its active ingredient (Tr. 24). He stated that there is no evidence that chromium will prevent hypoglycemia, be effective in treating hypertension, or increase the making or utilization of insulin. He stated that chromium treatment will only help individuals who suffer from a chromium deficiency and he knows of no case of chromium deficiency in the United States (Tr. 25). Furthermore, he knows of no evidence that chromium will prevent diabetes, control hunger, prevent weight gain, or cause individuals to appear or feel younger (Tr. 28, 29).

Dr. Schwartz stated that studies indicated that RNA in large amounts can aid rats to regenerate their livers. However, rats can regenerate their livers while humans cannot (Tr. 31, 32). He stated that there is no evidence that a RNA deficiency in humans can be alleviated. As to the representation that RNA can enrich the cells, he stated that an attempt to stimulate a cell beyond its normal life is in most cases a precurser of cancer or a benign tumor (Tr. 34). He testified that there is no reason to conclude that this product could change cells' behavior (Tr. 34). He also stated that there is no evidence that RNA Creme will diminish crows feet or wrinkles or prolong the skin's youthful appearance (Tr. 35).

Dr. Schwartz testified that Superoxide Dismutase (SOD) is nothing more than freeze-dried liver. He is not certain that it contains any other active ingredient (Tr. 35, 36). Dr. Schwartz testified that this protein enzyme, taken orally, would be deactivated in the digestive system. This is why a diabetic must inject insulin and cannot take it orally (Tr. 36-38). Dr. Schwartz denied that this preparation, taken orally as directed, will slow the aging process by retarding cell degeneration, stabilize cellular oxygen, protect genetic material within the cells, prevent degenerative diseases or destroy free radicals (Tr. 38-40).

Youth Extension System (YES) combines GTF, SOD, RNA, and Neocel into a regimen. When asked whether these preparation, taken together, could have a synergistic effect, Dr. Schwartz stated that based upon scientific information, none can be expected (Tr. 41). He testified that there is no evidence that YES will retard the aging process; prevent hypoglycemia, obesity, adult onset of diabetes, arteriosclerosis, rupture of cell membranes by food radicals; or improve the quality of cell reproduction (Tr. 41, 42). The creams will have a moisturizing effect. However, there is no evidence that YES will tighten the skin or reduce the skin's tendency to wrinkle (Tr. 42). Except for individuals who have a chromium or vitamin deficiency, this program will not increase energy (Tr. 42).

Dr. Schwartz described some of Brainpower's ingredients. Gotu Kola is an Indian preparation which contains about 10 percent of the caffeine of an average cup of coffee (Tr. 42, 43). Lily of the valley contains glycoside which increases the rate and force of the heart's contractions. However, the amounts contained in this preparation probably are not harmful (Tr. 44). Brainpower also contains ginseng which might have some stimulant activity. Blessed thistle, according to legend, is a blood purifier, although Dr. Schwartz does not know what a blood purifier is. The final ingredient is cayenne powder, a condiment similar to tabasco (Tr. 45). Dr. Schwartz stated that there is absolutely no information to confirm that Brainpower could improve mental capacity; produce stimulating, healing and toning effect in the nervous system; rejuvenate the brain or nervous system; or improve the function of the optic nerve or spinal column (Tr. 46). Dr. Schwartz stated that once a brain cell dies, it is gone and cannot be replaced (Tr. 47).

Dr. Schwartz found no clinical studies to support any of these claims for Respondents' products (Tr. 47). He stated that he is knowledgeable as to the consensus of informed medical and scientific opinion regarding these preparations and his testimony is consistent with that consensus, although there is a number of minority opinions, including books on herbology (Tr. 48).

On cross-examination, Dr. Schwartz stated that double-blind studies are not always advisable, for example in connection with cancer (Tr. 52). He admitted that some medicines, which were used many years, solely on the basis of anecdotal information, were found to be helpful. These include aspirin, digitalis and morphine. However, he stated that most anecdotal drugs have been found to be without merit (Tr. 56, 57). He stated that, absent a reason to the contrary, a double-blind study should be used (Tr. 65).

Dr. Schwartz testified that double-blind studies are not always accurate. Sometimes they must be repeated. Designing these studies is very complex. Interpretation also can be complex, but the better-designed the study, the easier it is to interpret (Tr. 72, 73).

Dr. Schwartz indicated that scientifically he cannot say that X does not cure Y. Rather, he will say that there is no evidence that X cures Y (Tr. 78).

He stated that in the rat study, RNA was orally administered in large does. That study is at least 30 years old. He does not believe that it is valid. He does not know of any subsequent studies either way with regard to liver regeneration. He emphasized that rat liver regenerates, but human liver does not (Tr. 104-106).

Dr. Jerry R. Williams is a Professor of Radiology and Pharmacology at George Washington University Medical School and an expert in Pharmacology and old age problems.

Dr. Williams testified that NEOCEL Creme produces a temporary moisturizing effect. However, this product has no effect on improving the skin, reducing the severity of wrinkling, affecting grayness in hair, or making one look or feel younger. He stated that moisturizers mitigate the appearance of wrinkles and aging, but only temporarily (Tr. 114, 115).

Dr. Williams stated that SOD, taken orally, is broken down in the stomach and has no biological activity. If given exogenously, it cannot interact with free radicals (Tr. 116, 117). He testified that SOD will not increase cellular oxygen, protect genetic material within cells, retard oxidation, or prevent degenerative diseases (Tr. 117, 118).

He stated that there is no RNA deficiency in the average American. The cell does not depend upon external sources for RNA. It makes its own RNA, using food. He knows of no case of a human RNA deficiency (Tr. 119). He stated that RNA will not retard the aging process and RNA as a creme will not help crows feet. RNA would not penetrate the skin (Tr. 120).

Dr. Williams stated that there is no evidence that GTF will prevent hypoglycemia. There are no studies to demonstrate that life-span can be extended or that diseases of aging can be mitigated by GTF (Tr. 120, 121). There is no evidence that this product will prevent diabetes; control hunger or prevent weight gain; or make the user feel or appear younger. He stated that, based on his studies, there is no substance to extend the life-span of mammals (Tr. 123).

He stated that the placebo effect is between 10 and 50 percent (Tr. 126). He agrees with Dr. Schwartz that, in the absence of double-blind studies, claims for curative properties should be considered false (Tr. 127).

He stated that his testimony and views are consistent with the consensus of informed medical and scientific opinion concerning these subjects (Tr. 128).

Dr. Williams stated that Neocel will have no effect in the absence of a vitamin deficiency (Tr. 129). He stated that SOD, taken orally will have no effect since it cannot pass through (1) the digestive barrier, (2) the intestinal wall and (3) the blood system barrier to get into cells (Tr. 130). He knows of no reason to believe that Respondents' RNA product will have any biological effect (Tr. 131). With regard to GTF, he could find no case of chromium deficiency in the United States or in other countries about which he checked (Tr. 132). There is no evidence of any biological effect of GTF. Furthermore, a small number of individuals who are hypersensitive to chromium could suffer reactive attacks (Tr. 132).

Dr. Williams stated that there is no evidence that YES' ingredients have a synergistic effect, and there is no theory to support such a claim (Tr. 133). He agreed with Dr. Schwartz that it is difficult to prove negatives (Tr 133). He stated that there is no evidence that any substance will retard the aging process (Tr. 134). He stated that there is no evidence that YES will tighten the skin; prevent hypoglycemia or adult onset diabetes; improve the quality of cells; or prevent arteriosclerosis or obesity (Tr. 134).

On cross-examination, Dr. Williams stated that nutrition is not his field. His specialty is the subject of aging. However, he is knowledgeable in nutrition as it relates to aging and diseases of aging (Tr. 135).

He testified that older people generally have less chromium than younger people and that the average person has but a small trace of chromium and needs but a small trace. he stated that there is no evidence that a change in chromium content will effect the aging process (Tr. 140).

Dr. Williams stated that he performed researchers with regard to Respondents' products himself without a computer. He stated that he found no studies in any major journals to substantiate Respondents' claims for its products. He also said that any claims with regard to aging would be widely circulated and he knew of none to support Respondents' representations (Tr. 141, 142).

With regard to the study that Respondents presented which told of the effect of nucleic acid in regenerating livers in rats,

Dr. Williams stated that humans do not regenerate their livers while rats do (Tr. 154, 155).

Dr. Victor Herbert, a board-certified internist and nutritionist, who is also an attorney and a member of many professional societies, also testified for Complainant. Dr. Herbert has written about 450 scientific papers which have been published in peer-reviewed scientific literature. He has excellent professional credentials.

Dr. Herbert stated that ordinarily enzymes taken by mouth have zero utility. All enzymes are proteins and all proteins are destroyed in the stomach and intestines during digestion. The only exception is that oral digestive enzymes are helpful to people who have diseases of the pancreas (Tr. 172, 173).

Dr. Herbert stated that Neocel will not improve skin tone, lessen severity of wrinkles, decrease amounts of gray in hair, make individuals feel younger, or increase the users' energy or stamina (Tr. 180-184).

Dr. Herbert stressed the scientific axiom that no proposed remedy is effective until proven effective and safe and it is for the proponent to present controlled studies to prove the remedy effective and safe (Tr. 181).

He stated that even in poorly nourished people you cannot retard aging or decrease gray hair (Tr. 182). He also stated that Neocel will not reverse cell degeneration or make more oxygen available for any cells (Tr. 184). He indicated that a vitamin deficiency usually relates to poor people who suffer from malnutrition. It is unusual in middle-class and upperclass individuals (Tr. 185). He stated that there is zero evidence to support any claim of retarding the aging process and, if such a claim were valid, one proving it surely would win the Nobel Prize (Tr. 185).

Dr. Herbert testified that his testimony is consistent with the consensus of informed medical opinion in the field of nutrition. He is vice-chairman of the Committee on Nutrition Information of the American Institute of Nutrition, a prestigious society, and is familiar with the consensus of nutritional opinion (Tr. 185), 186).

As to GTF, Dr. Herbert stated that the body only requires a trace amount of chromium. It is impossible not to get adequate quantities of chromium in a well-balanced diet. He believes that the purchaser of Respondents' GTF product is being ripped off. He stated that this product will not prevent hypoglycemia, prevent or cure atherosclerosis, prevent or alleviate diabetes, control hunger, promote weight gain or cause the average American to appear or feel younger (Tr. 186-190). He stated that the label for Respondents' GTF product is misleading. It is not a glucose tolerance factor. It is chromium and yeast (Tr. 188, 189). He indicated that people often feel younger if they are told they will feel younger, due to the placebo effect (Tr. 190).

Dr. Herbert testified that RNA is a basic blueprint which tells human cells what to do. However, only human RNA can do this. He assumes that Respondents' product does not contain human RNA since they would have to kill humans to obtain it (Tr. 191). RNA, taken by mouth, is destroyed in the pancreas and intestines (Tr. 191, 192). RNA is not needed in the diet. He stated that it is nonsense to say that you can take RNA and help the body. Even if it got into the body, it would reproduce yeast, since yeast RNA only can reproduce itself (Tr. 192). Dr. Herbert stated that this product enriches no one but its seller (Tr. 192). He testified that the product will not diminish crows feet or wrinkles, or prolong the youthful appearance of skin beyond any emollient action of its creme (Tr. 193).

Dr. Herbert stated that SOD is an enzyme and all enzymes are proteins. As a protein, it will be destroyed by pancreatic agents as soon as it reaches the intestinal tract (Tr. 194). Also, like RNA, unless humans are killed to make the product, it will only function in its own species. Therefore, it is a pure rip-off (Tr. 194). He stated that SOD will not slow the aging process by retarding cell degeneration; protect genetic material in cells; prevent or retard oxidation of the body or degenerative diseases; or neutralize free radicals (Tr. 194, 195).

He stated that the products in the Youth Extension System are a massive rip-off. He testified that YES will not prevent or cure hypoglycemia, diabetes, arteriosclerosis, premature rupture of cell membranes caused by free radicals, and that it would not reduce a tendency to wrinkling, improve the quality of cell reproduction or increase energy levels (Tr. 195, 196).

Dr. Herbert stated the ingredients in Brainpower have no useful effect; perhaps some are harmful. Ginseng has estrogen and has been reported to produce painful breasts and breast swelling in men as well as in women. He stated that there is no evidence that Brainpower will produce a feeling of wellbeing, rejuvenate the nervous system or improve the optic nerve or spinal column (Tr. 197, 198).

He stated that the modern view of what constitutes a medical fact is as follows. When a claim is made for the efficacy of an agent, it must be demonstrated that the claimed results are produced by the product. This is done by taking two comparable groups of people, giving the product to one group and giving the other a fake which is designed to look like the product. Once this test has been completed, it is submitted to a scientific journal. The editor reviews the paper. Two experts review it and if the paper contains flaws they reject it. If there is a colorable claim but some flaws in interpretation, the reviewers indicate the problem and the paper is sent back to the author to answer the criticisms. When he successfully answers the criticisms the paper is published. If not, it is not considered reputable. If there has not been peer review literature and the product has been around for a substantial period of time, it is reasonable to conclude that the results claimed for the product are fraudulent. He indicated that this is consistent with the consensus of the scientific community. This peer-review process is the major way of separating fact from fiction in the field of medicine and nutrition (Tr. 198-200).

Dr. Herbert was asked about John Paul Reeve. He stated that Dr. Reeve had zero expertise in science and nutrition, and had two cult degrees which were similar to witch doctoring. He had a degree as a chiropractor. Dr. Herbert said that a 1980 Consumers Union book indicates that chiropractors are cult types and essentially masseurs and manipulators of the spine (Tr. 201), 202). He defined a health cult as one that alleges that all disease proceeds from one simple cause of which the cult has special knowledge and can bring about a cure (Tr. 202).

Dr. Herbert stated that Dr. Richard P. Huemer is an associate editor for the Journal of the International Academy of Preventive Medicine. This academy is a practicing arm of the lucrative questionable nutrition remedy industry and includes among its membership major promoters of quack remedies like laetrile, chelation therapy, and kinesiology (Tr. 203, 204). He stated that there are no organizations in Dr. Heumer's curriculum vitae which require scientific expertise in the field of nutrition (Tr. 205). Many of these organizations promote questionable practices. He stated that Dr. Huemer wrote papers in 1965 and 1968 which were published by responsible journals but the articles did not relate to nutrition. His nutrition-related articles are all in anecdotal journals and not in peer-reviewed journals (Tr. 206-207).

Dr. Herbert stated that Dr. Hans J. Kugler is an officer in an organization that promotes questionable nutritional practices headed by a Dr. Donsbach. Dr. Donsbach served two California prison sentences for nutritional fraud during the past decade. Dr. Kugler is on Donsbach's advisory board. Dr. Herbert testified that in California you can get an university accreditation of a lower rank by paying $50,000. Donsbach University is such an institution. It sells degrees for money (Tr. 207, 208).

Dr. Herbert stated that Dr. Kugler's curriculum vitae lists eight publications. None of these appear to be nutrition articles in peer-reviewed journals (Tr. 211, 212). Dr. Kugler's Ph.D. is not in nutrition.

On cross-examination, Dr. Herbert indicated that he did not research the literature. He follows most articles through subscriptions and information he receives in the nutritional field. If an article were published in recent years, he would know about it (Tr. 214).

Dr. Herbert stated that the Food and Nutrition Board of the National Academy of Science determines Recommended Daily Allowances (RDAs) by adding safety factors to Minimum Daily Requirements (MDRs) (Tr. 217, 218). he stated that people under stress require vitamin doses up to 10 percent above MDRs (Tr. 226). However, RDAs exceed this factor. Therefore, anyone taking a RDA will receive enough vitamins for stress situations (Tr. 227). The RDA panel believes that the average American diet contains sufficient essential nutrients except that it is marginal in iron content for children up to five years old, children at the onset of puberty, and women of child-bearing years. Also, the average diet may be marginal in folic acid for pregnant women (Tr. 230-232). Poor people may suffer from inadequate nutrition. However, elderly people generally do not unless they also are poor. He stated that the nutritional needs for people after age 50 are the same as before age 50 (Tr. 233).

Dr. Herbert stated that is is a good idea to supplement milk with vitamin A for children (Tr. 246). He testified that the U.S. RDAs are based on 1974 criteria (Tr. 248). Except for vitamin C, which was increased from 45 to 60, generally the revisions of RDAs from 1974 to 1980 were downward (Tr. 248, 249).

Dr. Herbert testified that food processing cannot destroy minerals but can destroy vitamins, especially water-soluble ones. Canning can destroy vitamins, especially folic acid and vitamin C. Vitamin C is easily destroyed. Orange juice that is squeezed and bottles loses vitamins (Tr. 255-258). Choline and inositol supplements are not needed (Tr. 165). They relate to fat metabolism. As is the case with cholesterol, the body makes what it needs of these substances (Tr. 266). He stated the amounts of choline and inositol that Neocel contains would not be harmful, but they would not be helpful either (Tr. 266, 267).

Dr. Herbert stated that humans do not need food containing biotin because their intestinal bacteria make biotin (Tr. 277). Humans do not suffer biotin deficiencies except for persons who eat 12 or more raw egg whites in a day. This is because excessive raw egg whites contain avidin, which destroys biotin. This would not apply if the egg whites were cooked.

He stated that the U.S. RDAs are set above the largest numbers needed for any person (Tr. 278). The Food and Drug Administration proposed a rule to limit consumption to 150 percent of the RDA. However, this was defeated in a federal court by the health food industry (Tr. 276). He stated that all foods are health foods in moderation; in excess, they are unhealthy (Tr. 276).

When questioned regarding his credentials in dermatology, Dr. Herbert stated that he studies this for approximately 50 hours in medical school, he attends lectures in this specialty and obtains consultations from specialists in dermatology. In addition, as Chief of Medical Service in a major hospital, he is responsible for its Division of Dermatology (Tr. 300, 301).

As far as he knows, no RNA is absorbed by the human body (Tr. 301, 302). Even if it were absorbed, it is too big a molecule to pass through cell walls. This has been proven in test-tube experiments (Tr. 302, 303). Finally, only human RNA can effect humans (Tr. 303).

Dr. Herbert stated that the Journal of the International Academy of Preventive Medicine is a nonsense journal listed in the catalog of Donsbach University, a California diploma mill (Tr. 309). With respect to a publication called American Laboratory, he indicated that he believes that this is a throwaway. He defined a throwaway as something sent through the mail for which there is no subscription price. He stated that "The Combination Theory of Aging" by Dr. Kugler appears to have been printed in the American Laboratory (Tr. 310, 311).

Dr. Herbert stated that there is almost no peer review of International Journal for Vitamin and Nutritional Research articles. They publish almost every paper that they receive. He stated that Dr. Cheraskin, "a promoter of distortion and misrepresentation," publishes there (Tr. 314, 315). He testified that Longevity Research Institute of Santa Barbara is the Pritikin Cult. He stated that Dr. Pritikin still refuses to allow the American Heart Association to look at his data regarding longevity. Dr. Herbert stated that Pritikin's diet was used in Ceylon for thousands of years and in Ceylon the average life expectancy is 33 years (Tr. 317, 318).

Dr. Herbert emphasized that the article in the Journal of the American Medical Association entitled "Single Nutrient effects on Immunologic Functions," is a summary article. He pointed to the caveat in the middle of page 57 of that article (Tr. 321).

Dr. Hans J. Kugler testified for Respondents. Dr. Kugler was educated in Europe, has received a Ph.D. in chemistry, and teaches at El Camino College. He is president of the International Academy of Holistic Health and Medicine. He does individual research, is on the advisory board of several associations, and does consulting for industry. He also does nutritional consulting with doctors regarding disorders, unhappiness, and bad states of moods of patients. he gives patients pep talks about good health and nutrition. He tries to associate mental health and depression with faulty health habits and faulty nutrition (Tr. 348-350).

Dr. Kugler heard part of Dr. Herbert's statements. Dr. Kugler stated that Professor Cheraskin is a full professor of medicine at the University of Alabama. He stated that he questioned Dr. Herbert's reliability and gave some examples. Dr. Kugler stated that the International Academy of Preventive Medicine has nothing to do with Donsbach University. He stated that he was a trustee of that organization until recently. He disagreed with Dr. Herbert's statement that Dr. Richard Passwater bought a degree. He took exception to Dr. Herbert's remark that Dr. Kugler's computer programs are designed for use in health food stores to mislead consumers. he indicated that his computer program is used by doctors and deals with cancer, excesses, weight control, smoking, etc. (Tr. 351-355).

Dr. Kugler defined holistic medicine as evaluating the entire person as contrasted with orthodox medicine which gets money from the drug companies (Tr. 357-361). He stated that most researchers in gerontology agree that any health remedy increases the life-span. He stated that nutrition is the most important aspect of aging (Tr. 365, 368).

He testified that one must look to the optimum intake of nutrients and not to MDRs or RDAs. he stated that when MDRs did not work well, the authorities increased them by 50 percent on an arbitrary basis. He testified that an MDR is what is required to keep you from dropping dead now (Tr. 368). He indicated that the state of nutrition in the United States represents an extreme problem. He testified that a Professor Anderson at the VA Hospital at Lexington, Kentucky treats diabetes just with good nutrition but the drug companies oppose this (Tr. 370). He disagrees with Dr. Herbert that most people get sufficient vitamins from their diet. He stated that he found that as individuals get healthier, 400 to 800 percent above the RDA is taken (Tr. 380). These are not double-blind studies. Double-blind studies are not necessary here (Tr. 382).

Dr. Kugler stated that not every one should take supplemental nutrition, but a very large percentage of people should. Such factors as processing, cooking, transport and storage of food effect vitamins. Most people do not know if they are getting enough nutrition. He stated that a deficiency in a single nutrient can effect a person (Tr. 384, 385). Dr. Kugler stated that Respondents' Exhibit 12 confirms how single nutrient deficiencies effect the immune system which relates to resisting colds and illnesses. He stated that the immune system is important with regard to cancer in animals and humans. He testified that there is a study showing that the higher the selenium content in animals, the lower their cancer rate (Tr. 387-390).

Dr. Kugler uses vitamin, mineral, and enzyme products similar to neocel in his practice. He stated that it does not matter what you label them. He testified that he would expect the Neocel Tablets will make up for deficiencies and improve the immune system since most people need more than the RDAs (Tr. 399, 400).

Dr. Kugler stated that there are several pathways by which large protein enzyme molecules can make it through the digestive tract and into the human body. He disagrees with Drs. Schwartz, Williams and Herbert with regard to this. He stated that there are studies and that the literature has shown that this is a fact (Tr. 402, 404).

He stated that if one is below nutritional requirements, Neocel could improve skin tone by supplying those requirements. He also agreed that Neocel could make one look and feel younger, since stress depletes nutrients and adding nutrients will improve the way one feels (Tr. 405, 406). Dr. Kugler stated that Neocel would improve energy and stamina because B vitamins are energy vitamins which affect blood sugar. He also agreed that Neocel can prevent and reverse cell degeneration for the many people who are below nutritional requirements. He also stated that Neocel can make more oxygen available for use by the cells since vitamins C, E, and selenium are antioxidants (Tr. 406, 407).

He stated that the free radical theory that SOD is a free radical scavenger that helps to deactivate harmful free radicals. SOD increases the life-span of enzymes. It is also an anti-inflamitant which is important in the treatment of arthritis. It is used on horses that have arthritis (Tr. 408-410).

Thus, Dr. Kugler concluded that since SOD neutralizes and destroys free radicals in human beings, it will slow aging; increase cellular oxygen; protect genetic material in cells; prevent or retard oxidation; and have a high chance of preventing degenerative disease (Tr. 415-417).

Dr. Kugler stated that treatment with nucleic acid is mainly done in Europe. He stated that RNA has an effect on the aging process and that Dr. Benjamin Frank showed that this product decreases wrinkles (Tr. 417, 418). When asked about Dr. Herbert's statement that RNA can only create its own species, Dr. Kugler said, "I have never heard a more ignorant statement than this one." (Tr. 422).

Dr. Kugler stressed Respondents' Exhibit 1, which related to the effect of RNA in rats. He stated that although it is 30 years old, "anything that works in an animal or the animal model has a bery high chance to work in humans" (Tr. 426).

He stated that the request for double-blind studies in nutrition is a gimmick (Tr. 427). Dr. Kugler stated that RNA will relieve crows feet and wrinkles and prolong the youth of skin. He does not know how it does it but he knows that it does it. He stated "I have seen the pictures." (Tr. 431, 432).

Dr. Kugler stated that protein together with chromium is what makes Respondents' GTF effective. He stated "It's a complex molecule with a chromium molecule in it." He stated that the average American diet does not have sufficient chromium and the average American is very low in chromium. GTF restores that deficiency. However, he stated that he is not familiar with the sources of chromium in the diet and he is not much of a specialist in chromium (Tr. 432-434).

When Dr. Kugler was asked if he referred to Respondents' Exhibit 15 in preparing for his testimony, he first hesitated and then answered in the affirmative (Tr. 435). He corrected himself twice in answering and looked nervous and uncomfortable. Based upon this demeanor and language, I found him to be untruthful in this answer.

Dr. Kugler testified that sugar imbalances may effect arteriosclerosis. Individuals with normal blood sugar levels will be less hungry. GTF can effect weight gain by controlling hunger. It can normalize metabolism (Tr. 438, 439). GTF can effect appearance. If you prevent depression, the person will look better. If one looks better, one looks younger (Tr. 439, 440). He also stated that GTF can prevent hypoglycemia and diabetes. First you have hypoglycemia. Then you eat too much sugar. This breaks down the insulin mechanism and causes diabetes in adults. GTF helps to normalize blood sugar and prevents the progression from hypoglycemia to diabetes (Tr. 440, 441).

Dr. Kugler stated that there is no indication that a combination of these ingredients in the Youth Extension System is detrimental (Tr. 442). He uses many products to maximize effects. Thus, he concluded that the Youth Extension System will retard the aging process; prevent hypoglycemia, obesity, adult diabetes and arteriosclerosis; prevent radical rupture of cell membranes; tighten skin and reduce wrinkling; improve the quality of cell reproduction; and increase energy levels (Tr. 442, 443).

On cross-examination, Dr. Kugler admitted that Respondents' Exhibit 1 referred to regeneration of livers in rats. He stated that there is some indication that humans can also regenerate their livers. However, he admitted that he knew of no such case history (Tr. 446, 447).

He stated that RDAs are a totally outdated system which should be reviewed. However, his computer program uses RDAs even though they are inefficient standards (Tr. 449).

He stated that Respondents' Exhibits 8 and 9 show that individuals with the fewest complaints took the most vitamin A and niacin. From that, Cheraskin concluded that the more vitamin A and niacin you take in, the healthier you are. Dr. Kugler agrees (Tr. 466). The holistic approach tells us that we need more vitamin A (Tr. 467).

Dr. Kugler admitted that once broken down, the RNA molecule ceases to be an RNA molecule (Tr. 471). When asked about his statement that a small percentage of SOD passes unhydrolized through the digestive tract into the blood stream, he stated that he knows of no study that supports this theory. It is a new concept (Tr. 474). He admitted that Respondents' Exhibit 14 did not involve SOD (Tr. 474). He also admitted that there is no established requirement for RNA in humans (Tr. 478) and that a double-blind study is an accepted method for establishing truth (Tr. 478).

Dr. Richard P. Huemer, a medical doctor who first specialized in development biology and later in nutritional medicine and metabolic diseases, testified next. He stated that since 1970 he has been in private practice in the Los Angeles area. He testified that the International Academy of Preventive Medicine is over 10 years old and includes as members physicians, dentists, chiropractors, osteopaths and Ph.D.s who are interested in holistic medicine. After he sees a patient for the first time, Dr. Huemer has laboratory tests performed. This includes tests of trace elements in the patient's hair. He then instructs the patient in choosing foods, good health habits, aerobic exercises and prescribes for nutritional deficiencies (Tr. 490-499).

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pordi

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Re: Eine massive Klage gegen etliche Täter, absolut lesenswichtig
« Reply #1 on: April 19, 2011, 02:38:25 PM »

Dr. Huemer stated that he does not get involved in holistic medicine, Chinese or Hindu remedies, acupuncture, or spiritual or psychological approaches (Tr. 500). Dr. Huemer stated that he has seen between 600 and 800 and 800 new patients a year since 1975. His office is located in a middle class residential community. He has identified nutritional problems in a large percentage of the patients that he has seen. Although the stereotype of malnutrition is the undernutritioned person, malnutrition can also include nutritionally imbalanced and obese people. It is a frequently repeated misconception that the American diet supplies enough vitamins. This is not true (Tr. 500-502). He stated that he was taught in medical school that 80 percent of patients have functional or psychological complaints. He believes this figure is grossly overstated. It is a catch-all to cover our ignorance (Tr. 506).

He testified that groups who are likely to have nutritional deficiencies include the elderly. They tend not to eat as well as younger people, especially if they live alone. They eat foods that are easier to prepare and convenience foods like potato chips. Also, elderly people may not have sufficient funds to buy appropriate food. Poor people also are trapped by diet into a cycle of poverty. Pregnant malnourished women will have sub-standard offspring with inadequate brain development. Also, food fadists such as those who go on the latest crash weight loss diet that they read about in ladies' magazines may suffer from inadequate nutrition (Tr. 507-508).

Dr. Huemer stated that he found the work of Dr. Herman Baker and Dr. Levy, as contained in Respondents' Exhibit 19, to be reliable in showing that the elderly have nutritional problems. He believes that elderly people have higher requirements and greater deficiencies for nutrients. Also, vitamin requirements increase during pregnancy (Tr. 514). However, he stated that he prefers to recommend foods as sources of nutrients whenever possible (Tr. 514).

He indicated that some of the theoretical sources of deficiencies are as follows: 1. Higher individual requirements for certain substances by some people. There is need to study this more. 2 Malabsorption. This refers to nutrients passing out in the stool. 3. Poor intake. The debasement of the food supply by the American food industry. There is a showing that people who are highly processed diets had a higher instance of illness (Tr. 515).

With regard to RDA's, Dr. Huemer testified that foods can lose nutrients in cooking, processing and canning. Thus, nutrients analyzed may differ from those eaten (Tr. 517). He further stated that there is no average American requirement. This varies from one person to another. He was reminded of a statistician who drowned in a stream which had an average depth of three feet. There are approximately 40 known nutrients. We don't have RDAs for all 40. Statistically, there is a reasonable chance that not all the people in the United States will be well-nourished by RDA criteria. He uses RDA standards as guides (Tr. 517, 518).

Dr. Huemer uses supplements extensively. These include 50 to 60 vitamins, minerals, glandular products, multivitamins, herbal products such as ginseng, as well as non-essential nutrients such as choline, inositol and amino acids (Tr. 519).

He found Neocel products to be good formulations. He stated that they are quite complete, contain a whole range of nutrients, and are rather well-balanced. If a patient does not eat properly or is under stress, it is better for him to have too many nutrients than not enough. Such products give the patient a cushion (Tr. 520, 521).

He stated that the Neocel enzyme supplement is a vegetable concentrate powder. In general, vegetables are good sources of vitamins and minerals. The vegetable powder could be there for that purpose or it could serve as a base. Tablets which contain yeast afford better absorption (Tr. 522). He stated that RNA carries a copy of the genetic blueprint or plan and the yeast in Neocel is rich in RNA. Yeast RNA provides raw materials that build RNA in cells. He stated that bee pollen is noted for its mineral content.Spleen powder and thymus powder are believed to nourish the glands and provide sources of nutrients. Desiccated liver is a source of vitamins and minerals. Fish concentrate 28-65-217 disputant to has respondent order Helps to activitate enzymes. Lecithin is a source of lipids and is used to manufacture cell membranes (Tr. 522-524).

With regard to Neocel 2, which is a mineral supplement, he stated that the minerals present are nowhere near the toxic range and are of considerable biological importance (Tr. 525, 526).

Dr. Huemer testified that Neocel products will tighten and improve connective tissue under the skin. He agrees that they will make an individual look and feel younger, assuming the individual needs nutrients. Many individuals need one or more nutrients. Symptoms of need are tiredness and feeling older. If the prepara tion improves tiredness, the individual will feel younger. If it improves skin tone, the individual will look younger. He believes that these products will increase energy and stamina levels in that they will improve tiredness feelings. As to the claim that Neocel products will reverse and prevent cell degeneration, he stated "I should think that they would." He stated that selenium and vitamins C and E will prevent and reverse cell degeneration. Vitamins A and C can reverse cancel cells which he considered degeneration. As to the claim that Neocel makes more oxygen available for use by the cells, he first answered "I don't know that specifically" but then he stated "Yes, because of its iron and copper." (Tr. 526-529).

Dr. Huemer stated that he has given yeast RNA to elderly patients who have many deficiencies. His impressions are favor able. His patients report subjectively that they sense improve- ment in memory, such as remembering phone numbers. He does not have any controlled studies to support this conclusion. However, he indicated that Dr. Cameron, who gave yeast RNA, administered intra- venously and orally, to elderly patients with memory defects of various causes such as senility and arteriosclerosis, obtained significant improvement in memory. Intravenous doses were more effective than oral doses but there were more adverse reactions from intravenous doses. Cameron's article appeared in the American Journal of Psychiatry. Dr. Huemer is not certain that this is a peer review publication. These studies suggest to him that oral RNA is effective (Tr. 530-537).

Dr. Huemer stated a theory that digestive enzymes from the pancreas break down RNA molecules into fragments which are water-absorbed and then built up into other molecules (Tr. 538, 539). However, there are no tests to support this theory.

When asked if the average American diet is sufficient in RNA, Dr. Huemer answered that the average American diet is highly processed. He is not aware whether food processing depletes RNA in the diet but this would not surprise him (Tr. 541).

Dr. Huemer stated that SOD, like all enzymes, is a protein. He knows of no studies that indicate that SOD can be absorbed into the body if taken orally. However, he believes that several kinds of proteins can make it into the body through the gastro-intestinal system (Tr. 543).

Dr. Huemer stated that he has not personally done any double-blind studies. He takes a more relaxed view of things. Dr. huemer believes that a test of whether a method is scientific is whether it works for the purpose for which it is intended. He agrees that questions of safety should be established beyond all doubt. He believes that properly conducted double-blind studies should be mandatory before a therapeutic drug is put on the market. This is because drugs alter natural processes and can have harmful side effects. He does not apply the same standard to natural substance in nutrients because there is a nearly zero risk of harm. He stated that if the risk of harm is near zero and the beneficial effect is unknown, he will tend to use an ingredient. The worst that can happen is that someone will spend money for something that is unnecessary. As an example, he stated that there is no double-blind study to confirm or deny whether or not, as contended by Linus Pauling, vitamin C is effective in reversing cancerous formations in malignant cells. However, with little or no risk and potential benefit, he would consider it immoral to withhold the benefit. However, when asked if he would prescribe vitamin C for cancer to the exclusion of all else, he responded, "Heavens no." (Tr. 547-551).

Dr. Huemer has not used Respondents' GTF formula in his practice although he has used other forms of GTF for diabetic patients (Tr. 555, 556). He stated that it is unquestionable that a chromium deficiency occurs in the American diet (Tr. 558). Also, processing of foods, such as white flour and white sugar, and canning removes chromium. Thus, people who use processed foods are likely to have chromium deficiencies (Tr. 558).

Since no RDA has been established for chromium, Dr. Huemer thinks that it is presumptuous for Dr. Herbert to say that people have no deficiency (Tr. 559). Dr. Huemer stated that the main medical indication of a chromium deficiency is impaired glucose tolerance (Tr. 560). However, there is reason to believe that arteriosclerosis may, in part, result from a chromium deficiency (Tr. 561).

He gives GTF to patients who have an elevated blood sugar and history of diabetes. The results are improvements in glucose tolerance. It is very likely that GTF has an effect on hypoglycemia. He believes that chromium also reduces serum cholesterol and triglyceride levels (Tr. 562-565).

Dr. Huemer stated that ginseng is quite commonly used in the Far East and has a reputation as a "cure-all" there. Ginseng contains steroids. It was found that under certain conditions tumor growth in mice was inhibited by ginseng extract (Tr. 566). He stated "this is a tremendously complicated therapeutic agent." (Tr. 567).

On cross-examination, Dr. Huemer stated that he is not board- certified (Tr. 568). He admitted that mixing cells of different animals stimulated the type of cell division that is cancerous or carcinogenic (Tr. 568, 569).

He stated that Linus Pauling presented cogent arguments that increased intake of vitamin C could improve the function of cells and extend life by about eight years. However, Dr. Huemer conceded that this is not a generally accepted use of vitamin C (Tr. 570, 571).

He admitted that very large doses of vitamin C such as five to ten grams a day could be toxic. Large doses could cause kidney stones. He stated that vitamin A toxicity is a more worrisome matter, "although not to the point of hysteria." In one experiment, adults taking several hundred thousand units a day above the RDA for several months developed toxicity (Tr. 576, 577).

Dr. Huemer stated that the United States Department of Agriculture studies found vitamin A and iron deficiencies to be 20 to 25 percent. Complainant's Counsel agreed with Dr. Huemer with regard to iron deficiencies in women of child bearing years but he though that the others were slight and there were but minor instances of deficiencies in other people. In answer to Complainant's Counsel's questions, Dr. Huemer agreed that the typical pizza-eating, hamburger-munching citizen of Orange County probably gets enough protein from his diet (Tr. 582-584).

Dr. Huemer stated that he did not do any tests with regard to Neocel creme. He is not a dermatologist and he feels uncomfortable when testifying about dermatology (Tr. 585). With regard to the contention that Neocel decreases gray in hair, he stated that paraominobenzoic acid (PABA) in one Neocel product is reputed to reduce gray. However, he admitted that this is based on one rat study made many years ago which was not repeated. He knows of no double-blind study which supports this contention (Tr. 587). He stated that the placebo effect may be as high as 50 percent (Tr. 588). He stated that Neocel may make people look and feel younger and increase energy and stamina levels but admitted that there may be a large placebo effect with respect to this (Tr. 592). With regard to the claim that Neocel will prevent and reduce cell degeneration, he stated that if a deficiency contributed to this, nutrient intake would help. However, if the individual had no deficiency, it would not help. Similarly, Neocel will not help make more oxygen available for use in cells in people who have enough oxygen (Tr. 595, 596).

Dr. Huemer stated that he is not aware whether or not the normal diet contains enough SOD of the type in Respondents' product (Tr. 597). He would expect that SOD of this type will be digested, but he is not sure (Tr. 598). As for the contention that SOD will slow cell degeneration, he stated that this would have to be by destroying free radicals. However, he knows of no study which establishes that this product can improve cellular oxygen (Tr. 598, 599).

Dr. Huemer knows of no information to support the claim that Respondents' SOD product will protect genetic material within the cells (Tr. 599). As to the claim that this will prevent unnecessary oxidation in the body, Dr. Huemer stated that in general he would expect this. However, he was hesitant and uncertain about the product in question, and he had no data to support this claim (Tr. 599, 600). He also knew of no facts to support the claim to neutralize and destroy free radicals (Tr. 600).

As to the ingredients in the Neocel Enzyme product, he stated that some types of vegetable powder, for instance pineapple and papaya extract, can have enzyme activity. He stated that, in general, proteins and enzymes are broken down in the gastro intestinal system but some may be absorbed intact. Bee pollen is perhaps a sources of trace minerals be he is uncertain as to which ones. The thymus gland could be a hormone but conventional wisdom is that it will not be absorbed (Tr. 602).

Dr. Huemer stated that the average, healthy person manufactures all the RNA he needs in foodstuffs not including RNA (Tr. 604). There is no RNA deficiency syndrome that he has found in any textbook. However, that is not to say that such a deficiency cannot occur (Tr. 604). As to the claim that RNA will retard the aging process by enriching the body's cells, Dr. Huemer is not sure that he knows what that statement means (Tr. 604).

Dr. Huemer stated that he has seen few people who markedly were deficient in chromium (Tr. 613). He stated that he has not experience in the use of chromium for hypoglycemia (Tr. 614, 615). He stated that it is highly probable that chromium will help only those who are deficient.

Dr. Huemer stated that he has used ginseng as a anti-stress agent and as a mild stimulant. With regard to Complainant's Exhibits 115 and 116, a copy of a New Rochelle Medical letter and an article from the Journal of the American Medical Association, respectively, which deal with ginseng toxicity, Dr. Huemer stated that both seem reliable and accurate. He stated that he has not encountered ginseng abuse in his practice since he uses fairly low doses. However, this is an area of possible abuse by the layman since the products are widely available in health food stores (Tr. 619, 620).

Dr. John Paul Reeve stated that in 1978 he obtained a doctorate in naturapathy after an eight-month course. He expects to receive a chiropractic degree next month.

Dr. Reeve formulated Brainpower. He has studies and been interested in herbs for many years. Mr. Rinaldi, the editor of Body Forum Magazine, which is owned by Braswell Corp. asked Dr. Reeve to formulate Brainpower. Dr. Reeve receives royalties from Brainpower's sales (Tr. 634). He identified Respondents' Exhibits 29 through 33, which are articles that describe the effects of ingredients included in Brainpower. The articles contained in Respondents' Exhibit 29 state that sweet almond is high in calcium, protein, and phosphate; nourishing for the brain, nerves, muscular weaknesses, and weak digestion; and contains potassium and magnesium phosphate. Based on that, he concluded that this is a nutrient that would tone up the body, primarily the nervous system and the brain (Tr. 635-637). Respondents' Exhibit 30 indicated that gotu kila is relatively safe, has long been used in India and is thought to energize and preserve the brain (Tr. 637). Respondents' Exhibit 31 deals with ginseng. Dr. Reeve stated that most authorities mention that ginseng has a stimulant action on the nervous system and has been known for thousands of years in the Orient (Tr. 638). Respondents' Exhibit 32 emphasizes holy thistle or blessed thistle's tonic use for toning, its affect as a stimulant and its lack of negative side effects (Tr. 639). Respondents' Exhibit 33 states that capcicum or cayenne stimulates the flow of blood through the body as a carrying agent and increases the metabolic rate (Tr. 640).

He used these herbs on himself and found them helpful (Tr. 640). He believes that they will improve the mental capacity, stimulate and have a toning effect on the brain and nerves, rejuvenate the nervous system in the sense of bringing vigor and stimulation and improve the function of the optic nerve and spinal column (Tr. 641, 642).

On cross-examination, Dr. Reeve stated that he conducted no double-blind studies for Brainpower. However, he believes that double-blind studies may have been conducted for ginseng (Tr. 642, 643).

I found Complainant's witnesses to be individuals of the highest academic credentials. They are experts at the very top ranks of their fields, who appear to be recognized by their peers as authorities in their specialties. All three of Complainant's witnesses testified responsible and consistently with themselves and with each other. They supported their conclusions with logical reasoning. I found them to be truthful and persuasive.

Dr. Kugler attempted to substitute quantity of testimony for quality. He talked at great length, in generalities and frequently wandered from the subject. He did not support many of his conclusions with logical information. Additionally, I had questions with regard to his credibility, especially when he was asked whether he relied upon various articles. I felt that in many instances he was not truthful. There were contradictions in his testimony. I found him to be an unreliable witness.

I found Dr. Huemer to be more reliable. However, his credentials were not as good as those of any of Complainant's witnesses. He is not board-certified. His medical associations are not as impressive as Complainant's witnesses. He published articles on nutrition in peer review journals such as those in which Complainant's witnesses frequently published. I had no reason to question Dr. Huemer's sincerity or credibility. In fact, I was impressed by his candor in admitting his lack of knowledge in certain areas and in making some statements which were not helpful to Respondents. This contrasted with Dr. Kugler, who seemed determined to advocate Respondents' positions regardless of whether or not the facts supported his statements.

I also found Dr. Reeve to be an unimpressive witness. His conclusions regarding Brainpower were not based upon any scientific testing but merely upon various untested claims which he read, sometimes tested on himself, and then accepted. Furthermore, since he formulated the product and shares in its royalties, he has much to gain by praising Brainpower.

The parties also introduced an extensive number of exhibits into evidence. Complainant's Exhibits included copies of advertisements of Respondents' products, which are in issue, transcripts of labels for those products, copies of curricula vitae of its witnesses, affidavits of its witnesses, copies of documents relating to the transmission of the products by mail, copies of Body Forum magazine and a photocopy of material relating to Donsbach University.Respondents' Exhibits included copies of curricula vitae of its witnesses, articles regarding nutrition, a copy of Dr. Kugler's computer profile and various other articles. I have considered all of these exhibits. Unless an exhibit is relied upon in my findings of fact, I consider it to insufficiently persuasive or irrelevant.

CONCLUDING FINDINGS AND

CONCLUSIONS OF LAW

I. Respondents Obtain Money Through The Mail In Connection With The Sale Of The Products At Issue In These Cases

Respondents' businesses are largely dependent on mail order sales. Most of their advertising materials contain a coupon inviting the prospective customer to remit money through the mail to the address specified in the advertisement. In the alternative, the customer is urged to use the order form and business reply envelope included in each issue of Body Forum magazine. Examples include the advertisements in CX 1 and 3 (for SOD); CX 11 and 15 (for GTF); CX 18 and 19 (for Brainpower); CX 22 and 23 (for YES); CX 24 and 25 (for NEOCEL); and CX 33 and 34 (for RNA).

II. Respondents Make the Representations Alleged in Paragraphs 3 of the Complaints

The following are allegations contained in paragraph three of each Complaint and quotations from Respondents' advertisements in which the representations are made.

THE NEOCEL SYSTEM (Docket Nos. 9/173 and 9/174)

(a) The NEOCEL system will improve skin tone.

"Most patients reported an improvement in skin tone."

(CX-24)

"Among them was an improvement in skin tone."

CX-28)

"THE RESULTS. Dr. Frank reports that many of his test subjects experienced an improvement in skin tone."

CX-30)

"And in fact, Dr. Frank reports an improvement in cell quality among his Neocel patients. Improved skin tone, fewer wrinkles, decrease in graying hair and even better nail growth were all in evidence."

CX-31)

"Regular supplementation of Neocel imparted amazing effects. Among them was an improvement in skin tone."

CX-32)

(b) The NEOCEL system will lessen the severity of wrinkles more effectively than ordinary moisturizers.

"Neocel creme in combination with the other nutrients in the system helps fade the visible results of aging. With Neocel creme, wrinkles are not so noticeable, and age spots lighten. The whole package of nutrients feeds the skin from the inside and the outside.

CX-25)

"Wrinkling decreased and skin actually became tighter."

CX-27)

"Dr. Frank reported that many of his test subjects experienced a visible tightening of facial skin, resulting in a decrease in the severity of wrinkles."

CX-28)

"The visible tightening of skin resulted in a marked decrease in the prominence of wrinkles and loose flesh, especially in the facial area."

CX-30)

"Neocel cream will reduce wrinkling after only several weeks of daily use. Special prob- lem areas such as wrinkles on the forehead, 'crows feet' around the eyes, and 'liver spots' disappear with daily use after only a few months."

(CX-52f)

"Neocel creme in combination with the other nutrients in the system helps fade the visible results of aging. With Neocel creme, wrinkles are not noticeable, and age spots lighten. The whole package of nutrients feeds the skin from the inside and the outside."

CX-76)

(c) The NEOCEL system will decrease the amount of gray in the hair.

"From his work with nucleic acids and antioxidants, amazing results include patients who reported ... a decrease in the amount of gray in their hair."

(CX-25)

"Graying hair subsided."

(CX-27)

"Another visible effect was a decrease in the amount of the test subject's gray hair."

(CX-28)

"And a large number of Dr. Frank's test subjects saw a decrease in the amount of gray in their hair."

(CX-30)

"Another visible effect was a decrease in the amount of the test subject's gray hair."

(CX-32)

(d) The NEOCEL system will make the individual look and feel younger.

"PATIENTS LOOK AND FEEL

YOUNGER WITH NEOCEL."

(CX-24)

"DR. FRANK'S DECADE OF

RESEARCH CAN GIVE YOU

YEARS OF ADDED YOUTH."

"The many benefits of Neocel mean years of added youth for you."

"Dr. Frank noted that his patients who regularly used Neocel showed dramatic improvements in youthfulness."

(CX-27)

"A DOCTOR-DEVELOPED SYSTEM

FOR LOOKING YOUNGER."

(CX-29)

"THANKS TO THIS DOCTOR,

YOU CAN LOOK

AND FEEL YOUNGER FOR

YEARS TO COME."

(CX-31)

"Science Develops

A System For

Staying Young."

(CX-83)

(e) The NEOCEL system will significantly increase the user's energy stamina levels.

"The majority of Dr. Frank's patients also reported an increase in energy levels, more stamina, and better endurance."

(CX-24)

"More importantly, the test subjects felt a dramatic increase in stamina and energy after only two weeks. This was due to no ordinary set of circumstances. Dr. Frank's Neocel System produced these extraordinary results."

(CX-25)

"But most important were the overall improvements in stamina and energy. After only one or two weeks, patients reported impressive new levels of a general feeling of well-being and renewed vitality."

(CX-27)

"Dramatic increases in stamina and energy were reported by the test subjects, most ex- periencing greater vitality after taking Neocel for only one to two weeks."

(CX-28)

"INCREASED ENERGY LEVELS.

The majority of Dr. Frank's test subjects reported an increase in stamina and energy after taking Neocel for only a few weeks."

(CX-30)

"Dr. Frank's subjects also reported increased energy levels and stamina after using Neocel for just several weeks."

(CX-31)

(f) The NEOCEL system will prevent and reverse cell degeneration.

"WORKS TO IMPROVE

CELL QUALITY.

Neocel contains a combination of grandular extracts, vitamins, enzymes, minerals, and nucleic acids. Most of these nutrients are not available in optimal amounts in the food we eat, or in ordinary nutritional supplements.

The Neocel System works to improve cell quality. Each cell in your body contains genetic material that controls not only color of your hair and eyes, but how fast you age. It stands to reason, that if you improve your cells, you then improve your entire body. The aging process is, after all, basically cell degeneration."

(CX-25)

"Dr. Frank believes this is because Neocel's ingredients help release more oxygen for use in the cells."

(CX-27)

"The nutrients in Neocel appear to allow better quality reproduction take place. sic The ensuing improvement in cell quality is demonstrated by the dramatic visual changes in appearance noted by Dr. Frank."

(CX-28)

"NEOCEL IS DR. FRANK'S

EXCLUSIVE FORMULA

FOR FIGHTING CELLULAR

DEGENERATION."

(CX-31)

"Neocel's nutrients are designed to induce better cell functioning. By supplying nucleic acids that serve to enhance your cell's reproductive ability, an improvement in cell quality takes place."

(CX-83)

(g) The NEOCEL system will make more oxygen available for use by cells.

"High-quality cell reproduction and optimum cellular oxygen certainly appear to be major factors in the startling visible improvements and energy increases reported by Dr. Frank's patients."

"So he began formulating a combination of nutrients --vitamins, minerals, enzymes, nucleic acids and glandular extracts --especially designed to promote healthy cell reproduction and oxygen levels.

Neocel was the remarkable result."

(CX-27)

"thus the blood hemoglobin releases more oxygen for the cell's use."

(CX-28)

" T he ingredients in Neocel decrease the affinity of hemoglobin for oxygen. Thus the blood hemoglobin releases more oxygen for the cell's use."

(CX-32)

SUPEROXIDE DISMUTASE (SOD) (9/175), 9/176)

(a) The use of SOD will slow the aging process by retarding cell degeneration.

"WHY GROW OLD"

BEFORE YOUR TIME?"

"... which means cell membranes aren't as prone to break down."

If you'd rather not grow old before your time, use the postpaid enveloped or the coupon below and order Dismutase today."

(CX-1)

"CELL DEFENSE

STOP AGING

AT THE SOURCE

WITH SOD."

(CX-2)

"So if you'd like to avoid the un- appealing consequences of premature aging due to cellular degeneration, take Dismutase."

(CX-4)

"CELLS. THE BASIC UNIT OF LIFE.

IMPROVE THEM AND IMPROVE

THE QUALITY OF LIFE."

(CX-7)

"WHY DOCTORS THINK

DISMUTASE CAN SLOW

THE AGING PROCESS."

(CX-8)

(b) The use of SOD will increase and stabilize cellular oxygen at optimum levels.

"Dismutase helps stabilize cellular oxygen at the optimum level."

(CX-1)

"Thus, cellular oxygen supply remains at its optimal level."

(CX-2)

"As a result, cellular oxygen is stabilized at its most beneficial level. Cell membranes are much less likely to break down."

(CX-4)

"Dismutase has the ability to neutralize and destroy free radicals within the body. This causes cellular oxygen supply to return to higher levels."

(CX-5)

(c) The use of SOD will protect genetic material in the cells.

"So reproductive genetic material is better protected."

(CX-1)

"Superoxide Dismutase tablets provide the dismutase activity needed to protect your cells."

(CX-2)

"And therefore genetic material remains protected."

(CX-4)

"And genetic material is protected as cell membranes become less susceptible to break down."

(CX-5)

(d) The use of SOD will prevent or retard unnecessary oxidation in the body.

"Foreign bodies that consume oxygen intended for the cells are called free radicals. They not only restrict the oxygen supply, but also invade the cell membrane to injure and destroy the reproductive material."

* * *

"Dismutase is able to neutralize and destroy free radicals. This causes cellular oxygen supply to return to higher levels."

(CX-6)

"SOD is an enzyme. Its function is to 'disarm' a specific free radical --super- oxide. SOD turns this into less toxic products. By doing this, SOD keeps un- necessary oxidation from occurring, a process linked to degenerative diseases like obesity. Since cellular oxygen supply remains at its optimum level with SOD, cell membranes are less susceptible to breakdown."

(CX-48d)

RNA 9Ribonucleic Acid) (9/177), 9/178)

(a) The average American diet is deficient in RNA

"RNA Tablets and Creme --RNA transmits the genetic material needed for cellular reproduction. But as we age, RNA levels tend to deplete. This results in poorer quality cell reproduction, one of the signs of degenerative aging."

(CX-45e)

"Except for a few selective foods, it is almost impossible to receive enough RNA through the average diet."

(CX-72)

(b) The ingestion of RNA TABLETS as a nutritional supplement will alleviate the body's RNA deficiency.

"You can supplement that RNA your body needs in two ways. In tablet form, RNA provides all the RNA needed to maintain optimum health and cell quality."

(CX-45e)

"Modern research is showing that there is no need for your RNA to have only 50 cellular reproductive cycles.

Instead, with the proper nutri- tional supplementation, RNA can continue to regenerate, sometimes to over 100 extra cellular reproductions. And healthy vital reproductions. So even if your chronological age is approaching 50, keep your cell cycle strong with RNA creme and tablets."

(CX-43-c and d)

(c) The ingestion of RNA TABLETS will retard the destructive effects of the aging process by enriching the body's cells.

"Science has now demonstrated that RNA can be supplemented to return levels to their normal state. In so doing, cell reproduction improves, eliminating one of the major factors of degenerative aging."

(CX-45e)

"This nutritional supplement enriches each and every cell. Anti-aging experts feel that an RNA supplement to the diet slows down the destructive effects of the aging process."

(CX-72)

Anti-aging experts feel that an RNA supplement slows down the destructive effects of the aging process. Except for a few foods, it is almost impossible to receive enough RNA through the average diet."

(CX-35)

(d) RNA is an integral and essential active ingre- dient of RNA CREME and, whether used separately or in combination with RNA TABLETS, will diminish crows feet and wrinkles and prolonging sic the youthful appearance of the skin.

"RNA may also be supplemented topically with RNA Creme. One application a day can help skin regain tone and youthfulness once thought forever lost."

(CX-45e)

"By moistening and smoothing your face with RNA creme, you can prolong your youthful, beautiful appearance. your skin will be more supple, diminishing crow's feet and wrinkles. With RNA creme, your skin will feel softer to the touch. RNA tablets are an important part of the system to protect your face and your body."

(CX-72)

"RNA Creme provides your skin with nutrients that are particularly important as you reach middle age. These include nucleic acids; those entities that determine the rebuilding process of the cell, the building blocks of life."

(CX-43c)

"RNA creme supplies your skin with a vital nucleic acid that smooths and protects your delicate face.

By moistening and smoothing your face with RNA creme, you can prolong your youthful appearance. Your skin will be softer and more supple, diminishing crow's feet and wrinkles."

. . . . .

"Don't let unnecessary wrinkles betray you. RNA creme and tablets are scientifically formulated to fight the enemies of youth --wrinkles."

(CX-35)

GLUCOSE TOLERANCE FACTOR (GTF) (9/179, 9/180 and 9?181)

(a) The use of GTF will prevent hypoglycemia in the average American.

"If we don't have enough GTF then too much insulin is released into the blood- stream, and our blood sugar is burned too quickly. Hypoglycemia (low blood sugar) can result."

. . . .

"MOST DIETS ARE

LOW IN GTF.

The bottom line here is that most of us have insufficient amounts of GTF in our diets."

(CX-11, 12, and 13)

"GTF helps activate insulin to remove sugar from the bloodstream. Lower levels of GTF mean higher levels of insulin. By supplementing GTF to its normal levels, insulin's potency can be increased so as to reduce the amount released. This ability allows GTF to help control hypoglycemia, and normalize blood sugar levels."

(CX-14)

"GTF helps facilitate insulin to remove sugar from the bloodstream. Lower levels of GTF increase the levels of insulin. And increased insulin levels drive the blood sugar too low, often leading to a condition known as hypoglycemia (low blood sugar)."

"PROTECT YOURSELF

WITH GTF."

(CX-15)

"But that's not all you have to worry about if you're deficient in GTF. Because low levels can also result in hypoglycemia, a condition caused by excessive levels of insulin released in response to sugar in the blood."

"Because GTF is so hard to obtain naturally, the only way to assure yourself of getting enough is through supplementation. Which is why we developed a tablet containing all the GTF needed for healthy functioning."

(CX-16)

(b) The use of GTF will prevent arteriosclerosis in the average American.

"This condition called atheroscelrosis hampers the circulatory system and taxes the heart.

This disorders sic might have been prevented by adequate levels of GTF."

(CX-14)

"Higher levels of insulin also tend to erode Glucagon, a hormone-like substance that burns body fat. The resulting condition called atherosclerosis hampers the entire circulatory system, in addition to taxing the heart."

"PROTECT YOURSELF WITH GTF

Conditions such as these resulting from inadequate amounts of GTF can be prevented. Because now you can take GTF in supplement form."

(CX-15)

"Without enough Glucagon, fat is poorly utilized and can collect on the interior surface of artery walls. The condition that results is called atherosclerosis. A condition that could have been prevented with adequate levels of GTF."

(CX-16)

(c) The use of GTF will prevent diabetes in the average American.

"THE LITTLE-KNOWN SUBSTANCE

THAT HELPS PREVENT

THE BEST-KNOWN DISEASES.

Diabetes, hypoglycemia, arterio- sclerosis. Some of the best-known dis- eases to plague modern man. They often strike in the prime of life. Sometimes they kill. Always they leave the victim crippled.

Yet, there are measures that can be taken to prevent these maladies. One of the best is a little-known substance that can make a big difference in your health.

It's called GTF."

"Because of GTF's role in regulating insulin's effectiveness, it can increase insulin's potency so as to reduce the amount released. This ability allows GTF to help control hypoglycemia, and its related disorder, diabetes."

(CX-16)

(d) The use of GTF will control hunger and prevent weight gain in the average American.

"LOW BLOOD SUGAR

CAUSES EXTREME HUNGER."

"One immediate effect of hypo- glycemia is ravenous hunger. This leads to tremendous overeating, which unfortunately leads to obesity. And no one has to tell you what that means. So it's really important to prevent this vicious chain reaction. GTF is the way to do it."

"Now there's a way to give your body the GTF it requires. It's available in convenient tablet form. Don't take chances with your health. Protect yourself with GTF."

(CX-11, 12 and 13)

"A low blood sugar condition can also affect the way you look. As the blood sugar level falls due to an over-response of insulin, the desire to eat is increased. And these eating binges can grossly add to your weight."

"PROTECT YOURSELF WITH GTF."

(CX-15)

(e) The use of GTF will cause the average American user to appear and feel younger.

"GTF CAN MAKE A

DIFFERENCE IN HOW

YOU AGE. GTF can make a big difference in the way you look and feel."

(CX-11, 12 and 13)

"Old age isn't a number. It;s a feeling. And those with poor health feel it a lot sooner than others.

The best way to stay young is to stay healthy. That's where GTF can help."

(CX-14)

"PREVENTING

DEGENERATIVE AGING

One way is to make sure you have a proper intake of GTF."

(CX-15)

YOUTH EXTENSION SYSTEM (YES) (9/182)

(a) The Youth Extension System will retard the aging process.

"The Youth Extension System is based on medical research in the field of human aging."

"WE CAN KEEP YOU

YOUNGER LONGER."

(CX-21)

"WE'VE DEVELOPED

A COMPLETE SYSTEM FOR

STAYING YOUNG.

There are no magic potions for retaining your youth, but recent scientific research has formulated several products for slowing down the effects of premature aging.

We've combined four of these treatments which work together particularly well into our new Youth Extension System."

(CX-22, 75)

"But there are treatments that slow down the effects of aging."

(CX-23)

(b) The Youth Extension system will prevent hypoglycemia, obesity, adult onset diabetes and arteriosclerosis, by maintaining a blood sugar balance.

"GTF makes the insulin you produce work more effectively. This reduces the possibility that a hypoglycemia state will exist."

(CX-21)

"GTF keeps your all-important blood sugar level in balance."

"Other serious problems such as diabetes and atherosclerosis can also result from insufficient GTF. (GTF is not a replacement for any diabetic medication; never change such medication without consulting your doctor.)"

(CX-22, 75)

"GTF works in concert with insulin to maintain a delicate balance between low and high blood sugar. Recent research shows an overproduction of insulin is a precipitating cause of weight gain. Being overweight makes you look and feel older. It can also contribute to adult onset diabetes, hypoglycemia and arteriosclerosis."

(CX-23)

(c) The Youth Extension System will prevent the premature rupture of cell membranes caused by free radicals.

"SOD helps protect cells from premature degeneration.

"As your body ages, its oxygen can be converted to a harmful substance with the addition of a free-floating electron (a 'free radical').

This in turn ruptures cell membranes, which causes incorrect metabolism and destroys cells.

SOD (superoxide dismutase) is a natural antidote which can reduce this crucial effect of aging."

(CX-22, 75)

"Because it's supercharged, the free radical ruptures cell membranes with its force. This causes a disruption of your metabolism and destroys cells. An antidote which disarms superoxide is provided by nature. It's called superoxide dismutase (SOD)."

(CX-23)

"Dismutase is the antidote provided by nature. It protects each cell's general material. And Dismutase is already being considered as an anti-cancer agent because of its function in maintaining cell integrity."

(CX-51e)

(d) The Youth Extension System will tighten the skin and reduce the tendency of wrinkling.

"Neocel creme and tablets reportedly gave Dr. Frank's test subjects tighter skin and decreased the severity of wrinkles."

(CX-21)

"The Neocel formula was created after years of research. Dr. Benjamin S. Frank, renowned physician and author, found a unique combination of nutrients to be effective in treating human aging. Dr. Frank's clinical results are impressive. He reports that his test subjects experience tighter skin and fewer wrinkles."

(CX-23)

(e) The Youth Extension System will improve the quality of cell reproduction.

"According to anti-aging experts, an extra boost of RNA strengthens the possibility of improved quality cell production."

(CX-21)

"RNA is thought to improve the quality of cell reproduction."

(CX-22, 75)

"Some experts feel an extra boost of RNA strengthens the possibility of improved quality cell production. And this could certainly affect the aging process."

(CX-23)

"Science has now demonstrated that RNA can be supplemented to return levels to their normal state. In so doing, cell reproduction improves, eliminating one of the major factors of degenerative aging."

(CX-51e)

(f) The Youth Extension System will increase the user's energy levels.

"His patients report increased energy levels, tighter skin and fewer wrinkles."

(CX-75)

"Not only did Dr. Frank notice other appearance changes, but also a feeling of increased well being. His theory on increased energy levels in Neocel users is based on its anti-anoxia effect, the release of more oxygen where it's needed."

(CX-23)

BRAINPOWER (9/183), 9/184)

(a) The ingestion of BRAINPOWER will improve the user's mental capacity.

"Is Increased Mental Capacity

Only For a Privileged Few?"

"Harness your mind's potential with Brainpower. Use the coupon below to order today."

(CX-17)

"So if you want to use your mind to the fullest, order Brainpower today. It might well be the smartest thing you'll ever do."

(CX-18)

"If you want to extend your mind's capacity, order Brainpower today."

(CX-19)

"DEVELOP YOUR MIND

TO IT'S FULLEST."

"According to their studies, these substances provide elements the brain needs for better functional capacity."

(CX-20)

"Stimulating brain and memory to its highest functioning capacity involves proper nourishment and use; herbs can provide the wholesome ingredients needed by the brain and body to produce these desirable results."

(CX-63)

(b) The ingestion of BRAINPOWER will produce a stimulating, healing and toning effect on the user's nervous system.

"Herbologists have long sought an answer to this matter. They believe that certain herbs and nutrients can have a toning effect on the nervous system."

"These are the ingredients in Brain- power. One tablet provides the elements the brain needs for better functional capacity."

(CX-17)

"Sweet Almond is a protein particularly beneficial to the nervous system."

"Gotu Kola is a herb with caffeine-like qualities that gently stimulate the nervous system."

(CX-18)

"Gotu Kola provides a 'lift' for the nervous system."

(CX-19)

"They've learned that certain herbs and nutrients can have a toning quality on the nervous system."

"Sweet Almond, for example, provides a protein especially beneficial to the nervous system."

(CX-20)

" H herbs can produce a pronounced stimulating, healing and toning effect on the nervous system."

(CX-63)

(c) The ingestion of BRAINPOWER will rejuvenate the user's brain and nervous system.

"Brainpower is a 100% natural formulation with ingredients which many respected herbologists believe can help improve the functions of your brain and nervous system."

"In fact, every Brainpower ingredient adds to the vitamin and mineral content which is needed by the brain and nervous system for peak functioning and rejuvenation."

(CX-18)

"Brainpower also contains Gotu Kola, an herb with a caffeine-like quality that provides a lifting effect to the nervous system."

(CX-20)

"AN HERBAL WAY TO MENTAL REJUVENATION AND BRAIN STIMULATION."

(CX-63)

(d) The ingestion of BRAINPOWER will improve the functioning of the user's optic nerve and spinal column.

"Thistle has positive effects on the optic nerve and spinal column."

(CX-18)

III. THE REPRESENTATIONS MADE IN RESPONDENTS' ADVERTISEMENTS ARE MATERIALLY FALSE.

A. The NEOCEL SYSTEM (9/173, 9/174)

NEOCEL Tablets essentially are a multi-vitamin preparation not too dissimilar from others that are sold in drug and health food stores. The testimony of Complainant's witnesses supports this conclusion and Respondents' witnesses do not dispute it.

The evidence further supports the finding that this preparation would not be helpful except to individuals suffering from deficiencies in the vitamins contained in Neocel (Tr. 20).

I find more believable the conclusions of Complainant's witnesses that the incidence of vitamin deficiency in the United States is not great.

While NEOCEL appears to be a sound preparation which would not be harmful to the average user, that is not the issue. The question is whether the product fulfills the impressive claims of its advertising literature. In Leach v. Carlile, 258 U.S. 138, 139 (1922), the Supreme Court stated this criterion as follows:

". . . it is sufficient to say that the question really decided by the lower Courts was, not that the substance which appellant was selling was entirely worthless as a medicine, as to which there was some conflict in the evidence, but that it was so far from being the panacea which he was advertising it through the mails to be, that by so advertising it he was perpetrating a fraud upon the public."

To the same effect, in United States v. One Device, Etc., 160 F.2d 194 (10th Cir. 1947), it was held that a product which contributed to overall health to some extent was falsely represented in violation of the Federal Food, Drug and Cosmetic Act because it was not the cure-all that its advertising represented.

With respect to the NEOCEL enzyme product, I find that enzymes as intact proteins are destroyed in the process of digestion by the human stomach and intestines. Therefore, enzymes taken by mouth have zero utility. This was stated as an accepted scientific fact by Complainant's witnesses and was not effectively disputed by Respondents' witnesses. Drs. Kugler and Huemer believed that some enzymes might pass through the stomach and intestines but they could offer no substantiation for this conjecture. Therefore, I find that the enzymes in NEOCEL contribute nothing to the human body.

I find that beyond its temporary moisturizing effect, Neocel in cream form will not benefit the skin either in helping loss of skin tone, lessening wrinkling, or any other claimed benefit listed in paragraph 3 in the Complaints regarding NEOCEL. I also find that the nutrients in the product will not penetrate the skin into the body.

Thus I find that Respondents, Cosvetic Laboratories and Braswell, Inc. made materially false statements 1/ in their advertisements when they represented that the four NEOCEL products or any of them would:

1. Improve skin tone;

2. Lessen the severity of wrinkles more effectively than ordinary moisturizers;

3. Decrease the amount of gray in the hair;

4. Make the individual look and feel younger;

5. Significantly increase the user's energy stamina levels;

6. Prevent and reverse cell degeneration; and

7. Make more oxygen available for use by cells.

B. SUPEROXIDE DISMUTASE (SOD) (9/175, 9/176)

The label on Respondents' SUPEROXIDE DISMUTASE product (CX-69) described it as "Superoxide Dismutase activity equivalent to that found in raw freeze-dried liver (specially processed to retain enzymes)." (CX-69).

The evidence overwhelmingly proves, as previously found, that enzymes taken by mouth do not pass through the stomach and the intestines into the rest of the body. All of Complainant's witnesses confirmed this as a scientific axiom and Respondents' witnesses could only conjecture without substantiation that there might be exceptions to this rule (CX-93); Tr. 116-118, 129-130; CX-92; Tr. 35-40; CX-90).

Also I find, as persuasively testified to by Dr. Herbert, that enzymes are species specific - only human enzymes will help humans-and unless this was human enzyme, obtained from killing humans, which apparently is not the case, it will not benefit humans, even if absorbed (CX-93, p. 3).

Since the enzymes in SOD cannot benefit the human body, I find Respondents' SOD product to be nothing more than freeze-dried liver. Therefore, I find that Respondents, Braswell, Inc. and Cosvetic Laboratories made materially false statements in their advertisements when they represented that their SOD product will:

1. Slow the aging process by retarding cell degeneration.

2. Increase and stabilize cellular oxygen at optimum levels.

3. Protect genetic material in the cells.

4. Prevent or retard unnecessary oxidation in the body.

5. Prevent degenerative diseases.

6. Neutralize and destroy free radicals.

C. RNA TABLETS AND CREME (9/177, 9/178)

RNA Tablets (CX-68a) are identified on their label simply as "500 mg RNA in a base of brewer's yeast." RNA Creme is identified on its label (CX-68b) as a "super moisturizer" to which has been added an undisclosed amount of Ribonucleic Acid (RNA).

I find, as testified to unequivocally by Drs. Schwartz, Williams and Herbert, that the body is unable to use exogenously administered RNA (Tr. 29-35), 118-120, 130, 131, 191-193).

Dr. Schwartz stated in his affidavit (CX-90, p. 8):

No clinical or experimental studies were found in the scientific literature which would substantiate any claim that the ingestion and/or topical application of RNA will slow the aging process. The statement in the advertising which suggests that RNA is an essential nutrient is completely false. The only nucleic acid which the body can utilize is that which is contained in the individual's own genes. The body is unable to use exogenously administered nucleic acids. This suggests nucleic acids from other humans may be used when exogenously administered.

Dr. Williams stated in his affidavit (CX-92, p. 3):

RNA taken orally will be digested to its component parts by acid hydrolysis and enzymatic degradation. RNA administered topically will never be absorbed to the capillaries, and thus will never be found in the circulating blood. Even if RNA reached the external environment of somatic cells, the plasma membrane would act as an effective barrier to the large, highly polar RNA. Any RNA which has a specific biological effect and reaches the cytoplasm of the cell, also has a finite lifetime and would be degraded by cellular enzymes. Oral or topical administration will have no significant biological effect. To claim that RNA so taken will have any value other than a small nutritive effect is false.

In his affidavit, Dr. Herbert stated (CX-93, p. 3):

The advertising regarding RNA tablets have no basis in nutrition science and are materially false as a matter of fact. RNA taken by mouth is destroyed in the intestine by the pancreatic enzyme ribonuclease, and none of the RNA is absorbed. The reason nature has this system for destroying RNA in the intestine may be the fact that RNA is a specific blueprint, i.e., sardine

RNA is a blueprint which can only create sardines, human RNA is a blueprint that can only create humans, etc. Thus, if Defendants' RNA were absorbed, which it is not, if it is sardine RNA, the eater would grow fins and a tail. One of the products to which the body breaks down the undesired RNA is uric acid; hence, Defendants' product could be hazardous to people predisposed to development of gout.

I accept the conclusions of Complainant's witnesses as being more plausible and consistent with the weight of informed scientific opinion when they state that the body is capable of making its own RNA and the average American diet is not deficient in RNA.

Therefore, I find that Respondents, Earthquest, Ltd. and Cosvetic Laboratories made materially false statements in their advertisements when they represented that:

1. The average American diet is deficient in RNA (Ribonucleic Acid);

2. The ingestion of RNA TABLETS as a nutritional supplement will alleviate the body's RNA deficiency;

3. The ingestion of RNA TABLETS will retard the destructive effects of the aging process by enriching the body's cells; and

4. RNA is an integral and essential active ingredient of RNA CREME and, whether used separately or in combination with RNA TABLETS, will diminish crows feet and wrinkles and prolong the youthful appearance of the skin.

D. GLUCOSE TOLERANCE FACTOR (GTF) (9/179, 9/180, 9/181)

According to its label (CX-67), GLUCOSE TOLERANCE FACTOR (GTF) tablets contain "15 mcg. of Chromium as natural, biologically formed compounds in yeast, including Glucose Tolerance Factor chromium."

I find that the incidence of chromium deficiency in the United States is very small, less than 1 percent. Drs. Schwartz, Williams and Herbert supported this conclusion logically. Although Drs. Kugler and Huemer found the problem to be serious, I did not find their testimony to be persuasive on this question.

Dr. Herbert testified that it was impossible not to get adequate quantities of chromium if one follows a normal balanced diet (Tr. 327).

In his affidavit (CX-92, p. 3), Dr. Williams stated:

Regarding the substance GTF, there is no scientific basis in experimental fact to substantiate the defendant's claim. In the study of the biology of aging, diabetes mellitis, a disease state including abnormal glucose metabolism, has been considered by some as a partial model of aging, as the Hutchinson-Gilford syndrome of precocious aging. Both of these conditions show certain characteristics of accelerated aging, and both show abnormal glucose metabolism. Individuals with a chromium deficiency also show abnormal glucose metabolism; in the experimental rat this deficiency accents the development of aortic plaques. In the experimental system, supplying chromium restores normal glucose, and arrests to some extent plaque development. There is no evidence that chromium arrests plaque development in human beings, nor in animals free from chromium deficiency. On the other hand, chromium in several forms can elicit toxic response. A small proportion of human beings appear to be hypersensitive to chromium in some forms. In conclusion deficiency has no known correlate in affecting the process of aging through alteration in glucose metabolism. Any claim that GTF has a beneficial effect for normal individuals has no basis in fact, and, GTF may indeed place a certain number of human beings at jeopardy due to chromium hypersensitivity.

Dr. Schwartz' testimony agrees with that of Dr. Williams and Dr. Herbert to the effect that there appears to be no particular need for chromium supplementation in the average person (R. 25).

Dr. Schwartz' affidavit (CX-90, p. 9) notes the following about Glucose Tolerance Factor:

Glucose Tolerance Factor tablets are labeled as containing biologically formed compounds in yeast including glucose tolerance factor chromium (Exhibit 67). The term, glucose tolerance factor, is not generally recognized within the fields of biochemistry and endocrinology as being related to the function of insulin. It is assumed that the reference is to ionic chromium. Chromium deficiency mimics diabetes mellitus and produces aortic plaques in rats. Chromium supplementation improves or normalizes glucose tolerance in diabetics, older people, and malnourished children, and it has been suggested that a deficiency of chromium may be a basic factor in atherosclerosis. However, once atherosclerosis has occurred, supplementation of the diet with chromium does not appear to reverse the effect. Therefore, any suggestion in the advertisements (Exhibits 11-16) that the product, GTF, might be useful in the treatment of atherosclerosis is false. The implication that the product will prevent atherosclerosis is also misleading in that such prevention would be likely to occur only in the case of chromium deficiency. The statement is made that the product 'can increase insulin's potency so as to reduce the amount released.' Chromium might result in an increase in the effects of insulin but, again, only if there were a pre-existing deficiency of chromium.

Since the incidence of chromium deficiency is very low --less than 1 percent --mainly among the elderly poor it is highly unlikely that the readers of Body Forum would benefit from chromium supplementation. Unless the user has a specific deficiency, the product is worthless and possibly toxic.

Therefore, I find that Respondents, Earthquest, Ltd., Cosvetic Laboratories and Braswell, Inc. made materially false statements when they represented in their advertisements that:

1. The use of Glucose Tolerance Factor (GTF) will prevent hypoglycemia in the average American;

2. The use of GTF will prevent arteriosclerosis in the average American;

3. The use of GTF will prevent diabetes in the average American;

4. The use of GTF will control hunger and prevent weight gain in the average American; and

5. The use of GTF will cause the average American user to appear and feel younger.

E. YOUTH EXTENSION SYSTEM (YES) (9/182).

The YOUTH EXTENSION SYSTEM is a program involving the combined use of the NEOCEL system, SUPEROXIDE DISMUTASE, RNA and GLUCOSE TOLERANCE FACTOR.

I have already found that except for the nutritional value of NEOCEL as a vitamin supplement for the small part of the population that requires supplements and the effects of the two creams as moisturizers, these four products are valueless to the human body and in no way fulfill the grandiose claims contained in their advertising. I further find that the weight of believable evidence supports the conclusion that in this case the whole is no greater than the sum of its parts.

Dr. Schwartz described the YOUTH EXTENSION SYSTEM and the claims made for it in his affidavit (CX-90, p. 9) as follows:

The advertisements for the Youth Extension System (Exhibits 21-23) reveal that it is nothing more than a program involving the combined use of the products, Neocel, Superoxide Dismutase, RNA and Glucose Tolerance Factor all of which are discussed above. These products are equally worthless whether used singularly or in combination. The advertising claim that this is a 'complete system for staying young' is completely false.

Dr. Williams said that he knew of no theory, "based on modern biological science, that would predict that any of the elements of the YOUTH EXTENSION SYSTEM would have any effect at all. Inter- actions though are ve
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pordi

  • Jr. Member
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  • Posts: 173
Re: Eine massive Klage gegen etliche Täter, absolut lesenswichtig
« Reply #2 on: April 19, 2011, 02:39:42 PM »

Teil 2:

Dr. Huemer stated that he does not get involved in holistic medicine, Chinese or Hindu remedies, acupuncture, or spiritual or psychological approaches (Tr. 500). Dr. Huemer stated that he has seen between 600 and 800 and 800 new patients a year since 1975. His office is located in a middle class residential community. He has identified nutritional problems in a large percentage of the patients that he has seen. Although the stereotype of malnutrition is the undernutritioned person, malnutrition can also include nutritionally imbalanced and obese people. It is a frequently repeated misconception that the American diet supplies enough vitamins. This is not true (Tr. 500-502). He stated that he was taught in medical school that 80 percent of patients have functional or psychological complaints. He believes this figure is grossly overstated. It is a catch-all to cover our ignorance (Tr. 506).

He testified that groups who are likely to have nutritional deficiencies include the elderly. They tend not to eat as well as younger people, especially if they live alone. They eat foods that are easier to prepare and convenience foods like potato chips. Also, elderly people may not have sufficient funds to buy appropriate food. Poor people also are trapped by diet into a cycle of poverty. Pregnant malnourished women will have sub-standard offspring with inadequate brain development. Also, food fadists such as those who go on the latest crash weight loss diet that they read about in ladies' magazines may suffer from inadequate nutrition (Tr. 507-508).

Dr. Huemer stated that he found the work of Dr. Herman Baker and Dr. Levy, as contained in Respondents' Exhibit 19, to be reliable in showing that the elderly have nutritional problems. He believes that elderly people have higher requirements and greater deficiencies for nutrients. Also, vitamin requirements increase during pregnancy (Tr. 514). However, he stated that he prefers to recommend foods as sources of nutrients whenever possible (Tr. 514).

He indicated that some of the theoretical sources of deficiencies are as follows: 1. Higher individual requirements for certain substances by some people. There is need to study this more. 2 Malabsorption. This refers to nutrients passing out in the stool. 3. Poor intake. The debasement of the food supply by the American food industry. There is a showing that people who are highly processed diets had a higher instance of illness (Tr. 515).

With regard to RDA's, Dr. Huemer testified that foods can lose nutrients in cooking, processing and canning. Thus, nutrients analyzed may differ from those eaten (Tr. 517). He further stated that there is no average American requirement. This varies from one person to another. He was reminded of a statistician who drowned in a stream which had an average depth of three feet. There are approximately 40 known nutrients. We don't have RDAs for all 40. Statistically, there is a reasonable chance that not all the people in the United States will be well-nourished by RDA criteria. He uses RDA standards as guides (Tr. 517, 518).

Dr. Huemer uses supplements extensively. These include 50 to 60 vitamins, minerals, glandular products, multivitamins, herbal products such as ginseng, as well as non-essential nutrients such as choline, inositol and amino acids (Tr. 519).

He found Neocel products to be good formulations. He stated that they are quite complete, contain a whole range of nutrients, and are rather well-balanced. If a patient does not eat properly or is under stress, it is better for him to have too many nutrients than not enough. Such products give the patient a cushion (Tr. 520, 521).

He stated that the Neocel enzyme supplement is a vegetable concentrate powder. In general, vegetables are good sources of vitamins and minerals. The vegetable powder could be there for that purpose or it could serve as a base. Tablets which contain yeast afford better absorption (Tr. 522). He stated that RNA carries a copy of the genetic blueprint or plan and the yeast in Neocel is rich in RNA. Yeast RNA provides raw materials that build RNA in cells. He stated that bee pollen is noted for its mineral content.Spleen powder and thymus powder are believed to nourish the glands and provide sources of nutrients. Desiccated liver is a source of vitamins and minerals. Fish concentrate 28-65-217 disputant to has respondent order Helps to activitate enzymes. Lecithin is a source of lipids and is used to manufacture cell membranes (Tr. 522-524).

With regard to Neocel 2, which is a mineral supplement, he stated that the minerals present are nowhere near the toxic range and are of considerable biological importance (Tr. 525, 526).

Dr. Huemer testified that Neocel products will tighten and improve connective tissue under the skin. He agrees that they will make an individual look and feel younger, assuming the individual needs nutrients. Many individuals need one or more nutrients. Symptoms of need are tiredness and feeling older. If the prepara tion improves tiredness, the individual will feel younger. If it improves skin tone, the individual will look younger. He believes that these products will increase energy and stamina levels in that they will improve tiredness feelings. As to the claim that Neocel products will reverse and prevent cell degeneration, he stated "I should think that they would." He stated that selenium and vitamins C and E will prevent and reverse cell degeneration. Vitamins A and C can reverse cancel cells which he considered degeneration. As to the claim that Neocel makes more oxygen available for use by the cells, he first answered "I don't know that specifically" but then he stated "Yes, because of its iron and copper." (Tr. 526-529).

Dr. Huemer stated that he has given yeast RNA to elderly patients who have many deficiencies. His impressions are favor able. His patients report subjectively that they sense improve- ment in memory, such as remembering phone numbers. He does not have any controlled studies to support this conclusion. However, he indicated that Dr. Cameron, who gave yeast RNA, administered intra- venously and orally, to elderly patients with memory defects of various causes such as senility and arteriosclerosis, obtained significant improvement in memory. Intravenous doses were more effective than oral doses but there were more adverse reactions from intravenous doses. Cameron's article appeared in the American Journal of Psychiatry. Dr. Huemer is not certain that this is a peer review publication. These studies suggest to him that oral RNA is effective (Tr. 530-537).

Dr. Huemer stated a theory that digestive enzymes from the pancreas break down RNA molecules into fragments which are water-absorbed and then built up into other molecules (Tr. 538, 539). However, there are no tests to support this theory.

When asked if the average American diet is sufficient in RNA, Dr. Huemer answered that the average American diet is highly processed. He is not aware whether food processing depletes RNA in the diet but this would not surprise him (Tr. 541).

Dr. Huemer stated that SOD, like all enzymes, is a protein. He knows of no studies that indicate that SOD can be absorbed into the body if taken orally. However, he believes that several kinds of proteins can make it into the body through the gastro-intestinal system (Tr. 543).

Dr. Huemer stated that he has not personally done any double-blind studies. He takes a more relaxed view of things. Dr. huemer believes that a test of whether a method is scientific is whether it works for the purpose for which it is intended. He agrees that questions of safety should be established beyond all doubt. He believes that properly conducted double-blind studies should be mandatory before a therapeutic drug is put on the market. This is because drugs alter natural processes and can have harmful side effects. He does not apply the same standard to natural substance in nutrients because there is a nearly zero risk of harm. He stated that if the risk of harm is near zero and the beneficial effect is unknown, he will tend to use an ingredient. The worst that can happen is that someone will spend money for something that is unnecessary. As an example, he stated that there is no double-blind study to confirm or deny whether or not, as contended by Linus Pauling, vitamin C is effective in reversing cancerous formations in malignant cells. However, with little or no risk and potential benefit, he would consider it immoral to withhold the benefit. However, when asked if he would prescribe vitamin C for cancer to the exclusion of all else, he responded, "Heavens no." (Tr. 547-551).

Dr. Huemer has not used Respondents' GTF formula in his practice although he has used other forms of GTF for diabetic patients (Tr. 555, 556). He stated that it is unquestionable that a chromium deficiency occurs in the American diet (Tr. 558). Also, processing of foods, such as white flour and white sugar, and canning removes chromium. Thus, people who use processed foods are likely to have chromium deficiencies (Tr. 558).

Since no RDA has been established for chromium, Dr. Huemer thinks that it is presumptuous for Dr. Herbert to say that people have no deficiency (Tr. 559). Dr. Huemer stated that the main medical indication of a chromium deficiency is impaired glucose tolerance (Tr. 560). However, there is reason to believe that arteriosclerosis may, in part, result from a chromium deficiency (Tr. 561).

He gives GTF to patients who have an elevated blood sugar and history of diabetes. The results are improvements in glucose tolerance. It is very likely that GTF has an effect on hypoglycemia. He believes that chromium also reduces serum cholesterol and triglyceride levels (Tr. 562-565).

Dr. Huemer stated that ginseng is quite commonly used in the Far East and has a reputation as a "cure-all" there. Ginseng contains steroids. It was found that under certain conditions tumor growth in mice was inhibited by ginseng extract (Tr. 566). He stated "this is a tremendously complicated therapeutic agent." (Tr. 567).

On cross-examination, Dr. Huemer stated that he is not board- certified (Tr. 568). He admitted that mixing cells of different animals stimulated the type of cell division that is cancerous or carcinogenic (Tr. 568, 569).

He stated that Linus Pauling presented cogent arguments that increased intake of vitamin C could improve the function of cells and extend life by about eight years. However, Dr. Huemer conceded that this is not a generally accepted use of vitamin C (Tr. 570, 571).

He admitted that very large doses of vitamin C such as five to ten grams a day could be toxic. Large doses could cause kidney stones. He stated that vitamin A toxicity is a more worrisome matter, "although not to the point of hysteria." In one experiment, adults taking several hundred thousand units a day above the RDA for several months developed toxicity (Tr. 576, 577).

Dr. Huemer stated that the United States Department of Agriculture studies found vitamin A and iron deficiencies to be 20 to 25 percent. Complainant's Counsel agreed with Dr. Huemer with regard to iron deficiencies in women of child bearing years but he though that the others were slight and there were but minor instances of deficiencies in other people. In answer to Complainant's Counsel's questions, Dr. Huemer agreed that the typical pizza-eating, hamburger-munching citizen of Orange County probably gets enough protein from his diet (Tr. 582-584).

Dr. Huemer stated that he did not do any tests with regard to Neocel creme. He is not a dermatologist and he feels uncomfortable when testifying about dermatology (Tr. 585). With regard to the contention that Neocel decreases gray in hair, he stated that paraominobenzoic acid (PABA) in one Neocel product is reputed to reduce gray. However, he admitted that this is based on one rat study made many years ago which was not repeated. He knows of no double-blind study which supports this contention (Tr. 587). He stated that the placebo effect may be as high as 50 percent (Tr. 588). He stated that Neocel may make people look and feel younger and increase energy and stamina levels but admitted that there may be a large placebo effect with respect to this (Tr. 592). With regard to the claim that Neocel will prevent and reduce cell degeneration, he stated that if a deficiency contributed to this, nutrient intake would help. However, if the individual had no deficiency, it would not help. Similarly, Neocel will not help make more oxygen available for use in cells in people who have enough oxygen (Tr. 595, 596).

Dr. Huemer stated that he is not aware whether or not the normal diet contains enough SOD of the type in Respondents' product (Tr. 597). He would expect that SOD of this type will be digested, but he is not sure (Tr. 598). As for the contention that SOD will slow cell degeneration, he stated that this would have to be by destroying free radicals. However, he knows of no study which establishes that this product can improve cellular oxygen (Tr. 598, 599).

Dr. Huemer knows of no information to support the claim that Respondents' SOD product will protect genetic material within the cells (Tr. 599). As to the claim that this will prevent unnecessary oxidation in the body, Dr. Huemer stated that in general he would expect this. However, he was hesitant and uncertain about the product in question, and he had no data to support this claim (Tr. 599, 600). He also knew of no facts to support the claim to neutralize and destroy free radicals (Tr. 600).

As to the ingredients in the Neocel Enzyme product, he stated that some types of vegetable powder, for instance pineapple and papaya extract, can have enzyme activity. He stated that, in general, proteins and enzymes are broken down in the gastro intestinal system but some may be absorbed intact. Bee pollen is perhaps a sources of trace minerals be he is uncertain as to which ones. The thymus gland could be a hormone but conventional wisdom is that it will not be absorbed (Tr. 602).

Dr. Huemer stated that the average, healthy person manufactures all the RNA he needs in foodstuffs not including RNA (Tr. 604). There is no RNA deficiency syndrome that he has found in any textbook. However, that is not to say that such a deficiency cannot occur (Tr. 604). As to the claim that RNA will retard the aging process by enriching the body's cells, Dr. Huemer is not sure that he knows what that statement means (Tr. 604).

Dr. Huemer stated that he has seen few people who markedly were deficient in chromium (Tr. 613). He stated that he has not experience in the use of chromium for hypoglycemia (Tr. 614, 615). He stated that it is highly probable that chromium will help only those who are deficient.

Dr. Huemer stated that he has used ginseng as a anti-stress agent and as a mild stimulant. With regard to Complainant's Exhibits 115 and 116, a copy of a New Rochelle Medical letter and an article from the Journal of the American Medical Association, respectively, which deal with ginseng toxicity, Dr. Huemer stated that both seem reliable and accurate. He stated that he has not encountered ginseng abuse in his practice since he uses fairly low doses. However, this is an area of possible abuse by the layman since the products are widely available in health food stores (Tr. 619, 620).

Dr. John Paul Reeve stated that in 1978 he obtained a doctorate in naturapathy after an eight-month course. He expects to receive a chiropractic degree next month.

Dr. Reeve formulated Brainpower. He has studies and been interested in herbs for many years. Mr. Rinaldi, the editor of Body Forum Magazine, which is owned by Braswell Corp. asked Dr. Reeve to formulate Brainpower. Dr. Reeve receives royalties from Brainpower's sales (Tr. 634). He identified Respondents' Exhibits 29 through 33, which are articles that describe the effects of ingredients included in Brainpower. The articles contained in Respondents' Exhibit 29 state that sweet almond is high in calcium, protein, and phosphate; nourishing for the brain, nerves, muscular weaknesses, and weak digestion; and contains potassium and magnesium phosphate. Based on that, he concluded that this is a nutrient that would tone up the body, primarily the nervous system and the brain (Tr. 635-637). Respondents' Exhibit 30 indicated that gotu kila is relatively safe, has long been used in India and is thought to energize and preserve the brain (Tr. 637). Respondents' Exhibit 31 deals with ginseng. Dr. Reeve stated that most authorities mention that ginseng has a stimulant action on the nervous system and has been known for thousands of years in the Orient (Tr. 638). Respondents' Exhibit 32 emphasizes holy thistle or blessed thistle's tonic use for toning, its affect as a stimulant and its lack of negative side effects (Tr. 639). Respondents' Exhibit 33 states that capcicum or cayenne stimulates the flow of blood through the body as a carrying agent and increases the metabolic rate (Tr. 640).

He used these herbs on himself and found them helpful (Tr. 640). He believes that they will improve the mental capacity, stimulate and have a toning effect on the brain and nerves, rejuvenate the nervous system in the sense of bringing vigor and stimulation and improve the function of the optic nerve and spinal column (Tr. 641, 642).

On cross-examination, Dr. Reeve stated that he conducted no double-blind studies for Brainpower. However, he believes that double-blind studies may have been conducted for ginseng (Tr. 642, 643).

I found Complainant's witnesses to be individuals of the highest academic credentials. They are experts at the very top ranks of their fields, who appear to be recognized by their peers as authorities in their specialties. All three of Complainant's witnesses testified responsible and consistently with themselves and with each other. They supported their conclusions with logical reasoning. I found them to be truthful and persuasive.

Dr. Kugler attempted to substitute quantity of testimony for quality. He talked at great length, in generalities and frequently wandered from the subject. He did not support many of his conclusions with logical information. Additionally, I had questions with regard to his credibility, especially when he was asked whether he relied upon various articles. I felt that in many instances he was not truthful. There were contradictions in his testimony. I found him to be an unreliable witness.

I found Dr. Huemer to be more reliable. However, his credentials were not as good as those of any of Complainant's witnesses. He is not board-certified. His medical associations are not as impressive as Complainant's witnesses. He published articles on nutrition in peer review journals such as those in which Complainant's witnesses frequently published. I had no reason to question Dr. Huemer's sincerity or credibility. In fact, I was impressed by his candor in admitting his lack of knowledge in certain areas and in making some statements which were not helpful to Respondents. This contrasted with Dr. Kugler, who seemed determined to advocate Respondents' positions regardless of whether or not the facts supported his statements.

I also found Dr. Reeve to be an unimpressive witness. His conclusions regarding Brainpower were not based upon any scientific testing but merely upon various untested claims which he read, sometimes tested on himself, and then accepted. Furthermore, since he formulated the product and shares in its royalties, he has much to gain by praising Brainpower.

The parties also introduced an extensive number of exhibits into evidence. Complainant's Exhibits included copies of advertisements of Respondents' products, which are in issue, transcripts of labels for those products, copies of curricula vitae of its witnesses, affidavits of its witnesses, copies of documents relating to the transmission of the products by mail, copies of Body Forum magazine and a photocopy of material relating to Donsbach University.Respondents' Exhibits included copies of curricula vitae of its witnesses, articles regarding nutrition, a copy of Dr. Kugler's computer profile and various other articles. I have considered all of these exhibits. Unless an exhibit is relied upon in my findings of fact, I consider it to insufficiently persuasive or irrelevant.

CONCLUDING FINDINGS AND

CONCLUSIONS OF LAW

I. Respondents Obtain Money Through The Mail In Connection With The Sale Of The Products At Issue In These Cases

Respondents' businesses are largely dependent on mail order sales. Most of their advertising materials contain a coupon inviting the prospective customer to remit money through the mail to the address specified in the advertisement. In the alternative, the customer is urged to use the order form and business reply envelope included in each issue of Body Forum magazine. Examples include the advertisements in CX 1 and 3 (for SOD); CX 11 and 15 (for GTF); CX 18 and 19 (for Brainpower); CX 22 and 23 (for YES); CX 24 and 25 (for NEOCEL); and CX 33 and 34 (for RNA).

II. Respondents Make the Representations Alleged in Paragraphs 3 of the Complaints

The following are allegations contained in paragraph three of each Complaint and quotations from Respondents' advertisements in which the representations are made.

THE NEOCEL SYSTEM (Docket Nos. 9/173 and 9/174)

(a) The NEOCEL system will improve skin tone.

"Most patients reported an improvement in skin tone."

(CX-24)

"Among them was an improvement in skin tone."

CX-28)

"THE RESULTS. Dr. Frank reports that many of his test subjects experienced an improvement in skin tone."

CX-30)

"And in fact, Dr. Frank reports an improvement in cell quality among his Neocel patients. Improved skin tone, fewer wrinkles, decrease in graying hair and even better nail growth were all in evidence."

CX-31)

"Regular supplementation of Neocel imparted amazing effects. Among them was an improvement in skin tone."

CX-32)

(b) The NEOCEL system will lessen the severity of wrinkles more effectively than ordinary moisturizers.

"Neocel creme in combination with the other nutrients in the system helps fade the visible results of aging. With Neocel creme, wrinkles are not so noticeable, and age spots lighten. The whole package of nutrients feeds the skin from the inside and the outside.

CX-25)

"Wrinkling decreased and skin actually became tighter."

CX-27)

"Dr. Frank reported that many of his test subjects experienced a visible tightening of facial skin, resulting in a decrease in the severity of wrinkles."

CX-28)

"The visible tightening of skin resulted in a marked decrease in the prominence of wrinkles and loose flesh, especially in the facial area."

CX-30)

"Neocel cream will reduce wrinkling after only several weeks of daily use. Special prob- lem areas such as wrinkles on the forehead, 'crows feet' around the eyes, and 'liver spots' disappear with daily use after only a few months."

(CX-52f)

"Neocel creme in combination with the other nutrients in the system helps fade the visible results of aging. With Neocel creme, wrinkles are not noticeable, and age spots lighten. The whole package of nutrients feeds the skin from the inside and the outside."

CX-76)

(c) The NEOCEL system will decrease the amount of gray in the hair.

"From his work with nucleic acids and antioxidants, amazing results include patients who reported ... a decrease in the amount of gray in their hair."

(CX-25)

"Graying hair subsided."

(CX-27)

"Another visible effect was a decrease in the amount of the test subject's gray hair."

(CX-28)

"And a large number of Dr. Frank's test subjects saw a decrease in the amount of gray in their hair."

(CX-30)

"Another visible effect was a decrease in the amount of the test subject's gray hair."

(CX-32)

(d) The NEOCEL system will make the individual look and feel younger.

"PATIENTS LOOK AND FEEL

YOUNGER WITH NEOCEL."

(CX-24)

"DR. FRANK'S DECADE OF

RESEARCH CAN GIVE YOU

YEARS OF ADDED YOUTH."

"The many benefits of Neocel mean years of added youth for you."

"Dr. Frank noted that his patients who regularly used Neocel showed dramatic improvements in youthfulness."

(CX-27)

"A DOCTOR-DEVELOPED SYSTEM

FOR LOOKING YOUNGER."

(CX-29)

"THANKS TO THIS DOCTOR,

YOU CAN LOOK

AND FEEL YOUNGER FOR

YEARS TO COME."

(CX-31)

"Science Develops

A System For

Staying Young."

(CX-83)

(e) The NEOCEL system will significantly increase the user's energy stamina levels.

"The majority of Dr. Frank's patients also reported an increase in energy levels, more stamina, and better endurance."

(CX-24)

"More importantly, the test subjects felt a dramatic increase in stamina and energy after only two weeks. This was due to no ordinary set of circumstances. Dr. Frank's Neocel System produced these extraordinary results."

(CX-25)

"But most important were the overall improvements in stamina and energy. After only one or two weeks, patients reported impressive new levels of a general feeling of well-being and renewed vitality."

(CX-27)

"Dramatic increases in stamina and energy were reported by the test subjects, most ex- periencing greater vitality after taking Neocel for only one to two weeks."

(CX-28)

"INCREASED ENERGY LEVELS.

The majority of Dr. Frank's test subjects reported an increase in stamina and energy after taking Neocel for only a few weeks."

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pordi

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Re: Eine massive Klage gegen etliche Täter, absolut lesenswichtig
« Reply #3 on: April 19, 2011, 02:40:22 PM »

(CX-30)

"Dr. Frank's subjects also reported increased energy levels and stamina after using Neocel for just several weeks."

(CX-31)

(f) The NEOCEL system will prevent and reverse cell degeneration.

"WORKS TO IMPROVE

CELL QUALITY.

Neocel contains a combination of grandular extracts, vitamins, enzymes, minerals, and nucleic acids. Most of these nutrients are not available in optimal amounts in the food we eat, or in ordinary nutritional supplements.

The Neocel System works to improve cell quality. Each cell in your body contains genetic material that controls not only color of your hair and eyes, but how fast you age. It stands to reason, that if you improve your cells, you then improve your entire body. The aging process is, after all, basically cell degeneration."

(CX-25)

"Dr. Frank believes this is because Neocel's ingredients help release more oxygen for use in the cells."

(CX-27)

"The nutrients in Neocel appear to allow better quality reproduction take place. sic The ensuing improvement in cell quality is demonstrated by the dramatic visual changes in appearance noted by Dr. Frank."

(CX-28)

"NEOCEL IS DR. FRANK'S

EXCLUSIVE FORMULA

FOR FIGHTING CELLULAR

DEGENERATION."

(CX-31)

"Neocel's nutrients are designed to induce better cell functioning. By supplying nucleic acids that serve to enhance your cell's reproductive ability, an improvement in cell quality takes place."

(CX-83)

(g) The NEOCEL system will make more oxygen available for use by cells.

"High-quality cell reproduction and optimum cellular oxygen certainly appear to be major factors in the startling visible improvements and energy increases reported by Dr. Frank's patients."

"So he began formulating a combination of nutrients --vitamins, minerals, enzymes, nucleic acids and glandular extracts --especially designed to promote healthy cell reproduction and oxygen levels.

Neocel was the remarkable result."

(CX-27)

"thus the blood hemoglobin releases more oxygen for the cell's use."

(CX-28)

" T he ingredients in Neocel decrease the affinity of hemoglobin for oxygen. Thus the blood hemoglobin releases more oxygen for the cell's use."

(CX-32)

SUPEROXIDE DISMUTASE (SOD) (9/175), 9/176)

(a) The use of SOD will slow the aging process by retarding cell degeneration.

"WHY GROW OLD"

BEFORE YOUR TIME?"

"... which means cell membranes aren't as prone to break down."

If you'd rather not grow old before your time, use the postpaid enveloped or the coupon below and order Dismutase today."

(CX-1)

"CELL DEFENSE

STOP AGING

AT THE SOURCE

WITH SOD."

(CX-2)

"So if you'd like to avoid the un- appealing consequences of premature aging due to cellular degeneration, take Dismutase."

(CX-4)

"CELLS. THE BASIC UNIT OF LIFE.

IMPROVE THEM AND IMPROVE

THE QUALITY OF LIFE."

(CX-7)

"WHY DOCTORS THINK

DISMUTASE CAN SLOW

THE AGING PROCESS."

(CX-8)

(b) The use of SOD will increase and stabilize cellular oxygen at optimum levels.

"Dismutase helps stabilize cellular oxygen at the optimum level."

(CX-1)

"Thus, cellular oxygen supply remains at its optimal level."

(CX-2)

"As a result, cellular oxygen is stabilized at its most beneficial level. Cell membranes are much less likely to break down."

(CX-4)

"Dismutase has the ability to neutralize and destroy free radicals within the body. This causes cellular oxygen supply to return to higher levels."

(CX-5)

(c) The use of SOD will protect genetic material in the cells.

"So reproductive genetic material is better protected."

(CX-1)

"Superoxide Dismutase tablets provide the dismutase activity needed to protect your cells."

(CX-2)

"And therefore genetic material remains protected."

(CX-4)

"And genetic material is protected as cell membranes become less susceptible to break down."

(CX-5)

(d) The use of SOD will prevent or retard unnecessary oxidation in the body.

"Foreign bodies that consume oxygen intended for the cells are called free radicals. They not only restrict the oxygen supply, but also invade the cell membrane to injure and destroy the reproductive material."

* * *

"Dismutase is able to neutralize and destroy free radicals. This causes cellular oxygen supply to return to higher levels."

(CX-6)

"SOD is an enzyme. Its function is to 'disarm' a specific free radical --super- oxide. SOD turns this into less toxic products. By doing this, SOD keeps un- necessary oxidation from occurring, a process linked to degenerative diseases like obesity. Since cellular oxygen supply remains at its optimum level with SOD, cell membranes are less susceptible to breakdown."

(CX-48d)

RNA 9Ribonucleic Acid) (9/177), 9/178)

(a) The average American diet is deficient in RNA

"RNA Tablets and Creme --RNA transmits the genetic material needed for cellular reproduction. But as we age, RNA levels tend to deplete. This results in poorer quality cell reproduction, one of the signs of degenerative aging."

(CX-45e)

"Except for a few selective foods, it is almost impossible to receive enough RNA through the average diet."

(CX-72)

(b) The ingestion of RNA TABLETS as a nutritional supplement will alleviate the body's RNA deficiency.

"You can supplement that RNA your body needs in two ways. In tablet form, RNA provides all the RNA needed to maintain optimum health and cell quality."

(CX-45e)

"Modern research is showing that there is no need for your RNA to have only 50 cellular reproductive cycles.

Instead, with the proper nutri- tional supplementation, RNA can continue to regenerate, sometimes to over 100 extra cellular reproductions. And healthy vital reproductions. So even if your chronological age is approaching 50, keep your cell cycle strong with RNA creme and tablets."

(CX-43-c and d)

(c) The ingestion of RNA TABLETS will retard the destructive effects of the aging process by enriching the body's cells.

"Science has now demonstrated that RNA can be supplemented to return levels to their normal state. In so doing, cell reproduction improves, eliminating one of the major factors of degenerative aging."

(CX-45e)

"This nutritional supplement enriches each and every cell. Anti-aging experts feel that an RNA supplement to the diet slows down the destructive effects of the aging process."

(CX-72)

Anti-aging experts feel that an RNA supplement slows down the destructive effects of the aging process. Except for a few foods, it is almost impossible to receive enough RNA through the average diet."

(CX-35)

(d) RNA is an integral and essential active ingre- dient of RNA CREME and, whether used separately or in combination with RNA TABLETS, will diminish crows feet and wrinkles and prolonging sic the youthful appearance of the skin.

"RNA may also be supplemented topically with RNA Creme. One application a day can help skin regain tone and youthfulness once thought forever lost."

(CX-45e)

"By moistening and smoothing your face with RNA creme, you can prolong your youthful, beautiful appearance. your skin will be more supple, diminishing crow's feet and wrinkles. With RNA creme, your skin will feel softer to the touch. RNA tablets are an important part of the system to protect your face and your body."

(CX-72)

"RNA Creme provides your skin with nutrients that are particularly important as you reach middle age. These include nucleic acids; those entities that determine the rebuilding process of the cell, the building blocks of life."

(CX-43c)

"RNA creme supplies your skin with a vital nucleic acid that smooths and protects your delicate face.

By moistening and smoothing your face with RNA creme, you can prolong your youthful appearance. Your skin will be softer and more supple, diminishing crow's feet and wrinkles."

. . . . .

"Don't let unnecessary wrinkles betray you. RNA creme and tablets are scientifically formulated to fight the enemies of youth --wrinkles."

(CX-35)

GLUCOSE TOLERANCE FACTOR (GTF) (9/179, 9/180 and 9?181)

(a) The use of GTF will prevent hypoglycemia in the average American.

"If we don't have enough GTF then too much insulin is released into the blood- stream, and our blood sugar is burned too quickly. Hypoglycemia (low blood sugar) can result."

. . . .

"MOST DIETS ARE

LOW IN GTF.

The bottom line here is that most of us have insufficient amounts of GTF in our diets."

(CX-11, 12, and 13)

"GTF helps activate insulin to remove sugar from the bloodstream. Lower levels of GTF mean higher levels of insulin. By supplementing GTF to its normal levels, insulin's potency can be increased so as to reduce the amount released. This ability allows GTF to help control hypoglycemia, and normalize blood sugar levels."

(CX-14)

"GTF helps facilitate insulin to remove sugar from the bloodstream. Lower levels of GTF increase the levels of insulin. And increased insulin levels drive the blood sugar too low, often leading to a condition known as hypoglycemia (low blood sugar)."

"PROTECT YOURSELF

WITH GTF."

(CX-15)

"But that's not all you have to worry about if you're deficient in GTF. Because low levels can also result in hypoglycemia, a condition caused by excessive levels of insulin released in response to sugar in the blood."

"Because GTF is so hard to obtain naturally, the only way to assure yourself of getting enough is through supplementation. Which is why we developed a tablet containing all the GTF needed for healthy functioning."

(CX-16)

(b) The use of GTF will prevent arteriosclerosis in the average American.

"This condition called atheroscelrosis hampers the circulatory system and taxes the heart.

This disorders sic might have been prevented by adequate levels of GTF."

(CX-14)

"Higher levels of insulin also tend to erode Glucagon, a hormone-like substance that burns body fat. The resulting condition called atherosclerosis hampers the entire circulatory system, in addition to taxing the heart."

"PROTECT YOURSELF WITH GTF

Conditions such as these resulting from inadequate amounts of GTF can be prevented. Because now you can take GTF in supplement form."

(CX-15)

"Without enough Glucagon, fat is poorly utilized and can collect on the interior surface of artery walls. The condition that results is called atherosclerosis. A condition that could have been prevented with adequate levels of GTF."

(CX-16)

(c) The use of GTF will prevent diabetes in the average American.

"THE LITTLE-KNOWN SUBSTANCE

THAT HELPS PREVENT

THE BEST-KNOWN DISEASES.

Diabetes, hypoglycemia, arterio- sclerosis. Some of the best-known dis- eases to plague modern man. They often strike in the prime of life. Sometimes they kill. Always they leave the victim crippled.

Yet, there are measures that can be taken to prevent these maladies. One of the best is a little-known substance that can make a big difference in your health.

It's called GTF."

"Because of GTF's role in regulating insulin's effectiveness, it can increase insulin's potency so as to reduce the amount released. This ability allows GTF to help control hypoglycemia, and its related disorder, diabetes."

(CX-16)

(d) The use of GTF will control hunger and prevent weight gain in the average American.

"LOW BLOOD SUGAR

CAUSES EXTREME HUNGER."

"One immediate effect of hypo- glycemia is ravenous hunger. This leads to tremendous overeating, which unfortunately leads to obesity. And no one has to tell you what that means. So it's really important to prevent this vicious chain reaction. GTF is the way to do it."

"Now there's a way to give your body the GTF it requires. It's available in convenient tablet form. Don't take chances with your health. Protect yourself with GTF."

(CX-11, 12 and 13)

"A low blood sugar condition can also affect the way you look. As the blood sugar level falls due to an over-response of insulin, the desire to eat is increased. And these eating binges can grossly add to your weight."

"PROTECT YOURSELF WITH GTF."

(CX-15)

(e) The use of GTF will cause the average American user to appear and feel younger.

"GTF CAN MAKE A

DIFFERENCE IN HOW

YOU AGE. GTF can make a big difference in the way you look and feel."

(CX-11, 12 and 13)

"Old age isn't a number. It;s a feeling. And those with poor health feel it a lot sooner than others.

The best way to stay young is to stay healthy. That's where GTF can help."

(CX-14)

"PREVENTING

DEGENERATIVE AGING

One way is to make sure you have a proper intake of GTF."

(CX-15)

YOUTH EXTENSION SYSTEM (YES) (9/182)

(a) The Youth Extension System will retard the aging process.

"The Youth Extension System is based on medical research in the field of human aging."

"WE CAN KEEP YOU

YOUNGER LONGER."

(CX-21)

"WE'VE DEVELOPED

A COMPLETE SYSTEM FOR

STAYING YOUNG.

There are no magic potions for retaining your youth, but recent scientific research has formulated several products for slowing down the effects of premature aging.

We've combined four of these treatments which work together particularly well into our new Youth Extension System."

(CX-22, 75)

"But there are treatments that slow down the effects of aging."

(CX-23)

(b) The Youth Extension system will prevent hypoglycemia, obesity, adult onset diabetes and arteriosclerosis, by maintaining a blood sugar balance.

"GTF makes the insulin you produce work more effectively. This reduces the possibility that a hypoglycemia state will exist."

(CX-21)

"GTF keeps your all-important blood sugar level in balance."

"Other serious problems such as diabetes and atherosclerosis can also result from insufficient GTF. (GTF is not a replacement for any diabetic medication; never change such medication without consulting your doctor.)"

(CX-22, 75)

"GTF works in concert with insulin to maintain a delicate balance between low and high blood sugar. Recent research shows an overproduction of insulin is a precipitating cause of weight gain. Being overweight makes you look and feel older. It can also contribute to adult onset diabetes, hypoglycemia and arteriosclerosis."

(CX-23)

(c) The Youth Extension System will prevent the premature rupture of cell membranes caused by free radicals.

"SOD helps protect cells from premature degeneration.

"As your body ages, its oxygen can be converted to a harmful substance with the addition of a free-floating electron (a 'free radical').

This in turn ruptures cell membranes, which causes incorrect metabolism and destroys cells.

SOD (superoxide dismutase) is a natural antidote which can reduce this crucial effect of aging."

(CX-22, 75)

"Because it's supercharged, the free radical ruptures cell membranes with its force. This causes a disruption of your metabolism and destroys cells. An antidote which disarms superoxide is provided by nature. It's called superoxide dismutase (SOD)."

(CX-23)

"Dismutase is the antidote provided by nature. It protects each cell's general material. And Dismutase is already being considered as an anti-cancer agent because of its function in maintaining cell integrity."

(CX-51e)

(d) The Youth Extension System will tighten the skin and reduce the tendency of wrinkling.

"Neocel creme and tablets reportedly gave Dr. Frank's test subjects tighter skin and decreased the severity of wrinkles."

(CX-21)

"The Neocel formula was created after years of research. Dr. Benjamin S. Frank, renowned physician and author, found a unique combination of nutrients to be effective in treating human aging. Dr. Frank's clinical results are impressive. He reports that his test subjects experience tighter skin and fewer wrinkles."

(CX-23)

(e) The Youth Extension System will improve the quality of cell reproduction.

"According to anti-aging experts, an extra boost of RNA strengthens the possibility of improved quality cell production."

(CX-21)

"RNA is thought to improve the quality of cell reproduction."

(CX-22, 75)

"Some experts feel an extra boost of RNA strengthens the possibility of improved quality cell production. And this could certainly affect the aging process."

(CX-23)

"Science has now demonstrated that RNA can be supplemented to return levels to their normal state. In so doing, cell reproduction improves, eliminating one of the major factors of degenerative aging."

(CX-51e)

(f) The Youth Extension System will increase the user's energy levels.

"His patients report increased energy levels, tighter skin and fewer wrinkles."

(CX-75)

"Not only did Dr. Frank notice other appearance changes, but also a feeling of increased well being. His theory on increased energy levels in Neocel users is based on its anti-anoxia effect, the release of more oxygen where it's needed."

(CX-23)

BRAINPOWER (9/183), 9/184)

(a) The ingestion of BRAINPOWER will improve the user's mental capacity.

"Is Increased Mental Capacity

Only For a Privileged Few?"

"Harness your mind's potential with Brainpower. Use the coupon below to order today."

(CX-17)

"So if you want to use your mind to the fullest, order Brainpower today. It might well be the smartest thing you'll ever do."

(CX-18)

"If you want to extend your mind's capacity, order Brainpower today."

(CX-19)

"DEVELOP YOUR MIND

TO IT'S FULLEST."

"According to their studies, these substances provide elements the brain needs for better functional capacity."

(CX-20)

"Stimulating brain and memory to its highest functioning capacity involves proper nourishment and use; herbs can provide the wholesome ingredients needed by the brain and body to produce these desirable results."

(CX-63)

(b) The ingestion of BRAINPOWER will produce a stimulating, healing and toning effect on the user's nervous system.

"Herbologists have long sought an answer to this matter. They believe that certain herbs and nutrients can have a toning effect on the nervous system."

"These are the ingredients in Brain- power. One tablet provides the elements the brain needs for better functional capacity."

(CX-17)

"Sweet Almond is a protein particularly beneficial to the nervous system."

"Gotu Kola is a herb with caffeine-like qualities that gently stimulate the nervous system."

(CX-18)

"Gotu Kola provides a 'lift' for the nervous system."

(CX-19)

"They've learned that certain herbs and nutrients can have a toning quality on the nervous system."

"Sweet Almond, for example, provides a protein especially beneficial to the nervous system."

(CX-20)

" H herbs can produce a pronounced stimulating, healing and toning effect on the nervous system."

(CX-63)

(c) The ingestion of BRAINPOWER will rejuvenate the user's brain and nervous system.

"Brainpower is a 100% natural formulation with ingredients which many respected herbologists believe can help improve the functions of your brain and nervous system."

"In fact, every Brainpower ingredient adds to the vitamin and mineral content which is needed by the brain and nervous system for peak functioning and rejuvenation."

(CX-18)

"Brainpower also contains Gotu Kola, an herb with a caffeine-like quality that provides a lifting effect to the nervous system."

(CX-20)

"AN HERBAL WAY TO MENTAL REJUVENATION AND BRAIN STIMULATION."

(CX-63)

(d) The ingestion of BRAINPOWER will improve the functioning of the user's optic nerve and spinal column.

"Thistle has positive effects on the optic nerve and spinal column."

(CX-18)

III. THE REPRESENTATIONS MADE IN RESPONDENTS' ADVERTISEMENTS ARE MATERIALLY FALSE.

A. The NEOCEL SYSTEM (9/173, 9/174)

NEOCEL Tablets essentially are a multi-vitamin preparation not too dissimilar from others that are sold in drug and health food stores. The testimony of Complainant's witnesses supports this conclusion and Respondents' witnesses do not dispute it.

The evidence further supports the finding that this preparation would not be helpful except to individuals suffering from deficiencies in the vitamins contained in Neocel (Tr. 20).

I find more believable the conclusions of Complainant's witnesses that the incidence of vitamin deficiency in the United States is not great.

While NEOCEL appears to be a sound preparation which would not be harmful to the average user, that is not the issue. The question is whether the product fulfills the impressive claims of its advertising literature. In Leach v. Carlile, 258 U.S. 138, 139 (1922), the Supreme Court stated this criterion as follows:

". . . it is sufficient to say that the question really decided by the lower Courts was, not that the substance which appellant was selling was entirely worthless as a medicine, as to which there was some conflict in the evidence, but that it was so far from being the panacea which he was advertising it through the mails to be, that by so advertising it he was perpetrating a fraud upon the public."

To the same effect, in United States v. One Device, Etc., 160 F.2d 194 (10th Cir. 1947), it was held that a product which contributed to overall health to some extent was falsely represented in violation of the Federal Food, Drug and Cosmetic Act because it was not the cure-all that its advertising represented.

With respect to the NEOCEL enzyme product, I find that enzymes as intact proteins are destroyed in the process of digestion by the human stomach and intestines. Therefore, enzymes taken by mouth have zero utility. This was stated as an accepted scientific fact by Complainant's witnesses and was not effectively disputed by Respondents' witnesses. Drs. Kugler and Huemer believed that some enzymes might pass through the stomach and intestines but they could offer no substantiation for this conjecture. Therefore, I find that the enzymes in NEOCEL contribute nothing to the human body.

I find that beyond its temporary moisturizing effect, Neocel in cream form will not benefit the skin either in helping loss of skin tone, lessening wrinkling, or any other claimed benefit listed in paragraph 3 in the Complaints regarding NEOCEL. I also find that the nutrients in the product will not penetrate the skin into the body.

Thus I find that Respondents, Cosvetic Laboratories and Braswell, Inc. made materially false statements 1/ in their advertisements when they represented that the four NEOCEL products or any of them would:

1. Improve skin tone;

2. Lessen the severity of wrinkles more effectively than ordinary moisturizers;

3. Decrease the amount of gray in the hair;

4. Make the individual look and feel younger;

5. Significantly increase the user's energy stamina levels;

6. Prevent and reverse cell degeneration; and

7. Make more oxygen available for use by cells.

B. SUPEROXIDE DISMUTASE (SOD) (9/175, 9/176)

The label on Respondents' SUPEROXIDE DISMUTASE product (CX-69) described it as "Superoxide Dismutase activity equivalent to that found in raw freeze-dried liver (specially processed to retain enzymes)." (CX-69).

The evidence overwhelmingly proves, as previously found, that enzymes taken by mouth do not pass through the stomach and the intestines into the rest of the body. All of Complainant's witnesses confirmed this as a scientific axiom and Respondents' witnesses could only conjecture without substantiation that there might be exceptions to this rule (CX-93); Tr. 116-118, 129-130; CX-92; Tr. 35-40; CX-90).

Also I find, as persuasively testified to by Dr. Herbert, that enzymes are species specific - only human enzymes will help humans-and unless this was human enzyme, obtained from killing humans, which apparently is not the case, it will not benefit humans, even if absorbed (CX-93, p. 3).

Since the enzymes in SOD cannot benefit the human body, I find Respondents' SOD product to be nothing more than freeze-dried liver. Therefore, I find that Respondents, Braswell, Inc. and Cosvetic Laboratories made materially false statements in their advertisements when they represented that their SOD product will:

1. Slow the aging process by retarding cell degeneration.

2. Increase and stabilize cellular oxygen at optimum levels.

3. Protect genetic material in the cells.

4. Prevent or retard unnecessary oxidation in the body.

5. Prevent degenerative diseases.

6. Neutralize and destroy free radicals.

C. RNA TABLETS AND CREME (9/177, 9/178)

RNA Tablets (CX-68a) are identified on their label simply as "500 mg RNA in a base of brewer's yeast." RNA Creme is identified on its label (CX-68b) as a "super moisturizer" to which has been added an undisclosed amount of Ribonucleic Acid (RNA).

I find, as testified to unequivocally by Drs. Schwartz, Williams and Herbert, that the body is unable to use exogenously administered RNA (Tr. 29-35), 118-120, 130, 131, 191-193).

Dr. Schwartz stated in his affidavit (CX-90, p. 8):

No clinical or experimental studies were found in the scientific literature which would substantiate any claim that the ingestion and/or topical application of RNA will slow the aging process. The statement in the advertising which suggests that RNA is an essential nutrient is completely false. The only nucleic acid which the body can utilize is that which is contained in the individual's own genes. The body is unable to use exogenously administered nucleic acids. This suggests nucleic acids from other humans may be used when exogenously administered.

Dr. Williams stated in his affidavit (CX-92, p. 3):

RNA taken orally will be digested to its component parts by acid hydrolysis and enzymatic degradation. RNA administered topically will never be absorbed to the capillaries, and thus will never be found in the circulating blood. Even if RNA reached the external environment of somatic cells, the plasma membrane would act as an effective barrier to the large, highly polar RNA. Any RNA which has a specific biological effect and reaches the cytoplasm of the cell, also has a finite lifetime and would be degraded by cellular enzymes. Oral or topical administration will have no significant biological effect. To claim that RNA so taken will have any value other than a small nutritive effect is false.

In his affidavit, Dr. Herbert stated (CX-93, p. 3):

The advertising regarding RNA tablets have no basis in nutrition science and are materially false as a matter of fact. RNA taken by mouth is destroyed in the intestine by the pancreatic enzyme ribonuclease, and none of the RNA is absorbed. The reason nature has this system for destroying RNA in the intestine may be the fact that RNA is a specific blueprint, i.e., sardine

RNA is a blueprint which can only create sardines, human RNA is a blueprint that can only create humans, etc. Thus, if Defendants' RNA were absorbed, which it is not, if it is sardine RNA, the eater would grow fins and a tail. One of the products to which the body breaks down the undesired RNA is uric acid; hence, Defendants' product could be hazardous to people predisposed to development of gout.

I accept the conclusions of Complainant's witnesses as being more plausible and consistent with the weight of informed scientific opinion when they state that the body is capable of making its own RNA and the average American diet is not deficient in RNA.

Therefore, I find that Respondents, Earthquest, Ltd. and Cosvetic Laboratories made materially false statements in their advertisements when they represented that:

1. The average American diet is deficient in RNA (Ribonucleic Acid);

2. The ingestion of RNA TABLETS as a nutritional supplement will alleviate the body's RNA deficiency;

3. The ingestion of RNA TABLETS will retard the destructive effects of the aging process by enriching the body's cells; and

4. RNA is an integral and essential active ingredient of RNA CREME and, whether used separately or in combination with RNA TABLETS, will diminish crows feet and wrinkles and prolong the youthful appearance of the skin.

D. GLUCOSE TOLERANCE FACTOR (GTF) (9/179, 9/180, 9/181)

According to its label (CX-67), GLUCOSE TOLERANCE FACTOR (GTF) tablets contain "15 mcg. of Chromium as natural, biologically formed compounds in yeast, including Glucose Tolerance Factor chromium."

I find that the incidence of chromium deficiency in the United States is very small, less than 1 percent. Drs. Schwartz, Williams and Herbert supported this conclusion logically. Although Drs. Kugler and Huemer found the problem to be serious, I did not find their testimony to be persuasive on this question.

Dr. Herbert testified that it was impossible not to get adequate quantities of chromium if one follows a normal balanced diet (Tr. 327).

In his affidavit (CX-92, p. 3), Dr. Williams stated:

Regarding the substance GTF, there is no scientific basis in experimental fact to substantiate the defendant's claim. In the study of the biology of aging, diabetes mellitis, a disease state including abnormal glucose metabolism, has been considered by some as a partial model of aging, as the Hutchinson-Gilford syndrome of precocious aging. Both of these conditions show certain characteristics of accelerated aging, and both show abnormal glucose metabolism. Individuals with a chromium deficiency also show abnormal glucose metabolism; in the experimental rat this deficiency accents the development of aortic plaques. In the experimental system, supplying chromium restores normal glucose, and arrests to some extent plaque development. There is no evidence that chromium arrests plaque development in human beings, nor in animals free from chromium deficiency. On the other hand, chromium in several forms can elicit toxic response. A small proportion of human beings appear to be hypersensitive to chromium in some forms. In conclusion deficiency has no known correlate in affecting the process of aging through alteration in glucose metabolism. Any claim that GTF has a beneficial effect for normal individuals has no basis in fact, and, GTF may indeed place a certain number of human beings at jeopardy due to chromium hypersensitivity.

Dr. Schwartz' testimony agrees with that of Dr. Williams and Dr. Herbert to the effect that there appears to be no particular need for chromium supplementation in the average person (R. 25).

Dr. Schwartz' affidavit (CX-90, p. 9) notes the following about Glucose Tolerance Factor:

Glucose Tolerance Factor tablets are labeled as containing biologically formed compounds in yeast including glucose tolerance factor chromium (Exhibit 67). The term, glucose tolerance factor, is not generally recognized within the fields of biochemistry and endocrinology as being related to the function of insulin. It is assumed that the reference is to ionic chromium. Chromium deficiency mimics diabetes mellitus and produces aortic plaques in rats. Chromium supplementation improves or normalizes glucose tolerance in diabetics, older people, and malnourished children, and it has been suggested that a deficiency of chromium may be a basic factor in atherosclerosis. However, once atherosclerosis has occurred, supplementation of the diet with chromium does not appear to reverse the effect. Therefore, any suggestion in the advertisements (Exhibits 11-16) that the product, GTF, might be useful in the treatment of atherosclerosis is false. The implication that the product will prevent atherosclerosis is also misleading in that such prevention would be likely to occur only in the case of chromium deficiency. The statement is made that the product 'can increase insulin's potency so as to reduce the amount released.' Chromium might result in an increase in the effects of insulin but, again, only if there were a pre-existing deficiency of chromium.

Since the incidence of chromium deficiency is very low --less than 1 percent --mainly among the elderly poor it is highly unlikely that the readers of Body Forum would benefit from chromium supplementation. Unless the user has a specific deficiency, the product is worthless and possibly toxic.

Therefore, I find that Respondents, Earthquest, Ltd., Cosvetic Laboratories and Braswell, Inc. made materially false statements when they represented in their advertisements that:

1. The use of Glucose Tolerance Factor (GTF) will prevent hypoglycemia in the average American;

2. The use of GTF will prevent arteriosclerosis in the average American;

3. The use of GTF will prevent diabetes in the average American;

4. The use of GTF will control hunger and prevent weight gain in the average American; and

5. The use of GTF will cause the average American user to appear and feel younger.

E. YOUTH EXTENSION SYSTEM (YES) (9/182).

The YOUTH EXTENSION SYSTEM is a program involving the combined use of the NEOCEL system, SUPEROXIDE DISMUTASE, RNA and GLUCOSE TOLERANCE FACTOR.

I have already found that except for the nutritional value of NEOCEL as a vitamin supplement for the small part of the population that requires supplements and the effects of the two creams as moisturizers, these four products are valueless to the human body and in no way fulfill the grandiose claims contained in their advertising. I further find that the weight of believable evidence supports the conclusion that in this case the whole is no greater than the sum of its parts.

Dr. Schwartz described the YOUTH EXTENSION SYSTEM and the claims made for it in his affidavit (CX-90, p. 9) as follows:

The advertisements for the Youth Extension System (Exhibits 21-23) reveal that it is nothing more than a program involving the combined use of the products, Neocel, Superoxide Dismutase, RNA and Glucose Tolerance Factor all of which are discussed above. These products are equally worthless whether used singularly or in combination. The advertising claim that this is a 'complete system for staying young' is completely false.

Dr. Williams said that he knew of no theory, "based on modern biological science, that would predict that any of the elements of the YOUTH EXTENSION SYSTEM would have any effect at all. Inter- actions though are very complicated in the human body and it is very difficult to say categorically that in combination they could not have a biological effect. But I see no reason why they should have a biological effect" (Tr. 133).

When asked whether the ingredients involved in the YOUTH EXTENSION SYSTEM when used in combination would have any utility in retarding the aging process Dr. Herbert replied, "none whatsoever. They represent a massive ripoff" (Tr. 195).

Therefore, I find that Respondents, Cosvetic Laboratories made materially false statements when it represented in its advertising that YOUTH EXTENSION SYSTEM will:

1. Retard the aging process;

2. Prevent hypoglycemia, obesity, adult onset diabetes and arteriosclerosis, by maintaining a blood sugar balance;

3. Prevent the premature rupture of cell membranes caused by free radicals;

4. Tighten the skin and reduce the tendency of wrinkling;

5. Improve the quality of cell reproduction; and

6. Increase the user's energy levels.

F. BRAINPOWER (9/183, 9/184)

BRAINPOWER is a mixture of herbs (CX-66) including Gotu Kola, Sweet Almond, Lily of the Valley, Ginseng, Blessed Thistle and Cayenne Powder.

The weight of creditable evidence on the record does not support the product's massive curative and beneficial claims.

Dr. Schwartz testified that on the basis of current scientific knowledge there is no support for the advertising claims made for BRAINPOWER. He characterized the claim that it would improve the user's mental capacity as misleading (R. 46).

Dr. Schwartz' conclusions are summarized in his affidavit (CX-90, p. 10), in which he stated:

Brainpower tablets are labeled as containing gotu kila, sweet almond (deskinned), lily of the valley, ginseng, blessed thistle and cayenne powder (Exhibit 66). There is no recognized pharmacologic evidence which supports the advertising claims (Exhibits 17-20) that certain herbs have a toning quality on the nervous system or that any of the ingredients will have positive effects on the optic nerve and spinal column. No controlled clinical trials have been designed or executed which could lead to the conclusion that these substances have the properties claimed for them. By current scientific standards, the absence of any such studies warrants the conclusion that the advertisements for this product are false and misleading.

Dr. Herbert testified that the ingredients in BRAINPOWER would have no useful effect on the human body if ingested and perhaps might cause some harm. He pointed out that ginseng contains small amounts of estrogen which has been reported to produce painful breasts and breast swelling in men as well as women. Other harmful effects also have been reported in peer review scientific literature.

Dr. Herbert's views are summarized in his affidavit (CX-93, p. 3), in which he stated:

The advertising regarding the product, BRAINPOWER has no basis in human biochemistry and is materially false as a matter of fact. None of the ingredients contained therein have been scientifically demonstrated to improve mental capacity, produce any salutary effect on the nervous system, rejuvenate the brain or nervous system or improve the functioning of the optic nerve and spinal column. Additionally, at least one of the products (ginseng) contained in the tablets has been reported to produce hypertension, skin eruptions, nervousness, edema and diarrhea. (R.K. SIEGEL, JAMA 241:1614-1615, 1979); breast pain (PALMER, BRITISH MEDICAL JOURNAL 1:1284, 1978; DUKES, BRITISH MEDICAL JOURNAL 1:1621, 1978); difficulty regulating diabetes (DUKES, Side Effects of Drugs Annual 1:374, 1977), interfere with digitalis preparations (Oura et al., J. Biochem 77:1057, 1975).

Brainpower was formulated by John Paul Reeve, a naturopathic doctor (Tr. 28). Dr. Herbert testified that Dr. Reeve's background indicates "zero expertise in the science of nutrition." He described naturopathy as a "nutrition cult which practices anecdotal therapy using herbs . . . a practice which in Africa is called witch doctoring" (Tr. 201).

Dr. Reeve formulated BRAINPOWER (Tr. 629) based on various books on herbs which are widely used by naturopaths (Tr. 635-642).

Dr. Reeve conceded that neither he nor any of the authors upon whom he relied conducted any double-blind studies to test the validity of the claims made for BRAINPOWER (Tr. 642, 643). As I have previously stated I found Dr. Reeve to be an unimpressive witness because of (1) his lack of training and expertise in nutrition (2) his reliance on untested claims and (3) his financial interest in BRAINPOWER.

Therefore, I find that Respondents, La Fleur Natural and Cosvetic Laboratories made materially false statements in their advertising when they represented that:

1. The ingestion of BRAINPOWER will improve the user's mental capacity;

2. The ingestion of BRAINPOWER will produce a stimulating, healing and toning effect on the user's nervous system;

3. The ingestion of BRAINPOWER will rejuvenate the user's brain and nervous system; and

4. The ingestion of BRAINPOWER will improve the functioning of the user's optic nerve and spinal column.

G. THE HOME SALES BY THIRD PARTIES (9/185)

In addition to selling its products directly, Respondent, Braswell, Inc. as well as Respondents, Home Sales Division and Head Start, Inc. enlisted others to become sales representatives (CX-77, 78, 80 and 112). Respondents urged their sales agents to use the same sales materials and advertising representations as Respondents use for direct sales. Therefore, Respondents are seeking money through the mail indirectly, through their agents' orders by means of the same false representations. 2/

In Gottlieb v. Schaffer, 141 F. Supp. 7, 15 (S.D. N.Y. 1956), the Court held, "The mail order statutes are aimed at protecting the public against fraudulent schemes - the prevention of future injury to the public."

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, Inc. v. Christenberry, 169 F. Supp. 746 (S.D. N.Y. 1959).

The average person reading Respondents' advertisements would interpret them substantially as characterized in Paragraph 3 of the Complaints.

The effect of false representations is not dispelled by a money-back guarantee. Borg-Johnson Electronics, Inc. v. Christenberry, supra; Farley v. Heininger, 105 F.2d 79 (D.C. Cir. 1939).

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.

In their proposed conclusions of law, Respondents stated, "In order for an advertisement to be 'material,' it must be shown to have some influence on the buying decisions made by consumers" and to the same effect that "a plaintiff, to prevail, must establish by actual evidence that particular representations have, in fact, misled consumers." I do not agree. In Farley v. Heininger, the Court held at page 84, "The decisive factor, therefore, is not whether the mails are being used to project a scheme which may result in obtaining money from members of the public by means of false and fraudulent statements." See also Ger-Ro-Mar, Inc. v. F.T.C., 518 F.2d 33, 37 (2d Cir. 1975) where in interpreting another fraud statute with similar objectives the Court stated, " C courts have not required proof of actual deception."

I also do not accept without qualification the statement in Respondents' proposed conclusions that "Respondents' right to use the mails in the conduct of their business is a constitutional right." In Donaldson v. Read Magazine, the Supreme Court stated at page 192, "A contention cannot be seriously considered which assumes that freedom of the press includes a right to raise money to promote circulation by deception of the public." To the same effect, in Hollywood House International, Inc. v. Klassen, 508 F.2d 1276, 1277 (9th Cir. 1974), the Court held, "Fraudulent commercial appeals are not a protected form of expression ..." Similarly, in United States Postal Service v. Beamish, 466 F.2d 804, 807 (3d Cir. 1972), the Court held, "Advertisers possess no constitutional right to disseminate false or misleading materials. Therefore, Congress has the power to prohibit such deception through appropriate legislation." 39 U.S. Code § 3005 was held to be appropriate legislation in that case.

Therefore, Respondents are engaged in conducting a scheme for obtaining money through the mail by means of false representations in violation of 39 U.S. Code § 3005. 3/

Therefore, Orders of the type authorized by 39 U.S. Code § 3005, similar to the forms attached, should be issued against Respondents.

1/ In Reilly v. Pinkus, 338 U.S. 269, 274 (1949), the Supreme Court described material representations as representations which went beyond puffing on which credulous persons eager to achieve the represented results were entitled to rely. The representation here fits that definition.

2/ In United States v. International Term Papers, Inc., 477 F.2d 1277 (1st Cir. 1973), the Court held that, even if the buyer and not the seller makes the false representations, 39 U.S.C. § 3005 is violated if the seller used the mails to assist the buyer in making the representations.

3/ The proposed findings of fact and conclusions of law that the parties submitted have been fully considered. To the extent that I have indicated in this decision, they are adopted. All other proposed findings and conclusions are rejected either because they are unsupported by the evidence or because they are irrelevant.
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