February 5, 1981
In the Matter of the Complaint Against
GREAT LIFE LABORATORIES, INC.
500 Dorian Road P. O. Box 837 at
Westfield, NJ 07090
P.S. Docket No. 8/82; 02/05/81
Duvall, William A.
APPEARANCE FOR COMPLAINANT:
Kris tin L. Malmberg, Esq.
Consumer Protection Division
United States Postal Service
Washington, D.C. 20260
APPEARANCE FOR RESPONDENT:
Christopher S. Barnard, Esq.
Katz, Paller & Land
470 E. Paces Ferry Road Suite 2000
Atlanta, GA 30305
This proceeding was initiated on May 16, 1980, when the Consumer Protection Division, Law Department, United States Postal Service, Washington, D.C. (Complainant) filed a Complaint in which it alleged that Great Life Laboratories, Inc., 500 Dorian Road, P. O. Box 837 Westfield, NJ 07090 (Respondent) is engaged in conducting a scheme or device for obtaining money or property through the mails by means of false representation within the meaning of 39 U. S. Code § 3005.
Complainant alleges in paragraph I of the Complaint that attention is attracted to the scheme or device by advertisements which are calculated to induce the readers thereof to remit money or property through the mails.
Paragraph II advises that copies of advertisements typical of those referred to in paragraph I are attached to the Complaint as Exhibits A and B. (Copies attached hereto as Appendices A and B.)
In paragraph III of the Complaint, Complainant alleges that by means of such advertisements, or others similar thereto, Respondent represents, directly or indirectly, in substance and effect, whether by affirmative statements, omission or implication that:
a) The RNA in RIBOMINS will cause wrinkles to disappear.
b) The RNA in RIBOMINS will make some individuals look ten to fifteen years younger.
c) The RNA in RIBOMINS reduces breathlessness and fatigue.
d) The RNA in RIBOMINS heals acne, age spots and other skin ailments.
e) The RNA in RIBOMINS promotes good health and a general sense of well-being.
f) The RNA in RIBOMINS prevents aging and disease.
g) RIBOMINS increases resistance to flu and other diseases.
h) RIBOMINS have been scientifically tested and proven effective in making the user feel younger and more energetic and have healthier skin.
Complainant alleges in paragraph IV that the aforesaid representations are materially false as a matter of fact.
Complainant then requests that an order conforming with 39 U. S. Code § 3005(a) (1) and (2) be issued against Respondent.
In its Answer, Respondent denied each of the charges as stated in the Complaint, and with respect to each charge it further denied specifically each and every other allegation set forth directly or indirectly, in substance and effect, whether by affirmative statements, omission, or implication, in each separate paragraph beginning with the preamble paragraph of the Complaint and ending with the Ad Damnum paragraph thereof.
The product sold by Respondent is a tablet called Ribomins, the ingredients of which are as follows:
|1 Tablet 4 times daily provides||
RDA* % U.S.A.
|Vitamin A (fish oils) 10,000 units||
|Vitamin D 400 units||
|Vitamin B-1 (yeast & thiamin) 20 mg||
|Vitamin B-2 (yeast & riboflavin) 10 mg||
|Vitamin B-6 (pyridoxine 10 mg||
|Vitamin B-12 15 mcg||
|Vitamin C (rose hips & other Natural sources) 300 mg||
|Vitamin E 100 I.U.||
|Niacinamide 100 mg||
|Panthotenic Acid 50 mg||
|Folic Acid 100 mcg||
|Calcium 600 mg||
|Iodine (kelp) 15 mg||
|Iron (ferrous fumarate) 19.6 mg||
|Magnesium (oxide) 200 mg||
|Zinc sulfate 90 mg. supplying Zinc 36 mg||
|Selenium (in special yeast) 4 mcg||
|Ribo-Nucleic Acid 180 mg||
|ONLY THE FINEST NATURAL INGREDIENTS AVAILABLE ARE USED IN THIS PRODUCT.|
|Contents including base Made from fish oils, fermentation extract, rose hips, special yeast, vegetable oils, kelp, and pure vitamins and minerals as indicated in a base containing para-aminobenzoic acid 30 mg. inositol 40 mg. lecithin, citrus-bioflavinoids 100 mg. betaine (HCL) 40 mg. liver, alfalfa, choline, biotine, manganese and torula yeast.|
|DIRECTIONS: Adults as a dietary supplement of various essential vitamins and minerals 1 tablet 4 times a day as a dietary supplement.|
* Recommended Daily Allowance as established by US Government.
In less detail Respondent describes Ribomins as a dietary supplement consisting of ribo-nucleic acid (RNA) plus essential vitamins and minerals. Four tablets a day are said to "provide 180 mg. of RNA - and a whole lot more." (App. A) At the bottom of the fourth column of text in Appendix A, Respondent solicits orders for Ribomins, and offers a refund of the purchase price if, after 30 days of use as directed, the purchaser is dissatisfied and returns the unused tablets to Respondent. The purchase orders and the refund requests are to be sent to Respondent at 500 Dorian Road, P. O. Box 837, Westfield, NJ 07090.
The following excerpts from Appendix A provide a basis, but not necessarily the only basis, for each of the alleged representations set forth in paragraph III of the Complaint.
- a) The RNA in RIBOMINS will cause wrinkles to disappear.
- b) The RNA in RIBOMINS will make some individuals look ten to fifteen years younger.
- c) The RNA in RIBOMINS reduces breathlessness and fatigue.
- d) The RNA in RIBOMINS heals acne, age spots and other skin ailments.
- e) The RNA in RIBOMINS promotes good health and a general sense of well-being.
- Cause wrinkles to disappear...
- Make some individuals look ten to fifteen years younger...
- Reduce breathlessness and fatigue...
- Combat acne, ugly brown 'age spots', and other skin ailments...
- Promote good health and general sense of well-being...
- A major Health Journal reported:...The most immediate effect observed in dosages as low as 30 mg. of RNA daily was an increase in energy and well being. Reports disclose that the most striking effects were observed on the skin of the face. The first results observed were a healthier, rosier appearance and an apparent smoothing of the skin of the face. After one or two months of treatment, lines and wrinkles began to diminish."
f) The RNA in RIBOMINS prevents aging and disease.
"A significant breakthrough in the fight against the effects of aging."
* * *
"Hailed by doctors as the scientific breakthrough of our time, RNA (Ribo-Nucleic Acid) is opening up exciting new possibilities in the fight against the effects of aging and disease."
g) RIBOMINS increases resistance to flu and other diseases.
"This safe and effective nutritional supplement may significantly contribute to your family's health and resistance to flu and other illness."
h) RIBOMINS have been scientifically tested and proven effective in making the user feel younger and more energetic and have healthier skin.
"If you are between 20-60 years of age, a major medical authority reports that RNA may significantly contribute to making you feel more energetic, may help your skin to look its healthiest, and may help to make you feel younger, more alert, and alive."
In general, the hope of the reader as to the benefit to be obtained by purchasing and taking the product is fortified by the confidence and assurance of the seller as to the ability of the product to accomplish the advertised results. This confidence and assurance is made manifest in the banner caption of the advertisement stating that what is being offered for sale constitutes "a significant breakthrough in the fight against the effects of aging." This display by the seller of its confidence in the product is undergirded and strengthened by the no-risk, money-back guarantee made by the seller.
Complainant called as its first witness Dr. Theodore Robert Reiff, a medical doctor who is Associate Professor of Medicine in the School of Medicine at the University of North Dakota. Based upon his education, training and experience, including his private practice of medicine, as stated at the hearing and in his curriculum vitae, all of which reflect a special interest in geriatrics and gerontology, Dr. Reiff is well qualified to give expert testimony in respect to the issues in this proceeding. (Tr. 4-7, CX-E) Dr. Reiff, with what appears to be an excess of modesty, did not claim to be an expert in nutrition, but his credentials unequivocally establish that he is expert in (1) the mechanisms of aging and (2) the kind and character of preliminary study and testing that must be performed before valid claims can be made that products advertised and sold through the mail and over the counter will arrest or reverse the aging process. Dr. Reiff's testimony is summarized through page 20 of this decision. His testimony is adopted as part of the basis for this decision.
The process of establishing a scientific fact usually begins with a theory or hypothesis which is arrived at by definitive reasoning. It can be initiated, also, by observation which leads to the formulation of a theory or hypothesis. Next, experimentation is performed in a proper, scientific manner which includes, among other things, proper controls and adequate statistical evaluation. The results of the experiment are then objectively reported in the scientific literature, followed by confirmation of the results of the experiments by other independent, objective scientists using accepted techniques. If the results can be replicated by others and if the information is of value, the knowledge then becomes accepted by the scientific, professional community.
In designing the test or the experiment one factor to be considered is whether the experimental subjects are to be humans or animals. The subjects have to be of quantity and quality that would result in a valid experiment and be statistically significant. Unethical or inhumane practices are not be carried out in the experiment and the means must be justified by the ends sought to be accomplished, by the professional standards of society and of the individual profession.
The process of having writings accepted for publication in scientific journals begins, generally, when the author sends a copy of the article to the appropriate journal. The paper is reviewed by the board of editors and the consulting editor. After appropriate peer review, if the research and the description of it are considered to be acceptable, in good form, methodologically and ethically acceptable, and scientifically valid, the paper is accepted. Otherwise, the paper can be rejected. (Tr. 8, 9)
In discussing the process of the aging of living things, Dr. Reiff began by defining aging as a series of biological processes or events, including physical and chemical events, that take place, rather than just the passage of time. When aging is so defined, the question becomes: can the rate at which those processes and events take place be altered, thereby altering the rate of aging? The answer is: probably, yes. (Tr. 10)
Theories of aging, or more properly mechanisms of aging, at various levels of biological organization were discussed.
Some of these mechanisms are now summarized.
A. The molecular level is the lowest level of biological organization.
1. The cross-linking theory is that aging is due to the cross-linking of collagen molecules, which are large protein molecules that form and help form the structural framework of the body. With aging there is an increased cross-linking of the collagen fibers in the cell. When this occurs there is created a mesh or network of fibers that entrap the cell and make diffusion of nutrients by the circulatory system more difficult. In turn, this collagen network makes more difficult the diffusion of the waste products from the cell through the capillary where they are excreted. The cell's metabolism is impaired and it becomes less viable. Here, in order to retard the aging process, it would be necessary to reduce the cross-linking process by chemical means since these are chemical cross-linkings.
2. The error theory of aging is that aging may be due to an accumulation of genetic error in DNA, which is the chemical from which genes are formed. Each time cells replicate there is, ideally, a complete replication of the original cell, but this is not always the case. There may be only a 99 per cent replication, which when carried through a series of ten replications, there might be almost a 10 per cent error in the DNA. There would result an interference with further replication because there might be enough error to prevent correct multiplication and cell division.
An offsetting factor is that within cells there are certain enzymes, called "endonuclear enzymes" that have the capability of recognizing and correcting error in DNA. These endonuclear enzymes are thought to be over 99 per cent efficient. Despite this modification of the error theory, it probably is an important mechanism of aging at the molecular level.
3. The "free radical" theory is a third mechanism of aging. The term "free radicals" refers to reactive molecules and atoms. One way in which radicals are made by chemists is to radiate a chemical reaction. An incident of radiation can raise the energy state of an orbiting electron by having the energy of the photon added to it thereby making the atom molecule more reactive chemically.
The "free radical" theory is that aging may be due to an increase in the number of free radicals that occur with aging and these free radicals cause a lot of unwanted reactions thereby accelerating the aging process. Efforts have been made to reduce the number of free radicals by giving certain chemical agents in the food of experimental animals. One such experiment appears to have had some success in pregnant rats, but it has not been established that it works in humans.
4. Another theory of aging at the molecular level is called the "pigment" theory. A brown, fatty pigment, "lipofusion," is found in heart muscle, and other, cells and the amount of this pigment increases with age. Some recent reports indicate that certain chemicals may be given which allow the cell to get rid of the pigment. Experiments can be done that show that this chemical process works in tissue culture, but this has not been validated in humans. (Tr. 11-16)
B. The next higher level of biological organization is the cellular level. Most cellular studies in aging stem from the work of Leonard Hayflick and the so-called "Hayflick Phenomenon."
From his study of connective tissue from the lung of a human fetus that had been aborted Hayflick found that the cells reproduced as normal cells did and that they did so for about fifty generations of cells. Hayflick, among other things, calculated that from the amount of tissue that would be produced at the time an individual is a new-born fetus enough tissue could be produced to last 150 to 175 years.
In the past few years there have been reports that there is an extract of brain tissue, probably in the class of peptides known as "encalfrines," which are chemical messengers for the brain. It has been reported that when this substance is added to cells and tissue culture it is capable of more than doubling cell replication potential from fifty to over one hundred. Thus, even if there is a cellular limitation to the life span for certain of us, it is conceivable that this might be capable of being altered. Dr. Reiff stated that this extract of brain tissue is leading the way to psychological control over the cell replication potential, or cellular aging. This may have a tremendous therapeutic potential in the future, but at present, there are no therapeutic aspects to it. (Tr. 16-21)
C. The next biological level of organization is the organ or organism level, these being made of cells.
About 20 or 30 years ago, Dr. Nathan Shock and his colleagues at the National Institute of Gerontology initiated a longitudinal study in which they brought healthy humans into the laboratory and studied the organ function in these people. They studies the function of the heart, lungs, kidneys, muscles, bone strength, nerve conduction velocity, liver, endocrine system and, lately, the immune system.
They found that if a plot is made of the percentages of maximal function in relation to age, from about age 30 on, there is a decline from 100 per cent of maximal function in the twenties of all the organism function studied at an average rate of decline of one-half to three-quarters per cent per year. This has caused people to think, erroneously, that is why we live only threescore and ten years -- that by the age of 70 we have lost function and can not continue to exist. The reason it is not true is because humans are born with a surfeit of function. Humans are born with two kidneys, but they can get along fine with less than one. They are born with an excess in the capacity of bone strength, bone muscle, strong lung function and heart function, all serving in good stead as reserve capacity. Physiological difficulties do not begin to develop until these functions are reduced to about one third of maximal. That is the time when one starts getting symptomatic with normal day-to-day functions and the level of activity. But from the point of view of the organism, there is enough function to last at least a century. It is believed that the reason for the earlier decline in organ function is atrophy, or the decrease of function or size of the organ with disuse. If one does not use it, he loses it. If one does not exercise his muscles, not only do they get weaker, but, also, the cells decrease in size; they have decreased RNA and protein synthesis. Conversely, it should be possible to extend the period of normal functioning of muscles, and other organs, by the process of hypertrophy, increasing their function and size. Therefore there may be ways of extending the healthy human life span by keeping people active physically, mentally and emotionally so as to prevent or delay the atrophic process. If so, nutrition is very important because in order to produce the hypertrophy, sufficient nutrients must be supplied to allow the body to rebuild and undergo the hypertrophic process. Instead of needing fewer nutrients because they have lower caloric and protein requirements, as formerly was thought, some studies indicate that older people may even need more of certain foods in order to allow the hypertrophic response. (Tr. 21-26)
Generally, in the higher levels of biological organization it appears that the life span is increasingly shorter. The cellular limitations do not appear to be the limiting factor because there are enough connective tissues to last possibly as long as 150 years. If atrophy is not permitted to set in, there should be enough organ function to last in excess of 100 years. The Hayflick studies on cell longevity have not been done sufficiently on living people, they having been performed only in the test tube. Experimentation is in progress to determine if all cells are capable of 50 replications. In addition, the competence of the immune system has been studied during the last decade. There are some reports from the University of Rochester School of Medicine that the immune system is capable of being psychologically and behaviorally conditions. (Tr. 29-31)
The primary causes of death in the very old appear to be infection, pulmonary emboli (blood clots that break off from the veins in the lower extremities and go to the lungs), and cancer. Infection and cancer are very much related to the decreased immunal competence, while pulmonary emboli are very much related to physical inactivity. (Tr. 32)
Life is shortened by increased psychological factors reflecting depression, inactivity, and putting people out to pasture. Sociological aspects come into play - such things as pollution, environmental hazards, war and other factors which further shorten the life span below its biological potential. Much work is being done on this problem, but most of this work gives information that has to be used in the futre. Very few of the claims being made for treatment to enhance longevity have been scientifically established. For instance, claims that certain elements or chemicals, when added to food, are free radicals which increase the human life span have not been proven in humans. (Tr. 34-35)
In testifying about the ingredients in Ribomins Dr. Reiff began by defining and discussing ribonucleic acid, or RNA. RNA is an element or chemical in the cells that is responsible for a number of things, including protein synthesis. RNA is produced by deoxyribonucleic acid, commonly referred to as DNA. DNA is within the nucleus of the cell and it is the chemical that makes up the genes of the cell. It is responsible for synthesizing RNA which goes into the plasm of the cell and synthesizing protein. (Tr. 35)
When the RNA in Ribomins is ingested, it is broken down in the intestinal tract to its constituent parts, purine and pyrimidine, which are absorbed and are available for utilization in the body, for the building up of nucleic acids in the cells and for other uses in cells and energy metabolism.
People who have an adequate diet are believed to obtain adequate amounts of RNA and DNA, as well as other nutrients. RNA and DNA, being cellular constituents, are found in organs that are rich in cells such as liver. They are found, also, in certain beans and nuts. Materials that are very cellular contain a lot of RNA and DNA. Individuals do not get enough RNA in their diets when they do not get enough food, or enough of the right kind of food, or if they are on diets that significantly restrict the organ foods or other foods that are rich in cells. (Tr. 36)
The treatment for people who do not receive enough RNA is to give them proper nutrition if they are able to eat the diet, if their digestive systems are intact, and if they are able to absorb the nutrients. The diet should be a therapeutic diet which should contain not just vitamins and RNA but, also, all the other nutrients that are needed by the body. If someone is deficient in RNA, he very likely will have a protein deficiency. (Tr. 37)
"Cellular therapy", which was also referred to as "Sickle Cell Therapy", a process in which ground animal tissues were given by injection to older people, was tried in Europe a number of decades ago. It was supposed to supply a lot of RNA and DNA and cause rejuvenation. The treatment was never scientifically validated and it was discredited by the medical profession in the United States and abroad. It is now in disrepute. Some people who received this treatment claimed to be helped, but these anecdotal accounts were never validated. (Tr. 38)
There are certain conditions in which giving a diet that is particularly rich in nucleic acid could be hazardous. One such condition is gout which is caused by too much uric acid and when uric acid builds up in the body beyond its saturation point, it can precipitate uric acid deposits in joints, causing arthritis. Urates (salts of uric acid) can also deposit in the kidneys causing kidney stones and kidney damage. Also, if there is kidney failure, the nucleic metabolic products and the urates could accumulate and do further damage. If patients who have certain types of tumors, certain malignancies, including lymphomas, Hodgkin's disease and lymphosarcoma, are treated by radiation or chemical therapy, resulting in destruction of large amounts of tumor tissue, the urate levels in the blood would rise very high and kidney failure and gout could be precipitated. Persons with the foregoing conditions constitute groups for whom the use of increased amounts of RNA in the diet may be contraindicated and such supplementation should be used with care.
It previously has been pointed out that the kidney function reduces at the rate of three-quarters percent per year after the age of 30, so that an 80 year old person might have a reduction of 40 pre cent from the maximum. (supra, p. 11) In treating older persons, therefore, it must be realized that they have decreased kidney function. (Tr. 37-40)
There is no recommended dietary allowance (RDA) for RNA. Nutrition is a very important part of the treatment of older people. Undernutrition is a very serious and qualitatively important health hazard in the elderly due to inflation and the depressed economic circumstances of older people. Since they have to pay their rent, utility bills, and taxes, one of the few places where they can cut back on expenses is in nutrition. Nutrition in the elderly is becoming an increasingly serious problem of major proportions in the United States. (Tr. 40-41)
Nothing in the scientific literature confirms that RNA, taken in Ribomins as directed, by persons not so malnourished that they have nutritional deficiencies, would make skin wrinkles disappear, or make individuals look 10 to 15 years younger, or reduce breathlessness or fatigue (except for a possible placebo effect), or heal acne, age spots and other skin ailments, or promote good health and a general sense of well-being (again, except for a possible placebo effect), or prevent aging and disease (unless there were a disease caused by a deficiency of RNA which was part of a generalized nutritional deficiency, in which event the patient would need other nutrients as well), or increase resistance to flu and other diseases (unless there was a deficiency in the vitamins and minerals contained in the product). There is no credible evidence to indicate that Ribomins have been scientifically tested and proven effective in making the user feel younger and more energetic and have healthier skin. From the foregoing statements it follows that there is no scientific evidence that Respondent's product, taken as directed, will have any effect on the progress of the mechanisms of aging described by Dr. Reiff.
The foregoing testimony of Dr. Reiff is in accord with the consensus of informed medical opinion as reflected in his studies, his reading of scientific literature, and his discussions with his colleagues. (Tr. 41-44)
Dr. Reiff has read about attempts by certain organizations and persons to promote RNA supplements and RNA plus vitamins as a great therapeutic advance. In his readings and discussions with colleagues the medical findings and conclusions have always been that these efforts have been discredited and that there is no evidence that these supplements have any benefits. (Tr. 50)
The evening before the hearing Dr. Reiff read a book entitled "No Aging Diet, Eat and Grow Younger" by Dr. Benjamin S. Frank, of whom Dr. Reiff had not previously heard. A photocopy of the book had been furnished to Dr. Reiff by Complainant's Counsel, and so far as he was aware, Dr. Reiff had never read any other of Dr. Frank's writings. (Tr. 49)
There are some weekly scientific journals which publish hypotheses and preliminary experiments. There are two geriatric medical journals, one of which is the Journal of the American Geriatric Society which has been published for many years, and the second is "Geriatrics" which has been published more recently. "Geriatrics" is not a classical journal. It is more of a news magazine type of journal, but it is read by doctors interested or specializing in geriatrics. (Tr. 53)
Referring to his earlier statement that it is probable that medical science can interfere with the aging process, Dr. Reiff mentioned some experiments in which calorie and protein restriction in developing animals, rats and others, appeared to increase their life span. This restriction is not be applied to humans, however, because no experiments with humans have been performed. Many treatments that have been developed through practice are not being tested to determine the mechanism of their action and to scientifically validate them. It is possible that RNA has a place in the treatment of some of the degenerative aspects of aging and that it is worthy of further experiments. (Tr. 54, 55)
The mechanisms of aging described as cross-link, error, error modified by enzyme, free radical and pigment are interrelated. For example, the free radical theory interrelates with the cross-link theory because cross-links cause changes in the oxidation by free radicals. (Tr. 57) The limited cellular potential is probably very much related to the error theory. (Tr. 58) Culture experiments are going on to see if human cultures can have healthy longevity increased by free radicals. It is hoped that in the next few years there will be sufficient information to determine whether free radical inhibitions may be a really important therapeutic modality. (Tr. 59) There are multiple mechanisms that cause or permit aging and they are all interrelated. This field is in scientific infance in many respects and there is a tremendous amount of work that needs to be done. (Tr. 60, 61)
When RNA is ingested it is broken down into its constituent nucleic acids and it is then absorbed. If it is properly absorbed it goes into the bloodstream and it is carried to the cells where it is reconstituted and utilized in the synthesis of DNA and RNA. There is information to the effect that with advancing age and with increased atrophy the ability to synthesize and produce RNA decreases. The ingestion of more RNA will assist in alleviating those problems if there is a deficiency of RNA in the diet. (Tr. 67-68)
Wrinkles are caused by atrophy of the subcutaneous tissue of the skin which does not then provide the supporting base for the epithelium which then wrinkles. Wrinkling probably is also related to: a loss of elastic tissue; changes in collagen caused by cross-linking and other factors; a decreased blood supply to the tissues resulting in less ability of the tissues to maintain their original shape and to retain their elasticity. (Tr. 72-73)
In the book "No Aging Diet" by Dr. Frank there is a statement to the effect that ingestion of RNA will alleviate or remove wrinkles, but there is no credible information in the book that would indicate that there is any scientific validation of the statement. (Tr. 72) Most of the information was anecdotal information about what a patient said after taking the tablets. Such a statement is of little scientific credibility. Dr. Reiff is of the opinion that the hypothesis or theory that oral RNA therapy can alleviate some of the symptoms or aspects of aging has little merit, especially in terms of giving isolated RNA. In the case of an isolated deficiency of nucleic acid, if, contrary to the witness's belief, such a specific deficiency could be demonstrated, then there might be some reason to give large amounts of RNA. Otherwise, if there is a deficiency of nucleic acids the proper treatment would be by giving ordinary nutrients, or foods. (Tr. 75-76)
Dr. Reiff concluded the major part of his testimony by commenting, generally, about the Frank book, "The No Aging Diet". He stated that there was no presentation of any validity to the claims made therein; there was no substantiation; there was no credible information that any of the claims have been validated. (Tr. 75)
Arnold J. Susser was called as the first witness for the Respondent. Dr. Susser, President of Respondent, was awarded a B.S. Degree in Pharmacy at Rutgers University in 1955, and a Doctorate in Naturopathy by the Quebec Institute of Naturopathy in 1974. He is a licensed pharmacist in New York and New Jersey and he is the founder and President of the American Academy of Nutritional Consultants, which claims a membership of only 80-100, including members of The Nutrition Society of America. A more detailed statement of Dr. Susser's background is set forth in Respondent's Exhibit 1. Dr. Susser outlined the history of the development of Ribomins, the product which is the subject of this proceeding. (Tr. 92-94, 111)
Dr. Susser defined naturopathy as a natural approach to health as opposed to allopathic care which employs drugs and medication. He continued: "***it is allowing the body, by encouraging the body's normal, natural function with the necessary nutrients, to kind of heal itself, bring in the materials because, after all, our glands, organs and systems can not make things out of thin air. We have to make hormones, enzymes and everything else from nutrient factors.***" (Tr. 94) In Stedman's Medical Dictionary, 23rd Ed., copyright 1976, naturopathy is defined as "a system of therapeutics in which neither surgical nor medicinal agents are used, dependence being placed only on natural (nonmedicinal) forces."
Dr. Susser formulated Ribomins which at first consisted of certain vitamins and minerals. To this mixture he added RNA, in order to provide (as he said virtually all experts would agree) for the body to form energy, or energy molecules, known as "ATP." His authorities for foregoing statement are Dr. Benjamin S. Frank, previously mentioned, of New York, and Dr. Allen Nitler, of the State of Washington, who is listed, according to Dr. Susser's belief, in some San Francisco-Los Angeles directory. Dr. Nitler published an article in the Journal of Dr. Susser's American Academy of Nutritional Consultants. Dr. Susser describes the journal as a "prestigious, nutritionally oriented, but still a very widely read, medically, journal." (Tr. 99) Dr. Susser says that Dr. Nitler concluded, among other things, that RNA, when ingested, is absorbed intact, or virtually so, even though it is a large molecule. (Tr. 99) The article adds, according to Dr. Susser, that more and more experts are agreeing that RNA in tissue and glandular substances, as part of the protein of the substances, does indeed become absorbed and can be recognized in the cells of the person who is absorbing it. (Tr. 100)
Dr. Susser says that naturopathists use the words "counseling" and "person" instead of "treating" and "patient." There are fewer than 300 naturopathic physicians in the United States. There is no licensure for that particular specialty. In his practice he sees people who are referred to him by medical doctors and he sees some who have been to many medical doctors but who need additional help. These people are given a form on which they keep a record of their food intake over a four-day period. Dr. Susser's nutritional staff breaks down the foods into the grams of proteins, carbohydrates and fats and milligrams of vitamins and minerals. Deficiencies and excesses of nutrients, including nucleic acids, are looked for as well as excess amounts of "antagonists" such as preservatives and chemical agents. The diet is discussed with the person and the environment in which the person lives and works is considered. If a report has been requested by the referring doctor, one will be prepared, and a regimen of dietary changes will be suggested. In about five years, Dr. Susser has recommended Ribomins to literally thousands of people. Also, the food intake of the person is adjusted to meet recommended dietary allowance standards, and if this entails the addition of more food than can be ingested, such supplements as Ribomins with RNA are suggested. According to Dr. Susser, over 90 per cent of the people he sees have a nutritional deficiency in 21 or more substances because of the effects of food processing and the promotion of junk foods. (Tr. 101-105)
Dr. Susser developed the advertisement on which the Complaint herein is based on Dr. Frank's works, and on written materials which Dr. Susser had accumulated for a number of years. In 1969 Dr. Frank had written an article entitled "Nucleic Acid, the Better Answer to Aging." In his article Dr. Frank mentioned the substances he added to certain vitamins, and he stated that the health of his patients improved in such matters as cardia function, retardation of aging, improved mental acuity, more youthful appearance of the skin, diminution of wrinkles and improved hair condition. These judgments of Dr. Frank were concurred in by Drs. Nitler, Lutz and Susser, and according to Dr. Susser, hundreds of others. It is Dr. Susser's reasoning that if RNA is involved in energy production, if the energy is increased within the cellular function, the efficiency of the function will be increased, and the food supplements will be more greatly utilized by the body. Collaborating with Dr. Susser in the preparation of the advertisement were, primarily, Dr. Frank and a Milton Pierce of New York City, as advertising copywriter. On a few occasions there were present, also, Dr. Frank's wife, a news editor of a radio station in New York, O. Miele, involved in the communications field, and Mrs. Susser, who is Vice-President of the Respondent. (Tr. 105-110)
On cross-examination, Dr. Susser stated that in the American Academy of Nutritional Consultants and its affiliate, the Nutrition Society of America, there is a total of 80-100 members. (Tr. 111)
The Quebec Institute of Naturopathy was accredited and authorized to award Ph.D degrees for some time prior to and including 1974, the last graduating class of which Dr. Susser was a member in that year. The witness stated that the reason for the closing was due to the fact that there were so few naturopaths in Canada that the Canadian government refused continued funding. (Tr. 112)
RNA is present in all American diets, but to varying degrees. Dr. Susser has never found people who have not had RNA in their diet, except perhaps two or three persons who had either near zero or negligible amounts in the diet. These persons were primarily vegetarians. According to the witness RNA is not contained in the cellular matter of foods. The amounts of RNA contained in the diets of the persons with whom Dr. Susser consults are described by him as being either small or negligible, moderate or high. A diet high in glandular intake, such as fish, yeast and certain other foods, is recognized as a high RNA diet. A lacto-vegetarian diet is moderate to low in RNA intake, while a strict vegetarian diet is low in RNA. Depending on the individual involved, a moderate RNA intake may range from 3000 down to a few hundred milligrams of RNA per day, which is a wide range. Dr. Susser defined a diet with a high RNA content as containing 3000 milligrams and up per day, but he could not give the range of RNA to be found in the average hamburger. he did say that beef is low in RNA compared to other meats. A low RNA intake would be 50 milligrams or lower. If a person, as determined from a consideration of his or her daily intake, ingests a low to moderate amount of RNA, then the 180 milligrams provided by four tablets a day of Ribomins would be a judicious suggested addition to the diet. Even if a person had a significantly high intake of nucleic acid, the 180 milligrams added by four tablets of Ribomins with RNA would be regarded, by Dr. Susser and to most doctors who use it, as a safe and conservative amount, yet an amount that would be effective in terms of the production of energy factors in the body. (Tr. 111-118)
Dr. Susser agreed with Dr. Reiff that no RDA for RNA has been established. (Tr. 121) Dr. Susser said, however, that humans do have a requirement for RNA. In support of this statement he cited Drs.s Frank, Nitler and Lutz and a release entitled "Morbidity and Mortality, Reportable Diseases," issued by the County of Los Angeles Health Department for the Ninth Report Week ending March 1, 1969. (RX-2. This article speaks of the need for "clinical trials involving interferon inducers in experimental and naturally occurring viral disease in humans." It also speaks of speculation that "interferon induction might be of use in preventing tumor induction," but it is said that such speculation is premature.)
With reference to his earlier statement that Dr. Nitler's article suggested that the RNA molecules are digested and used intact, Dr. Susser referred to some telephone conversation he said he had with a Dr. Howard Lutz of Washington, D.C. Dr. Lutz is reported by Dr. Susser as saying that he believed that the March, April or May, 1980, issue of the British medical journal "Lancet" contained an article in which it is stated that large molecular nuclear proteins, which Lutz called globulin, and which are larger than RNA molecules, which Lutz called globulin, and which are larger than RNA molecules, were found to be able to bypass the destruction presumably the breakdown into its component parts by the digestive process in the intestines contrary to the belief of the orthodox, or the adherents to the old school of thought. (Tr. 130-131) Among the weaknesses of the foregoing argument are that (1) the appropriate issue of "Lancet" was not produced; (2) Dr. Lutz did not appear; (3) Dr. Nitler's work could be found only in the journal of the American Academy of Nutritional Consultants, which journal, also, was not offered; and (4) Dr. Nitler did not appear.
Although he is (or was) the founder and President of the American Academy of Nutritional Consultants, Dr. Susser stated that he did not know whether the journal of that organization is listed in MEDLARS and MEDLINE, systems for performing research in medical literature. (Tr. 134-135) One of the past presidents of the Academy founded by Dr. Susser is Dr. Carlton Fredericks, Ph.D in radio communication. (Tr. 142, 311)
Dr. Susser stated that even if a person has a diet that has no nutritional deficiencies, and which would, therefore, supply all of the body's needs for the synthesizing of RNA, there would still be a requirement for exogenous RNA. (Tr. 137-142) Again, the witness relied on the works of Drs. Frank and Nitler. He claimed that support could be found in Respondent's Exhibit 2, but this exhibit does not deal specifically with the question put to the witness, or with the issues in this proceeding. Finally, the witness agreed that "If it is a specialized situation with a person of exact stress levels of a known factor which is absolutely known hypothetically (sic), perhaps he will have enough RNA from his diet if he is absorbing it and making it on his own." Also, according to Dr. Susser, the providing of 100 to 200 milligrams a day, at a minimum, assures a person of receiving some RNA nutrient intake in his or her diet. The authorities for the last statement are Drs. Frank, Nitler and Atkins, the MEDLARS and the journal of the American Academy of Nutritional Consultants, although the studies that were performed by Dr. Frank have not, the witness agreed, been published in any reputable scientific publication. (Tr. 142-148)
The next witness called by Respondent was Dr. John G. Ledney, an osteopathic physician in general practice, who lives in Richwood (or Ridgewood) New Jersey. he was graduated from Youngstown College, Youngstown, ohio, in 1962, with a B.A. degree and majors in chemistry and biology. He was graduated in 1967, after four years of study, from the college of Osteopathy in Kansas City, Missouri, by which institution he was awarded the D.O. degree. He was appointed to a general practice internship for the period 1967 to 1968 at Rocky Mountain Hospital in Denver, Colorado. Following his internship, he entered private practice. (Tr. 156, 157, 166)
Dr. Ledney defined an osteopathic physician as "a person who treats with an idea of the whole system, and his watchword is treating the whole patient and not in particular reference to disease only. He is interested in his financial, spiritual and emotional as well as physical well-being." Dr. Ledney is a licensed osteopathic physician and he is a member of the American Osteopathic Association, of Chicago, Illinois. (Tr. 157) The official definition of osteopathy adopted by the American Osteopathic Association is: "That system of the healing art which places the chief emphasis on the structural integrity of the body mechanism, as being the most important single factor to maintain the well-being of the organism in health and disease." (The American Illustrated Medical Dictionary, Dorland, 21st Ed.)
Nutrition is an elemental part of Dr. Ledney's practice. In keeping abreast in his profession Dr. Ledney attends seminars and he reads the current and recent literature in his field. (Tr. 158) For the last 15 years he has been interested in the practice of nutrition as therapeutic maintenance, and for the past five or six years he has put strong emphasis on it in his practice. (Tr. 158)
RNA is one of the two nucleic acids in the nucleus of the cells and it is very important for the conversion of ATP to energy and in utilizing other nutrients in the production of energy. Some of the sources of RNA are fish, glandular animal tissue and yeast. (Tr. 158)
When asked whether there is any correlation or relationship between RNA and extending the age and normal body functions, Dr. Ledney said that he believes that Dr. Frank's book is probably the most thorough discussion of that subject. He added that while he does not think Dr. Frank's work was scientifically documented or validated by doubleblind studies, he sees in his practice the same things Dr. Frank mentioned in his book, namely, that people who have a high RNA diet are healthier and younger appearing people. (Tr. 158-159)
Dr. Ledney sees an average of 120 to 140 patients a week. The majority of his patients complain primarily of fatigue, followed in order by backache, headache, and obesity. Dr. Ledney became familiar with Ribomins early in 1975 when Dr. Susser brought it to his attention. he uses the product heavily in his practice and he uses it personally. If a patient requests a strong, good, safe multivitamin, Dr. Ledney refers them to Ribomins and has very good success with it. he has never had an adverse reaction when he has used Ribomins with an obese patient and on an overall basis 99 per cent of his patients have given a positive report of their experience in taking the product.
They have reported such things as increase in energy, vigor, improved sense of humor and well-being; sleeping patterns improved; less depressions and changes in emotional levels; increased work output; less fatigue at the end of a full day and the requirement for less sleep. Other vitamin products have not produced the same favorable results and he attributes the difference in results to the presence of RNA which most other vitamin preparations do not contain. (Tr. 159-162)
In addition to the foregoing results, he reported that the hair loss condition called alopecia areata improved; there were two patients whose eyebrows returned; and two patients came to him because some of his other patients had their hair return. In some patients their general facial expressions and countenances were brighter, their eyes were brighter, they were more alert and they could follow directions better; in some patients the general turgor of the skin improved. He thinks there is something about Ribomins that increases the whole health of a person and he believes that it is the circulatory system that is improved.
There is a known need in the diet for RNA, but that need has not been quantified. Further, Dr. Ledney referred to a newspaper article in which it was indicated that RNA is directly related to interferon which, in turn, is related to virus protection. These are not validated reports but the curiosity of the scientific world has been aroused. When he is working nutritionally with his patients he sees less disease of all types and he attributes this result to an increase in the support of the immune system. He has observed in his own patients quite a decrease in susceptibility to colds and fever which he attributes to Ribomins with RNA, with which he has also had great success in treating mouth sores. Initial relief is quickly realized. The normal course of the problem is about eight days, but if he sees the persons when they are in the early stage of getting sick, and if they take this product, the cold sores respond within a couple of days. (Tr. 160-164)
All of the patients who come to see Dr. Ledney can use some nutritional support. He does not prescribe Ribomins in all cases, but he modifies the diet according to the needs of the individual. If he feels that a patient will benefit from the taking of Ribomins, he prescribes the product. Dr. Ledney does not know how many or what proportion of osteopathic physicians use Ribomins with RNA, or any other RNA type of supplement. (Tr. 165)
Dr. Ledney factors out the effect of Ribomins by means of his experience with them over the past five years of his 12 years of practice. He has not used synthetic vitamins to a great extent but he has used natural vitamins extensively. Synthetic vitamins are man-made materials sold by drug companies, while natural vitamins are made of natural ingredients. Synthetic and natural vitamins do not have different chemical structures, but they do have different biological properties. The basis for this difference is not known. (Tr. 168) The vitamin ingredients of Ribomins are natural. For example the Vitamin D comes from fish liver oils.
Dr. Ledney's statement of the results obtained by him in his use of Ribomins is based on what his patients have told him and, also, on what he observed of them. His statement that 99 per cent of his patients have given him a positive report of their experience in taking Ribomins is based on the fact that it is difficult for him to recall one patient who has failed to report favorably on his use of the product. It is possible that the placebo effect accounts for some of the favorable comments he has received. (Tr. 169)
Dr. Ledney reported that he observed increased resistance to colds among his patients. A cold is not the same as an allergy, although allergists might say they are the same. Many patients have a seasonal allergy, usually in May and August or September and, as he follows the patients during the first year, he sees less and less allergy reactions. These patients usually have been under the care of an allergist with weekly injections of different substances. He has gotten 50 to 100 patients off of allergy injections who have stayed healthy and have no allergic manifestations. He said that the fact that he noticed an increased resistance to colds is a fairly important scientific breakthrough, but he did not report it in scientific literature.
According to Dr. Ledney if RNA is ingested, it stays more or less intact, it is absorbed intact and it then goes to the particular site in the body where it is needed. This statement is based on carbon-tagged studies reported by Nitler which showed that RNA was transported to the utilization site. (Tr. 171)
While no need for RNA supplementation has been established, Ledney takes the position that there is an RNA shortage in all or nearly all people. He has no support for this position other than his observations in his practice; there are no studies, and no reports in scientific literature. He stated that the addition of RNA to nutrients previously used by him has brought about a tremendous change in his patients. (Tr. 172)
One of the main problems of all people is their emotional state. He feels he is qualified to differentiate between a psychotic patient and a nutritionally affected patient. Some patients come to him after having visited a psychologist or psychiatrist. he treats them nutritionally and sees great results.
He thinks "the mental metabolism that goes on with this RNA and all the supplementation and therapy, the therapeutic regimen has made major breakthroughs in my practice which was, basically, not a part of my medical training. *** Most of my nutritional learning has been on my own, and the medical establishment does not treat maintenance or preventive medicine. It treats disease, and that is down the road." (Tr. 173)
Dr. Ledney spends a good deal of time with each patient, but he thinks that the patient who just takes the product without having the benefit of his other consultative measures would be likely to derive the same benefits. Twenty-five to 30 per cent of his patients will not do anything else but take something by mouth. Dr. Ledney starts them on Ribomins and they get additional amounts of the product from other sources. He recognizes that about 25 to 30 per cent of the population achieves beneficial results by virtue of the placebo effect. These percentages are reflected in his practice. (Tr. 174-175)
Martin D. Feit, M.D., who lives and engages in private practice in Staten Island, New York, was called as Respondent's next witness. Dr. Feit was graduate from Gettsburgh College in 1955 with a B.A. degree in Biology, and from the Chicago Medical School in 1960. He is a diplomate of the American Academy of Bariatric Physicians and the American Academy of Family Physicians. He is also a certified acupuncturist in New York and New Jersey. (Other items of note are stated in Dr. Feit's curriculum vitae, RX-3.) In his practice he specializes in nutrition. Dr. Feit described RNA as a substance which, when taken into the body, aids in normal cell metabolism and aids in preventing the running down of the cells. So far as the skin is concerned, RNA helps in the nutrition of the cell metabolism, hair growth, skin turgor, skin health, and the function of the other organs of the body. (Tr. 179-181)
RNA is derived endogenously, being built up in the body, or exogenously, from outside sources such as fish, meat organs and yeast. Whether the body synthesizes enough RNA or needs an exogenous source depends on where the person is living. No quantitative requirement for RNA has been established by any medical group, but it is recognized as being essential. (Tr. 182) Dr. Feit became interested in RNA when he was Assistant Director of the
Methadone Clinic in Staten Island. The instant product is not expensive and former heroin users could take it to feel better and to function better. (Tr. 183)
As a person ages, if he is not health conscious, the skin gets loose, loses its color, loses its turgor, it wrinkles and the person physically degenerates. If patients are health conscious, or if they had taken a lot of RNA and other supplements all of their lives, there was a noticeable difference - seventy-year-old patients looked forty. (Tr. 183)
Dr. Feit's practice became nutritionally oriented in 1971 or 1972 and he first knew of Ribomins in about 1974. Dr. Feit prescribes Ribomins with RNA for patients who complaint of fatigue and for persons who say they feel that they are aging too rapidly. In his methadone practice, there was a general improvement in the way patients felt and even in their mental performance. He has used Ribomins with RNA in treating obesity, drug addiction, and as a supplement to acupuncture for persons with alopecia areata. In terms of skin improvement, Dr. Feit found that after about a two- to four-week period, depending on how a patient followed the diet, there would be a tightening of the skin and improvement in skin turgor. (Tr. 184-185)
The physiological process that occurs when Ribomins are ingested is that the RNA and vitamins go to the skin for skin metabolism. The elasticity of the cells would be increased, the skin would tighten and small wrinkles may be taken away. In addition, there would be a lessening of fatigue and there would be some relief from stress. Most of his patients who are on a proper diet, supplemented by Ribomins with RNA, do not get ill as much, the intensity of colds is diminished and the severity of flu is decreased. Ribomins with RNA builds up a person's resistance and prevents him from becoming sick or lessens the degree of sickness. (Tr. 185-186) Despite this endorsement of the use and value of RNA, Dr. Feit stated that the state of knowledge of his profession with regard to the requirement of the body for RNA, the role of RNA, and the body's needs for RNA, as well as other nutrients, "is in its infance." (Tr. 187)
In addition to nutritional treatment, Dr. Feit employs osteopathic techniques and acupuncture, the latter of which he has found to be helpful in treating lung patients. Dr. Feit has published papers in the American Journal of Acupuncture, primarily on acupuncture and nutrition, but none on nutrition alone. (Tr. 194-195)
The next witness called by Respondent was Robert C. Atkins, M.D., who is engaged in the private practice of Internal Medicine, in the subspecialty of Nutrition and Carbohydrate Metabolism, in New York City. Dr. Atkins received his A.B. degree at the University of Michigan in 1951 and his M.D. degree at Cornell University Medical College in 1955. (Dr. Atkin's curriculum vitae is with the record as RX-5)
Dr. Atkins has been working with diets since 1964 and with a full scope of nutrition since sometime in the early 1970's. Only about one percent of the practicing physicians in the country base their practice on, or emphasize, nutrition.
Dr. Atkins said that Ribonucleic acid is an intermediary metabolite. "Metabolite" is defined in Dorland's American Illustrated Medical Dictionary, 21st edition, as "any substance produced by metabolism." The experience of Dr. Atkins is in the clinical use of RNA as contrasted with the biochemistry of the substance, as a result of which he said that his answers to questions on this phase of the subject were less precise than he would have liked them to be. He stated, however, that the body gets the RNA it needs for its cells from the many precursors from which the various component parts can be synthesized. (Tr. 200)
Dr. Atkins does not use RNA with every patient, but there are certain times, e.g., for persons suffering fatigue or angina pectoris, when he does add it to his basic routine as an isolated addition for the purpose of determining whether there is going to be any improvement in the patient's well-being. There are certain clinical situations in which he has come to use it, including fatigue that is not responsive to other measures, and angina pectoris. He began to use RNA four or five years ago, but more especially during the past two years, and he estimates that he has used it with between 100 and 200 patients. (Tr. 201)
Dr. Atkins was introduced to using RNA through reading "No-Aging Diet" and "Nucleic Acid Nutrition and Therapy" by Dr. Benjamin S. Frank. (RX-6 and 7) In conversations with Dr. Frank, Dr. Atkins asked for what indications Dr. Frank found RNA useful; what complications or side effects RNA produced; in what dosage Dr. Frank used it; and for what clinical indications. Dr. Atkins then believed it worth while to try RNA on his own patients. (Tr. 202)
Dr. Atkins does not particularly recommend sardines or other so-called high RNA foods, but he recommends RNA in tablet form as a food or nutritional supplement. He prescribes RNA for patients with whom he has started his overall program, which is a diet the main purpose of which is the stabilization of the blood sugar, and the secondary purpose of which is the elimination of any specific allergenic foods which that individual may be eating. Then there is added a comprehensive vitamin formulation and a mineral formulation based, in large part, on the epidemiology of the area and on the mineral results of the hair analysis. Occasionally, if the presented complaint is angina pectoris, the use of RNA may be started during the first week. More often RNA is withheld so as to provide a chance to evaluate the specific impact of RNA on that patient somewhere in the midst of the course of therapy.
There is a solid core of patients - approximately between 20 and 30 per cent - who seem to be quite responsive to RNA. Their clinical response had been unimpressive with all the other vitamins and minerals until the RNA was added, at which point a dramatic improvement would take place in well-being; in so-called energy and sleep requirements; and in a variety of other complaints, such as depression, that seemed to accompany the fatigue. Upon discontinuing the RNA, these patients would slip back to their old previous level of not feeling so well. So, having taken these patients on and off RNA often enough he was able to convince himself that, at least for these individuals, RNA was helpful and did have a detectable and discernible clinical role. There were many patients for whom it just seemed to be part of the general improvement, or in whom nothing dramatic was noted that would cause him to believe that RNA was really making any major contribution. (Tr. 203-204)
There were some other effects reported as being noticed very subjectively, which Dr. Atkins said he believed he saw, such as an improvement in the appearance of the patients. There is one other study, which should be, but has not been done, which is "before and after" photography. Dr. Atkins does believe that there is some efficacy in taking RNA because these people seem to look either healthier or younger or to have less lines, less crows feet around their eyes. Dr. Atkins stated that this observation is so subjective that it is an impression which, at best, would be very difficult to document. Dr. Atkins has prescribed RNA in ever adult age group including adolescence, but the emphasis has been on the older patient - the patient past the age of 50. (Tr. 204-205)
Dr. Atkins described the state of medical knowledge of RNA, its uses and therapeutic value as being "in its infance." He is not aware of any new investigations or information emerging. He said that Dr. Frank was certainly the leading proponent of the concept that supplementary RNA makes a difference. He added that everybody recognizes the essentiality of RNA to every cell in the body, but heretofore the feeling had been that we were going to be able to synthesize all the RNA that we need with whatever nutritional precursors we have and this is the currently prevailing thinking. It is only because there is the possibility of showing detectable differences with supplementary RNA that we might raise the question as to whether or not RNA production really has rate-limiting features which can be overcome by the utilization of additional dietary RNA. Continuing, the witness said that the question that really has to be addressed in order to determine whether RNA is a valuable nutrient, is whether or not our ability to synthesize RNA is not limited by the rate at which we can do it. Can we make enough molecules of RNA to supply our needs at a rate at which we might use it, or would supplementary RNA actually change the availability of it by providing so much more than we are getting from our manufacture of it through precursor nutrients?
As to whether RNA supplementation might be beneficial to everyone rather than to those patients of Dr. Atkins who are put on a carbohydrate-limiting diet, it was his opinion that the carbohydrate-limiting diet does not play much role in whether or not RNA is useful. He has a group of patients who are on full carbohydrate diets and who take RNA and the same percentage of responders seems to prevail in that group as well.
As to the value of using RNA supplements, Dr. Atkins is somewhere between enthusiastic and skeptical. He believes that there is a base for RNA in medical management or the nutritional management of some patients. On the other hand, there is actually a risk factor which had not even been talked about - the possibility that the uric acid level might be elevated. Therefore, he can not recommend its across the board usage, but he does see it as having a place in some individuals. More work has to be done and it has to be delineated. The right clinical situation has to be studied. In his opinion studying exercise tolerance in the angina patient would be a good place to start because one can document such a study. It would be quite admissible of a doubleblind study here, and he thinks such work should be done. (Tr. 205-207)
On cross-examination, Dr. Atkins stated that he has published essays in Medical Counterpoint and in Medical TImes. (Tr. 208) He is, also, the author of two books entitled "The Dr. Atkins Super Energy Diet" and "Dr. Atkins Diet Revolution." (RX-5) Doubt was expressed by a witness for Complainant, and no evidence to the contrary was adduced, that Medical Counterpoint and Medical Times were listed in Index Medicus, maintained by the National Library of Medicine to aid physicians in locating responsible, reliable, scientific writings. Both of the named publications are now defunct. (Tr. 229) Dr. Atkins stated that the American Medical Association, of which he is a member, has expressed a negative opinion concerning the diets described in his books. (Tr. 218) He conceded that the books by Dr. Frank on which he placed significant reliance (RX-6 and 7) were not subjected to the peer review and testing by which writings submitted for publications in authoritative scientific and professional journals are screened. (Tr. 215)
Dr. Atkins is of the opinion that there is a certain risk associated with taking RNA by a person with a high uric acid (Tr. 214), but he is uncertain as to the degree of risk associated with taking Ribomins with RNA because of the relatively small amount of RNA contained in the product. A person could get 45 milligrams of RNA at one meal if he ate a lot of sardines or nuts or glandular meats. (Tr. 220-224)
Dr. Atkins is of the opinion that when RNA is ingested at least some of it is absorbed intact. This opinion is said to be based on his observation of the effectiveness of RNA when given to some of his patients. He did not know whether RNA, when absorbed, is still RNA. (Tr. 213) The witness said that no RDA for RNA has been established - he thinks the presumption is that it is non-essential. (Tr. 221)
Complainant called as its rebuttal witness Dr. Victor Herbert, 130 West Kingsbridge Road, Bronx Veterans Administration Medical Center, Bronx, New York. Dr. Herbert's educational background includes the following degrees: Columbia University, New York B.S., 1948; Columbia University College of Physicians and Surgeons, M.D., 1952; and Columbia University School of Law, J.D., 1974. He is certified by the American Board of Internal Medicine and by the American Board of Nutrition. He has published over 400 scientific papers in peer review scientific journals, primarily in internal medicine, hematology and nutrition, particularly relating to patient care, diagnosis, treatment and biochemistry and physiology of nutrition. He currently is the President of the American Society for Clinical Nutrition, which is the arm of the United States in international nutrition matters. He is a member of the Joint Subcommittee on Human Nutrition Research of the executive Office of the President of the United States and a member of the Food and Nutrition Board of the National Academy of Sciences. (Tr. 226-227) Other matters comprising the qualifications of Dr. Herbert, including his professional society memberships, editorial board memberships, consultant positions, hospital training and positions, intra-institutional posts, inventions, honors, lectureships, and memberships in organizations not requiring a degree in science, are stated in CX-J, which was received in evidence.
Dr. Herbert defined essential nutrients as those which must be taken in the diet for life and health because the body can not make them. He defined ribonucleic acid or RNA as a chemical compound which is produced in cells, particularly outside of the nucleus of the cell in the cell plasma or cytoplasm, and it consists of sticking together of purine bases, sugars and phosphate, phosphoric acid. He has done research involving RNA and DNA and he has published a number of papers in that area. In fact, he developed a diagnostic test used in hematology and in cancer research which revolves around DNA synthesis, and RNA synthesis is also involved.
There is not RDA for RNA. He is one of the fifteen members of the Food and Nutrition Board which created the Recommended Dietary Allowances and there is no RDA for RNA because RNA is not absorbed. RNA in food is chopped up completely be pancreatic nuclease, so that it is unabsorbed. If it were absorbed, it would be dangerous because that RNA which is not human in origin could be allergenic for humans if absorbed intact. "It's chopped up in the gut and after being chopped up, the individual purines colorless crystalline substances forming the base of the uric acid group of compounds known collectively as purines or purine bases. --Dorland, supra, are absorbed and they then add to the burden of body uric acid to be disposed of as a waster product. RNA is made within cells; none of that which comes in diet is absorbed. The pancreatic nuclease and other pancreatic enzymes have this specific function of chopping up various undesirable substances so that they are not absorbed, only their end products are absorbed." (Tr. 227-228)
Dr. Herbert pointed out that "RNA as it comes in food, like in sardines, is generally not RNA; it's ribonucleo protein and in the intestine when the pancreatic enzymes start chopping up the bib molecule, they chop off the protein first and that leaves RNA, which then gets chopped up by other enzymes." Thus, what is in sardines is not RNA; it is ribonucleo protein, which is a much bigger molecule than RNA.
Concerning peer review he said that it is the scientific system for separating wheat from chaff - that is, for separating, for example, a nutrition book for the public which may be completely fiction, from a nutrition book for scientists. The process of peer review involves the writing being submitted to an editor competent in medical science who then sends it out to a minimum of two reviewers known to be competent in the specific area of the scientific paper in question. These reviewers then do their best to tear the writing apart, both as to theory and fact and experimental method and conclusions. Their criticisms are then synthesized by the editor and sent back to the author who is not allowed to publish until he successfully meets the criticisms of his work. (Tr. 228-229)
The membership of the American Academy of Nutritional Consultants is not composed of scientific nutritionists according to uncontroverted testimony of Dr. Herbert. He said, also, and there was no testimony to the contrary, that several members of that organization have been convicted of criminal charges involving nutrition fraud. This is the group of which Dr. Susser is shown as the Founder/President in Dr. Susser's curriculum vitae. (Tr. 230; RX-1)
There is no relationship between interferon and dietary RNA. Dietary RNA is destroyed in the intestines. There are some studies which show that in tissue culture, if one adds a variety of substances, interferon production can be stimulated. One such substance which can be added to a tissue culture as an intact substance is RNA in certain forms, and in some tissue cultures it will stimulate interferon production. In other tissue cultures it will not; some RNA's will stimulate, others will not. * * * One can think of RNA as a necklace - that is, it is a string of substances strung together and that necklace is called RNA regardless of whether it is made out or pearls or diamonds or glass; its component parts can be considerably different so long as it meets the basic criteria of purine bases and sugar and so on, so that the RNA from a mouse, for example, can produce a fatal allergic reaction if injected into a human. "***That's one of the reasons that we have intestinal enzymes to chop up our foods so that we don't absorb food RNA which is not human, except for cannibals, and get allergic reactions and even possibly an anaphylactic reaction from absorbing a sardine or an animal RNA - we chop it up in our intestines." (Tr. 230-231)
Dr. Herbert stated that there is no scientific evidence that dietary RNA will cause wrinkles to disappear; make some individuals look 10-15 years younger; reduce breathlessness and fatigue; heal ace, age spots and other skin ailments; promote a good health and a general sense of well being; or prevent aging and disease. (Tr. 231-232, 303) He also testified that none of the other ingredients in Ribomins would produce the results expressed in the alleged representations. (Tr. 314-15)
On cross-examination Dr. Herbert stated that scientific evidence is a report published in a peer-reviewed scientific journal based upon data which is sufficiently valid to allow the possibility of such an interpretation. (Tr. 232) Without specific controls such as double-blind testing it is impossible to separate cause and effect from coincidence. (Tr. 232, 301-2) Therefore, conclusions drawn from treatment without controls, such as the conclusions stated in the testimony of Respondent's witnesses, are not valid. (Tr. 301) Dr. Herbert further testified that conclusions drawn from observing patients and hearing their comments are anecdotal and should be given no weight.
In his cross-examination Dr. Herbert traced, in lay terms, the function of RNA in the production and replication of cells as follows:
"***The sequence of events is, that in the nucleus you have DNA. DNA is the basic cellular blueprint. It tells the cell what it is going to be. That is, the DNA blueprint says you are going to be a human being or you are going to be a salmon or you are going to be a cow. That basic blueprint in the nucleus is transferred by the DNA to a negative for the blueprint, just like if you are taking a picture of a blueprint, you a a negative. That negative for the blueprint, which carries the same information, is called messenger RNA. That messenger is made in the nucleus. That is RNA. That messenger RNA then goes to the cytoplasm. It travels out of the nucleus into the cytoplasm where, as you recited my testimony, I indicated the majority of RNA is made. That messenger RNa then goes to tiny bodies in the cytoplasm called ribosomes. On those ribosomes another form of RNA is made from that blueprint of the messenger RNA. And then yet another form of RNA called transfer RNA picks up individual amino acids in the cell and brings them to the ribosome where they hook on in specific relation to the negative of the blueprint and create a protein. That is the life process and it follows a specific blueprint.
"So human RNA only makes humans. Sardine RNA only makes sardines and so on. If sardine RNa, for example, worked in a human, the human would grow fins and a tail, because it is a specific blueprint for making sardines. But RNA is mainly made in the sytoplasm. Messenger RNA is made in the nucleus." (Tr. 250-251)
Commenting on whether the statement "RNA is a protein" is scientifically correct and on the manner of the digestion of RNA, Dr. Herbert said:
"If you use it 'RNA is a protein' to describe ribonucleic protein, yes. If you use it to describe ribonucleic acid, without the protein, no. It depends on how the term is being used. But RNA, ribonucleic acid, is ribos, which is a sugar, and nucleic acid. And nucleic acid is two things. *** It is a molecule made from smaller molecules and the smaller molecules are molecules of purines and paradigms strung to gather with phosphoric acid. *** an RNA molecule is a mixture of a sugar purine and paradigms and phosphate. *** 'RNA is digested just like protein is digested by pancreas ribonuclease, a specific enzyme, which we put in our intestines to destroy sardine RNA, for example, so we don't absorb it and absorb the blueprint that makes us a sardine." (Tr. 253)
Much of the cross-examination of Dr. Herbert consisted of questions concerning articles or reviews in various scientific publications. Dr. Herbert had either written or contributed to the writing of these articles and reviews. Dr. Herbert's answers to questions put to him on cross-examination did not modify his direct testimony, and they contained little, if anything, to which Respondent could point for support of its position or for weakening of Complainant's case. The following typical series of questions and answers is illustrative of the foregoing statement.
"Q. The Journal of American Medical Associate, (sic) June 27, 1980, Volume 243, number 24 in the Medical News section, there is an article 'Vitamin B15 - whatever it is, it won't help.' Are you familiar with this?
Q. You did not author this?
A. The author's name is stated at the end of the article.
Q. William Check?
Q. It mentions you. I want to read the mention of you and you tell me if this is an accurate characterization of yourself. First, it describes the work reported at the American Society for Clinical Nutrition by Neville Colman and I assume you also?
A. Correct, I was a co-author.
Q. 'This work is a continuation of the campaign against scientific health fads being waged by Victor Herbert, MD, JD, chief of the Hematology and Nutrition Laboratory,' etcetera. Is that accurate?
A. It is an interesting characterization.
Q. Is it accurate?
A. I don't perceive myself as waging a campaign. I conceive myself as speaking the truth in the field of nutrition.
Q. You are familiar with the product in question in this hearing, the vitamin RNA product?
Q. Does that fall within your category of unscientific health fads?
Q. So this is part of your campaign being waged?
A. No, I am not waging a campaign. That is a characterization by someone else not by me. I characterized myself as speaking the truth about nutrition. This is part of my speaking the truth about nutrition." (Tr. 269-270)
The remainder of the cross-examination of Dr. Herbert, as in the case of that which has just been quoted above, consisted principally of effort, entirely unsuccessful, to discredit this witness (e.g., Tr. 274-277; 293-295; 297-299; 300-301).
The testimony of Dr. Herbert relating to the issues in this proceeding concluded with two statements. The first such statement was that there is no recommended dietary allowance for RNA because RNA in the diet serves no dietary purpose. (Tr. 313) Secondly, the witness was asked whether the other ingredients in Ribomins with RNA, namely certain vitamins and minerals, would contribute to the accomplishment of the results stated in the representations alleged in paragraph III of the Complaint as having been made by Respond ent. Dr. Herbert replied that, with one exception, the other ingredients alone or with RNA included can do none of those things. The exception, he stated, is in charge III (e) (that the RNA in Ribomins promotes good health and a general sense of well-being of a person suffering from a specific nutrient deficiency of one of the listed vitamins or minerals would be promoted. However, because the occurrence of deficiency in those vitamins is so rare, such a benefit would be accidental and coincidental. (Tr. 314-315)
Based upon the evidence hereinbefore summarized and cited below, and based upon other considerations of record noted below, I make the following findings of fact:
1. Respondent has used the advertisement which is Appendix A hereto in the conduct of its business. (Item 1, Respondent's Response to Request for Admission (hereinafter, Response))
2. Respondent solicits remittances of money through the mail to the name and address shown in the caption hereof for a product called Ribomins, or Ribomins with RNA, consisting of ingredients as heretofore stated. (Items 2, 3 and 4, Response; supra, pp. 3-4; Appendix A)
3. Respondent guarantees that purchasers will be satisfied with the product or they can obtain a full cash refund. (Appendices A and B)
4. Respondent makes the representations set forth in paragraph III of the Complaint. (Appendix A; supra, pp. 5-7)
This finding is predicated on the principle that an advertisement is to be considered as a whole and the meaning is to be determined in light of the probable impact of the entire advertise- ment on the person of ordinary mind. Donaldson v. Read Magazine, 333 U.S. 178, 189 (1948); Peak Laboratories, Inc. v. United States Postal Service, 556 F.2d 1387, 1389 (5th Cir. 1977); Unique Ideas, Inc. v. United States Postal Service, 416 F. Supp. 1141, 1145 (S.D.N.Y., 1976).
5. Persons of ordinary mind reading Respondent's advertisement would interpret it substantially as characterized in paragraph III of the Complaint.
6. The representations found to have been made by Respondent are material representations because they are of the kind and character which would persuade readers to order and pay for Respondent's product.
7. The material representations heretofore found to have been made by Respondent in its advertising material are false as a matter of medical fact.
a. Respondent's Dr. Susser, is the originator and seller of the product and he is, or has been, the organizer/president of the American Academy of Nutritional Consultants. (Tr. 92-94); supra, p. 21) Dr. Susser bases his statements concerning the effects of taking of Ribomins on the writings of Dr. Jerome S. Frank, a Dr. Allen Nitler, a medical doctor in the State of Washington who is to be reached through California, and a Dr. Howard Lutz, of Washington, D.C. (Tr. 99, 100)
b. The testimony in this record is to the effect that Dr. Frank's writings have never been subjected to peer review, and that the results of taking RNA reported therein are anecdotal and without scientific verification. The same lack of verification is true with respect to the results of the self-designated "testing" of the product by Drs. Susser, Ledney, Feit, and Atkins. Dr. Frank's writings, the evidence indicates, are without "scientific validation" and the results of his use of RNA with patients lacks "scientific credibility." (Dr. Reiff - Tr. 72-76, supra - p. 20; Dr. Susser - Tr. 148; Dr. Atkins - Tr. 215, supra - p. 42; Dr. Herbert - Tr. 300, supra -. 47)
c. Dr. Nitler's writings, so far as revealed by this record, appear only in the Journal of the American Academy of Nutritional Consultants. This group is not recognized as being composed of scientific nutritionists. (Dr. Herbert - Tr. 230, supra - p. 45) Furthermore, Dr. Susser, who has an obvious and an admitted interest in the outcome of this proceeding, was evasive in respect to some questions and he claimed not to know whether the journal of that group is listed in MEDLARS or MEDLINE. (Tr. 135; supra - pp. 21, 26; see, also, Susser at Tr. 141-144; Dr. Herbert's description of the Nutritional Consultant's group makes it clear that he does not think the writings of Dr. Nitler referred to in this proceeding would be published in recognized scientific and professional journals Tr. 230; supra p. 45)
d. Dr. Lutz is cited frequently by Dr. Susser, but no citation is given for his work. Although Dr. Lutz is said to be located in Washington, D.C., where three of the four sessions of the hearing were held, Dr. Lutz did not appear as a witness. Thus, testimony concerning his writings and statements is uncorroborated hearsay and of no legal significance.
e. Dr. Susser cites Dr. Nitler as his authority for the proposition that RNA is "absorbed intact or virtually intact." (Tr. 99-200, supra - p. 22) Dr. Susser is joined in this statement by Dr. Ledney, except that Dr. Ledney is more positive that dietary RNA is absorbed intact and then it is carried to the particular site in the body where it is needed. Dr. Nitler is referred to as the authority for Dr. Ledney's opinion. (Tr. 171-172; supra - p. 32)
f. Dr. Feit, although a warm advocate of the use and value of RNA in the treatment of patients, says that the state of knowledge of his profession concerning RNA is in its infancy. (Tr. 187; supra - p. 32)
f. Dr. Feit, although a warm advocate of the use and value of RNA in the treatment of patients, says that the state of knowledge of his profession concerning RNA is in its infancy. (Tr. 187; supra - p. 36)
g. Dr. Atkins said that, based on its effectiveness as observed by him in patients for whom he has prescribed it, he has "reason to believe that at least some supplemental dietary RNA is absorbed intact" (Tr. 213; supra - p. 42).
h. Opposing the above statements that dietary RNA is absorbed intact are the following comments: Dr. Reiff --when RNA as presented in Respondent's product is ingested, it "is broken down in the intestinal tract to its constituent parts ***"; Dr. Herbert --"RNA is made within cells; none of that which comes in diet is absorbed intact " (Tr. 228, 253; supra - p. 44). Further excerpts from Dr. Herbert's testimony are:
"Any textbook of biochemistry will tell you that dietary RNA is not absorbed intact . This is Principles of Biochemistry, 5th edition by Abraham White, Phylis Handler and Emil Smith. This is published in 1973 by McGraw Hill and I am reciting from chapter 9, entitled nucleic acids and nucleo proteins, tables 9.2, which lists the specificity of nuclease and says 'pancreas deoxyuridine nuclease destroys DNA and pancreas ribonuclease destroys RNA.'" (Tr. 297)
* * *
"It is well established science. Every biochemist including any who might work for your client knows that pancreatic ribonuclease destroys all of the RNA you eat as soon as it hits the small bowel, because if you, for example, absorbed sardine RNA and it got in your cells and worked as RNA, you would turn into a sardine, because it is a specific blueprint." (Tr. 298)
* * *
"Q Did you rely on that particular text when you testified?"
"A No, I relied on what I learned in medical school from Irwin Chigaff, among others, in first year biochemistry and my own work in breaking up RNA, which I have done in the course of my research, using pancreatic extract, pancreate and bile case (sic, in transcript), which is a commercial tradename for an Illinois company's brand of mixture of pancreatic proteins, which were used to digest tissue.
"The purpose of the pancrease enzymes is to digest all the things from food that we want to break down before we absorb. Digestion means breaking down and the pancrease enzymes, which go out into the food, as the food leaves the stomach, food comes in the mouth, goes into the stomach, where it is turned into a turgid, muddy, semi-liquid. And then it is poured out of the bottom of the stomach into the top of the intestine. In the top of the intestine there is a tube coming from the pancreas and that tube pours into this liquified mixture of food, the pancreas enzymes, whose job is to chop up things like RNA and DNA and enzymes, so that they don't get absorbed. Because if they are not from a human source, all they can do is harm if they are absorbed intact. They cannot do any good absorbed intact. That is known to every medical student who took first year biochemistry and first year physiology."
i. Dr. Reiff said categorically that there is nothing in the scientific literature which confirms that Respondent's product, it taken as directed by persons without nutritional deficiencies, would produce the results represented by Respondent in its advertisement. (Tr. 41-44)
j. Dr. Herbert testified that there is no scientific evidence that dietary RNA, or Ribomins as constituted, taken as directed, will produce the results represented by Respondent. (Tr. 231-232, 303; supra, pp. 45-46)
8. There is some risk, the magnitude of which is uncertain, involved in the taking of Respondent's product. (Dr. Reiff - Tr. 38-40, supra - p. 15; Dr. Atkins - Tr. 207, 214, supra - p. 42; Dr. Herbert - Tr. 228, 303; supra - p. 44)
9. The fact that the placebo effect may occur in the case of some users does not support the efficacy of the product or the truthfulness of Respondent's representations. Stauffer Laboratories v. F.T.C., 343 F.2d 75 (9th Cir., 1965); Original Cosmetics Products, Inc. v. Strachan, 459 F. Supp. 496 (S.D.N.Y., 1978); aff'd. 603 F.2d 214, Table, (2nd Cir., 1979), cert. den. 444 U.S. 915 (1979); Wilmont Products, P.S. Docket No. 6/46 (P.S. De., 1979).
10. Expert opinion testimony need not be based upon tests of the particular product in issue to constitute sufficient evidence of false advertising representations. Reilly v. Pinkus, 338 U.S. 269, 274 (1949); Original Cosmetics Products, Inc. v. Strachan, supra; Skinny Suit, P.S. Docket No. 3/44 (P.S. Dec., 2/19/76, p. 6).
11. A finding of falsity can be based on the testimony of expert witnesses whose testimony is in accord with the consensus of informed medical or scientific opinion when there is no contradictory evidence which is said to be in accord with such a consensus of opinion. Athena Products, Ltd., P.S. Docket No. 7/99 (Initial Decision, August 8, 1980, decision now on appeal); Standard Research, P.S. Docket No. 7/78 (Initial Decision, December 18, 1979); Standard Research, P.S. Docket No. 7/48 (Initial Decision, August 31, 1979); Modern Age Products, Inc., P.S. Docket No. 5/102 (P.S. Decision, June 29, 1977; Initial Decision, April 6, 1977); Nutrient Laboratories, P.S. Docket No. 5/48 (Initial Decision, November 17, 1976).
12. The views and opinions expressed by Complainant's witnesses are in accord with the consensus of informed scientific and medical opinion.
13. There was no claim that the views and opinions of Respondent's witnesses were in conformity with the consensus of informed scientific and medical opinion.
14. In the last paragraph of Respondent's Proposed Findings of Fact and Conclusions of Law it is suggested that there is a diversity of opinion among the medical experts which precludes the issuance of a mail-stop order in this matter. Without question there is a division of the opinions of the doctors called as witnesses by the respective parties. When, however, consideration is given to the qualifications of the witnesses, their obvious knowledge, or lack thereof, concerning the action within and by the digestive system on the ingredients of the product involved herein, the interest of the witnesses, and other matters which are weighed in determining authenticity of evidence and credibility of witnesses, the conclusion is inescapable that the clear and decisive preponderance of the evidence is on the side of Complainant.
15. The falsity of Respondent's representations has been established by the preponderance of the competent, credible evidence.
16. Respondent's offer of a refund to dissatisfied purchasers does not overcome the effects of the making of false sales representations. Borg-Johnson Electronics v. Christenberry, U.S.D.C., S.D.N.Y., 169 F. Supp. 746, 751 (1959)
1. The foregoing Findings of Fact are incorporated herein by reference as Conclusions of Law.
2. Upon the basis of the entire record it is concluded as a matter of law that Respondent is engaged in conducting a scheme or device for obtaining money or property through the mails by means of materially false representations within the meaning of 39 U. S. Code 3005.
Proposed findings of fact and conclusions of law submitted by the parties have been fully considered, and to the extent indicated herein, they have been adopted. Otherwise, such proposed findings of fact and conclusions of law are rejected for the reason that they are unsupported by or contrary to the evidence or because of their immateriality.
Accordingly, an order of the type authorized by Section 3005 of Title 39, United States Code, substantially in the form attached, should be issued against this Respondent.
This page was posted on July 20, 2004.