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December 14, 1961

UNITED STATES of America, Libellant,
An article of drug consisting of 47 BOTTLES, MORE OR LESS, each containing 30capsules of an article labeled in part: '* * * JENASOL RJ FORMULA 60* * *', Respondent, (Marvin Schere d/b/a the Jenasol Co.), Claimant

The opinion of the court was delivered by: WORTENDYKE

This is a seizure case under the Federal Food, Drug and Cosmetic Act, 21 U.S.C.A. § 301 et seq. The subject matter of the seizure is a quantity of drug labelled 'Jenasol RJ Formula 60' capsules or 'Jenasol' containing as active ingredients a substance designated as 'Royal Jelly' *fn1" and certain vitamins. *fn2"

The libel of information charges misbranding within the meaning of 21 U.S.C.A. § 352(a), because labelling claims as to the therapeutic effectiveness of the drug are false and misleading. It is represented in the labelling that the product will cause a person who ingests it to obtain increased sexual vitality, relief from irritability, headaches, insomnia, physical and spiritual convulsions, and depression, restoration of vitality, alleviation of the ills of old age, improvement of memory, stimulation of appetite, normalization of the growth of under developed children, extension of life-span, palliation of glandular activation, alleviation of the physical and mental symptoms of approaching old age, help for tired eyes, and the achievement of a pleasing state of relaxed well-being.

 In addition to the issue of fact posed by the charge that the claims are false and misleading, two questions of law are raised, namely: (1) whether the printed matter seized with the article of drug constitutes labelling within the meaning of 21 U.S.C.A. § 321(m), and (2) whether the evidence disclosed a substantial difference of medical opinion with respect to the claims upon which the issue of fact arises. Having charged misbranding, the burden rests upon the Government to support the accusation by competent evidence. Chichester Chemical Co. v. United States, D.C.Cir.1931, 49 F.2d 516. In undertaking to discharge this burden the Government called nine expert witnesses, whose identity, qualifications and opinions were as hereinafter summarized.

 Howard Smith, a chemist in the field of food analysis, conducted a 'regular' food analysis on pure royal jelly for the purpose of determining the percentages of protein, sugars, acid and ash contained therein; and found that the ingredients of the royal jelly aggregated a total of 100.7%.

 Dr. Paul Gyorgy, specializing in nutrition and pediatrics, the discoverer of certain vitamins and an author and professor in his fields, testified, on the basis of knowledge of royal jelly, derived from scientific literature dealing therewith, that Jenasol would have none of the effects claimed in its labelling, except in cases of loss of appetite resulting from insufficiency of the thiamin vitamin. He was further of the opinion, based upon his studies and professional contacts, that there was no basis for believing that royal jelly is useful in the treatment of any disease.

 Dr. Herbert S. Kupperman, Associate Professor of Medicine, specializing in the fields of endocrinology and clinical pharmacology, had made a study prior to the institution of the present litigation for the purpose of determining the effects of ingested royal jelly upon the human body with particular reference to the endocrine glands, the libido, and the gonadal function of the human male. His study involved the administration of royal jelly to a number of rats, and a comparison of its effect, with that of an inert substance, upon the weights of the adrenals, testes, prostate, seminal vesicles, levator ani muscles, thymus, thyroid and pituitary glands of the animals. Finding that the weight of these organs was not affected by the administration of the substance, Dr. Kupperman concluded that royal jelly had no hormonal or other effect on the male sex organs. It was, moreover, his opinion that the results obtained from the administration of the substance to the rats would be similar in the case of human beings. Supplementing his tests upon rats, he administered the product to several healthy males. He observed no effect of the tests, except the development of diarrhea in the patients. In a second test on human beings, the Doctor administered the royal jelly to seven patients who suffered from problems relating to fertility and libido, with glandular deficiencies. By measuring the quantity of steroid substances, an index of the activity of the male sex organs, in the blood and urine of the patients, and comparing the findings with those present prior to the administration of the royal jelly, no significant differences were manifested. Dr. Kupperman concluded from these tests that none of the patients had experienced any enhancement of libido, increase in sperm count, or change in sterility. His findings that the substance administered did not enhance potency was based upon information given him by the patients. In sum, it was the opinion of Dr. Kupperman that the Jenasol formula would not be effective in the treatment of the diseases and conditions for which it was recommended in its promotional literature, and that his opinion thereon represented the informed medical consensus upon the subject.

 Another witness for the Government was Dr. Lewis Barness, an Associate Professor Pediatrics and board-certified specialist therein, who had conducted research in nutritional pediatrics. It was his opinion that royal jelly was not a recognized treatment for underdeveloped children. He had administered Jenasol to six underdeveloped children for thirty days, and noted no improvement, and he testified that he would not prescribe the Jenasol formula for such patients because it did not contain vitamins A or D. Throughout his participation in meetings of physicians and other scientists, and his connection with medical schools, Dr. Barness had never heard any discussion regarding royal jelly.

 Dr. William H. Lewis, a medical professor presently associated with the Sloan-Kettering Medical Center, and an author of articles and books dealing with diseases connected with the aging process, voiced the opinion that the Jenasol product, except as a B-vitamin supplement when necessary, was ineffective for the geriatric diseases, and that royal jelly was not recognized as a treatment for them. The substance had been tested at the institution with which he was connected as a possible cancer remedy, and found to be ineffective for that purpose as well.

 Dr. Ernest J. Umberger, a pharmacologist employed by the Food and Drug Administration, specializing in the study of glands, had administered royal jelly to rats. He found through two tests that the animals to which royal jelly had been given did not react any differently than did the control, and concluded, therefore, that royal jelly did not stimulate the ovaries or adrenal glands at which the tests were directed. In a third study, this doctor administered royal jelly and a control to castrated male rats in an effort to determine the presence of male sex hormonal activity and growth stimulant effects, if any. He found no such activity as a result of the administration of the substance, and concluded, as the result of several tests, that royal jelly contained no substance stimulative of the adrenal gland, and also that it had no toxic effect.

 Another expert witness who testified in behalf of the Government was Dr. Arthur Grollman, who had been teaching medicine at Johns Hopkins University and at the University of Texas over a period of thirty-eight years. He is a prolific writer on medical subjects and the recipient of numerous academic honors and fellowships, including an honorary professorship of medicine at the University of Guadalajara, Mexico. He has studied and written upon the subject of royal jelly, which he recognizes as a plentiful source of pantothenic acid. It was his considered opinion that the Jenasol product would not be effective in the treatment of any of the conditions mentioned in its labelling, except in cases of certain well-defined vitamin deficiencies. Dr. Grollman also confirmed Dr. Umberger's opinion that the results of the tests which the latter made upon rats were significant of similar effects upon human beings. Dr. Grollman stated that the antibiotic activity of royal jelly was but a negligible fraction of that afforded by the usual dosage of bacitracin, streptomycin, polymixin, neomycin and penicillin. The doctor also stated that he knew of no medical school in which the use of royal jelly as a therapeutic agent was taught, and that his opinion represented the consensus of medical opinion on the subject.

 The case of the Government concluded with the testimony of Mr. Bernard Arrett, an employee of the Division of Antibiotics of the Food and Drug Administration. He had made certain tests to determine the effect of royal jelly in Jenasol as inhibitors of bacterial growth. From these experiments he found that the antibiotic activities of the substances lay in the range attributable to such foods as honey, sugar, butter, milk, green peppers, foods having a high salt content, and cranberries.

 The evidence adduced in behalf of the claimant was in the form of testimony by Dr. Angel Lozano Abarca, a thirty-three year old Mexican physician with a background of only five years' practice, and Dr. Ricardo Galeazzi-Lisi, formerly a physician to the Pope, who admitted that he was neither a scientist nor a researcher, and had kept no records of his clinical use of royal jelly.

 Dr. Abarca testified that he had employed royal jelly principally for the treatment of physical impotency in men with favorable results in 80% Of the cases treated. He explained the absence of response in the remaining 20% By the presence of diabetes in those unresponsive cases. The doctor was, however, of the opinion that royal jelly was effective in the treatment of diabetes, and testified that he had used it for that purpose. He also stated that he had used the substance in the treatment of some accompaniments of old age, including arthritis, with apparently resultant improvement. His admitted source of knowledge respecting the composition and effects of royal jelly was, however, information which he obtained from a veterinarian, Hector Lopez Arista, who was engaged in the business of distributing royal jelly in Mexico City, and who had worked out for Dr. Abarca the dosages to be used. The witness conceded that he had no knowledge of any recommendations for the use of the substance in medical testbooks, or in medical schools, and his opinion as to its efficacy for the purposes stated in the labelling was based only on his own work, and the 'study' of the veterinarian, whose testimony was not presented.

 Dr. Galeazzi-Lisi initially claimed that he had administered royal jelly to 'many thousands' of persons since he first learned of it in 1947 or 1948; but later in his testimony the doctor reduced his estimate of the number of subjects from thousands to hundreds. He testified that he used the drug primarily in efforts toward the retardation of the aging process and in the treatment of the symptoms associated with old age; also, but to a lesser extent, as a means of increasing the weight of underdeveloped children. He claimed to have achieved favorable results in these directions. He was unable to afford any specific information concerning the food value or protein content of royal jelly, or to name any one of the forty ingredients of which he claimed it was ...

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