Dupuytren's contracture, deformity of ligaments, dehydration, dullness, dat ened skin, difficult perspiration, difficult swallowing, dry mouth with thi ropey saliva, decreased blood sugar, decreased cholesterol, decreased bix calcium, decreased carbohydrate tolerance, diabetic retinitis, duodenal ulcer dementia praecox, enzymatic tranquilizing, emphysema, edema of ankles easily formed "goose flesh", excessive intake of carbohydrates, excessive sin line-ash foods, endocrine insufficiency, eating when not hungry, emaciatist. edema, epistaxis, excessive appetite, earache, endocervicitis, epilepsy, e conditions, eczema, excessive hair growth, early dentition, excessive perspire tion, early appearance of pubic hair, early menstruation, exophthalmos, extreme response to stress, edema of the lids, eyebrows meeting in center, excess water saliva, extra systoles, endometritis, encephalomyelitic paralysis, exophthalm goiter, fullness after meals, fatigue, faulty digestion, fluid loss, feeling worse after eating, fevers, frequent sighing, failure of adrenal mechanisms caused by excessive mental stress or shock, “flu", fibroid tumors, febrile diseases, flatulence, fair skin, frequent winking and blinking of the eyes, fibrillations of the heart, fibrositis, gingivitis, glossitis, gallbladder dysfunction, glandus” disorders, gastric hyperacidity, grippe, gout, gastric ulcer, goiter, gynecomastia, "goose flesh" not easily formed, glaucoma, gallbladder inflammation, gallstores gastritis, gingival bleeding, glomerulonephritis, hypochlorhydria, hydrochlor: loss from longstanding hyperacidity, hypertrophic arthritis, halitosis, hyperirritability, hypercholesterolemia, heavy, slow pulse, hypertension, high-altitude discomfort, hay fever, heart abnormalities, herpes simplex, histamine reas tions, hives, hypocholesterolemia, hypotension, heat prostration, hemorrhoids hernia, hepatitis, herpes zoster, headaches, hypoglycemia, high-pitched voE high blood pressure, hyperdevelopment, heavy-toned voice, heavy and coarse axillary and pubic hair, heavy growth on legs and chest, hypoactivity of the adrenals, heart block, hypertrophy of heart, high sedimentation rate, hemolytic anemia, irregular respiration, inability to metabolize carbohydrates, itch:4 skin, insomnia, irritation to inflamed stomach mucosa, increased metabol requirements, infections, intermittent claudications, intestinal worms, increased urination, impaired vision, increased metabolic rate, increased hair growi irregular menstruation, immature mammary glands, increased strength 1 women, irregularities of the teeth, increased tears, increased flow of bu increased flow of pancreatic juice, increased blood sugar, increased cholester increased blood calcium, increased body weight with low body temperatu increased carbohydrate tolerance, increased appetite, intestinal cramps, ir tation to the eye, infectious hepatitis, impotency, intestinal stasis, irritaba disposition, infantilism, improving tissue tone, jaundice, kidney stones, ketosis kidney overload, keloids, liver disease, liver insufficiency, loss of taste for mest lower bowel gas, leg ulcers, lumbago, leukopenia, lymph node infection, les corrhea, lowered metabolic rate, lack of hair growth, long eyelashes, low str tolerance, loss of control of voice, lowered sexual activity and power, larg sexual organs, large breasts and clitoris, leucocytosis, laryngitis, loss of tast and smell, liver cirrhosis, lymphatism, metabolic diseases, mental strea mastitis, mouth and tongue disorders, menopausal disorders, menoreza symptoms, menstrual dysfunction, menstruation symptoms, muscular trem migraine headaches, myocarditis, multiple sclerosis, mucous colitis, men's dullness, muscular dystrophy, marked pigmentation of skin, marked gag reflex, measles, mumps, muscular cramps, malaria, Meniere's disease, meri depression, mitral stenosis, muscular weakness, myasthenia gravis, meatcholia, mental retardation, male sterility, mongoloids, milk intolerance, nigh: mares, neuralgia, night cough, night cramps, nervous tension due to hydrochloric loss, neurasthenia, nephritis, nausea of pregnancy, neuromuscular disorders, nervous strain, numbness, night blindness, neurodermatitis, nose polyps, numbness from poor circulation, nymphomania, obesity, osteoarthritis, oily skin, osteoporosis, ovarian tumors, pernicious anemia, promoting muscle tone, preventing eclampsia, pregnancy, pallor, protein metabolism, prostatitis, photophobia, peridontoclasia, poison ivy and oak, pruritus, purpura, perspiration, promotion of healing, pain, psoriasis, pneumonia, phlebitis, preserving integrity of nails, pellagra, Peyronie's disease, prostate disease, pruritus vulvae, pruritus ani, palsy, pigmentation of skin, palpitation, precocious development, precocity, poor nervous stamina, puffiness, pale, undernourished mucous membrane, precocious sexual development and desire, pain in bones, Paget's disease, painful breasts, paralysis agitans, Parkinson's disease, pyorrhea, poliomyelitis, polpus recta, poor memory, prostate hypertrophy, paroxysmal tachycardia, prolapsed uterus, paresis, paroxysmal hemoglobinuria, pulmonary hypertension, pituitary overactivity of male climacteric, peptic ulcer, reducing tissue oxidation rate, relief of pain in cancer, renal calculi, rapid blood-clotting time, reactions to foods, recovery from stroke, rheumatoid arthritis, receding gums, rheumatic fever, respiratory embarrassment, reduced lachrymal secretion, rapid shallow respiration, reduced flow of bile, reduced flow of pancreatic juice, rapid digestion with hunger pains, recurrent fevers, Raynaud's disease, restlessness, skin irritation, sinusitis, sciatica, salivary disorders, starvation, systemic hyperacidity, stiffness of joints, secondary anemia, sterility, systemic toxicity, sneezing attacks, strictures, shock, specific deficiency reactions of glandular conditions, sluggish mentality, sexual precocity, smooth thin skin, short stature, severe instability, stenosis, sluggish gagging reflex, spastic constipation, spastic sphincter, sparse growth of axillary and pubic hair, slow blood clotting, slow digestion with sour stomach and fermentation, stiff neck, scarlet fever, simple goiter, streptococcus infections, staphylococcus infections, skin itching, stiffness of jaw muscles, sweat gland inactivity, sunstroke, sympathetic ophthalmia, schizophrenia, styes, tachycardia, toxemia, telangiectasis, tinnitus aurium, torticollis, tonsillitis, teething in children, thickened nose, lips. and tongue, tremors, tendency to sweating, thick heavy eyebrows, thin outer % of eyebrows, thick, infiltrated, dry, rough, and wrinkled skin, toxic goiter, tuberculosis, uremia, urinary incompetence, ulcerative colitis, uterine congestion, underdeveloped sexual organs, uterine cramps, undulant fever, underdeveloped children, voice affected during stress, vomiting, vasomotor involvements, varicose veins, Vincent's infection, virus infections, vaginitis, warts, weakness of legs, white skin, weight gain, weight loss, well-developed hair growth, and X-ray burns. It was alleged further that the drugs were misbranded under 502(a) in that their labeling contained false and misleading representations that the drugs were necessary and essential adjuncts to the diet because: all disease conditions are the result of malnutrition; the American diet is "terribly deficient" in essential vitamins and minerals; practically everyone in this country is suffering from, or is in danger of suffering from, a serious dietary deficiency of vitamins and minerals due to foods being grown on depleted soils and due to pasteurization, storage, canning, processing, refining, shipping, freezing, and cooking of foods; medical men should cure disease by use of foods and food supplements rather than by use of drugs; practically the whole array of chronic and acute diseases may in some degree be related to acid-base disorders which should be treated by use of the defendants' products; a positive 691-269-63 -3 relationship between heart disease and malnutrition has now been firmly established; as a nation we are starving to death in the presence of medical men who know more about poisons than they do about food and who think first of what poison to use instead of what food to use when confronted by a therapeutic problem; the leading cause of death in America is heart disease which is caused by nutritional deficiencies; 700,000 people a year die of preventable and curable heart disease caused by deficiency of natural vitamins: dental caries are due to a diet deficient in natural vitamins; the value of antigenic extracts of specific organs (cytotropic extracts) is of unquestionable value in restoring health to the target organ; arthritis and tooth decay are caused by the eating of cooked food; polio is a degenerative disease caused by the eating of overcooked and refined foods; and that each of the drugs contains "unknown factors" of therapeutic value. The drugs were alleged further to be misbranded under 502(f) (1) in tha: their labeling failed to bear adequate directions for use in the treatment of the symptoms, diseases, and conditions for which they were claimed to be effective. Further allegations of the complaint charged the defendants with violating the Act by introducing and delivering for introduction into interstate commerce, misbranded drugs; by receiving and causing to be received in interstate commerce, misbranded drugs; by delivering and proffering for delivery, misbranded drugs, for pay or otherwise; and by causing the drugs to be accompanied by the above-mentioned labeling, while held for sale after shipment in interstate commerce, which act resulted in the drugs being misbranded. DISPOSITION: On 1-15-62, the defendants having consented to entry of a decree. the court entered a decree of permanent injunction enjoining the defendants from directly or indirectly introducing or delivering for introduction into interstate commerce, the drugs referred to in the complaint, or the same drugs by any other designation, or any other drugs which are accompanied by the labeling described in the complaint or accompanied by other written, printed or graphic matter containing the false and misleading representations alleged in the complaint or any similar false and misleading representations; or which fail to bear in their labeling a statement of all conditions and purposes for which such drugs are intended to be used and sufficient information to enable a layman to safely and efficaciously use such drugs for such purposes. The decree also enjoined the defendants (1) from receiving in interstate com merce such drugs in a misbranded condition and delivering such drugs, or proffering them for delivery, for pay or otherwise, and (2) from doing any act with respect to such drugs, while they are held for sale by the defendants after shipment in interstate commerce, which will result in the drugs being misbranded. The decree further enjoined the defendants from directly or indirectly introducing or delivering for introduction into interstate commerce, any of the drugs designated in the complaint, or the same drugs by any other designstion, or any other drug, to any person who has in his possession any written printed, or graphic matter as specified in the complaint, or similar thereto. The decree also enjoined defendants from writing, printing, or distributing any of the specified written, printed, or graphic matter, or any other written. printed, or graphic matter, which contains any statements that represent or suggest that any of the drugs named in the complaint, or the same drugs by any other designation, or any other drugs, are adequate and effective for the treatment, mitigation, cure, or prevention of any of the symptoms, diseases. or conditions specified in the complaint, or any other symptom, disease, or 1 conditions; or which makes any of the other representations specified in the complaint or any similar representations. 078. Nutri-Bio food supplement. (F.D.C. No. 47370. S. Nos. 51-416 T, 52-770 T, 53-103 T.) QUANTITY: 64 ctns. at Seattle, Wash. SHIPPED: Between 11-20-61 and 12-8-61, from Beverly Hills, Calif., by NutriBio Corp. LABEL IN PART: (Ctn.) "Nutri-Bio dietary food supplements *** Formulated for and Distributed by Nutri-Bio Corporation *** Beverly Hills, Calif. Available only through Authorized Nutri-Bio Distributors" and "Vitamins and Minerals from natural food sources ** 728 Mineral Tablets 364 Vitamin Tablets." ACCOMPANYING LABELING: Bound volume and single issues of "Nutri-Bio News" for Nov. 1958-Oct. 1959, 1960, and 1961; Nutri-Bio Sales Manuals; reprints designated, “San Jose State College Track Coach/Nutri-Bio letter July 31, 1958," "Great Falls Electric letter with enclosure June 25, 1958," "Rex Johnston/Nutri-Bio letter August 9, 1958," "San Jose State College Boxing Coach/Nutri-Bio letter July 31, 1958," "More Athletes on Nutri-Bio," "Southern Association Vitamins Help," 1957 issue of "Specialty-Salesman," and May 25, 1959 issue of "Life"; pamphlets entitled, "For More Radiant Living," "Why a Food Supplement," "How to get started in Nutri-Bio," "Food Supplement-Protein," "How Much Health Did You Buy Today," "Protein Recipes," "What is the Secret of Our Success," "The Nutri-Bio Open Door," and “A Nutri-Bio Discount Schedule"; leaflets entitled, "Let's Take a Peek," "The Nutri-Bio Program For Better Living," "Do You Know," and "Vitamin and Mineral Food Supplement"; film strips entitled, "You and Your Future With Nutri-Bio," "Give Yourself a Break," and "Just To be Sure"; records entitled, "Take Care of Yourself For Me," "You and Your Future With NutriBio," "Give Yourself a Break," and "Just To Be Sure"; Basic Food Charts; Basic Charts Balanced Nutrition; post cards, “Better Nutrition Through BioChemistry"; and Starting Kits. IBELED: 3-12-62, W. Dist. Wash. HARGE: 502 (a)-when shipped and while held for sale, the labeling contained false and misleading representations that the articles were adequate and effective to prevent loss of appetite, constipation, hemorrhage of mucous membranes, palpitation of the heart, nervousness, excess bleeding, rundown feeling, toxic elements in the digestive system, to promote resistance to infections, stamina and endurance, quicker reflexes, mental alertness, strength, growth, radiant living, general well-being, athletic ability, added energy, increased physical endurance, and zest for living; that everyone needs food supplements; that the articles were of special significance for special dietary supplementation and therapeutic use because the ingredients were of natural or organic origin; and that the article was of significant value for special dietary supplementation and therapeutic use by reason of the presence therein of unsaturated fatty acids, inositol, para-aminobenzoic acid, rutin, biotin, bioflavonoid complex, hesperidin complex, choline, alfalfa juice and powder concentrate, potassium, sulfur, copper, zinc, manganese, magnesium, and montmorillonite; and 502(f) (1)—the labeling failed to bear adequate directions for use in the treatment and prevention of dental caries, anemia, colds, "flu," arthritis, restlessness, insomnia, heart disease, increased blood cholesterol, and pimples; to build up the body; build up the blood; to rebuild tissues that have been broken down by cancer and to keep cancer from spreading, which were the conditions and purposes for which the articles were offered and intended, in oral statements, made by Mr. and Mrs. Alf Kvinge, whe were Nutri-Bio distributors. DISPOSITION: 4-23-62. Default-destruction. 7079. Nutri-Bio food supplement. (F.D.C. No. 47188. S. Nos. 10-076/7 I 10-670 T.) QUANTITY: 31 units, each consisting of 2 ctns. enclosed in a cardboard sleeve each ctn. containing 13 envelopes of 14 yellow tablets and 28 green tablets each, at Buffalo, N.Y. SHIPPED: 11-27-61, from Elk Grove Village, Ill., by Nutri-Bio Corp. Pak Pocket Carriers *** Contains a 7-Day Adult Supply of Nutri-Bis This Package contains 26 Nutri-Paks. * * * Nutri-Bio Corporation"; and (envelope) "Your Seven Day Supply of Nutri-Bio Dietary Food Supplement Natural or Organic Vitamins and Minerals for the Entire Family. Formulated for and Distributed by Nutri-Bio." ACCOMPANYING LABELING: Folders entitled, "Do You Know . . .," "The Nutr Bio Program For Better Living," and "Baby-Bio by Nutri-Bio"; and booklets entitled, "Why A Food Supplement." LIBELED: 3-6-62, W. Dist. N.Y. CHARGE: 502(a)—when shipped and while held for sale, the labeling of the article contained false and misleading representations that the article was adequate and effective to promote being alert, pleasant, calm, and vibrant; to feel well, and to have a zest for living; promote mental and physical health happiness, sociability, enthusiasm, liveliness, vigor, and awareness; and the the article was of significant value for special dietary supplementation ar therapeutic use by reason of the presence therein of unsaturated fatty acids inositol, para-aminobenzoic acid, rutin, biotin, bioflavonoid complex, hesperid: complex, chlorine, alfalfa juice and powder concentrate, potassium, sulfur copper, zinc, manganese, magnesium, and montmorillonite; that every one needs food supplements; and that the article was of special significance for special dietary supplementation and therapeutic use because the ingrediens were of natural or organic origin; and 502(f) (1)—while held for sale, the labeling failed to bear adequate directions for use in the treatment and pre vention of hemorrhage of the eyes, diabetes, high blood pressure, arthritis and bursitis, which were the conditions and purposes for which the artic was intended and offered, in oral statements, by Ralph Tatro, sales agent for the Nutri-Bio Corp. DISPOSITION: 4-17-62. Default-destruction. 7080. Special dietary foods. (F.D.C. No. 46032. S. Nos. 85-361/3 R.) QUANTITY: 145 300-tablet btls. of Foenugreek tablets; 10 cases, 12 1-lb. bags each, of fenugreek seeds; 118 300-tablet btls. of mangrove tablets, at Tulsa Okla. |