2159 Adulteration and misbranding: of Dwarfies 10-Vitamin Tablets. U. S. v. Dwarfies Corporation and James John Oberdin. Pleas of guilty. Each defendant fined $200 and costs. (F. D. C. No. 17831. Sample No. 26455-H.) INFORMATION FILED: October 1, 1946, Southern District of Iowa, against the Dwarfies Corporation, Council Bluffs, Iowa, and James John Oberdin, secre- tary and treasurer. * ALLEGED SHIPMENT: On or about March 14, 1945, from the State of Iowa into the State of Colorado. The article was accompanied by a leaflet entitled "Vitamin Chart," a letter entitled "Dear Friend," and a circular entitled "Thousands of Folks use Dwarfies 10-Vitamin Tablets Daily . . . and live a more healthy life because of it." The Vitamin Chart was shipped with the drug, and the other material was delivered to the consignee on or about March 19,1945. PRODUCT: Examination of a sample showed that it contained 2,760 U. S. P. units of vitamin A per tablet. LABEL, IN PART: "Dwarfies 10 Vitamins All-in-One Daily Tablet Each tab- let contains: Vitamin A, D, Ba, Ba, C, E, Niacin, Calcium Pantothenate, Paraminobenzoic Acid * * * Each tablet contains the following propor- tion of established minimum requirements: A, 125? * * * A . . . 5000 U. S. P. Units." NATURE OF CHARGE: Adulteration, Section 501 (c), the strength of the article differed from, and its quality fell below, that which it purported and was represented to possess since it contained less than 5,000 U. S. P. units of vitamin A per tablet. Misbranding, Section 502 (a), the label statements "Each Tablet Contains * * * A 5000 USP Units" and "Each Tablet Contains the Following Pro- portion of Established minimum Requirements * * * A, 125?" were false and misleading. Certain statements in the accompanying letter, circular, and leaflet were misleading. These statements represented and suggested that the following conditions are frequently caused by lack of the vitamin substances contained in the article, and that the reader might reasonably expect correc- tion and relief from those conditions by use of a product containing such sub- stances: Abnormal vitality of mucous membrane or epithelial cells, low re- sistance to infection, abnormal functioning of the visual purple (bad eye- sight), abnormal glandular function, abnormal lactation, improper forma- tion of bone and teeth, poor appetite, poor utilization of carbohydrates, ab- normal intestinal function, improper nerve function and cell respiration, ab- normal nerve tissues, unclear, dull eyes, improper healing of wounds and repair tissue, faulty control of collagen formation, abnormalities of the vascu- lar system, poor health, abnormal function of the gastrointestinal tract, poor utilization of unsaturated fatty acids, lack of virility, unsound muscle func- tioning and general well-being, poor intestinal motility, lack of growth, loss of natural hair color, abnormal blood calcium level, lack of vigor and well-being, loss of characteristics of youth, and a shortened life span. The stated condi- tions commonly and usually result from causes other than lack of the vitamin substances contained in the article, and the article would not ordinarily cor- rect and relieve such conditions. Further misbranding, Section 502 (a), certain statements in the labeling were misleading since they represented and suggested that the following con- ditions are frequently caused by lack of the vitamin substances contained in ?See also No. 2152. the article, and that the reader might reasonably expect correction and relief ( from such conditions by use of a product containing such substances: Lack of body strength, sleeplessness, body aches, neuritis, indigestion, poor body function, a run-down, tired, and worn-out feeling, arthritis, back ailment, poor appetite, heart disease, disability of the legs, retarded growth, diarrhea, intestinal disorders, poor appetite, poor teeth and gums, lack of vigor, a dry skin, night blindness, poor resistance to infection, xerophthalmia (eye dis- ease), hyperkeratosis of the skin, weakness, sterility, loss of weight, atrophy of glands, calculi (stones) in kidneys and bladder, nerve degeneration, infec- tions entering through epithelia, eyes, tear ducts, tongue, alimentary tract, ear canal, sinuses, bladder, and kidneys, colitis, weakness (fatigue), slow heartbeat, poor appetite, retarded growth, cardiovascular disturbances, poor assimilation, nervousness, decreased peristalsis, impaired reproductive func- tioning, heaviness of legs, burning feet, pain in legs, paresthesia of toes, calf muscle cramps, anorexia, paralysis, loss of weight, atrophy of glands, atrophy of musculature, gastric atony, convulsions, enlarged heart, serious effusions and colitis, lesions of the lips, cracks at the angles of the mouth and other facial lesions, abnormal changes in the eyes which result in failing vision, diges- tive disturbances, lack of vigor, poor lactation, impaired growth, photophobia (evidenced by easy watering of the eyes in sun-glare), small blood vessels advance into the corneal area of the eyes, clouding the vision, itching, burn- ing, a sensation of roughness of the eyes, weakness, atrophy of intestines, atony, loss of body weight, cataract (in eyes), keratitis, "sharkskin," glossitis, chei- losis, dermatitis (seborrheic), breakdown of central nervous system, anemia, hemorrhage, pyorrhea, defective teeth, tender joints, poor bone knitting, head- ache, poor resistance to infection, retarded growth, weakened blood capillaries, weakness, restlessness, tendency to bruise easily, as evidenced by dark dis- color of skin, anemia, swollen joints, swollen, bleeding gums, loose teeth, fragile bones, lesions in bone, marrow, sterility, respiratory and intestinal in- fections, paralysis, hypertrophy of adrenals, gastric ulcers, colitis, erythema, soreness of mouth, indigestion, constipation, headache, anorexia, dermatitis, redness of tongue, glossitis, diarrhea, insanity, poor memory, muscular de- rangements and disorders, retarded growth, edema, muscle incoordination, "fatty" livers, microcytic hypochromic anemia, lesions of various tissues, ophthalmia, abscesses, epileptiform fits, low fertility, impaired placental func- tion, muscle dystrophy, degenerative diseases of the nervous system, graying of the hair, hemorrhagic adrenals, low blood calcium, low blood phosphate, "bow legs," poor deposition of lime and phosphorus in teeth and bones, rest- lessness, lack of vigor, poor growth, enlarged joints, curved spine, beaded ribs, retarded growth, lesions in bones and teeth, and tetany. These conditions com- monly and usually result from causes other than lack of the vitamin substances contained in the article, and the article would not ordinarily correct and relieve such conditions. DISPOSITION : October 1, 1946. Pleas of guilty having been entered, the defend- ants were each fined $200, plus costs.