FEDERAL SECURITY AGENCY FOOD AND DRUG ADMINISTRATION NOTICES OF JUDGMENT UNDER THE FEDERAL FOOD, DRUG, AND COSMETIC ACT [Given pursuant to section 705 of the Food, Drug, and Cosmetic Act] 1451-1500 DRUGS AND DEVICES The cases reported herewith were instituted in the United States district courts by the United States attorneys acting upon reports submitted by direction of the Federal Security Administrator. MATJBICE COLLINS, Acting Administrator, Federal Security Agency. WASHINGTON, D. C, January 2ff, 19^6. CONTENTS * Page Drags actionable because of potential danger when used according to directions 499 Drugs actionable because of decomposition or contamination with filth 500 Drugs and devices actionable because of devia- tion from official or own standards 601 Page Drugs and devices actionable because of false and misleading claims 609 Drugs and devices for human use.. 609 Drugs for veterinary use - 613 Index 617 DRUGS ACTIONABLE BECAUSE OF POTENTIAL DANGER WHEN USED ACCORDING TO DIRECTIONS 1451. Misbranding: of Bristol's Compound and Kemp's Vermifuge (liquid). U. S. v. 153 Dozen Packages of Bristol's Compound and 289 Dozen Packages of Kemp's Vermifuge (Liquid). Default decree of forfeiture and destruc- tion. (F. D. C. No. 14428. Sample Nos. 33165-F, 33169-F.) On November 14, 1944, the United States attorney for the District of Puerto Rico filed a libel against 153 dozen packages of Bristol's Compound and 289 dozen packages of Kemp's Vermifuge (liquid) at San Juan, P. R., alleging that the articles had been shipped between the approximate dates of March 14 and October 23, 1944, from New York, N. Y., by Lanman and Kemp-Barclay and Co., Inc. Examination of the Bristol's Compound showed that it contained extracts of plant drugs, including a laxative plant drug such as senna, and an iodide such as potassium iodide. It was alleged to be misbranded in that its labeling failed to warn that the article should not be used in cases of abdominal pain, nausea, vomiting, or other symptoms of appendicitis, and that frequent or continued use of the article or use in accordance with the directions, namely, "For adults, one tablespoonful * * * three times daily * * * For children 3 to 5 years old, Va teaspoonful; 6 to 11 years, 1 teaspoonful; 12 to 15 years, 2 teaspoonfuls; 16 to 18 years, 3 teaspoonfuls * * * three times daily," might result in de- pendence upon laxatives to move the bowels. It was alleged to be misbranded ? For drugs actionable because of failure to bear adequate directions or warning statements, see No. 1451; omission of, or unsatisfactory, ingredients statements, Nos. 1470,1485,1494; failure to bear a label containing the name and place of business of the manufacturer, packer, or distributor, No. 1481; failure to bear an accu- rate statement of the quantity of the contents, No. 1492; cosmetics, subject to the drug provisions of the Act, Nos. 1491,1492. 682980-46 1 499 eruptions resulting from faulty elimination," was misleading since a puslcpiser had no way of knowing whether skin eruptions were due to faulty elimiUation t to some other condition. The Kemp's Vermifuge (liquid) was labeled in part: "Formula per 100 c. c-I Active Ingredients: Oil chenopodium 3.40 c. c, castor oil 82.80 c. c, and the matter! extracted from: pomagranate bark 2.80 gms., spigelia root 1.80 gms., senna leaves 1.10 gms. * * * Dose: Children 1 to 2 years, 30 Drops (1.20 cc.) Children 2 to 5 years, 1 Teaspoonful 4 c. c. Children 5 to 8 years, 2 Teaspoonfuls 8 c> c. Children 8 to 12 years, 3 Teaspoonfuls 12 c. c. Adults 1 Tablespoonful 15 c. c Instructions: Take at night on retiring. If desired result is not produced by morning, the dose may be repeated." Examination of the article indicated that it possessed essentially the composition stated upon its label. It was alleged to be misbranded in that, by reason of its content of Chenopodium oil, it was danger- ous to health when used in the dosage and with the frequency prescribed, recom- mended, and suggested in its labeling. It was alleged to be misbranded further in that the following statements appearing in the circular entitled "Kemp's Vermifuge" were misleading: "Usual Symptoms of The Presence of Intestinal Worms. The patient loses color and weight and his abdomen becomes swollen and hard, he complains of pains in the stomach and in the region of the navel; hia appetite is capricious and he craves sweets; he scratches his nose almost con- tinuously or grinds his teeth in his sleep." The conditions mentioned above might have been due to various causes other than the presence of intestinal worms, and they might have led to the use of the article in conditions for which it would be of no value. On April 17, 1945, no claimant having appeared, judgment of forfeiture was entered and the product was ordered destroyed.