U. S. Department of Health, Education, and Welfare 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] 3861-3880 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 the U. S. Department of Health, Education, and Welfare, and include, where indicated, the results of investigations by the Department, prior to the institution of the pro- ceedings. Published by direction of the Secretary of Health, Education, and Welfare. CHARLES W. CRAWFORD, Commissioner of Food and Drugs. WASHINGTON, D. C, May 14,1953. CONTENTS * Page New drug shipped without effective application _ 358 Drug for veterinary use 358 Violative sales of prescription drugs 358 Drugs and devices actionable be- cause of failure to bear ade- quate directions or warning statements 359 Drugs actionable because of con- tamination with filth 364 Page Drugs actionable because of devia- tion from official or own stand- ards 365 Drugs actionable because of false and misleading claims 366 Drugs for human use 366 Drugs for veterinary use 370 Index 371 *For drug actionable because of potential danger when used according to directions, see No. 3861 (veteri- nary preparation); presence of a habit-forming narcotic without warning statement, Nos. 3863-3866; omission of, or unsatisfactory, ingredients statements, Nos. 3861 (veterinary preparation), 3864, 3865, 3867; imitation of, and sale under name of, another drug, No. 3867; failure to bear a label containing an accurate statement of the quantity of the contents, Nos. 3863-3867; failure to bear a label containing the name and place of business of the manufacturer, packer, or distributor, Nos. 3863, 3865-3867. 357 250655-53- NEW DRUG SHIPPED WITHOUT EFFECTIVE APPLICATION DRUG FOR VETERINARY USE 3861. Adulteration and misbranding of Wonder mange capsules. U. S. v. John /" M. Adams. Plea of guilty. Defendant placed on probation for 2 years, v (F. D. C. No. 32708. Sample Nos. 21028-L, 21212-L, 29044-L.) INFORMATION FILED : June 6, 1952, Northern District of Alabama, against John M. Adams, manager of the J. Q. Adams Drug Co., Ashland, Ala. ALLEGED SHIPMENT: On or about March 15 and April 25, 1951, from the State of Alabama into the States of Texas and Oregon. LABEL, IN PART: "Wonder Mange Capsules (Canine) Caution:-Not for Human Use Each capsule contains 10 grains Sodium 2 Arsenious Acid." NATURE OF CHARGE: Section 505 (a), the article was a new drug within the meaning of the law, and an application filed pursuant to the law was not effective with respect to the article. Adulteration, Section 501 (c), the strength of the article differed from that Which it purported and was represented to possess since it purported and was represented to contain 10 grains of a sodium compound of arsenious acid in each capsule, whereas the article did not contain 10 grains of a sodium com- pound of arsenious acid in each capsule but contained in excess of 10 grains of arsenic trioxide in each capsule. Misbranding, Section 502 (a), the label statement "Each capsule contains 10 grains Sodium 2 Arsenious Acid" was false and misleading since the article contained in excess of 10 grains of arsenic trioxide in each capsule, and the label statements "Wonder Mange Capsules (Canine)" and "Uses: These cap- sules may be used in the treatment of All Types of Mange On Dogs" were false and misleading since the statements represented and suggested that the article would be effective in the treatment of all types of mange on dogs, whereas it would not be effective in the treatment of any type of mange on dogss Further misbranding, Section 502 (e) (1), the article was not designated solely by a name recognized in an official compendium, and its label failed to bear the common or usual name of the article, namely, arsenic trioxide; and, Section 502 (j), the article was dangerous to health when used in the dosage and with the frequency and duration prescribed, recommended, and suggested in the labeling, namely, "Dogs over 10 pounds body weight should receive one capsule every 3 days until symptoms disappear." DISPOSITION : October 24,1952. A plea of guilty having been entered, the court placed the defendant on probation for 2 years. VIOLATIVE SALES OF PRESCRIPTION DRUGS