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] 5381-5400 DRUGS AND DEVICES The cases reported herewith were instituted in the United States district courts by United States attorneys, acting upon reports submitted by the Department of Health, Education, and Welfare. They involve drugs and devices which were ?adulterated or misbranded within the meaning of the Act when introduced into 1 and while in interstate commerce or while held for sale after shipment in inter- state commerce. These cases involve (1) seizure proceedings terminated with the entry of default decrees of condemnation; (2) criminal proceedings termi- nated with a verdict of guilty; (3) injunction proceedings terminated with the entry of an injunction; (4) contempt proceedings for violation of an injunction which were terminated with a verdict of guilty. The seizure proceedings are civil actions taken against the goods alleged to be in violation; and the criminal, injunction, and contempt proceedings are against the firms or individuals charged to be responsible for violations. Published by direction of the Secretary of Health, Education, and Welfare. GEO. P. LARBICK, Commissioner of Food and Drugs. WASHINGTON, D. C, January 26, 1959. CONTENTS Page Page New drug shipped without effective application 280 Drugs actionable because of failure to bear adequate directions or warning statements 281 Drugs and devices actionable be- cause of deviation from official i or own standards 293 492095-59 1 279 Drugs actionable because of false and misleading claims 309 Drugs for human use 309 Drugs for veterinary use 310 Index 310 SECTIONS OF FEDERAL FOOD, DRUG, AND COSMETIC ACT INVOLVED IN VIOLATIONS ( REPORTED IN D. D. N. J. NOS. S381S400 ' \ Adulteration, Section 501 (b), the article purported to be and was represented as a drug, the name of which is recognized in an official compendium (United States Pharmacopeia or National Formulary), and its strength differed from the standard set forth in such compendium; Section 501 (c), the article was not subject to the provisions of Section 501 (b), and its strength differed from, or ita purity or quality fell below, that which it purported or was represented to possess. Misbranding, Section 502 (a), the labeling of the article was false and mis- leading; Section 502 (f) (1), the labeling of the article failed to bear adequate directions for use. New-drug violation, Section 505 (a), the article was a new drug within the meaning of Section 201 (p), which was introduced into interstate commerce, and an application filed pursuant to Section 505 (b) was not effective with respect to such drug. NEW DRUG SHIPPED WITHOUT EFFECTIVE APPLICATION 5381. Pega Palo vine. (F. D. O. No. 40311. S. No. 65-347 M.) QUANTITY : 68 pliofilm pkgs. at Elyria, Ohio. SHIPPED: 3-30-57, from A-l Import Co., Chicago, 111., by Joe C. George, Jr. LABEL IN PART: "Pega Palo Vine Packed by A-l Import Company Chicago, Illinois Contents: 7 grams." RESULTS OF INVESTIGATION : Examination of the article disclosed that it was. ( Pega Palo vine (Rhynohosia pyramidalis). \ - LIBELED : 6-4-57, N. Dist. Ohio. CHARGE: 502 (f) (1)-the labeling of the article, when shipped and while held for sale, failed to bear adequate directions for use as an aphrodisiac, which was the purpose for which the article was intended; and 505 (a)-the article was a new drug which may not be introduced into interstate commerce since an application filed pursuant to law was not effective with respect to the drug. DISPOSITION: 7-23-57. Default-destruction.