FOOD AND DRUG ADMINISTRATION 1950 NOTICES OF JUDGMENT UNDER THE FEDERAL FOOD, DRUG, AND COSMETIC ACT [Given pursuant to section 705 of the Food, Drug, and Cosmetic Act] 2731-2750 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 Federal Security Agency. Published by direction of the Federal Security Administrator. PAUL B. DUNBAR, Commissioner of Food and Drugs. WASHINGTON, D. C, January 3,1950. Page Drugs and devices actionable be- cause of failure to bear ade- quate directions or warning statements 367 CONTENTS* Page Drugs actionable because of devia- ' tion from official or*own stand- ards. 371 Drugs and devices actionable be- cause of false and misleading claims. 373 Drugs for human use.__ __ 373 Drugs for veterinary use 376 Drugs actionable because of omis- sion of, or unsatisfactory, in- gredients statements 377 DRUGS AND DEVICES ACTIONABLE BECAUSE OF FAIL- URE TO BEAR ADEQUATE DIRECTIONS OR WARNING STATEMENTS 2731. Misbranding of Nanette Hormone Cream. U. S. v. Nix Cosmetics Co., Inc. Plea of nolo contendere. Fine, $800. (F. D. C. No. 23603. Sample Nos. 50260-H, 61334-H to 61336-H, incl.) INFORMATION FILED : May 20, 1949, Western District of Tennessee, against the Nix Cosmetics Co., Inc., Memphis, Tenn. ALLEGED SHIPMENT: Between the approximate dates of April 30, 1946, and March 21,1947, from the State of Tennessee into the States of Alabama and Pennsylvania. LABEL, IN PAST: "Nanette Hormone Cream * * * Distributed By-Nan- ette Company Memphis 1, Tenn." ?For failure to bear a label containing an accurate statement of the quantity of the contents, No. 2732; failure to bear a label containing the name and place of business of the manufacturer, packer, or distribu* tor, No. 2733; cosmetic, subject to the drug provisions of the Act, No. 2731. 854459-49 367 and the label statement "Each 2 Oz. Contains 5 Mgs. Stilbestrol (Synthetic Estrogenic Substance)" were false and misleading since the name and the statement represented and suggested that the article contained a hormone and that it would exert a beneficial hormone-like, or beneficial estrogenic, effect upon the body when used as directed. The article did not contain a hormone and would produce no beneficial hormone-like, or beneficial estrogenic, effect upon the body when used as directed. Further misbranding, Section 502 (f) (1), the directions for use in the label- ing "Apply gently V2 heaping teaspoonful at bedtime. Leave on overnight" were inadequate since they failed to indicate the conditions in which the article was to be used, the body area to which the article was to be applied, and the duration of its use. DISPOSITION: May 20, 1949. A plea of nolo contendere having been entered, the court imposed a fine of $800.