eptember 1951 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] 3421-3440 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 Fed- eral Security Agency, and include, where indicated, the results of investigations of the Agency, prior to the institution of the proceedings. Published by direc- tion of the Federal Security Administrator. CHARLES W. CRAWFORD, Commissioner of Food and Drugs. WASHINGTON, D. CL, September 26, 1951. CONTENTS* Page Drugs actionable because of failure to bear adequate directions or warning statements 410 Drugs for human use 410 Drugs for veterinary use 415 Drugs actionable because of con- tamination with filth 416 Drugs and devices actionable be- cause of deviation from official or own standards 417 Page Drugs and devices actionable be- cause of false and misleading claims 418 Drugs for human use 418 Drug for veterinary use 429 Drug actionable because of failure to comply with packaging re- quirements of an official com- pendium 430 Index 430 *For presence of a habit-forming narcotic without warning statement, see No. 3423; omission of, or unsatisfactory, ingredients statements, Nos. 3422, 3424-3427, 3429; failure to bear a label containing an accurate statement of the quantity of the contents, Nos. 3422-3427, 3429, 3440; failure to bear a label containing the name and place of business of the manufacturer, packer, or distributor, Nos. 3422, 3423, 3425-3427, 3429, 3440. 964161-51- 409 DRUGS ACTIONABLE BECAUSE OP FAILURE TO BEAR ADEQUATE ( DIRECTIONS OR WARNING STATEMENTS - DRUGS FOR HUMAN USE 3421. Misbranding of Estinyl tablets, Hormotone "T" tablets, Oreton-M tablets, Neo-Hombreol tablets, and Metandren Linguets. U. S. v. Ace Mail Order Co. and Mendel Bernstein. Pleas of nolo contendere. Each defendant fined $750. (F. D. C. No. 29421. Sample Nos. 4737-K, 19885-K, 19888-K, 19893-K to 19895-K, incl.) INFORMATION FILED: June 27, 1950, District of New Jersey, against the Ace Mail Order Co., a partnership, East Orange, N. J., and Mendel Bernstein, a partner in the firm. ALLEGED SHIPMENT: On or about June 2 and 24 and July 11, 1949, from the State of New Jersey into the States of Massachusetts and Tennessee. LABEL, IN PART: "Schering Tablets Estinyl * * * Brand of Ethinyl Estradiol * * * Each tablet contains 0.05 mg. Crystalline Pure Ethinyl Estradiol Schering Corporation Bloomfield, New Jersey," "Schering Estinyl tablets .05 m. g.," "Hormotone 'T' Estrogenic Hormones * * * Each tablet contains estrogens (estradiol, estrone) equivalent to 1,000 International Units and ?o g*. thyroid * * * G. W. Carnrick Co. Newark, N. J.," "Schering Oreton-M * * * Brand of Methyl Testosterone Crystalline pure testicular hormone preparation * * * Schering Corporation Bloomfield, New Jer- sey * * * Each tablet contains 10 mg. Methyl Testosterone," "Tablets 10 mg. each Neo-Hombreol (M) 'Roche-Organon' * * * (Androgenic Prep- aration-Brand of Methyl Testosterone) * * * Roche-Organon, Inc. Nutley, New Jersey Organon, Inc. Formerly known as Roche-Organon, Inc. Orange, New Jersey," and "Metandren Linguets Brand of Methyltestosterone U. S. P. * * * 10 mg. * * * Ciba Pharmaceutical Products, Inc. Summit, New Jersey." NATURE OF CHARGE: Misbranding, Section 502 (f) (1), the labeling of the articles -failed to bear adequate directions for use since the labeling bore no directions for use. Further misbranding, Section 502 (f) (2), the labeling of the articles failed to bear such adequate warnings against use in those pathological conditions where their use may be dangerous to health, and against unsafe dosage and duration of administration in such manner and form as are necessary for the protection of users. The labeling of the Estinyl tablets failed to warn that their use by the male may result in sterility and loss of sexual power and may have a feminizing effect upon the male; that their use by the female may result in sterility, injury to the female generative system, and bleeding from the uterus; and that their use by f emales with carcinoma of the breast, cervix, and uterus may result in acceleration of malignant growth. The labeling of the Hormotone "T" tablets bore no warnings against unsafe dosage and dura- tion of administration. The labeling of the Oreton-M tablets, Neo-Hombreol tablets, and Metandren Linguets failed to warn that the use of such tablets and linguets may result in sterility and that their use by individuals with carcinoma of the prostate may result in acceleration of the malignant growth.' DISPOSITION: March 30, 1951. Pleas of nolo contendere having been entered, the court imposed a fine of $750 against each defendant.