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] 3301-3320 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, and include, where indicated, the results of investigations of the Agency, prior to the institution of the proceedings. Published by direction of the Federal Security Administrator. PAUL B. DUNBAR, Commissioner of Food and Drugs. WASHINGTON, D. 0., April 4, 1951. Page Drugs and devices actionable be- cause of failure to bear ade- quate directions or warning statements 276 Drugs and devices actionable be- cause of deviation from official or own standards 291 CONTENTS* Page Drugs and devices actionable be- cause of false and misleading claims 292 Drugs for human use 292 Drugs for veterinary use 296 Index 297 *For presence of a habit-forming narcotic without warning statement, see Nos. 3301-3308: omission of, or unsatisfactory, ingredients statements, Nos. 3302, 3303, 3305; failure to bear a label containing an accurate statement of the quantity of the contents, Nos. 3301-3308,3313; failure to bear a label containing the name and place of business of the manufacturer, packer, or distributor, Nos. 3302-3305,3307,3308,3313,3316; cosmetics actionable under the drug provisions of the Act, No. 3316 (DermaCulture Formula No. 103, cleansing lotion herbal astringent, granular cleanser, DermaCulture Formula No. 102, and DermaCulture Formula No. 104) 933396??51 1 27 DRUGS AND DEVICES ACTIONABLE BECAUSE OF FAILURE TO BEAR ADEQUATE DIRECTIONS OR WARNING STATEMENTS 3301. Misbranding of Seconal Sodium capsules. U. S. v. Jones Drug Co. and Walter W. Hafley. Pleas of guilty. Fine of $20 against each defendant. (F. D. C. No. 29478. Sample Nos. 31933-K, 31935-K, 58077-K, 58152-K.) INFORMATION FILED : November 1, 1950, District of Arizona, against the Jones Drug Co., a partnership, Tucson, Ariz., and Walter W. Hafley, a partner in the partnership. INTERSTATE SHIPMENT : Between the approximate dates of April 14 and June 15, 19^9, from the State of Indiana into the State of Arizona. ALLEGED VIOLATION : On or about July 20 and August 12, 23, and 25,1949, while the drug was held for sale after shipment in interstate commerce, the defendant caused a number of the Seconal Sodium capsules to be repacked and sold with- out a prescription, which acts resulted in the capsules being misbranded. NATURE OF CHARGE: Misbranding, Section 502 (b) (2), the repackaged capsules failed to bear a label containing a statement of the quantity of the contents. Further misbranding, Section 502 (d), the capsules contained a chemical derivative of barbituric acid, which derivative, the Federal Security Admin- istrator, after investigation, has found to be, and by regulations designated as, habit forming; and the label of the repackaged capsules failed to bear the name, and quantity or proportion of such derivative and in juxtaposition there- with the statement "Warning??May be habit forming. Further misbranding, Section 502 (f) (1), the directions for use "One cap- sule at bedtime," borne on the labeling of the repackaged capsules, were not adequate directions for use. DISPOSITION : November 15, 1950. Pleas of guilty having been entered, the court imposed a fine of $20 against each defendant.