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] 3384-3400 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 direc- tion of the Federal Security Administrator. CHABT.ES W. CBAWFOBD, Commissioner of Food and Drugs. WASHINGTON, I>. C., August 20, 1951. CONTENTS* New drug shipped without effective application 380 Drug requiring certificate or release, for which none had been issued 380 Drugs and devices actionable be- cause of failure to bear ade- quate directions or warning statements 381 Drugs for human use 381 Page Drugs and devices actionable be- cause of failure to bear adequate directions or warning state- ments-Continued Drugs for veterinary use 383 Drugs and devices actionable be- cause of deviation from official , or own standards .__ 384 Drugs and devices actionable be- cause of false and misleading claims 385 ?For presence of a habit-forming narcotic without warning statement, see Nos. 3386, 3387; failure to bear a label containing an accurate statement of the quantity of the contents, Nos. 3386, 3387. 958377-51 379 NEW DRUG SHIPPED WITHOUT EFFECTIVE APPLICATION?( 3384. TB-1 tablets. U. S. v. 338 Bottles, etc. (F. D. C. No. 31055. Sample No. 17965-L.) LIBEL FILED : April 11,1951, Southern District of California. ALLEGED SHIPMENT: On or about April 5, 1951, by Stanley Lindo and Co., for* account of the Strand Pharmacal Corp., Los Angeles, Calif., consigned to Bangkok, Thailand. PRODUCT: 338 bottles, each containing 100 tablets, ^ind 54 bottles, each con- taining 1,000 tablets, of TB-1 at Long Beach, Calif. LABEL, IN PABT : "T-B RX Strand Brand of TB-1 Each tablet provides Para- Acetylamino Benzaldehyde Thiosemicarbazone 25 mg." 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. DISPOSITION : May 2, 1951. Default decree of condemnation and destruction. DRUG REQUIRING CERTIFICATE OR RELEASE, FOR WHICH NONE HAD BEEN ISSUED