4580. Triethylene glycol and vaporizer device. (F. D. C. No. 36835. S. Nos. 78-696/7 L.) QUANTITY : An unknown number of 4-oz. btls. of triethylene glycol and an un- known number of cartons containing 1 Insect-O-Lite vaporiser, 1 1-oz. bag of Insectane, and 1 4-oz. btl. of triethylene glycol, at Cincinnati, Ohio. SHIPPED : Triethylene glycol was shipped in bulk from South Charleston, W. Va., on 3-6-54, 4-22-54, and 4-24-54. seet-O-Lite Vaporizer for disinfection of the air, destruction of air-borne bac- teria and virus germs * * * Insect-O-Lite Co., Inc. Cincinnati 6, Ohio"; (carton) "One Insect-O-Lite Vaporizer with Insectane * * * Tricol." ACCOMPANYING LABELING : Placards designated "Insect-O-Lite—Vapor Lamp"; window streamers designated "Destroy Insects with Insect-O-Lite"; circulars designated "Kills Crawling and Flying Insects," "Let 'em Have Both Barrels," "Insect-O-Lite Vapor Lamp," and "Insect-O-Lite Vaporizer with Tricol"; and shipping case labels designated "One Insect-O-Lite Vaporizer with Insectane * * * Tricol." RESULTS OF INVESTIGATION : The triethylene glycol in bulk was received by Ber- nard's Laboratories at Cincinnati, Ohio, from South Charleston, W. Va., and was repackaged by that firm on the order of Insect-O-Lite Co., Inc., Cincin- nati, Ohio, into bottles labeled as described above. A number of the bottles were then delivered by the Insect-O-Lite Co., Inc., to the Norvelle Co., which placed each bottle into a carton labeled as described above, together with 1 Insect-O-Lite vaporizer, 1 1-oz. bag of Insectane, and a copy of a circular designated "Insect-O-Lite Vaporizer with Tricol." The Norvelle Co. then delivered a number of assembled Insect-O-Lite cartons to the Insect-O-Lite Co., Inc., for distribution by that firm. LIBELED : 6-14^54, S. Dist. Ohio. CHARGE: 502(a)—the labeling of the triethylene glycol and the Insect-O-Lite vaporizer while held for sale contained false and misleading representations that the articles were effective for preventing colds, streptococci infection, in- fluenza, pneumonia, measles, mumps, scarlet fever, rheumatic fever, catarrhal fever, tonsillitis, otitis media, chickenpox, sinusitis, infections due to Bacillus coli and Bacillus suotilis, throat infections, and respiratory infections. DISPOSITION : 6-22-54. Consent—claimed by Insect-O-Lite Co., Inc., and re- labeled. INDEX TO NOTICES OF JUDGMENT D. D. N. J. NOS. 4561 TO 4580 N. Alfalfa meal, alfalfa seed, and powdered mixture of alfalfa meal and seed 4577 Alfalfacon tables 4575 Amphetamine, dextro, sulfate tablets 4565,4569 Arthban tablets 4573 Arthritis, remedies for. See Rheumatism, remedies for. Ascorbate, sodium, injection 4561 Bursitis, remedies for. See Rheumatism, remedies for. Cassia reticulata, Willd. See Leaves, dried whole. Devices 4580 Dextro-amphetamine sulfate tab- lets 4565, 4569 PRODUCTS J. No. N. J. No. The cases reported herewith were instituted in the United States district courts by United States attorneys, acting upon reports submitted by the Depart- ment of Health, Education, and Welfare. They involve drugs and devices which were adulterated or misbranded within the meaning of the Act when introduced into and while in interstate commerce. These cases involve (1) seizure pro- ceedings which were terminated with the entry of default or consent decrees of condemnation; (2) criminal proceedings which were terminated upon pleas and verdicts of guilty and upon motion for acquittal; (3) injunction proceedings terminated with the entry of injunctions; and (4) contempt proceedings for violation of an injunction which were terminated upon a plea 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. Similar actions with respect to products alleged to be in violation while held for sale after shipment in interstate commerce are reported in other supplements. Published by direction of the Secretary of Health, Education, and "Welfare. GEO. P. LABBICK, Commissioner of Food and Drugs. WASHINGTON, D. C, March 9, 1956. CONTENTS* Page Drugs actionable because of poten- tial danger when used accord- ing to directions 44 Drugs requiring certificate or re- lease, for which none had been issued 46 Drugs and devices actionable be- cause of failure to bear ade- quate directions or warning statements 46 Drug actionable because of con- tamination with filth 60 Page Drugs actionable because of devia- tion from official or own stand- ards 61 Drugs and devices actionable be- cause of false and misleading claims 63 Drugs for human use 63 Drugs for veterinary use 67 Index 6*8 •For omission of, or unsatisfactory, Ingredients statements, see No. 4583; failure to bear a label containing an accurate statement of the quantity of the contents, No. 4583. 8739184—56 1 43 Adulteration, Section 501 (a) (1), the article consisted in part of a filthy substance; and, Section 501 (c), the article was not subject to the provisions of Section 501 (b), and its strength differed from, or its 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 (b) (2), the article was in package form, and it failed to bear a label containing an accurate statement of the quantity of contents; Section 502 (e) (2), the article was not designated solely by a name recognized in an official compendium and was fabricated from two or more ingredients, and its label failed to bear the common or usual name of each active ingredient; Section 502 (f) (1), the labeling of the article failed to bear adequate directions for use; Section 502 (f) (2), the labeling of the article failed to bear adequate warnings against use in those pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods or dura- tion of administration or application, in such manner and form, as are necessary for the protection of users; Section 502 (j), the article was dangerous to health when used in the dosage, or with the frequency or duration, prescribed, recommended, or suggested in its labeling; and, Section 502 (1), the article purported to be and was represented as a drug composed partly of a kind of penicillin or aureomycin, and it was not from a batch with respect to which a certificate or release had been issued pursuant to Section 507. DRUGS ACTIONABLE BECAUSE OF POTENTIAL DANGER WHEN USED ACCORDING TO DIRECTIONS