4660. Vitozone ozone generator device. (F. D. C. No. 372S1. S. Nos. 85-616/T L.) QUANTITY : 1 device at Sheridan, Wyo. SHIPPED : During May or June 1954, from Billings, Mont., by Luther J. Martin. ACCOMPANYING LABELING: Booklets designated "Ozone God's Gift To Hu- manity No. 3 * * * by J. H. Effenberg" and "Better Health and Better Living," and leaflets designated "Vitozone The Only Ozone Generator with so many EXCLUSIVE practical features" and "Ozone Instructions." LIBELED: 10-8-54, Dist. Wyo. CHARGE: 502 (a)—the accompanying labeling of the device when shipped con- tained false and misleading representations that the device was effective in the treatment of arthritis, nephrolithiasis, cholelithiasis, acute and chronic inflam- matory conditions, asthma, diseased body cavities, including the pleural cavity, peritoneal cavity, bladder, urethra, intestines, impure blood, chlorosis, anemia, nervous prostration, tuberculosis of the skin, diphtheria, scarlet fever, infectious disease, tuberculosis, carbon monoxide poisoning, pneumonia, gas. poisoning, whooping cough, amebic dysentery, Bright's disease, dropsy, and insomnia. DISPOSITION : 12-14-54. Default—destruction. INDEX TO NOTICES OF JUDGMENT D. D. N. J. NOS. 4641 TO 4660 PRODUCTS N. J. No. Adhesive bandages and adhesive strips 4652 Alpha tablets 4656 Androgenic substance 4655 N. J. No. Anterior pituitary aqueous ex- tract 4645 whole ovarian solution 4644 The cases reported herewith were instituted in the United States district courts toy United States attorneys, acting upon reports submitted by the Department of Health, Education, and Welfare. They involve drugs and devices which were adulterated or misbranded within the meaning of the Act when introduced or ¦delivered for introduction into, or while in, interstate commerce, or while held for sale after shipment in interstate commerce. These cases involve (1) seizure proceedings in which decrees of condemnation were entered after default, consent, •or summary judgment; (2) criminal proceedings which were terminated upon pleas of nolo contendere or guilty and, in one case, upon a verdict of guilty; and (3) injunction proceedings in which decrees of injunction were entered upon default or consent of the defendants or after trial. The seizure proceedings are civil actions taken against the goods alleged to be in violation, and the criminal And injunction proceedings are against the firms or individuals charged to be responsible for violations. Published by direction of the Secretary of Health, Education, and Welfare. GEO. P. LABBICK, Commissioner of Food and Drugs. WASHINGTON, D. 0., June 7, 1956. CONTENTS* Page Drugs and devices actionable be- cause of failure to bear ade- quate .directions or warning statements 116 Drugstore human use 116 Drugs for veterinary use 129 Drug actionable because of con- tamination with filth 133 Page Drugs actionable because of devia- tion from official or own stand- ards 134 Drugs and devices actionable be- cause of false and misleading claims 135 Drugs for human use 135 Drugs for veterinary use 141 ?For omission of, or unsatisfactory, ingredients statements, see Nos. 4661, 4662, 4664; sale under name of another drug, No. 4673; failure to bear a label containing an accurate statement of the quantity of the con- ¦tents, No. 4662; failure to bear a label containing the name and place of business of the manufacturer, packer, or distributor, No. 4662. 384842—58 1 115 Adulteration, Section 501 (a) (2), the article had been held under insanitary conditions; Section 501 (b), the article purported to be and was represented as a drug, the name of which is recognized in an official compendium (United States Pharmacopeia), and its quality and purity fell below the standard set forth in such compendium; Section 501 (c), the article was not subject to the- provisions of Section 501 (b), and its strength differed from, and its quality fell below, that which it purported or was represented to possess; and, Section 501 (d), the article was a drug, and a substance had been (1) mixed with the article so as to reduce its quality or (2) substituted wholly or in part therefor. Misbranding, Section 502 (a), the labeling of the article was false and mis- leading; Section 502 (b), the article was in package form, and it failed to bear a label containing (1) the name and place of business of the manufacturer,, packer, or distributor, and (2) 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 including the quantity, kind, and proportion of any alcohol contained therein; 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 duration of administration or application, in such manner and form, as are necessary for the protection of users; and, Section 502 (i) (3), the article was offered for sale under the name of another drug. DRUGS AND DEVICES ACTIONABLE BECAUSE OF FAILURE TO BEAR ADEQUATE DIRECTIONS OR WARNING STATEMENTS DRUGS FOR HUMAN USE