6580. Clear-Air Electronic Air Purifier device. (F.D.C. No. 45081. S. No. 36- 165 R.) QUANTITY : 9 cartoned devices at Bloomfield, N. J., in possession of "Variety Elec- tronics Corp. SHIPPED: 5-18-60, from New York, N.T., by Radio Merchandise Sales, Inc. LABEL IN PART: (Ctn.) "Clear-Air Electronic Air-Purifier Deluxe Model CA-64 RMS Bronx 62, N.Y." ACCOMPANYING LABELING : Instruction sheets entitled "Portable Clear Air Elec- tronic Air-Purifier Model CA-64"; display cards reading in part "Clear Air portable electronic air-purifier"; and circulars reading in part "Portable Electronic Air Purifiers." RESULTS OF INVESTIGATION : The article was a portable table model type cab- inet containing dual fan blades, four ultra-violet lamps, and three nylon fil- ters. In operation the room air was reportedly circulated through the device so as to be exposed to the ultra-violet lamps and then filtered out into the room. The instruction sheets and display cards described above were received from the shipper, and the circulars were printed at the request of the dealer. LIBELED : 11-7-60, Dist. N.J. CHARGE: 502(a)-when shipped and while held for sale, the labeling of the article contained false and misleading representations that the article was an adequate and effective treatment for aiding sufferers of hay fever, sinus, allergies, and asthma, and for clearing and purifying the air for better health. DISPOSITION : 1-9-61. Default-delivered to the Food and Drug Administra- tion. INDEX TO NOTICES OF JUDGMENT D.D.NJ. NOS. 6541 TO 6580 PRODUCTS N.J. No. A-C tablets 6576 Air purifiers 6577, 6579, 6580 Alfacon tablets 6576 Allergies, remedies for_ 6577,6579, 6580 Alma-Cado Oil 6549 Amphetidisin capsules 16546 N.J. No. Analjel 6559 Anemia, pernicious, remedy for_ 6571 Arthritis, remedies for. See Rheumatism, remedies for. Asthma, devices for 6577, 6579, 6580 remedy for , 6572 1 (6546, 6552) Injunction issued. 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, 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 or consent, and (2) an injunction proceeding terminated upon the entry of a permanent in- junction after a trial by the court. The seizure proceedings are civil actions taken against the goods alleged to be in violation, and the injunction proceedings are against the firms and individuals charged to be responsible for violations. Published by direction of the Secretary of Health, Education, and Welfare. GEO. P. LARBICK, Commissioner of Food and Drugs. WASHINGTON, D.O., July 25,1962. CONTENTS* Page New drugs shipped without effec- tive application 68 Drugs in violation of. prescription labeling requirements 74 Drugs and devices actionable be- cause of failure to bear ade- quate directions or warning statements 76 Drugs for human use 76 Drug for veterinary use 81 Drug actionable because of con- tamination with filth 82 Page Drugs and devices actionable be- cause or deviation from official or own standards 82 Drugs for human use 82 Drugs for veterinary use 84 Drugs and devices actionable be- cause of false and misleading claims 85 Drugs for human use , 85 Drug for veterinary use . 94 Index 95 ?For omission of, or unsatisfactory, ingredients statements, see Nos. 6584, 6586, 6589; an imitation of an- other drug, No. 6586; failure to bear a label containing an accurate statement of the quantity of the contents, Nos. 6584, 6586; failure to bear a label containing the name and place of business of the manufacturer, packer, or distributor, Nos. 6584, 6586, 6592. SECTIONS OF FEDERAL FOOD, DRUG, AND COSMETIC ACT INVOLVED IN VIOLATIONS REPORTED IN D.D.NJ. NOS. 6581-6620 Adulteration, Section 501(a) (1), the article consisted in part of a filthy sub- stance; 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 fell below the standard set forth in such com- pendium; 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), 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 the contents in terms of weight, measure or numerical count; Section 502(e), the article was a drug not designated solely by a name recognized in an official compendium, and its label failed to bear (1) the common or usual name of the drug, and (2), in the case where the article was fabricated from two or more ingredients, the common or usual name of each active ingredient; Section 502(f), the labeling of the article failed to bear (1) adequate directions for use, and (2) 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; Section 502(i) (2), the article was an imitation of another drug; and Section 503(b) (4), the article was a drug subject to Section 503(b) (1), and its label failed to bear the statement "Caution: Federal law prohibits dispensing without prescription." New-drug violation, Section 505(a), the article was a new drug within the meaning of Section 201 (p), which was introduced into interstate commerce, and an application filed pursuant to Section 505(b) was not effective with respect to such drug. NEW DRUGS SHIPPED WITHOUT EFFECTIVE APPLICATION