Yours If you'd like a National Archives Subscription Rate: $15 a year, $1.50 a month Place subscription with: Supt. of Documents, Government Printing Office Washington 25, D. C. for the asking SAMPLE COPY The Federal Register publishes the full text of Presidential Proclamations and Executive Orders, and the rules and regulations of the various Departments of the Federal Government. U.S. Department of Health, Education, and Welfare 781-6830 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 CosticatLnTY OF MICHIGAN 6781-6820 DRUGS AND DEVICES JAN 4 1903 LIBRARY ་ The cases reported herewith were instituted in the United States district courts by 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 into and while in interstate commerce or while held for sale after shipment in interstate commerce. These cases involve seizure proceedings in which decrees of condemnation were entered after default or consent. The seizure proceedings are civil actions taken against the goods alleged to be in violation. Published by direction of the Secretary of Health, Education, and Welfare. For failure to bear a label containing an accurate statement of the quantity of the contents. See Nos. 6786, 6794, 6820; failure to bear a label containing the name and place of business of the manufacturer, packer, or distributor, Nos. 6783, 6784, 6786, 6801 6815, 6820; cosmetics, actionable under the drug provisions of the Act, Nos. 6815-6817. 662216-62 189 sections of federal foOD, DRUG, AND COSMETIC ACT INVOLVED IN VIOLATIONS REPORTED in d.D.N.J. NOS. 6781-6820 Adulteration, 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 misleading; 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), ir the case where the article was fabricated from two or more ingredients, the com mon 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 warings 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 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 6781. Entoquel syrup and Entoquel with Neomycin syrup (2 seizure actions). (F.D.C. Nos. 46217, 46220. S. Nos. 88-031/2 R, 91-339/40 R.) QUANTITY: 20 6-oz. btls. of Entoquel syrup and 21 6-oz. btls. of Entoquel with Neomycin syrup at Baltimore, Md.; 44 6-oz. btls. of Entoquel syrup and 6-oz. btls. of Entoquel with Neomycin syrup at Jamaica, Queens, N.Y. SHIPPED: Between 2-6-61 and 2-10-61, from Kenilworth, N.J., by White Laboratories, Inc. LABEL IN PART: Each "Entoquel Syrup (Thihexinol Methyl Bromide) Teaspoon (5 cc) contains *** Thihexinol Methyl Bromide - 5 mg. Alcohol 1%" and "Entoquel With Neomycin Syrup *** Each Teaspoon (5 cc) contains *** Thihexinol (Entoquel) 5 mg. Neomycin (from the sulfate) 50 mg. Alcohol - 0.5%." ACCOMPANYING LABELING: A promotional form letter mailed on or about 4-1061, addressed to "Dear Doctor"; a promotional folder mailed on or about 4-27-61, entitled "Are opiates now outmoded in pediatric diarrhea?"; and a premotional folder mailed in June or July 1961, entitled "Are opiates now outmoded in pediatric diarrhea?" with a picture of an infant and a bottle of paregoric on the cover. CHARGE: 502(a)—when shipped and while held for sale, the labeling of the articles was false and misleading: |