› U.S. Department of Health, Education, and Welfare CITY FOOD AND DRUG ADMINISTRATION MICHIGAN MAY 14 1963 NOTICES OF JUDGMENT UNDER THE FEDERAL FOORARY 31-7060 [Given pursuant to section 705 of the Food, Drug, and Cosmetic Act] 7001-7060 DRUGS AND DEVICES 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 (1) seizure proceedings in which decrees of condemnation were entered after default, consent, or summary judgment, and including, in one case, the entry of a decree of injunction; (2) criminal proceedings which were terminated upon pleas of nolo contendere or guilty; and (3) an injunction proceeding terminated upon the entry of a permanent injunction by consent. 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. LARRICK, Commissioner of Food and Drugs. For omission of, or unsatisfactory, ingredients statements, see Nos. 7007, 7009, 7011, 7023, 7030, 7047; an itation of, and sale under name of, another drug, see No. 7042; failure to bear a label containing an accurate tement of the quantity of the contents, Nos. 7007, 7030; failure to bear a label containing the name and ace of business of the manufacturer, packer, or distributor, Nos. 7007-7009, 7011, 7029, 7030; labeling inforation not likely to be read and understood by the ordinary individual under customary conditions of rchase and use, No. 7023; cosmetics, actionable under the drug provisions of the Act, Nos. 7054, 7055. 678106-63 -1 1 SECTIONS OF FEDERAL FOOD, DRUG, AND COSMETIC ACT INVOLVED IN VIOLATIONS REPORTED IN D.D.N.J. NOS. 7001-7060 Adulteration, 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 or National Formulary), and its quality or purity fell below the standard set forth in such compendium; Section 501(c), the article was D subject to the provisions of Section 501(b), and its strength differed from or its quality fell below that which it purported or was represented to possess; ar Section 501 (d) (2), the article was a drug, and a substance had been substitute. wholly or in part therefor. Misbranding, Section 502 (a), the labeling of the article was false and mislead ing; Section 502(b), the article was in package form, and it failed to bear a labe. containing (1) the name and place of business of the manufacturer, packer, e distributor, and (2) an accurate statement of the quantity of the contents terms of weight, measure, or numerical count; Section 502 (c), a word, statement. or other information required by, or under authority of, the Act to appear on the label or labeling of the article was not prominently placed thereon with sul conspicuousness (as compared with other words, statements, designs, or devices in the labeling) and in such terms as to render it likely to be read and understoo by the ordinary individual under customary conditions of purchase and use Section 502 (e), the article was a drug not designated solely by a name recognize. in an official compendium, and its label failed to bear (1) the common or usi.. name of the drug, and (2), in the case where the article was fabricated fre two or more ingredients, the common or usual name of each active ingredieĽ 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 condities or by children where its use may be dangerous to health, or against una dosage or methods or duration of administration or application, in such manne and form, as are necessary for the protection of users; Section 502 (i) (2), “ article was an imitation of another drug; Section 502(i)(3), the article offered for sale under the name of another drug; Section 502(1), the arti was composed wholly or in part of a kind of penicillin, and was not from a bath with respect to which a certificate or release had been issued pursuant to Se tion 507; and Section 503(b) (4), the article was a drug subject to Section 3. (b) (1), and its label failed to bear the statement "Caution: Federal law pr hibits 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 commer and an application filed pursuant to Section 505(b) was not effective with spect to such drug. NEW DRUGS SHIPPED WITHOUT EFFECTIVE APPLICATION 7001. Pre-Creatine capsules, Neo-Creatine capsules, Neo-Creatine granules, and Vi-Arthra-M capsules. (Inj. No. 419.) COMPLAINT FOR INJUNCTION FILED: 10-13-61, N. Dist. Calif., against Andres Doty, San Francisco, Calif. CHARGE: The complaint alleged that the defendant was engaged in the busine of promoting the interstate sale and distribution of the following drugs: Pre Creatine capsules, Neo-Creatine capsules, Neo-Creatine granules, and Th thra-M capsules; that the Pre-Creatine capsules, Neo-Creatine capsules, 2 Neo-Creatine granules were offered for increasing available energy to mus POSITED BY THE 001-7060] NOTICES OF JUDGMENT 3 and nerves damaged by heart and neuromuscular diseases; that the Vi-ArthraM capsules were offered for energy restoration in detoxification and for the relief of pain associated with rheumatism and arthritis; that the Pre-Creatine capsules contained betaine anhydrous and glycocyamine; that the Neo-Creatine capsules and the Neo-Creatine granules contained betaine anhydrous and glycine; and that the Vi-Arthra-M capsules contained betaine, glycocyamine, glucuronolactone, para-aminobenzoic acid, sodium gentisate, and vitamin C. It was alleged further that all of these drugs were new drugs within the meaning of the law and that they may not be introduced into interstate commerce in the absence of an effective new drug application. The complaint alleged also, with respect to the Pre-Creatine capsules, that the defendant submitted a new drug application in the name of Mercury Pharmaceuticals, Inc.; that, in November 1958, this new drug application became effective; and that, on November 27, 1959, this new drug application was suspended on the ground that it contained a number of untrue statements of material facts. The complaint alleged further that, with respect to the other drugs, no new drug application was filed or ever became effective; that subsequent to November 27, 1959, the defendant continued to introduce all of these new drugs into interstate commerce without having an effective new drug application with respect to any of them; and that the defendant violated the law by causing the introduction and delivery for introduction into interstate commerce of such new drugs since there was no effective new drug application with respect to any of them. DISPOSITION: On 10-16-61, a consent decree of permanent injunction was entered, enjoining the defendant from causing to be introduced or delivered for introduction into interstate commerce Pre-Creatine capsules, Neo-Creatine capsules, Neo-Creatine granules, Vi-Arthra-M capsules or any similar drug, or any other drug containing betaine anhydrous, glycocyamine, glycine, betaine, glucuronolactone, para-aminobenzoic acid, or sodium gentisate, without having an effective new drug application for such drug. 02. Pre-Creatine capsules. (F.D.C. No. 45212. S. No. 23-401 R.) NFORMATION FILED: 6-12-61, N. Dist. Calif., against Andrew Doty, t/a Creatine Laboratories, Inc., San Francisco, Calif. HIPPED: 1-19-60, from San Francisco, Calif., to Kansas City, Mo. ABEL IN PART: (Btl.) "100 Capsules, PRE-CREATINE, Contains Precursors of Creatine Caution Federal Law Prohibits Dispensing without Prescription Manufactured for Creatine Laboratories, Inc., San Francisco." HARGE: 505(a)—when shipped, the article was a new drug which may not be introduced into interstate commerce since an application filed pursuant to law was not effective with respect to such drug. EA: Guilty. SPOSITION: 11-6-61. $300 fine and probation for 2 years. )3. Li-Bex with iron and succinylcholine chloride injection. (F.D.C. No. 47155. S. Nos. 23-357/8 T.) ANTITY: 357 vials, each in a plastic case, of Li-Bex with iron and 755 vials, ach in a plastic case, of succinylcholine chloride injection, at Denver, Colo., in possession of Lyle A. Wittney & Co., Inc. IPPED: Between 9-19-61 and 12-14-61, from Decatur and Chicago, Ill. LABEL IN PART: (Vial and case) "30 cc. *** Li-Bex With Iron " Each 2 cc ! Represents Vit. B-12 Activity (From Liver Inj. U.S.P. Beef) Equivalent to Cyanocobalamin 1.0 mcgm. *** Caution:" and "10 cc. Vial Succinylcholine Chloride Injection 20 mg. per cc. * Warning: For use only by skilled anesthetists with facilities for immediate artificial respiration. Manufactured for Wittney & Co., Inc. Denver, Colorado." ACCOMPANYING LABELING: Leaflet entitled "Succinylcholine Chloride Injection." | RESULTS OF INVESTIGATION: The leaflets were prepared by the dealer and the labels of succinylcholine chloride injection were supplied to the manufacturer by the dealer. The Li-Bex with iron was shipped by Medical Chemicals Corp. Chicago, Ill. LIBELED: 2-21-62, Dist. Colo. CHARGE: (Li-Bex with iron) 505(a)—the article was a new drug which may not be introduced into interstate commerce since an application filed pursuan: to the law was not effective with rspect to the drug; (succinylcholine chlorié. injection) and 502 (f) (1)—while held for sale, the labeling of the article failed to bear adequate directions for use and it was not exempt from such require ment since it was a drug intended for veterinary use which, because of its toxicity or other potentiality for harmful effect, or the method for its use was not safe for animal use except under the supervision of a licensed veter inarian, and its label failed to bear the statement "Caution: Federal law restricts this drug to sale by or on the order of a licensed veterinarian,” an its label also failed to bear the recommended or usual dosage for each anima species for which the article was intended. DISPOSITION: 4-9-62. Consent-claimed by Lyle A. Wittney & Co., Inc. T Li-Ber with iron was destroyed and the succinylcholine chloride injection wa› released under bond for relabeling. 7004. Tain oral suspension and Tain Inlay-Tab tablets. S. Nos. 27-395/6 T, 28-879/80 T, 29-401/2 T.) (F.D.C. No. 46 50-tablet ctnd. btls.; 9 cases, 12 8-oz. ctnd. btls. each; and 14 & Kansas City, Mo. SHIPPED. Between 12-29-61 and 1-29-62, from Lincoln, Nebr., by Dore Laboratories. LABEL IN PART: (Btl. and ctn.) "8 Fl. Oz. List No. 6050 Dorsey Tain Ors Suspension Caution *** Dorsey Laboratories a division of the WandCompany, Lincoln, Nebraska *** Each Teaspoonful (5 ml.) contains: T acetyloleandomycin 125 mg. Triaminic2 25 mg. (phenylpropanolamine hycr chloride) 12.5 mg. pheniramine maleate 6.25 mg. pyrilamine maleate mg. Acetaminophen 150 mg. *** Expiration Date May '63"; (etn. ong "Triacetyloleandomycin is effective against most gram positive organisms volved in respiratory infections. ** Has analgesic and antipyretic sets: *** is an effective oral nasal decongestant and has antihistaminic action" and (50-tablet btl. and ctn.) "50 Tablets List No. 1339 Dorsey Tain Ar biotic Decongestant Analgesic Each Tain Inlay-Tab contains: Triacetylon andomycin equivalent to 125 mg. oleandomycin Triaminic3 25 mg. pbeat propanolamine hydrochloride 12.5 mg. pheniramine maleate 625 2 pyrilamine maleate 6.25 mg. Calurin (calcium acetylsalicylate carbamid(equivalent to aspirin 300 mg.) Caution: *** Dorsey Laboratories a divis of The Wander Company Lincoln, Nebraska Expiration Date Dec. '6" ACCOMPANYING LABELING: Leaflet entitled "Dorsey Tain" Composition" and folder entitled "Time to Take 'Em Out Again." RESULTS OF INVESTIGATION: New drug applications for these articles were made effective with labeling offering them specifically for the "symptomatic relief of the common cold (malaise, headache, muscular cramps, aches and pains) and the prevention of secondary complications due to susceptible organisms" and with the caution that "if resistant infection or super infection appears discontinue the drug and institute specific therapy or supportive treatment," whereas the article was being recommended and suggested for the treatment of susceptible infections which complicate the common cold, other respiratory infections and other infections. LIBELED: On or about 2-13-62, W. Dist. Mo. CHARGE: 502 (a)—when shipped and while held for sale, the labeling accompanying the articles contained false and misleading representations that the articles were adequate and effective as a treatment for tonsillitis, pharyngitis, otitis media, bronchitis, pneumonitis, bronchopneumonia, rhinitis, cervical lymphadenitis, coryza, lobar pneumonia, tracheitis or tracheobronchitis, influenza, adenoiditis, bronchial asthma, croup and postnasal infection; that the analgesic ingredient, namely, acetaminophen, was safer in children than salicylates; that the antipyretic effect of the articles did not mask the diagnostic importance of persistent fever; and (Tain oral suspension) that it met pediatric requirements in upper respiratory infections; that when side effects occur they were not usually attributable to the article; that the article was an upper respiratory infections antibiotic proved effective in pediatric use; that it was indicated in the treatment of susceptible infections which complicate the common cold, and other respiratory infections; that children did not become drowsy from antihistamines; 502(f) (1)—the labeling failed to bear adequate directions for use and the articles were not exempt from the requirement, since the promotional material for the articles was not the same as, or substantially the same as, the labeling authorized by the new drug applications filed with respect to the articles; and 505(a)—the articles were new drugs, and the new drug applications filed with respect to the articles did not apply to the conditions for which the articles were promoted to the medical profession as set forth in statements contained in the promotional material. DISPOSITION: 4-24-62. Default-destruction. >RUGS REQUIRING CERTIFICATE OR RELEASE FOR WHICH NONE HAD BEEN ISSUED DRUG FOR HUMAN USE 005. Streptomycin-procaine penicillin. (F.D.C. No. 47744. S. No. 32-899 T.) UANTITY: 448 vials at Los Angeles, Calif. HIPPED: During 1960, from New York, N.Y. LABEL IN PART: "Control: 7G50 10 cc. Streptomycin-Procaine Penicillin Aqueous Suspension Procaine Penicillin 400,000 Units Streptomycin 0.5 Gm. Base per 2 cc." ESULTS OF INVESTIGATION: Assay showed no significant penicillin potency in the article. IBELED: 6-11-62, S. Dist. Calif. |