D.D.N.J., F.D.C. 5641-5660 Issued December 1959 THE UNIVERSITY U.S. Department of Health, Education, and Welfare 22 1959 200.9 FOOD AND DRUG ADMINISTRATION LIBRARY NOTICES OF JUDGMENT UNDER THE FEDERAL FOOD, 5641-5660 DRUG, AND COSMETIC ACT [Given pursuant to section 705 of the Food, Drug, and Cosmetic Act] 5641-5660 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, when shipped to a holder of a guaranty, 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) a criminal proceeding terminated upon a plea of nolo contendere. The seizure proceedings are civil actions taken against the goods alleged to be in violation, and the criminal proceedings are against the firm and individual charged to be responsible for violations. Published by direction of the Secretary of Health, Education, and Welfare. *For presence of a habit-forming substance without warning statements, see No. 5649; omission of, or unsatisfactory, ingredient statements, No. 5649; failure to bear a label containing an accurate statement of the quantity of the contents, No. 5649; failure to bear a label containing the name and place of business of the manufacturer, packer, or distributor, No. 5649. sections of FEDERAL FOOD, DRUG, And cosmetic ACT INVOLVED in violaTIONS REPORTED IN D.D.N.J. NOS. 5641-5660 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), and its strength differed from, and its quality and purity fell below, the standard set forth in such compendium; and Section 501(c), the article was not subject to the provisions of Section 501 (b), and its strength and quality differed from 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 contents; Section 502(d), the article contained a chemical derivative of barbituric acid, and its label failed to bear the name, and quantity or proportion of such derivative and in juxtaposition therewith the statement "Warning-May be habit forming"; 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) the drug 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), 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(1), one article was, or purported to be, or was represented as, a drug composed partly of dihydrostreptomycin, a derivative of streptomycin, and another article was represented as a drug containing bacitracin, and neither of the articles was from a batch with respect to which a certificate or release had been issued pursuant to Section 507; and Section 503 (b) (4), the article was 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 5641. Vitamin B12 injection. (F.D.C. No. 41235. S. No. 75-724 M.) QUANTITY: 52 vials at Riverside, Calif. SHIPPED: 11-13-57, from Memphis, Tenn., by Morton Pharmaceuticals. LABEL IN PART: "10 cc Vial *** Vitamin B12 Crystalline USP 1000 micrograms per cc *** Intramuscular-Intravenous." RESULTS OF INVESTIGATION: Examination showed that each cubic centimeter of the article contained 988 micrograms of cyanocobalamin (vitamin B), 9.05 milligrams of sodium chloride, and a substantial amount of unidentified dissolved material, the presence of which was not stated on the label. LIBELED: 12-20-57, S. Dist. Calif. CHARGE: 501 (b)-when shipped, the quality and purity of the article fell below the standard for cyanocobalamin injection set forth in the United States Pharmacopeia since it contained a substantial amount of unidentified DEPOSITED BY THE 5641-5660] NOTICES OF JUDGMENT 75 dissolved material in addition to those constituents permitted to be present in cyanocobalamin injection; 505(a)—the article, because of the presence of unidentified dissolved material, was a new drug within the meaning of the law, and an application filed pursuant to the law was not effective. DISPOSITION: 3-23-59. Consent-destruction. 5642. Vitamin B12 injection. (F.D.C. No. 40316. S. No. 43-464 M.) QUANTITY: 3 ctns. containing a total of 1,550 10-cc. vials at St. Louis, Mo. SHIPPED: 5-20-57, from Chicago, Ill., by Hallmark Laboratories, Inc. LABEL IN PART: (Shipping ctns.) "Vitamin B12 1000 mcg. per cc (Cyanocobalamin, U.S.P.) in water for injection. Sodium chloride 0.9% Benzyl alcohol as bacteriostatic agent, 2% average dose: 1 cc for intramuscular and intravenous use. * Hallmark Laboratories, Inc., Chicago, Illinois." RESULTS OF INVESTIGATION: Examination showed that each cubic centimeter of the article contained 978 micrograms of cyanocobalamin (vitamin B12), 8.32 milligrams of sodium chloride, and a quantity of unidentified dissolved material. LIBELED: 6-7-57, E. Dist. Mo.; amended libel 6-18-57 and 4-4-58. CHARGE: 501(b)-when shipped, the quality and purity of the article fell below the standard for cyanocobalamin injection set forth in the United States Pharmacopeia since it contained a quantity of dissolved material which is not permitted by the standard as an ingredient of cyanocobalamin injection; and 505(a)-the article, because of the presence of unidentified dissolved material, was a new drug within the meaning of the law, and an application filed pursuant to the law was not effective. DISPOSITION: Hallmark Laboratories, claimant, filed an answer denying that the article was adulterated or a new drug as charged. The Government filed written interrogatories which claimant answered in part and objected to in part. Subsequently, the Government filed a motion to compel further and more complete answers and also a motion for discovery and production of documents. The claimant took issue with the Government's motions, and after a hearing on 12-16-58, the court ordered the claimant to answer some of the interrogatories and sustained claimant's objections to the remainder. The Government's motion for discovery and production of documents was sustained. Thereafter, on 3-11-59, claimant having consented, a decree of condemnation was entered and the article was destroyed. SHIPPED: 8-9-57, from Los Angeles, Calif., by E. S. Miller Laboratories, Inc. LABEL IN PART: "No. 320 Pyrdex 10 CC. Vial Each CC. Contains Pyrilamine Maleate 25 Mg. Dextro-Amphetamine HCL 2 Mg. * * * Control #16071." LIBELED: On or about 10-28-57, S. Dist. Tex. CHARGE: 505(a)—the article was a new drug within the meaning of the law, and an application filed pursuant to the law was not effective with respect to the article. DISPOSITION: 7-31-58. Consent-destruction. 5644. Thorazine hydrochloride tablets, Butazolidin tablets, Ansolysen Tartrate tablets, Serpasil Apresoline tablets, Doriden tablets, Meticortelone tablets, and Meticorten tablets. (F.D.C. No. 39504. S. Nos. 61–941/43 M, 61-946/9 M.) QUANTITY: 41 50-tablet vials of Thorazine hydrochloride tablets; 14 100tablet vials and 5 1000-tablet vials of Butazolidin tablets; 19 100-tablet vials of Ansolysen Tartrate tablets; 12 100-tablet vials of Serpasil Apresoline tablets; 14 100-tablet btls. of Doriden tablets; 37 100-tablet vials of Meticortelone tablets; and 19 100-tablet vials of Meticorten tablets at Woodside, N.Y., in possession of Henry Schein. SHIPPED: At various times, including July or August, 1956, from Philadelphia, Pa.; Cleveland, Ohio; Summit, N.J.; and Bloomfield, N.J. RESULTS OF INVESTIGATION: The articles were all new drugs which had been repackaged by the dealer, Henry Schein, under his own labels. LIBELED: 10-8-56, E. Dist. N.Y. CHARGE: 505 (a)—the articles were new drugs which may not be lawfully introduced into interstate commerce since applications filed pursuant to law were not effective with respect to such drugs. DISPOSITION: Henry Schein appeared as claimant and filed an answer to the libel on 11-21-56. The Government served written interrogatories upon the claimant. Subsequently, answers were filed to the interrogatories after which the Government filed a motion for summary judgment. On 2-6-59, the court handed down the following decision in denial of the motion: RAYFIEL, J., District Judge: "The plaintiff moves for summary judgment under Rule 56 of the Federal Rules of Civil Procedure. "The Government commenced this action by filing a libel in rem for the seizure and condemnation of certain vials and bottles containing various kinds of drugs which had been shipped in interstate commerce by their respective manufacturers to one Henry Schein, the claimant herein, a pharmacist of Woodside, Queens County, New York, in this District, and repacked and relabeled by him. "The basis for the libel was the claim, made by the Government, that the said claimant had not filed 'New Drug' applications with the Secretary of Health, Education and Welfare for the repacked articles, as required by the Federal Food, Drug and Cosmetic Act, Title 21, U.S. Code, Sections 301 et seq. "Section 355(a) of said title provides that no person shall introduce a new drug in interstate commerce unless an application, filed pursuant to subsection (b) thereof, is effective with respect thereto. Subsection (b) sets forth the requirements of the application, such as reports of investigations as to the safety thereof, its components, specimens of labels, etc. "The claimant contends, and the Government does not deny, that the manufacturers of all of the drugs seized have filed the applications required by Section 355 (a), and that they are effective. The Government argues, however, that because the drugs have been repacked by the claimant, and in some instances relabeled, he, too, is required to file effective 'New Drug' applications therefor. "The claimant admits that he did not file such applications, but contends that he was not required to do so, since he did nothing more with the drugs in question than repack them in smaller containers and quantities for sale only to physicians and institutions such as hospitals, etc. "It is apparent, therefore, that there are triable issues presented which can be disposed of only by a trial. "Accordingly, the motion for summary judgment is denied." On 3-26-59, with the consent of the claimant and the Government, a decree was entered dismissing the libel against the Ansolysen Tartrate, Serpasil Apresoline, Doriden, Meticortelone, and Meticorten tablets, and ordering that such articles be returned to the claimant. In addition, on the same day, a consent decree of condemnation and destruction was entered against the Thorazine hydrochloride tablets and the Butazolidin tablets. 5645. Beauty for Life Capsules. (F.D.C. No. 41312. S. Nos. 24-644 M, 75–231 M.) QUANTITY: 205 75-capsule btls. at El Segundo, Calif. SHIPPED: 10-16-57, from Roslyn, N.Y., by Helena Rubenstein, Inc. LABEL IN PART: "Beauty For Life Three Capsules Contain *** Vitamin A 4000 U.S.P. Units Vitamin D 400 U.S.P. Units Vitamin B, * * * 1 mg. Vitamin C ** 30 mg. Riboflavin *** 2 mg. Niacin 10 mg. Vitamin B. 3 mg. Vitamin B12 9 micrograms Folic Acid 0.6 Pantothenate 6.6 mg. Gelatin 1800 mg. Royal Jelly 30 mg. mended Dosage: Three (3) a day.” LIBELED: 1-6-58, S. Dist. Calif. mg. Calcium *** Recom CHARGE: 502(a)—when shipped, the name "Beauty For Life Capsules" and the labeling of the article contained false and misleading representations that the article was an adequate and effective treatment for restoring abnormal skin, hair, and nails to normal, that it would aid looks and physical well-being, make one look younger, prevent dryness, brittleness, and splitting of nails indefinitely, and would have beneficial effects in treating nervous tension; and 505 (a) the article was a new drug within the meaning of the law, and an application filed pursuant to the law was not effective with respect to the drug. DISPOSITION: 2-7-58. Default-destruction. 5646. Royal jelly capsules. (F.D.C. No. 40974. S. No. 55-060 M.) QUANTITY: 585 capsules in btls. at Louisville, Ky., in possession of Royal Drugs of Kentucky. SHIPPED: 10-11-57, from Cambridge, Mass. LABEL IN PART: "15 Capsules Queen Bee Brand Royal Jelly ✶✶✶ Distributed by Royal Drugs of Ky. * * * Each capsule contains 50 mg. Royal Jelly Dietary Supplement." ACCOMPANYING LABELING: Reprints entitled "Royal Jelly, by R. B. Willson." RESULTS OF INVESTIGATION: The capsules in the bottles were repackaged and relabeled by the consignee from bulk stock which had been shipped as described above. The above-mentioned accompanying labeling had been produced locally from a reprint of an article in the "American Bee Journal." LIBELED: 12-4-57, W. Dist. Ky. CHARGE: 502(a)—the labeling accompanying the article, while held for sale, contained false and misleading representations that royal jelly would prolong life, produce sexual rejuvenation, cure cerebral neuritis (pains in the head and down the arm), arthritis, diabetes, asthma, failing eyesight, sterility in women, impotency in men, and increase lactation in women; and 505 (a)—the article was a new drug within the meaning of the law, and an application filed pursuant to the law was not effective with respect to the article. |