NOTICES OF JUDGMENT UNDER THE FEDERAL FOOD, 6741-6780 DRUG, AND COSMETIC ACT [Given pursuant to section 705 of the Food, Drug, and Cosmetik Act). "ERCITY OF MICHIGAN 6741-6780 DRUGS AND DEVICES NOV 28 1962 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. GEO. P. LARRICK, Commissioner of Food and Drugs. *For omission of, or unsatisfactory, ingredients statements, see No. 6773; an imitation of, and sale under name of, another drug, No. 6757; failure to bear a label containing the name and place of business of the manufacturer, packer, or distributor, No. 6777; labeling information not likely to be read and understood by the ordinary individual under customary conditions of purchase and use, No. 6768; cosmetics, actionable under the drug provisions of the Act, Nos. 6777, 6778. 658982-62-1 163 Sections of federal foOD, DRUG, AND cosmetic aCT INVOLVED IN VIOLATIONS REPORTED IN D.D.N.J. NOS. 6741-6780 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 strength differed from. or its quality or 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, or its quality fell below, that which it purported or was represented to possess; and Section 501 (d) (2), the article was a drug, and a substance had been substituted in whole or in part therefor. Misbranding, Section 502 (a), the labeling of the article was false and misleading; Section 502 (b) (1), the article was in package form, and it failed to bear a label containing the name and place of business of the manufacturer, packer, or distributor; 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 such 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 understood by the ordinary individual under customary conditions of purchase and use; Section 502(e) (2), the article was a drug not designated solely by a name recognized in an official compendium. and its label failed to bear, 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) (1), the labeling of the article failed to bear adequate directions for use; Section 502(i) (2), the article was an imitation of another drug; Section 502 (i) (3), the article was offered for sale under the name of another drug; Seetion 502 (j), the article was dangerous to health when used in the dosage, or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof; 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. DRUGS ACTIONABLE BECAUSE OF POTENTIAL DANGER WHEN USED ACCORDING TO DIRECTIONS 6741. Ferbetex tablets. (F.D.C. No. 45801. S. No. 32-280 R.) QUANTITY: 287 50-tablet btls. at Santurce, P.R. SHIPPED: 2-28-61, from Los Angeles, Calif., by Strand Pharmacal Corp. LABEL IN PART: "Ferbetex (Improved) Formula Per Tablet *** Folic Acid 0.4 mg. * 50 Tablets Strand Pharmacal Corporation, Los Angeles, California * * Dosis: 2 Tablets with Meals or as Prescribed." LIBELED: 5-16-61, Dist. P.R.; amended libel 5-23-61. CHARGE: 502(j)—when shipped, the article was dangerous to health when used in the dosage, or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof, since the article, under the directions for use, would supply 2.4 milligrams of folic acid daily. EPOSITED BY THE 6741-6780] NOTICES OF JUDGMENT 165 6742. Armatinic liquid. (F.D.C. No. 45807. S. Nos. 32-281/82 R.) LABEL IN PART: (Btl.) "Armatinic Liquido-Cada 29.57 ML Contiene-Acido CHARGE: 502(j)—when shipped, the article was dangerous to health when used in the dosage, or with the frequency or duration prescribed, recommended, or suggested in its labeling, since, under the label directions for use, 2 tablespoonfuls twice a day (1 lot) and 2 teaspoonfuls twice a day (second lot), the article would supply 4 mg. and 1.3 mg. of folic acid daily respectively. DISPOSITION: 7-20-61. Default-destruction. NEW DRUGS SHIPPED WITHOUT EFFECTIVE APPLICATION DRUG FOR HUMAN USE 6743. Biphetamine-T 121⁄2 and Biphetamine-T 20. (F.D.C. Nos. 46260, 46264. S. Nos. 97-215 R, 97-217/18 R.) QUANTITY: 33 50-capsule btls. of 121⁄2-mg. capsules; 49 50-capsule btls. of 20-mg. capsules; 5 cases, each containing 12 50-capsule btls. of 121⁄2-mg. capsules; and 4 cases, each containing 12 50-capsule btls. of 20-mg. capsules, at Pittsburgh, Pa. SHIPPED: Between 4-14-61 and 6-30-61, from Rochester, N.Y., by Strasenburgh Laboratories, Div. of Wallace & Tiernan, Inc. LABEL IN PART: "Biphetamine T-121⁄2 [or “T-20"] * * * Strasenburgh Laboratories Division Wallace & Tiernan, Inc., Rochester, N.Y." ACCOMPANYING LABELING: File card entitled "Biphetamine-T" and a brochure entitled "The Clinical Importance of Weight Reduction in Exogenous Obesity." LIBELED: 8-23-61, W. Dist. Pa. CHARGE: 502(a)—when shipped and while held for sale, the labeling of the drug, namely, the file card entitled "Biphetamine-T," contained false and misleading representations that the article reduced the insulin requirement in diabetes, reduced the nitroglycerin requirement in arteriosclerosis, and reduced the blood pressure in hypertension; 502(f) (1)—the labeling of the article failed to bear adequate directions for use and it was not exempt from the requirement that the article bear such directions for use, since the promotional material for the new drug was not the same as, or substantially the same as, the labeling authorized by the effective new drug application; 505 (a) the article was a new drug which may not be introduced or delivered for introduction into interstate commerce, since the effective new drug application filed with respect to the article did not apply to the conditions for which the article was promoted to the medical profession, namely, (a) in the physician's file card entitled "Biphetamine-T," distributed to physicians, the drug was represented as being capable of reducing the insulin requirement in diabetes, of reducing the nitroglycerine requirement in arteriosclerosis, and of reducing blood pressure in hypertension; and (b) in the brochure entitled "The Clinical Importance of Weight Reduction in Exogenous Obesity" the drug was offered for diabetes. arteriosclerotic heart disease, hypertension, and ulcers; which labeling representations differed materially from the labeling claims permitted by the effective new drug application. DISPOSITION: 10-13-61. Default-destruction. 6744. Iro-Jex injectable. DRUG FOR VETERINARY USE (F.D.C. No. 45628. S. Nos. 61-044/45 R.) QUANTITY: 226 30-cc. btls. and 607 100-cc. btls. at Kansas City, Mo. SHIPPED: 2-7-61 and 3-22-61, from Los Angeles, Calif. LABEL IN PART: "Iro-Jex Injectable Iron-Arsenic Solution each 2 cc contains: Ferric Cacodylate 1 Gr. Copper Sulfate 1/100 Gr. ** Suggested dosage: 2 cc given intramuscularly or intravenously-distributed by the National Laboratories Corp. Kansas City.” RESULTS OF INVESTIGATION: When shipped, the labeling offered the drug for human use. The dealer relabeled the article for veterinary use. LIBELED: On or about 4-17-61, W. Dist. Mo.; amended libel on or about 5-17-61. CHARGE: 505(a)—the article was a new drug which may not be introduced or delivered for introduction into interstate commerce, since an application filed pursuant to law was not effective with respect to such drug. DISPOSITION: 7-12-61. Default-destruction. DRUGS IN VIOLATION OF PRESCRIPTION LABELING REQUIREMENTS 6745. Vigo Forte tablets, Altocaps capsules, and vitamin B12 and B1 injection. (F.D.C. No. 45900. S. Nos. 32-274/77 R.) QUANTITY: 19 50-tablet btls. of Vigo Forte tablets; 18 20-capsule btls. of 50mg. Altocaps capsules; 20 20-capsule btls. of 100-mg. Altocaps capsules; and 79 10-cc. vials of vitamin B12 and B1 injection, at San Juan, P.R. SHIPPED: Between 10-1-60 and 11-17-60, from Newark, N.J., by Benson Pharmacal Corp. LABEL IN PART: (Btl.) "Vigo Forte *** Testosterona 2 mgm. Vitamin E 10 mgm. Extracto de damiana 60 mgm. Extracto de nucz vomica 5 mgm. Clorhidrato de yohimbine 5 mgm. Puerto Rico Drug *** San Juan, P.R.Distributors"; "Benson Altocaps 50 Mg. [or "100 Mg."] Each capsule contains * Vitamin E (from d-alpha Tocopheryl Acetate Concentrate, N.F.) Directions: One to six capsules daily ** Benson Pharmacal Co., Inc., New York, N.Y."; and (vial) “Multiples Dosis 10 cc Frasco Vitaminas B1 y B Cada cc contiens vitamina B12 1000 mcgm. Vitamina B1 100 mg. muscular Benson Pharmacal Corp., Newark, N.J." LIBELED: 5-29-61, Dist. P.R. intra CHARGE: Altocaps capsules, 502(a)—when shipped, the labeling of the article contained false and misleading representations that the article was adequate and effective as a treatment for habitual abortion, ovarian failure, muscular dystrophy, and amyotrophic lateral sclerosis. Vigo Forte tablets and vitamin B12 and B1 injection, 503(b) (4)—the articles were drugs subject to the provisions of 503(b) (1) and their labels failed to bear the statement "Caution: Federal law prohibits dispensing without a prescription." DISPOSITION: 7-20-61. Default-destruction. DRUGS AND DEVICES ACTIONABLE BECAUSE OF FAILURE TO BEAR ADEQUATE DIRECTIONS OR WARNING STATEMENTS 6746. Insta-Pep tablets. DRUGS FOR HUMAN USE* (F.D.C. No. 43373. S. No. 82-806 P.) QUANTITY: 17 cases of 36 50-tablet btls. and 10 cases of 72 25-tablet btls. at North Kansas City, Mo., in possession of Katz Drug Co. SHIPPED: Between 6-24-59 and 8-26-59, from New York, N.Y., by Drug Research Corp. LABEL IN PART: "Insta-Pep with Dynamol and 'Vitamin Feed' for prolonged Vitamin-Mineral Release A high potency therapeutic Vitamin-Iron formula *** Each tablet contains: Thiamine Chloride (Vit. B1) 15.0 mg. Riboflavin (Vit. B2) 6.0 mg. Cobalamin Concentrate (Vit. B, Activity) 3.0 mg. Nicotinic Acid 30.0 mg. *Calcium Pantothenate 3.0 mg. *Choline Bitartrate 10.0 mg. Folic Acid 0.1 mg. *Inositol 20.0 mg. *dl-Methionine 20.0 mg. Iron (from Ferrous Sulfate) 30.0 mg. Ascorbic Acid (Vit. C) 90.0 mg. Pyridoxine Hydrochloride (Vit. B.) 0.5 mg. Whole Liver Desiccate 25.0 mg. Calcium (from Dicalcium Phosphate) 30.0 mg. Phosphorus (from Dicalcium Phosphate) 20.0 mg. Sodium Acid Phosphate 100.0 mg. *Vitamin E (from d-alpha Tocopheryl Acid Succinate) 1.0 I.U. Iodine (from Potassium Iodide) 0.1 mg. Copper (from Cupric Sulfate) 1.25 mg. *Manganese (from Manganese Sulfate) 0.85 mg. *Cobalt (from Cobalt Sulfate) 0.04 mg. Potassium (from Potassium Sulfate) 0.65 mg. Magnesium (from Magnesium Sulfate) 0.50 mg. together with factors natural to liver content Caffeine Alkaloid Anhydrous 3.0 gr. Sole Distributors: Drug Research Corp. New York, N.Y." ACCOMPANYING LABELING: Newspaper tear sheet, reading in part "Insta-Pep Stops Rapid Vitamin-Mineral Loss in Your Body! Fights Fatigue in 20 minutes! The Kansas City Star, Sunday, August 2, 1959.” RESULTS OF INVESTIGATION: The newspaper tear sheets were displayed with the article at various Katz Drug Stores in Kansas City, Mo. LIBELED: 9-25-59, W. Dist. Mo. CHARGE: 502 (a)-when shipped and while held for sale, the labeling of the article contained false and misleading representations that the article was capable of providing instant pep; was the first new development in the vitamin field in over 20 years; stopped rapid vitamin-mineral loss in the body; fought fatigue in 20 minutes; stopped "vitamin let-down" even if tense, worried, or working under pressure; that feeling of fatigue as a result of tensions, worry and working under pressure is due to "vitamin let-down"; that chronic fatigue not aided by other vitamin preparations would be aided by Insta-Pep tablets to the extent that users would never feel tired any more; that Insta-Pep tablets contained a new, remarkable, amazing antifatigue factor; that "Dynamol" was a new "Vitamin-Mineral" discovery; that Insta-Pep tablets contained all necessary vitamins-minerals to build up the body; that the body throws off *See also No. 6743. |