U.S. Department of Health, Education, and Welfare FOOD AND DRUG ADMINISTRATION f) / PfcC ) NOTICES OF JUDGMENT UNDER THE FEDERAL FOOD, DRUG, AND COSMETIC ACT [Given pursuant to section 705 of the Food, Drug, and Cosmetic Act] 5701-5740 DRUGS AND DEVICES The eases 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; (2) criminal proceedings terminated with a plea of guilty or nolo contendere; and (3) an injunction proceeding terminated with a dismissal after the granting of a tem- porary restraining order. 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. LABBICK, Commissioner of Food and Drugs. WASHINGTON, D.O., February 26, i960. CONTENTS* Page Drug actionable because of poten- tial danger when used accord- ing to directions 108 New drugs shipped without effec- tive application 109 Drugs in violation of prescription labeling requirements 111 Drugs and devices aetionable be- cause of failure to bear ade- quate directions or warning statements, , 113 Page Drugs actionable because of con- tamination with filth 118 Drugs and devices actionable be- cause of deviation from official or own standards 119 Drugs and devices actionable be- cause of false and misleading claims ,_, 122, Index 12 ?For presence of a habit-forming substance wftftont winrafn^ statements, see No. 5707; omission of, or unsatisfactory), ingredient rtsttmenfis, Nos. 5795* 5707, 5709, 5718; an Imitation of, and sale under name etr another d*BJrr Nov 5705; failure to bear a label con- taining'an accurate statement ?dfate'^BSirfityaf the contents; No?. 5705, 5707, 5709, 5716; failure toF*iear'*&I>e^confetf^nii^tB? name and1 place of business of the manufac- turer,, pgefery. eg tt&iSJtftEaa^ Noav 5705, 570Tv 571ft; cosmetic, actionable under the drug proTistons of the Act, No. 571%. 5380S*-60> 1 107 SECTIONS OF FEDERAL FOOD, DRUG, AND COSMETIC ACT INVOLVED IN VIOLATIONS REPORTED IN DJ).NJ. NOS. 5701-5740 Adulteration, Section 501(a) (1), the article consisted in part of a filthy sub- ^- stance; Section 501(a) (2), the article had been prepared, packed, or held under ( insanitary conditions; Section 501(b), the article purported to be and was rep- resented as a drug, the name of which is recognized in an official compendium (United States Pharmacopeia or National Formulary) and its strength differed from, and its quality and purity 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 quality fell below, that which it purported or was represented to possess. 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 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 deriva- tive; 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 com- mon 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(i) (2), the article was an imitation of another drug; and (3) the article was offered for sale under the name of another drug; Section 502(j), the article was dangerous to health when used in the dosage, or with the fre- quency or duration prescribed, recommended, or suggested in the labeling thereof; and Section 503(b) (4), the article was subject to 503(b) (1), and its label failed to bear the statement "Caution: Federal law prohibits dispensing without prescription"; and, in another case, the article bore the caution state- ment quoted above, but the article was not one to which Section 503(b) (1) applies. Neto-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. D?UG ACTIONABLE BECAUSE OF POTENTIAL DANGER WHEN USED ACCORDING TO DIRECTIONS 5701. Vitamin capsules. (F.D.C. No. 41851. S. No. 35-361 P.) QUANTITY : 171 btls. at Philadelphia, Pa. ? SHIPPED : The capsules were shipped in bulk, on 3-1&-58, from Detroit, Mich. LABEJ, IN PAST: (Btl.) "500 Capsules List No. 100 VITAL B-C THERA- PEUTIC FORMULA Each capsule contains 25,000 units of Vitamin A * * * 1 mg. of Vitamin Bi * * * 5 mg. Ascorbic Acid * * * Prepared for Daniel Cooperman." ACCOMPANYING LABELING : Folder entitled "Directions for the ttse of Vital B-C Capsules.", reading in part: "Three capsules four times a day before meals and at bedtime." RESULTS OP INVESTIGATION : The capsules in the above-described shipment were, after arrival at Philadelphia, Pa., repackaged into bottles and labeled as described above. LIBELED : 6-4-58, E. Dist. Pa. CHARGE: 502(a)-the labeling of the article, while held for sale, contained false and misleading representations that the article "was an adequate and effective treatment for acne; and 502(j)-the article, because of its content of vitamin A, was dangerous to health when used in the dosage, and with the frequency and duration prescribed, recommended, and suggested in its labeling, namely, "Three capsules four times a day before meals and at bedtime," which were the recommended directions contained in the folder entitled "Directions for the use of Vital B-C Capsules." DISPOSITION: 8-29-58. Consent-claimed by Daniel Cooperman Pharmacy, Philadelphia, Pa., and relabeled. NEW DRUGS SHIPPED WITHOUT EFFECTIVE APPLICATION