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 Cosmetic Act] 6161-6200 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 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) a criminal proceeding terminated upon a plea of guilty; and (3) an injunction proceed- ing terminated upon the entry of a consent decree of temporary injunction. 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. LAEEICK, Commissioner of Food and Drugs. WASHINGTON, D.C, December 13,1960. CONTENTS* Page Devices actionable because of poten- tial danger when used accord- ing to directions 110 New drugs shipped without effec- tive application 111 Drug for human use 111 Drugs for veterinary use 112 Drugs and device actionable because of failure to bear adequate di- rections or warning state- ments 112 Page- Drugs and device actionable because of deviation from official or own standards 119 Drugs for human use 119- Drug for veterinary use 124 Drugs and device actionable because of false and misleading claims.- 125 Drugs for human use 125 Drugs for veterinary use 131 Index 132 ?For drugs in violation of prescription labeling requirements, see No. 6163; omission of, or unsatisfactory, ingredient statements, Nos. 6172, 6175; failure to comply with the packaging requirements of an official compendium, No. 6175; failure to bear a label containing an accurate statement of the quantity of the con- tents, No. 6172; failure to bear a label containing the name and place of business of the manufacturer, packer, or distributor, No. 6172; cosmetic, actionable under the drug provisions of the Act, No. 6165. 673794-60 1 109 SECTIONS OF FEDERAL FOOD, DRUG, AND COSMETIC ACT INVOLVED IN VIOLATIONS REPORTED IN DJD.NJ. NOS. 6161-6200 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 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 differed from, or its purity or quality fell below, that which it purported or was represented to possess. Misoranding, Section 502(a), the labeling of the article was false and mis- leading; 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 con- tents; Section 502(e)(2), the article was a drug not designated solely by a name recognized in an official compendium and 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(g), the article purported to be a drug, the name of which is recognized in an official compendium (United States Pharmacopeia), and it was not labeled as prescribed therein; Section 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 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. DEVICES ACTIONABLE BECAUSE OF POTENTIAL DANGER WHEN USED ACCORDING TO DIRECTIONS 6161. Allure bust development device. (F.D.C. No. 44114. S. No. 26-112 R.) QtrANTiTT: 1 device at Lompoc, Calif. SHIPPED : 1-17-60, from Alamogordo, N. Mex., by Mrs. Patra Roland. LABEL IN PAET: (Metal plate on device) "Allure Mfd. by Allure Incorporated, Hollywood, Calif., Model 31358, Serial No. 1032." RESULTS OP INVESTIGATION : The article consisted of rubber-ringed plastic cups of various sizes which had small openings for connection to rubber hoses at- tached to an air compressor or pump operated by an electric motor. Attached to the compressor was a pressure regulator, a vacuum gauge, and a valve to regulate the amount of vacuum produced in each of the two breast cups. While in use, the plastic cups were pressed over the breasts against the chest and the rubber-ringed edge formed an airtight seal. The air compressor was then operated to form a vacuum inside the cups to exercise the breasts by contraction and relaxation. The air compressor and accessory equipment were contained in a metal cabinet 36" x 22" x 18". LIBELED: 4-5-60, S. Dist. Calif. CHARGE: 502(f) (1)-when shipped, the labeling of the article failed to bear adequate directions for use for the purposes for which it was intended, namely, for developing the human breast; and 502(j)-the labeling of the article was dangerous to health when used in the dosage, or with the frequency or dura- tion, prescribed, recommended, or suggested in the labeling thereof. DISPOSITION : 5-10-60. Default-destruction.