U.S. Department of Health, Education, and Welfare FOOD AND DRUG ADMINISTRATION NOTICES OF JUDGMENT UNDER THE FEDERAL FOOD, 190-194 DRUG, AND COSMETIC ACT [Given pursuant to section 705 of the Food, Drug, and Cosmetic Act] 6301-6340 DRUGS AND DEVICES THE UNIVERSITÝ MAY 10 1961 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 (1) seizure proceedings in which decrees of condemnation were entered by default, by consent, or by summary judgment; (2) a criminal proceeding dismissed after the jury failed to reach a verdict; and (3) injunction proceedings terminated by consent with the entry of a permanent injunction or a supplemental permanent 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. LARRICK, Commissioner of Food and Drugs. *For omission of, or unsatisfactory, ingredients statements, see No. 6312; failure to bear a label containing an accurate statement of the quantity of the contents, No. 6312; failure to bear a label containing the name and place of business of the manufacturer, packer, or distributor, Nos. 6304-6307, 6312; cosmetic, actionable under the drug provisions of the Act, No. C324. 203 SECTIONS Of federal FOOD, DRUG, AND COSMETIC ACT INVOLVED IN VIOLATIONS REPORTED IN D.D.N.J. NOS. 6301-6340 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 Pharmacopoeia), 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 differed from, and its purity and quality fell below, 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 in terms of numerical count; Section 502 (e) (1), the article was a drug not designated solely by a name recognized in an official compendium, and its label failed to bear the common or usual name of the drug; 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 dura tion of administration or application, in such manner and form, as are necessary for the protection of users; 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; 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. DEVICES ACTIONABLE BECAUSE OF POTENTIAL DANGER WHEN USED ACCORDING TO DIRECTIONS 6301. Allure bust development device. (F.D.C. No. 43516. S. No. 71-808 P.) QUANTITY: 4 devices at Tampa, Fla., in possession of Mrs. J. H. Burns. SHIPPED: During 1957 or 1958, from Los Angeles, Calif., by Allure, Inc. LIBELED: 8-31-59, S. Dist. Fla. CHARGE: 502(f) (1)—when shipped and while held for sale, 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 article was dangerous to health when used in the dosage, or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof. DISPOSITION: 10-17-60. Consent-claimed by Mrs. J. H. Burns. The devices were dismantled. Some of the parts were destroyed and the remainder of the parts were released to the claimant. 6302. Allure bust development device (4 seizure actions). (F.D.C. Nos. 43512, 43513, 43514, 43515. S. Nos. 71–806 '7 P., 71–809/10 P.) CO STATES OF AMERICA 6301-6340] NOTICES OF JUDGMENT 205 QUANTITY: 2 devices at Clearwater, Fla., and 5 devices at Tampa, Fla. SHIPPED: Between the latter part of 1957 and January 1959, from Los Angeles and Hollywood, Calif., by Dimco Kitchen Equipment, and Allure, Inc. LABEL IN PART: "Allure Mfd. by Allure Inc. Hollywood, Calif." ACCOMPANYING LABELING: Claim (one device) for patent application and (one device) circulars entitled "Allure Salon Bust Developing and Firming." RESULTS OF INVESTIGATION: The article consisted of rubber-ringed plastic cups of various sizes which had small openings for connection to rubber hoses attached to an air compressor or electrically operated pump. 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: 8-31-59, S. Dist. Fla. CHARGE: 502(a)—when shipped and while held for sale, the labeling, namely, the circular entitled "Allure Salon Bust Developing and Firming," which accompanied one device at Tampa, Fla., contained false and misleading representations that the device was a safe, adequate, and effective treatment for increasing the size of the female breast; for developing the breasts without surgery, hormones, creams, or exercise; that it was capable of bringing about complete bust correction and a beautiful bust line; that it would restore youth, beauty, and glamour; and that use of the device was healthful; and the labeling, namely, the claim for patent application, which accompanied another device at Tampa, Fla., contained false and misleading representations that the article was an adequate and effective treatment for development of the human female breast; 502(f)(1)—the labeling of the article (all lots) failed to bear adequate directions for use for the purposes for which it was intended; and 502(j)--the article (all lots) was dangerous to health when used in the dosage, or with the frequency or duration prescribed, recommended, or suggested in the labeling. DISPOSITION: istration. 12-7-59. Default-delivered to the Food and Drug Admin NEW DRUGS SHIPPED WITHOUT EFFECTIVE APPLICATION DRUGS FOR HUMAN USE 6303. Supplement to notice of judgment on drugs and devices, No. 6003. Vitamin B12 injection. F.D.C. No. 40930, S. No. 67-040 M. The notice of judgment in the above-identified case is incomplete in that it fails to report the order of dismissal with respect to the adulteration charge under Section 501(b) and the basis upon which the claimant of the article, Maizel Laboratories, Inc., consented to the entry of a decree of condemnation. In order that the notice of judgment may reflect these facts, the provisions of the decree of condemnation are set forth below in their entirety: IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MARYLAND UNITED STATES OF AMERICA V. 144 vials, more or less, of an article of drug Civil No. 10122 labeled in part: "Intramuscular 10 c.c. Intravenous VITAMIN B12 INJECTION Cyanocobalamin U.S.P. 1000 mcg. Each c.c. contains a sterile solution of 1000 micrograms Vitamin B12 U.S.P. (Cyanocobalamin) in normal saline with 2% Benzyl Alcohol as preservative. *** 28590 ***." CONSENT DECREE OF "On November 1, 1957, a Libel of Information against the above-described article was filed in this Court on behalf of the United States of America by the United States Attorney and Assistant United States Attorney for this District. The Libel alleges that the article proceeded against is a drug which is violative of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 334 in that it was adulterated when introduced into and while in interstate commerce within the meaning of 21 U.S.C. 351 (b) and that it is a New Drug which may not be introduced or delivered for introduction into interstate commerce under the provisions of 21 U.S.C. 355(a) since an application filed pursuant to 21 U.S.C. 355 (b) is not effective with respect to such drug. Pursuant to Monition issued by this Court, the United States Marshal for this District seized said article of drug on November 5, 1957. Thereafter, Maizel Laboratories, Inc., of Chicago, Illinois, appeared as claimant and filed answer to the Libel. "Claimant, through its attorney, represents to the Court that the intrinsic value of the drug under seizure in this case is negligible, and further that the standard set forth in the United States Pharmacopoeia for this drug has been clarified to include a specific test for solids, which test was not part of the United States Pharmacopoeia monograph at the time of shipment, and without admitting any of the issues of law and fact involved, claimant consents that a Decree of Condemnation and Destruction may be entered in this case pursuant to 21 U.S.C. 334, for violation of 21 U.S.C. 355. "The Court being fully advised in the premises, and in view of claimant's consent to condemnation and destruction of the seized drug for violation of 21 U.S.C. 355, it being unnecessary to adjudicate the allegation of violation under 21 U.S.C. 351(b), and the parties having therefore agreed to the dismissal of the allegation of violation under 21 U.S.C. 351(b) it is, "ORDERED, ADJUDGED, AND DECREED that the article of drug under seizure is violative of 21 U.S.C. 355, in that it is a New Drug which may not be introduced or delivered for introduction into interstate commerce under the provisions of 21 U.S.C. 355 (a) since an application filed pursuant to 21 U.S.C. 355(b) is not effective with respect to such drug, and it is hereby condemned pursuant to 21 U.S.C. 334 (a) and that said article shall be destroyed by the United States Marshal for this District pursuant to 21 U.S.C. 334 (d); and it is further "ORDERED, ADJUDGED, AND DECREED, that the allegation of violation under 21 U.S.C. 351(b) be, and hereby is dismissed; and it is further "ORDERED, ADJUDGED, AND DECREED, pursuant to 21 U.S.C. 334(e). that the libelant shall recover from the claimant all court costs and fees and storage and other proper expenses to be taxed after destruction of said article of drug." Dated this 10th day of August 1959. W. CALVIN CHESTNUT, United States District Judge. [6304. Trim Reducing-Aid cigarettes. (F.D.C. No. 42216. S. No. 34-778 P.) QUANTITY: 354 bulk ctns., each containing 1 display ctn. containing 10 retail pkgs., 20 cigarettes each, at Trenton, N.J. SHIPPED: Between 3-24-58 and 7-11-58, from New York, N.Y., by Cornell Drug Corp. LABEL IN PART: (Bulk ctn.) "TRIM Reducing-Aid Cigarettes" and (retail pkg.) "TRIM Reducing-Aid Cigarettes Filter Tip-20 Active ingredients: Combustible tartaric acid, combined with tobacco and flavoring." ACCOMPANYING LABELING: Window display streamers reading in part "OVERWEIGHT *** Smoke Trim Reducing-Aid Cigarettes" and catalog sheets reading in part "Mr. Retailer How To Get Your Share." LIBELED: 10-6-58, Dist. N.J. CHARGE: 502 (a)-when shipped and while held for sale, the labeling of the article contained statements which, when considered and interpreted in the setting in which they were presented, represented and suggested that smoking three Trim cigarettes per day would bring about a definite weight loss over a given period of time: that Trim cigarettes were safe for use by all persons; that use of Trim cigarettes would enable one to lose weight without dieting; that the user of Trim cigarettes could continue to eat the same kinds and amounts of food he ordinarily consumed and still lose weight; that Trim cigarettes were a new, scientific discovery approved by doctors and other scientists; that Trim cigarettes were marketed only after being subjected to years of clinical tests by doctors and other scientists; and that Trim cigarettes were the miracle reducing discovery of the century, which statements were false and misleading since they were contrary to fact; 502(b) (1)—the article failed to bear a label containing the place of business of the manufacturer, packer, or distributor; and 505(a)-the article was a new drug which may not be introduced into interstate commerce since an application filed pursuant to the law was not effective with respect to the drug. DISPOSITION: On 12-20-58, Cornell Drug Corp., appeared as claimant and filed an answer denying that the article was misbranded and that the article was a new drug. Thereafter, the Government filed written interrogatories and upon the claimants failing to answer, the Government filed a motion for a default decree of condemnation. The claimant filed motions to dismiss similar libel proceedings against the article pending in the United States District Courts for Dist. Kans., S. Dist. Calif., and N. Dist. Ohio, and for an order consolidating the proceedings and their removal for trial to the United States District Court for the E. Dist. N.Y. On 6-15-59, the court denied the motions of the claimant and the Government, and further ordered that the motion for consolidation be denied on condition that the Government hold in abeyance, proceedings on all similar seizures in other jurisdictions pending the decision in the Dist. N.J. Thereafter, the claimant filed written interrogatories against the Government. The Government subsequently filed a motion to compel the claimant to make further and more complete answers to the previously served interrogatories, and objections to the claimants interrogatories, and a motion for protective order. The claimant filed a motion for a partial summary judgment striking out the new drug charge of the libel. Thereafter, the Government filed a motion for summary judgment. After a hearing on the motion for summary judgment the court, on 11-30-59, handed down the following opinion: |