Purity Drug Co.: Crisp Tonic Pills (veterinary)- 5863 Theresa Pharmacy: Research Laboratories, Inc.: various drugs___. I.O.D. powder (veterinary)___ 5874 United Contact Lens Corp.: contact lens wetting solution__ 5878 Strong, Cobb & Co., Inc.: 5864 5865 Ripet Products Co., Inc.: Vibra Mfg. Corp.: Rolender, S. S., Inc.: Vita Fluor Corp.: San Joy Mfg. Co.: Vitamix Corp.: The Federal Register publishes the full text of Presidential Proclamations and Executive Orders, and the rules and regulations of the various Departments of the Federal Government. U.S. Department of Health, Education, and Welfare 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] 5901-5940 DRUGS AND DEVICES དང SEP 13 1960 LIBRARY The cases reported herewith were instituted in the United States district courts. One of the cases was instituted against the Government and the remainder of the cases were instituted 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 after default or consent; (2) criminal proceedings terminated by pleas of guilty; (3) an injunction proceeding terminated by entry of a permanent injunction; and (4) a contempt proceeding for violation of a injunction which was terminated by a judgment of guilty. The seizure proceedings are civil actions taken against the goods alleged to be in violation, and the criminal, contempt, and one of the injunction proceedings are against the firms or individuals charged to be responsible for violations, and the other injunction proceeding is against the Government. Published by direction of the Secretary of Health, Education, and Welfare. For omission of, or unsatisfactory, ingredients statements, see Nos. 5905, 5908; failure to bear a label containing an accurate statement of the quantity of the contents, Nos. 5907, 5940; failure to bear a label containing the name and place of business of the manufacturer, packer, or distributor, No. 5907. 556350-60-1 231 SECTIONS OF FEDERAL FOOD, DRUG, AND COSMETIC ACT INVOLVED IN VIOLATIONS REPORTED IN D.D.N.J. 5901-5940 Adulteration, 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 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 (e) (2), the article was a drug not designated solely by a name recognized in an official compendium, and it 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 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. 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 5901. Clarimycin. Suit for injunction. COMPLAINT FILED: On or about 2-10-58, Merritt Corp., Jersey City, N.J., filed a complaint for injunction in the United States District Court for the District of Columbia, against Marion B. Folsom, the Secretary of the Department of Health, Education, and Welfare, George P. Larrick, the Commissioner of the Food and Drug Administration, and William P. Rogers, the Attorney General of the United States. NATURE OF CHARGE: The complaint alleged that Merritt Corp., plaintiff, was engaged in the distribution and sale of drug and cosmetic products, including "Clarimycin," an antibotic lotion used in the treatment of acne pimples, which contained the active ingredient neomycin sulfate; that plaintiff had expended large sums of money on the product "Clarimycin"; that the defendants had, on 1-7-58 and 1-22-58, commenced libel actions against "Clarimycin” in the S. Dist. of Ohio, and the E. Dist. of Mich., respectively, by the seizure of plaintiff's product then being held for sale by retail customers of plaintiff; that such actions involve the same product, and the same issues, and that the defendant had interposed answers to the libel actions; that the issue in both libel actions involved a technical construction of Section 505, which, since its enactment, had not been subject to the review of the courts. The complaint alleged further that the Government had already committed multiple seizures of plaintiff's product, and, that unless further seizures were enjoined, plaintiff would suffer irreparable harm and damage to its good will, reputation, and business; and that plaintiff would be deprived of its property without due process of law. PRAYER FOR RELIEF: That a permanent injunction be issued restraining and enjoining defendants from instituting further proceedings, seizures, or condemnations against plaintiff's product "Clarimycin" under Section 304 of the Federal Food, Drug, and Cosmetic Act, pending determination of the libel ANITED STATES OF AMERICA 5901-5940] NOTICES OF JUDGMENT 233 proceedings instituted by the defendants against "Clarimycin" in the S. Dist. of Ohio, and the E. Dist. of Mich. DISPOSITION: The Government filed motions (1) for dismissal of the complaint on the ground that the complaint failed to state a claim on which relief could be granted, and (2) for the entry of a summary judgment, for the reason that the complaint and the affidavits of the plaintiff and the defendants showed that there was no genuine issue as to any material fact, and that defendants were entitled to judgment of dismissal as a matter of law. On 5-5-58, the matter came on for hearing before the court, and thereafter, on 5-21-58, the court filed the following findings of fact and conclusions of law: CURBAN, District Judge: FINDINGS OF FACT "1. On February 11, 1958, the plaintiff, Merritt Corp., filed a Complaint for Injunction seeking to restrain the defendant government officials from instituting further seizure actions against plaintiff's drug product, ‘Clarimycin Anti-Biotic Acne Lotion.' "2. Pursuant to Section 304 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 334] the defendants have caused to be instituted six seizure actions in various parts of the country against 'Clarimycin.' There was no Section 304 determination of probable cause. 3. Each of the seizure actions instituted allege that 'Clarimycin' is a New Drug which may not be introduced into interstate commerce under the provisions of Section 505(a) [21 U.S.C. 355(a)], since an application filed pursuant to Section 505(b) [21 U.S.C. 355(b)] is not effective with respect to the drug. "4. The active ingredient of 'Clarimycin' is the antibiotic neomycin sulfate. "5. From 1949 to 1955 all neomycin sulfate preparations were deemed to be New Drugs requiring the filing of an application pursuant to Section 505 [21 U.S.C. 3551 before the drug could be marketed in interstate commerce. "6. In 1955 certain types of neomycin sulfate preparations were declared by the United States Food and Drug Administration no longer to be new drugs when labeled for use only for the prevention of infections in the temporary self-limiting conditions of minor cuts, burns and abrasions. "7. Plaintiff markets its neomycin sulfate lotion preparation in interstate commerce for sale to the layman with labeling recommending use of the product for the treatment of acne. "8. Acne vulgaris is a chronic, recurring disease condition of the skin which may last for years and which therefore requires treatment for a prolonged period of time. "9. When viewed in the light most favorable to it, plaintiff's medical affidavits assert that topical neomycin sulfate is generally recognized by experts as safe in the treatment of acne, even when used over prolonged periods of time. "10. Defendant's medical affidavits assert that topical neomycin sulfate is not generally recognized as safe by experts in the treatment of acne, because it has been shown to produce sensitization and cross-sensitization to streptomycin, an antibiotic valuable in the treatment of serious disease conditions. In addition, that use of neomycin sulfate for the treatment of acne is a new use for neomycin sulfate both because it has not been generally used for such a disease before and also because prolonged administration, which is required in an acne treatment, is a new method of utilizing the drug. CONCLUSIONS OF LAW "1. The Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 334, imposes no limitations upon the number of seizure actions which may be instituted under a 'New Drug' charge, i.e. that the drug is one which may not, under the provisions of Section 505 [21 U.S.C. 355] be introduced into interstate commerce. |