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] 2351-2400 DRUGS AND DEVICES The cases reported herewith were instituted in the United States district courts by the United States attorneys acting upon reports submitted by direction of the Federal Security Administrator. J. DONALD KINGSLEY, Acting Administrator, Federal Security Agency. WASHINGTON, D. C, October 29,1948. CONTENTS* Page New drug shipped without effective application. 79 Drug requiring certificate or release, for which none had been issued 80 Drugs and devices actionable because of failure to bear adequate directions or warning state- ments 80 Drug actionable because of contamination with filth - 88 Drugs and devices actionable because of devia- tion from official or own standards .. 89 Page Drugs and devices actionable because of false and misleading claims , - 93 Drugs for human use 93 Drugs for veterinary use 111 Dru? actionable because of omission of, or unsat- isfactory ingredients statements- - 113 Drugs actionable because of failure to bear an ac- curate statement of the quantity of the con- tents - - U4 Index- 115 NEW DRUG SHIPPED WITHOUT EFFECTIVE APPLICATION 2351. Doctor's Prescription Rx 7-11. U. S. v. 11 Bottles, etc. (F. D. C. 23882. Sample Nos. 16802-K to 16804-K, incl.) LIBEL FILED : October 30, 1947, Eastern District of Wisconsin. ALLEGED SHIPMENT: On or about May 8, June 5, and July 8 and 19, 1947, by Murrell Laboratories, from Norman, Okla. PRODUCT: 11 1-gallon bottles, 6 cases, each containing 12 1-pint bottles, and 81 cases, each containing 12 8-ounce bottles, of Doctor's Prescription Bw 1-11 at Milwaukee, Wis. NATURE OF CHARGE: Section 505 (a), the article was a drug which should not have been introduced or delivered for introduction into interstate commerce, since it was a new drug and an application filed pursuant to the law was not effective with respect to the drug. It was a new drug in that its composition consisting essentially of a colored solution containing alcohol, glycerin, sul- fanilamide, and sulfathiazole, was not generally recognized among experts qualified by scientific training and experience to evaluate the safety of drugs, as safe for use under the conditions suggested in its labeling, i. e., "Doctor's Tor presence of a habit-forming narcotic without warning statement, see No. 2357; deceptive packaging and imitation of another drug, No. 2376; labeling information not likely to be understood by the ordinary individual under customary conditions of purchase and use, No. 2352; cosmetic, subject to the drug pr?> visions of the Act, No. 2351. 813806-49 1 79, i" Prescription Seven-11 Guarantee 'Guaranteed to remove loose dandruff or your money will be refunded. This preparation is not sold as a hair tonic, but is a special prepared medicine and sold only to remove itching, scaly dandruff. Caution: For External Use Only Directions for Treatment Use once a day for four days, then once every other day for one week, or as needed. Apply freely and massage into the scalp. For best results shampoo and dry hair thoroughly before first application. Murrell Laboratories Norman, Oklahoma." DISPOSITION : February 5,1948. Default decree of condemnation and destruction. DRUG REQUIRING CERTIFICATE OR RELEASE, FOR WHICH NONE HAD BEEN ISSUED