24647. Misbranding of Pheno-Isolln and Menno. U. S. v. Scientific Manufac- turing: Co., Inc., and Howard J. Force. Pleas of nolo contendere. Fine, $30. (F. & D. no. 33350. Sample nos. 43036-A, 43993-A.) This case was based on shipments of drug preparations which were mis- branded because of unwarranted curative and therapeutic claims in the label- ing. The labeling of the Pheno-Isolin was further objectionable since the cir- cular showed the results of germicidal tests under conditions of prolonged ex- posure, while the bottle label conveyed the misleading impression that it would produce the same result under conditions of practical use. On December 18, 1934, the United States attorney for the Middle District of Pennsylvania, acting upon a report by the Secretary of Agriculture, filed in the district court an information against the Scientific Manufacturing Co., Inc., and Howard J. Force, Scranton, Pa., alleging shipment by said defendants in violation of the Food and Drugs Act as amended, on or about March 23, 1933, from the State of Pennsylvania into the State of New York, of a quantity of Menno; and on or about August 23, 1933, from the State of Pennsylvania into the State of New Jersey of a quantity of Pheno-Isolin which were mis- branded. Analysis of the Pheno-Isolin showed that it consisted of a brown oily liquid containing chiefly volatile oils dissolved in fixed oil, the fixed oil apparently consisting of a fish oil with rosin and/or rosin oil, and the volatile oils ap- parently consisting of turpentine, camphor, menthol, and a small amount of thy- mol. Bacteriological examination showed that it was not a germicide when used as directed. Analysis of the Menno showed that it consisted of a dark brown liquid with a light brown sediment. The liquid contained chiefly water, glycerol, sodium bicarbonate, and alcohol. The sediment apparently was chiefly magnesium carbonate and plant material. An amodin-bearing drug and a small amount of ipecac alkaloids were present. The articles were alleged to be misbranded in that certain statements, de- signs, and devices appearing in the respective labeling, falsely and fraudu- lently represented that the Pheno-Isolin was effective to prevent and destroy infection, effective as a local antitoxin; effective as a relief from pain and as a preventive of pain, swelling, and fever when caused by infection; effective as a preventive of tetanus; effective as a treatment, remedy, and cure for sore mouth, sore gums, sore throat, coughs, bronchial cases, boils, carbuncles, ulcers, old ulcers, bed sores, pyorrhea, mouth ulcers, ulcerated cancer, skin affections, neuritis, and ear infections; effective to protect wounds and ulcers from infec- tion; and that the Menno was effective as a treatment, remedy, and cure for indigestion, gas condition, or ptomaine poisoning. Misbranding of the Pheno- Isolin was alleged for the further reason that the following statements con- tained in a circular shipped with the article, and the statement "Germicide * * * Use Full Strength", borne on the bottle label, were false and mislead- ing in that they represented that the article was a germicide when used as directed; whereas it was not a germicide when used as directed: "Germicidal Test Method—F. D. A. Wet Filter Paper, U. S. Dept. of Agriculture Circular 198. December, 1931. Organism—Staph, aureus. F. D. A. Culture No 209. Age of culture—24 hours at 37 degrees C. Medium—Standard broth. Pep- tone—Armours Special. Organic matter—None. Temperature of medication— 37 degrees C. Sterile 0.5 cm. squares of Whatman's No. 2 Filter Paper were impregnated with Staph, aureus having the standard resistance to phenol at 37 degrees C. The wet impregnated papers were then immersed in the sample under test and a paper square removed at stated intervals and retransferred to 10 cc. of sterile broth, washed by agitation and use of a sterile needle, and transferred to a second 10 cc. of sterile broth. Both sets of tubes were then incubated at 37 degrees C. for 48 hours with the following results: Hours of Exposure Sanfple 123456789 Pheno-Isolin Undiluted + + + + + + + + — Minutes of Exposure 5 10 15 Phenol 1:80 + - - 1:90 + + + "Comments: These results show that Pheno-Isolin had germicidal action in a nine hour period of exposure under the conditions of the test. * * * In the germicidal test, the Pheno-Isolin is slowly absorbed by the bacteria, as the Phenol-Isolin is very slowly soluble in aqueous solutions, which, of course, are different from the albuminous serum in the wound or toxin compounds." On March 11, 1935, the defendants entered pleas of nolo contendere and the court imposed a fine of $30. W. R. GBEQG, Acting Secretary of Agriculture.