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] 2711-2730 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 the Federal Security Agency. Published by direction of the Federal Security Administrator. PAUL B. DTJNBAB, Commissioner of Food and Drugs. WASHINGTON, D. C, January S, 1950. CONTENTS* Page Drugs actionable because of poten- tial danger when used according to directions 355 Drugs and devices actionable be- cause of failure to bear adequate directions or warning state- ments 357 Page 359 Drugs actionable because of devia- tion from official or own stand- ards Drugs and devices actionable be- cause of false and misleading claims 361 Drugs for human use 361 Drugs for veterinary use 365 DRUGS ACTIONABLE BECAUSE OF POTENTIAL DANGER WHEN USED ACCORDING TO DIRECTIONS 2711. Misbranding of Foille Emulsion. U. S. T. 77 Bottles, etc (F. D. C. No. 26960. Sample Nos. 53355-K to 53358-K, incl.) LIBEL FILED : March 28,1949, Eastern District of Louisiana. ALLEGED SHIPMENT: On or about February 9 and July 15, 1948, and January 21 and March 15, 1949, by the Carbisulphoil Co., from Dallas, Tex. PBODTJCT: 2 1-pint bottles, 1 1-gallon bottle, and 60 1?-ounce bottles of Foille Emulsion at New Orleans, La., together with 14 sample kits, each con- taining one bottle of Foille Emulsion, one tube of Foille Ointment, and various pieces of literature. ?For new drug shipped without effective application, see No. 2713; cosmetics, subject to the drug pro- visions of the Act, Nos. 2726, 2727. 853400-49 355 LABEL, IN PAST: (Bottle) "Foille Emulsion A Protective Dressing. Anal- gesic-Antiseptic. Ingredients: Benzocaine, Carbolic Acid (Less than 2 Per- cent), Calcium Oleate, Calcium and Potassium Iodides, Oxyquinoline Base, Calcium Thiosulfate and sulphur in a Vegetable Oil Base * * * Direc- f??~ ?tions: Apply liberally to gauze compress or directly to wound area." NATIVE OF CHARGE: Misbranding, Section 502 (f) (2), the labeling of the article failed to bear such adequate warnings against unsafe dosage and methods and duration of administration and application, in such manner' and form as are necessary for the protection of users. The article con- tained carbolic acid, and its labeling failed to warn against application to large areas of the body, and against bandaging the fingers and toes to which the article was applied. Further misbranding, Section 502 (j), the article was dangerous to health when used in the dosage and with the frequency and duration prescribed, recommended, and suggested in its labeling, namely (bottle label), "Apply liberally to gauze compress or directly to wound area" and (brochure en- titled "Burns") "Dressing saturated with Foille Emulsion should be applied directly to the wound and the dressing kept moist with Foille. * * * In some cases, * * * it may be appropriate to continue with the original dressings for a longer period of time by frequently saturating them with Foille in order to keep the area moist, soft, and pliable. Such treatment may be continued either with or without changing the dressings until healing is complete or until conditions are satisfactory for grafting. * * * Foille Emulsion is applied directly to the injured areas .either by pouring, spreading with a camel's-hair brush or spraying with a special atomizer. Under open, cradle treatment method, Foille Emulsion is reapplied at regular intervals, either with saturated compresses or direct without benefit of dressings as indicated above." DISPOSITION : April 28, 1949. Default decree of condemnation and destruction.