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] 2991-3000 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, May 24, 1950. CONTENTS* Page Drugs and devices actionable be- cause of failure to bear ade- quate directions or warning statements 622 Drug actionable because of con- tamination with filth 624 Page Drugs and devices actionable be- cause of false and misleading claims 626 Index.. 630 ?For omission of, or unsatisfactory, ingredients statements, see No. 2998. 621 885435-50 DRUGS AND DEVICES ACTIONABLE BECAUSE OF FAILURE TO BEAR ADEQUATE DD3ECTIONS OR WARNING STATEMENTS 2991. Misbranding of Gold-N-Ray Eucalyptus Oil Liniment. U. S. v. Edward N. Golden (Golden Boy Distributing Co.), and Dorothy D. Golden (Doro- thy D. Dickstein). Pleas of guilty. Fine of $500 against each defendant. (F. D. C. No. 25590. Sample No. 19602-K.) INFORMATION FILED: February 9, 1949, Eastern District of Michigan, against Edward N. Golden, trading and doing business as the Golden Boy Distributing Co., at Detroit, Mich., and against Dorothy D. Golden, also known as Dorothy D. Dickstein, who was associated with Edward N. Golden in the conduct of the business. ALLEGED SHIPMENT: Between the approximate dates of May 5 and 15, 1948, from the State of Michigan into the State of Ohio. PRODUCT: Analysis disclosed that the product contained some eucalyptus oil and menthol in a high boiling oil, probably mineral oil. LABEL, IN PART: "Gold-N-Ray Eucalyptus Oil Liniment * * * The Golden Boy Dist. Co. 85 Walton Street Brooklyn, New York." NATURE OF CHARGE: Misbranding, Section 502 (a), the statement on the bottle label "Eucalyptus Oil Liniment" was false and misleading. The statement represented and suggested that the article consisted of eucalyptus oil, whereas it consisted of volatile oils, including eucalyptus and peppermint oils, approxi- mately 28 percent, and nonsaponifiable oil such as petroleum oil, approximately 72 percent. Further misbranding, Section 502 (a), certain statements in accompanying circulars entitled "Gold-N-Ray Eucalyptus Compound" were false and mis- leading since they represented and suggested that the article was a refined and improved distillate from eucalyptus leaves; that it possessed the power of producing and maintaining health and energy; that it would exhibit miraculous properties; that in vapor form it would cleanse and disinfect the air and banish malaria, yellow fever, and epidemic fever; that it would play an important part in keeping one well; that it was of value in keeping the body sound, sturdy, and safe against infection and many common ailments; that it was a powerful antiseptic; that it would be efficacious in the treatment of asthma and catarrhal conditions; and that it would give beneficial results in cases where stimulation and disinfection were needed. The article was not a refined and improved distillate from eucalyptus leaves but consisted of volatile oils and nonsaponifiable oil, as indicated above; it was not a powerful anti- septic; and it would not fulfill the promises of benefit stated and implied. Further misbranding, Section 502 (f) (1), the labeling of the article failed to bear adequate directions for use in the treatment of hay fever, sinus affections, colds, sore throat, asthma, neuritis, arthritis, and rheumatism, which were the diseases, symptoms, and conditions for which the article was intended to be used. DISPOSITION : On November 21,1949, the defendants filed a consent for transfer of the case to the Southern District of New York for pleading and sentence. Thereafter, pleas of guilty were entered by the defendant, and on January 24, 1950, the court imposed a fine of $500 against each defendant.