28339. Misbranding of Formula 281. 17. S. v. Harry Gorov (Isabella Labora- tories). Plea of nolo contendere. Fine, $50. (F. & D. Nos. 39730, 39822. Sample Nos. 12804-C, 14459-C, 33781-C, 41238-C.) The labeling of this preparation bore false and fraudulent representations regarding its curative or therapeutic effects and false and misleading represen- tations that it was a safe and appropriate remedy for the reduction of fat whereas it contained dinitrocresol, a drug which is potentially dangerous. On July 8, 1937, the United States attorney for the Northern District of Illinois, acting upon a report by the Secretary of Agriculture, filed in the district court an information against Harry Gorov, trading as Isabella Labora- tories, Chicago, Ill. On November 24, 1937, a second information was filed against the same defendant in the said judicial district. The informations alleged shipment by the defendant in violation of the Food and Drugs Act as amended, on or about October 7, 1936, and June 1, 11, and 28, 1937, from the State of Illinois into the States of Ohio, Utah, Michigan, and Wisconsin of quantities of Formula 281 which was misbranded. The article was labeled in part: "Improved Formula 281 * * * Isabella Laboratories * * * Chi- cago, Ill." Analyses showed that the article consisted of tablets containing dinitrocresol and phenolphthalein, the samples examined containing from 0.32 grain to 0.46 grain of the former and 0.25 grain to 0.29 grain of the latter per tablet. The article was alleged to be misbranded in that the bottle label bore the statements (1) "Scientifically Correct Fat Reducing Preparation," (2) "Dos< age—1 to 3 Tablets Daily"; that there was attached to the bottle a leaflet bear- ing the statements (3) "Directions—For the first 3 days, take 1 tablet with. a glass of water, after breakfast only; the next four days, take 1 tablet after breakfast and 1 after lunch; after that, take 1 tablet after each meal, 3 a day, no more," (4) "we * * * have had proven beyond any question of doubt that this preparation does not affect the heart or other vital organs"; that the statement (1) represented that the article was a medicinally correct fat-reducing- preparation in the sense of being in accordance with scientific standards, whereas it was not a medicinally correct preparation in such sense; in that the statements (2 and 3) implied that use of the article as directed was approved and recommended by scientific authority, i. e., those having scientific knowledge of the effects of drugs on the human body and that it was a medicinal agent capable of reducing fat without potential harm, whereas the use of the article had not been approved by such authority, and the statement (4) representing that it had been proven that the use of the article as directed for reducing fat would not affect the heart or other vital organs, whereas the article con- tained as its active ingredient dinitrocresol, a drug potentially dangerous to the heart and other vital organs; and that the said statements were false and misleading The article was alleged to be misbranded further in that the statements borne on the labeling, (bottle) "Fat Reducing Preparation," (attached to bottle) "Have lost 77 lbs. Cannot praise them enough." "Have lost 75 lbs.," "Have lost 18 lbs. Never felt better in my life," "The three of us are well pleased with the- results. We feel much better and it has shown absolutely no ill effects," "I have lost 27 lbs. in two months," "I used two bottles and lost 15 lbs.," "Have lost 10 lbs. and do not feel any discomfort from taking it," "Having wonderful results from your preparation. Walking more and feeling better than I have for a good many years," "Now literally burning the fat away. Glad I persevered- Am making my dresses smaller"; (bottle) "Dosage—1 to 3 Tablets Daily"; (leaflet attached to bottle) "Directions. For the first 3 days, take 1 tablet with a glass of water, after breakfast only; the next 4 days, take 1 tablet after breakfast and 1 after lunch; after that, take 1 tablet after each meal, 3 a day, no more," were false and fraudulent in that they represented that the article was capable of reducing fat without endangering the health of any person if used as directed; whereas the article contained dinitrocresol as its active ingredient in a quantity sufficient to have a potentially harmful effect on the heart and other vital orKans. On December 7, 1937, the cases having been consolidated and a plea of nolo contendere having been entered by the defendant, he was sentenced to pay a fine of $50. HAEEY L. BROWN, Acting Secretary of Agriculture.