80978. Misbranding of Prescription A Compound, Anti-Rheumatic Fever Com- pound, Camfo-Phenol Lotion, Astringent Compound, Alterative Com- pound, Alkaline Laxative, Cascara Compound Tablets, Aromatic Cascara Sagrada, Medicated Discs, Eye Drops, Tablets Iron Tonic Compound. Liquid Iron Tonic Compound, Pepsin and Acid Compound, Pleasant Laxative 'Wafers, Quinine Compound Tablets, Anti-Rheumatic Oint- ment, Antacid Tablets, Astringent Mouth Wash and Gargle. U. S. v. Modern Drugs, Inc. Plea of guilty. Fine, 8555. (F. & D. No. 42668. Sample Nos. 16831-D, 16844-D, 16847-D, 16848-D. 16849-D, 16860-D, 16862-D to 16865-D, Incl., 16867-D, 16869-D, 16870-D, 16872-D, 16873-D, 16877-D, 16878-D, 16879-D, 16880-D, 16883-D, 16884-D, 17335-D, 17337-D, 17338-D, 34202-D, 34211-D, 34212-D, 34213-D.) The labeling of these products bore false and fraudulent representations regarding their curative and therapeutic effectiveness. Certain of the products also bore false and misleading representations as stated hereinafter. On July 22, 1939, the United States attorney.for the Northern District of West Virginia, acting upon a report by the Secretary of Agriculture, filed in the district court an information against Modern Drugs, Inc., Philippi, W. Va., alleging shipment by said defendant within the period from on or about Octo- ber 18, 1937, to on or about June 2, 1938, from the State of West Virginia into the States of Maryland and Virginia of quantities of the above-named drug products which were misbranded in violation of the Food and Drugs Act as amended. Analysis of Prescription A Compound showed that it consisted essentially of extracts of plant drugs, including an alkaloid-bearing drug, sodium salicylate, alcohol, sugar, and water. Two of the three shipments of this product were alleged to be misbranded in that certain statements in the labeling regarding its therapeutic and curative effects falsely and fraudulently represented that Jt was effective as a treatment in fever temperature and pneumonia. The third shipment of this product was alleged to be misbranded in that certain statements in the labeling regarding its therapeutic and curative effects falsely and fraudulently represented that it was effective as a treatment in fever temperature and summer flu; effective as a first aid in stopping any emergency fever; effective to break up an emergency fever which otherwise might "run into" pneumonia; effective as a treatment in every emergency fever; effective for the treatment and prevention of acute childhood fevers and measles, acute infectious fevers, scarlet fever, mumps, German measles, chicken-pox, and other acute childhood fevers; effective to promote free sweating and to help patient to "break out" fully; effective for the treatment and prevention of re- spiratory infections, flu, bronchitis, grippe, pneumonia, laryngitis, croup, broncho- pneumonia, lobar pneumonia, pleurisy, influenza, and tonsillitis; effective to abort or "break up" serious conditions that may come from colds; and effective to reduce fever temperature and break up the cold before it becomes serious. Analysis of the Anti-Rheumatic Fever Compound showed that it consisted essentially of extracts of plant drugs including an alkaloid-bearing drug, small proportions of sodium salicylate, potassium acetate, potassium iodide, alcohol, sugar, and water. It was alleged to be misbranded in that certain statements In the labeling of one shipment regarding its therapeutic and curative effects, falsely and fraudulently represented that it was effective as a treatment for rheumatic fever, rheumatism, and various forms of rheumatism, such as neu- ralgia, lumbago, muscular aches and pains, and in that of the other shipment that it was effective in the treatment of rheumatic fever and rheumatism. Analysis of Camfo-Phenol showed that it consisted essentially of camphor, phenol (31.7 percent by weight in one sample and 35.5 percent by weight in the other), alcohol, and iodine. It was alleged to be misbranded in that certain statements in the labeling regarding its therapeutic and curative effects falsely and fraudulently represented that it was effective as a treatment for infection, wounds, abscesses, boils, carbuncles, chronic sores, burns, scalds, and ulcers including ulcers in syphilis, tuberculosis, and other debilitating diseases; effective to prevent infection and to prevent abscesses from forming; effective as a first aid treatment of ulcer; and effective to give quick relief in first- degree burns and to prevent germs from entering the blood or lymph channels and causing blood poison. Analysis of the Astringent Compound showed that it consisted essentially of extracts of plant drugs including ginger and nutmeg, small proportions of zinc sulfocarbolate, calcium sulfocarbolate, sodium sulfocarbolate, menthol, pepsin, bismuth subnitrate, alcohol, glycerin, sugar, and water, flavored with aromatics and colored with a red dye. It was alleged to be misbranded in that the statement "Contains No Opiates or Other Harmful Drugs," borne on the bottle label, was false and misleading since the article contained zinc sulfocarbolate, calcium sulfocarbolate, and sodium sulfocarbolate, ingredients which might be harmful in the dosage recommended in the directions on the label. It was alleged to be misbranded further in that certain statements in the labeling regarding its therapeutic and curative effects falsely and fraud- ulently represented that it was effective as an intestinal antiseptic; effective as a diarrhea remedy; effective to soothe the irritated intestinal membrane, to stop the absorption of poison and to neutralize the offending toxins; effective for the treatment and prevention of disturbances of the digestive system, inflammation of the stomach (gastritis), ulcer of stomach, duodenal ulcer, gall-bladder disease, Inflammation of the intestines (enteritis), appendicitis, gastro-intestinal disorders, digestive disturbances, rectal disorders, piles or hemorrhoids, proctitis, fissure-in-ano or fissure, perirectal abscess, fistula and rectal irritations; and effective to heal irritated intestinal membranes. Analysis of the Alterative Compound showed that it consisted essentially of potassium iodide, small proportions of an ammonium salt and volatile oils including methyl salicylate, plant extractives including cascara, and an alka- loid-bearing drug, alcohol, sugar, glycerin, and water. It was alleged to be misbranded in that certain statements in the labeling regarding its therapeutic and curative effects falsely and fraudulently represented that it was effective as a treatment in conditions arising from a sluggish system and as a treatment for abscesses, boils, carbuncles, and infections; effective to prevent abscesses from forming; and effective as a tonic. Analysis of Alkaline Laxative showed that it consisted essentially of extracts of plant drugs including cascara and licorice, sodium bicarbonate, volatile oils (including oil of anise, oil of orange, and a mint oil) alcohol, glycerin, sugar, and water. It was alleged to be misbranded in that the statement, "Improves the action of the bowels without establishing the laxative habit," borne on the bottle label, was false and misleading, since the article would not improve the action of the bowels without establishing the laxative habit, since it con- tained cascara and licorice, laxative drugs. It was alleged to be misbranded further in that certain statements in the labeling regarding its therapeutic and curative effects falsely and fraudulently represented that it was effective for the treatment and prevention of appendicitis, gastro-intestinal disorders, ulcer of the stomach, digestive disturbances and hives; and effective to keep the stomach sweet. Analysis of the Cascara Compound Tablets showed that they contained plant material including cascara and podophyllum, aloin, and sodium bicarbonate and were coated with sugar. They were alleged to be misbranded in that certain statements in the labeling regarding their therapeutic and curative effects falsely and fraudulently represented that they were effective for the treatment and prevention of disturbances of the digestive system, inflammation of the stomach (gastritis), ulcer of stomach, duodenal ulcer, gall-bladder disease, inflammation of the intestines (enteritis), appendicitis, gastro-intestinal disorders, digestive disturbances and hives; effective to clean out the bowels; and effective to keep the stomach sweet. Analysis of the Cascara Sagrada (Aromatic) showed that It consisted essen- tially of extract of cascara, glycerin, licorice, alcohol, and water, sweetened with saccharin and flavored with oil of anise. It was alleged to be misbranded in that certain statements in the labeling regarding its therapeutic and curative effects falsely and fraudulently represented that it was effective for the treatment and prevention of disturbances of the digestive system, inflammation of the stomach (gastritis), ulcer of the stomach, duodenal ulcer, gall-bladder disease, inflammation of the intestines (enteritis), appendicitis, gastro-intes- tinal disorders, or digestive disturbances; and effective to keep the stomach sweet. Analysis of the Medicated Discs showed that they contained small propor- tions of anesthesin, creosote, volatile oils (including methyl salicylate, menthol, and oil of cubeb), balsam of tolu, elm bark, gum, sugar, and talc, colored with a pink dye. The article was alleged to be misbranded in that certain statements in the labeling regarding its therapeutic and curative effects falsely and fraudulently represented that it was effective for the treatment and prevention of diseases of the eye, ear, nose, and throat; effective for the treatment and prevention of sore mouth, pyorrhea, thrush, and trench mouth; effective to relieve soreness and irritation; and effective as a medication for irritated bronchial tubes. Analysis of the Eye Drops showed that the article consisted essentially of boric acid (3.9 percent), traces of zinc sulfate, hydrastic alkaloids, and chlore- tone, flavored with oil of rose and colored with a yellow dye. Bacteriological examination showed that it was not an antiseptic. It was alleged to be misbranded in that the statement, "Antiseptic," appearing in a booklet which accompanied it, was false and misleading since it was not an antiseptic. It was alleged to be misbranded further in that certain statements in the labeling regarding its therapeutic and curative effects falsely and fraudu- lently represented that it was effective as a treatment for conimbn irritations of the eyes and eyelids; effective for the prevention and treatment of eye irritation and other infections which are carried to the eyes; and effective as an antiseptic. Analysis of the Iron Tonic Compound Tablets showed that they contained iron and manganese compounds and plant material (including nux vomica, capsicum, and an emodin-bearing drug such as cascara), coated with sugar, calcium car- bonate, and talc. It was alleged to be misbranded in that the statement "Tab- lets Iron Tonic Compound," borne on the box label, was false and misleading since it represented that the article contained iron as its essential physiologically active ingredient; whereas it contained other physiologically active ingredients, to wit, manganese, and plant material including nux vomica, capsicum, and an emodin-bearing drug such as cascara. It was alleged to be misbranded further in that certain statements in the labeling regarding its therapeutic and curative effects falsely and fraudulently represented that it was effective as a tonic; effective as a treatment for abscesses, boils, carbuncles, infections, hay fever, and eczema; effective to prevent abscesses from forming; effective for the treatment and prevention of disturbances of the blood and circulatory sys- tem ; and effective to build health, vigor, strength, and endurance. Analysis of the Liquid Iron Tonic Compound showed that it consisted essen- tially of extracts of plant drugs including cascara, small proportions of compounds of arsenic, manganese, calcium, and iron, hypophosphites, alcohol, sugar, and water. It was alleged to" be misbranded in that the statement "Liquid Iron Tonic Compound," borne on the bottle label, was false and misleading since it represented that the article contained iron as its essential physiologically active ingredient: whereas it did not contain iron as its essential physiologically active ingredient but did contain other physiologically active ingredients, namely, extracts of plant drugs including cascara, and small proportions of compounds of arsenic, manganese, calcium, and hypophosphites. It was alleged to be misbranded further in that certain statements in the labeling regarding its therapeutic and curative effects falsely and-fraudulently represented that it was effective as a tonic; effective as a treatment for abscesses, boils, carbuncles, hay fever, eczema, and infections; effective to prevent abscesses from forming; effective for the treatment and prevention of respiratory infections, flu, grippe, bronchitis, pneumonia, laryngitis, croup, broncho-pneumonia, lobar pneumonia, pleurisy, influenza, and disturbances of the blood and circulatory system; effective to prevent recurrences and improve the general health; effective to build up strength and endurance and prevent a relapse; and effective to build health, vigor, strength, and endurance. Analysis of the Pepsin and Acid Compound showed that it consisted essen- tially of pepsin, a small proportion of hydrochloric acid, alcohol, glycerin, and water, flavored with aromatics and colored with a red dye. It was alleged to be misbranded in that certain statements in the labeling regarding its thera- peutic and curative effects falsely and fraudulently represented that it was effective as a treatment, remedy, and cure for sick stomach and vomiting. Analysis of the Pleasant Laxative Wafers showed that they contained phenolphthalein (2 grains per tablet), sugar, starch, and aromatics including oil of sassafras. It was alleged to be misbranded in that the statement, 234567°—40 4 "Pleasant Laxative Wafers * * * Good tasting candy containing a mild * * * laxative," borne on the box label, was false and misleading since it represented that the article was a mild laxative; whereas it contained in each tablet 2 grains of phenolphthalein, which is not a mild laxative. It was alleged to be misbranded further in that certain statements in the labeling regarding its therapeutic and curative effects falsely and fraudulently represented that it was effective for the treatment and prevention of disturbances of the diges- tive system, inflammation of the stomach (gastritis,), ulcer of stomach, duodenal ulcer, gall-bladder disease, inflammation of the intestines (enteritis), and appendicitis; effective as a treatment, remedy, and cure for gastro-intesti- nal disorders and ulcer of the stomach; and effective to keep the stomach sweet Analysis of the Quinine Compound Tablets showed that they contained acetani- lide, quinine sulfate, camphor, aloin, resin of podophyllum, and sodium bicarbonate, coated with calcium and colored with a pink dye. It was alleged to be mis- branded in that certain statements in the labeling regarding its therapeutic and curative effects falsely and fraudulently represented that it was effective for the treatment and prevention of respiratory infections, flu, grippe, bron- chitis, pneumonia, laryngitis, croup, broncho-pneumonia, lobar pneumonia, pleurisy, and influenza; and effective to keep nose and throat dry, and to check excessive sweating. Analysis of the Anti-Rheumatic Ointment showed that it contained sodium salicylate, methyl salicylate, capsicum, turpentine, volatile oils (including cam- phor, menthol, and oil of cajuput), incorporated in a petrolatum base. It was alleged to be misbranded in that certain statements in the labeling regarding its therapeutic and curative effects falsely and fraudulently represented with respect to both shipments that it was effective as an anti-rheumatic ointment; effective as a relief of pain and swellings; effective for the treatment of conges- tion of the lungs, pneumonia, muscular soreness, aches and pains, simple neu- ritis, simple neuralgia, lumbago, myalgia, and other similar forms of what is commonly known as rheumatism; effective to aid in the restoration of the affected parts to normal; and with respect to one of the shipments that it was also effective for the treatment and prevention of respiratory infections, flu, grippe, bronchitis, pneumonia, laryngitis, croup, broncho-pneumonia, lobar pneu- monia, pleurisy, and influenza; and effective for the treatment of tightness in the chest. Analysis of the Antacid Tablets showed that they contained calcium phosphate, calcium carbonate, small proportions of a protein-like material, and saccharin, and starch, flavored with aromatics. It was alleged to be misbranded in that certain statements in the labeling regarding its therapeutic and curative effects falsely and fraudulently represented that it was effective to aid protein diges- tion; effective to relieve heartburn, sour stomach, flatulence, and gas; effective as a treatment for indigestion, gastro-intestinal disorders, ulcer of the stomach and digestive disturbances; effective to aid the stomach in digestion; effective for the treatment and prevention of disturbances of the digestive system, inflam- mation of stomach (gastritis), ulcer of stomach, duodenal ulcer, gall-bladder disease, inflammation of the intestines (enteritis), and appendicitis; and effec- tive to keep the stomach sweet. . Analysis of the Astringent Mouth Wash and Gargle showed that it consisted essentially of boric acid, sodium benzoate, volatile oils (including thymol, men- thol, eucalyptol, and oil of wintergreen), tannic acid, alcohol, and water. It was alleged to be misbranded in that certain statements in the labeling regard- ing its therapeutic and curative effects falsely and fraudulently represented that it was effective for the treatment and prevention of diseases of the eye, ear, nose and throat, sore mouth, pyorrhea, thrush, trench mouth, and other common Irritations of the mouth; effective as an antiseptic throat gargle for tonsillitis; and effective as an antiseptic mouth wash. The information charged that Camfo-Phenol was also misbranded in viola- tion of the Federal Caustic Poison Act, reported in notices of judgment pub- lished under that act. On November 22, 1939, a plea of guilty was entered on behalf of the defend- ant. On December 22, 1S39, the court imposed a fine of $555 for violation of the Food and Drugs Act and a fine of $30 for violation of the Federal Caustic Poison Act. GROVER B. HILL, Acting Secretary of Agriculture.