19876. Adulteration and Misbranding of Pyros. IT. S. v. 8 Dozen Packages, et al., of Pyros. Decrees of condemnation, forfeiture, and de- struction. (F. & D. Nos. 26409, 26489, 27628, 27644, 28820. I. S. Nos. 11056, 12500, 22424, 22425. S. Nos. 4693, 4783, 5658, 5659. Sample No. 2740-A.) Examination of the drug preparation involved in these cases disclosed that the article contained no ingredient or combination of ingredients capable of producing certain curative and therapeutic effects claimed for the product in representations appearing on the bottle and carton labels and in the circu- lars. The article also was represented, on all cartons and in the circulars accompanying certain of the shipments, as being an antiseptic, whereas examination showed that it was not an antiseptic when used as directed. On May 26, 1931, the United States attorney for the Eastern District of Washington, acting upon a report by the Secretary of Agriculture, filed in the District Court of the United States for the district aforesaid, a libel praying seizure and condemnation of 8 dozen packages of Pyros at Spokane, Wash. On or about October 7, 1931, the libel was amended in accordance with a recommendation from this department. On June 11, 1931, the United States attorney for the District of Oregon filed a libel against 66 bottles of Pyros at Portland, Oreg.; on January 11, 1932, the United States attorney for the Eastern District of Washington filed 2 libels against 50 bottles and 13 dozen bottles, respectively, of Pyros at Spokane, Wash.; and on August 31, 1932, the United States attorney for the District of Iowa filed a libel against 7 cases of the same product at Sioux City, Iowa. It was alleged in the libels that the article had been shipped in interstate commerce, in various shipments, on or about January 5, March 23, August 1, and November 2, 1931, and February 25, 1932; that the shipments had been made in interstate commerce by the Pyros Co., from Denver, Colo., to Spokane, Wash., Portland, Oreg., and Sioux City, Iowa, respectively; that it remained in the original unbroken packages, and that it was misbranded in violation of the food and drugs act, and that 4 of the 5 shipments also were adulterated. Analysis of a sample of the article by this department showed that it con- sisted essentially of a dilute solution in water of sodium chloride and zinc sulphate. Bacteriological examination showed that the article was not anti- septic. Adulteration of the article was charged in the 3 libels filed in the Eastern District of Washington and 1 filed in the District of Oregon for the reason that it was sold under the following standard of strength, (carton in all 4 shipments) "Antiseptic," (circular accompanying 2 shipments) "Pyros is an ideal anti- septic," and fell below such professed standard in that it was not antiseptic. Misbranding was alleged with respect to the said 4 shipments for the reason that the following statements appearing on the cartons of all the said 4 ship- ments of the article, "A Penetrative Antiseptic," and the following statement appearing in the circular shipped with 2 of the said shipments, (circular) "The Penetrative Antiseptic * * * Pyros is an ideal antiseptic mouth wash, for it has a definite, selective action on disease germs in the mouth. * * * The definite and selective germicidal action of Pyros stops the bacterial acid detrition in the first stages of tooth decay. * * * Pyros is a combination of simple ingredients resulting in a product of definite value as an * * * antiseptic, * * * Its penetrating and bactericidal action is then more pronounced * * * You can ' feel' its position and penetrating antiseptic properties," were false and misleading. Misbranding was alleged with respect to all 5 shipments for the reason that certain statements quoted below regarding the curative or therapeutic effects of the article, were false and fraudulent. Two different sets of labeling were found in the consignments; in the libels filed against the shipments of January 5, 1931, to Spokane, Wash, and March 23, 1931, to Portland, Oreg., the following statements were charged to be false and fraudulent: (Bottle label) "An aid in treatment of infectious mouth conditions, * * * and attendant tooth decay. Sore, tender, ulcer- ated gums, and general oral infections;" (carton) "A successful aid in the care of tender, bleeding, spongy or receding gums * * * for pre- venting decay of the teeth keeping the gums firm and healthy * * * Give solution time to penetrate gums and affected parts. * * * A success- ful aid in the care of tender or ulcerated gums and teeth and all mouth infec- tions generally;" (circular) "Good Health Depends on Mouth Health The mouth is the one main entrance whereby disease germs gain entrance to the body. In the mouth disease germs multiply, infect the nasal passages or throat and, sooner or later, the entire system. Nature, (the perfect physician) installed in the mouth the simple machinery necessary for warding off of disease, viz: clean saliva, abundant blood supply and properly adjusted teeth. Therefore, it can be readily seen that a remedy which causes the mouth to properly function is the one that assists nature in warding off disease. The present day customs, diet and mental habits do not permit the mouth to function perfectly as in the days of savagery when the mouth received ex- ercise from the eating of hard, coarse food, and tooth decay and gum disease were unknown. Pyros Makes Healthy Mouths * * * Pyros Penetrates. Pyros has a peculiar penetrating action, so that it even attacks deep, under- lying, inflamed conditions. Pyros makes clean, healthy saliva, nature's mouth wash. * * * In diseased conditions of the mouth Pyros should be used as near full strength as possible. For Pyorrhea—Take one teaspoonful in mouth and let it penetrate the affected parts * * * If the upper teeth or gums are affected, hold head downward or sideways. * * * For Trench Mouth (Vincent's Angina) or other acute inflammations of the mouth where pain is present * * * For Ulcerative Gums. * * * Tender Gums. * * * Bleeding Gums. * * * Spongy Gums. Where the gums are soft, flabby and bleed easily use one part Pyros to four of water * * * Turgid Gums. Where gums are conjested and swollen use Pyros the same as for spongy * * * Tartar. When annoyed by excessive tartar on the teeth use Pyros full strength for a few days, brushing the teeth after-each treatment. When most of the tartar is gone, go to a dentist and have the teeth thoroughly cleaned. * * * After Extraction. There is more danger of alarming con- ditions after the extraction of teeth than most people realize. Pyros * * * prevents the development of infectious conditions * * * By its daily use you can guard the entire system against contagion and disease. The teeth remain clean, the gums firm and natural in color. Finish with a single gargle and you will have a healthy, clean throat. * * * It will save you endless dental and medical expense and many anxious hours. It is an excel- lent preventive. * * * How To Prevent Decay Of The Teeth At Home. Pyros actually prevents and arrests decay of the teeth. The definite and selective germicidal action of Pyros stops the bacterial acid detrition in the first stages of tooth decay. * * * take Pyros one part to water four parts and brush this solution into the cheeks, gums and teeth for three minutes. If this is done morning and evening you will keep your teeth free from cavities or decay. * * * pyros is of value in checking ruptured arteries and restoring proper circulation." In the libels filed against the shipments of August 1 and November 2, 1931, to Spokane, Wash., the following statements were charged to be false and fraudulent: (Carton) "A successful aid in the care of tender, bleeding, spongy or receding gums * * * for preventing decay of the teeth, keeping the gums firm and healthy * * * A successful aid in the care of tender or ulcerated gums and teeth and all mouth infections generally;" (bottle) "The use of Pyros as directed will aid in relieving conditions often associated with sore, tender, or bleeding gums, and will tend to discourage conditions that induce or predispose to Pyorrhea; " (circular) " ' Used Pyros on several cases of pyor- rhea, one in particular that was chronic and got results that I have been unable to get with any other remedy, and I have used many on it.' * * * ' Pyros is the best relief for mouth troubles, pyorrhea, * * * etc., that I have ever used.' * * * ' I have achieved results with Pyros in the subse- quent treatment of pyorrhea far superior to that obtained in the use of any other preparation.' * * * ' We find Pyros our most effective agent in the treatment of pyorrhea.' * * * 'My treatment for pyorrhea is two scalings and bottle of Pyros.' * * * ' Excellent results obtained by using Pyros in case of Vincent's Angina.' * * * 'Have been trying the sample of your Pyros for pyorrhea and can say I am very much pleased with re- sults.' * * * «Have used Pyros in connection with air pressure in pyorrhea with marvelous results.' * * * 'As a last resort I advised Pyros. The result was astonishing. In two days inflammation and soreness had subsided, and in five days the teeth and gums were entirely normal.' * * * ' From personal experience I know that it is a specific for Trench Mouth.' * * * * I have used Pyros in several cases of Vincent's Angina (trench mouth) and have had excellent results.' * * * ' I received the sample bottle of your mouth wash Pyros not long ago and tried it out on a real bad case of Ulcerative Gingivitis, and the result was most wonderful.' * * * ' Have had wonder- ful results with Pyros in cases of so-called Trench Mouth.' * * * Pyros is an efficient remedy to combat that very common and dangerous oral disease pyorrhea. I prescribe Pyros for healing bleeding and receding gums. Several of my patients show marked benefit.' * * * ' Tried your preparation, Pyros, on several cases of pyorrhea, and wish to say it has done the work with better results than any other preparation I have ever used.'" The shipment of February 25, 1932 to Sioux City, Iowa, was labeled as in the 2 shipments of August 1 and November 2, 1931, to Spokane, Wash. The libel against this shipment omitted certain portions of the therapeutic claims quoted above, also the adulteration charges recommended by this department. On September 12, 1932, counsel for the Government and counsel for F. P. Bicknell trading as the Pyros Co., claimant, having stipulated that decrees might be entered in the cases instituted in the Eastern District of Washington in accordance with the prayers of the libels, judgments of condemnation and forfeiture were entered, and it was ordered by the court that the product be destroyed by the United States marshal. On October 3, 1932, claimant having withdrawn the answer filed in the case instituted in the District of Oregon, a similar decree was entered; and on November 1, 1932, a default decree of con- demnation and destruction was entered in the case in the District of Iowa. HENEY A. WALLACE, Secretary of Agriculture.