22016. Misbranding of Histeen. V. S. v. 2,515 Packages, et al., of Histeen. Default decrees of condemnation, forfeiture, and destruction. (F. & D. Nos. 31046, 31052, 31098, 31099, 31100. Sample nos. 42510-A, 49486-A, 49487-A, 49490-A, 49491-A, 49492-A.) Examination of the drug product, Histeen, disclosed that it contained no in- gredient or combination of ingredients capable of producing certain curative and therapeutic effects claimed in the labeling. It was also represented on the car- ton and bottle labels that the article could be taken with perfect safety, and circulars enclosed with certain of the shipments contained the statement that the product was not habit forming, whereas the article contained a drug or drugs that might be harmful and habit forming. On September 5 and September 14, 1933, the United States attorney for the Eastern District of Missouri, acting upon reports by the Secretary of Agricul- ture, filed in the district court libels praying seizure and condemnation of 3,751 packages of Histeen at St. Louis, Mo. On September 6, 1933, a libel was filed in the Southern District of Indiana against 195 dozen packages of Histeen at Indianapolis, Ind. It was alleged in the libels that the article had been shipped in interstate commerce between the dates of August 8, 1933, and September 6, 1933, by the Histeen Corporation, from Chicago, Ill., and that it was misbranded in violation of the Food and Drugs Act as amended. Analysis of a sample of the article by this Department showed that it con- sisted essentially of phenobarbital, antipyrine, and a small proportion of plant material. The libels charged that the article was misbranded in that the following statements appearing in the labeling were false and misleading: (Carton and bottle labels) " May be taken with perfect safety as long as required "; (circular shipped with portions) " Non-habit forming." Misbranding was alleged with re- spect to portions of the article for the further reason that the following state- ments regarding its curative or therapeutic effects were false and fraudulent: (Bottle and carton) " Indicated in the palliative treatment of asthma, hay fever and bronchitis. Directions: Take two tablets one half hour after each meal and at bed time until the attacks are thoroughly relieved, then one tablet four times daily will probably be found sufficient. Where necessary three tablets per dose may be taken with perfect safety as long as required." Misbranding was alleged with respect to the remainder of the article for the further reason that the following statements regarding its curative or therapeutic effects were false and fraudulent: (Bottle label and carton) "Indicated in the Palliative Treat- ment of Asthma, Hay Fever and Bronchitis * * * Directions—Take 2 tab- lets one-half hour after each meal and at bed time until the attacks are thor- oughly relieved. Then 1 tablet four times daily, will probably be found suffi- cient. Where necessary 3 tablets per dose may be taken with perfect safety as long as required"; (circular) "Indicated in The Palliative Treatment of Hay Fever, Asthma, Bronchitis, Hives * * * Rose Fever and similar Allergic Conditions. For years hay fever has been a common disease, and a mysterious disease. As we know today, the pollen-producing plants which have always been blamed for the distress—sneezing, watery nasal discharge, watering eyes and some fever—are not the only causes of hay fever. Hair—fur—even some rug-dust cause hay fever in certain people. In fact it is estimated there are at least 350 causes. Why does hay fever hit some people—and leave others alone- Why do some plants produce hay fever in A, while B gets it only from other plants, and remains totally insensitive to the pollens that cause A's distress- Not Pollens * * * Poison. It was this very fact of mystery that led to the discovery of the Histeen treatment of hay fever. A Chicago physician, well-known for his work in hay fever and asthma, had long been puzzled by it. ' All hay fever patients have the same symptoms,' he reasoned. ' They all feel about the same—though some patients suffer more severely than others. But— not all hay fever patients are stricken by the same causes. Ragweed pollen is. the cause in some persons. Others can breathe ragweed pollen for a month, urn- harmed—yet come down with hay fever the minute they breathe certain other pollens, like timothy, or are exposed to certain furs, hairs, or dusts. The trouble must lie, not with the pollens, but with the poison which these pollens produce in the blood streams of certain persons—and it must be the same poison always, or the symptoms would not always be the same. If, then, I can find a way to neutralizing the poison, it will be necessary to fight pollens. It won't make any difference which pollen leads to the body poison, if I can check the effect of the poison itself.' What Poison? * * * The Problem. But this doctor's inquir- ing mind went further. Hay fever is an 'allergic' disease—a disease in which the patient is very sensitive to certain substances. But—there are other aller- gic diseases, besides hay fever. Hives is one of them. Certain people cannot eat certain foods—eggs, for example, or strawberries—without having a skin rash. In other words, while some people are super-sensitive to things they breathe, others are super-sensitive to foods they eat. And a great number of people who suffered from hay fever were also the victims of hives: Also, a good many hay fever victims, sooner or later developed asthma—also known to be an allergic or ' sensitivity ' disease. ' Was it possible ', he asked, ' that the same poison caused all three of these diseases ?' It was possible. The Poison Exposed. Independent medical research was being carried on simultaneously in great laboratories in other parts of the country which convinced this Chicago specialist that he was on the right track. Recently certain important announce- ments were made which further confirmed his belief. At last he felt certain of one thing: That all who suffered from hay fever or asthma have one thing in common with the others—an overload in the blood stream of a body poison very similar to histamine. Was a histamine-like substance the poison? He set out to investigate. In a famous Medical University where his tests were made, he injected small amounts of histamine in his control cases, and the results of these tests convinced him that a histamine-like substance is present in excessive amounts in all hay fever, asthma and other allergic disorders. Amazing Drug Discovery. However—The drug to counteract it was not found yet. Months of experimenting followed. Finally a clue was found—a small one but a clear one. He narrowed his experiments to the various salts and derivatives of the [blocked in center]. "1. Histamine (or a substance very similar to this common body poison), was found in excess amounts in the blood of all hay fever, asthma and other allergic cases observed. "2. The histamine-like substance was identical in all patients regardless of what pollens they were sensitive to (or what foods in the case of asthma, hives, etc.) " 3. Histamine poisoning is now believed by medical scientists to be the under- lying cause of hay fever, asthma, and other allergic disturbances. " 4. Histeen acts to neutralize and overcome histamine-poisoning and in test cases of hay fever, asthma and hives it has produced rapid and remark- able relief—often appearing in the first few minutes and producing an appar- ently complete absence of irritation and distressing symptoms. * * * drug which had shown the first hint of results. And then one day, a simple variation of a previous experiment gave the answer. It was amazing. The new drug brought prompt relief in the test cases almost as quickly as did the so-called ' emergency' asthma and hay fever drugs—but its effects did not wear off as rapidly—it was more lasting. A wholly new degree of lasting relief had been found. Careful Testing To Prove Results That was the first discovery of Histeen. Then followed long and exhaustive tests—two and one-half years of them. Tests were watched carefully. Test after test was conducted, Finally the doctor took his researches out of his clinic, and enlisted the aid of the laboratory of a great Medical University. The relief-results in some of the doctor's asthma cases lasted as long as the two and one-half years. And the University tests served to verify the doctor's beliefs. Two and one-half years after Hihieen was discovered and only after the tests had shown His- teen's power time and titi.a again, the secret was at last released. An End To Hay Fever Torture The miicago specialist's find may easily be considered the most basic work in the long war on hay fever. It may be the final answer to this baffling problem. For by bringing action directly to bear on the common poison found in all hay fever and asthma cases examined, the long-drawn-out experience process of pollen testing and injections may now be entirely unneces- sary. Certainly this new drug promises quick, inexpensive short-cut relief "; (testimonials) "Mrs. J. B., age 51 years. Hay Fever and Asthma. Had Hay Fever for 11 years. Attacks every August brought on Asthma, wheezing, run- ning nose and inflamed eyes. Treatment: 2 Histeen tablets one-half hour after meals and at bedtime. Case immediately relieved and all symptoms disappeared. Mrs. J. R., age 30 years. Asthma and Hay Fever every summer and fall for 5 years with persistent cough and other usual symptoms. Treatment: Two Histeen tablets one-half hour after each meal and at bedtime. Gave prompt relief, irritat- ing cough stopped and patient states feels much better. Miss P. H., child 6 years of age. Mother stated child had Asthma since 1 year old. More severe during Hay Fever season. Chokes up and breathing very difficult. Treatment: 1 Histeen tablet at bedtime daily has given complete relief for past 18 months. Mr. F. W., age 54 years, Bronchial Asthma. Unable to sleep in bed for 9 years because of choking spasms. Sat up in easy chair instead. Treatment: 2 Histeen tablets 4 times daily, since reduced to 1. Has been free of Asthma attacks since treatment began 2 months ago and now sleeps comfortably in bed. Miss E. B., age 21. Hay Fever and Asthma for past 10 years. Espe- cially bad during Hay Fever season. Treatment: 2 Histeen tablets one-half hour after each meal and at bedtime (since reduced to 1 tablet per dose) brought complete relief from all asthmatic and hay fever symptoms. Mr. A. L., age 29. Hay Fever and Asthma for past 6 years. Treatment: Histeen tablets in usual doses aborted all hay fever and asthmatic attacks. Has been free from all symptoms for more than one year. Mr. E. S., age 47. Hay Fever for 10 years beginning in August. So severe unable to work. Treatment: 2 Histeen tablets 4 times daily (later reduced to one per dose). Immediately relieved of all attacks and symptoms. Has not had return of symptoms since August, 1931, when first treated Directions * * * in Hay Fever * * * Take Two Histeen Tablets one-half hour after every meal, and Two each night before retiring until the attacks are thoroughly relieved. Then One Tablet four times daily will probably be found sufficient. Where necessary, Three Tablets per dose may be taken with perfect safety as long as required— * * * It should be understood that Histeen is taken in order to combat the histamine- like poison which according to the latest scientific theory is a basic cause of hay fever, asthma and other allergic disorders. Histeen will not prevent this poisonous matter from forming. It acts, however, to counteract and neu- tralize excess amounts as they appear and thus assist in promptly overcoming the attacks. For children from 6 to 12 years of age, begin with One Tablet at night and if necessary increase to One Tablet four times daily. Note: These same directions should also be followed in cases of Rose Fever. In Asthma And Bronchitis Observe the same routine in asthma as in hay fever. And, even though the attacks may disappear promptly, be sure to continue taking fif- teen long enough to get the best results. In Hives Take Two Histeen Tablets one-half hour after each meal, and Two just before retiring, as in hay fever and asthma." On December 9, 1933, and January 24, 1934, no claimant having appeared for the property, judgments of condemnation and forfeiture were entered, and it was ordered by the court that the product be destroyed by the United States marshal. M. L. WILSON, Acting Secretary of Agriculture.