21513. Misbranding of Stuart's Dyspepsia Tablets. U. S. v. 141 and 141 Packages of Stuart's Dyspepsia Tablets. Default decrees of con- demnation, forfeiture, and destruction. (F. & D. nos. 30928, 31045. Sample nos. 40571-A, 40597-A.) Examination of the drug preparation Stuart's Dyspepsia Tablets disclosed that the article contained no ingredient or combination of ingredients capable of producing certain curative and therapeutic effects claimed in the labeling. On August 22 and September 21, 1933, the United States attorney for the Northern District of Illinois, acting upon reports by the Secretary of Agricul- ture, filed in the district court libels praying seizure and condemnation of 282 packages of Stuart's Dyspepsia Tablets at Chicago, Ill. alleging that the article had been shipped in interstate commerce, in part on or about June 19, 1933, by F. A. Stuart, and in part on or about August 14), 1933, by the F. A. Stuart Co., from Marshall, Mich., and charging misbranding in violation of the Food am* Drugs Act as amended. ( Examination of- a sample of the article by this Department showed that it insisted of large tablets composed essentially of calcium carbonate, magnesium carbonate, ginger, sugar, and starch; and small tablets composed essentially of calcium carbonate, extracts of plant drugs including red pepper and a bitter drug, sugar, and starch. It was alleged in the libels that the article was misbranded in that the following statements appearing on the tin container and in a leaflet and booklet shipped with the article, regarding its curative and therapeutic effects, were false and fraudulent: (Tin container) "Dyspepsia * * * Dyspepsia * * * If relief is not obtained, as in cases of acute indigestion, with severe pain, repeat the above dose of two large and one small tablet every 20 minutes if necessary. * * * Dyspepsia * * * to be used whenever any distress or discomfort is felt in the stomach "; (leaflet) " Dyspepsia * * * bilious- ness"; (booklet) "The Treatment of * * * Duodenal and Stomach Ulcer Cardialgia and Similar Stomach Disorders * * * Dyspepsia * * * In the past, sodium bicarbonate has been the alkali used by the public and phy- sician in treating gastric and duodenal disorders. It has many disadvantages. Stuart's Dyspepsia Tablets * * * has these superior qualities: Only small doses are required, and it can be used continuously in any amount without pro- ducing renal calculi, constipation or diarrhoea. It cannot produce alkalosis, because not enough is absorbed in the blood, practically the entire amount taken being discharged from the body through the intestinal tract. Increased dosage is not required to relieve pain. Its effects are not just temporary. It is sooth- ing and corrective. Reduced dosage is usually the result of using Stuart's (dyspepsia) Tablets. The resulting relief from pain makes life more enjoyable and improves the morale of the sufferer. Gastric Ulcers: Duodenal and Stomach Backache may be the only symptom, but usually the symptoms of chronic dyspepsia are present for months or years. The pain in ulcer occurs one to three hours after a meal, when the food has become saturated with acid. It disappears as the stomach empties itself. It occurs later after a large rather than after a small meal. Pain in an empty stomach not relieved by Stuart's Tablets is not due to ulcer. Periodicity of symptoms with spring and ¦fall re-occurrence is characteristic of peptic ulcer. Regardless of treatment, eventually chronicity is prone to result. Ulcers should be treated medically until cure or chronicity results. Ninety percent of all cases recover under medical treatment. Gastric Ulcers usually show some, if not all, the symptoms of chronic dyspepsia. Belching gas, heartburn, cardialgia, coated tongue, fetid breath, bad taste in the mouth, food retained in the stomach causes gase- ous distension, possibly nausea and vomiting; appetite capricious, headache, lassitude, heart palpitation and vertigo are common. Remissions, and as a re- sult of dietetic errors, recurrence, Diarrhea may occur. The result depends on the stage to which the disease has advanced. Much is accomplished by calcium carbonate treatment (part of Stuart's formula). * * * dyspepsia is often permanently relieved by the use of the proper alkalies (Stuart's Tablets) * * * Practically all of the functional and organic or neurotic symptoms accompanying stomach or duodenal ulcers or mentioned in the description of dyspepsia, usually are accompanied by excess acidity of the stomach. This is relieved either by Stuart's Tablets or by vomiting. * * * 'In such a case these alkalies, Stuart's formula, which neutralize the excessive acid and de- crease the secretion, is an appropriate remedy.' * * * ' They are almost solely employed in forms of dyspepsia. Without doubt cardialgia, gastric un- easiness. * * * ' Cardialgia Heart Pain. A symptom of dyspepsia occur- ring at the height of digestion one-half to three or four hours after eating. The presence of hyperacidity is shown by the sense of weight and burning sensation over the stomach in the aesophagus, belching gas, pain over the heart, spasm of the upper end of the stomach; relieved by the proper alkalies or by vomiting. * * * Heartburn accompanies most all dyspepsia, following acute and chronic diseases that are characterized by malnutrition and loss of weight (a usual symptom of dyspepsia). (6) 'But experience shows that Lime salts (used in Stuart's formula) is a valuable remedy in deficient nutrition, and in convalescence from serious disease. In some instances these good re- sults are traceable to the action of this lime salts on the mucous membrane of the intestines.' * * * (7) Hard and Rivers describe cases treated for duodenal ulcer, who developed definite toxemia with renal changes due to Wing sodium bicarbonate.' The advantages of the Stuart formula over sodium 72592—34 2 and other alkalies in cases of dyspepsia, and other gastric diseases, is discussed in the Introductory herewith. * * * Stuart's Tablets can produce no if effects, and form no habits if long administered, and are more effective in gas trie diseases than any other drug in allaying pain, producing comfort and caus- ing cure. Growing Children Dyspepsia (Sub-acidity, Anacidity, Achylia are almost unknown), is a common symptom due to dietetic errors. In infancy, ulcer of the stomach or duodenum is rare, and is usually diagnosed at autopsy. In older children ulcers are rare, but dyspepsia presents the same picture as in adults and its resulting gastric catarrh is more common in children, and heart- burn and loss of weight and malnutrition more pronounced. The chief value to children, however, of Stuart's formula, is that it contains vital minerals needed by growing bodies. Important medical authorities have published the following opinions on the actual need in the system of the growing child of these vital minerals: (8) 'They have this advantage over other remedies in children. They are particularly serviceable for diarrhea of children with sour smelling stools and other symptoms of gastric intestinal acidity.' (9) 'The heart and other muscles deprived of calcium in proper form will no longer contract.' (10) 'Entering the blood in small quantities, they promote construc- tive metamorphosis (growth)'; (11) 'They are useful restoratives and ant- acids in the diarrhea of strumous (undernourished) children. * * * dys- pepsia * * * (12) 'Administered in the ordinary way, they furnish mate- rial needed by the organism in its growth.' ' * * * associated with diar- rhea.' * * * In treating gastric diseases in children, who are suffering from malnutrition, loss of weight, and the usual symptoms of dyspepsia (where the carbohydrate foods are restricted, as they must be) an ant-acid-like cal- cium carbonate compounded as in Stuart's formula, which does not cause alka- losis, is imperative. It is far superior to sodium bicarbonate, or other alkali. * * * Growing Children." On October 9, and November 13, 1933, 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.