In the Council report (The Journal A. M. A., Oct. 4, 1919, p. 1077) on the ineffectiveness of lozenges claimed either to contain formaldehyd or to liberate formaldehyd in the mouth, the composition of Formitol Tablets of the E. L. Patch Co. was briefly discussed in the following terms:
“The A. M. A. Chemical Laboratory reported that Formitol Tablets contained formaldehyd (or paraformaldehyd), an ammonium compound, and some hexamethylenamin. It is probable that the formaldehyd (or paraformaldehyd) was produced by the decomposition of hexamethylenamin originally present in the tablets but decomposed by long contact with the acid.”
At the time this report was published, the label and the advertising matter contained but vague and indefinite statements with regard to the composition of Formitol Tablets. In the October, 1919, issue of Patchwork, the house organ of the E. L. Patch Co., it was denied that these tablets contain hexamethylenamin since none had ever been used in their manufacture. It was also claimed that the company had a “printed sheet giving the formula of these tablets.”
The Council advised the E. L. Patch Co. that it desires to publish only facts about the products which it examines and that if the report on Formitol Tablets was inaccurate in any way the Council would want to correct any error it might have unintentionally made. As the Formitol advertising in the files of the Council contained no information as to the composition of the tablets, the firm was also requested to send the printed sheet giving the “formula.”
When this printed “formula” came it was found to be a sheet used by the E. L. Patch Co. for the purpose of giving its salesmen information regarding Formitol tablets, to be passed on to the physician. This printed sheet conveyed the information that Formitol Tablets contain ammonium chlorid, benzoic acid, citric acid, guaiac, hyoscyamus, menthol, paraformaldehyd and tannic acid, but it gave no information in regard to the amount of any of the ingredients except that it declared that each tablet represents the equivalent of 10 minims of a 1 per cent. formaldehyd solution.
Because of the nonquantitative, and, therefore meaningless printed “formula” and because, also, of its complexity, it was thought desirable to make a more complete analysis of Formitol Tablets. Experience has shown that frequently the real formula of a thing is quite different from the alleged formula published by the manufacturer. The details of the laboratory’s later analysis will appear in the Annual Reports of the Chemical Laboratory or may be had on request.
The result of the laboratory’s additional experimental work, especially when taken in connection with investigations made elsewhere on the interaction of formaldehyd and ammonium chlorid justifies the conclusion that Formitol Tablets do contain some hexamethylenamin, even though the amount may be very small. As the E. L. Patch Co. declare that no hexamethylenamin is put into Formitol Tablets the conclusion drawn in the Council’s original report to the effect that the formaldehyd probably was formed by the decomposition of hexamethylenamin was evidently an error. The hexamethylenamin present is doubtless produced by the action of the paraformaldehyd on the ammonium chlorid present.
The analysis also showed that more than 78 per cent. of the weight of Formitol Tablets was made up of sugars and about 16.5 per cent. was starch and other material, some of which was talcum or similar material. This means that about 94 per cent. of the total weight of the tablets is sugar and starch, neither of which is mentioned in the printed “formula.” The significance of this is apparent when it is considered that there are eight ingredients listed in the “formula” for which therapeutic effects are claimed. Since a tablet weighs about 13.5 grains, the combined weight of all the claimed active ingredients is less than 1 grain per tablet!
The amount of ammonium chlorid found, as indicated by the total nitrogen, was not more than 1.0 per cent. or about 1⁄8 grain per tablet. The amount of benzoic acid found was 0.34 per cent. or 1⁄25 grain per tablet. Yet these two drugs are said to exert their peculiar expectorant action. (The U. S. P. lozenge of ammonium chlorid contains 11⁄2 grains ammonium chlorid or twelve times the amount of this drug in a Formitol Tablet.)
The tannic acid contained in the tablets could not be determined with accuracy but it was much less than 1 per cent. (or 1⁄8 grain per tablet) yet it is said to add valuable astringent qualities to Formitol Tablets! (The U. S. P. lozenge of tannic acid contains 1 grain of tannic acid.)