FORMALDEHYDE LOZENGES
Report of the Council on Pharmacy and Chemistry
The Council has voted Hex-Iodin (Daggett and Miller Co., Inc., Providence, R. I.), Formitol Tablets (E. L. Patch Co., Boston), and Cin-U-Form Lozenges (McKesson and Robbins, New York City) inadmissible to New and Nonofficial Remedies, and authorized publication of the report which appears below.
W. A. Puckner, Secretary.
Some years ago, the Council published (The Journal A. M. A., Aug. 28, 1915, p. 816) a report on Formamint, a proprietary medicine widely exploited as a peculiar chemical compound of sugar of milk and formaldehyde. The formaldehyde was said to be liberated slowly by the action of the saliva, and because of this liberation of formaldehyde, Formamint was claimed to be a powerful germicide. Extravagant claims were made for its curative and prophylactic effects. The Council found that the therapeutic claims were grossly unwarranted and that its exploitation to the public was a public danger.
During the recent epidemic of influenza, a variety of tablets or lozenges were advertised, and are still being advertised, having formaldehyde, in some form or other, as the nucleus around which revolve the therapeutic claims. In some cases, the advertising clearly indicates the character of the formaldehyde compound that is claimed to be present; in others the statements are vague and indefinite or misleading.
It is hardly necessary to remind physicians that the use of tablets containing hexamethylenamin or other formaldehyde compounds can neither cure respiratory infections, nor even confer protection against such infections. To be effective, formaldehyde would need to be supplied to the entire respiratory tract continuously for some time or else in concentrations that would be distinctly irritant and damaging to the tissues. Saliva-dissolved tablets, obviously cannot reach the nasal or tracheal mucosae directly; and the application of quickly acting concentrations of formaldehyde is out of the question. This altogether aside from the fact that hexamethylenamin, the basis of some of these tablets, does not liberate formaldehyde in the mouth, and for this reason alone would be quite useless for this purpose! (See Hanzlik and Collins, Archives of Internal Medicine, November, 1913.)
An inefficient antiseptic is more than merely useless; it is a menace to public safety, in that it tends to lead to the neglect of rational and effective protective measures. It therefore seems advisable for the Council again to call the attention of physicians to the subject. Accordingly, three specimens of these products were purchased and examined in the Association’s Chemical Laboratory.
Hex-Iodin
Hex-Iodin (Hexamethylenetetramine and Iodum) Lozenges are manufactured by Daggett and Miller Company, Inc., Providence, R. I. They weigh 151⁄2 grs. each, are sweetened and are flavored with mint or menthol. The package and circulars do not contain a definite statement of composition. The rather indefinite synonyms “Hexameth. and Iodine Comp.” and “Hexamethylenetetramine and Iodum” suggest that the lozenges contain hexamethylenamin and free iodin. The further statement that they “contain the combined medicinal antiseptic and prophylactic properties of Hexamethylenetetramine and Iodum” is also rather indefinite. The therapeutic action claimed for the lozenges, however, could only be produced by free iodin and by liberated formaldehyde.
It is unnecessary to discuss in detail the extravagant claims made for these lozenges. The inefficiency of hexamethylenamin has already been referred to; the limitations of iodin, free or combined, in lozenge form, need not be discussed because the examination made in the A. M. A. Chemical Laboratory showed that Hex-Iodin lozenges contained no free iodin, and only traces of combined iodin. Neither formaldehyde nor paraformaldehyde was present; hexamethylenamin was present but, the lozenges being neutral no formaldehyde is generated in contact with water or with the alkaline saliva.
Thus Hex-Iodin is shown to be worthless for the purpose for which it is advertised. Of the two important ingredients said to be present, iodin and hexamethylenamin, only traces could be found of the former while the latter, as has been shown, is incapable of exerting any effect when used as the manufacturers direct.
Formitol Tablets
These tablets are prepared by the E. L. Patch Co., Boston. Each tablet weighs 131⁄2 grs. They have the odor of thymol or menthol and an acid taste and reaction. They are, according to the label:
“For the throat and mouth. Soothing, Astringent, Antiseptic. Rapidly destroys germs of infection, preventing and relieving sore throat and mouth.”
In a circular, it is stated, that one of the qualities of Formitol:
“... is the generation of formaldehyde when in contact with water or the saliva.”
“Besides generating formaldehyde, Formitol, Patch contains astringent, demulcent and soothing ingredients which render the combination unusually effective.”
A bacteriologic report is given in this circular in which it is stated that, in 21⁄2 minutes one Formitol Tablet rendered sterile a plate culture of a “characteristic throat micrococci.” The instructions are to dissolve a tablet in the mouth, slowly, once an hour or a half-tablet every half hour.
The A. M. A. Chemical Laboratory reported that Formitol Tablets contained formaldehyde (or paraformaldehyde), and ammonium compound, and some hexamethylenamin. It is probable that the formaldehyde (or paraformaldehyde) was produced by the decomposition of hexamethylenamin originally present in the tablets but decomposed by long contact with the acid.[128]
These tablets differ from Hex-Iodin in that they really contain active formaldehyde and, therefore, possibly produce antiseptic effect in test-tube cultures. The conditions in the mouth, however, are very different from those in the test-tube, since in the mouth the formaldehyde would be immediately “bound” or absorbed. The claimed absence of irritation indicates sufficiently the absence of efficient quantities of formaldehyde under clinical conditions.
Cin-U-Form Lozenges
Cin-U-Form Lozenges, manufactured by McKesson and Robbins, New York City, are marketed in bottles of 24 for 25 cents. They have a strong odor of cinnamon, weigh 151⁄2 grs. each, and are acid in taste and reaction. The label states that they contain:
“Cinnamon, Eucalyptus, Formaldehyde and Menthol—all powerful germicides against Influenzal bacilli, but not injurious to the system in this palatable form.”
A circular contains the same statement as to composition and claims further that they:
“... help to prevent the infection of Spanish Influenza, Pneumonia, Grip Colds and to guard against Sore Throat, Tonsillitis, Pharyngitis, etc.”
The A. M. A. Chemical Laboratory reported that Cin-U-Form Lozenges contained some formaldehyde (or paraformaldehyde) and no hexamethylenamin. It is obvious that the mouth and throat cannot be “disinfected” by these lozenges. They would be totally ineffective against bacteria that enter through the nose; they cannot prevent influenza, pneumonia, etc.—(From The Journal A. M. A., Oct. 4, 1919)