COLALIN OMITTED FROM N. N. R.
Report of the Council on Pharmacy and Chemistry
The following report explaining the omission from New and Nonofficial Remedies of Colalin has been authorized for publication.
W. A. Puckner, Secretary.
Colalin is a bile salt preparation claimed to consist essentially of hyoglycocholic and hyotaurocholic acids. It is manufactured by Rufus Crowell and Company, Somerville, Mass., and marketed by Schieffelin and Company, New York.
An examination of the current advertising by the referee of the Council in charge of bile salt preparations having revealed that claims were made for Colalin which were not in harmony with the known action of bile preparations, Schieffelin and Company were informed that in the opinion of the referee the Colalin circular matter required radical revision. In this communication the referee’s objections to the claims were set forth in detail.
No reply to this letter was received, and hence a copy of the letter was sent to Schieffelin and Company and also to Rufus Crowell and Company with the explanation that unless the statements in the Colalin advertising which the referee had questioned were substantiated by satisfactory evidence, were suitably revised, or else the advertising matter withdrawn pending revision, the referee would be obliged to recommend to the Council that Colalin be omitted from New and Nonofficial Remedies.
In reply, Schieffelin and Company wrote that they were not “engaged actively in the introduction of Colalin,” and agreed to the omission of Colalin from N. N. R.
In view of the failure to substantiate the claims objected to or an agreement to discontinue them, the Council directed that Colalin and Colalin Tablets be omitted from New and Nonofficial Remedies for conflict with Rule 6 (unwarranted therapeutic claims).
The following are the claims which the referee questioned:
“Colalin embodies the physiological function of the bile in the intestinal canal and also possesses properties of its own which are intimately connected with the function of the liver.”
The quotation implies that Colalin has properties essentially different from those of bile salts, a claim which requires substantiation.
“In the liver its action seems to be that of a general stimulant of all the hepatic functions.”
This is a claim which requires substantiation.
“By the introduction of Colalin it has therefore become possible to actually utilize the bile for therapeutic purposes.”
This is an unwarranted claim, for bile was used therapeutically before Colalin was introduced.
“As gall-stones are chiefly composed of cholesterin, experiments were made to determine whether Colalin would dissolve these concretions outside of the body. These were completely successful and were then followed by an extensive series of clinical investigations on persons suffering with cholelithiasis, which demonstrated that by the administration of Colalin in many instances gall-stones were evacuated by the natural passages and their further formation prevented without resort to surgical intervention.”
This is misleading in that the context shows that “without surgical intervention” is meant to imply a connection between the experiments showing the solvent power of Colalin and the passage of concretions.
“... Colalin not only acts as a solvent of cholesterin calculi, but prevents their further formation by removing the causes upon which their development depends.”
This conveys the impression that such solvent action is exerted in the body, that is, that such concretions in the gallbladder may be dissolved and evacuated by the use of Colalin. For this claim there is no evidence.
“To understand the value of Colalin in intestinal disorders it is necessary to bear in mind the important functions of the bile in the intestinal canal, namely, its participation in the digestion of fats, its antitoxic action, and its influence upon the peristalsis.”
“... through its antiseptic influence inhibits the production of toxins in the intestines.”
The referee believes that there is no satisfactory evidence that bile or bile salts can inhibit the production of toxins in that part of the intestine—the colon—in which they are commonly produced.—(From Reports of Council on Pharmacy and Chemistry, 1918, p. 52.)