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.