[5] In [late] 1950[,] our Kansas City District received a complaint that children became ill after eating this candy.
Investigation of the manufacturing process by our Denver District revealed that the candy contained about 0.25% of dye [FD&C Orange No.
Our Division of Pharmacology found that the candy caused abdominal cramps and diarrhea in human volunteers.
It was further shown that an amount of the Orange Blend contained in twelve kisses caused identical symptoms.
Since practically no information was available regarding the amount of coal-tar color used in various food products, it was decided to initiate an investigational program to assemble such data.