In 1910, the Bureau of Chemistry attempted to prosecute the promoter of “Dr. Johnson’s Mild Combination Treatment for Cancer.” The Supreme Court, however, ruled that the 1906 Pure Food and Drugs Act did not prohibit false “therapeutic” claims on drug labels – only false statements about drug composition.

With the admonition that “there are none so credulous as sufferers from disease,” President William Taft called on Congress to close this loophole. The Sherley Amendment of 1912 made it a crime to label drugs with false and fraudulent claims of therapeutic effectiveness, but it also saddled FDA with the burden of demonstrating fraudulent intent, a legal handicap until passage of the 1938 Food, Drug, and Cosmetic Act.