The Pure Food and Drug Act of .1906 included among its goals the regulation of the flood of "patent" medicines that were marketed with outrageous claims and dangerous ingredients. Charged with enforcing the new law was a man who had been instrumental in its passage, Harvey W.. Wiley, chief of the Department of Agriculture's Bureau of Chemistry. Wiley chose a headache remedy called Cuforhedake Brane-Fude, which Robert N. Harper had been making since .1888, as his first test case.

Brane-Fude was a combination of several compounds and a large amount of alcohol, a standard ingredient for patent medicines of the day. After the 1906 law passed, Harper tried to comply with its provisions and changed his medicine's label. Wiley believed the change was insufficient, since the label continued to claim the medicine was "harmless" and had "no . . . poisonous ingredients of any kind." Wiley also felt the name...