“[O]n 30 June 1906 President Roosevelt signed the Food and Drugs Act, known simply as the Wiley Act… The basis of the law rested on the regulation of product labeling rather than pre-market approval.”
“An Act for preventing the manufacture, sale, or transportation of adulterated or misbranded or poisonous or deleterious foods, drugs, medicines, and liquors, and for regulating traffic therein, and for other purposes…
That for the purposes of this Act an article shall also be deemed to be misbranded… if the package fail to bear a statement on the label of the quantity or proportion of any alcohol, morphine, opium, cocaine, heroin, alpha or beta eucaine, chloroform, cannabis indica, chloral hydrate, or acetanilide, or any derivative or preparation of any such substances contained therein.”