By 1900 there were an
estimated one million opiate
addicts in the United States,
the majority of whom became
addicted unwittingly, through
the use of patent medicines
whose ingredients were
proprietary secrets. Public
outcry inspired the 1906 Pure
Food and Drug Act, which outlawed
the manufacture and sale
of poisonous patent medicines
and required that drugs be
labeled with their ingredients.
However, it did not forbid the
sale of patent medicines containing
cocaine or opium so
long as they were properly
labeled. Under pressure from
newly informed consumers,
responsible companies stopped
using and supplying opiates,
and opium was eventually
placed under federal restrictions
by the Harrison Act of 1914.
In 1927, the Food and Drug
Administration (FDA) as we
know it was formed, and in
1938, the Food, Drug, and
Cosmetic Act instituted mandatory
pre-market approval of
drugs by the FDA.