was a void in national regulation of food and drugs.
British patents, which had already been awarded to
American drug recipes, also became null and void.
Over-the-counter (OTC) medicines (or ‘patent’
medicines) thrived in this void. The American
patent process was also undeveloped, so these
became what we would perhaps view as trade
secrets held by named apothecaries and their
apprentices. There were also no inspectors. More-
over, the British were not quickly mollified by the
new political reality: European medicines were
included in the embargo, and yankee ingenuity
began to be expressed to the full. The problem
quickly evolved: Who was to say that the ‘eye of
newt’ in the Scottish witches’ potion was not actu-
ally a bit of chicken?
It has been said that the drug law in the United
States developed in the eighteenth and nineteenth
century with all the red, white and blue of the
anilene dyes that quickly became available. Reg-
ulations in this country rapidly developed in a
characteristically idiosyncratic manner.
Sewers and food do not mix. This was the era
of rapid expansion of Boston, Philadelphia,
New York, Baltimore and eventually Washington,
DC itself. Massachusetts regulated food for the first
time in 1784, but this again was a feeble attempt to
control purity. No attempt was made to address the
potions used to treat ineffectively the infectious
diseases that were rampant.
‘Dr Feelgood’ potions, typically named after the
apothecary who compounded them, had epon-
ymous effects. These potions usually contained
alcohol and morphine, were used indiscriminately
and at least made people feel good. One of these
survives, ironically enough in England, and is
called ‘Dr John Collis-Brown’s Compound’.
The American geography constrained the regula-
tory environment. First, there was a lot of pioneer
activity in the West: trained professionals were not
the first to climb on the covered wagons. Second,
new religions were being spawned at a rate far faster
than had ever occurred in any European country.
Third, worthless medicines were being distributed
and used over millions of square miles with, at best,
only rudimentary communications. The promotion
of medicines became a form of entertainment, by
bogus professors, showmen, fakers and embezellers
in Desert Gulch! Meanwhile, little opportunity was
taken to learn from the Native Americans, whose
herbals were often quite well developed with active
pharmacognosy. But the national government was
not stirred into action until its own interests were
directly affected: soldiers in the Mexican American
War were poisoned by ineffective antimalarials
south of the Rio Grande.
And so it was, in 1848, that the first drug regula-
tion was established in the United States. It simply
banned the import of impure drugs. The medicine
man shows were left to local regulation (a legisla-
tive omission that is still with us today). And so it
was that in 1850, the State of California became the
first to enact anything resembling a comprehensive
drug regulation.
By 1900, it is estimated that about $40 million
per annum was being spent on drug advertising.
This was mostly in newspapers, which were thus
only too happy to ally with potion makers in
stirring up public opinion against the national
regulation of their products. Medicines (some up
to 50% alcoholic tinctures) became the only
source of alcohol in some communities where
religion forbade wine and whisky. For the more
adventurous, morphine, opium, cannabinoids and
cocaine were available, even in some of the ear-
liest formulations of Coca-Cola, although not,
of course, today.
Harvey Wiley was a hero among the villains. He
headed the Federal Bureau of Chemistry, and
began calling for national regulation in 1890. His
‘poison squad’, the forerunners of the Inspectorate
Branch of FDA today, began documenting and on
occasion prosecuting the makers of fake and poi-
sonous drugs. The convictions were usually for
things that were very egregious, probably because
Dr Wiley could only prosecute under the general
laws. Unlike today’s FDA inspectors, the members
of this squad were expected to sample the ques-
tionable product themselves, and then give first-
hand evidence of the adverse effects that they
experienced!
Specific regulation began in 1902, and con-
cerned the purity of serums and vaccines to be
used in humans; The Center for Biologics Evalua-
tions and Research (CBER) thus has a longer his-
tory than its colleague center for drugs (CDER).396 CH31 UNITED STATES REGULATIONS