Part of United States food and drug regulatory
lore includes, at this point, an unlikely convergence
of two famous characters. Onewas President Theo-
dore Roosevelt, nationalist ex-‘rough-rider’, sol-
dier in Cuba and hero of San Juan Hill. The other
was Upton Sinclair, United States’ first published
communist, and author of ‘The Jungle’, intended as
an e ́xpose ́ of North American capitalism at its
worst. Sinclair’s book was being serialized in the
DC newspapers, which the President habitually
read during his high-cholesterol breakfast, which
always included sausages. In one daily episode of
the book, Sinclair described the use of offal, floor-
waste and other abominations at the end of the
daily sausage run, in the attempt to maximize
profits. Dr Wiley had his political ally, and the
Pure Food and Drug Act (PFDA) and Meat Inspec-
tion Act were the result (1906).
The PFDA banned adulterated or misbranded
drugs from interstate commerce, and this remains
the legal basis for FDA actions to this day. Today’s
definitions of ‘adulterated’ and ‘misbranded’ are
also those of nearly a century ago. The philosophy,
however, has long been forgotten: if you made bad
drugs, then you had to sell them within your own
community, and the local law enforcement people
should have found you out fairly easily for them-
selves. This is, arguably, a survival of the Anglo-
Saxon principle of frankpledge within the twenti-
eth century US laws.
From among the wide variety of dyestuffs avail-
able in the north-eastern factories before the First
World War, just seven were authorized for human
consumption by the Certified Color Regulations
(1907). This brought dyestuffs within the canon
of interstate commerce law. This is not as incon-
gruent as it might seem because among these dye-
stuffs were the first, primitive antibiotics.
But, then as now, the US Supreme Court was not
averse to getting involved in unprecedented situa-
tions. In 1911, the Court held that the 1906 Act did
not prohibit false or misleading therapeutic claims,
but was strictly to be interpreted in terms of purity
and composition.PFDAwas thus amended in 1912,
to include specifically false therapeutic claims.
However, the Act now required proof of intent to
be fraudulent: it was essentially a criminal matter.
This need for proof of intent made the Act hard to
enforce, and few could be punished or made to
change their ways. In 1914, a further amendment
defined the presence of poisonous or adulterated
substances was specifically a violation of the Act,
although the definitions of precisely what was a
poisonous or adulterous substance would have to
be developed on precedent.
It was not until 1924 that a further PFDA amend-
ment that made mere statements potentially a vio-
lation under the Act. For the first time, exaggerated
claims of therapeutic effectiveness could be pro-
scribed. This amendment went further to specify
that even true statements that nonetheless deceive
or misinform would henceforth fall foul of the Act
(malt vinegar without any written claim to be apple
cider vinegar, but with an apple depicted on the
label, was cited as an example of how this situation
could arise).
Ever since 1906, there had been many chal-
lenges to the Act and its amendments, and this
consumed much administrative time and money.
The innovation of 1930, expansion of the Bureau of
Chemistry into a renamed Food and Drug Admin-
istration, was designed to relieve this administra-
tive burden. The new Agency introduced a Bill into
Congress, that was designed to invigorate and
modernize the by now patchwork and creaking
amended PDFA.
Once again, there was resistance to the Bill.
However, communications were modernized, and
public opinion was molded not only by newspapers
but also by radio: and radio could be heard hun-
dreds of miles away. One small fly in the proverbial
ointment, however, was that Teddy Roosevelt’s
nephew, Franklin Roosevelt, was now President;
the President was wheel-chair bound due to polio,
and believed in the therapeutic value of hot springs
and other complementary therapies.
At about this time (1931), an OTC potion called
‘Jake’ poisoned hundreds of people. It was prob-
ably a peripheral neurotoxin due to an adulterant in
an extract of Jamaican ginger: ‘Jake-leg’ became a
recognized syndrome. While Jake ‘the Peg’, with
an extra leg (i.e. an axillary crutch), became
famous, it needed a much bigger disaster to move
legislative and public opinion.
Domagk demonstrated in 1935 that sulfonamide-
containing dyes could protect mice from infection;31.1 THE FOOD AND DRUG ADMINISTRATION: HOW WE GOT TO WHERE WE ARE 397