31 United States Regulations

1

William Kennedy

31.1 The Food and Drug

Administration: how we

got to where we are

Once upon a time...there was no FDA. However,
the history of food and drug regulation began well
before any modern government administration,
anywhere in the World. Drugs and foods have
only become distinguished from each other in the
relatively recent past, and, it can be argued, as yet
incompletely in the United States.
The ancient Greeks, Romans and Arabs all regu-
lated food and drugs. Principally, their concern was
with product purity, one of the three pivotal con-
cepts that still form the basis for drug approval
today. The typical penalty in ancient times for
violating the standards was the loss of the dominant
hand that had made the adulterated product. The
Arabs were probably the most conscientious of
regulators, with standards for about 2000 drug
products, and, like today’s FDA, they were the
first to establish a professional staff of food and

drug inspectors. Their penalty for a baker of under-

weight loaves exceeded that of the drug adulterer:

the bakers went summarily into their own ovens.

In 1202, the first English regulation was identi-

fied, traditionally, as the Assize of Bread. In fact,

this assize had been held by manorial lords for a lot

longer than this, and the lords were often also the

exclusive owners of the ovens. To remedy this

small aspect of local despotism, presumably with

skepticism about self-regulation, the new national

law forbade the incorporation of ground peas or

beans in the flour meal. Meanwhile, the London

Grocers had organized, and formed their own

guild, again with self-regulation of a wider range

of foodstuffs. In the seventeenth century, the

London apothecaries (makers of medicines and

also licensed medical practitioners in their own

right) devolved from the Grocers. The Worshipful

Society of Apothecaries of London still exists, can

still award a medical license (although this is quite

rare among British physicians) and is now the

largest of all the London guilds.

What with 1776 and all that, the British jurisdic-

tion of food and drug regulation ceased to obtain in

what were to become the United States. The

apothecaries were still people who had trained

mostly in London or Germany, or had graduated

to professional status by apprenticeship. But, there

Principles and Practice of Pharmaceutical Medicine, 2nd Edition Edited by L. D. Edwards, A. J. Fletcher, A. W. Fox and P. D. Stonier
#2007 John Wiley & Sons, Ltd ISBN: 978-0-470-09313-9

(^1) The paragraphs about the year 2005, immediately preceding
the Summary to this chapter, were inserted after going to
press by the Editors; the Editors are also grateful to Dr Tim
Franson for his perspective on pediatric issues.