FDA History 08
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HISTORY OF A CRIME AGAINST
THE FOOD LAW
CHAPTER VIII: THE UNITED STATES PHARMACOPOEIA
by Harvey W. Wiley, M.D., the very
first commissioner of the Food and Drug Administration (FDA), then known
as the “US Bureau of Chemistry.”
The United States Pharmacopoeia
is a book prepared by a national organization
chosen by the medical and pharmaceutical
colleges and societies of the country.
This organization meets once in each ten
years. The principal object of these
decennial conventions is to appoint a
committee for revising the United States
Pharmacopoeia. At the Convention which
assembled in Washington in 1910, much to
my surprise, I was elected president of
the Convention for the decennial period
ending in 1920. Ex officio I became a
member of the committee on revision. The
food-law specifically recognizes the United
States Pharmacopoeia, both as to the
standard of quality of the remedies described
therein and the methods of
analysis by which the purity of remedies
is established. Its activities,
therefore, are specifically prescribed
by the Congress of the United States as
one of the methods of administering the
Food and Drugs Act. Essential oils are
frequently standardized and prescribed
in the Pharmacopoeia. I was allowed to
select the particular part of the revision
work over which I was chosen to
preside. I had for several years, on account
of essential oils being
agricultural products, collected and studied
large numbers of these bodies. This
work was assigned to the committee studying
essential oils. I was very much
surprised, therefore, to receive from
the Secretary of Agriculture a written
statement for the amount of time consumed
in these investigations and the
probable expense to date of the work done.
Any one who is interested in the
further details of this remarkable request
will find them recorded on page 808
and following of the proceedings of the
Moss Committee.
The methods of analysis and
the standards of purity of drugs prescribed by
the Pharmacopoeia are specifieally adopted
by the Food and Drugs Act. The
regulations enacted for the enforcement
of the Food and Drugs Act are as
follows:
Unless otherwise
directed by the Secretary of Agrieulture, the methods of
analysis employed shall be those
employed by the Amociation of Official
Agricultural Chemists and the United
States Pharmacopoeia.
I made the following statement
to the committee:
I may say, Mr.
Chairman, that never in the history of the Pharmacopoeia has
such pains been taken to make it
as perfect as possible. In view of the fact
that Congress has made it the official
standard of drugs and medicines, the
present committee is taking special
pains to get all the information possible
to make the new edition as useful
as possible, for the purpose of securing
purity of drugs in this country.
During my absence from the
city I was informed by the Secretary of
Agriculture on June 15 that Dr. Dunlap
had told him he had information that work
was going on in the Bureau of Chemistry
in the revision of the Pharmacopoeia.
When Dr. Dunlap appeared
as a witness before the committee he was asked:
"What are your duties as associate chemist?"
He replied: "I have none."
Evidently he was mistaken.
It was he who by his detective abilities
discovered that the Chief of the Bureau
of Chemistry had deceived the Secretary
of Agriculture and induced him to appoint
Dr. Rusby illegally. Continuing the
exercise of these Sherlock Holmes activities
he discovered the Bureau of
Chemistry was doing illegal work in examining
the agricultural products known as
essential oils. These were noble and important
functions that somebody had to
perform. It was a great stroke of good
luck that put Dr. Dunlap into the
Department for this worthy purpose. President
Roosevelt deserves the gratitude
of the future for discovering and having
appointed a scientist of such ethical
activities and achievements. As a result
of Dr. Dunlap's activities the
Solicitor had told the Secretary that
these activities of the Chief of the
Bureau were clear violations of law and
the Secretary instructed me to do no
more work of any kind in connection with
revision of the Pharmacopoeia. At this
same time the members of the Referee Board
were paid salaries exactly as Dr.
Rusby was and had spent already several
hundred thousand dollars in their
attempts to prevent the food law from
being enforced. I found that the total
expense which had been incurred by the
Bureau of Chemistry up to the time the
order was issued to "cease and desist"
from these activities as violations of
law was exactly $55. Of all the tremendous
inconsistencies in regard to illegal
expenditures in the Bureau of Chemistry
in connection with the Remsen Board,
there was nothing so clearly and distinctly
disclosed as the complete propriety
of the activities of the Bureau of Chemistry
in securing a proper revision of
the Pharmacopoeia. This order forbidding
work in the Bureau of Chemistry along
that line was still in force in 1912 when
I retired from the Bureau. I do not
think it was removed during the remainder
of my decennial term.
This pusillanimous persecution
of itself amounts to nothing. It illustrates
the petty meanness of the environment
which the Chief of the Bureau was forced
to endure for so many years. The report
of the Moss Committee disclosed the
whole fabric of the net in which the enemies
of the food law had planned to
enmesh those charged by law to enforce
it. In regard to this matter the
following quotation from the Moss Committee's
record' is illuminating:
(MOSS COMMITTEE)
Page 887-888.
THE CHAIRMAN: Did I understand
you correctly in your testimony, when I was
asking questions, to say you can extend
the functions of the Bureau of
Chemistry, provided it is not prohibited
by law?
SECRETARY WILSON: I can use
administrative discretion that is not prohibited
by law. * * * I can illustrate that by
what happened at Denver. Dr. Long is a
member of the Referee Board from Chicago.
There had been going through the
papers and being stated by the chemists,
and so forth, that the best use to
which we could put benzoate of soda, and
the use to which it generally was put,
was to preserve decaying vegetables and
fruits. Dr. Long had made some extensive
investigations and reported there that
benzoate of soda would not preserve
either vegetables or fruits.
THE CHAIRMAN: Did I understand
you to say, in answer to Mr. Sloan, that there
was no authority in law for this pharmacopoeia
work--that it was absolutely
forbidden by law to do this work?
SECRETARY WILSON: No authority.
THE CHAIRMAN: Coming back
to your idea that you can extend the functions of
the Bureau of Chemistry, providing it
is not forbidden by law, would you not
have authority, under your construction,
to permit Dr. Wiley to do this work if
you had cared to do so?
SECRETARY WILSON: No; administrative
discretion can only be used in
furtherance of the object of the law.
Page 894-895.
MR. HIGGINS: Have you pursued,
Mr. Secretary, any different policy toward the
Chief of the Bureau of Chemistry than
with reference to any other chief in your
department?
SECRETARY WILSON: Not a particle.
You could not understand, if you happened
to look over the transom of the door and
see Dr. Wiley and me discussing one of
his new farms
MR. HIGGINS (interposing):
He is also an agriculturist?
SECRETARY WILSON: He has
farms, but he and I discuss them. I give him advice.
I am no chemist; but, then, he is no farmer
(laughter), and so we swap
information, you know. There is one delightful
thing about the Doctor: he has
humor, and unless I once in awhile get
a laugh I would run back to Iowa and stay
there. The Doctor has pleasant humor,
and he is a pleasant companion. If you saw
us in one of these interviews you would
not believe there ever was any trouble
about benzoate of soda.
MR. HIGGINS: You discuss
pleasant subjects at those interviews?
SECRETARY WILSON: Always.
MR. SLOAN: You are both bonnie
Scots, are you not?
SECRETARY WILSON: I am direct,
but I imagine he is tainted with the blood.
The Bureau of Chemistry was
not treated like other Bureaus. Secretary Wilson
was well aware of that fact. In no other
Bureau did he appoint an Associate
Chief, as he did in the Bureau of Chemistry,
without ever consulting the Chief
of that Bureau. In no other bureau were
funds specifically appropriated for
definite purposes used without the consent
of the chief for diametrically
opposite purposes. In no other Bureau
were changes made in administration
without consulting the Chief of the Bureaus
involved. No other Chief of Bureau
was ever secretly tried before the personnel
board, found guilty, and sentenced
to be dismissed from the service, as was
the Chief of the Bureau of Chemistry.
In no other Bureau were important component
parts thereof separated and put into
an independent bureau as was the case
in the Bureau of Chemistry with Soils and
Investigations of Road Building Materials.
While it is true that the Secretary
and the Chief of the Bureau were on friendly
terms personally, the Secretary
never took the advice of the Chief of
the Bureau of Chemistry on the important
matters above mentioned. In no other bureau
were funds appropriated for a
specific purpose used for paying employees
who were ordered to report to the
Solicitor of the Department. These are
only a few of the illustrations of the
different treatment accorded to the Bureau
of Chemistry.
DR. F. L. DUNLAP'S DUTIES
Page 644.
THE CHAIRMAN: Will you please
state your precise duties as existing in the
department when you are not acting as
chief chemist; what are your precise
duties today in the Bureau of Chemistry?
DR. DUNLAP: I am associate
chemist of the Bureau of Chemistry and member of
the Board of Food and Drug Inspection.
THE CHAIRMAN: As associate
chemist, what are your duties?
DR. DUNLAP: I have no duties.
THE CHAIRMAN: Then, having
no duties as associate chemist, your sole duty is
as a member of the Board of Food and Drug
Inspection?
DR. DUNLAP: Exactly.
Dr. Dunlap seems to forget the important
office be was to perform, namely, to
see that the Chief of the Bureau did no
unauthorized work to make the official
standard of drugs as perfect as possible.
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