FDA History 08

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Sneaky Politics in the Fledgling FDA (Originally Known

as the Bureau of Chemistry)

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.