Sneaky Politics in the Fledgling FDA (Originally Known as the Bureau of Chemistry)

FDA History 08
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 
     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:

   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 
   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?
   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.

   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.


Dr. Andrew Saul

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