The FDA History Office
White Oak, Bldg. 1, Rm. 1201, 10903 New Hampshire Ave., Silver Spring, MD 20993
The origins of the FDA History Office can be traced back to March 1968, when Commissioner James Goddard assigned Wallace Janssen, a Public Information Specialist and Special Assistant to the Assistant Commissioner for Education and Information, the responsibility of establishing an agency-wide historian's office. The office was located within the short-lived Science Information Facility, but Janssen reported directly to the Commissioner. Three months later Janssen engaged James Harvey Young, a distinguished scholar from Emory University and an authority on the history of food and drug control, as a Consultant on History. Also in 1968, Young received a grant from the National Library of Medicine, part of the National Institutes of Health in Bethesda, Maryland, to begin conducting oral histories with former FDA officials and others who were pertinent to his work in progress on the history of the FDA. The tapes and transcripts were deposited in the History of Medicine Division of the NLM.
Janssen continued as FDA Historian after 1975 as a re-employed annuitant, and in 1976 a Historian Staff was to be established in the Office of the Commissioner, the staff to include a full-time professional historian. However, a government hiring freeze aborted this effort, and this proposal was no longer pursued. The following year FDA gave Young a contract to permit him to pursue research for his history of the agency.
In 1977, long-time FDA employees Fred Lofsvold and Robert Porter wrote a memo to the Executive Director of Regional Operations pointing out their growing concerns about the lack of organized and sustained efforts to collect and preserve documents, artifacts, and other material documenting the history of the agency. None of the original inspectors appointed in 1907 was alive by that time, but several retired former employees from the 1920s and 1930s were still around. The recent deaths of two FDA retirees who "knew all kinds of things that were now lost to history" highlighted the need to institute a means to recover these memories before it was too late.
Lofsvold and Porter proposed that, in addition to seeking documentary information from these former employees, their recollections be collected and preserved as a supplement to the written record. Lofsvold and Porter recognized that these interviews would be a valuable resource in the recruiting and training of new employees, and a tool to engender the kind of esprit de corps they had experienced in the agency. Later that year, Commissioner Donald Kennedy signed a memo to all Food and Drug Administration field offices enlisting their help in identifying and collecting documents, photographs, and artifacts, and other documentary material dating from the earliest era of the agency's history.
Figure 1 - left to right: Robert Porter, James Harvey Young, Fred Lofsvold, 1986
Lofsvold and Porter met with Professor Young (Figure 1) who shared with them interviews on the history of food and drug control that he and his students had developed over the years. The former FDA employees soon schooled themselves in the techniques of oral history through one of the workshops offered by the Oral History Association, a national organization of oral historians. In addition, they contracted with the NLM to preserve the tapes and transcripts of these oral history interviews as they were completed.
As the volume of their task became greater, in 1986 Lofsvold and Porter (based in field offices) recruited another longtime FDA employee, Ronald Ottes, who worked out of headquarters conducting interviews and editing transcripts. Following Porter and Lofsvold's retirement, Robert Tucker, another Rockville employee, arrived as the second oral historian in 1994. To date there are over 150 oral histories in the collection at NLM, accompanied by an updated cumulative index to virtually all the transcripts.
In 1984 the agency's history function--by this time housed in the Office of Legislative Affairs--was reinstituted formally as the FDA History Office and placed in the Office of Regulatory Affairs. The latter, an organizational descendant of the early chemists and inspectors in the Bureau of Chemistry, and a part of FDA especially rich with career employees, was a likely component of the agency to foster the growth of the history program. The History Office remained agency-wide in scope. Also, it assumed additional responsibilities; the oral history project was folded into this office, and the extant effort to collect and preserve historically significant papers and objects also became a major office responsibility (see Functions below).
The full-time professional staff was increased to fulfill the office's expanded mission. Suzanne White Junod (Ph. D., Emory University, 1994) became Historian in 1985. She specializes in the history of food regulation. John Swann (Ph. D., University of Wisconsin, 1985) was hired in 1989. His specialty is the history of drug regulation.
The mission of the FDA History Office is to increase knowledge of the history, mission, and activities of the FDA and its predecessor, the Bureau of Chemistry of the U. S. Department of Agriculture. The office provides perspective on current policy objectives and increases public understanding of FDA's purpose and function. In general, office activities concern research, documentation, consultation, and information.
Research includes but is not limited to the preparation of published articles, long-term projects designed to
result in monographs, and staff papers in areas where the FDA Historian believes there is a need for research.
This function informs all other activities the office pursues. Documentation refers to our role as preservers of the institutional memory of FDA. This includes but is not limited to the collection and preservation of paper records, oral histories, objects (although producing exhibits really is more a research enterprise), photographs, videotapes, and so on.
Consultation consists of broad assistance to and collaboration with our fellow FDA employees, historians, and other outsiders as national experts on the history of the regulation of foods, drugs, devices, biologics, and cosmetics (Figure 2). Information, usually narrow in scope, is provided on a frequent basis to a host of individuals representing many different institutions and organizations. These are divided roughly equally between FDA queries and those originating outside the agency. The following exemplifies some of the activities of the History Office:
Figure 2 - Some outside publications in which the authors have drawn from resources at the FDA History Office.
• development of historical background on legislative initiatives
• creation of briefing documents on precedents to major organizational changes in the agency
• background papers on policy considerations
• scholarly articles and monographs on select areas of scientific and regulatory history
• oral history interviews to fill in gaps in the paper record (see below)
• collection, preservation, and exhibition of museum objects illustrating the history of the agency (see below)
• identification and preservation of historically significant records
• development of commemorations of significant agency events and milestones
• facilitation of scholarly studies of FDA history
• referee and review of articles, books, and grant applications in the general area of FDA history
• promotion of accurate and informed FDA history, including sponsorship of a lecture series for FDA employees and interaction with colleagues in other government agencies and professional organizations
• on-the-spot information to centers, offices, and all field offices
• historically-related freedom of information queries
• reference or guidance for industry, law firms, students, the media, foundations, historical societies, and anyone else with a question about the agency's past
The Oral History Program
This project has produced scores of cumulatively indexed interviews; transcripts are available at the NLM; many also are available at Emory University. The former also has the interview tapes. Individuals interviewed represent a broad spectrum of the agency's activities. Included are oral histories with former FDA Commissioners, scientists, executive officers, early inspectors and analysts, public information and consumer information officers, and many others. The interviews of James Harvey Young and his students, which are included in the cumulative index, include Morris Fishbein, former editor of the Journal of the American Medical Association, Robert Fischelis, former Secretary of the American Pharmaceutical Association, and Rexford Tugwell, Under Secretary of the Department of Agriculture during the New Deal.
The oral histories have had wide use within and outside of the agency. The interviews have served as the basis for briefing reports for virtually all centers and offices in the FDA. They are frequently consulted by historians and others interested in the development of FDA and its functions. In addition, they have been an important reference for new hire training of investigators, analysts, consumer affairs officers, and others.
The success of this program has been due largely to the involvement of experienced employees, people who have spent their entire careers in various program areas of the Food and Drug Administration. By applying their collective experience in the selection of those to be interviewed, these former employees have ensured that the oral histories reflect the depth and breadth of FDA's regulatory and scientific experience.
While professional historians on staff and outside the agency can and do provide some questions, the interviews have a special interest, accuracy, and flow because they take place between like-minded colleagues. No matter how uninhibited the interviewee may be, the success of an oral history--and thus the success of an oral history program--depends on the ability of the interviewer to push the session in the direction most likely to fill in the gaps in our understanding of FDA history.
More examples of oral histories can be found at the link below:
The Museum Collection
One of the first actions Lofsvold and Porter took, in conjunction with the oral history program, was to solicit submissions of significant artifacts from the field offices. These, along with a wide variety of objects representing self-contained individual collections and miscellaneous acquisitions gathered from unknown sources over the past decades, make up the museum collection of the FDA History Office. All the objects, which total several thousand individual items, illustrate products the FDA regulates, and many document key enforcement cases in the history of the agency. In addition to these, the Smithsonian Institution, the St. Louis Science Center, and the Science Museum of Minnesota have a significant number of objects on loan from the FDA.
For example, the collection includes a box of Pillsbury Blueberry Pancake Mix (Figure 3), which the FDA seized in 1959 for misbranding. Contrary to the listed ingredients and the picture on the box, this product had no blueberries. The collection also includes bogus bust developers such as Lady Ample, seized in the 1960s, and misbranded and dangerous faux exercise devices including different models of the Relaxacizor, against which FDA took action several times in the 1970s. Other notable items included in this collection are samples of Elixir Sulfanilamide and Kevadon (thalidomide), the culprits that killed or maimed many patients in this country and thereby revolutionized drug laws in 1938 and 1962, respectively, as well as Lash Lure, a synthetic aniline eyelash dye in which a number of women suffered injuries to their eyes, including one confirmed case of permanent blindness, before cosmetics came under regulation(Figure 4). The museum collection also includes about 4000 reference samples of pharmaceuticals from the 1950s to the 1980s, including products that accompanied new drug applications and reference standards issued for the United States Pharmacopoeia.
The objects are organized under many categories and subcategories, determined by the agency's regulatory jurisdictions: pharmaceuticals (including labels, promotional matter, drug containers, and weight loss pharmaceuticals--the latter because of the volume of such objects), biologic agents, foods (including vitamins, labels, and promotional items), medical devices, cosmetics, veterinary feed and drugs, equipment used for inspections and for laboratory analyses (mostly chemical and microbiological), quack products (including devices, pharmaceuticals, foods, biologics, and cosmetics), pesticides, and colors. Finally, the collection includes ephemeral objects, including awards that employees or offices received and unusual company promotional items not included elsewhere, such as paperweights, letter openers, and pill trays (Figure 5).
Figure 5 - This hand puppet was used to help promote a food-borne bacteria
educational campaign in the 1990's
History Office Staff
Hired in 2015, Catherine is the point of contact for the FDA Oral History Program.
Came to FDA as a medical historian in 1984 and received permanent appointment as Historian in 1985. Received Ph.D. from Emory University (History of Medicine) in 1994. Specializes in the history of food and food regulation as well as history of medical devices and regulation.
Joined the staff in 2002, with prior experience in training and other functions in the Office or Regulatory Affairs. Serves as Research Assistant in the office.
Hired as Historian in 1989. Received Ph. D. from the University of Wisconsin (Pharmacy and History of Science) in 1985. Specializes in the history of drugs, biologics, and their regulation.