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.

 
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. In 1985 Suzanne White Junod (Ph. D., Emory University, 1994) was hired as an Historian, specializing in the history of food regulation. John Swann (Ph. D., University of Wisconsin, 1985) joined the History Office in 1989, specializing in the history of drug regulation.  The staff grew to three full time historians in 2017, with the addition of Vanessa Burrows (Ph.D., City University of New York Graduate Center, 2015), who specializes in the history of medical consumerism, regulatory policy and digital history.  Dr. Junod retired in February 2019.