Researching FDA with Published Primary Sources
The Food and Drug Review began in 1917 as a means of communicating information privately to state food and drug officials to assist them in helping enforce the 1906 federal act. Soon the Review became a vehicle for FDA headquarters to inform field offices about relevant publications, speeches by FDA staff, personnel changes in the agency, the status of legislation, enforcement activities in other field offices, and so on. In many ways the Review is a sort of diary of activities at FDA, issued monthly with illustrations and indexed annually (except the last three volumes). A few research libraries have purchased microfilm copies of the Review, which ceased publication in 1966. Microfilms are still available through the Library of Congress. The cumulatively indexed FDA Papers--which changed its name to FDA Consumer in 1973--succeeded the Review, but its thrust was very different than the Review, emphasizing articles of interest to consumers, as the newer title suggests, and including the official summaries of agency enforcement activities (see below). FDA Today, a monthly employee newsletter with illustrations, began in 1974 and ceased publication in 1996; it was closer in scope to the Review, but much less comprehensive.
The annual reports of the Bureau of Chemistry and the FDA are another useful source on agency activities (see the bibliography below). Earlier reports of the Chief Chemist of the Chemical Division and the Division of Chemistry were included in the annual report of the Secretary of Agriculture. The modern annual reports of the agency have been collected and published in two volumes: Federal Food, Drug and Cosmetic Law: Administrative Reports, 1907-1949 (Chicago: Commerce Clearing House, 1951), and Food and Drug Administration, Annual Reports, 1950-1974 (Washington: Government Printing Office, ).
The first volume has a fairly short index, while the latter collection has a separately published index, compiled by Edward M. Shoemaker and published (under the same title as the main volume) in 1983 by the American Institute of the History of Pharmacy, Madison, Wisconsin. The unpublished reports from headquarters bureaus and field offices on which these annual reports are based are included in the decimal files in the FDA unpublished records (see below). The FDA Quarterly Activities Report, somewhat similar to the annual reports, began publication in 1970. These contain a straightforward factual account that includes internal reorganizations, executive personnel changes, enforcement highlights and statistics, major court decisions and laws, and so on. The QAR ended in 1995. Since the early 1990s from time to time the agency has issued compilations of current information on budget, staff, center and office highlights, and other succinct data under the title, FDA Almanac.
One can glean the concerns and interests of regulated industry through the trade literature, which includes periodicals such as Oil, Paint and Drug Reporter (founded in 1871 and continuing after 1972 as Chemical Marketing Reporter), FDC Reports (1939 to the present), Food Chemical News (1959 to the present), and Drug and Cosmetic Industry (established in 1914 as Weekly Drug Markets and continuing under the present title after 1932). The Food Drug Cosmetic Law Journal (1946 to the present) provides useful insight on FDA history from a variety of viewpoints. This journal has a cumulative chronological listing of articles in broad subject areas.
Several publications trace details of the evolution of food and drug legislation and how it played out in the courts. A publication of the U. S. Department of Agriculture, Mastin G. White and Otis H. Gates, Decisions of Courts in Cases under the Federal Food and Drugs Act (Washington, D. C.: Government Printing Office, 1934), identifies and analyzes major cases stemming from the 1906 act. An ongoing publication, Federal Food, Drug, and Cosmetic Act: Judicial and Administrative Record (Chicago: Commerce Clearing House, c. 1949 ff.), assumes a similar task for the 1938 act and its amendments. An FDA publication comprised of 34 volumes, including appendices, A Legislative History of the Federal Food, Drug and Cosmetic Act and Its Amendments, is a documentary history of the 1938 act. It explains why the laws are couched the way they are. Peter Barton Hutt and Richard A. Merrill's Food and Drug Law: Cases and Materials, 2d ed. (Westbury, N. Y.: Foundation Press, 1991), is a more recent interpretation of the impact of court decisions on FDA policies; the authors reproduce a variety of primary and secondary sources as well.
Sources on Regulations and Enforcement
FDA has long pursued a policy of enforcing food and drug laws that relies on full and frequent notification of regulated industry and others about how statutes and regulations affect them. On 17 October 1906 the U. S. Department of Agriculture issued "Rules and Regulations for the Enforcement of the Food and Drugs Act" as Circular No. 21 from the Office of the Secretary. The forty rules and regulations published at that time underwent several revisions up to the time of the 1938 act; however, each of these revisions continued to be published as Circular No. 21.
Food Inspections Decisions (FIDs) were another published venue for notification of changes in regulations. These were formal statements issued over the signature of the Secretary of Agriculture or, in some case, over the signatures of the Secretaries of Agriculture, Treasury, and Commerce. The first thirty-nine FIDs pertained to interpretations of the Imported Food Act of 1899, which the Bureau of Chemistry was charged to enforce. From 1906 to 1934, the Bureau of Chemistry and then the FDA issued FID 40 through 212 to explain regulation of the 1906 act. The agency published Service and Regulatory Announcements (SRAs) until shortly after the 1938 act, first as a monthly and later on an irregular basis. The SRAs included FIDs as well as other policy matter that did not have the formality of FIDs, subject to prompt change if developments warranted.
After the 1938 act, FDA issued informal opinions, known as Trade Correspondence, based on its daily correspondence with manufacturers. They contained excerpts from the replies to regulated companies' queries about regulations under the act. The issues of Trade Correspondence were not published, but rather were mimeographed and distributed to the staff to maintain uniformity in policy throughout the country. They were available for inspection in field offices and at FDA headquarters. The complete series of Trade Correspondence, which ran from 26 August 1938 to 4 April 1946, was published in Vincent A. Kleinfeld and Charles Wesley Dunn, Federal Food, Drug, and Cosmetic Act: Judicial and Administrative Record, 1938-1949 (Chicago: Commerce Clearing House, c. 1949), 561-753, which is indexed. The agency's press releases and talk papers present FDA's viewpoints and policies on a wide variety of issues; the FDA Medical Library has many of these on microfilm, and a list of press release titles exists for those issued from about 1950 to 1965. The Office of Public Affairs has indexed the recent press releases and talk papers.
The most important source to track changes in FDA regulations, from 1936 to the present, is the annually indexed Federal Register; this is particularly the case after passage of the Administrative Procedure Act in 1946. The Preambles to final regulations in the Federal Register can be especially useful in discerning public reaction to proposed regulations and the agency's response.
An essential tool for researching enforcement actions taken by the agency are the Notices of Judgment under the Food and Drugs Act and the Notices of Judgment under the Federal Food, Drug and Cosmetic Act, required by provisions of the laws. These were published in groups of fifty by the Department of Agriculture (and later by the Federal Security Agency and the Department of Health, Education and Welfare) beginning in 1908. They summarize the government's case against a product, including the evidence of a product's adulteration or misbranding; often the notice will include a chemical analysis of the offending product. The Notices report the outcome of the cases as well.
The first 10,000 notices are indexed, from 1908 to 1922, as are notices 10,000 to 20,000. Thereafter, indices covered 1000 notices at a time. The indices are especially useful in revealing recidivism. For example, the Pabst Chemical Company, purveyor of Pabst Okay specific drug, was cited in twenty-seven Notices of Judgment from 1915 to 1919. The published Notices, which were distributed to government depository libraries, also provide keys to more detailed information in the manuscript records of FDA (see below). The separately published Notices ceased in 1966; thereafter they were appended to FDA Papers (and later, in a significantly curtailed format.
Sources on Science and Research
The Bulletins and Circulars of the Bureau of Chemistry also are helpful on the history of the agency; these total hundreds of separate publications, from the late-nineteenth century origins of regulation to the 1920s. Most are just a few pages each, but Bulletin 13 and 84 are notable exceptions. The former, on Foods and Food Adulterants, was issued in ten parts in over 1500 pages, from 1887 to 1902. Bulletin 84, on Influence of Food Preservatives and Artificial Colors on Digestion and Health, was a five-part, 1500-page study from 1904 to 1908. Agency scientists did not publish their work in the Bulletins and Circulars exclusively. Indeed, many in the Bureau were highly respected in their fields and published in the standard professional journals of the day. But the Bulletins and Circulars are the most significant single source to document science and research in the early history of FDA.