Circulating Now welcomes guest blogger Dr. Suzanne Junod, a historian in the FDA History Office. In celebration of the completion of NLM’s digital archive of court case summaries published as the Food and Drugs Act Notices of Judgment, Dr. Junod offers a brief history of U.S. food and drug regulation and a use case for the areas of research the collection offers.
The 1906 Pure Food and Drugs Act is generally viewed by historians as a signature achievement of the Progressive Era in American history and this founding statute established what would become today’s Food and Drug Administration. From the time a statute was first proposed in 1880 until the day on which Theodore Roosevelt signed it into law—June 30, 1906—it had taken 100 bills and 27 years to enact a federal law to protect consumers from adulterated and misbranded foods and drugs moving across state lines. Some states had protective statutes, and some worked better than others, but increasingly states themselves supported federal protection from spurious, mislabeled, and substandard products. True or not, for example, supporters of the new federal law claimed that there was more ordinary corn syrup claiming to be “Pure Vermont Maple Syrup” shipped from Iowa each year, than Vermont had produced of the genuine article since the settlers arrived. Without a federal law, Vermont was nearly helpless to stop shipments of the counterfeit product. With it, they could literally “make a federal case” out of it.
Making a federal case, however, depended on careful documentation and detailed records, something at which the Bureau of Chemistry, the predecessor of the Food and Drug Administration, excelled. These early federal records were required to be held “until repeal of the enabling legislation.” In 1938, Congress did just that. It repealed the 1906 statute and replaced it with a new federal food and drugs statute that is still the law of the land today: the 1938 Food, Drug, and Cosmetic Act. As a result, many of the earliest Bureau of Chemistry records were destroyed. Years later, however, my colleague, John Swann, and I in the FDA History Office discovered a treasure trove of these records: the case seizure files documenting all enforcement actions under the 1906 statute. These records were later transferred to NLM’s History of Medicine collections and inspired the multi-year collaboration to digitize the published notices of judgment, the final outcomes of the ‘federal cases.’ This collection offers insight into U.S. legal and governmental history, as well as the evolution of clinical trial science and the social impact of medicine on health. The legal history of some of our best-known consumer items of today, such as Kellogg’s Corn Flakes, can be traced in the collection. Product packaging and labeling, including the cereal packaging below, are commonly found in the prosecutorial evidence files of the collection.
During the timeframe covered by these records there were profound changes in the nation’s food and drug supply and its regulation. The 1906 Act recognized the standards published in the U.S. Pharmacopeia and the National Formulary as the basis for drug regulation. Although state food and drug officials, as well as professional organizations, had established food standards adopted by some states, a group of manufacturers successfully blocked the adoption of food standards at the federal level in 1906. Nonetheless, within a couple of decades, and even without federal food standards, regulators made great strides in “cleaning up” the nation’s food supply. When the Great Depression hit, however, the market for lower priced groceries exploded and, in the absence of federal standards, drew the quality of the U.S. food supply into a seemingly bottomless downward spiral. To address this and other concerns, Congress replaced the original 1906 law with a new federal statute—the 1938 Food, Drug, and Cosmetic Act—which allowed FDA to establish legally binding food standards “in the interests of consumers.” Standards for enriched breads and cereals were soon in place as part of the nation’s preparations for World War II. After the war, great effort was expended creating and enforcing the new “recipe” standards that dictated exact ingredients for standardized foods. This time-consuming process ultimately proved unworkable, but it was this shift into food standards work which most likely explains the fact that notices of judgment for foods found in the collection splits off from those for drugs around the mid-1940s. At this time, drug regulation too, began to change dramatically after the 1938 Food, Drug, and Cosmetic Act required that all new drugs be demonstrated safe before marketing.
I am pleased to be one of the first researchers to begin mining these amazing records. Early regulatory work was largely food related and these records provide a comprehensive record of the Bureau of Chemistry’s focus on food. Surprises abounded. I was interested in the reported widespread fraud in food packaging and labeling that had led to the 1913 passage of an obscure statute with a profound impact—the Gould Net Weight Amendment required that all food products have their “net weight” displayed prominently on the front panel of the product. It was the first mandatory labeling requirement for foods and established the legal basis for today’s well-known “Nutrition Facts” label.
In 1906, packaged foods were rare and expensive but they soon entered middle class households and began to replace many bulk food purchases. (Think a cracker barrel vs. Nabisco). Regulators had begun to hear an increasing number of complaints about deceptive packaging and inaccurate item counts. What I discovered in the seizure file records was documentation for an extensive net weight seizure initiative in 1908 which was never mentioned in the agency’s official annual report. It seems clear that while the official records reflected many, many seizures for spoiled peas, corn, tomato products, and other canned goods, an unofficial tally was simultaneously being taken of short weight violations for the express purpose of collecting evidence for a resurrected effort to amend the 1906 Act to prevent commercial fraud, a campaign that began in earnest in 1910 and achieved success in 1913. Other interesting findings: the biggest short weight offender in the canned foods contingent was pineapple with 150,000 units seized; the most lucrative were boxed cheese and bottled honey; and in 1908, almost all of the short weight offenses were in canned foods.
Of course, as with any other research project, the temptations to digress were many, especially with early Coca-Cola seizures in the offing. I decided to leave those for another day, and hopefully for another researcher who will find these early food records as valuable as I have.
The Archives and Modern Manuscripts Program at the History of Medicine Division, National Library of Medicine is pleased to announce the fourth and final release of court case summaries published as the Food and Drugs Act Notices of Judgment (https://fdanj.nlm.nih.gov). This release comprises 30,700 notices of judgments, published between 1940 and 1966, related solely to adulterated or misbranded foods. The notices of judgment are resources in themselves, but they also lead users to the over 2,600 linear foot collection of the evidence files used to prosecute each case. Visit http://oculus.nlm.nih.gov/fdanj608 for the collection’s finding aid. These files include materials such as correspondence, lab results, photographs, and product samples and labeling. The digital library is a collaboration between the National Library of Medicine’s History of Medicine Division and the Communications Engineering Branch, Lister Hill National Center for Biomedical Communications.