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History and Context

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History and Context CHAPTER 1 HISTORY AND CONTEXT A. GLOBAL PRECEDENTS Peter Barton Hutt, Government Regulation of the Integrity of the Food Supply 4 ANNUAL REVIEW OF NUTRITION 1 (1984). For centuries, government has had an essential role in assuring the integrity of the food supply. The focus of the regulatory function has, of course, evolved over the years. It originated essentially as a means to protect against fraud in the marketplace. Very quickly, it expanded into a mechanism for preventing the sale of unsafe food. As the science of nutrition has developed, it has assumed the role of protecting the nutritional integrity of the food supply as well .... Ancient Times . ... The first great botanical treatise on plants as a source of food and medicine, the Enquiry Into Plants written by Theophrastus (370-285 BC), reported on the use of artificial preservatives and flavors in the food supply even at that early date. Theophrastus noted that "even uncompounded substances have certain odors which men endeavor to assist by artificial means even as they assist nature in producing palatable tastes." He reported that items of commerce, such as balsam gum, were mixed with adulterants for economic reasons. The treatise On Agriculture by Cato (234-149 BC) recommended the addition to wine of boiled-down must, salt, marble dust, and resin, and included a method "to determine whether wine has been watered." Pliny the Elder (23-79 AD) found widespread adulteration throughout the food supply. He described, for example, the adulteration of bread with chalk, vegetable meals, and even cattle fodder. He pointed out that pepper was commonly adulterated with juniper berries. Indeed, his Natural History is replete with so many references to adulteration of the natural food and drug supply that he observed: "So many poisons are employed to force wine to suit our taste-and we are surprised that it is not wholesome!" Pliny, describing "the remedies that are in the control of a man's will,'' stated that "the greatest aid to health is moderation in food." He urged the value of a kitchen garden for "harmless" market supplies. Galen (131-201 AD), a renowned Roman physician who followed the philosophical tradition of the School of Hippocrates, similarly warned against the adulteration of common food products, such as pepper .... The Roman civil law reflected the concern expressed by these early writers about preserving the integrity of the food supply. Fraud in the sale of merchandise not only gave rise to a private right of action, but also constituted the offense of stellionatus, which included the adulteration of food: "And, where anyone has substituted some article for another; or has put aside goods which he was obliged to deliver, or has spoiled them, he is also liable for this offense." Although 1 CHAPTER 1 2 HISTORY AND CONTEXT stellionatus was technically not a crime, it was comparable to a civil offense under present law, subject to government prosecution, and resulted in such punishment as condemnation to the mines or temporary exile. The English Experience, 1200-1875 ... At the end of the Dark Ages ... concern about the food supply once again emerged. Nowhere is this more evident than in the experience reflected in the laws of England at that time. Initial governmental concern came in the form of regulating the price of bread, and perhaps other staple food products as well. It did not take long for the English government to realize that the price of food could be regulated only in relation to the quality of that food. Accordingly, the early English regulatory statutes prohibited the adulteration of any staple food that was also subject to price controls. These regulatory enactments, called assizes, were codified by Parliament in 1266. The 1266 statutes prohibited the sale of any "corrupted wine" or of any meat, fish, bread, or water that was "not wholesome for Man's body" or that was kept so long "that it loseth its natural wholesomeness." These laws, with periodic amendments, continued in effect throughout England until 1844. They were supplemented, from time to time, with additional statutes directed at other food commodities that became a source of commerce, such as butter, cheese, and spices. In addition to the statutes enacted by Parliament, local cities enacted their own ordinances to prevent food adulteration. The judicially-created common law, reflecting the principles underlying the statutes and ordinances, created both a civil cause of action for damages for any aggrievetl party, and a criminal offense as well. Numerous examples of early enforcement actions against the purveyors of adulterated food may be found in the records of the City of London. Finally, the trade guilds . also performed a major regulatory function. These guilds covered every important food category, including the bakers, butchers, cooks, grocers, fruiters, poulters, and salters. Using their power to search all premises and to seize all unwholesome products, the guilds exercised a relatively strong regulatory power in policing the marketing of food to the public. The Development of Chemistry and the Accum Treatise As the Renaissance emerged out of the Middle Ages, a few pioneers in the newly developing discipline of "chymistry" broke away from the philosophic mysticism of alchemy and initiated modern scientific inquiry. While earlier analyses of food adulteration depended almost completely upon taste and sight, the new science of chemistry, led particularly by Boyle, slowly began to develop chemical methods of analysis .... By the beginning of the 19th century ... chemical analysis had advanced to the point where at least qualitative methods had become available for detecting many common food adulterants. In 1820, a German-born chemist, Frederick Accum, working in England, published his landmark Treatise on Adulterations of Food and Culinary Poisons .... Accum undertook to describe both the numerous kinds of CHAPTER 1 SECTIONB THE DEVELOPMENT OF FDA AS AN INSTITUTION 3 to a civil adulteration practiced at that time and the various methods available ition, and to detect them. His treatise was an immediate and worldwide mines or success. The treatise spawned a generation of books on food adulteration in England, the United States, and Europe. Ultimately, it resulted in the modern era of food regulatory statutes . [T]he English Parliament enacted statutes in 1860, 1872, and ::iod supply 1875, replacing the assizes that had been repealed in 1844, to assure m in the strong regulatory authority to protect the integrity of the food supply. As would be expected, these English statutes reflect only the state tlating the of scientific, medical, and nutritional knowledge at that time. There is . It did not no specific mention in those statutes of nutrition. Instead, they broadly ·ice of food prohibited any form of food adulteration, thus assuring that food would that food. reach the marketplace and the consumer in its natural and most .ibited the nutritious state. Indeed, the prohibitions against adulteration contained :ontrols. in these statutes encompass the same prohibitions contained in our :odified by most modern food regulatory statutes, and were in fact the models for ale of any the 1906 and 1938 legislation enacted in the United States. t was "not t loseth its iendments, THE DEVELOPMENT OF FDA AS AN INSTITUTION rhey were The history of food and drug regulation in the United States is directed at chronicled both in congressional enactments and in the establishment :e, such as and growth of an institution, the Food and Drug Administration (FDA). local cities Peter Barton Hutt, ation. The A Historical Introduction lerlying the 45 FOOD DRUG COSMETIC LAW JOURNAL 17 (1990). or damages In his 1837 annual report, Patent Commissioner Henry L. Numerous Ellsworth recommended a· national agency for the encouragement of irveyors of agriculture. Congress responded in 1839 by an appropriation of $1000 ::indon. to the Commissioner of Patents for "the collection of agricultural regulatory statistics, and for other agricultural purposes." From then on, the y, including Patent Office collected and reported agricultural statistics, sponsored or md salters. conducted chemical investigations on agricultural matters, monitored iwholesome agricultural developments, and reported on all of these in its annual ry power m reports. Beginning in 1849, a separate report was made by the Patent Commissioner to Congress on agricultural matters. An Agricultural Division was established in the Patent Office and a chemical laboratory was created in that Division. 'ew pioneers ay from the In 1846, Professor Lewis C. Beck, M.D., of Rutgers College and n scientific Albany Medical College, published the first American treatise on ided almost adulteration of food and drugs. Two years later, at the request of Patent ?mis try, led Commissioner Edmund Burke, Congress appropriated $1000 for the methods of Commissioner of Patents to conduct chemical analyses of "vegetable substances produced and used for the food of man and animals in the United States." Commissioner Burke recruited Dr. Beck to do this work malysis had for the Patent Office. Dr. Beck submitted his Report on the Breadstuffs had become of the United States in 1849 and a second report in 1850. In 1820, a d,published When the United States Department of Agriculture (USDA) was Ld Culinary created by Congress in 1862, it included authorization to employ ous kinds of chemists. The Agricultural Division of the Patent Office, including its CHAPTER 1 4 HISTORY AND CONTEXT chemical laboratory, was transferred to the new department and the USDA occupied the office space in the basement of the Patent Office that previously had belonged to that Division. The first Commissioner of Agriculture, Isaac Newton, immediately established the Chemical Division from the former Patent Office chemical laboratory, which became the Division of Chemistry in 1890; the Bureau of Chemistry in 1901; the Food, Drug, and Insecticide Administration in 1927; and the Food and Drug Administration (FDA) in 1930.
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