History and Laws Behind the Federal Food and Drug Act of 1906
History and Laws behind the Federal Food and Drug Act of 1906 As one of the primary federal consumer-protection laws in existence today, The Federal Food and Drug Act of 1906 was a law that had two primary goals for food and drugs: (a) forbid harmful ingredients and additions and (b) demand labeling of ingredients to inform consumers. According to Janssen (1981), it was hoped that the enactment of this law would eliminate adulterations and poisons sometimes found in foods, sometimes in drugs and often in both.
The foundation of food and drug protection came from the development of scientific methods of analysis by the Federal Bureau of Chemistry, which we know today as the Food and Drug Administration (FDA) (Janssen). Brief History of the Legislation The regulations of the FDA which we know today were born from a grass roots effort in the 1870’s, the Pure Food Movement. Originally, it focused on trade interests because of competition from “replacement” food products (glucose for sugar, “lard” from cottonseed oil, oleomargarine for butter, etc. and the intolerable differences in existing state laws to which manufacturers had to comply (Janssen, 1981). As industrialization created a demand to provide the rapidly increasing localized populations with food from distant areas, a “buyer beware” era emerged. From the use of chemical preservatives and toxic colors to the development of “patent medicines” which contained opium, morphine, heroin and cocaine; all were sold without restriction and labels did not list ingredients. The effort to enact a federal law was led by Dr. Harvey W. Wiley, head of the Bureau of Chemistry in the Department of Agriculture.
Through his own research with human volunteers to determine the effects of food preservatives on digestion and health, dubbed the “Poison Squad,” Wiley enlisted the support of the American Medical Association, the General Federation of Women’s Clubs and other consumer groups (Janssen). Meanwhile, his staunchest opposition came from the largest advertisers in the country; distillers and patent medicine firms. “But the tide was turned, according to historians and Dr. Wiley himself, when the voteless, but militant club of women throughout the country who rallied to the pure food cause” Janssen, 1981, ¶ 12).
Undoubtedly, these women supported Dr. Wiley because he had become a popular speaker at their supper clubs where crusading writers of national magazines also joined his campaign by publishing his findings as editorials. Ultimately, legislation closely followed the January 1906 publishing of Upton Sinclair’s best-selling novel The Jungle, which portrayed dangerous working conditions as well as the unsanitary methods of Chicago’s meatpacking industry. On June 30, 1906, The Pure Food and Drug Act was passed providing inspection of meat products and prohibiting the sale, manufacture, and transport of harmful patent medicines.
Major Provisions of the Legislation “Widely recognized as the ‘Wiley Act,’ the new law, it was hoped would put a stop to food adulteration and quack remedies – the two major evils and targets of a 20-year crusade for Federal regulation of foods and drugs” (Janssen, 1981). Ultimately, the law sought to protect the consumer from being deceived or harmed based on the assumption that the consumer would avoid risk if labeling made him or her aware of said risk (Young, 1981). Its main provisions are as follows (Langran & Schnitzer, 2007, p. 108): 1.
The Federal Food and Drug Administration was formed to administer and enforce the provisions of the act. 2. The law prohibited the sale in interstate commerce of adulterated or misbranded food and drugs. Adulteration was defined as the hiding of damage or inferiority through the use of artificial covering or coating, the addition of poisonous or other deleterious ingredients injurious to health, and the inclusion of decomposed or diseased animals in vegetable substances. 3. Food and drugs were considered misbranded if their packages or labels bore statements that were false and misleading, or if one was sold under the label of another.
Food was regarded as misbranded if its weight or measure was not plainly shown, as were drugs if their packages or labels bore false claims of their curative powers. 4. Criminal sanctions were provided, with a fine of up to $200 for a first offense and $300 or one year in prison for subsequent offenses. 5. Forfeiture of adulterated or misbranded products upon their entry into interstate commerce was used as a remedy to prevent public injury. According to Elsner & Maibach (2000), administration of the new law was delegated by Congress to Dr. Wiley’s Bureau of Chemistry under the U. S.
Department of Agriculture (USDA) who defined the legal procedures and techniques of inspection until 1927 when the Bureau was reorganized and renamed the Food and Drug Administration (FDA) in 1931. To prevent recurring conflicts between producer interests and consumer interests, the FDA was transferred from the USDA to the Federal Security Agency (FSA) which, in 1953, became the Department of Health, Education, and Welfare (DHEW); today the FDA is a regulatory agency that exists within the executive branch of the government as a part of the Department of Health and Human Services (DHHS) (Elsner & Maibach).
Consumer Protection The Pure Food and Drug Act of 1906 is considered to be the first significant piece of consumer protection legislation in our nation’s history with three main objectives: (a) to protect consumers from the adulteration, misbranding or mislabeling of food and drugs; (b) to protect consumers from unfair competition, such as false of misleading advertising or various forms of product misrepresentation; and (c) involves product safety (Langran & Schnitzer, 2007).
Enactment of this Law was a legislative response to the demand for federal action although it was largely ineffective because of inadequate congressional appropriations and political pressure to weaken enforcement of the law. Necessity of the Legislation The Federal Food and Drug Act of 1906 became one of the most important federal laws in the U. S. in the 20th Century. As the origin of the current FDA practices and policies the law was far from perfect, but it represents a revolutionary landmark in the history of consumer protection as we know it in America today.
The enactment of this law set the stage for many subsequent amendments as a result of improvements in manufacturing techniques, technological advancements, scientific research and pharmaceutical development which have all further contributed to making the problem of consumer protection that much more complex. Strengthened by additional legislation; the Food, Drug, and Cosmetic Act of 1938, the food and drug law continued to evolve with key court decisions and amendments. The last major change to the food and drug legislation made it what we know today; the 1962 Kefauver-Harris Drug Amendments.
This legislation requires drug makers to prove to the FDA the effectiveness of new products before selling on the market. As a result of these greater responsibilities outlined by government legislation and regulations, I believe the FDA should take stronger enforcement action to ensure consumer protection and ultimately consumer safety. References Elsner, P. , & Maibach, H. (2000). Cosmeceuticals: Drugs vs. Cosmetics [Electronic version]. New York: Marcel Dekker, Inc. Janssen, W. (1981). The story of the laws behind the labels. U.
S. Food and Drug Administration: Center for Food Safety and Applied Nutrition. Retrieved September 9, 2008, from http://www. cfsan. fda. gov/~lrd/history1. html#toc Langran, R. & Schnitzer, M. (2007). Government, Business, and the American Economy [Electronic version]. Maryland: Rowman & Littlefield Publishers, Inc. Young, J. (1981). The long struggle for the 1906 Law. U. S. Food and Drug Administration: Center for Food Safety and Applied Nutrition. Retrieved September 9, 2008, from http://www. foodsafety. gov/~lrd/history2. html