|Enacted by||the 59th United States Congress|
|Effective||January 1, 1907|
|Statutes at Large||34 Stat. 768, Chapter 3915|
|Titles amended||21 U.S.C.: Food and Drugs|
| Food, Drug, and Cosmetic Act (1938)|
Food Quality Protection Act (1996)
|United States Supreme Court cases|
|United States v. Johnson (1911)|
The Pure Food and Drug Act of 1906 was the first of a series of significant consumer protection laws which was enacted by Congress in the 20th century and led to the creation of the Food and Drug Administration. Its main purpose was to ban foreign and interstate traffic in adulterated or mislabeled food and drug products, and it directed the U.S. Bureau of Chemistry to inspect products and refer offenders to prosecutors. It required that active ingredients be placed on the label of a drug's packaging and that drugs could not fall below purity levels established by the United States Pharmacopeia or the National Formulary. The Jungle by Upton Sinclair, with its graphic and revolting descriptions of unsanitary conditions and unscrupulous practices rampant in the meatpacking industry, was an inspirational piece that kept the public's attention on the important issue of unhygienic meat processing plants that later led to food inspection legislation. Sinclair quipped, "I aimed at the public's heart and by accident I hit it in the stomach," as outraged readers demanded and got the pure food law.
The Pure Food and Drug Act of 1906 was a key piece of Progressive Era legislation, signed by President Theodore Roosevelt on the same day as the Federal Meat Inspection Act. Enforcement of the Pure Food and Drug Act was assigned to the Bureau of Chemistry in the U.S. Department of Agriculture which was renamed the U.S. Food and Drug Administration (FDA) in 1930. The Meat Inspection Act was assigned to what is now known as the Food Safety and Inspection Service, which remains in the U.S. Department of Agriculture. The first federal law regulating foods and drugs, the 1906 Act's reach was limited to foods and drugs moving in interstate commerce. Although the law drew upon many precedents, provisions, and legal experiments pioneered in individual states, the federal law defined "misbranding" and "adulteration" for the first time and prescribed penalties for each. The law recognized the U.S. Pharmacopeia and the National Formulary as standards authorities for drugs, but made no similar provision for federal food standards.The law was principally a "truth in labeling" law designed to raise standards in the food and drug industries and protect the reputations and pocketbooks of honest businessmen.
Under the law, drug labels, for example, had to list any of 10 ingredients that were deemed "addictive" and/or "dangerous" on the product label if they were present, and could not list them if they were not present. Alcohol, morphine, opium, and cannabis were all included on the list of these "addictive" and/or "dangerous" drugs. The law also established a federal cadre of food and drug inspectors that one Southern opponent of the legislation criticized as "a Trojan horse with a bellyful of inspectors and other employees." [ example needed ], which had become noticeable by the 1920s, led to the replacement of the 1906 statute with the Federal Food, Drug, and Cosmetic Act which was enacted in 1938 and signed by President Franklin Roosevelt. This act, along with its numerous amendments, remains the statutory basis for federal regulation of all foods, drugs, biological products, cosmetics, medical devices, tobacco, and radiation-emitting devices by the U.S. Food and Drug Administration.Penalties under the law were modest, but an under-appreciated provision of the Act proved more powerful than monetary penalties. Goods found in violation of various areas of the law were subject to seizure and destruction at the expense of the manufacturer. That, combined with a legal requirement that all convictions be published as Notices of Judgment, proved to be important tools in the enforcement of the statute and had a deterrent effect upon would-be violators. Deficiencies in this original statute
It took 27 years to adopt the 1906 statute, during which time the public was made aware of many problems with foods and drugs in the U.S. Muckraking journalists, such as Samuel Hopkins Adams, targeted the patent medicine industry with its high-alcoholic content patent medicines, soothing syrups for infants with opium derivatives, and "red clauses" in newspaper contracts providing that patent medicine ads (upon which most newspapers of the time were dependent) would be withdrawn if the paper expressed support for food and drug regulatory legislation. The Chief Chemist of the Bureau of Chemistry, Dr. Harvey Washington Wiley, captured the country's attention with his hygienic table studies, which began with a modest Congressional appropriation in 1902. The goal of the table trial was to study the human effects of common preservatives used in foods during a period of rapid changes in the food supply brought about by the need to feed cities and support an industrializing nation increasingly dependent on immigrant labor. Wiley recruited young men to eat all their meals at a common table as he added increased "doses" of preservatives including borax, benzoate, formaldehyde, sulfites, and salicylates. The table trials captured the nation's fancy and were soon dubbed "The Poison Squad" by newspapers covering the story. The men soon adopted the motto "Only the Brave dare eat the fare" and at times the publicity given to the trials became a burden. Though many results of the trial came to be in dispute, there was no doubt that formaldehyde was dangerous and it disappeared quickly as a preservative. Wiley himself felt that he had found adverse effects from large doses of each of the preservatives and the public seemed to agree with Wiley. In many cases, most particularly with ketchup and other condiments, the use of preservatives was often used to disguise insanitary production practices. Although the law itself did not proscribe the use of some of these preservatives, consumers increasingly turned away from many products with known preservatives.
The 1906 statute regulated food and drugs moving in interstate commerce and forbade the manufacture, sale, or transportation of poisonous patent medicines.The Act arose due to public education and exposés from public interest guardians such as Upton Sinclair and Samuel Hopkins Adams, social activist Florence Kelley, researcher Harvey W. Wiley, and President Theodore Roosevelt.
The 1906 Act paved the way for the eventual creation of the Food and Drug Administration (FDA) and is generally considered to be that agency's founding date, though the agency existed before the law was passed and was not named FDA until later. "While the Food and Drug act remains a foundational law of the FDA mission, it's not the law that created the FDA. [Initially,] the Bureau of Chemistry (the precursor to the FDA) regulated food safety. In 1927, the Bureau was reorganized into the Food, Drug, and Insecticide Administration and the Bureau of Chemistry and Soils. The FDIA was renamed the FDA in 1930."
The law itself was largely replaced by the much more comprehensive Federal Food, Drug, and Cosmetic Act of 1938.
The Pure Food and Drug Act was initially concerned with ensuring products were labeled correctly. Later efforts were made to outlaw certain products that were not safe, followed by efforts to outlaw products which were safe but not effective. For example, there was an attempt to outlaw Coca-Cola in 1909 because of its excessive caffeine content; caffeine had replaced cocaine as the active ingredient in Coca-Cola in 1903.In the case United States v. Forty Barrels and Twenty Kegs of Coca-Cola , the judge found that Coca-Cola had a right to use caffeine as it saw fit, although Coca-Cola eventually lost when the government appealed to the Supreme Court. It reached a settlement with the United States government to reduce the caffeine amount.
In addition to caffeine, the Pure Food and Drug Act required that drugs such as alcohol, cocaine, heroin, morphine, and cannabis, be accurately labeled with contents and dosage. Previously many drugs had been sold as patent medicines with secret ingredients or misleading labels. Cocaine, heroin, cannabis, and other such drugs continued to be legally available without prescription as long as they were labeled. It is estimated that sale of patent medicines containing opiates decreased by 33% after labeling was mandated.The Pure Food and Drug Act of 1906 is cited by drug policy reform advocates such as Jim Gray as a successful model for re-legalization of currently prohibited drugs by requiring accurate labels, monitoring of purity and dose, and consumer education.
The Food and Drug Administration is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.
The Federal Meat Inspection Act of 1906 (FMIA) is an American law that makes it a crime to adulterate or misbrand meat and meat products being sold as food, and ensures that meat and meat products are slaughtered and processed under strictly regulated sanitary conditions. These requirements also apply to imported meat products, which must be inspected under equivalent foreign standards. USDA inspection of poultry was added by the Poultry Products Inspection Act of 1957. The Food, Drug, and Cosmetic Act authorizes the FDA to provide inspection services for all livestock and poultry species not listed in the FMIA or PPIA, including venison and buffalo. The Agricultural Marketing Act authorizes the USDA to offer voluntary, fee-for-service inspection services for these same species.
Harvey Washington Wiley was an American chemist who fought for the passage of the landmark Pure Food and Drug Act of 1906 and subsequently worked at the Good Housekeeping Institute laboratories. He was the first commissioner of the United States Food and Drug Administration. Wiley was awarded the Elliott Cresson Medal of the Franklin Institute in 1910.
The United States Federal Food, Drug, and Cosmetic Act, is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, medical devices, and cosmetics. A principal author of this law was Royal S. Copeland, a three-term U.S. Senator from New York. In 1968, the Electronic Product Radiation Control provisions were added to the FD&C. Also in that year the FDA formed the Drug Efficacy Study Implementation (DESI) to incorporate into FD&C regulations the recommendations from a National Academy of Sciences investigation of effectiveness of previously marketed drugs. The act has been amended many times, most recently to add requirements about bioterrorism preparations.
Food policy is the area of public policy concerning how food is produced, processed, distributed, and purchased. Food policies are designed to influence the operation of the food and agriculture system. This often includes decision-making around production and processing techniques, marketing, availability, utilization and consumption of food, in the interest of meeting or furthering social objectives. Food policy can be promulgated on any level, from local to global, and by a government agency, business, or organization. Food policymakers engage in activities such as regulation of food-related industries, establishing eligibility standards for food assistance programs for the poor, ensuring safety of the food supply, food labeling, and even the qualifications of a product to be considered organic.
United States v. Forty Barrels and Twenty Kegs of Coca-Cola, 241 U.S. 265 (1916), was a federal suit under which the government unsuccessfully attempted to force The Coca-Cola Company to remove caffeine from its product.
Food safety is used as a scientific discipline describing handling, preparation, and storage of food in ways that prevent food-borne illness. The occurrence of two or more cases of a similar illnesses resulting from the ingestion of a common food is known as a food-borne disease outbreak. This includes a number of routines that should be followed to avoid potential health hazards. In this way food safety often overlaps with food defense to prevent harm to consumers. The tracks within this line of thought are safety between industry and the market and then between the market and the consumer. In considering industry to market practices, food safety considerations include the origins of food including the practices relating to food labeling, food hygiene, food additives and pesticide residues, as well as policies on biotechnology and food and guidelines for the management of governmental import and export inspection and certification systems for foods. In considering market to consumer practices, the usual thought is that food ought to be safe in the market and the concern is safe delivery and preparation of the food for the consumer.
The Center for Food Safety and Applied Nutrition is the branch of the United States Food and Drug Administration (FDA) that regulates food, dietary supplements, cosmetics, drugs, biologics, medical devices, and radiological products.
The regulation of food and dietary supplements by the U.S. Food and Drug Administration is a process governed by various statutes enacted by the United States Congress and interpreted by the U.S. Food and Drug Administration ("FDA"). Pursuant to the Federal Food, Drug, and Cosmetic Act and accompanying legislation, the FDA has authority to oversee the quality of substances sold as food in the United States, and to monitor claims made in the labeling about both the composition and the health benefits of foods.
Adulteration is a legal term meaning that a food product fails to meet the legal standards. One form of adulteration is an addition of another substance to a food item in order to increase the quantity of the food item in raw form or prepared form, which may result in the loss of actual quality of food item. These substances may be either available food items or non-food items. Among meat and meat products some of the items used to adulterate are water or ice, carcasses, or carcasses of animals other than the animal meant to be consumed.
The history of early food regulation in the United States started with the 1906 Pure Food and Drug Act, when the United States federal government began to intervene in the food and drug businesses. When that bill proved ineffective, the administration of President Franklin D. Roosevelt revised it into the Federal Food, Drug and Cosmetic Act of 1937. This has set the stage for further government intervention in the food, drug and agricultural markets.
The Food Safety and Inspection Service (FSIS), an agency of the United States Department of Agriculture (USDA), is the public health regulatory agency responsible for ensuring that United States' commercial supply of meat, poultry, and egg products is safe, wholesome, and correctly labeled and packaged. The FSIS draws its authority from the Federal Meat Inspection Act of 1906, the Poultry Products Inspection Act of 1957 and the Egg Products Inspection Act of 1970. The FSIS also acts as a national health department and is responsible for the safety of public food-related establishments as well as business investigation.
This article is about the history of the United States Food and Drug Administration.
Seafood species can be mislabelled in misleading ways. This article examines the history and types of mislabelling, and looks at the current state of the law in different locations.
POM Wonderful LLC v. Coca-Cola Co., 573 U.S. ___ (2014), was United States Supreme Court case that held that a statutory private right of action under the Lanham Act is not precluded by regulatory provisions of the Food, Drug, and Cosmetic Act.
Food defense is the protection of food products from intentional contamination or adulteration by biological, chemical, physical, or radiological agents introduced for the purpose of causing harm. It addresses additional concerns including physical, personnel and operational security.
Carl L. Alsberg was an American chemist who served as Commissioner of Food and Drugs from 1912 to 1921. Alsberg was born to a secular German-Jewish family, the oldest of four children. His father Meinhard, a chemist who immigrated to the U.S. from Germany in 1865, was a founder of the American Chemical Society. Carl Alsberg attended Columbia University, where he founded a literary magazine, The Morningside.
Consumer Health Laws are laws that ensure that health products are safe and effective and that health professionals are competent; that government agencies enforce the laws and keep the public informed; professional, voluntary, and business organizations that serve as consumer advocates, monitor government agencies that issue safety regulations, and provide trustworthy information about health products and services; education of the consumer to permit freedom of choice based on an understanding of scientific data rather than misleading information; action by individuals to register complaints when they have been deceived, misled, overcharged, or victimized by frauds.
Food safety in the United States relates to the processing, packaging, and storage of food in a way that prevents food-borne illness within the United States. The beginning of regulation on food safety in the United States started in the early 1900s, when several outbreaks sparked the need for litigation managing food in the food industry. Over the next few decades, the United States created several government agencies in an effort to better understand contaminants in food and to regulate these impurities. Many laws regarding food safety in the United States have been created and amended since the beginning of the 1900s.