Pure Food And Drug Act
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Pure Food and Drug Act of 1906 The Pure Food and Drug Act of 1906, also known as Dr. Wiley's Law, 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 ...
, also known as Dr. Wiley's Law, was the first of a series of significant
consumer protection law Consumer protection is the practice of safeguarding buyers of goods and services, and the public, against unfair practices in the marketplace. Consumer protection measures are often established by law. Such laws are intended to prevent business ...
s which was enacted by Congress in the 20th century and led to the creation of the
Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...
. 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. In the late 1800s, the quality of food in the United States decreased significantly as populations moved to cities and the time from farm to market increased. Many food producers turned to using dangerous preservatives, even
formaldehyde Formaldehyde ( , ) (systematic name methanal) is a naturally occurring organic compound with the formula and structure . The pure compound is a pungent, colourless gas that polymerises spontaneously into paraformaldehyde (refer to section F ...
, to keep food fresh. Simultaneously, the quality of medicine was abysmal.
Quack medicine Quackery, often synonymous with health fraud, is the promotion of fraudulent or ignorant medical practices. A quack is a "fraudulent or ignorant pretender to medical skill" or "a person who pretends, professionally or publicly, to have skill, k ...
was frequent, and many drugs were addictive or dangerous without actually providing a curative effect. Opium and alcohol were chief ingredients, even in infant medicines. The work of
muckraking The muckrakers were reform-minded journalists, writers, and photographers in the Progressive Era in the United States (1890s–1920s) who claimed to expose corruption and wrongdoing in established institutions, often through sensationalist publ ...
journalists exposed the horrific practices of both industries and caused public outcry. Foremost among such exposés was ''
The Jungle ''The Jungle'' is a 1906 novel by the American journalist and novelist Upton Sinclair. Sinclair's primary purpose in describing the meat industry and its working conditions was to advance socialism in the United States. However, most readers we ...
'' by
Upton Sinclair Upton Beall Sinclair Jr. (September 20, 1878 – November 25, 1968) was an American writer, muckraker, political activist and the 1934 Democratic Party nominee for governor of California who wrote nearly 100 books and other works in seve ...
, published the same year as the act. With its graphic and revolting descriptions of unsanitary conditions and unscrupulous practices rampant in the meatpacking industry, it was an inspirational piece that kept the public's attention on the important issue of unhygienic meat processing plants. 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 and Drug Act, as well as the 1906
Federal Meat Inspection Act The Federal Meat Inspection Act of 1906 (FMIA) is an American law that makes it illegal 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 r ...
.


Historical significance

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 The Federal Meat Inspection Act of 1906 (FMIA) is an American law that makes it illegal 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 r ...
. 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 The Federal Meat Inspection Act of 1906 (FMIA) is an American law that makes it illegal 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 r ...
was assigned to what is now known as the
Food Safety and Inspection Service 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 pro ...
, 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 The Commerce Clause describes an enumerated power listed in the United States Constitution ( Article I, Section 8, Clause 3). The clause states that the United States Congress shall have power "to regulate Commerce with foreign Nations, and amo ...
. 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.


Particular drugs deemed addictive

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 Morphine is a strong opiate that is found naturally in opium, a dark brown resin in poppies (''Papaver somniferum''). It is mainly used as a analgesic, pain medication, and is also commonly used recreational drug, recreationally, or to make ...
,
opium Opium (or poppy tears, scientific name: ''Lachryma papaveris'') is dried latex obtained from the seed capsules of the opium poppy ''Papaver somniferum''. Approximately 12 percent of opium is made up of the analgesic alkaloid morphine, which i ...
, and
cannabis ''Cannabis'' () is a genus of flowering plants in the family Cannabaceae. The number of species within the genus is disputed. Three species may be recognized: ''Cannabis sativa'', '' C. indica'', and '' C. ruderalis''. Alternatively ...
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." 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, which had become noticeable by the 1920s, led to the replacement of the 1906 statute with the
Federal Food, Drug, and Cosmetic Act The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C) is a set of laws passed by the United States Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of f ...
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 The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...
.


History of passage

An 1882 article in
Scientific American ''Scientific American'', informally abbreviated ''SciAm'' or sometimes ''SA'', is an American popular science magazine. Many famous scientists, including Albert Einstein and Nikola Tesla, have contributed articles to it. In print since 1845, it i ...
describes "New Laws for Analyzing Food and Drugs" and highlights historical aspects. Part of the draft stated:
"An article shall be deemed to be adulterated within the meaning of this act.

A.-In the case of drugs:
* If, when sold under or by a name recognized in the United States Pharmacopeia, it differs from the standard of strength, quality, or purity laid down in such work.
* If when sold under or by a name not recognized in the United States Pharmacopeia, but which is found in some other pharmacopeia or ether standard work on materia medica, it differs from the standard of strength, quality, or purity laid down in such work.
* If its strength or purity fall below the professed standard under which it is sold

B.-In the case of food or drink:
* If any substance or substances has or have been mixed with it as to reduce or lower or injuriously affect its quality of strength
* If any inferior or cheaper substance or substances have been substituted wholly or in part for the article
*If any valuable constituent of the article has been wholly or is part abstracted
* If it be an imitation of or be sold under the name of another article
* If it consists wholly or in part of a diseased or decomposed, or putrid or rotten, animal or vegetable substance, whether manufactured or not, or in the case of milk, if it is the produce of a diseased animal
* If it be colored, or coated, or polished, or powdered, whereby damage is concealed, or it is made to appear better than it really is, or of greater value"

Scientific American ''Scientific American'', informally abbreviated ''SciAm'' or sometimes ''SA'', is an American popular science magazine. Many famous scientists, including Albert Einstein and Nikola Tesla, have contributed articles to it. In print since 1845, it i ...
, 7 Jan 1882
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 The muckrakers were reform-minded journalists, writers, and photographers in the Progressive Era in the United States (1890s–1920s) who claimed to expose corruption and wrongdoing in established institutions, often through sensationalist publ ...
journalists, such as
Samuel Hopkins Adams Samuel Hopkins Adams (January 26, 1871 – November 16, 1958) was an American writer who was an investigative journalist and muckraker. Background Adams was born in Dunkirk, New York. Adams was a muckraker, known for exposing public-health inju ...
, targeted the
patent medicine A patent medicine, sometimes called a proprietary medicine, is an over-the-counter (nonprescription) medicine or medicinal preparation that is typically protected and advertised by a trademark and trade name (and sometimes a patent) and claimed ...
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 Harvey Washington Wiley (October 18, 1844 – June 30, 1930) 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 ...
, 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 Florence Moltrop Kelley (September 12, 1859 – February 17, 1932) was a social and political reformer and the pioneer of the term wage abolitionism. Her work against sweatshops and for the minimum wage, eight-hour workdays, and children's rig ...
, researcher
Harvey W. Wiley Harvey Washington Wiley (October 18, 1844 – June 30, 1930) 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 ...
, and President Theodore Roosevelt.


Beginnings of the Food and Drug Administration

The 1906 Act paved the way for the eventual creation of the
Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...
(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. nitially,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 The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C) is a set of laws passed by the United States Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of f ...
of 1938.


Enforcement of labeling and future ramifications

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 Coca-Cola, or Coke, is a carbonated soft drink manufactured by the Coca-Cola Company. Originally marketed as a temperance drink and intended as a patent medicine, it was invented in the late 19th century by John Stith Pemberton in Atlanta ...
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 ''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. Context In 1906, Har ...
'', 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 The federal government of the United States (U.S. federal government or U.S. government) is the national government of the United States, a federal republic located primarily in North America, composed of 50 states, a city within a fede ...
to reduce the caffeine amount. In addition to caffeine, the Pure Food and Drug Act required that drugs such as alcohol,
cocaine Cocaine (from , from , ultimately from Quechuan languages, Quechua: ''kúka'') is a central nervous system (CNS) stimulant mainly recreational drug use, used recreationally for its euphoria, euphoric effects. It is primarily obtained from t ...
,
heroin Heroin, also known as diacetylmorphine and diamorphine among other names, is a potent opioid mainly used as a recreational drug for its euphoric effects. Medical grade diamorphine is used as a pure hydrochloride salt. Various white and brow ...
,
morphine Morphine is a strong opiate that is found naturally in opium, a dark brown resin in poppies (''Papaver somniferum''). It is mainly used as a analgesic, pain medication, and is also commonly used recreational drug, recreationally, or to make ...
, and
cannabis ''Cannabis'' () is a genus of flowering plants in the family Cannabaceae. The number of species within the genus is disputed. Three species may be recognized: ''Cannabis sativa'', '' C. indica'', and '' C. ruderalis''. Alternatively ...
, be accurately labeled with contents and dosage. Previously many drugs had been sold as
patent medicines A patent medicine, sometimes called a proprietary medicine, is an over-the-counter (nonprescription) medicine or medicinal preparation that is typically protected and advertised by a trademark and trade name (and sometimes a patent) and claimed ...
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 An opiate, in classical pharmacology, is a substance derived from opium. In more modern usage, the term ''opioid'' is used to designate all substances, both natural and synthetic, that bind to opioid receptors in the brain (including antagonist ...
decreased by 33% after labeling was mandated. The Pure Food and Drug Act of 1906 is cited by
drug policy reform Drug liberalization is a drug policy process of decriminalizing or legalizing the use or sale of prohibited drugs. Variations of drug liberalization include: drug legalization, drug re-legalization and drug decriminalization. Proponents of drug ...
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.


References


Sources

* * For years preceding and following passage of the Act:
1896
First report of the station on adulterated food products
189718981899

1900190119021903190419051906
1907
FoodFoodDrugs
1908: Not located; 1909: Not located; 1910: Not located; 1911
FoodDrugs
* * * *
James Harvey Young James Harvey Young (September 8, 1915 – July 29, 2006) was social historian most well known as an expert on the history of medical frauds and quackery. Young was born in Brooklyn, New York. He received his Ph.D. in history from the University ...
, Pure Food: Securing the Federal Food and Drugs Act of 1906 (New Jersey: Princeton University Press, 1989). *Mitchell Okun, Fair Play in the Marketplace: The First Battle for Pure Food and Drugs (Dekalb: University of Illinois Press, 1986). *Suzanne White Junod, Chemistry and Controversy: Food Additive Regulation, unpublished dissertation, Emory University, 1994. *Andrew F. Smith, Pure Ketchup: A History of America's National Condiment (Columbia: University of South Carolina Press, 1996) *Goodwin, Pure Food, Drug, and Drink Crusaders


External links

* * {{Theodore Roosevelt 1906 in American politics 1906 in law Food and Drug Administration Food law Food safety in the United States Presidency of Theodore Roosevelt Progressive Era in the United States United States federal controlled substances legislation United States federal health legislation