The Pure Food and Drug Act of 1906 was the first of a series of significant
consumer protection laws enacted by the Federal Government 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 was an inspirational piece that
kept the public's attention on the important issue of unsanitary meat
processing plants that later led to food inspection legislation.
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.
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 in 1930. The Meat Inspection Act was assigned to
what is now known as the Food Safety and Inspection Service that 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. Particular drugs deemed dangerous
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
and 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." Penalties under
the law were modest, but an underappreciated provision of the Act
proved more powerful than monetary penalties. Goods found in violation 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, 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, which, was
enacted in 1938 and signed by President Franklin Roosevelt. The 1938 Food, Drug,
and Cosmetic 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. FDA. History of passage
It took 27 years to pass 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 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. Beginnings of the Food and Drug
Administration The 1906 Act paved the way for the
eventual creation of the Food and Drug Administration 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 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.
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 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 James P. 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 = Footnotes =
= Works cited = External links
59th U.S. Congress. "S. 88, Draft bill of the Pure Food and Drug Act". Chapter
3915, cited 34 U.S. Stats. 768. U.S. Capitol Visitor Center. Retrieved April
8, 2013. 59th U.S. Congress. "THE WILEY ACT".
Public Law Number 59-384, 34 Stat. 768. U.S. Food and Drug Administration.
Retrieved April 8, 2013.