
The first federal law in the US that regulated medicine was the Pure Food and Drug Act of 1906, also known as Wiley's Law or the Wiley Act, after Dr. Harvey Washington Wiley, the Chief Chemist of the Bureau of Chemistry. The law was enacted to ban foreign and interstate traffic in adulterated or mislabeled food and drug products, and it directed the US Bureau of Chemistry to inspect products and refer offenders to prosecutors.
| Characteristics | Values |
|---|---|
| Name of the law | Pure Food and Drug Act of 1906 |
| Other names | Wiley Act, Dr. Wiley's Law |
| Purpose | To ban foreign and interstate traffic in adulterated or mislabeled food and drug products |
| Enforcement | The Bureau of Chemistry in the U.S. Department of Agriculture |
| Requirements | Active ingredients be placed on the label of a drug's packaging, drugs could not fall below purity levels established by the United States Pharmacopeia or the National Formulary |
| Replaced by | Federal Food, Drug, and Cosmetic Act of 1938 |
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What You'll Learn

The Pure Food and Drug Act of 1906
The Act's main purpose was to ban foreign and interstate traffic in adulterated or mislabeled food and drug products. It directed the US 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 Act was a response to the decline in food quality in the late 1800s as populations moved to cities, and food producers turned to using dangerous preservatives, including formaldehyde, to keep food appearing fresh. The quality of medicine was also appalling, with patent medicines containing high levels of alcohol and opium derivatives. Muckraking journalists, such as Samuel Hopkins Adams, exposed these hazards, and Upton Sinclair's novel, "The Jungle," revealed food adulteration and unsanitary practices in meat production, prompting public outrage and leading to the establishment of federal responsibility for public health and welfare.
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Federal regulation of imported drugs in 1848
Federal control over the drug supply in the US began with the inspection of imported drugs in 1848. While this was the first instance of federal regulation of imported drugs, it was not the first federal law related to drugs. The first federal biologics law, which addressed the provision of reliable smallpox vaccines to citizens, was passed in 1813.
In the late 1800s, as populations moved to cities, the quality of food and medicine in the US decreased significantly. Food producers began using dangerous preservatives, including formaldehyde, to keep food appearing fresh. The quality of medicine was also appalling. It took 27 years of advocacy and awareness-building by muckraking journalists, such as Samuel Hopkins Adams, and scientists, such as Dr. Harvey Washington Wiley, to adopt a federal law regulating foods and drugs.
The first federal law regulating foods and drugs was the Pure Food and Drug Act of 1906, also known as Wiley's Law or the Wiley Act, after Dr. Wiley. This law was the first of a series of significant consumer protection laws enacted by the United States Congress and led to the creation of the Food and Drug Administration (FDA). The main purpose of the law was to ban foreign and interstate traffic in adulterated or mislabeled food and drug products. It directed the US Bureau of Chemistry to inspect products and refer offenders to prosecutors.
The Pure Food and Drug Act of 1906 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. This law was largely replaced by the more comprehensive Federal Food, Drug, and Cosmetic Act of 1938, which outlawed products that were not safe or effective.
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The Meat Inspection Act of 1906
The primary purpose of the Meat Inspection Act was to prohibit the sale of adulterated or misbranded livestock and their derived products for human consumption. It ensured that livestock were slaughtered and processed under sanitary conditions, reforming the meatpacking industry. The law mandated inspections of all cattle, swine, sheep, goats, and horses both before and after slaughter by the United States Department of Agriculture (USDA). This marked a shift from previous meat inspection acts, which had proven ineffective in regulating the industry.
The 1906 Act also authorized the Secretary of Agriculture to inspect and condemn any meat product deemed unfit for human consumption. It required accurate labelling on meat products, and while not all ingredients had to be listed, warnings were provided on the containers. The Act allowed for the interstate shipment of products from whole carcasses and the import of uninspected meat, addressing issues related to intrastate commerce.
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The Sherley Amendment of 1912
The first federal law regulating food and drugs in the United States was the Pure Food and Drug Act of 1906, also known as Wiley's Law or Dr. Wiley's Law. The Act was the first of a series of significant consumer protection laws enacted by the United States Congress and led to the creation of the Food and Drug Administration (FDA).
The Amendment also addressed the perceived lack of enforcement of fraud related to therapeutic claims. However, enforcement under the Amendment required proof of fraudulent intent, which was a difficult standard to meet.
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The Federal Food, Drug, and Cosmetic Act of 1938
The Act was drafted with the FDA's principal representative, Charles W. Crawford, and authored by Royal S. Copeland, a three-term U.S. senator from New York. The Federal Food, Drug, and Cosmetic Act of 1938 replaced the Pure Food and Drug Act of 1906, which was the first federal law regulating foods and drugs. The 1938 Act expanded the scope of regulation to include cosmetics and medical devices, and it strengthened provisions to prevent dangerous and ineffective products from reaching the market.
The Pure Food and Drug Act of 1906, also known as Wiley's Law or Dr. Wiley's Law, was enacted to ban foreign and interstate traffic in adulterated or mislabeled food and drug products. It directed the US Bureau of Chemistry, the precursor to the FDA, to inspect products and refer offenders to prosecutors. The law also required that active ingredients be listed on the label of a drug's packaging and that drugs meet certain purity levels.
The 1938 Act introduced several significant provisions, including the requirement for drugs to be labelled with adequate directions for safe use and the mandate for pre-market approval of all new drugs. Manufacturers had to prove to the FDA that their products were safe before they could be sold. The Act also explicitly prohibited false therapeutic claims for drugs and brought cosmetics and medical devices under regulatory control. Additionally, it clarified the FDA's right to conduct factory inspections and control product advertising.
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Frequently asked questions
The first federal law regulating food and medicine was the Pure Food and Drug Act of 1906, also known as Wiley's Law or the Wiley Act.
The main purpose of the Act was to ban foreign and interstate traffic in adulterated or mislabelled food and drug products. It also required that active ingredients be listed on the packaging and that drugs met certain purity levels.
In the late 1800s, the quality of food and medicine in the US decreased significantly as populations moved to cities. Many food producers turned to using dangerous preservatives, including formaldehyde, to keep food appearing fresh. Investigative journalism exposing these practices, such as Upton Sinclair's 1906 novel 'The Jungle', played a key role in provoking legislators to enact federal regulation.
The Act led to the creation of the Food and Drug Administration (FDA), which was initially called the Food, Drug, and Insecticide Administration. The FDA was responsible for enforcing the Pure Food and Drug Act and inspecting products. The law was largely replaced by the Federal Food, Drug, and Cosmetic Act of 1938.


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