Kara Sears
The Food and Drug Administration (FDA) is a federal agency of the United States formed in 1930. The FDA's modern regulatory functions began with the passage of the 1906 Pure Food and Drugs Act, which prohibited interstate commerce in adulterated and misbranded food and drugs. However, the Federal Food, Drug, and Cosmetic Act of 1938, also known as the FD&C Act, is considered a significant milestone in the history of the FDA. This law was passed after a toxic elixir killed over a hundred people, including many children, and it completely overhauled the public health system. The 1938 Act expanded the FDA's authority and regulatory powers, mandating pre-market safety reviews of new drugs, authorising factory inspections, and bringing cosmetics and therapeutic devices under federal regulatory control.
| Characteristics | Values |
|---|---|
| Name of the law that created the FDA | Federal Food, Drug, and Cosmetic Act of 1938 (also known as the Food, Drug, and Cosmetic Act or FD&C Act) |
| Year the law was passed | 1938 |
| Name of the US President who signed the law | Franklin Delano Roosevelt |
| Date the law was signed | June 24, 1938 or June 25, 1938 |
| What the law did | Overhauled the public health system, authorized the FDA to demand evidence of safety for new drugs, issue standards for food, and conduct factory inspections |
| Amendments to the law | Kefauver-Harris Amendments of 1962, Medical Device Amendments of 1976, Family Smoking Prevention and Tobacco Control Act of 2009, Insulin Amendment, Penicillin Amendment, Durham-Humphrey Amendment of 1951 |
| Previous laws related to food and drug regulation | 1202: Assize of Bread in England; 1813: first federal biologics law; 1848: inspection of imported drugs; 1902: Biologics Control Act; 1906: Pure Food and Drugs Act (also known as the Federal Food and Drugs Act or Wiley Act) |
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What You'll Learn
The Pure Food and Drugs Act, 1906
The Pure Food and Drugs Act of 1906, also known as the Wiley Act and Dr. Wiley's Law, was the first significant consumer protection law enacted by the United States Congress. It laid the foundation for the nation's first consumer protection agency, the Food and Drug Administration (FDA).
The Act was signed into law by President Theodore Roosevelt on the same day as the Federal Meat Inspection Act. Its enforcement was assigned to the Bureau of Chemistry in the US Department of Agriculture, which was later renamed the FDA. The Act's main purpose was to ban the sale of adulterated or mislabelled food and drug products in interstate commerce. It directed the US Bureau of Chemistry to inspect products and refer offenders to prosecutors.
The Act required that active ingredients be listed on the label of a drug's packaging and that drugs meet minimum purity levels established by the United States Pharmacopeia and the National Formulary. Foods were not defined according to analogous standards, but the law prohibited the addition of any ingredients that would substitute for the food, conceal damage, pose a health hazard, or constitute a filthy or decomposed substance. If the manufacturer chose to list the weight or measure of a food, this had to be done accurately. The food or drug label could not be false or misleading, and the presence and amount of dangerous ingredients, including alcohol, heroin, and cocaine, had to be disclosed.
The Pure Food and Drugs Act of 1906 was largely replaced by the much more comprehensive Federal Food, Drug, and Cosmetic Act of 1938, which was passed after a legally marketed toxic elixir killed over 100 people. The new law significantly increased federal regulatory authority over drugs and food and brought cosmetics and therapeutic devices under federal regulatory authority.
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The Federal Food, Drug, and Cosmetic Act, 1938
The Federal Food, Drug, and Cosmetic Act of 1938, also known as the FD&C Act, was signed into law by President Franklin Delano Roosevelt on June 24, 1938. The Act was passed following a mass poisoning incident in which over 100 people, including many children, died after consuming an untested toxic elixir sulfanilamide antibiotic containing the toxin diethylene glycol.
The 1938 Act significantly expanded federal regulatory authority over drugs and food safety. It mandated a pre-market review of the safety of all new drugs, requiring drug manufacturers to submit evidence of safety before marketing their products to the general public. This marked a significant shift in consumer protections and public health. The law also banned false therapeutic claims on drug labels and expanded enforcement powers, allowing the FDA to conduct factory inspections.
The Federal Food, Drug, and Cosmetic Act of 1938 also brought cosmetics and therapeutic devices under federal regulatory authority. It authorized the FDA to oversee the production, sale, and distribution of food, drugs, medical devices, and cosmetics, with the intent to protect the public from adulterated and misbranded products. This included setting regulatory standards for foods and defining cosmetics as products applied to the human body.
Since its enactment, the 1938 Act has undergone numerous amendments to meet evolving public needs and address emerging issues. For example, the 1951 Durham-Humphrey Amendment securely codified the category of "prescription-only" drugs, and subsequent amendments mandated potency testing for specific lifesaving pharmaceuticals. The Act remains the central foundation of FDA regulatory authority, with its influence extending to over $1 trillion worth of products regulated by the FDA annually.
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The Insulin Amendment
The Federal Food, Drug, and Cosmetic Act of 1938 was passed after a toxic elixir killed over 100 people, including many children. This law was amended several times over the years, including with the Insulin Amendment, which mandated potency testing for formulations of specific lifesaving pharmaceuticals.
Congresswoman Pramila Jayapal also pushed for amendments to be included in the National Defense Authorization Amendment to expand access to insulin. Amendment #203 authorized the Department of Defense to engage in the public manufacturing of insulin to meet the needs of military and TriCare health programs. This amendment would break the pharmaceutical industry's greedy hold on this life-saving drug by reducing the cost of a vial of insulin from $300 to as little as $10.
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The Penicillin Amendment
The Food and Drug Administration (FDA) is a federal agency of the United States that was formed in 1930. The history of the FDA can be traced back to the latter part of the 19th century and the U.S. Department of Agriculture's Division of Chemistry (later the Bureau of Chemistry).
In 1927, the Bureau of Chemistry's regulatory powers were reorganised under a new USDA body, the Food, Drug, and Insecticide Organisation. This name was shortened to the Food and Drug Administration (FDA) in 1930.
The Federal Food, Drug, and Cosmetic Act of 1938 was passed after a legally marketed toxic elixir killed 107 people, including many children. The law completely overhauled the public health system and significantly increased federal regulatory authority over drugs. It mandated a pre-market review of the safety of all new drugs, banned false therapeutic claims in drug labelling, authorised factory inspections, and set new regulatory standards for foods.
While pre-market testing of drug efficacy was not authorised under the 1938 FD&C Act, subsequent amendments such as the Insulin Amendment and the Penicillin Amendment did mandate potency testing for formulations of specific lifesaving pharmaceuticals. The Penicillin Amendment specifically addressed the standardisation of penicillin units, as the original form of penicillin was an ill-defined mixture of active compounds, leading to variations in potency from batch to batch. Penicillin, a β-lactam antibiotic, was discovered in 1928 by Scottish physician Alexander Fleming as a crude extract of P. rubens. It was the first medication effective against many bacterial infections caused by staphylococci and streptococci and is still widely used today for various bacterial infections.
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The Kefauver-Harris Amendments, 1962
The Food and Drug Administration (FDA) is a federal agency of the United States, formed in 1930. The Federal Food, Drug, and Cosmetic Act of 1938 was passed after a toxic elixir killed over 100 people. This Act overhauled the public health system and authorized the FDA to demand evidence of safety for new drugs, issue standards for food, and conduct factory inspections.
The Kefauver-Harris Amendments of 1962 strengthened and expanded upon the rules for drug safety and effectiveness. The Amendments were inspired by the thalidomide tragedy in Europe, which highlighted the need for stronger regulations. The law was signed by President John F. Kennedy on October 10, 1962.
The Kefauver-Harris Amendments introduced a "`proof-of-efficacy"` requirement, mandating that drug manufacturers demonstrate the effectiveness of their products in addition to ensuring their safety. This marked a significant shift in the way new drugs were approved and regulated. The Amendments also required accurate disclosure of side effects and efficacy in drug advertising and prevented cheap generic drugs from being marketed as expensive "breakthrough" medications under new trade names.
The Drug Efficacy Study Implementation was initiated to classify pre-1962 drugs as effective, ineffective, or requiring further study. The Amendments also strengthened the FDA's control of experimentation on humans and promoted good manufacturing practices, recognizing that quality should encompass both the process and the product. Estes Kefauver, who advised on the Amendment, considered it his "finest achievement" in consumer protection.
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Frequently asked questions
The Food and Drug Administration (FDA) was created to enforce the Pure Food and Drugs Act of 1906.
The 1906 Act, also known as the Wiley Act, prohibited the adulteration and misbranding of food and drugs.
The Act set the initial steps of regulatory oversight that the FDA is charged with enforcing today.
The Federal Food, Drug, and Cosmetic Act of 1938 was passed after a toxic elixir killed over 100 people. The new law significantly increased federal regulatory authority over drugs and brought cosmetics and therapeutic devices under the FDA's control.
The 1938 Act remains the central foundation of FDA regulatory authority to the present day. It authorized the FDA to demand evidence of safety for new drugs and conduct factory inspections.
