Federal Food, Drug, and Cosmetic Act of 1938

Great Seal of the United States (obverse)

The Federal Food, Drug, and Cosmetic Act of 1938 (FD&C Act) is a set of laws passed by the United States Congress giving authority to the Food and Drug Administration (FDA) to oversee the safety of food, drugs, and cosmetics. The act was signed into law by President Franklin D. Roosevelt on June 25, 1938.

Background

The FD&C Act was enacted in response to the public outcry following the deaths caused by the toxic elixir sulfanilamide in 1937. The previous law, the Pure Food and Drug Act of 1906, was deemed insufficient in regulating the safety of food and drugs.

Provisions

The FD&C Act introduced several key provisions:

• **Pre-market approval**: Required that new drugs be proven safe before marketing.
• **Labeling requirements**: Mandated accurate labeling of ingredients and directions for use.
• **Factory inspections**: Authorized the FDA to inspect factories and manufacturing processes.
• **Cosmetics and medical devices**: Extended regulatory oversight to cosmetics and medical devices.

Amendments

The FD&C Act has been amended numerous times to address emerging issues and improve regulatory oversight. Notable amendments include:

• The Durham-Humphrey Amendment of 1951, which defined prescription and over-the-counter drugs.
• The Kefauver Harris Amendment of 1962, which required drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval.
• The Medical Device Amendments of 1976, which established regulatory controls over medical devices.

Impact

The FD&C Act has had a profound impact on public health by ensuring the safety and efficacy of food, drugs, and cosmetics. It has also set a precedent for subsequent legislation and regulatory practices in the United States and around the world.

Related Pages

• Food and Drug Administration
• Pure Food and Drug Act of 1906
• Durham-Humphrey Amendment
• Kefauver Harris Amendment
• Medical Device Amendments

See Also

• Drug regulation
• Food safety
• Cosmetic safety