Explain how the Food and Drug Administration regulate drugs and cosmetics

Question

What will be an ideal response?

Answer 1

The first federal statute regulating the wholesomeness of food and drug products was enacted in 1906, but a much more comprehensive act—the federal Food, Drug, and Cosmetic Act (FDCA)—was enacted in 1938 . This statute, as amended, provides the basis for the regulation of much of the testing, manufacture, distribution, and sale of foods, drugs, cosmetics, and medicinal products and devices in the United States, and is administered by the Food and Drug Administration (FDA). The Drug Amendment to the FDCA gives the FDA broad powers to license new drugs in the United States. After a new drug application is filed, the FDA holds hearings and investigates the merits of the application. This process can take many years. The FDA may withdraw approval of any previously licensed drug. This law requires all users of prescription and nonprescription drugs to receive proper directions for use (including the method and duration of use) and adequate warnings about any related side effects. The manufacture, distribution, or sale of adulterated or misbranded drugs is prohibited. The FDA's definition of cosmetics includes substances and preparations for cleansing, altering the appearance of, and promoting the attractiveness of a person. For example, eye shadow and other facial makeup are cosmetics subject to FDA regulation. Ordinary household soap is expressly exempted from this definition. The FDA has issued regulations that require cosmetics to be labeled, to disclose ingredients, and to contain warnings if they are carcinogenic (cancer causing) or otherwise dangerous to a person's health. The manufacture, distribution, or sale of adulterated or misbranded cosmetics is prohibited. The FDA may remove from commerce cosmetics that contain unsubstantiated claims of preserving youth, increasing virility, growing hair, and such.