Which of the following acts established the FDA and regulated new drug marketing practices?

The Food, Drug, and Cosmetic Act is the correct choice because it established the framework for regulating food, drugs, and cosmetics in the United States. Enacted in 1938, this act expanded the authority of the FDA significantly. It required that all new drugs be proven safe before they could be marketed and also set standards for product labeling and advertising. The act aimed to protect consumers from unsafe and misbranded products, thus improving public health and safety.

The Pure Food and Drug Act, which predates the Food, Drug, and Cosmetic Act, primarily focused on preventing the manufacture, sale, or transportation of adulterated or misbranded food and drugs, but it did not grant the FDA regulatory authority over the safety of drugs or cosmetics in the same comprehensive manner as the later act.

The Kefauver-Harris Amendment made significant changes to drug regulation by ensuring that all new drugs would have to provide proof of both safety and efficacy before approval, which further strengthened the FDA's role but came after the establishment of the FDA and the fundamental regulatory framework.

The Orphan Drug Act focused on encouraging the development of drugs for rare diseases but is unrelated to the original establishment of the FDA or its authority to regulate new drug marketing practices.

Therefore, the