How does the Federal Food, Drug and Cosmetic Act (FFDCA) define a drug?

The Federal Food, Drug, and Cosmetic Act (FFDCA) defines a drug as any substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. This definition emphasizes the purpose of the substance, indicating that it must have a specific therapeutic intention related to health and medical conditions.

Choosing this definition is crucial because it outlines the regulatory framework under which pharmaceutical products are evaluated for safety and efficacy. It sets a clear distinction between drugs and other substances, such as food or cosmetics, which do not have the same therapeutic claims and regulatory scrutiny. This definition allows the FDA to monitor and regulate medications based on their intended use, ensuring that drugs meet safety standards before they can be marketed to the public.

The other options do not reflect the regulatory definition and focus of the FFDCA regarding drugs. For instance, recreational substances do not align with the purpose of diagnosis or treatment. Similarly, natural compounds found in food may not be intended for therapeutic use, and merely being an ingredient in over-the-counter products does not determine whether something qualifies as a drug under the law. It is the specific intent related to disease and therapeutic outcomes that is defining in this context.