In the context of medication, what is a key aspect of FDA regulation?

The classification of products as food or drugs is a key aspect of FDA regulation because it determines how different products are treated under the law, influencing the path for regulation, safety, and efficacy requirements. The FDA classifies substances based on their intended use, which directly impacts their approval process, labeling, manufacturing, and marketing.

For instance, products intended for use in diagnosing, curing, mitigating, treating, or preventing disease are classified as drugs and must undergo rigorous testing and approval processes to ensure safety and efficacy prior to being marketed. Conversely, products classified as food have different regulatory requirements and may not require the same level of evidence regarding safety and effectiveness. This classification system is fundamental to ensuring that consumers have access to safe and effective products while also allowing for proper oversight of the market.

While approval processes for dietary supplements, regulation of animal feed, and setting prices for pharmaceuticals are important aspects of FDA's broader mandate, they are not fundamental to the primary classification system that governs how products are managed and regulated. Therefore, understanding the distinction between foods and drugs is essential for comprehending the framework and responsibilities of the FDA.