In the context of FDA regulations, what does "labeling" refer to?

In the context of FDA regulations, "labeling" encompasses a broad range of written, printed, or graphic matter that is associated with a product. This definition is crucial because it acknowledges not just the label itself but also any accompanying information that provides context about the product's use, benefits, risks, and other important details. Labeling can include product labels, brochures, online content, and any other materials that inform the consumer or healthcare provider about the product.

This comprehensive interpretation aligns with FDA's regulatory requirements, which mandate that labeling must be truthful and not misleading, providing essential details for safe and effective use. It ensures that consumers make informed decisions based on all relevant information available with the product, fostering safe usage and compliance with health regulations.

In contrast, the other options are more limited in scope or do not adequately encompass the full range of materials considered under the term "labeling." These definitions miss the regulatory nuances and obligations that manufacturers and distributors must adhere to under FDA guidelines.