Final answer:
If a drug's established name of both active and inactive ingredients is missing from its label, it is described as misbranded. This is a violation of FDA regulations, which require full disclosure of a drug's contents for it to be safely and effectively used and advertised.
Step-by-step explanation:
If a product's established name of drug of both active and inactive ingredients is missing from the label or labeling, it is described as misbranded. This is a critical issue as both active and inactive components must be clearly denoted for consumer safety, and for compliance with the U.S. Food and Drug Administration's (FDA) regulations. Misbranding can lead to consumer confusion and misuse, which potentially has serious health implications. The established name being missing from the label violates the drug advertising regulation, which requires a "fair balance" between the benefits and the risks of a drug, and mandates that products be advertised only for the indications for which they were approved by the FDA.
For example, a new drug must go through a New Drug Application (NDA) and must be shown to be "safe and effective when used as directed" before it gets FDA approval. Similarly, a generic drug, which is a chemical equivalent to a name-brand drug whose patent has expired, requires an Abbreviated New Drug Application (ANDA) for approval. Any deviations from these processes, such as omitting the established names of active or inactive ingredients from labeling, could be considered misbranding and could have serious consequences, both for patient safety and for the manufacturer's standing with regulatory agencies.