To be considered misbranded, what must a drug label fail to disclose?

A drug label is considered misbranded if it contains misleading information that could deceive the consumer regarding the product's efficacy, safety, or quality. The core principle behind this regulation is to ensure that consumers have truthful and transparent information about the medications they are using. Misleading facts can include incorrect claims about the drug's effectiveness, false representations of its intended use, or any ambiguity that might confuse the consumer about what the drug actually does.

Misbranding is primarily focused on protecting consumers from false or deceptive practices, ensuring they can make informed decisions about their health and medication. Therefore, when a label includes misleading facts, it violates the standards set forth by regulatory agencies, which could include a lack of clarity about potential side effects, contraindications, or the scope of use.

The other options, such as not listing an expiration date, omitting active ingredients, or neglecting to mention the dosage form, may potentially result in compliance issues, but they do not directly fall under the category of misleading information that could constitute misbranding. Misbranding fundamentally revolves around the truthfulness and clarity of the information presented to consumers, making it essential for drug labels to avoid any chance of misleading impressions.