Misbranding

Misbranding of Drugs and Medical Devices

A drug or medical device is “misbranded” if its labeling or packaging violates the rules and regulations defined by health and safety authorities such as the U.S. Food and Drug Administration.

The most common ways a drug or device may be considered misbranded are:

False or Misleading Information: If the labeling, packaging, or promotional material of the product contains information that is false or misleading, it can be considered misbranded. This might include overstating the benefits of the product, minimizing or omitting information about risks or side effects, or providing false information about the product’s composition or function.

Insufficient Information: If necessary information is missing from the labeling or packaging, the product may be considered misbranded. This can include failure to provide adequate directions for use, not listing all the active and inactive ingredients in a drug, or not including necessary warnings about potential side effects or contraindications.

Misrepresentation: Misbranding can also occur if the product’s labeling or packaging misrepresents its nature, contents, or origin. This might include using a name that is confusingly similar to another product, suggesting that the product is from a different manufacturer or source, or implying that the product has certain properties or benefits that it doesn’t actually have.

Noncompliance with Standards or Regulations: If the product does not adhere to established standards for safety, efficacy, quality, or manufacturing practices, it can be considered misbranded.

Misbranding is a serious issue because it can mislead consumers, healthcare providers, and others, potentially leading to inappropriate or unsafe use of the drug or device. Federal laws and regulations aim to prevent misbranding in order to protect public health and safety.