Legal Definitions - labeling

Under the Federal Food, Drug, and Cosmetic Act, labeling refers to all written, printed, or graphic information associated with a product. This broad term includes not only the information directly affixed to the product or its container, but also any other materials that are distributed as part of the same overall program to inform consumers about the product. Crucially, these materials do not need to physically accompany the product at the exact moment of delivery; they can be sent before or after the product itself, as long as their distribution is part of the coordinated effort to provide information about that specific product.

Here are some examples to illustrate what constitutes "labeling" under this definition:

• Example 1: Nutritional Information on Cereal Boxes

  Imagine a box of breakfast cereal that has a detailed nutrition facts panel, an ingredient list, and allergy warnings printed directly on its cardboard packaging. This information is considered labeling because it is graphic and printed matter directly on the product's container, providing essential details about the food item to the consumer.

• Example 2: Instruction Leaflets Inside Medication Packaging

  Consider a bottle of over-the-counter cough syrup that comes inside a small cardboard box. Within that box, there is a folded paper leaflet detailing dosage instructions, potential side effects, and warnings. Even though this paper insert is not physically glued to the bottle itself, it "accompanies" the product within its primary packaging and is part of the information provided at the point of sale. Therefore, it falls under the definition of labeling.

• Example 3: Educational Brochures for Prescription Drugs

  A pharmaceutical company launches a new prescription medication. As part of their patient education initiative, they provide doctors' offices with comprehensive brochures about the drug's benefits, risks, and proper administration. A patient might receive one of these brochures from their doctor a few days before they pick up their prescription from the pharmacy. This brochure, even though distributed separately and earlier than the physical drug, is considered labeling because it is part of the manufacturer's coordinated distribution program to inform users about the product and its safe use.