The FDA requires manufacturers to put specific information on labels.
The U.S. Food and Drug Administration (FDA) requires manufacturers to provide specific information on product labels and ensure their labels meet regulations. The FDA label quality requirements will provide a customer with information they need to make an informed decision before they purchase food, drugs, medical devices or biological products such as vaccines or allergenics used to treat a variety of medical conditions. The requirements apply to all labels, such as equipment, controls, packages, directions and manuals.
Food
The FDA gives food product manufacturers two options for labeling products. They may place all required label information in the same place on the front label, or they may put certain specified information, such as the name and amount of the product, on the front label, and additional information on the panel directly to the right of it, such as nutritional facts or ingredients. Labels must contrast with artwork enough so that a customer can easily read the information. Nonessential material, such as artwork or the UPC bar code, must not separate the required information labels from each other. Food labels must also include the name and address of a label manufacturer, packer or distributor. If this company is not the primary product developer, the label must state who it has prepared the label for, for example by printing "Prepared for" and listing the company's name.
Medical Devices
Medical device manufacturers must secure package labels in a way that the label will not peel off. Any labels and instructions included with a product must remain legible when a purchaser uses and stores the item. The FDA also requires manufacturers to thoroughly examine products to ensure that they have the correct label attached to them. Sterile devices have a modified set of requirements. Products that a user should sterilize before use must include at least one method for sterilization, while labels for products that the manufacturer has sterilized must state this fact. Manufacturers who make changes to label information must first formally review proposed changes and make sure they meet FDA requirements before implementing the changes.
Cosmetics
Labels must not state false or misleading information. They must name the manufacturer, packer or distributor and its address. Labels must state the use of the product in a way understandable to the public. The label also must include the quantity of the contents, such as weight, measurement, numerical count or a combination of these items. The Federal Food, Drug and Cosmetic Act requires any hazards, warnings or caution statements about the product to be clearly printed on the label. Cosmetic labels cannot say that the FDA has approved the product. The FDA requires all labels to include information in English, unless the product will sell exclusively in a U.S. territory, such as Puerto Rico, where another language predominates.
Tags: must state, Labels must, requires manufacturers, Food Drug, front label, information labels, label information
