Abeling

All labels and other written, printed, or graphic matter upon or accompanying a food, drug, device, or cosmetic, or any of their containers or wrappers (section 201(m) of the Federal Food, Drug, and Cosmetic Act). Labeling for all of these products is regulated by the FDA, while advertising for these products (with exception of prescription drugs) is regulated by the Federal Trade Commission. Labeling cannot contain any false or misleading statements and must include adequate directions for use, unless exempt by regulation. Courts have taken a broad view of the term labeling in FDA cases: it includes al written material that is associated with a product (including leaflets, books, and reprints of journal articles or materials that explain or are designed to be used with the product), and point-of-purchase display material (such as placards and signs). Written material need not have been provided to the purchaser at the same time as the product to be considered labeling.


 


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