This document is intended to assist industry in complying with the labeling requirements of the Dietary Supplement and Nonprescription Drug Consumer Protection Act (Public Law 109-462, 120 Stat. 3469). The statute created a new section 502(x) in the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 352(x)). These requirements apply to manufacturers, packers, and distributors of nonprescription (over-the-counter (OTC)) human drug products marketed without an approved application.