This Compliance Policy Guide (CPG) provides guidance to importers whose U.S. Food and Drug Administration (FDA) regulated articles offered for import have been detained by U.S Customs and Border Protection (CBP). A previous version of this CPG, numbered 110.800, was revised in FDA’s Compliance Policy Guides Manual in 1989. This CPG supersedes that version and includes minor revisions to clarify existing language, as well as other minor stylistic revisions.
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA’s guidances means that something is suggested or recommended, but not required.