Inspections, Compliance, Enforcement, and Criminal Investigations
9-4 - FDA National Import Procedure Regarding Warehouse Entries
To provide districts with guidance regarding submission of entry notification to FDA by Customs for importers filing warehouse entries.
When a product is imported into the United States, the Importer of Record (Importer) must file entry paperwork with the U.S. Customs and Border Protection (CBP). The importer may choose to file a consumption entry, pay any applicable duty, and introduce the product into domestic commerce. Alternatively, the importer may file a warehouse entry, store the product in a bonded warehouse for up to five years, and pay duty only when the product is withdrawn for domestic commerce (withdrawal for consumption). If the importer exports the product while it is under bond, no duty is incurred.
There have been several instances where importers have questioned FDA's authority over, or right to see paperwork for, FDA regulated product covered by warehouse entries and intended for later export rather than domestic consumption.
Any product brought into the United States from a foreign country is "imported" and, therefore, subject to the import provisions set forth in section 801 of the Federal Food, Drug, and Cosmetic Act (FFDCA). Thus, all importers, including those filing warehouse entries, are subject to section 801 procedures, regardless of whether the intent is to later export the imported products. See also Compliance Policy Guide Sec. 110.200, "Export of FDA Regulated Products From U.S. Foreign Trade Zones."
To fulfill its obligation to ensure that regulated products comply with the requirements of the FFDCA, FDA should receive notification either electronically or by paper, no later than the time the warehouse entry is filed with CBP.