Customs & Compliance
FDA-Regulated Imports: Plan Delivery Around the Agency Decision
Food, drugs, devices, cosmetics and other FDA-regulated products can require a separate agency review during U.S. import. The delivery plan should reflect the actual FDA status, not an assumed release date.
Identify the product and its requirements
FDA receives entries of regulated products through CBP and reviews them for admissibility. Requirements differ by commodity, manufacturer and intended use. Confirm product identifiers, manufacturer details, labeling and any relevant registration or listing information before filing.
Watch for a document request or manual review
FDA says incomplete or inaccurate entry information can be flagged for manual review. A request for records changes the timing of the shipment even if a truck was tentatively planned. Respond to the stated requirement and keep pickup partners informed of the current status.
Do not equate customs movement with FDA admissibility
FDA says imported items should not be distributed into commerce until it has determined admissibility. Confirm that decision before scheduling final distribution. Storage or transfer may be part of the operating plan, but it must follow the agency's instructions for that cargo.
Official sources
Check these agencies for current requirements and product-specific instructions.
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