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FDA Import Procedures

The U.S. Food and Drug Administration (FDA) is responsible for regulating the safety of all foods apart from meat and poultry, human and veterinary drugs, biological products, medical devices and electronic products that emit radiation, as well as cosmetics. The FDA works closely with the United States Customs and Border Protection (CBP), which is an agency within the Department of Homeland Security, to ensure the safety of these imported products when they enter the country.

  1. Entry Processing

    • The FDA district office is notified by the CBP of all imports under the FDA's regulation most efficiently via the FDA's electronic entry system called Operational and Administrative System for Import Support (OASIS). The FDA reviews the entry documents to determine whether a physical examination of the imported goods is needed.

    Field Examination

    • The FDA sends a notice of action to the importer, consignee and the filer indicating which items are pending FDA review. The importer of record or filer must then submit a location letter to the FDA containing the entry number, address where the product is held, dates when the entry is available for field examination and point of contact's name and phone number.

    Sample Collection

    • FDA investigators determine whether a sample collection is necessary based on the nature of the product, past history of the commodity and FDA priorities. FDA investigators collect samples and send them to the lab for analysis. A notice of FDA action is sent to the importer and to the filer indicating which products have been sampled. If the sample is determined to be in compliance with FDA requirements, the importer receives a release notice. FDA will pay for samples that pass analysis.

    Detention

    • If a product is in violation, the FDA will issue a notice of detention and hearing. The owner or consignee is entitled to an informal hearing and is generally given 10 working days to provide FDA with testimony or evidence in support of the products' admissibility.

    Admissibility Hearing

    • If the district determines the product is not in violation, the product may be released into the country. If the district considers the evidence and finds the product to be in violation, the FDA will issue a Notice of Refusal of Admission to the importer. Products refused admission must be destroyed or exported under CBP's supervision within 90 days of receiving the Notice of Refusal.

    Request to Relabel or Recondition

    • Depending on the violation, the importer may be allowed to relabel or recondition the product so it meets FDA guidelines. The FDA will review the importer's application to relabel or recondition and inform the importer whether the request is approved or denied.

    Further Inspection

    • The FDA may conduct a follow-up inspection and/or sampling to make sure the importer's relabeling or reconditioning sufficiently complies with FDA regulations. A Report of Inspector will be completed by the inspecting officer and forwarded to the appropriate FDA office.

    If Relabeling Conditions Are Fulfilled

    • If the importer sufficiently meets the FDA conditions of authorization to relabel or recondition the product, the district will notify the owner or consignee that the relabeled or reconditioned product is no longer subject to detention or refusal of admission. A copy of the notice will be sent to CBP and the filer.

    If Relabeling Conditions Are Not Met

    • Any product not properly relabeled or reconditioned must be destroyed or re-exported under FDA or CBP supervision. The FDA will not consider a second application to relabel or recondition unless the applicant provides reasonable assurance that the second attempt will be successful. Once conditions are not met, the FDA issues a Notice of Refusal of Admission to the importer, consignee, where applicable and the filer, with a copy of the Notice to CBP.

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