U.S. Food and Drug Administration
Center for Food Safety & Applied Nutrition
Industry Affairs Staff Flyer: 1996
FDA IMPORT PROCEDURES 1. Importer or agent files entry documents with U.S. Customs Service within five working days of the date of arrival of a shipment at a port of entry. 2. FDA is notified of an entry of a regulated food through: - Duplicate copies of Customs Entry Documents (CF 3461, CF 3461 ALT, CF 7501 or alternative), - Copy of commercial invoice, and, - Surety to cover potential duties, taxes and penalties. 3. FDA reviews Importer's Entry Documents to determine if a physical examination, wharf examination, sample examination should be made. 4A. Decision is made not to collect a sample. FDA sends a "May Proceed Notice" to U.S. Customs and the importer of record. The shipment is released as far as FDA is concerned. 4B. Decision is made to collect a sample based on: - Nature of the product, - FDA priorities, and, - Past history of the commodity. FDA sends a "Notice of Sampling" to U.S. Customs and the importer of record. The shipment must be held intact pending further notice. A sample will be collected from the shipment. The importer of record may move the shipment from the dock to another port or warehouse (contact U.S. Customs for details). 5. FDA obtains a physical sample. The sample is sent to an FDA District Laboratory for analysis. 6A. FDA analysis finds the sample to be in compliance with requirements. FDA sends a Release Notice to U.S. Customs and the importer of record. 6B. FDA analysis determines that the sample "appears to be in violation of the FD&C Act and other related Acts." FDA sends U.S. Customs and the importer of record a Notice of Detention and Hearing which: - Specifies the nature of the violation, and, - Gives the importer of record 10 working days to introduce testimony as to the admissibility of the shipment. The hearing is the importer's only opportunity to present a defense of the importation and/or to present evidence as to how the shipment may be made eligible for entry. 7A. Consignee, true owner, importer of record, or a designated representative responds to the Notice of Detention and Hearing. The response permits the introduction of testimony, either orally or written, as to the admissibility of the shipment. 7B. Consignee, true owner, importer of record, or a designated representative neither responds to the Notice of Detention and Hearing nor requests an extension of the hearing period. 8A. FDA conducts a hearing concerning the admissibility of the product. The hearing is an opportunity to present relevant matters and is confined to the submission of pertinent evidence. 8B. FDA issues a Notice of Refusal of Admission to the importer of record. This is the same person or firm who was sent a Notice of Sampling. All recipients of the Notice of Sampling and the Notice of Detention and Hearing are sent a copy of the Notice of Refusal. 9A. Importer of record presents evidence indicating that the product is in compliance. Certified analytical results of samples, examined by a reliable laboratory and which are within the published guidelines for levels of contaminants and defects in food for human use, may be presented. 9B. Importer of record submits an Application for Authorization to Recondition or to Perform Other Action (FDA Form FD 766). The form requests permission to try to bring a food that is adulterated or misbranded into compliance by relabeling or other action, or by converting to a non-food use. A detailed method to bring the food into compliance must be given. 9C. FDA receives verification of the exportation or destruction of the shipment from U.S. Customs. The exportation or destruction of the merchandise listed on the Notice of Refusal of Admission is carried out under the direction of U.S. Customs. 10A. FDA collects follow-up sample to determine compliance with guidelines. 10B. FDA evaluates the reconditioning procedure proposed by the importer. A bond is required for payment of liquidated damages. 11A. FDA finds that the sample is "in compliance." A Release Notice with the statement "Originally Detained and Now Released" is sent to U.S. Customs and the importer. 11B. FDA finds that the sample is not in compliance. The importer may either submit an Application for Authorization to Recondition or to Perform Other Action (see 9B), or, FDA will issue a Notice of Refusal of Admission (see 8B). 11C. FDA approves importer's reconditioning procedures. The approved application contains the statement "Merchandise Should Be Held Intact Pending the Receipt of FDA's Release Notice." 11D. FDA disapproves applicant's reconditioning procedure if past experience shows that the proposed method will not succeed. A second and final request will not be considered unless it contains meaningful changes in the reconditioning operation to ensure a reasonable chance of success. The applicant is informed on FDA Form FD 766. 12. Importer completes all reconditioning procedures and advises FDA that the goods are ready for inspection/sample collection. 13. FDA conducts follow-up inspection/sample collection to determine compliance with the terms of the reconditioning authorization. 14A. FDA analysis finds that the sample is in compliance. A Release Notice is sent to the importer and to U.S. Customs. The charges for FDA supervision are assessed on FDA Form FD 790. Copies are sent to U.S. Customs which is responsible for obtaining total payment including any expenses incurred by their personnel. 14B. FDA analysis finds that the sample is still not in compliance. Charges for FDA supervision are assessed on FDA Form FD 790. Copies are sent to U.S. Customs which is responsible for obtaining total payment including expenses incurred by their personnel. IMPORTERS CAN SPEED FOOD ENTRIES! - Determine before shipment that the product to be imported is legal. - Have private laboratories examine samples of foods to be imported and certify the analysis of the processor. While not conclusive, these analyses might serve as an indication of the processor's ability to produce acceptable, legal products. - Become acquainted with FDA's legal requirements, before contracting for a shipment. - Request assistance from the FDA District Office responsible for your port of entry. - Know the food importing procedures described on this information sheet.