What are the requirements for importing foods into the United States?

With the exception of most meat and poultry, all food, drugs, biologics, cosmetics, medical devices, and electronic products that emit radiation, as defined in the Federal Food, Drug, and Cosmetic Act and related laws, are subject to examination by FDA when they are being imported or offered for import into the United States.

All imported products are required to meet the same standards as domestic goods. Imported foods must be pure, wholesome, safe to eat, and produced under sanitary conditions; drugs and devices must be safe and effective; cosmetics must be safe and made from approved ingredients; radiation-emitting devices must meet established standards; and all products must contain informative and truthful labeling in English.

General Procedures. To ensure that FDA is notified of all regulated products imported into the United States, the importer, or his/her representative, must file an entry notice and acquire a bond to cover their goods for release with the U.S. Customs Service (Customs). FDA is notified by Customs of the entry and makes a decision as to the article's admissibility. If FDA does not wish to examine the entry, the product is allowed to proceed into the United States. Generally, if FDA samples an entry, an FDA representative will collect the sample from the shipment and have it analyzed in FDA's laboratory. If the analysis shows that the product is in compliance, the shipment is released into United States commerce. However, if there is a violation, the product is refused admission. Before the product is refused admission, however, the importer is provided an opportunity to challenge the detention by proving that the product complies with the law. Alternatively, the importer can submit an application to FDA to recondition the product to bring it into compliance. For specific information on U.S. Customs procedures, requirements, and forms contact your local Customs office.

Section 801 of the Federal Food, Drug, and Cosmetic Act directs FDA to refuse admission of any article that appears to be in violation. When a sample of an article offered for import has been requested by FDA, the owner or consignee shall hold the shipment and not distribute it until further notice is received regarding the results of the examination of the sample. If it appears that the article is violative, FDA issues a Notice of Detention and Hearing to the owner or consignee of the article specifying the place and time at which the individual may appear before FDA to introduce testimony either verbally or in writing for consideration by the agency before any further action is taken. Section 801(b) permits importers to try to bring the violative article into compliance. The owner or consignee may submit an application to FDA to relabel or perform other actions to bring the article into compliance, or render the product no longer a regulated article. This section also provides that the reconditioning application be covered by a bond for payment of liquidated damages in the event of default. The approval of the application, which must specify the time and place where such reconditioning operations will be carried out and the approximate timetable for completion, is at FDA's discretion. Efforts to bring the product into compliance, including any sorting, reprocessing, or relabeling, must be performed under FDA supervision and at the expense of the importer. Both foreign shippers and importers in the United States should realize that conditional release of an illegal importation, to bring it into compliance, is not a right but a privilege. Abuse of the privilege, such as repeated shipments of the same illegal article, may result in denial of the privilege in the case of subsequent importations.

If the product is refused admission, the importer is required to either re-export or destroy the article under U.S. Customs or other approved supervision. If the refused product is not destroyed or re-exported, Customs issues a notice for redelivery to the importer of record. Failure to redeliver the refused product may result in Customs assessing liquidated damages against the importer's bond.

Detention Without Physical Examination. FDA has developed a procedure whereby some products may be detained when they enter the United States. This procedure is an administrative act of detaining a product without physical examination and is generally based on past history and/or other information indicating the product may be violative. Once a product is detained without physical examination, normal entry may not resume until the shipper or importer proves that the product meets FDA standards.

Computerization.To assure the expeditious handling of imported products, FDA is in the process of automating its import operations. Efforts are currently underway to combine FDA's Operational and Administrative System for Import Support (OASIS) and Customs' Automated Commercial System (ACS), to permit the FDA reviewer to more efficiently evaluate and process each import entry. Under the automated system the import filer transmits the required shipment-specific FDA data into the ACS. Within several minutes, that individual receives notification that either their shipment has been released or FDA wishes to review it. This system provides FDA with immediate data on products imported, provides information on potential problems, and maintains national historical data files to develop profiles on specific products, shippers, and manufacturers. Eventually all filers processing entries through Customs' ACS will provide FDA information electronically.

Foreign trade zones. Foreign trade zones are areas within the United States as designated by Customs, to hold or otherwise manipulate goods for an unlimited period of time while awaiting a favorable market in the United States or nearby countries without being subject to Customs entry, payment of duty, tax, or bond. These areas are considered outside the Customs territory of the United States for purposes of Customs importing procedures. However, the location of an establishment in a foreign trade zone has absolutely no bearing on the jurisdiction of the FDA or the applicability of the laws it administers. Foreign trade zones are part of the United States and the movement of regulated products into or out of such zones, including exports, constitutes interstate commerce. Therefore, regulated products in foreign trade zones must comply with those laws administered by FDA.

Additional Forms and Submissions. In addition to required entry forms, certain products require specific information to be presented to FDA at the time of importation:

• Foreign firms must register and file processing information before shipping any low-acid canned food or acidified low-acid canned food to the United States. This information must be provided to FDA, for each affected product, at the time of importation in order to assure compliance with registration and process filing acceptance. Establishment registration forms (FDA 2541), and process filing forms (FDA 2541a - Food Process Filing For All Methods Except Low-Acid Aseptic; FDA 2541c - Food Process Filing for Low-Acid Aseptic Systems) can be obtained from the Food and Drug Administration, Center for Food Safety and Applied Nutrition, Division of HACCP Programs, Regulatory Food Processing and Technology Branch, LACF Registration Coordinator (HFS-618), 200 C Street S.W., Washington, D.C. 20204 (see Low-Acid Foods Registration and Process Filingfor further information).

• The Federal Import Milk Act requires a permit for milk and cream (including sweetened condensed milk) imported into the United States. Information regarding how to obtain a permit is discussed in the Import Milk Act (21 U.S.C. 141-149). This data, together with the permit request, should be directed to the Food and Drug Administration, Division of Cooperative Programs, Milk Safety Branch (HFS-626), 200 C Street S.W., Washington, D.C. 20204.