Q- What are the requirements for importing foods into the USA?

A - 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 United States of America Food and Drug Administration when they are being imported or offered for import into the USA.

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 United States of America Food and Drug Administration is notified of all regulated products imported into the USA, the importer, or his/her representative, must file an entry notice and acquire a bond to cover their goods for release with the United States of America Customs Service (Customs). United States of America Food and Drug Administration is notified by Customs of the entry and makes a decision as to the article's admissibility. If United States of America Food and Drug Administration does not wish to examine the entry, the product is allowed to proceed into the USA. usually, if United States of America Food and Drug Administration samples an entry, an United States of America Food and Drug Administration representative will collect the sample from the shipment and have it analyzed in United States of America Food and Drug Administration's laboratory. If the analysis shows that the product is in compliance, the shipment is released into USA 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 United States of America Food and Drug Administration to recondition the product to bring it into compliance. For specific information on United States of America Customs procedures, requirements, and forms contact your local Customs office.

Section 801 of the Federal Food, Drug, and Cosmetic Act directs United States of America Food and Drug Administration 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 United States of America Food and Drug Administration, 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, United States of America Food and Drug Administration 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 United States of America Food and Drug Administration 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 United States of America Food and Drug Administration 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 United States of America Food and Drug Administration's discretion. Efforts to bring the product into compliance, including any sorting, reprocessing, or relabeling, must be performed under United States of America Food and Drug Administration supervision and at the expense of the importer. Both foreign shippers and importers in the USA 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 United States of America 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. United States of America Food and Drug Administration has developed a procedure whereby some products may be detained when they enter the USA. This procedure is an administrative act of detaining a product without physical examination and is usually 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 United States of America Food and Drug Administration standards.

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

Foreign trade zones. Foreign trade zones are areas within the USA as designated by Customs, to hold or otherwise manipulate goods for an unlimited period of time while awaiting a favorable market in the USA 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 USA 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 United States of America Food and Drug Administration or the applicability of the laws it administers. Foreign trade zones are part of the USA 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 United States of America Food and Drug Administration.

Additional Forms and Submissions. In addition to required entry forms, certain products require specific information to be presented to United States of America Food and Drug Administration 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 USA. This information must be provided to United States of America Food and Drug Administration, for each affected product, at the time of importation in order to assure compliance with registration and process filing acceptence. Establishment registration forms (United States of America Food and Drug Administration 2541), and process filing forms (United States of America Food and Drug Administration 2541 A - Food Process Filing For All Methods Except Low-Acid Aseptic; United States of America Food and Drug Administration 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 USA. Information regarding how to obtain a permit is discussed in the Import Milk Act (21 United States of America 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.

Food Import / Export Regulations Advice Guidance and Information