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Last Update: 17-MAR-1999
The Food and Drug Administration (FDA) mission is to enforce the Federal Food, Drug, and Cosmetic (FD&C) Act and other laws which are designed to protect consumers' health, safety, and pocketbook. These laws apply equally to domestic and imported products.
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 FD&C and related Acts, are subject to examination by FDA when they are being imported or offered for import into the United States. Most meat and poultry products are regulated by the U.S. Department of Agriculture.
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.
As defined in the FD&C Act the term adulteration has to do with the content of a product (such as the addition of a substance which makes a product inferior, impure, not genuine, etc.) while misbranding includes statements on labels or labeling that are false or misleading.
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 an entry bond with the U.S. Customs Service (Customs) pending a decision regarding the admissibility of the product. FDA inspection and enforcement procedures for imports rely on coordination with Customs with whom FDA has an excellent working relationship. For specific information on U.S. Customs procedures, requirements, forms, etc., contact your local Customs office.
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 United States commerce.
Generally, if FDA decides to examine an entry, an FDA representative will collect a sample from the shipment for laboratory evaluation. If the analysis indicates the product is in compliance, the shipment may be released into United States commerce. If there is a violation, the product will be refused admission. The FD&C Act, Section 801, directs FDA to refuse admission of any article that appears to be in violation of the Act.
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 a place and period of time whereby the individual may introduce testimony either verbally or in writing.
The importer is provided an opportunity to submit a petition to recondition the product to bring it 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 article other than a food, drug, device, or cosmetic. An application for authorization to relabel or perform other actions to bring the article into compliance shall contain a detailed proposal and specify the time and place where such operations will be carried out and the approximate time for completion as specified by regulation. All petitions to recondition a product are subject to FDA review and approval.
If the product is refused, 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
In some instances a product may be detained as soon as it is offered for entry into the United States. This procedure is the administrative act of detaining a product without physical examination and is based on past history and/or other information indicating the product may be violative. A product may be subject to a detention without physical examination (DWPE) recommendation until the shipper or importer proves that the product meets FDA guidelines or standards.
Occasionally, FDA identifies products from an entire country or geographic region for DWPE when the violative conditions appear to be geographically widespread. Detention recommendations of this breadth are rare and are initiated only after other avenues for resolving the problem have been exhausted. (See FDA Regulatory Procedures Manual (RPM), Chapter 9-25-00 for details on Detention Without Physical Examination - formerly known as Automatic Detention).
Import Alerts have been developed to communicate guidance to FDA field offices. The purpose of an Import Alert is to identify and disseminate import information (problems, violative trends, etc.) to FDA personnel thus providing for more uniform and effective import coverage. Import Alerts identify problem commodities and/or shippers and provide guidance for import coverage. They will identify products or shippers that have met the criteria for DWPE (see RPM, Chapter 9-25-00). For additional information or questions regarding DWPE, import alerts or import bulletins policy contact the Division of Import Operations and Policy (DIOP), HFC-170, 5600 Fisher Lane, Rockville, MD 20857.
To assure the expeditious handling of imported products, FDA has automated its import operations. By combining FDA's Operational and Administrative System for Import Support (OASIS) and Customs' Automated Commercial System (ACS), an FDA reviewer will be able to more efficiently evaluate and process each import entry. The import filer transmits the required shipment-specific FDA data into the ACS. Within several minutes, the filer receives notification that either their shipment has been released or FDA wishes to review it. This system provides FDA with immediate data on imported products, 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.
A foreign trade zone (FTZ) is an area in the United States designated by Customs to hold or otherwise manipulate goods for an unlimited period of time 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 Customs importing procedures.
However, the location of an establishment in a foreign trade zone has absolutely no bearing on the jurisdiction or the applicability of the laws administered by FDA. Foreign trade zones are part of the United States and the movement of regulated products into or out of such zones, including export, constitutes interstate commerce. Therefore, regulated products in foreign trade zones must comply with those laws that come within the purview of the FDA.
In addition to required entry forms, certain products require specific information to be presented to FDA at 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 applicable product at the time of importation in order to assure compliance with registration and process filing acceptance. Establishment registration (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 LACF Registration Coordinator, (HFS-618), Regulatory Food Processing and Technology Branch, Division of HACCP Programs, Center for Food Safety and Applied Nutrition, 200 C Street SW, Washington, DC 20204.
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 USC 141-149. This data, together with the permit request should be directed to the Food and Drug Administration, Regulations and Enforcement Branch, Division of Program and Enforcement Policy (HFS-306), 200 C Street SW, Washington, DC 20204.
Although it is not a requirement for foreign drug firms to register their establishments, their products must be listed with the FDA. Forms required to obtain a labeler code (FD 2656) and drug list their product (FD 2657) should be requested from the Center for Drug Evaluation and Research, Product Information Management Branch (HFD-058), 5600 Fishers Lane, Rockville, MD 20857.
Drugs are restricted from importation unless they are covered under an Investigational New Drug Exemption (IND) or by an approved New Drug Application (NDA). Information on regulations covering INDs or NDAs and application forms should be requested from CDER Executive Secretariat (HFD-8), Center for Drug Evaluation and Research, 5600 Fishers Lane, Rockville, MD 20857.
There are several forms that are required to be filed with FDA prior to the importation of medical devices into the United States.
A premarket notification or 510(k) submission is required when the following occurs: (a) a foreign manufacturer intends to export a medical device to the U.S. that the firm has never before shipped to the U.S.; (b) either the foreign manufacturer or initial distributor changes the intended uses of devices that are legally being marketed in the U.S.; or (c) changes or modifications to a legally marketed device that could significantly affect its safety or effectiveness. Detailed information regarding the premarket notification process can be obtained from the following documents: Premarket Notification: 510(k), Regulatory Requirements for Marketing a Device, and 510(k) Review Program.
Firms are required to submit a properly completed form FDA 2892 (Medical Device Listing) before their medical device can be imported into the United States. Although, it is not a requirement for foreign medical device firms to register their establishments, it is requested that they do so. This can be done by submitting a properly completed form FDA 2891 (Initial Registration of Medical Device Establishment). Form FDA 2877 (Declaration for Radiation Standard) is required for radiation-emitting electronic products entering the United States.
To obtain these above forms, or information concerning premarket notification, radiation control standards, or Drug and Device Listing and Establishment Registration contact the Center for Devices and Radiological Health, Division of Small Manufacturers, International and Consumer Assistance (DSMICA), (HFZ-220), 1350 Piccard Drive, Rockville, MD 20850-4307, (800) 638-2041).
This is a mirror of the page at http://www.fda.gov/ora/import/ora_import_system.html
*Information on Importing Cosmetics
Hypertext updated by bap 2002-FEB-08