Import Program System Information
Last Update: 06/21/2004
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.
FDA's IMPORT PROGRAM / GENERAL PROCEDURES
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FOREIGN TRADE ZONES
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.
All Foreign firms are required to both register their establishments, and individually list their devices before they may import them into the United States. Establishment registration is accomplished by submitting a properly completed form FDA 2891 (Initial Registration of Device Establishment). In order to list their devices, establishments must submit a properly completed form FDA 2892 (Device Listing) for each medical device that they are importing into the United States. In addition, establishments must designate a U.S. Agent when submitting their FDA 2891 and 2892 forms. Complete information on registration and listing requirements and processes can be obtained from the Registration & Listing website, or by contacting DSMICA as described below. 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 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. Manufacturers outside the U.S. should call: (301) 443-6597.