Import Process - Background
The Office of Regulatory Affairs (ORA) is the lead office for all field activities conducted by the FDA. ORA Headquarters is comprised of the Office of Resource Management, the Office of Regional Operations, the Office of Enforcement, and the Office of Criminal Investigations. The Division of Import Operations and Policy (DIOP) within the Office of Regional Operations serves as the agency focal point for relationships between ORA Headquarters and the field on all import programs and operations.
DIOP’s responsibilities include:
- Overseeing field import operations, including investigation and compliance activities
- Developing and reviewing FDA import policies, procedures, programs, and assignments
- Coordinating FDA import activities with United States Customs and Border Protection (CBP) and other federal agencies and foreign governments
- Training field import personnel
ORA staff are dispersed throughout the United States. Over 85 percent of ORA’s staff work in the 5 Regional Offices, 20 District Offices, 13 Laboratories, and more than 150 Resident Posts and Border Stations located across the U.S.
Sections 801(a) and 536(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) authorize FDA to examine foods, drugs, cosmetics, tobacco products, devices, and radiation-emitting electronic products offered for import into the United States. FDA can refuse admission of imported products into the U.S. if, among other reasons, the product appears to be adulterated or misbranded. FDA works closely with CBP to prevent the importation of adulterated, misbranded, or otherwise violative products into the country.
In some cases, a product may be detained without physical examination (DWPE) when it is offered for importation into the United States. The DWPE decision is based on whether the agency has sufficient evidence or other information, other than from a physical examination, to refuse admission of an imported product. Such information could be based on, for example, a shipper or importer having a history of importing violative products such that future imports of the product appear to not be in compliance with the FD&C Act. When a product is detained, the owner or consignee has an opportunity to show that the product meets FDA requirements. In some situations, FDA may allow the importer to recondition a product that is violative.
FDA uses Import Alerts to identify and disseminate import information to FDA personnel. Import Alerts identify problem commodities and/or importers and provides information and direction to FDA personnel regarding the importation of those commodities as well as information to FDA personnel regarding the companies noted in the alert.
As part of the importation process, importers must file information about the product with CBP, and other agencies with jurisdiction. Importers can file this information themselves, or may use the services of a licensed customhouse broker to facilitate submission of the required documentation. FDA conducts evaluations of filers who participate in FDA’s electronic entry processing program to determine if filers are submitting accurate data to FDA.
Requirements and other information regarding importing products are set forth in the FD&C Act, FDA regulations, and in numerous documents and guidances issued by the agency. In addition, a section of the FDA Web site is dedicated to information of interest to the importer community.
FDA employs an import screening tool, the Operational and Administrative System for Import Support (OASIS), to help manage and oversee import operations. OASIS is an automated FDA system for processing and conducting admissibility screening determinations for imported FDA-regulated products. FDA’s Import Trade Auxiliary Communications System (ITACS) is an extranet application that will be available to any trade user with a valid entry number. It will enable a trade user to retrieve entry review status, to provide product availability information, and to submit documentation. ITACS is expected to be deployed in the next few months.
FDA also plans to issue a Strategic Plan for Imports (Strategic Plan) that will identify and address critical issues and performance gaps in current import operations. This Strategic Plan will address the entire life cycle of FDA-regulated products imported into the U.S., with a goal of increasing uniformity, and improving effectiveness and efficiency across the country. This will result in a more modern approach to import operations that focuses on prevention, intervention and response.