Special Import Declarations
Certain special U.S. import declaration requirements apply to imported foods (including conventional foods, beverages, dietary supplements, and ingredients), imported drugs, and imported medical devices. For instance, prior to importing food into the U.S., the importer, owner or consignee of the food must submit an FDA Prior Notice to FDA. This FDA Prior Notice for imported food contains information about the product and its manufacturer and importer, and it must be submitted before the imported food arrives in the U.S. If an adequate FDA Prior Notice is not submitted before imported food arrives in the U.S., the imported food will be subject to an FDA refusal of admission. Other specialized FDA import declarations apply for canned foods and canned beverages, imported drugs, and imported medical devices.
Whenever an importer must respond to an FDA import detention, a Customs hold or a U.S. Department of Agriculture manifest hold or Emergency Action Notification, detailed legal and regulatory knowledge of the respective federal agency's scope and requirements is necessary to identify and provide -- in the proper format and venue -- the specific information the agency is seeking. U.S. importers and foreign manufacturers and shippers can and should prepare in advance for such holds in order to avoid, or at least reduce, the length of importing delays.
Environmental Testing Laboratory, Inc. (ETL), regularly reviews entry requirements, documentation, and compliance factors for clients, their products and labels, and their supply chains to ensure the appropriate records, permits, and certifications are in place prior to exporting to the US. Even if a U.S. government agency stops an imported shipment, ETL is often able to expedite the agency review to obtain a more rapid release.
Do not hesitate to call us if a government agency has held or detained your imported shipment. Waiting too long makes it more difficult to resolve the problem. Call ETL as soon as you experience any FDA import detention. In an FDA import detention, the government is alleging the imported product is not in compliance with FDA requirements. That must be corrected as soon as possible. Waiting until FDA has issued an FDA import refusal on an imported product is waiting too long. It is much more difficult to obtain a rescission or reversal of an FDA refused shipment than it is to obtain a release of an FDA detained shipment. Let Environmental Testing Laboratory show you The Way Through before FDA detains or refuses your imported products.
Standard Operating Procedures and Import Manuals
ETL assists importers in developing import Standard Operating Procedures related to Customs and FDA compliance, which includes proper record keeping systems. These import SOPs or import manuals also help the importer’s employees and agents (such as customs brokers and freight forwarders) know which company employee is responsible for specific required tasks. Import SOPs also help the importer document that it is in compliance with federal requirements. One of the most important benefits obtained from a complete set of importing procedures, however, is assisting the company in ascertaining what information should be provided to which agency and when and how to provide answers and solutions to likely and foreseeable importation delays, investigations, and inquiries of Customs and FDA inspectors and compliance officers. In this way, ETL helps clients help themselves by teaching the requirements in a way that enables the importer to self assess and implement its own import procedures, thus improving and maintaining a good compliance record with FDA and Customs.
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