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FDA Import Process Procedure

Imports | Import Process & Procedure

All FDA-regulated products that are imported into the U.S. must meet both FDA and U.S. Customs and Border Protection (Customs) requirements. If it appears, from the examination of samples or otherwise, that an imported product may be noncompliant (adulterated, misbranded, or unapproved), FDA may detain the product upon its arrival in the U.S. If the apparent violation is not overcome with evidence, FDA will (ordinarily) refuse admission to the detained article. When FDA refuses admission to a product, the law requires that it be destroyed, unless it is exported within 90 days of FDA's refusal of admission.

FDAImports.com, LLC assists foreign manufacturers and shippers and U.S. importers in understanding and complying with the various documentation requirements that apply specifically to imported foods (such as canned foods, beverages, etc.), imported cosmetics, and imported drugs and devices in order to expedite the FDA and Customs review and clearance processes.

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The Customs Entry

The FDA import process begins with the importer or customs broker submitting the necessary Customs entry details to the local Customs port office. Most entries are filed electronically. Customs forwards the electronic data to FDA for its review. Even for electronic entries, FDA often requires the presentation of certain commercial documents related to the shipment. When FDA requires additional documentation, it makes the request to the customs broker. It is not uncommon for FDA to ask for information or documents from the foreign shipper or foreign manufacturer to verify compliance with FDA requirements.

Entry declarations and information must clearly identify the product by Customs Harmonized Tariff Schedule codes according to the Harmonized Tariff Schedule of the U.S. (HTSUS), and FDA product codes, which are different from the HTSUS codes. Most customs brokers can and will assist with classifying imported products according to the HTSUS; however, many require their importing clients to provide the FDA product codes. Improper classification can result in an improper payment of Customs duties, which can result in penalties.

The Customs entry and FDA declarations must include information about the product, the country of origin, the foreign manufacturer and the foreign shipper, the importer of record, the consignee, the quantity and value of the imported goods, and an appropriate description. All of these declarations are subject to specific regulations issued by Customs, primarily, as well as FDA. The FDCA also requires that the registration numbers of foreign food establishments and foreign drug and medical device establishments be included in entry-related filings (in the Prior Notice submission for food imports and in a statement provided to FDA for device and drug imports).

For canned foods, FDA recommends (but does not require) submission of the foreign manufacturer?s food canning establishment (FCE) number, and the scheduled process identification (SID) number.

Virtually all imported foods are subject to FDA's Prior Notice requirements under the Bioterrorism Act (BTA). In most cases the FDA Prior Notice is transmitted at the same time the Customs entry is filed by the customs broker using the same filing process and electronic system. However, importers and foreign exporters may separately file the FDA Prior Notice using an FDA electronic system as well.

Drugs (human and animal), medical devices, cosmetics, other food products (human and animal), food contact services (e.g., ceramic ware), and electronic products all have their own unique compliance affirmation codes relevant to the FDA import clearance process. Although FDA admits that many of these codes may be submitted voluntarily during the Customs entry process, FDA often issues FDA Import Detentions for Customs entries based upon the failure to provide such information electronically. In instances where the FDCA or FDA regulation requires submission of the data at Customs entry, such FDA Import Detentions are lawful.

However, where no statute or regulation requires submission of data at entry (e.g., submission of an FCE or SID number, submission of drug or medical device listing numbers, and other numerical identifiers not covered by statute or regulation), this kind of detention, based solely upon failure to submit the data at Customs entry and where the only evidence FDA has regarding the shipment is the alleged failure to submit the data, is unlawful.


Customs Conditional Release

Ordinarily, once the Customs entry information and a Customs basic importation (or other) bond is filed covering the imported goods, Customs will release the imported product to the importer's custody even while FDA is still deciding whether the product may be admitted entry to commerce for distribution. This Customs release prior to issuance of an FDA release is called a Customs conditional release.

Customs requires the importer of record to file an importation bond, which generally Customs requires to be in an amount at least equal to three times the invoice value of the goods. The importation bond is basically an agreement, or contract, between the importer and Customs and there are a number of terms in the agreement that are all defined by Customs regulation and based upon the type of bond that is filed.

One of the important terms of the importation bond is that the importer of record agrees to redeliver the conditionally released goods back into Customs' custody if Customs issues a lawful and enforceable demand for redelivery. If Customs issues a valid and enforceable demand for redelivery of a shipment that was conditionally released by Customs, the importer of record is given a specified amount of time to comply with the demand. If the importer fails to redeliver the Customs released merchandise, Customs can issue a civil claim for liquidated damages in an amount equal to three times the invoice value of the goods that were not redelivered, up to the limit of the value of the bond.

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At FDAImports.com, LLC we make certain our importing clients understand the importation process and assist our clients in identifying appropriate actions and responses should Customs demand redelivery of a conditionally released product, or should that agency issue a demand for payment of liquidated damages pursuant to the importation bond. It is important for your company to know and follow the laws, regulations, and procedures when importing products into the United States. Get Started.