Import For Export

Overview of Import For Export (IFE)

FDA’s import-for-export (IFE) provision in the Federal Food, Drug, and Cosmetic Act (FFDCA) section 801(d)(3) allows importers to import articles that are in violation of FDA regulations, further process them or incorporate them into another article, and then re-export them. However, the only types of products that can be declared as IFE entries are drugs or their components, devices or their components, food additives, dietary supplements, color additives, and biological products. Note that conventional foods (foods that are not dietary supplements) and cosmetics cannot be IFE entries.

 The IFE provision is often misunderstood by those in the import community – and even by many FDA officials. Importers and Customs brokers importing FDA-regulated products that have a good understanding of the IFE provision will have an advantage by knowing when it applies, how to file it correctly, and what to avoid in the filing. Many importers mistake IFE for a Customs entry type such as an IE (Immediate Export) entry type. In fact, IFE is a type of entry that is legally exempted from FDA refusal as long as the relevant criteria are met.

Certain information must be submitted at the time of entry.

• A statement of intent to further process the article or incorporate it into other article for export.
• Documentation identifying the entities in the chain of possession from the supplier to the owner or consignee.
• A certificate of analysis or equivalent documentation. Devices, device components, and certain biologics do not require a certificate of analysis.

FDA may release an entry upon receiving all the necessary documents required for an IFE entry. However, while IFE entries are exempt from FDA refusal, they are not exempt from detention; this is a common misconception. FDA may detain an IFE entry and keep it in detention status until the importer provides proof that the articles have been exported again, such as bills of lading and Customs exportation forms. Once FDA receives sufficient proof of exportation, it may release the entry. If the agency finds that the IFE requirements haven’t been met, though, it may still refuse the entry.

Some importers may ask why they shouldn’t simply request a refusal, since FDA law provides the importer the option of exporting refused goods. The reasons are simple. Most refusals cause the shipper/manufacturer and its product to be placed on an import alert, causing future shipments from that firm to be automatically detained. Even if the firm isn’t placed on an import alert, a record of the refusal will remain in FDA’s system, which could result in the agency increasing exams for products from that firm or otherwise scrutinizing the firm more heavily. Also, FDA may not allow a non-IFE entry to be further processed or incorporated into another article. 

Again, the IFE itself is not a Customs entry or bond type. However, this entry type affects the way FDA processes it and the time limit to export the goods.

Temporary Importation Under Bond

IFE entries are often entered under Custom’s Temporary Importation under Bond (TIB) provision. An entry imported under the TIB must be exported within one year from the date it is imported, unless Customs approves an application for an extension of up to two years, hence providing up to three years for the importer to export the goods under the TIB.

If the importer fails to provide Customs and FDA with proof of exportation within the timeframe of the TIB, Customs may issue the importer a liquidated damages claim and/or monetary penalties. FDA sometimes encourages entry filers to use the TIB because the agency will generally release an IFE entry immediately after it determines that it has met the IFE requirements. So FDA usually releases IFE entries without waiting for the products to be exported because Customs can still take action against the bond in the event that the importer fails to provide proof of exportation within the one-to-three year period.

However, IFE entries do not have to enter under the TIB provision. In fact, some activities that may qualify for IFE may not qualify for TIB. Entries may enter as consumption entries or warehouse entries. FDA law only requires that the entry be covered by a good and sufficient bond while it is in the US. If the entry is liquidated and thus no longer covered by a bond, then the entry is no longer exempt from FDA refusal.

There are several additional requirements that must be met to enter a shipment as an IFE entry. First, it is very important to declare the entry to FDA up front, using the IFE affirmation of compliance code. FDA does not accept an IFE declaration after the entry has been submitted to FDA.

Also, it is very important for the importer to not allow IFE articles, whether in its processed form or not, to be distributed into US commerce, as this is a prohibited act under FDA law. A person who commits a prohibited act is subject to legal enforcement action such as injunction or criminal prosecution. Even if the violations are removed during the processing of the IFE, the product may still not be distributed into US commerce, since it was declared to FDA as an IFE entry.

The initial owner or consignee must maintain records of the use of the articles of an IFE entry or destruction of any portion of the entry and must submit those records to FDA upon request. Also, the firm must, upon FDA’s request, submit a report that provides an account of the exportation or destruction of IFE articles and the way the owner or consignee complied with the requirements.

Need Help?

At FDAImports 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.