Imports | Import for Export
FDAís import-for-export (IFE) provision is often misunderstood by those in the import community Ė 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, leading the industry in knowing when IFE applies to them, how to file an IFE correctly, and what to avoid in the filing to avoid any problems with FDA. 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 by the Food Drug and Cosmetic Act, as long as the relevant criteria are met.Get Started Today.
The IFE provision in the Federal Food, Drug, and Cosmetic Act (FFDCA) 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 further processing of an IFE article may include labeling, packaging, sterilization, or other activities. An article cannot be imported as an IFE entry solely for storage purposes. If the imported article is incorporated into something else, it must be incorporated into a drug, device, food, food additive, color additive, dietary supplement, or biological product. These activities must be performed by the initial owner or consignee of the goods, and any portion of an IFE entry that is not exported must be destroyed by the initial owner or consignee.
Certain information must be submitted at the time of entry, including: 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, and 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 of the necessary documents required for an IFE entry. However, while IFE entries are exempt from FDA refusal, they are not exempt from FDA detention; this is a common misconception. FDA may detain an IFE entry, and keep it in detention status until the importer gives FDA 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 FDA finds that the IFE requirements havenít been met, though, it may still refuse the entry.
Some importers may ask why they shouldnít simply request that FDA refuse the articles, since FDA law provides the importer the option of exporting refused goods. The reasons are simple. Most FDA 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 by FDA. Even if the firm isnít placed on an import alert, a record of the refusal will remain in FDAís system, and thus FDA may increase its exams for products from that firm or otherwise scrutinize 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, the entry type of an IFE entry affects the manner in which FDA processes it and the time limit to export the goods. IFE entries are often entered under Customís 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 for IFE entries 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 after FDA releases the goods 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. So entries may enter as consumption entries or warehouse entries. FDA law only requires that the entry be covered by a good and sufficient bond. Some industry officials and even some FDA officials mistakenly believe that IFE entries are required to enter under the TIB. However, the only requirement is that an IFE entry must be covered by a 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 in order to enter a shipment as an IFE entry. First, it is very important for the entry to be declared to FDA up front as an IFE entry. Entries filed through the Automated Broker Interface (ABI) system can use the IFE affirmation of compliance code. Paper (manual) entries should clearly note their IFE status in the entry documentation. 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 FDAís request, submit a report that provides an account of the exportation or destruction of IFE articles and the manner in which the owner or consignee complied with the requirements.
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.