This page provides an overview of the import for export (IFE) provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) section 801(d)(3). It includes important information you will need to know in order to utilize the Import for Export (IFE) provisions.
IFE allows for the importation of a product that is unapproved or otherwise does not comply with FDA laws and regulations if it is coming into the U.S. for further processing and ultimately exported out of the U.S. In order to qualify for this exemption from refusal, at the time the products are offered for import you must provide FDA with certain information regarding your intention to further process the product. Products imported under the IFE provision may not be distributed or sold in the U.S.
- What products qualify for import for export?
- Do blood, blood components, plasma, and source leukocytes qualify for import for export?
- Can import for export be used for a finished food product that is to be relabeled?
- What type of entry should be used for IFE?
- What information should I submit to FDA for IFE entries?
- What information is required when the initial owner or consignee is not the importer?
- What does it mean to be further processed and/or incorporated?
- What records should be kept for IFE entries?
- What is the timeframe for holding IFE products?
- Drugs or drug components
- Medical devices, medical device components, accessories of a device, or other parts of a device requiring further processing, which are ready or suitable for use for health-related purposes
- Food additives
- Color additives
- Dietary supplements
Blood, blood components, plasma, and source leukocytes have IFE requirements that differ from those for drugs and other biological products. FDA laws and regulations allow for the importation of these blood products and components provided they comply with section 351(a) of the Public Health Service Act (PHSA), or if FDA permits such imports “under appropriate circumstances and conditions” as determined by the Center for Biologics Evaluation and Research (CBER). Find more information about Importing CBER-Regulated products into the United States.
No, IFE cannot be used for finished food products that need to be relabeled. IFE only applies to the products listed in the section above.
The most common entry types used for IFE entries are Consumption entries and Temporary Importation under Bond (TIB) entries. IFE entries are required to have a “good and sufficient bond” in place. Informal entries do not require a bond; therefore IFE entries cannot be made under an informal entry. For more information on these entry types, please visit the common entry types web page.
In order to maintain the bond in place for Consumption or Warehouse entry types, FDA will maintain detention of the entry until the product is exported.
For TIB entries, FDA will release the entry because a good and sufficient bond remains in place with Customs and Border Protection (CBP), even if FDA releases the entry.
When an IFE entry is submitted in the ABI system, the customs broker (entry filer) should use the FDA affirmation of compliance code “IFE”. The code indicates to FDA that the product in some way does not comply with FDA laws and regulations, is intended to be further processed while in the US, and will be exported. Visit our Affirmation of Compliance Codes page for more information.
The following documentation should be submitted to FDA at the time of entry:
- Statement of Intent - Provide a letter to FDA confirming the intent to process the product or to incorporate it into a final product. It should also state the product will be exported by the initial owner or consignee from the United States in accordance with section 801(e) or 802 of the Act or section 351(h) of the PHSA. (section 801(d)(3)(A)(i)(I))
NOTE: The product must be used and exported by the initial owner or consignee in accordance with the statement of intent. Unused portions of the product must be destroyed.
- Chain of Possession - Provide a statement to FDA identifying all firms that had possession of the product, including each processor, packer, distributor, or other firm that had possession of the product. This establishes a chain of possession from the manufacturer to the importer. The statement should include information sufficient to identify the chain of possession of the article through each entity, which could include information such as product coding, lot, batch, or other identification numbers. For medical devices, device history records required of domestic and foreign manufacturers, pursuant to section 21 of the Code of Federal Regulations (21 C.F.R.), Part 820.184, may provide information to assist in meeting this requirement. (section 801(d)(3)(A)(i)(II))
- Certificates of Analysis - Provide certificates of analysis that identify the product. Certificates of analysis or equivalent documentation should provide the product’s formulation, ingredients, components, or results of analysis determining the presence of a substance and the amount (i.e. assay), as appropriate to the type of article. (section 801(d)(3)(A)(i)(III))
Drug Example: Certificates of analysis for drug products could include:
- Documents to assure the identity of the substance and its components in the chemical and drug industries.
- A batch certificate.
- Documents that establishes a drug ingredient is certified to meet USP requirements could be a certificate of analysis.
- Documents that provide the level, potency, identity, strength, quality, and purity of the drug component, and whether a prohibited material has been used in the imported article.
Food Example: For an article of food additive or color additive, a document indicating specification of purity or documents establishing the article is a “certified” color or of “food grade” or “Codex Alimentarius” grade food additive could meet the requirement for a certificate of analysis.
For other products, documents that convey assurance as to the identity of the article and its components or substances could be a certificate of analysis. Sufficient information should be provided to determine if prohibited material has been used in the imported article.
Prohibited materials are not allowed unless authorized for emergency medical care under 801(d)(2).
A certificate of analysis is not required for devices.
If the above information is not submitted at the time of entry, the product may be subject to refusal of admission.
The importer should include information with the entry identifying the initial owner or consignee. If the product is intended for multiple owners or consignees, each of whom will act as the initial owner or consignee for a portion of the product, the importer should submit separate statements identifying each owner or consignee indicating the amount of the entry each will receive.
For products to qualify for the IFE provisions, they must be “further processed” and/or “incorporated”. These terms can cover a wide range of activities, including packaging or labeling of finished products and specialized processing (such as sterilization) of a product. Merely storing a product in the United States before export is not considered “further processing.”
Records indicating the manner in which the owner complied with the requirements of the IFE provisions must be maintained and provided to FDA upon request. Records for the initial owner or consignee to maintain include the use, exportation and/or destruction of the articles.
The records should include the statements and any certificates of analysis required to be submitted at the time of import as described above.
Additional records could include:
- Documentation with more specific identification of the product, such as Customs entry number, date, quantities, manufacturing process and controls, and intent of the importation (i.e., further processing into product intended for exportation).
- Records on export or other disposition need to be retained (section 801(d)(3)(A)(iv)) and should include information such as quantity, dates, destination, shipping, means of destruction, and any records required under the export record-keeping and notification regulation.
The initial owner or consignee must destroy any article or portion not used in an exported product.
These sections of FDA’s laws and regulations allow the importation of otherwise inadmissible products for manufacturing, further processing, or incorporation and export. The law does not impose any specific limitations on how long the product may be in the U.S. before it must be further processed or incorporated into a product and exported or destroyed. CBP, however, may impose a time limitation through its bond requirements.
- FDA Export Reform and Enhancement Act of 1996 (Export Reform Act), Public Law 104-134) amended section 801(d)(3) of the Act
- FDA Regulatory Procedures Manual Chapter 9-17: Import for Export
- FDA Investigations Operations Manual Chapter 6 - Imports
- Affirmation of Compliance Codes
- Device Registration and Listing