The FDA Export Reform and Enhancement Act of 1996, combined with certain provisions of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act), has led to the implementation of the FDA program known as the Import for Export (IFE) program. The IFE program allows for the importation of certain noncompliant articles, such as drugs or drug components, devices, food additives, color additives, and dietary supplements, into the United States. The program allows importers to further process the articles or incorporate them into another item for the exportation of final the product to other countries. The main caveat to this program is that these noncompliant articles be further processed or incorporated into another product and then exported. These final products never enter into United States commerce and FDA regulations require extremely strict record keeping and documentation throughout the entire process.
Fuerst Ittleman is knowledgeable of this unique program and familiar with utilizing it to meet the needs of our domestic and international clientele. Fuerst Ittleman’s regulatory team is experienced in guiding clients interested in taking advantage of the IFE program from the initial import of the articles through the further processing and documentation to the final export of the products. Our team assists clients in educating and training their personnel on IFE regulations, creating record-keeping systems, firm registration, and handling FDA facility inspections and inquiries. We are well-versed in the legal requirements of the IFE program and very comfortable working with FDA and CBP to ensure our clients’ needs are being met.
For information on how the Import for Export program can work for you, please contact us at contact@fuerstlaw.com or (305) 350-5690.
