Import and Export of FDA-Regulated Products
The U.S. Food and Drug Administration (FDA) regulates approximately 10 to 15 percent of all imports into the United States. These products come from more than 300,000 facilities based in over 150 different countries. As FDA-regulated industries become more globalized, clients doing business in this arena must be conscious of the regulations and statutes applicable to products imported and exported to, and from, the U.S. Fuerst, Ittleman, David, and Joseph’s attorneys are well-versed in helping clients import and export FDA-regulated products.
The FDA has the power to inspect, detain, and refuse all imported food, drugs, biologics, cosmetics, and medical devices entering the United States under its jurisdiction. These imported products must comply with the appropriate FDA rules and regulations and may be detained or refused entry into the United States if the products even appear to be in violation of United States law.
Fuerst, Ittleman, David, and Joseph has experience helping companies take a more proactive role and avoid detentions by the FDA by ensuring fully compliant products prior to entry. For those clients with products already detained by CBP or FDA due to an Import Alert or other reason, we work with the agency and our clients to pursue release through submission of testing and other documentation to rectify alleged violations to counter the government’s conditions for detaining or refusing the products.
It is critical for all importers to fully comply with FDA rules and regulations. Once a product is refused entry by the FDA, it is extremely difficult to achieve release of the product and, in many circumstances, the importer must export or destroy the products, which results in losses that impact the corporate bottom line. For example, detentions of perishable items not dealt with promptly can result in those items no longer being salable at the end of the detention period. Likewise, if the product is seized, the result is complete forfeiture of the goods. That translates into a loss of profit, time, product and even customers who went elsewhere to fulfill their need of your imported product.
Products are detained and refused by FDA for many reasons including FDA Import Alerts. Import Alerts result in automatic detention of products listed on the Import Alert. If the FDA detains a product due to an Import Alert, the importer must demonstrate that the products are compliant and not violative. Import Alerts are issued for all types of products, ingredients, manufacturers, country of manufacture, and many other reasons. We have worked successfully with the FDA Division of Import Operations and Policy (DIOP) to have clients removed from Import Alert or placed on an exemption list (called “Green List”) so that their imported products are no longer automatically subject to FDA detention.
Doing business internationally is highly competitive and particularly complicated when exporting FDA-regulated products from the United States. The attorneys at Fuerst Ittleman David & Joseph advise clients on legal issues and business strategies related to exporting products abroad. We are skilled and knowledgeable in federal, state, and international regulations and FDA and CBP programs. Fuerst Ittleman David & Joseph assists clients with many issues involved with exporting goods and merchandise out of the United States including:
- The Import for Export (IFE) program
- Export certificates, including Certificates of Pharmaceutical Products (CPP) and Certificates of Free Sale
- Foreign firm registration
- Labeling requirements
- Good manufacturing practices (GMPs)
- General export regulation compliance
Import for Export Program
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 the final 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 David & Joseph is knowledgeable of this unique program and familiar with utilizing it to meet the needs of our domestic and international clientele. Our regulatory team is experienced in guiding clients interested in taking advantage of the IFE program from the initial import of the articles through the 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 the FDA and CBP to ensure our clients’ needs are being met.