FDA Export Certificate

What is an FDA Export Certificate?

The export certificate is an official document issued by the FDA that provides information on a product or facility’s FDA or marketing status in the U.S. based on the certification issue date. The FDA issues export certificates to facilitate the export of FDA-regulated products from the U.S. when requested by external parties such as foreign customers or governments. A foreign government may require an export certificate to ensure regulatory compliance and to register or import a product into that country.

The FDA export certificates are tailored to each industry and supply specific information for different product categories. Depending on the type of product being exported, each sector may receive particular documentation, which can be issued by FDA centers such as CBER, CDRH, CFSAN, and CVM

FDA Export Certificates can be issued in the following industries:

●Food and Beverages: Includes conventional foods, dietary supplements, and ingredients.
●Pharmaceuticals: Encompasses both prescription and OTC drugs.
●Medical Devices: Ranges from class I simple devices to class III, such as MRI machines.
●Cosmetics: Covers skincare, makeup, and personal care products.
●Veterinary Products: Includes animal drugs, feeds, and devices.
●Biologics: Includes vaccines, blood products, and gene therapy products.
●Tobacco Products: Encompasses cigarettes, cigars, and other tobacco-based products.

Different types of export certificates issued by the FDA may have different titles and follow a particular template are listed below:

Certificate to Foreign Government: issued for exporting human food, human drugs, animal drugs and feed, and medical devices that meet the applicable marketing requirements in the United States.

Certificate of Exportability: This document allows the legal export of food, human drugs, animal drugs and feed, and medical devices not approved for marketing in the United States but comply with the requirements of sections 801 or 802 of the FD&C Act.

Certificate of a Pharmaceutical Product: This certificate is for human and animal drugs. It follows the format set by the World Health Organization (WHO) and is commonly used by the importing country to assess whether to approve the drug for sale within that country.

Certificate for Cosmetics: This certificate is issued for products that meet the US definition of cosmetics. It cannot be issued for products that make therapeutic claims on their label, such as cleansers marketed for acne treatment.

Certificate of Free Sale (CFS): issued for human dietary supplements, medical foods, foods for particular nutritional use consumption, animal food, animal drugs, or medicated animal feed that are regulated by the FDA and can be legally marketed in the United States.

Health Certificate: Foreign governments may request health certificates for human foods with animal-derived ingredients, often seeking FDA statements on compliance with foreign regulations. Generally, the FDA does not issue certificates confirming compliance with another country’s requirements but may work with other governments to create acceptable language for health certificates, such as those for collagen or gelatin products exported to the EU. Requests for new health certificates are considered on a case-by-case basis.

What Conditions Prevent The FDA From Issuing An Export Certificate?

The FDA reviews records for relevant establishments and products when deciding whether to issue export certification. The FDA will only issue the certification if it finds that the establishments or products are eligible, such as noncompliance with CGMP, lack of proper registration and listing, or enforcement actions in place.

Does The FDA Charge A Fee To Issue An Export Certificate?

The FDA charges a fee for export certifications for human food, human drugs, animal food, animal drugs, medicated animal feed, and medical devices if the certification is issued within 20 days of receiving a complete request. This fee may vary depending on the product type.

FDA Listing Inc. can help you obtain an expert certificate for your product. Before we do so, we gather information to verify whether you qualify to receive the export certificate.

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