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
Who Needs an FDA Export Certificate?
- ● Food and Beverages: Includes conventional foods, dietary supplements, and ingredients.
- ● Pharmaceuticals: Encompasses both prescription and OTC drugs.
- ● Medical Devices: Range 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.
FDA Fees
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.
The FDA Certificate to a Foreign Government is available for conventional foods, food additives, food contact substances, and infant formula that meet the applicable requirements of the FD&C Act for marketing in the United States. This certificate states, among other things that a product (or products) may be marketed in and legally exported from the United States. The fee for this certificate is $175 for the first certificate, $155 for the second certificate for the same products(s) issued in response to the same request, and $100 for each subsequent certificate for the same product(s) issued in response to the same request.
The FDA Certificate of Exportability is available for conventional foods, food additives, food contact substances, and infant formula products that cannot be legally marketed in the United States but that meet the requirements of section 801(e) of the FD&C Act and may be legally exported. This certificate states that a product (or products) meet(s) the requirements of section 801(e)(1) of the FD&C Act and may be legally exported. The fee for this certificate is $175 for the first certificate, $155 for the second certificate for the same products(s) issued in response to the same request, and $100 for each subsequent certificate for the same product(s) issued in response to the same request.
The FDA Certificate of Free Sale is available only for dietary supplements, medical foods, and foods for special dietary use. FDA does not charge a fee for this certificate.
The FDA Certificate for Cosmetics is issued for products that meet the definition of a cosmetic under section 201(i) of the FD&C Act (21 U.S.C. 321(i)). FDA does not issue cosmetic export certificates for raw or bulk materials and products marketed with drug claims, such as cleansers with acne treatment claims. The fee for this certificate is $10 per certificate.
FDA Fees for the above certificates may change, please visit the FDA export certificate website for the most recent fee schedule
The FDA Certificate of Exportability is available for conventional foods, food additives, food contact substances, and infant formula products that cannot be legally marketed in the United States but that meet the requirements of section 801(e) of the FD&C Act and may be legally exported. This certificate states that a product (or products) meet(s) the requirements of section 801(e)(1) of the FD&C Act and may be legally exported. The fee for this certificate is $175 for the first certificate, $155 for the second certificate for the same products(s) issued in response to the same request, and $100 for each subsequent certificate for the same product(s) issued in response to the same request.
The FDA Certificate of Free Sale is available only for dietary supplements, medical foods, and foods for special dietary use. FDA does not charge a fee for this certificate.
The FDA Certificate for Cosmetics is issued for products that meet the definition of a cosmetic under section 201(i) of the FD&C Act (21 U.S.C. 321(i)). FDA does not issue cosmetic export certificates for raw or bulk materials and products marketed with drug claims, such as cleansers with acne treatment claims. The fee for this certificate is $10 per certificate.
FDA Fees for the above certificates may change, please visit the FDA export certificate website for the most recent fee schedule
FDA Export Certificate Process Cost: $494
Step 1
Complete the initial form below, and tell us about your company
Step 2
We will issue you a short and simple questionnaire to collect additional company and product details
Step 3
Type of Export Certificate Evaluation (CFG, CFS, etc.)
Step 4
Export Certificate Application Submission to include FDA Fee Payment
Step 5
FDA Review and Verification, Export Certificate Issued by Official FDA in Digital Format