What are FDA export certificates?
Firms exporting products from the United States are often asked by foreign customers or foreign governments to supply a “certificate” for products regulated by the U.S. Food and Drug Administration (FDA). The fact that FDA has issued an export certificate does not preclude FDA from taking appropriate regulatory action against a product covered by the certificate. The FDA Center for Food Safety and Applied Nutrition (CFSAN) issues multiple forms of export certificates. For more information on the different types of certificates issued by FDA CFSAN visit Export Certificates.
How do I learn other countries' requirements?
If you are an exporter, it is your responsibility to ensure that your products comply with regulations in the destination country. Significant differences may exist across countries. FDA does not provide information on regulations in other countries. Embassies may be of assistance, or you may contact regulatory agencies in the destination countries directly for information.
Does the United States require export certificates to export foods to foreign countries?
No. FDA does not require exporters to obtain export certificates to export foods to foreign countries. Foreign governments may seek official assurance that products exported to their countries can be lawfully marketed in the United States or that the products meet specific U.S. requirements. Review of an export certificate may be required by the destination country as part of the process to register or import a product into the country.
Does CFSAN issue certificates for Good Manufacturing Practices (cGMPs)?
No. CFSAN does not provide written authorization or notarize cGMP Certification.
Can I request a CFSAN export certificate if I am not the manufacturer of the product?
Yes. The requestor will need to identify the manufacturer of the product or products for export to successfully complete an application for an export certificate.
How can I apply for a CFSAN-issued export certificate?
Applications for most CFSAN export certificates may be submitted through the FDA Unified Registration and Listing Systems (FURLS) CFSAN Export Certification Application and Tracking System (CFSAN eCATS). If you do not already have an account for FDA Industry Systems (FIS), you will need to create a new account to sign into the system. Get help and instructions for creating an FIS account. Get help and instructions for using CFSAN eCATS. If you are unable to use CFSAN eCATS, you may contact FDA for assistance at CFSANExportCertification@fda.hhs.gov or 240-402-2307. Please visit these links for additional information on applying for export certificates:
- Export Certificates,
- Online Applications for Export Certificates,
- Online Applications for Export Certificates for Cosmetics.
How long does the application review process take?
Requests for export certificates are usually processed within a few days, but the processing time may vary based on factors such as the following:
- The number of products on the application.
- Whether the application is complete or if additional information is required from the requestor to complete the application review.
- FDA’s regulatory workload when we receive your request.
Is there an option for expedited review/processing of applications?
No, we process requests in the order they are received.
What is meant by an application status of “Processed”?
An application status of “Processed” indicates the review of the application is complete, the application has been approved, and the certificate package may be downloaded and printed by the applicant.
What is meant by an application status of “Return for Action”? What prompts this?
An application status of “Return for Action” indicates that the application needs additional information from the requestor before processing of the application can be completed. Such information may include additional labeling information or an inspection report.
Can language be modified or added to certificates?
The standard attestation for each certificate cannot be modified. You may request additional language be printed on the following certificates: the certificate to a foreign government, certificate of exportability, and the specified risk materials certificate. CFSAN reserves the right to refuse any requests for additional language.
Can duplicate certificates be made?
Yes. You may request multiple copies of a certificate during the application process.
Can old certificates be updated?
No, we cannot update old certificates, but you may clone and re-submit a previously-submitted application to apply for a new certificate.
Verification of Certificates
Some foreign governments may require export certificates to be authenticated or apostilled. You will need to check with the country to which you are exporting to learn its authentication requirements.
There are two ways to authenticate your export certificate:
- The exporter can request an apostille or authentication from the U.S. Department of State, or
- For electronically issued certificates issued after April 2016, an official of a foreign government can use the unique Certificate ID, printed in the top left corner of every certificate, to independently verify whether the export certificate was issued by FDA.
For Exporters – How can I request an apostille or authentication from U.S. Department of State?
The U.S. Department of State offers apostille and authentication services for FDA's export certificates. To request authentication services, send your original export certificate that you downloaded and printed from one of the CFSAN eCATS modules, a DS-4194 Authentication Request Form, and payment to:
Office of Authentications
U.S. Department of State
44132 Mercure Circle P.O. Box 1206
Sterling, VA 20166-1206
If you have additional questions, you may contact the Office of Authentications at 202-485-8000.
For Foreign Government Officials – How can I verify that an export certificate was issued by FDA?
If a foreign government receives an electronically issued FDA export certificate dated after April 2016 without an apostille or authentication or does not accept these documents, an official of that government can independently verify that the export certificate was issued by FDA through the CFSAN Export Certification Application and Tracking System (CFSAN eCATS). To create an account, follow these steps:
- Visit https://www.access.fda.gov and select "Create New Account."
- Select "CFSAN Export Certification Application and Tracking System (CFSAN eCATS)" and select "Yes" when asked if "Are you a Foreign Government Official?" and fill in your contact information.
- Complete and submit the online form. You will receive an email notification when your account is activated.
To verify that an export certificate was issued by FDA, follow these steps:
- Log into https://www.access.fda.gov.
- Select "CFSAN Export Certification Application and Tracking System (CFSAN eCATS)" and then "Authenticate Certificate."
- In the space provided, enter the unique Certificate ID located at the top left corner of the certificate. Select "Continue" to view the export certificate that was issued by FDA with the entered Certificate ID. (Pop-up blockers must be disabled in your web browser.)
For export certificates issued prior to May 2016, a foreign government official may contact FDA at CFSANExportCertification@fda.hhs.gov for verification that the certificate was issued by FDA.
In the CAP module of CFSAN eCATS, when should I select “Dietary Supplement” as the certificate type?
You should select “Dietary Supplement” as the certificate type if you intend to export a dietary supplement product. The term "dietary supplement" is defined in the Federal Food, Drug, and Cosmetic Act, as amended by the Dietary Supplement Health and Education Act of 1994, as a product (other than tobacco):
- Intended to supplement the diet that bears or contains a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract, or combination of any of the preceding types of ingredients (21 U.S.C. 321(ff)(1)).
- Intended for ingestion in a form described in 21 U.S.C. 350(c)(1)(B)(i) or that complies with 21 U.S.C. 350(c)(1)(B)(ii) (21 U.S.C. 321(ff)(2)(A)).
- Not represented as conventional food or as a sole item of a meal or the diet (21 U.S.C. 321(ff)(2)(B)).
- Labeled as a dietary supplement (21 U.S.C. 321(ff)(2)(C)).
The definition excludes an article that is approved as a new drug, certified as an antibiotic, licensed as a biological, or authorized for investigation as a new drug, antibiotic, or biological for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, which was not before such approval, certification, licensing, or authorization marketed as a dietary supplement or as a food, unless an exception applies (21 U.S.C. 321(ff)(3)(B)). Generally, you should select "Dietary Supplements" as the certificate type for all products that bear a Supplement Facts label.
In the CAP module of CFSAN eCATS, when should I select “Medical Food” as the certificate type?
A medical food, as defined by section 5(b) of the Orphan Drug Act (21 U.S.C. 360ee(b)(3)) is “a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.” For more information about medical foods, please consult the Medical Foods Guidance.
In the CAP module of CFSAN eCATS, when should I select “Foods for Special Dietary Use” as the certificate type?
Foods for special dietary use are defined as follows: “The term special dietary uses, as applied to food for man, means particular (as distinguished from general) uses of food, as follows: (i) Uses for supplying particular dietary needs which exist by reason of a physical, psychological, pathological or other condition, including but not limited to the conditions of diseases, convalescence, pregnancy, lactation, allergic hypersensitivity to a food, underweight, and overweight; (ii) Uses for supplying particular dietary needs which exist by reason of age, including but not limited to the ages of infancy and childhood; (iii) Uses for supplementing or fortifying the ordinary or usual diet with any vitamin, mineral, or other dietary property” (21 CFR 105.3(a).
In CFSAN eCATS, when should I select “Infant Formula” as the product type?
The Federal Food, Drug, and Cosmetic Act defines infant formula as “a food which purports to be or is represented for special dietary use solely as a food for infants by reason of its simulation of human milk or its suitability as a complete or partial substitute for human milk” (21 U.S.C. 201(z)). FDA regulations define an infant as a person not more than 12 months of age (21 CFR 106.3).
In CFSAN eCATS, when should I select "Food Additive" as the product type?
The certificate type selection in CFSAN eCATS is intended to route your application to the appropriate office in FDA. Generally, you should select "Food Additive" as the certificate type for any substance regulated by the Office of Food Additive Safety (OFAS) in FDA’s Center for Food Safety and Applied Nutrition. OFAS oversees programs for food additives, color additives, food contact substances, and substances that are Generally Recognized as Safe (GRAS), among other things.
For which countries does CFSAN issue export certificates for seafood products?
CFSAN issues certificates of export for seafood for all countries except China and the countries of the European Union (EU). The National Oceanic and Atmospheric Administration (NOAA) Seafood Inspection Program offers certification of U.S. seafood products for export to China and the EU. FDA maintains lists that identify all fish and fishery product establishments in the United States that are in good regulatory standing with FDA and that seek to export fish and fishery products to China and the EU. For more information, please see Seafood Exports to the European Union and China.