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 CFSAN, please visit Export Certificates.
It is the exporter’s responsibility to comply with the laws of the importing country, so you may wish to consult your importer or the relevant regulatory authorities in the importing country to determine what type of export certification is required, if any. If CFSAN becomes aware of importing country certification requirements that apply to FDA-regulated food products, we will publish this information online in the Food Export Library.
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.
No. CFSAN does not provide written authorization or notarize cGMP Certification.
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.
Applications for most CFSAN export certificates may be submitted through the 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 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:
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.
No, we process requests in the order they are received.
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.
An application status of “Return for Action” indicates that CFSAN needs additional information from the applicant before the application can be processed. When an application status is changed to "Return for Action", the applicant will receive an email notification explaining what additional information is required.
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
Yes. You may request multiple copies of a certificate during the application process.
No, we cannot update old certificates, but you may clone and re-submit a previously-submitted application to apply for a new certificate.
Most FDA-issued export certificates for food are issued electronically via PDF. Anyone who receives an FDA-issued export certificate for food issued via PDF may verify the authenticity of these certificates online. Visit Online Verification of Export Certificates for Food for more information.
Dietary supplements are regulated by the Food and Drug Administration (FDA) pursuant to a number of laws, including the Federal Food, Drug, and Cosmetic Act (FD&C Act), the Fair Packaging and Labeling Act (FPLA), and applicable FDA regulations. These laws mandate compliance with the current good manufacturing practice (CGMP) requirements for dietary supplements as well as other requirements regarding safety, labeling, and other matters. The FDA does not approve dietary supplements, or their manufacturers and distributors, nor does it have statutory authority to do so. The FDA does not have complete records on all dietary supplements on the market, and in some cases may have no information on certain dietary supplements on the market.
Currently companies may request a "Certificate of Free Sale" for both packaged and bulk finished dietary supplements. FDA does not issue a Certificate of Free Sale when information is readily available that the products that are the subject of such request are not eligible for legal sale in the U.S. (e.g., if the product is under seizure or the firm is under injunction), but the issuance of this certificate does not suggest or imply that FDA has determined that a firm's products are in full compliance with the requirements of the FD&C Act or other applicable laws.
Because of the limited information readily available to FDA pertaining to dietary supplement products, FDA does not issue any other type of export certificate for dietary supplements at this time. Collecting sufficient information on which to base such alternative forms of certification would be time consuming and labor intensive, and such activities would be of lower priority than our public health and safety activities. Moreover, although FDA periodically inspects dietary supplement facilities to evaluate compliance with the CGMP requirements, FDA does not issue any certification to indicate CGMP compliance at the conclusion of or at any time after those inspections.
While FDA has limited resources to issue a broad array of export certificates, companies are free to obtain certificates, which may be both sufficient for their needs and acceptable to a foreign government, from state and/or local agencies with jurisdiction over their products or from other organizations such as trade associations.
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.
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.
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).
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).
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.
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.