Firms exporting food products from the United States are often asked by foreign customers or foreign governments to supply a certificate from FDA for products regulated by it providing official assurance that products exported to their countries can be marketed in the United States.
Types of export certificates issued by FDA:
- Certificate to a Foreign Government – this certificate is available for conventional foods, food additives, food contact substances and infant formula products and states that a product may be marketed in and legally exported from US.
- Certificate of Exportability – this certificate is available for conventional foods, food additives, food contact substances and infant formula products that cannot be marketed in US legally but may be legally exported.
- Certificate of Free Sale – This certificate is only available for dietary supplements, medical foods and special dietary use foods.
- Health certificates for collagen and gelatin products intended for export to the EU and Specified risk materials certificates for collagen and gelatin products intended for export to non-EU countries.
FDA will not issue an Export Certificate if
- FDA has initiated an enforcement action against the product
- The manufacturing facility is not cGMP compliant
- The manufacturing facility is not FDA Registered
- The manufacturing facility for which FDA has no inspectional information.
The facilities registered and listed with FDA are checked for cGMP compliance under an FDA inspection. For Export Certificates, FDA would use inspection and all other available information regarding a product or facility to make an attestation of compliance with cGMP regulations.
FDA fee for “Certificate to Foreign Government” and “Certificate of Exportability” is, $ 175 for 1st certificate, $ 155 for 2nd certificate and $ 100 for each subsequent certificate.
FDA does not charge a fee for “Certificates of Free Sale” or for “Health Certificates”.
Some foreign governments may question authenticity of an export certificate. There are two ways to authenticate an 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.
Liberty Management Group LTD is one of the leading FDA consulting group in the USA. LMG provides assistance with Export Certificates, Registrations, Label compliance, and many more FDA regulations.
Namrata Gusain
FDA Regulatory Consultant
support@libertymanagement.us
Published on March 13, 2019
how to get a certificate of fda registration for coffee
please complete the online form form at https://www.fdahelp.us/food-form.html please select number 9 in section 10a for coffee. if you are looking for a fda registration certificate as a proof of fda registration for Amazon please visit the below page also.
https://www.fdahelp.us/certificate-of-fda-registration.html
why my export certificate cannot verify on http://www.fdahelp.us
if this is FDA registration certificate issued by LMG, you can verify the validity at https://www.fdahelp.us/certificate/view-certificate.php . if this is an export certificate issued by FDA, you cannot verify it on our website.
how can i see a sample FDA registration certificate issued by your company ?
you can find a sample certificate of fda registration on our website
how can i get FDA Certificate for Amazon ? i am a re seller on amazon and amazon is asking for FDA certificate as a proof of FDA registration. do FDA issue a “certificate of fda registration” as a proof of registration or FDA issue only a registration number ?
we can help you to register with fda, after successfull registration we will issue a certificate of FDA registration as a proof of fda registration.
what are the services LMG provide to food manufacturing companies ?
LMG provide complete assistance to food manufacturers, LMG assist with
FDA Registration
US FDA Agent service
Label review service
Prior Notice
LMG fees for fda registration service can be found at http://www.fdahelp.us
I have a FDA registered warehouse and wanted to export dietary supplements to African countries, am I eligible to apply for “Certificate to Foreign Government”?
Dear Jose,
“Certificate to Foreign Government” is only for conventional foods, food additives, food contact substances and infant formula products. If you are looking for an export certificate, you can apply for “Certificate of Free Sale” for your dietary supplements.
Who is eligible to apply for Certificate of free sale? Do they need to register with FDA before applying for CFG?
The manufacturer or the exporter can apply for a Certificate of Free Sale. The exporter will need to identify the manufacturer on the application. The manufacturer must be FDA registered, should be cGMP compliant and should not have any impending FDA enforcement actions against him.
I am a manufacturer dietary supplements and not registered with FDA. Need help to apply certificate of sale, can you help me? what is the fees for that?
Sure we can help you. In order to obtain a certificate of free sale for you products, you need to first register with FDA and make sure your facility is GMP compliant. The fee for FDA registration is USD 349 and for Certificate of Free Sale is USD 349.