Tag: Export Certificate

US FDA Certificate of Free Sale

A Certificate of Free Sale (COFS) is a document issued by US FDA that certifies that a dietary supplement, food for special dietary use, or medical food meets all the regulatory requirements for sale and distribution and is either legally sold in the US or can be legally marketed from US.

COFS is used primarily for products intended for export to foreign countries, and it provides assurance to foreign buyers or regulatory authorities that the product is safe, of high quality, and complies with US regulations.

The COFS typically includes information about the product, its manufacturer, exporter and destination country.

Manufacturers looking to obtain a COFS from the FDA will need to submit an application, along with product labels and applicable fees. The FDA reviews the application and, if everything is in order, issues the certificate.

Depending on the nature of the product and the requirements of the importing country, you may also need to provide other documentation to the FDA upon request.

Export Certificate requests are usually processed within a few days, but the processing time may vary depending on the number of products on application, completeness of application and FDA’s regulatory workload.

Certificate of Free Sale have a validity of 2 years and they can be verified on FDA website.

Liberty Management Group Ltd. provides assistance with Certificate of Free Sale and other export certificates.

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Export Certificates for Food Products

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:

  1. 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.
  2. 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.
  3. Certificate of Free Sale – This certificate is only available for dietary supplements, medical foods and special dietary use foods.
  4. 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:

  1. The exporter can request an apostille or authentication from the U.S. Department of State, or
  2. 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

http://www.fdahelp.us

Published on March 13, 2019