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