For US exporters of food and dietary supplements, export certificates play a critical role in proving to foreign regulators that their products may be legally exported from the USA. Certificates such as the Certificate of Free Sale, Certificate to a Foreign Government, and Certificate of Exportability help smooth customs clearance and demonstrate compliance with the Federal FD&C Act.
What is a Certificate of Free Sale?
The Certificate of Free Sale is an FDA export certificate that confirms that certain products are regulated by FDA and meet the applicable requirements for marketing in the USA or, in specific circumstances, may be legally exported even if not marketed domestically.
The Certificate of Free Sale is available for Dietary supplements, Food for special dietary use and medical foods. The Certificate shows that these products can either legally be marketed in the US or qualify for legal export under the statute.
Other Common FDA Export Certificates for Foods
For Conventional foods and related products, below certificate options are available:
- Certificate to a Foreign Government (CFG) – Available for conventional foods, food additives, food contact substances, infant formula, and seafood. The certificate is often requested where a foreign government wants assurance that the product is legally marketed in the USA.
- Certificate of Exportability (COE) – Available for conventional foods, food additives, food contact substances, infant formula, and seafood that cannot be legally marketed in the USA. This certificate helps demonstrate that, although not sold domestically, the products satisfy FDA’s export provisions.
Liberty Management Group Ltd. provides assistance with Certificate of Free Sale and other export certificates.
Namrata
Regulatory Consultant
support@libertymanagement.us