Certificate of Free Sale

US FDA issues Certificate of Free Sale for dietary supplements, food for special dietary use, and medical foods that are regulated by the FDA and that meet the applicable requirements of the FD&C Act for marketing in the USA or, if they cannot be legally marketed in the USA, may be legally exported from USA.

• FDA does not charge a fee for issuing Certificate of Free Sale.

• Certificate of Free Sale contains information about the manufacturer, exporter, intended destination, and products.

• Certificate of Free Sale requests are usually processed by the FDA within a few days, but the processing time may vary based on factors such as the number of products on the application, whether the application is complete, or if additional information is required from the requestor and FDA’s regulatory workload.

• Certificate of Free Sale has a validity of 2 years and can be verified on the FDA website. FDA issues only soft copies of certificates.

• Certificate of Free Sale 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.

Liberty Management Group Ltd., a leading FDA consulting firm, assists with Certificate of Free Sale and Export Certificate Applications and other FDA regulations.