The Food Safety Modernization Act (FSMA) authorizes the U.S. Food and Drug Administration (FDA) to charge fees to cover the cost of issuing export certificates for human food. On October 1, 2018, the agency began issuing and collecting fees for two types of Export Certificates:
- Certificate to a Foreign Government: certifies that a product (or products) may be marketed in and legally exported from the United States
- Certificate of Exportability: certifies that an export only product meets the requirements of section 801(e)(1) of the Food Drug & Cosmetic Act and may be legally exported
These certificates are available for human food products, such as processed foods, produce, and grains that are not dietary supplements, medical foods, or foods for special dietary use.
FDA will charge $175 for the first certificate issued for a given product. Subsequent certificates, issued for the same product in response to the same request, will be made available at a reduced rate in accordance with the following schedule:
|Second certificate for the same product(s) issued in response to the same request||$155|
|Subsequent certificates for the same product(s) issued in response to the same request||$100|
FDA will continue to provide “Certificates of Free Sale” for dietary supplements, medical foods, and foods for special dietary use at no cost.
Not sure what type of certificate you need for your product? Registrar Corp’s Regulatory Specialists can answer your questions and help you obtain an Export Certificate. Call us at +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.