On November 8, 2024, the Food and Drug Administration (FDA) issued a notice of request for information (RFI) regarding the agency’s current approach to providing export certification in the form of lists (export lists) for human food products. The RFI seeks to learn more about U.S. exporters’ experiences and the challenges they face related to meeting export listing requirements of other countries and FDA’s certification processes for export lists. FDA will use this information to inform the continuing development of its export list program for human foods.

Background

Firms exporting products from the United States are often asked by foreign customers or foreign governments to supply a “certification” for products FDA regulates. In many cases, a foreign government may be seeking official assurance that the product can be marketed in the U.S. or otherwise meets specific U.S. requirements. A foreign government also may require export certification as part of the process to register or import a product into that country. For the importation of certain products, some countries require export certification in the form of inclusion on a list of establishments that the competent authority in the exporting country has certified as complying with applicable food safety requirements.

Under FDA’s Export Certification Program for FDA-regulated human food products, the agency provides an “export certification” in the form of an export certificate or export list.[1] FDA’s export certification provides the agency’s official attestation concerning a product’s regulatory status, based upon available information at the time FDA issues the certification. In addition, as of August 2024, FDA has established export lists that cover 19 categories of food products for Chile, China, the European Union, Saudi Arabia, Taiwan, and the United Kingdom.

FDA is authorized under section 801(e)(4)(B) of the FD&C Act to charge a fee of up to $175 for each written export certification that the agency issues within 20 days of receipt of the request for certification. The agency does not currently charge fees for food export lists, but is considering implementing fees to offset the associated operational costs.

Request for Information

The RFI requests input on four questions:

  1. There are many different types of establishment listing and certification procedures for establishments that produce human food products. Please share your experience with other countries’ establishment listing, certification, and registration requirements.
  2. FDA requires those on export lists to reapply regularly if they wish to remain listed. Do reapplicants experience any challenges with the renewal process? If you have experienced challenges, how were those challenges resolved?
  3. For those included on export lists, please describe any challenges you have experienced with exporting human food products included on the export lists.
  4. FDA is authorized to collect up to $175 per certification for each company and its human food products that FDA certifies through inclusion on an export list. For those that would be charged a fee, do you have any specific suggestions about how FDA should approach the implementation of fees? Please provide details relating to any suggestions you might have.

What Can You Do?

FDA encourages stakeholders to submit comments by January 7, 2025 to help inform FDA’s continuing development of its export list program for human foods. Interested stakeholders should submit comments electronically through the Federal eRulemaking Portal by searching “FDA-2024-N-4776.”

If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Beverage, and Dietary Supplements practice.

[1] Under section 801(e)(4)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), any person who exports a food, drug, animal drug, or device may request that FDA (i) certify in writing that the exported food, drug, animal drug, or device meets the requirements of sections 801(e)(1) or 802 of the FD&C Act, or (ii) certify in writing that the food, drug, animal drug, or device being exported meets the applicable requirements of the FD&C Act upon a showing that the food, drug, or device meets the applicable requirements of the FD&C Act.

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