Every food facility registered with FDA, domestic or foreign, has to renew its registration between October 1 and December 31, 2026. FDA has said it will treat any registration not renewed by December 31 as expired, and failing to renew is a prohibited act under the FD&C Act. For foreign facilities, the renewal is not done when you hit submit. FDA's rules say it will not confirm the registration until the person named as the facility's U.S. agent confirms that they agreed to serve. If your listed agent is a broker you stopped using, or an inbox nobody checks, fix that now rather than in the last week of December.
What FDA is doing at the border
FDA's Human Foods Program lists oversight of imported food among its 2026 priority deliverables, including a plan to enhance import screening with expanded data sources and AI and machine learning techniques. That is an agency plan, not a new rule, and FDA has published little about how these tools will work. Still, the direction is plain. Entries will be checked against more data, and we expect ordinary filing problems, such as a wrong unique facility identifier, the wrong party named as importer, or product descriptions that don't match the supplier, to become easier for FDA to catch.
Foreign Supplier Verification Program enforcement, meanwhile, is steady and unglamorous. Warning letters FDA sent to importers this year, including two we reviewed from June and July, cite the most basic failure: no FSVP at all for the foods being imported. One also faulted the importer for not verifying that its supplier of low-acid canned foods complied with FDA's canning regulations. Both letters warn that FDA may refuse admission and may put the importer's foods on Import Alert 99-41. In one, the importer's promise to finish its FSVP within six months, sent without supporting documents, was not enough for FDA to evaluate.
Why Import Alert 99-41 hurts
Import Alert 99-41 lets FDA detain, without physical examination, food offered by importers it lists as out of compliance with FSVP. It attaches to the importer, not the foreign supplier, and can cover some or all of that importer's foods. FDA updated the alert as recently as November 10. Getting off the list requires a written submission, in English, that adequately shows the conditions behind the violation have been fixed, and FDA may reinspect before agreeing. In practice that means shipments sitting while you build the program you should already have had. That alone is a good reason not to wait for an inspection to find the gaps.
What to do now
Start by confirming who the FSVP importer is. It is the U.S. owner or consignee of the food at entry or, if there is none, a U.S. agent or representative of the foreign owner who has signed a statement of consent. That importer's name, email address and unique facility identifier must be provided for each line entry. Then check that each food and supplier has a written hazard analysis, an evaluation of the supplier, verification activities that fit the hazards, and a reevaluation at least every three years or sooner when new information comes in. Keep FSVP records for at least two years and be able to produce them promptly when an investigator asks. Very small importers have modified requirements, but they still have requirements.
On registration, renew every facility now, confirm your U.S. agent's contact details and willingness to serve, and make sure the address tied to the facility's DUNS number matches the registration, since FDA checks that too.
How MDRXLaw can help
We build and review FSVPs, handle food facility registration and U.S. agent issues, respond to FSVP warning letters and work with importers seeking removal from import alerts. To discuss your imports, contact us at info@mdrxlaw.com or 212-668-0200.
Sources: FDA, FDA Reminds Food Facilities of Biennial Renewal Requirements; FDA, Human Foods Program 2026 Priority Deliverables; FDA, FSMA Final Rule on Foreign Supplier Verification Programs; FDA, Import Alert 99-41; eCFR, 21 CFR Part 1, Subpart H and Subpart L. This alert is for general information and is not legal advice.
