Imported foods must meet the same food safety standards as domestically produced foods, so the requirements for imported foods should be pretty much the same, right? Not quite. It takes quite a bit more, not only to ensure the food safety, but to assure FDA of its safety to enable admissibility.
Because of the complexity of importing foods into the U.S., FDA recently released a video, Importing FDA-Regulated Products: Human Foods, outlining the general process. The video begins simply enough, relaying the general standards we all know from domestic food production. But as it follows an importer (“Sarah”) through the steps of importing, the complexity grows, bringing in the requirements for an FSVP written plan, prior notice, commodity specifications, and shipment declaration – all needed to pass the FDA admissibility review.
As the video notes, the first step is conducting research to determine the requirements that will apply to each specific food you wish to import. What TAG would add is a recommendation to work through all the steps prior to taking action to ensure that you understand all that will be needed and are prepared and able to fulfill all steps. In addition to following “Sarah” through these, the video includes a number of links to regulations and guidance documents for more information.
While domestic food safety requirements also apply to imported foods, as applicable (e.g., FFR registration; applicable regulatory adherence – FSMA, Seafood/Juice HACCP, etc.; labeling standards – in English with allergen statements; etc.), FDA requires an assurance of compliance from the importer through written Foreign Supplier Verification Program (FSVP) documentation for each facility, identified by its UFI number. Certain commodities (e.g., those with restricted uses) also hold additional requirements, such as a need for approvals, certifications, permits, registrations, etc.
For every food shipment coming to the U.S., FDA must also receive Prior Notice – before the shipment arrives at the border. As a provision of the Bioterrorism Act of 2002, the primary purpose is to enable the interception of intentionally contaminated products and help prevent attacks on the U.S. food supply, thus the shipment also must be declared to Customs and Border Protection (CBP/Customs). This can be done by a licensed broker who can electronically transmit the submission, or an importer can submit the notice themselves through the PNSI system.
Once all this is completed, the shipment must still be approved by FDA. The agency reviews the declaration and either releases it, conditionally releases it, or refuses entry. If conditionally released, the shipment should be kept intact at the border to allow for FDA inspection and admissibility decision. If the shipment is determined to be noncompliant, it can then be refused entry … which brings up a whole different set of consequences from Import Alerts to Detention Without Physical Examination (DWPE).
FDA also provides an option for importers to expedite the review and import entry process, though it is not easy or cheap. To participate in the Voluntary Qualified Importer Program (VQIP), importers must meet eligibility criteria and pay an annual user fee ($14,975 for FY2024) to cover the FDA’s administration of the program.
As evidenced by the number of regulations and guidances that FDA references in the video, and the number of links we’ve included in this article, the importing of foods into the U.S. is a rather complex (and potentially expensive) process. The video provides a simple overview to help businesses determine if they want to start down the road to importing, but as its simplicity is belied the further one gets in the video, it also could dissuade businesses from taking the import road.
If you are interested in importing, would like assistance with your import program, or are facing an Import Alert or DWPE, we can help. TAG has extensive experience in import processes of the U.S. as well as Canada and can help you get started or improve. Give us a call!
For more information: