FDA's path from screening to May Proceed
When the entry is filed, FDA screens each line of FDA-regulated product electronically. Lines that pass, or that an entry reviewer clears, receive a May Proceed notice. Others get a closer look: FDA may ask for documents, order a field or label exam, or collect samples. If the product appears to violate the law, FDA can detain it, and the importer can present evidence at a hearing before FDA decides whether to refuse it.
Prior notice for food shipments
Food, including animal feed, needs prior notice to FDA. FDA must receive and confirm it before the shipment reaches the first U.S. port, and for food arriving by water the notice is due no less than eight hours before arrival. Food with missing or inadequate prior notice is subject to refusal and, if refused, must be held at the port of entry unless it is directed to another location. Brokers often submit prior notice with the entry, but confirm it for every food shipment.
Held goods can move but must stay intact
FDA does not require every product to wait at or near the port while it decides, and CBP may conditionally release a shipment pending FDA's decision. The goods still may not be distributed. When FDA calls for an exam or sample, the lines it names must be kept available, and product shipped onward too early can face a demand to bring it back. Temperature-controlled cargo needs suitable storage for the whole review.
Example
FDA flags a line of frozen shrimp in CMAU7029150 for sampling, so the importer keeps the cartons intact in a cold store until FDA reviews the results.
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Official sources
Questions
What does FDA Hold mean?
An FDA hold means an import of FDA-regulated goods, such as food, drugs or medical devices, cannot be distributed until the Food and Drug Administration decides whether to admit it. FDA may let it proceed, examine or sample it, detain it, or refuse it.
What does a May Proceed notice mean?
It means the shipment can continue without further FDA examination at that point. It is not a finding that the product complies, and FDA can still take action later if it finds a violation.
What happens if FDA refuses a shipment?
If the importer cannot overcome the appearance of a violation, FDA refuses admission. Refused products must then be exported or destroyed within 90 days of the refusal.