Reference
FDA import terms, defined
The regulatory vocabulary that turns up on notices and in messages, in plain language.
Licensed U.S. customs brokerage. Customs broker of record; movement coordinated through vetted partners.
In short
These are the terms that appear on FDA notices and in correspondence about held shipments. Several of them sound similar and mean quite different things, and the difference usually determines how much time you have.
Key takeaways
- A hold, a detention and a refusal are three different things.
- The differences between them decide your deadline.
- Prior notice and entry review are separate steps.
- Reconditioning is an outcome, not a request.
- Where a term affects your exposure, it has its own page.
Terms
- Prior notice Advance notification that a food shipment is arriving. Due before arrival.
- Entry review FDA's assessment of an entry to decide whether it may proceed.
- May proceed The entry is released from FDA's perspective and can continue.
- Hold An informal pause on release pending review. Less formal than a detention.
- Detention A formal action with a written notice and a defined response period.
- Notice of FDA Action The written notice communicating what has happened and what is required.
- Refusal A determination that the goods may not enter U.S. commerce.
- Reconditioning Bringing goods into compliance under supervision, where the issue permits it.
- Re-export Sending refused or detained goods out of the United States.
- Import alert A directive to detain specified goods, firms or origins without examination.
- DWPE Detention without physical examination, the mechanism an import alert uses.
- Sampling Collection of samples for laboratory analysis, with the entry held meanwhile.
- FSVP Foreign Supplier Verification Program. The importer's duty to verify suppliers.
- Product code The code identifying an article at entry and routing its review.
- Registration Facility registration required for certain regulated categories.
- Adulterated Goods that fail a substantive standard, for example contamination.
- Misbranded Goods whose labelling fails requirements, regardless of the contents.
- Affirmation of compliance A code transmitted with the entry asserting a specific requirement is met.
Questions
What is the difference between adulterated and misbranded?
Adulterated concerns the goods themselves, such as contamination. Misbranded concerns the labelling. A perfectly safe product can be misbranded, and it will still be held.
Is a hold the same as a detention?
No. A hold is an informal pause. A detention is a formal action with a written notice and a response deadline. Knowing which you have tells you how much time you have.
What does 'may proceed' mean?
That FDA has released the entry from its perspective. Customs requirements are separate and both have to be satisfied.
Related
Next Step
Tell us what you're importing.
Commodity, origin, port and arrival date is enough to start.