What is the difference between a detention and an import alert?

A detention holds one shipment pending a compliance decision. An import alert is a standing instruction that causes future shipments matching its criteria to be detained automatically (DWPE). An alert is the broader, ongoing status; a detention is a single event that an alert can cause repeatedly.

What is Detention Without Physical Examination?

DWPE lets FDA detain a shipment without first inspecting or testing it, based on a documented history of violations. It is authorized by Section 801(a) of the FD&C Act and shifts the burden to the importer to prove the goods comply before they are released.

How do I get my product off the Red List?

You petition FDA for removal by documenting that the root problem is fixed and that subsequent entries pass examination — typically a series of compliant entries backed by independent lab results and corrective-action records. If FDA is satisfied, your firm or product moves to the Green List.

Who is responsible for FDA compliance — me or my supplier?

The importer carries the legal responsibility for entries into the U.S., and for food the FSVP makes you responsible for verifying your foreign supplier. Your supplier’s cooperation matters, but FDA looks to the U.S. importer. An import alert is a manageable problem if you respond with evidence and a plan — and an avoidable one if you build compliance in upstream. Reidel Law Firm advises FDA-regulated importers on detentions, DWPE responses, FSVP, and removal petitions on flat-fee terms. Get an import compliance memo.

INTERNATIONAL TRADE LAW

FDA Import Alerts: How DWPE Detention Works

Schuyler 'Rocky' Reidel July 17, 2023 5 min read

An FDA import alert is a published notice that tells FDA field staff to detain specific products, from specific firms or countries, without physically examining them first — a status known as Detention Without Physical Examination (DWPE). In plain terms: once you are on an import alert, FDA can hold you