Guide
FDA detention without physical examination (DWPE), explained
Updated 7 min read7 primary sources
Detention without physical examination (DWPE) lets FDA detain an imported shipment without sampling or testing it, because the firm, product or country is listed on an import alert based on past violations or other information. To get a DWPE shipment released, the importer has to show FDA, usually with private laboratory results or other evidence described in the alert, that the shipment does not have the listed violation.
Key facts
- Legal basis
- FD&C Act section 801(a): refusal when an article appears violative
- Applied through
- Import alerts (red lists, and green list exemptions)
- First used by FDA
- 1974 (Regulatory Procedures Manual 9-8-2)
- Response window
- Usually 10 business days on the detention notice
- If not overcome
- Refusal, then export or destruction within 90 days
What is detention without physical examination?
Normally FDA decides whether to hold an imported food after examining it or testing a sample. Under DWPE, FDA can detain the shipment as soon as it is offered for entry, without that examination, because an import alert already lists the firm, product or country. FDA describes import alerts as a way to protect consumers against products with a history of known violations.
The detention is not the end of the shipment. FDA's Import Alerts page explains that a DWPE shipment will be detained and refused unless the importer can overcome the appearance of the violation by demonstrating that the product does not have it.
Where does FDA's authority for DWPE come from?
Section 801(a) of the Federal Food, Drug, and Cosmetic Act lets FDA refuse admission when an article appears violative from the examination of samples or otherwise. FDA calls this the appearance standard. The words or otherwise are what allow a decision based on history and other information rather than a test of the shipment in hand.
“If it appears from the examination of such samples or otherwise that (1) such article has been manufactured, processed, or packed under insanitary conditions or, in the case of a device, the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of section 360j(f) of this title, or (2) such article is forbidden or restricted in sale in the country in which it was produced or from which it was exported, or (3) such article is adulterated, misbranded, or in violation of section 355 of this title”
FDA's Regulatory Procedures Manual (RPM) chapter 9-8 says DWPE was first used in 1974 and is appropriate when there is a history of importing violative products, or other information indicates future entries may appear violative. The RPM adds that DWPE places the responsibility for ensuring compliance with the law on the importer.
How does a firm or product end up under DWPE?
Any FDA unit can recommend DWPE, with supporting data, to the Division of Import Operations. RPM chapter 9-8 describes the main grounds:
| Ground | What the RPM describes |
|---|---|
| One violative sample (9-8-8) | One sample can support DWPE in listed cases, for example a potential health hazard that would warrant a Class I or II recall, actionable pesticide, aflatoxin or chemical contaminant levels, a low-acid canned or acidified food without a process on file or registration, or a violation likely to continue because of ingredients or formulation such as an undeclared allergen or unapproved color |
| Information and historical data (9-8-9) | A pattern of violative imports from a manufacturer, shipper, grower, area or country, which may not require a new physical sample |
| Multiple samples (9-8-10) | For example, for specific products from one manufacturer or shipper with violations that are not a significant health hazard (such as filth or labeling): at least 3 detentions in a recent 6-month period that are at least 25% of that product's examined shipments |
| Establishment inspection (9-8-12) | Adverse findings from an inspection of the firm |
| Importers (9-8-11) | DWPE of a specific importer's entries rather than a manufacturer's products; Import Alert 99-41, for example, lists FSVP importers |
For country or area alerts, the RPM's multiple-sample criteria for one geographic area are at least 12 detentions in a recent 6-month period, representing at least 25% of examined shipments and a significant number of the area's firms.
What happens to a shipment under DWPE?
- 01
Entry is flagged
The shipment matches a red list entry (firm and product code) or falls under a country or product alert without a green list exemption.
- 02
Notice of FDA Action, Detained
FDA issues a Notice of Detention and Hearing listing the charges and a respond-by date. FDA's Detention and Hearing page says the RPM allows 10 business days, and the notice generally gives 20 calendar days.
- 03
Evidence or reconditioning
The owner, consignee or importer of record submits testimony, usually a private laboratory analysis of a representative sample as the alert's Guidance section describes, or applies to recondition the goods on Form FDA 766.
- 04
Release or refusal
If the evidence overcomes the appearance of the violation, FDA issues a release notice. If not, FDA issues a Notice of Refusal of Admission.
- 05
Export or destruction
Refused goods must be exported or destroyed under CBP supervision within 90 days of the refusal notice.
After a refusal, the steps and deadlines are covered in FDA import refusal: what happens next.
Is every FDA detention a DWPE detention?
No. FDA's Import Alert FAQ says not all detentions are due to import alerts; the Notice of FDA Action states the reason. A shipment can be detained after an examination or sample even if its supplier is on no alert. DWPE is the special case where the detention happens without that examination because of a listing.
How long does DWPE last?
DWPE has no end date. A firm or product stays subject to it until FDA removes the listing, based on evidence that the conditions behind it have been resolved. For violations under section 801(a)(3), RPM 9-8-15 says a minimum of five consecutive non-violative commercial shipments may be required, and sometimes more. The process is in How to get off an FDA import alert.
Frequently asked questions
- Does DWPE mean the shipment was tested and failed?
- No. Under DWPE, FDA detains the shipment without examining or testing it, because the firm, product or country is listed on an import alert based on past violations or other information.
- Can a shipment under DWPE be released?
- Yes, if the owner, consignee or importer of record shows FDA that the product does not have the violation, usually with private laboratory analysis or other evidence described in the alert's Guidance section. FDA may collect audit samples before deciding.
- Is DWPE the same as an import refusal?
- No. DWPE is a detention of a shipment at entry; a refusal is FDA's final decision that a detained shipment may not enter. A DWPE shipment becomes a refusal only if the evidence does not overcome the appearance of the violation.
- How do I know if my supplier is subject to DWPE?
- Search FDA's import alerts by manufacturer name, product and country of origin, as FDA's FAQ recommends, and check whether the supplier is on a red list or missing from a green list. SupplierRadar's supplier pages and free bulk check show active listings with links to each alert.
- Who has to provide the evidence to release a DWPE shipment?
- The owner or consignee may respond, and FDA also accepts information from the importer of record. A representative may respond on their behalf if authorized in writing.
Sources
Every legal and FDA-process claim above is cited to a primary source. Access dates show when each page was read.
- 01FDA: Import AlertsFDA · accessed
- 0221 U.S.C. 381, FD&C Act section 801 (Cornell LII)Cornell LII · accessed
- 03FDA Regulatory Procedures Manual, Chapter 9 Import Operations and Actions (March 2024)FDA · accessed
- 04FDA: Detention & HearingFDA · accessed
- 05FDA: Import RefusalsFDA · accessed
- 06FDA: Industry FAQs for Import AlertsFDA · accessed
- 07FDA Import Alert 99-19FDA · accessed
Related
Put it into practice
See which of your suppliers are under DWPE
The free bulk check looks up to five suppliers against FDA import alerts and refusal records and links each listing to its FDA page. Watch them and you hear about a new listing before your next shipment ships.
SupplierRadar is not affiliated with the U.S. Food and Drug Administration. Data comes from public FDA records and may contain errors. This is not legal advice; importers remain responsible for their supplier evaluations.