Tag Archives: DWPE


FDA Issues Draft Guidance on Sampling for Seafood Subject to DWPE

By Food Safety Tech Staff
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The U.S. Food and Drug Administration (FDA) has issued a draft guidance for industry titled “Recommendations for Collecting Representative Samples for Food Testing Used as Evidence for Release of Certain Fish and Fishery Products Subject to Detention Without Physical Examination (DWPE) and Removal of a Foreign Manufacturer’s Goods from DWPE.” The draft guidance provides recommendations for collecting representative samples for seafood products subject to Detention Without Physical Examination (DWPE) under an Import Alert because of the appearance of adulteration caused by pathogens, unlawful animal drugs, scombrotoxin (histamine), and/or decomposition.

The draft guidance, once finalized, will help foreign manufacturers and other processors of seafood products subject to DWPE submit evidence to the FDA to support a request to have their products removed from DWPE. It also addresses the concern that industry may experience challenges in supporting their arguments about the safety of seafood products subject to DWPE.

Per the draft guidance, foreign manufacturers or other interested parties requesting removal of product from DWPE should provide information to FDA to adequately demonstrate that the conditions that gave rise to the appearance of the violation have been resolved. This may include evidence of a root cause analysis, relevant corrections to the manufacturing process, and/or other controls that have been implemented to address the violation, and hazard analysis critical control point (HACCP) documents, in addition to testing results for consecutive non-violative shipments.

The number of consecutive non-violative shipments required is guided by the FDA’s Regulatory Procedures Manual (RPM), Chapter 9, Sections 9-8-15 and 9-8-16. Typically, five to 12 shipments help demonstrate that the conditions that gave rise to the appearance of the violation have been resolved, per the FDA.

The testing submitted should be from a statistically robust number of samples based on the size of the article and representative of the affected article. The draft guidance includes recommended analytical methods for testing, as well as sampling schedule recommendations with the amount (by weight) of product recommended for collection to represent each sample unit.

Download the draft guidance here.

Stakeholders can submit comments on the draft guidance by April 12, 2024, using docket number FDA-2023-D-5303.


FDA Issues First Import Alert for FSVP Non Compliance

By Trish Wester
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The Import Alert for FSVP noncompliance is applicable to any human and animal food subject to the FSVP regulation, and allows FDA to detain imported foods at the port of entry under the protocol for Detention Without Physical Examination (DWPE). DWPE is a standard enforcement tool for FDA.

July 31, 2019: FDA issued Import Alert #99-41, the first Import Alert based on noncompliance with the Foreign Supplier Verification Program (FSVP) regulation.
The FSVP Import Alert contains the following reason for the alert and the relevant charge.


“Section 805 of the FD&C Act (21 U.S.C. 384a) requires each importer of food to perform risk-based foreign supplier verification activities for the purpose of verifying that the food imported by the importer is produced in compliance with the requirements of section 418 (21 U.S.C. 350g) (regarding hazard analysis and risk-based preventive controls) or section 419 (21 U.S.C 350h)(regarding standards for produce safety) of the FD&C Act, as appropriate; and that the food is not adulterated under section 402 or misbranded under section 403(w).” – FDA


“The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in that it appears that the importer (as defined in section 805 of the FD&C Act) is in violation of section 805.” – FDA

Join Trish Wester for the closing plenary 2019 Food Safety Consortium panel discussion FDA Presentation on The Third-Party Certification Program | Thursday, October 3, 2019“Import alerts inform the FDA’s field staff and the public that the agency has enough evidence to allow for Detention Without Physical Examination (DWPE) of products that appear to be in violation of the FDA’s laws and regulations. These violations could be related to the product, manufacturer, shipper and/or other information,” states FDA on its webpage about import alerts.

A Trend of Increased Import Enforcement?

FDA enforcement actions in this area have recently seen a dramatic increase. Only one alert was posted in the first quarter, and less than 10 food-related alerts were posted prior to June. July 2019 saw eight food alerts, including one on radionuclides and the FSVP. FDA posted more than 30 food-related import alerts in August, and September is on a similar pace currently showing 21 food-related alerts, indicating this may be an ongoing focus for the agency.

The information in this update is provided by AFSAP, the Association for Food Safety Auditing Professionals. Please contact Patricia Wester @ trish@pawesta.com if you have any questions regarding DWPE, or to request a complete copy of the alert.