FDA Import Alert 99-52 and FSMA 801(q) import certification: what to know

FDA lists Import Alert 99-52 as a detention without physical examination (DWPE) enforcement tool tied to FSMA Section 801(q) import certification for certain human foods from specified regions in Indonesia. The alert shows a published date of 10/03/2025, and it says the import-certification requirement begins 10/31/2025 for shrimp and all spices from the covered Indonesian regions.

This matters to U.S. businesses that rely on fast border clearance: under the alert, shipments that are covered but missing the required certification (or using the wrong certification pathway) can face DWPE detention and, in some cases, refusal of admission.

What Import Alert 99-52 is (and what DWPE means in practice)

Import Alert 99-52 is FDA guidance to its field staff about handling certain human food products from the alert’s listed origins and firms. It is categorized as a DWPE alert, meaning FDA may treat covered shipments in a way that focuses on documentation and compliance demonstration rather than routine physical examination at the border.

FDA’s broader “Actions & Enforcement” guidance explains that import alerts are used to inform FDA field staff that there is enough evidence for Detention Without Physical Examination (DWPE) of products subject to the alert, and that products can still be imported if the importer demonstrates compliance.

What FSMA Section 801(q) import certification is designed to do

FDA describes import certification as a targeted tool it can use when, based on a risk determination, the agency requires industry to demonstrate that a food safety risk has been addressed before the food is imported into the U.S.

When FDA requires it for a covered food, the food must be accompanied by an import certification (or other specified assurance, such as shipment- or facility-specific assurance) as a condition of admission. FDA also describes import certification as working alongside other import tools—such as import alerts that use DWPE.

The two certification tracks in this alert (Red List vs. Yellow List)

The alert structures compliance into two categories:

• Red List (firm-level): Firms on the Red List are those for which FDA describes evidence of cesium-137 (Cs-137) contamination risk. To be removed from the Red List, the alert says firms are required to have an Accredited Third-Party Certification Program (TPP) certification to verify control of Cs-137.
• Yellow List (shipment-level): For covered foods from the covered regions, the alert says shipment-specific shipments must have a shipment certification from a Certifying Entity (CE) designated under 801(q)(3)(A). The alert describes that shipment-specific certificates may be submitted to FDA (including through ITACS for each entry submission), and that the certification must be provided by the designated CE, described as an agency or representative of the Government of Indonesia.

What can happen if documentation isn’t right

The alert’s guidance says FDA divisions may detain shipments without physical examination for items from firms on the Red List. It also says other shipments from the covered regions may be detained under the Yellow List when the shipment is not accompanied by a certificate from the Indonesian CE.

Separately, the alert’s charge states the article is subject to refusal of admission under Section 801(a) when it is subject to, but not compliant with, a requirement under 801(q) to be accompanied by an import certification that the article meets applicable requirements of the FD&C Act.

How to tell whether your shipment is covered

The fastest way to check is to use the alert’s own coverage language:

• Confirm the product and origin. The alert says the certification requirement starts 10/31/2025 for shrimp from the Island of Java and the Province of Lampung on the Island of Sumatra, and for all spices from those regions.
• Check whether the firm is on the Red List. Red List status determines whether the pathway centers on a TPP certification for Cs-137 control.
• Match the shipment to the Yellow List pathway. If the alert calls for a CE-issued shipment certificate, verify that your entry team has the correct certificate type and submission pathway for the covered entry.

What to watch next

Even when the underlying framework is stable, the practical risk for importers is often “documentation readiness.” For covered shipments, keep an eye on:

• Any FDA updates to Import Alert 99-52 and its described certification pathways (especially Red List firm listings and the shipment-certification expectations).
• FDA’s import certification resources that explain which entities may provide certification and what forms certification can take.
• Supplier/partner confirmation: downstream U.S. manufacturers, retailers, and foodservice businesses should ask suppliers how they will meet the alert’s required certification documentation to reduce delivery delays at the border.

Sources

• FDA Import Alert 99-52 (Detention Without Physical Examination; Section 801(q) import certification) — current alert text
• FDA: Import Certification (FSMA Section 801(q) authority and framework overview)

Look for updates to this story

Related News

• FDA Links Recalled Eggs to Salmonella Outbreak in 17 States
• FDA expands Cyclospora outbreak to nine states as lettuce recall continues
• FDA Proposes Drug-Facility Rules to Improve Supply-Chain Visibility
• Cincinnati moves temporary food-license applications and payments online