FDA National Entry Review: What Brokers and LSPs Must Change This Week

FDA centralized import entry review under the Nationalized Entry Review (NER) program, effective August 4, 2025. NER routes higher-risk and incomplete filings to national reviewer teams and relies on SERIO+ with PREDICT risk screening. Separately, CBP rescinded a long-standing PGA filing exemption on July 9, 2025, which means FDA-regulated goods must transmit FDA data at entry regardless of value. This post gives brokers and LSPs a practical playbook for pre-alerts, document sets, response SLAs, and three SKU scenarios you can brief to customers now.

What Changed

NER is live. FDA centralized entry review nationwide. Entries that do not auto-release after electronic screening route to NER teams for human review. FDA highlights coordinated national response, harmonized alerts, and reviewer availability gains under SERIO+. Implication: consistency improves, but cycle time still depends on data quality and risk flags.
Low-value no longer skips FDA review. CBP’s July 9 CSMS rescinded the PGA filing exemption on certain de minimis flows. FDA-regulated products now require the appropriate FDA data at entry, including when using Entry Type 86 where applicable. Implication: even small parcels need complete PGA message sets or they are at risk of holds.

What This Means For Ops This Week

Treat data completeness as the primary lever. Most slowdowns come from missing or invalid FDA data elements. Product codes, FSVP importer DUNS, intended use, and A of C codes must match FDA rules for the specific commodity.
Use ITACS as your default comms rail. Submit docs, check status, and respond to “Documents Required” in ITACS to avoid lost emails and version drift.
Do not promise fixed review days. NER centralizes decisions, but timing varies by risk, program center, and whether documentation resolves first pass questions. Quote planning baselines, not guarantees.

3 SKUs, 3 Entry Timelines

Planning baselines to brief teams and customers. Replace the example SKUs and tighten the windows using your lane history.

SKU	Data prerequisites	Typical reviewer touchpoints	Planning baseline	What improves the outcome
Dietary supplement capsules	Correct FDA product code, intended use, label copy, FSVP importer with DUNS, any relevant A of C (e.g., registration, listing where applicable)	Electronic screening; if flagged, NER document review via ITACS	Same-day to 1 business day if clean data and known supplier	Attach label and ingredient list in the pre-alert; confirm FSVP importer name matches the DUNS on file
Electronic nicotine device (tobacco product)	Accurate tobacco product code, intended use, mandatory A of C where applicable, evidence of required marketing authorization if subject	High likelihood of manual review; potential exam or DWPE check against Import Alert	Plan multi-day review when new supplier or novel product	Pre-validate marketing authorization status; include manufacturer identifiers and prior admissibility history
OTC medical device accessory	Device product code, intended use, device listing and registration A of C as applicable, UOM and packaging details per FDA ACE guide	Document request if codes or listings are inconsistent	1–2 business days if listings align; longer if reclassification or code correction is needed	Map HTS to the correct FDA device product code and include A of C up front

Pre-Alert Package Brokers Should Send Every Time

Commercial invoice and packing list with clear SKU-to-line mapping
HTS code and FDA product code per line
FSVP importer legal name and DUNS where required
Affirmations of Compliance that are mandatory or helpful for the commodity, with qualifiers populated
Manufacturer name and address, plus any FDA establishment identifiers if applicable
Intended use code, lot and date data if required, temperature qualifiers for perishables
Prior Notice for food when required, and any program-specific listings or authorizations
Label images for foods, supplements, cosmetics, and tobacco where label review is likely

Response SLAs For Your Team

ITACS check cadence: every 2 hours during local business hours until release or formal hold. Escalate internally if no status change after 24 hours on time-sensitive freight.
Document turn time: 2 hours from “Documents Required” to complete upload for fully pre-alerted entries. 1 business day if supplier artifacts are missing.
Correction protocol: if a product code or A of C is wrong, file correction promptly and document the change log in the file so customer service can explain any dwell.

Broker Playbook You Can Deploy Now

Tighten master data: lock product code libraries by SKU and country of origin. Train CSRs on when an A of C is mandatory vs optional but helpful.
Standardize pre-alerts: require the checklist above before filing. Refuse to file blind for FDA-regulated lines.
Use ITACS first: make ITACS your default for status, document delivery, and line availability. Mirror key updates into your TMS.
Set customer expectations: publish planning baselines by category. Avoid promising fixed days and focus on data readiness levers.

Tag FDA-regulated SKUs in TRADLINX Ocean Visibility. Share live ETAs and milestones with consignees so they can re-sequence delivery once a “May Proceed” posts.

What we are not claiming: that NER always speeds or always slows entries. Results hinge on data quality and risk flags.
What we can support: NER is effective Aug 4 with nationalized human review. FDA now expects FDA data on FDA-regulated products regardless of value following the July CSMS. ITACS remains the preferred channel for documents and status.
What to watch: FDA updates to the ACE Supplemental Guide and any program center notices that change A of C expectations by commodity.

References

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