Every year, hundreds of Brazilian food shipments are detained, refused, or placed on FDA hold at US ports. The reason is almost always the same: incomplete or incorrectly filed Prior Notice submissions. For freight forwarders managing food imports from Brazil, this is not a minor paperwork issue. It is a compliance requirement that, when mishandled, can result in thousands of dollars in demurrage, re-export costs, and permanent damage to your client relationships.

Brazil is one of the largest food exporters to the United States, shipping everything from frozen poultry and orange juice concentrate to coffee, sugar, and processed snacks. Every single one of these products requires a valid FDA Prior Notice before it can legally enter the country. If your US-side operations are not handling this correctly, your clients are exposed to serious risk.

This guide covers everything forwarders need to know about FDA Prior Notice: what it is, what information is required, when to file, common mistakes that lead to holds, and how to build a reliable compliance process that protects your brand and your clients.

What Is FDA Prior Notice?

FDA Prior Notice is a mandatory filing requirement established under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. The regulation requires that the FDA be notified in advance of any food shipment arriving in the United States, whether it is being imported for commercial distribution, personal consumption, or even as a sample.

The purpose is straightforward: give the FDA enough lead time to assess whether an incoming food shipment poses a risk to public health. The agency uses the prior notice data to identify shipments that may need inspection, sampling, or laboratory analysis before being released into US commerce.

The definition of 'food' under this regulation is broad. It includes human food, animal feed, dietary supplements, infant formula, food additives, color additives, and beverages including alcoholic beverages. If your Brazilian exporter is shipping any product that falls under FDA jurisdiction, prior notice is required. No exceptions.

What Information Is Required in a Prior Notice Filing?

A complete Prior Notice submission must include specific data points about the shipment, the product, and all parties involved. Missing or inaccurate information in any of these fields is the most common cause of FDA holds. Here is exactly what the FDA requires:

• Submitter information: The name, address, and contact details of the individual or organization filing the prior notice. This is typically the customs broker or the importer of record.
• Transmitter information: If the filing is submitted by a third-party agent on behalf of another party, the transmitter's details must also be included.
• Importer of record / owner / consignee: Full name and address of the US entity receiving the goods. This must match the information on the customs entry documentation.
• Manufacturer / processor: The name, address, and country of the facility that manufactured, processed, or packed the food product. For Brazilian exports, this is the production facility in Brazil.
• Shipper / grower: If different from the manufacturer, the grower or shipper details must be listed separately. This is common with Brazilian agricultural commodities like coffee and sugar.
• Product description: The complete common or market name of the food, the quantity, and the FDA product code. Generic descriptions like 'food products' or 'assorted goods' will be rejected.
• HS code (Harmonized System): The tariff classification code that corresponds to the specific product being imported. Incorrect HS codes are one of the leading triggers for FDA review.
• Country of production: The country where the food was produced, grown, or manufactured. For mixed-origin products, all countries involved in production must be listed.
• Arrival information: The anticipated arrival date, port of arrival, and mode of transportation. For ocean freight from Brazil, this includes the vessel name, voyage number, and container number.

All of this data must be submitted electronically through the FDA's Prior Notice System Interface (PNSI) or through the Automated Broker Interface (ABI) used by licensed customs brokers. Manual or paper submissions are not accepted.

When to File: Timeline and Best Practices

The FDA requires that Prior Notice be received no later than the time of arrival of the food at the US port. However, the minimum advance filing requirements depend on the mode of transportation:

• Ocean freight: Prior Notice must be submitted no later than 8 hours before the vessel arrives at the first US port.
• Air freight: No later than 4 hours before arrival at the first US port of entry.
• Truck (land border): No later than 2 hours before arrival.
• Rail: No later than 4 hours before arrival.

For Brazilian shipments, the vast majority arrive via ocean freight, making the 8-hour minimum the most relevant benchmark. However, the 8-hour window is the absolute minimum. In practice, best-performing customs brokers file Prior Notice 15 days before vessel arrival. This gives the FDA ample time to review the submission, reduces the chance of last-minute holds, and allows time to correct any errors before the container reaches the terminal.

Filing early is not just a best practice. It is a competitive advantage. When a Prior Notice is submitted well in advance and all data is accurate, the FDA can pre-clear the shipment before it even arrives. This means faster release at the port, lower demurrage risk, and a smoother experience for your importer client.

Common Mistakes Forwarders Make with Prior Notice

Most FDA holds on Brazilian food shipments are not caused by the food itself being unsafe. They are caused by filing errors. Here are the mistakes we see most frequently:

1. Incorrect or Generic Product Codes

The FDA product code must precisely match the food being imported. Using a general category code instead of the specific code for the actual product is one of the fastest ways to trigger a review. For example, frozen acai pulp, roasted coffee beans, and pasteurized orange juice each have distinct product codes. Using a generic 'fruit product' or 'beverage' code will flag the shipment immediately.

2. Missing or Incorrect Manufacturer Information

The Brazilian manufacturing facility must be identified with its full legal name and physical address. Many forwarders make the mistake of listing the exporter or trading company instead of the actual production facility. The FDA tracks manufacturer history, and the correct facility identification is critical for the agency's risk assessment.

3. Late Filing

Waiting until the last possible moment to file Prior Notice is a high-risk approach. If there is any error in the submission, there is no time to correct it before the vessel arrives. The shipment gets held, demurrage starts accumulating, and the importer starts asking questions. Forwarders who consistently file late create a pattern that puts every future shipment at higher risk.

4. Mismatched Data Between Prior Notice and Entry Documents

The information on the Prior Notice must align perfectly with the customs entry, the commercial invoice, and the bill of lading. Discrepancies in product descriptions, quantities, or consignee names between documents will trigger an FDA review. This is especially common when the forwarder uses one set of documents for customs and a different set for FDA filing.

5. Failing to Update Prior Notice After Changes

If the vessel changes, the port of arrival changes, or the shipment quantity is modified after the original Prior Notice has been filed, the filing must be updated. Failure to amend the Prior Notice to reflect actual arrival conditions is treated as a filing violation by the FDA.

Consequences of Non-Compliance

The FDA does not treat Prior Notice violations lightly. The consequences are immediate and financially painful:

• FDA Hold: The shipment is detained at the port pending review. During this time, the container sits on the terminal, and demurrage and per diem charges accumulate daily. For a container at a major US port, this can easily reach $300 to $500 per day.
• Refusal of Admission: If the Prior Notice is deemed inadequate or the product fails FDA review, the shipment can be refused entry into the United States entirely. A refused shipment must be exported or destroyed at the importer's expense.
• Re-export Costs: When a shipment is refused, the importer must arrange and pay for the return shipment. For ocean freight from the US back to Brazil, this can cost $4,000 to $8,000 per container, not including the original shipping cost that is now wasted.
• Import Alert Listing: Repeated violations can lead to the product, manufacturer, or shipper being placed on an FDA Import Alert. Once on this list, all future shipments from that source are subject to automatic detention without physical examination, creating ongoing delays for every subsequent import.
• Client Relationship Damage: For a freight forwarder, the worst consequence may not be financial. When an importer's cargo is stuck at the port because of a filing error made by the forwarder's US agent, trust evaporates. Importers talk to each other. One bad experience can cost you multiple accounts.

How to Ensure Smooth FDA Clearance

Building a reliable FDA compliance process is not complicated, but it requires discipline and attention to detail. Here are the practices that consistently produce the best results:

• File early: Submit Prior Notice at least 15 days before vessel arrival. This gives ample time for corrections and pre-clearance review.
• Verify manufacturer details directly: Do not rely on secondhand information. Confirm the exact legal name and address of the Brazilian production facility with the exporter before every filing.
• Use precise FDA product codes: Invest time in identifying the exact product code for each item. The FDA Product Code Builder tool is available on the FDA website and should be used for every new product.
• Cross-check all documents: Before submitting the Prior Notice, verify that product descriptions, quantities, consignee names, and HS codes match across the commercial invoice, bill of lading, packing list, and customs entry.
• Monitor for changes: Track vessel schedules actively. If the ETA changes, the port changes, or the carrier changes the vessel, update the Prior Notice immediately.
• Maintain a product database: For recurring shipments, build an internal database of verified product codes, manufacturer details, and HS classifications. This reduces errors on repeat shipments and speeds up the filing process.
• Know the FDA registration status: The manufacturing facility in Brazil must be registered with the FDA under the Food Facility Registration requirement. An unregistered facility will cause the Prior Notice to be rejected outright. Verify registration status before booking the shipment.

The Value of a US-Based Customs Broker for FDA Coordination

FDA compliance is not something that can be reliably managed from overseas. Time zone differences, limited access to the FDA's electronic filing systems, and the inability to respond quickly to hold notices or exam requests make remote FDA management a liability for forwarders handling Brazilian food exports.

A US-based licensed customs broker with direct FDA interface capabilities can file Prior Notice through the Automated Broker Interface, monitor confirmation status in real time, and respond to FDA inquiries within hours rather than days. This level of responsiveness is the difference between a container released on day one and a container sitting on demurrage for a week.

For freight forwarders who operate under a white-label model, having a US customs broker handle FDA coordination means the importer sees seamless, professional compliance work under your brand. The broker works behind the scenes while you maintain the client relationship and full operational control. This structure eliminates the need to build an in-house FDA compliance team while still delivering the level of service your importers expect.

When evaluating a US-based partner for FDA coordination, look for a broker with specific experience in Brazilian food products. Brazilian exports have unique regulatory characteristics, from USDA-inspected meat facilities to specific FDA product code requirements for tropical fruits and processed goods. A broker who understands these nuances will catch potential issues before they become costly problems.

Conclusion

FDA Prior Notice is a non-negotiable compliance requirement for every food shipment entering the United States from Brazil. The filing itself is not inherently complex, but accuracy, timeliness, and attention to detail are everything. A single wrong product code, a missing manufacturer address, or a late filing can turn a routine shipment into a weeks-long, expensive headache for your importer.

For freight forwarders, the quality of your FDA compliance directly impacts your reputation. Importers remember who got their cargo released on time and who caused a hold. Building a bulletproof Prior Notice process, whether through internal expertise or through a trusted US-based customs brokerage partner, is one of the highest-value investments you can make in your forwarding operation.