Exporting food to the U.S. presents major opportunities, but it also involves significant risks if businesses are unfamiliar with the regulations of the U.S. Food and Drug Administration (FDA). It’s not uncommon for a food shipment to be detained at U.S. ports, causing serious losses in cost, time, and brand reputation.
So what are the main reasons a food shipment gets held? And how can businesses legally and effectively avoid or resolve this issue? This article outlines 3 key causes for FDA detention and offers practical solutions based on real-world experience.
1. FDA registration documents are not up to standard
This is the most common issue for companies new to exporting or inexperienced with FDA documentation. Common mistakes include missing FCE-SID codes for canned products, improperly formatted English labels, or failing to declare the production facility—any of which can result in the food shipment being detained at the port.
Additionally, if registration isn’t updated on time or changes to product formula or packaging are not reported, the file will be deemed non-compliant. In these cases, the FDA may require further inspection, hold the food shipment for analysis, or deny entry altogether.
Solution: Carefully review all registration documents before exporting. It’s advisable to work with professional consultants to ensure everything is FDA-compliant from the start.
2. Not meeting FSMA food safety requirements
Since the Food Safety Modernization Act (FSMA) came into effect, U.S. importers are responsible for ensuring food safety from the source. This means Vietnamese exporters must demonstrate a safe production process, traceability, and have a registered FSVP (Foreign Supplier Verification Program) agent in the U.S.
Lack of international certifications (e.g., HACCP, ISO 22000) or missing test reports can raise red flags and result in the food shipment being held by the FDA.
Solution: Establish a robust quality control system and partner with a reliable FSVP agent to handle FDA communications effectively.
3. Being listed on an import alert
If a company violates FDA regulations severely or repeatedly, it can be placed on an Import Alert list. Any food shipment from such companies may be detained or refused without detailed inspection.
Common reasons for Import Alert:
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Excessive chemical residues
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Use of banned ingredients
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Misleading or non-compliant labels
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Delays or failures in responding to FDA document requests
Being on the Import Alert list not only puts your food shipment at risk but also seriously damages your brand’s reputation in the U.S. market.
4. Common technical errors that lead to detention
Many food shipments are detained due to technical errors such as missing facility registration or FCE-SID codes for canned food. English labels may be incorrect—missing ingredients, measurement units, allergy warnings, or incorrect formatting. Other issues include misclassifying the product (e.g., low-acid vs. regular food), lack of a U.S.-based legal representative, or incomplete traceability and safety testing documents.
These errors are preventable but can delay the entire clearance process when overlooked.
5. How to resolve a detained food shipment
Upon receiving an FDA notification (Notice of Action), businesses should identify the exact reason and quickly update or correct the required documents. Collaborating with your FSVP agent or an FDA compliance consultant ensures timely and accurate responses. If the food shipment is under suspicion for safety concerns, be prepared to submit relevant test reports.
This is also an opportunity to reassess internal compliance processes to prevent future issues.
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MettiFDA – Your complete solution for safe U.S. food shipments
With over a decade of experience in FDA legal and regulatory consulting, MettiFDA is a trusted partner for Vietnamese businesses entering the U.S. market.
We offer:
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FDA registration and documentation support
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U.S.-based FSVP representation
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Expert handling of detained food shipments
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Training and setup of international-standard food safety systems
MettiFDA not only helps you resolve shipment holds but also supports long-term compliance and brand credibility in the U.S. market.
Conclusion
Having a food shipment detained by the FDA is a serious but preventable risk. By understanding the regulations, preparing documentation properly, and partnering with experienced professionals, businesses can turn compliance into a competitive edge.
MettiFDA is committed to helping Vietnamese exporters confidently enter the U.S. market—starting with overcoming FDA challenges safely, strategically, and sustainably.
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