Your Products Are Detained at the Border. Here’s What to Do.
When the FDA detains a shipment at the U.S. border, your products are held — typically at the port of entry — while the agency decides whether to allow entry or refuse admission. For importers of dietary supplements, cosmetics, food, medical devices, and other FDA-regulated products, an import detention can halt your supply chain, threaten existing customer commitments, and trigger a cascade of business consequences.
Capote Law Firm helps importers respond to FDA detention notices, challenge improper detentions, submit voluntary reconditioning requests, and work toward releasing detained goods — or, when that is not possible, exploring options to legally re-export or destroy detained products.
Shipment detained? Time is critical — storage fees accumulate daily and deadlines are short. Call (786) 871-5680 immediately or request a free consultation.
Why Does the FDA Detain Imported Products?
The FDA detains imported shipments when it has reason to believe the products may be in violation of U.S. law. Common reasons for FDA import detention include:
- Import Alert: The facility or product is on an FDA Import Alert, which means the FDA has placed it on “automatic detention” — every shipment from that source is detained without physical examination until the alert is removed.
- Labeling violations: The product’s label is missing required information, makes unauthorized drug claims, or does not comply with U.S. labeling regulations.
- Unregistered facility: The foreign manufacturing facility is not registered with the FDA as required.
- Sampling and analysis: The FDA samples the shipment and finds that it fails to meet U.S. standards — contamination, undeclared ingredients, adulteration, or subpotency.
- Appearance of violation: The FDA has reason to believe the product appears to be adulterated or misbranded based on available information, without sampling.
- FSMA non-compliance: For food importers, failure to comply with FSVP (Foreign Supplier Verification Program) requirements can trigger detention.
- MoCRA non-compliance: For cosmetics, failure of the responsible person or foreign manufacturer to register under MoCRA can result in detention of cosmetics shipments.
The FDA Import Detention Timeline
Once your shipment is detained, you face tight deadlines. Understanding the process is critical to protecting your options:
- Notice of Detention and Hearing (FDA Form 2637): The FDA issues a formal notice of detention. You have the right to submit testimony — in writing or in person — to contest the detention within the time stated in the notice (typically a few days to two weeks).
- Testimony / Hearing: You can submit evidence and argument that the goods comply with U.S. law. This is your primary opportunity to get the detention released without refusal. Strong, well-documented testimony supported by testing results, labeling analysis, and regulatory argument is the most effective response.
- Reconditioning: If the violation is correctable — such as a labeling deficiency — you may be able to recondition the shipment (relabeling, for example) and resubmit it for entry. Reconditioning must be approved by the FDA in advance.
- Notice of Refusal: If testimony is unsuccessful and reconditioning is not possible or approved, the FDA issues a Notice of Refusal of Admission. At that point, you must either re-export the goods or destroy them under FDA supervision within 90 days.
What Is an FDA Import Alert?
An FDA Import Alert is an order that places a company, facility, or product on automatic detention. Unlike a standard detention — which is applied to a specific shipment — an Import Alert means that every future shipment from the listed source is automatically detained at the border, without individual examination. Import Alerts are public and searchable on the FDA’s website.
Getting removed from an FDA Import Alert requires demonstrating to the FDA that the underlying violation has been corrected — through a process called “reconditioning” or by petitioning for removal from the alert with documented evidence of corrective action. This is a demanding process that typically requires regulatory counsel.
How Capote Law Firm Helps with Import Detentions
- Immediate review: We analyze the FDA’s detention notice to understand the specific grounds for detention and identify your options and deadlines.
- Testimony preparation: We prepare a strong written response to the detention, including regulatory analysis, laboratory results, and corrective actions taken — the most effective tool for getting a detention released.
- Reconditioning petitions: Where relabeling or other reconditioning is possible, we prepare and submit the reconditioning request to the FDA and supervise the process.
- Import Alert removal: We assist companies in building the evidentiary record needed to petition for removal from an FDA Import Alert.
- FSVP compliance: For food importers, we help establish or remediate your Foreign Supplier Verification Program to prevent future detentions.
- Facility registration: If the detention is related to an unregistered facility, we assist with the FDA registration process for domestic or foreign facilities.
- MoCRA registration: For cosmetics detained due to MoCRA non-compliance, we assist foreign manufacturers with the U.S. registration process.
Frequently Asked Questions
How long can the FDA hold my shipment?
There is no fixed maximum detention period. While the FDA has internal processing timelines, shipments can be held for weeks or months during the testimony and reconditioning process. Storage and demurrage fees accumulate throughout — making rapid, effective response essential.
Can I release the goods while the detention is pending?
In some circumstances, the FDA may allow goods to be released under bond while the detention is pending, particularly if the violation is related to labeling rather than safety. Bond releases are not automatic and must be requested.
My shipment was refused — can I appeal?
After a Notice of Refusal, your options are to re-export the goods or destroy them. There is no formal FDA appeal process for a refused shipment. However, if you believe the refusal was legally improper, there may be administrative or judicial remedies available. Contact Capote Law Firm immediately if you receive a refusal notice.
Does Capote Law Firm handle import detentions for companies outside Miami?
Yes. FDA import detentions are federal matters handled at ports of entry nationwide. We represent importers and foreign manufacturers across the United States and internationally, regardless of which port the shipment entered.
Shipment detained at the border? Call (786) 871-5680 now. Every day of delay costs storage fees and risks refusal. Schedule a free consultation — we can begin reviewing your case same-day.