How to Reverse an FDA Import Refusal or CBP Seizure

What is the difference between an FDA import refusal and a CBP seizure?
FDA cannot seize goods itself, it can only refuse admission to products that appear violative. A refusal means the product cannot enter the U.S. and must be exported or destroyed, but the importer retains possession and title. CBP, by contrast, can seize goods outright, either physically or through a constructive seizure, and eventually seek forfeiture, which transfers ownership to the government. 

What typically triggers an FDA refusal or CBP seizure?
FDA refusals often stem from failure to overcome charges during detention (e.g., failing product testing related to an import alert). CBP seizures, however, are usually triggered by investigations into other issues (e.g., narcotics, counterfeit goods, or documentation problems) and may happen without warning if CBP has background concerns about the importer or shipment. 

What should an importer do first after receiving a Notice of FDA Action or CBP Seizure Notice?
With FDA, the importer should already have been working to avoid refusal. If refusal is issued, the next step is to either export or destroy the goods under supervision. With CBP, the importer should immediately request all documentation and review the seizure grounds, then consider petitioning for remission or hiring legal counsel to challenge the action. 

Can FDA refusals be reversed or rescinded?
Yes, but only in specific cases. Petitioning for rescission is possible when FDA has made a legal, factual, or procedural error. Benjamin England notes that while this process isn’t explicitly laid out in FDA procedures, he frequently secures reversals for clients, especially when FDA acted prematurely or misapplied regulations. 

Does resolving a seizure or refusal always involve litigation?
Not necessarily. FDA is risk-averse and typically prefers to avoid litigation. Refusals rarely go to court unless the product is extremely valuable or the case is compelling. CBP, on the other hand, is much more litigation-tolerant and frequently proceeds to forfeiture in federal court if disputes escalate. 

What are the most common mistakes importers make after receiving a notice?
One major mistake is distributing goods before receiving clearance. This can trigger a redelivery demand from CBP if FDA issues a refusal. Another common error is failing to read the notice carefully or to ask for legal interpretation. Importers often miss critical deadlines or misunderstand regulatory language, leading to preventable enforcement issues.

How does the redelivery process work after an FDA refusal?
If products are refused but already partially distributed, CBP may issue a redelivery demand under the importer’s bond. This creates compliance and liability issues, especially when some of the cargo can no longer be exported or destroyed. The safest approach is to keep all goods in bonded storage until the case is resolved. 

When should a business hire an attorney for customs seizures or FDA refusals?
For CBP seizures, it’s advisable to retain counsel immediately, especially since seizures are subject to litigation and complex procedural rules. For FDA refusals, petitioning without a lawyer is possible, but if rescission fails once, professional help is strongly recommended. Multiple failed petitions can jeopardize chances of success. 

How can businesses reduce the risk of FDA refusals or customs seizures?
Compliance is key. Businesses should ensure that all product labeling, documentation, country of origin declarations, and safety standards are accurate. With CBP, that includes complying with CPSC, EPA, DEA, and other agency regulations. For FDA-regulated products, proper markings, testing, and lawful formulation are essential. 

If you’re facing challenges with importing FDA-regulated products, we’re here to help you navigate the process smoothly. Let us be your guide through the complexities of trade tariffs, FDA compliance, and border issues. Visit us at FDAImports or contact us directly at contact@fdaimports.com for assistance.