FDA Delays & Detentions
Obtaining FDA Import Release of an FDA held or detained shipment can take weeks or months. The delay may occur because FDA exercises its jurisdictional right to examine, inspect, sample, or review documentation related to an imported product. This FDA import delay can cause an importer to miss a scheduled delivery to an important retail account and can mount up substantial demurrage fees and charges.
FDA import procedures focus upon imported products at the U.S. Customs and Border Protection (Customs) entry level after Customs has already conditionally released the imported shipment to the importer. Even after Customs releases imported products, the importer must wait to receive an FDA release or an FDA may proceed before the imported product can be further distributed into U.S. commerce. If an importer distributes an imported shipment that has not been released by FDA and FDA decides to examine, inspect or sample the imported product, Customs will demand the importer redeliver the imported product for FDA inspection or sampling. This may require the importer to contact buyers and attempt to retrieve the product for FDA examination.
FDA Import Detention Authority
The FDCA and FDA's import regulations authorize FDA to detain an imported product if it appears to be in violation of the FDCA or FDA regulations. If a product appears to be out of compliance, the FDA district office will issue a Notice of FDA Action (an FDA import detention notice) to the importer, the owner, the consignee and the customs broker. The FDA import detention notice will specify the nature of the violation and cite the relevant FDCA provision. Under the FDCA, the owner or consignee of an imported product is entitled by law to an informal hearing during which the importer may provide testimony to FDA regarding the admissibility of the product. If the owner: 1) fails to submit evidence that the product is in compliance; 2) fails to submit a plan to bring the product into compliance; or 3) fails to overcome the appearance of the violation in some other way, FDA will issue another Notice of FDA Action (FDA Import Refusal Notice) refusing admission to the product.
It is critical to solve an FDA import detention while it is still in the detention stage. ETL regularly assists importers with obtaining releases of FDA detained shipments. However, doing so after FDA issues an FDA Import Refusal notice is much more difficult. In most cases, if FDA issues an FDA Import Refusal notice for an imported article, FDA will not rescind or reverse the refusal later and release it into U.S. commerce -- even if the FDA refusal is wrong.
Do not wait to contact ETL if FDA has issued an FDA Import Detention Notice for your imported foods, imported cosmetics, or imported drugs or devices. FDA grants a limited amount of time to either correct the violation FDA believes exists or to convince FDA that the violation does not exist. ETL regularly advocates for its clients before FDA to obtain FDA import releases for FDA detained imported products. However, the longer an importer waits to contact ETL the more difficult (and expensive) the task. Let ETL find The Way Through for your imported products early in the FDA detention process to reduce costly delays.
In virtually all cases involving FDA import detentions, there are ways to bring an article into compliance and obtain an FDA import release. Under certain conditions, the importer may be given an opportunity to submit an application to recondition or re-label the FDA detained product. If the local FDA office permits an importer to recondition or re-label the shipment, FDA may conduct a second import examination or collect a second import sample to verify the import reconditioning process was successful. If FDA does not require a second sample, or if the second sample demonstrates the detained product complies with the relevant requirements, FDA will release the imported product into U.S. commerce.
ETL assists its clients in designing import reconditioning plans, protocols and proposals to apply to FDA for permission to bring detained imported products into compliance for U.S. distribution. In this way, ETL literally paves The Way Through for its importer clients.
Do not let an FDA import detention stand in the way of your imported products? entry, and certainly do not let an FDA import detention convert to an FDA import refusal without first contacting ETL for help.
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