FDA Import Holds and Detentions
FDA can examine any shipment of food, cosmetics, drugs, or devices to see if the products comply with applicable U.S. law. FDA uses a risk-based screening program called PREDICT to help them decide which shipments to hold for examination.
They can examine all FDA-regulated products in the shipment or choose to examine just some of them. There is no limit on the amount of time they can hold a product for examination.
FDA will keep products in hold status while they determine whether the products comply with U.S. law. While the product is in hold status, FDA may be reviewing the entry information, physically inspecting the shipment, or taking samples of the shipment and testing the samples in an FDA lab. If they determine that the product complies with U.S. law, FDA will allow the shipment to be released into U.S. commerce. If they took samples, FDA will pay for them.
If, however, FDA decides that any of the products appear to violate the law, they will detain those products and issue a corresponding Notice of FDA Action – Detention (a detention notice) to the importer, the owner, the consignee, and the customs broker. FDA does not need much evidence to detain a shipment – only evidence of an appearance of a violation. In fact, they do not need to even examine or test the specific products in question if FDA has other evidence that the products appear to violate the law. For example, in certain circumstances FDA may detain a shipment based on their examination of a previous shipment.
The detention notice identifies the violation that FDA is alleging and cites the relevant law. The owner or consignee of an imported product is entitled to an informal hearing in which they (or an authorized person acting on their behalf) can provide testimony to FDA about the admissibility of the product.
FDA will provide a “respond by” date on the detention notice. The respond by date typically gives the responsible party about 20 calendar days to respond to the detention notice. If you need more time to respond, you can request an extension.
If the owner or consignee: A) fails to submit evidence that the product is in compliance; B) fails to submit a plan to bring the product into compliance; or C) fails to overcome the appearance of the violation in some other way, FDA will issue a Notice of FDA Action – Refusal (a refusal notice) denying the product admission into the U.S.
Where’s my shipment?
Although FDA is said to “hold” and “detain” products, usually the importer maintains physical custody of the product. However, the importer should not distribute any of the held or detained products until they resolve the hold or detention with FDA.
When should an importer hire outside help if they have a detained entry?
We recommend you first consider the commercial value of the goods and whether you want to dispute or accept FDA’s justification for the detention. Even if the commercial value of the detained product is low, you may decide that accepting a refusal could hurt your relationship with your customers or cause FDA to add the supplier to an Import Alert (which is a much more time-consuming and costly issue to resolve).
Second, you should consider what the specific issue is with the shipment.
For example, can you fix the problem? In most detention cases there are ways to obtain a release of the goods by fixing the issue that prompted FDA to detain the products. FDA may permit an importer to recondition or re-label the products to bring them into compliance with the law. After the reconditioning or relabeling, FDA may conduct a second examination, or collect and test a second sample, to verify the reconditioning or relabeling was successful. If FDA determines the reconditioning or relabeling was successful, FDA will release the product into U.S. commerce.
Our team of consultants and affiliated attorneys helps clients design reconditioning and relabeling plans, protocols, and proposals to apply to FDA for permission to bring detained products into compliance, so that the product can be released for distribution in the U.S.
Alternatively, reconditioning or relabeling the product may be unnecessary if FDA made a mistake with the charges. Most importers assume FDA’s justifications for detaining the product are always correct. However, this is not the case. If FDA is wrong about the facts of the case or about what law applies, communicating promptly and clearly with the government agency is important.
Do not wait to contact us if you receive a detention notice from FDA. FDA only grants a limited amount of time to correct the violation or to demonstrate to FDA that there is no violation. The longer an importer waits to contact us, however, the more difficult (and expensive) the task can be. We regularly advocate before FDA on behalf of our clients to obtain releases of detained products. Do not let a detention convert to a refusal.
How do you minimize holds and detentions? Before you import your products, we recommend reviewing the requirements that apply to them, including requirements that apply to the product’s label and to any claims on the label or your website. Another important step is to verify the regulatory classification of the product. For example, something that is a cosmetic in another country may be considered to be a drug in the U.S. Our consultants and affiliated attorneys provide compliance counseling, advice, and reviews to ensure your products meet all applicable laws and regulations before you import them. This can help you avoid holds, detentions, and refusals, and, accordingly, can help prevent you from finding yourself in an emergency situation with upset customers and mounting costs for storage or replacement products.