FDA Refusals

FDA can stop any imported product from entering U.S. commerce if they believe it may not follow U.S. requirements. They would typically start with a detention, where they give importers an opportunity to respond to their concerns. A refusal generally follows this if they are not satisfied and believe that the product does not appear to comply with U.S. law. At that point, generally, the importer must export or destroy the merchandise.

Notice of Refusal

When FDA makes its final determination that the detained products appear to violate U.S. law they will issue a Notice of Refusal of Admission (refusal notice) to the importer. At that point the products are considered refused, and FDA and Customs will require you to destroy or export the products within 90 days of the date of the refusal notice.

Overturning a Refusal

If FDA detains your shipment, it is likely that they will ultimately refuse the product unless you successfully bring the product into compliance (after receiving FDA’s permission to do so) or demonstrate to FDA that their charges are incorrect.

Rescinding a refusal is much more challenging than resolving a detention. FDA’s policy is that a refusal is final and FDA will only reverse it if they made some mistake or error in managing the entry or the case. However, if FDA has the law, science, or facts wrong or followed an incorrect procedure, there is an opportunity to get the refusal reversed. In that situation it is very important to find the errors early and to quickly communicate the errors to FDA. Still, many compliance officers are reluctant to admit they have made a mistake. In those cases, we will appeal to the appropriate senior officials, explaining the errors, the law, and the science in a way that increases your chances of having FDA rescind or reverse the refusal.

It is necessary to act quickly in cases where FDA has already refused the shipment. You will want to resolve the issue before the deadline to export or destroy the goods. Accordingly, we expedite our handling of these cases. Ordinarily, when we successfully appeal a refusal, FDA will issue a release for your product and allow it to enter U.S. commerce. If you choose to accept the refusal, then you must export or destroy the product under the required government supervision. 

Preventing Refusals

It is critical to resolve an import detention while it is still in the detention stage and before FDA issues a refusal notice. In most cases involving detentions, prior to refusal by FDA, there are ways to obtain a release of the product by contesting the detention or bringing the product into compliance with the law. Under certain conditions, the importer may submit an application to recondition or re-label the detained product.

Of course, the best time to prepare for regulatory issues is before they happen. Our attorneys and regulatory consultants help companies determine the proper classification for their product, which is not always clear for certain cosmetics, drugs, devices, and dietary supplements. We then identify the regulatory requirements that apply to the product. Learn more about FDA holds and detentions here: FDA Import Holds and Detentions.

And if I Must Accept the Refusal?

If you are unable to overturn the refusal, you must export or destroy the product, under government supervision, within 90 days of the refusal date. Typically, either Customs or FDA may supervise the destruction or exportation, but you will need to follow local port rules regarding redelivery and supervision.

If you must destroy the product, you will need to find an appropriate location to do so. There may be local environmental laws to consider and it can take a lot of time to coordinate the government supervision. We strongly urge you to begin the export or destruction process promptly, as those 90 days can go by very quickly.

FDA’s refusal triggers U.S. Customs to issue a notice demanding redelivery of the goods. If you do not export or destroy the products before the 90-day deadline, you risk Customs assessing liquidated damages against your import bond. Customs will file a liquidated damages claim if you do not meet the deadline (unless an extension is granted) or if you do not redeliver 100% of the refused goods. Liquidated damages claims are three times the value of the goods, up to the value of the import bond. You can petition to mitigate the liquidated damages, and our affiliated attorneys represent companies before Customs in those cases.

It is possible to challenge an import detention, refusal, or a demand by Customs for redelivery, but you will need to act immediately. Any delay decreases your chances of obtaining the release of detained or refused products.

Get Help With FDA Refusals

At FDAImports we can help you understand what requirements you need to follow to protect yourself and your company from the expense of a detention or refusal.

Our Experts are Ready To Help You.