Fixing the FDA Entry Problems

• FDA or USDA Import Delays (examinations, samplings, etc.)

When FDA or USDA (or Customs Agriculture) wish to examine, sample, or review documentation related to a shipment of product under their jurisdiction, the time delay in obtaining release can drag on for weeks or months. This can be very detrimental to an importer's ability to meet a scheduled delivery. Because USDA conducts its import review on imported products at the manifest level (before the shipment is declared to Customs), if USDA stops cargo for review then the carrier is often prohibited from releasing the shipment to the importer or owner. This can cause an importer to incur substantial demurrage charges. FDA conducts its review at the entry level, and ordinarily Customs has already conditionally released the shipment to the importer while it awaits an FDA entry decision. If an importer distributes a shipment that has not been released by FDA and the agency decides to examine or sample it, Customs will demand that the importer redeliver it for FDA inspection or sampling. This may require the importer to contact buyers and attempt to retrieve the product for FDA examination.

When responding to a Governmental import hold for information or sampling, detailed knowledge of the pertinent agency's regulatory scope helps refine the type of information the agency is seeking. Preparing in advance for such holds is particularly important to reduce the length of the delay. FDAImports.com consultants and affiliated attorneys regularly review entry requirements for clients to ensure the appropriate records, permits, and certifications are in place prior to exporting to the US. When a government agency stops the shipment, we are often able to expedite the agency review and obtain a quicker release.

• Import Detentions

When FDA detains an imported product the FDA officer is required to provide the importer or consignee with sufficient notice indicating it appears the imported product is in violation of some substantive provision of the Food Drug & Cosmetic Act. The notice should indicate the imported article may be subject to refusal of admission under an appropriate provision of the law. The shipment remains under detention and will ultimately be refused admission unless the importer of record overcomes the appearance of a violation. Once refused, the product must be destroyed unless it is exported within 90 days of the date of the FDA refusal.

In certain cases, FDA is incorrect in its assumption that a detained article should be refused admission. In other cases, there are ways to bring the article into compliance or to remove it from FDA's legal jurisdiction. Moreover, it may be possible to overcome the appearance of the violation altogether. The first mistake is assuming the FDA officer is must be correct about the application or interpretation of the law or the evidence the officer is relying upon to find an apparent violation. In too many cases the FDA officer is not correct in applying or interpreting the law or interpreting or weighing the evidence regarding the violation. If the officer is not correct on any of these points, it can be very difficult to satisfy the officer that the violation is overcome -- because it is not a violation in the first place. In other cases, the officer may think it is important to provide certain information to which FDA is not entitled by law or that the importer cannot obtain because it is proprietary to the manufacturer or selling. In these cases, it is important to quickly engage assistance from someone who understands the law, the FDA import process, and the methods and arguments for obtaining release of the shipment.

FDAImports.com may be able to obtain an FDA release of your detained product and avoid the costs of exporting or the waste of destroying the product once refused admission.

• Reconditioning or Re-Labeling Plans

Even when FDA or USDA has detained an imported shipment, it may be possible to recondition or relabel the imported product to bring it into compliance and obtain release. Application must be made to recondition or relabel imported products and must be specific as to the steps to be taken, the place and timing where the process will occur, the person or company performing the process, and the method of verifying the reconditioning or re-labeling was successful. Second attempts at reconditioning or relabeling may also be applied for, but the second application must include an explanation why the first attempt failed and how the second attempt will be different and is likely to succeed.

FDAImports.com assists its clients in designing reconditioning protocols and making application to FDA or USDA to bring detained imported products into compliance for US distribution.

• Import Refusals of Admission

If an importer, owner or consignee fails to respond to a notice of detention, or fails to convince FDA or USDA that a detained shipment is not in violation of FDA or USDA law or regulation, FDA will issue a Notice of Refusal will be issued or Customs will reject the entry. Under these circumstances, Customs will issue a demand for redelivery (in the case of an FDA refusal) requiring exportation or destruction. In any case, the refused or rejected article ordinarily cannot be distributed in the US. Failing to comply with a refusal or rejection can have serious implications, including claims for liquidated damages up to three times the value of the goods, forfeiture and destruction of the imported product, and/or civil monetary penalties. Once a shipment is refused or rejected, it is much more difficult to obtain its release. FDA may use prior refused shipments to place the foreign manufacturer or shipper on import alert. This could be devastating to the foreign company, who may not even know that the importer has obtained the product from a third country or from a shipper who was not authorized to ship the product to the U.S.

Rescinding an FDA refusal is very difficult and very rare. FDA does not like to rescind a refusal of admission because the agency does not like to admit it was wrong and it does not like to rethink application of the law to a specific entry a second time.

FDAImports.com consultants and attorneys have had success in these actions, but every case is unique. Rescinding an FDA refusal depends upon the facts, how FDA handled the entry (including how and when FDA issued its notices to the importer), whether the importer or customs broker supplied information to FDA to try to resolve the detention, and whether FDA is correct in its application or interpretation of the law. Ordinarily, when we are successful at such appeals to the FDA, the product is released into domestic commerce for free sale within the US. It is necessary to act quickly in cases where FDA has already refused the shipment. It is important to resolve the issue prior to the exportation deadline. Therefore, these cases are handled in an expedited fashion.

FDAImports.com consultants and attorneys have been able to obtain rescission of FDA refusals and rejections for clients by quickly addressing the underlying reasons and authorities for the agency action.

• Re-importation of Previously Refused Foods

Under the Bioterrorism Act, it is now possible to re-import foods that were previously refused admission by FDA. An importer wishing to re-import previously refused food must establish that the food complies with the relevant provisions of the law and regulations when the product is reimported.

FDAImports.com affiliated attorneys have been able to obtain from FDA permission to export a refused shipment of food and reimport it by establishing the product complies with the Food Drug & Cosmetic Act.