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By Nick Lahey, EAS Independent Consultant

The U.S Food and Drug Administration (FDA) works hand and hand with U.S. Customs and Border Protection (CBP) with the import process of FDA-regulated commodities. Importing FDA-regulated commodities can be a complicated process. It can be even more challenging if FDA holds a shipment for an exam, issues detention, or even refuses a shipment. Confusing as it is, these are common FDA actions. What happens if something goes wrong?

If FDA holds a shipment and does not issue a release on import, it is important to act fast. The Customs Broker should submit entry documents and any additional information immediately when FDA makes the request. If FDA detains a shipment, the clock starts ticking and communication should start with FDA immediately. It may be wise to request an extension for the detention period while decisions are being made to address FDA’s concerns. Under most circumstances, FDA will allow a few options. If the product is subject to FDA Import Alert, private laboratory analysis may be an option. FDA will also allow products to be “reconditioned” which includes labeling corrections. The other two alternatives are re-exporting the product out of the United States and destruction.

It is important to remember that at the time entry is filed, CBP “conditionally” releases FDA-regulated commodities pending they meet FDA admissibility requirements. If FDA refuses entry for a shipment, CBP will issue redelivery and regain control of the shipment. If FDA refusal occurs, there is only an option to export or destroy the products which requires completing and submitting the proper CBP Forms (CBP Form 7512 or CBP Form 3499). These are common regulatory processes that EAS Consulting Group is familiar with and ready to help with.

Importing has many moving parts and can be confusing at times. Accidents do happen. What happens if FDA holds a shipment and something goes wrong? The importer is required to hold shipments in the area of the port of entry until FDA issues a “Release” or “May Proceed.” Miscommunication does happen. It may be the case that products were inadvertently distributed prior to FDA release. In most cases, corrective actions should take place immediately. FDA could request redelivery to CBP custody for failing to hold the products while they investigate further. Additionally, if products have been refused by FDA and are not present for destruction or export, CBP may issue liquidated damages and even penalties. Additionally, increasing storage costs may begin to occur for partial shipments while the matter is being investigated. There are also occasions where a voluntary recall should be initiated. This is particularly true if the product is misbranded or adulterated. If something does go wrong and CBP does issue liquidated damages or any penalties, any voluntary corrective steps taken can be conveyed to CBP Fines, Penalties, and Forfeiture (FP&F) for possible mitigation relief.

Everyone has the same goal of having safe products imported and distributed into the United States. These goals include having a smooth import process and fully understanding the many regulations and procedures involved. FDA’s mission includes being “responsible for the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.” EAS can assist in making sure the FDA’s mission is upheld and that the correct information is conveyed to FDA promptly. If something does go wrong, EAS is available to assist. EAS has many individuals and resources that can make the import process smooth, including FDA Exams, Detentions, Refusals, Exports, Destructions, Voluntary Recalls, and more. Importing does not have to be complicated and can be done with EAS!

Posted in Foods, Issue of the Month.