What Happens When Your Product Is Detained by the FDA?

What happens when your product is detained by the FDA? In short and simple words, a nightmare. If you thought that the FDA Compliance had always been strict in its enforcement of import rules, you would think again if you heard about what it has worked out lately.

Import Rules for FDA Imports1

The FDA has partnered with the Customs and Border Patrol Service (CBP) to put in place a sophisticated and agile method by which it can monitor the information it requires from importing firms, and also ensure their adherence to government procedures. The CBP has created a novel mechanism to intensify vigilance of imports, called the Automated Commercial Environment (ACE). This computer program has brought in many changes into import logistics and the method by which importing firms have to report information pertaining to FDA-regulated products.

So, what powers do the FDA and the CBP have by implementing the ACE? They have powers of delaying, detaining or refusing shipments of firms that fail to put in place a thoroughly executed import and export program. Importing firms that believe they can take this mechanism easily could not be more mistaken: noncompliance with the requirements set out by the ACE program empowers the FDA and the CBP to stop a shipment before it is even loaded at the point of origin, even if it is a foreign port. A ship that wants to be precluded from the ACE program attracts a fine of up to $10,000 for every offense. Alternately, if the FDA detains a product or products from such a company; it will start a long drawn out and costly legal process.

Import Rules for FDA Imports2

Since the agency expects companies to have the import coding information accurate and up-to-date; companies that do not have a clear understanding of the automated and human review process are very likely to have their shipments detained.

Another scenario

What happens to an importer whose product is deemed fit for release and to be brought back to the port of entry by the FDA, but the importer cannot locate the product that is already sold? On such companies, the FDA slaps a fine whose value is treble that of the shipment! And this is not all. This in no way waives the other usual legal actions that the FDA will initiate anyway.

Not everything is bleak

All this should not intimidate and put importers off. Alongside the ACE program, the FDA has also put in place a redressal mechanism under its Food Safety and Modernization Act. Called the Voluntary Qualification Importer Program, this FDA-monitored program is aimed at smoothening the review and import of food items from importers who can show the agency that they are serious about implementing a higher degree of control over the safety and supply chain elements of the food items they are importing. Those Importers who are serious about the quality of food they import.

The FDA also offers export certificates, which could give an importer a level of advantage in foreign markets. Also available for a fee, albeit a small one, an FDA export certificate is a shot in the arm for importers, because this certificate is required in some markets.

Familiarize yourself with all parts of FDA import rules for 2018

GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will be offering complete learning on all aspects of the FDA import rules for 2018 at a two-day seminar. The Director of this seminar on FDA import rules for 2018 is Casper Uldriks, an ex-FDA Expert and former Associate Center Director of CDRH, Olsson, who has served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health. This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

The full expanse of Casper’s many years of experience will be exhibited at this valuable seminar. He will show how to steer clear of the many common potholes and constraints that importers who don’t have a sound strategy run into. Participants will be offered tips on how importers need to put in place an established and effective business plan.

This course is of immense value to domestic importers, foreign exporters, initial importers, international trade executives, Venture Capitalists, marine insurance underwriters, import brokers, Regulatory Affairs managers, import/export consultants, in-house counsel, contract specialists, logistics managers, third party establishment inspection entities, sales managers, and investors.

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