Import Alert Effects

Import Alert Consequences

The effects of an Import Alert are astronomical, costing you money, wasting precious time and ruining your good name and reputation. FDA uses Import Alerts to automatically detain imported products, refusing them entry into the United States. FDA Automatic Detentions will affect future shipments of the product even if they comply with the law. This can prevent your company from gaining access to the entire U.S. market, crippling sales and future business ventures. But it does not stop with the products listed on Import Alert! In addition to automatic detentions, FDA also examines and samples other products from manufacturers listed on Import Alert, under the suspicion that they also violate U.S. law. Arguably the worst aspect of Import Alerts, however, is their public nature; they are on FDA’s website and easy for search engines to find. Therefore, your customers and competitors can see that your company has lost easy access to the U.S. market just by conducting an Internet search. This leads to lost business from potential buyers and distributors. It also causes long-term reputation damage with existing customers.  In the past, many companies have responded to being listed on an FDA Import Alert by starting a new company or changing the company name or mailing address, hoping to “start fresh” but continue with the same operation and product. They hoped the FDA screening system would think they were a different company from the one listed on the Automatic Detention Red List. That trick no longer works under FDA’s new PREDICT screening system. In fact, if FDA catches you (and they are likely to) it will actually lead to further and worse damage – and possibly a criminal investigation, depending on the circumstances.  Do not simply change your business name and think you can trick PREDICT. It will not work.

Working with FDA and private laboratories and importers to obtain release automatically detained products can be a complex process.  FDA may require relabeling, testing, and other types of sampling to prove the detained goods are not in violation. Relying on an importer to do this work for you may not always be wise. The importer may decide that FDA is demanding is too much or the process is taking too long, or they may miss a deadline in responding to FDA. If these things happen, the automatically detained shipment will be refused, resulting in mandatory destruction or exportation of the products. Removal or exemption from an Import Alert requires submission of a detailed petition containing specific information. Getting the petition right the first time is critical to avoid additional delays and costs.

The authority granted to FDA under the new Food Safety Modernization Act will further complicate the entire Import Alert process. For instance, FDA already tried to institute a user fee to charge importers and foreign manufacturers for the time and resources FDA spends detaining, reviewing data related to or releasing an automatically detained shipment. FDA has also proposed charging a fee to submit a petition. challenged FDA loudly on these attempts, and so far FDA has backed off, but eventually FDA will try this again. Because of the additional requirements FSMA imposes upon food importers, you can expect FDA to create import alerts that relate specifically to importers who fail to comply with the new Foreign Supplier Verification Program requirements. It certainly will not be getting easier.