Removal From Import Alert

Import Alert Removal

Did you know FDA will not tell you they placed your company on Import Alert?  Did you know FDA no longer accepts only 5 clean consecutive shipments to remove a company from Automatic Detention? Did you know some Import Alerts are written so that the promise of exemption is only an illusion? This is all true, and much of it is new. Companies usually do not find out that they were added to Import Alert until FDA automatically detains that first affected shipment at a U.S. port of entry.  After first learning that a shipment has been automatically detained, most companies scramble to get FDA to release it. Of course, while they are doing that, another customer calls to tell them FDA automatically detained another shipment! While trying to satisfy their customers, who are not getting their inventory to cover accounts that are due for delivery, companies try to scrape together five consecutive clean shipments, and ask an importer or customs broker to submit that evidence to FDA to petition for removal from import alert. Then what? FDA rejects the evidence, and the importers now know sensitive information about the company’s other customers. All of these are the wrong things to do. It wastes time, discloses confidential information to the wrong parties, puts you in a very weak bargaining position, and is unsuccessful with respect to the Automatic Detentions, which keep happening one after the other. As it turns out, obtaining removal or exemption from FDA Import Alert is more difficult and complex that you might realize – at least, doing it effectively and efficiently. Trying to manage this attempt from abroad is almost impossible.

So how exactly does a company succeed in getting off an Import Alert?

To begin with, FDA’s decision to remove a company or product from an Import Alert must be based on clear, convincing, and documented evidence proving that the conditions that gave rise to the appearance of a violation have been resolved and the agency can be confident that future entries will be compliant with the law.  The goal is to compel FDA to remove the company through the use of facts and the application of FDA law, regulations, guidance and precedents – not to beg. This can feel like a very subjective process, but usually it is about persuasion.  Moving for FDA to remove or exempt a company from Import Alert requires a thorough showing that the original conditions that gave rise to the appearance of a violation have been identified and remedied.  We use the petitioning process to prove these facts and make these arguments persuasively to FDA.

What’s the difference between a Red List and a Green List (or a Yellow List)?

An FDA Import Alert Red List includes companies that FDA has discovered (usually by testing imported products or inspecting documents or the facility) have previously exported unsafe, adulterated, misbranded, or unapproved products. It is a “bad company or product list”.

An FDA Import Alert Green List (sometimes called a “FDA Green Ticket” applies to Country-wide or Region-wide (or even World-wide) Import Alerts. Some problems exist more pervasively in a specific country or region than they do in the rest of the world. FDA creates an import alert that applies to certain products originating in that country – even if the company shipping the product has never had the problem, or was not even in business when FDA discovered the evidence! FDA issues exemptions from these alerts when a company proves, using strong evidence and argument, that the Import Alert should not apply to them. If FDA agrees, FDA places that company on the Import Alert’s “Green List.” It is a “good company list”.

An FDA Import Alert Yellow List is reserved for products that FDA is investigating more closely because of repeated previous problems. FDA might use a Yellow List to increase its scrutiny on products coming from listed companies to make sure the company does not belong on the Red List or to develop the evidence to eventually create a country-wide or region-wide import alert. Companies on the Yellow List will not usually have their shipments automatically detained; however, they will suffer many more FDA import inspections, examinations, and testing.

Contact the team immediately if your company is on FDA Import Alert.