In my previous two blog posts, I discussed certain precautionary measures an importer can take to prevent an import detention by the FDA and procedures used by the FDA for detention of imported products.

Import alerts are the most serious consequence for not taking import detentions seriously. Even though the phrase “import detention” may sound grave, in the regulatory world an import alert can be far more devastating. An import alert can taint a business’s goodwill in the international market, and not only with respect to the product against which the alert is issued. A business’s entire line of products may be affected. In most circumstances, firms and products that are listed on the FDA’s import alert are automatically detained by the FDA without the added step of an inspection, examination, or sampling.

Businesses should be cautious when they use the FDA’s import detention notices as means of discovering defects in their products. An import alert may be based on the violative history of a product, manufacturer, shipper, grower, importer, geographic area, or country. It may also be based on other information (e.g., food offered for entry was harvested from polluted waters, a product was manufactured or held under insanitary conditions, or a product was manufactured in non-compliance with good manufacturing practice [GMP]).

At the FDA’s website, import alerts are public information and can be viewed by country, industry, alert number, and date of publication. Companies involved in the export to or import into the U.S. of FDA-regulated products must watch for alerts issued against the companies with which they do business. If, for instance, a foreign manufacturer ships a product through a shipper who is on FDA’s import alert list, the product may be automatically detained by the FDA without physical examination. The manufacturer is then responsible for defending itself against unnecessary import detention. 

Often, the FDA requires a certain number of non-violative shipments before it removes an import alert, and violators should not consider splitting shipments to increase their number. Shipments that consist of less quantity than the normal industry practice may not be considered in the detention without physical examination removal process. To make matters more complicated, different types of import alerts face different compliance requirements for their removal.

Import alerts are serious sanctions through which the FDA reminds the entire import industry that it is a regulatory agency, not a quality control laboratory.