FDA Import Alerts

One of the worst places for any foreign manufacturer or shipper to be is on an FDA import alert. The effect of such an alert is that FDA automatically detains some or all products from that manufacturer or shipper and requires the U.S. importer to demonstrate the product complies with the Food Drug & Cosmetic Act before FDA will permit the product into the country.

This process can be expensive and adds unnecessary costs to a foreign manufacturer's product making it harder to compete in the U.S. market place. The FDA publishes its alerts on the Internet, so all of the listed manufacturer's or shipper's competitors, customers, and potential customers can know about the problem FDA believes exists with the listed manufacturer's or shipper's operations or products. It is very important for manufacturers or shippers appearing on an FDA import alert to get off of the alert as soon as possible.

Through Import Alerts (or the automatic detentions list) FDA publicly identifies products that are likely to be Detained Without Physical Examination ("DWPE") for a variety of reasons. FDA asserts its authority to automatically detain products under Section 801(a) of the Food Drug & Cosmetic Act. That Section states, "[i]f it appears from the examination of such samples or otherwise that (1) such article has been manufactured, processed, or packed under insanitary conditions or (2) such article is forbidden or restricted in sale in the country in which it was produced or from which it was exported, or (3) such article is adulterated, misbranded, or in violation of section 505 [relating to new drug approvals) . . . then such article shall be refused admission . . . ."

Typically FDA Import Alerts identify a manufacturer, shipper, grower, importer, a geographic area or a combination of these factors as the source of the problem that appears to be in violation of the law. The geographic region could be an entire country (country wide import alerts) or world wide (effectively creating an automatic barrier to all international trade in that commodity).

Import Alerts instruct FDA import inspectors, investigators, and compliance officers to automatically detain or detain without physical examination all imports of the affected products from the listed manufacturer, shipper, grower, importer, or geographic area. Once on an Import Alert, FDA will routinely continue to automatically detain the affected products in the future until the manufacturer, shipper, grower, or importer demonstrates to FDA that the apparent violation has been corrected.

Being listed on an FDA import alert could be devastating to the foreign company, which may not even be aware it is on the alert. For instance, an importer may have obtained the manufacturer's product from a third country or from a shipper who was not authorized to ship to the U.S. In such cases, the manufacturer may learn it is on the alert only after it ships to an authorized distributors in the U.S. and finds FDA automatically detaining legitimate shipments because the agency previously caught unauthorized shippers exporting products never intended for the U.S. market and out of compliance with U.S. laws. Product intended for other markets may be manufactured using non certified or illegal colors, or the label may not be in the English language. FDA will place the legitimate manufacturer and its product on the import alert even though the product was never intended for the U.S. and the manufacturer does not know it was imported. Still, future entries from that victim manufacturer, even when shipped through authorized distributors, will be automatically detained by FDA based upon the import alert data.

There are over 150 separate FDA Import Alerts that affect, literally, thousands of manufacturers, shippers, growers and importers, and hundreds of countries. FDA's Import Alerts can be accessed at the following link: FDA's Import Alert Page (fda. gov).

FDAImports.com consultants and affiliated attorneys routinely provide clients with regulatory and legal strategies to obtain removal from FDA Import Alerts. More importantly, we are able to guide clients in avoiding being placed on Import Alert status.