FDA Issues Fact Sheet on Import Alerts, Hopes FSMA Will Reduce Them
The Food and Drug Administration has issued an information piece on Import Alerts, including the factors that lead to them; the process for introducing evidence to counter an alert; their effect on future imports; etc. FDA also discusses the hope that the importer responsibility provisions in the Food Safety Modernization Act will reduce the number of Import Alerts.
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Alerts Allow Detention Without Examination, Can Refuse Future Shipments
FDA states that an Import Alert allows FDA to detain, without physically examining, products that either have or potentially could violate the Food, Drug, and Cosmetic Act. The alert lets FDA field staff know that the agency has enough evidence or other information to refuse admission of future shipments of an imported article.
Site Inspections, Current Recalls, History of Problems Can Lead to Import Alerts
There are a variety of factors that could lead FDA to place a product, manufacturer, shipper, grower, geographical area, or even a country on import alert. For example, questions could have been raised in an inspection of the manufacturing site, or flags could have been raised by a recall of products already on store shelves. There could be a history of problems with no signs that appropriate actions were taken to remedy them.
Importers Have to Introduce Evidence in 10 Days, Cannot Distribute Product
Once a shipment is refused admission to the U.S., the importer has an opportunity to introduce evidence, within 10 days, to overcome the appearance of a violation. During this time, the product is either held at a warehouse or at the importer’s premises and cannot be distributed.
If the shipment is not proven to be safe, it must be destroyed or exported within 90 days.
FDA Puts Screening Criteria into Place to Target Future Shipments
Screening criteria is put in place in FDA’s import systems to target shipments and the alert notice is e-mailed to FDA district offices and on FDA’s web page.
Import Alert May Remain Until Evidence of Compliance Provided
An imported product, firm, region, or country may remain in this status until evidence or other information is provided that gives FDA confidence that the shipment is safe for consumers and that future shipments will be in compliance with the law. The conditions that the importer has to meet vary depending on the stipulations in the Import Alert. For example, sometimes an inspection or testing is required. Other times a number of “clean” shipments will result in a lifting of the order.
Currently 264 Import Alerts of 3100 Types of Products from 150 Countries
There are currently 264 Import Alerts. They represent 3100 types of products from more than 11,000 manufacturers in 150 countries and regions. Products include seafood, fruits and vegetables, cheese, rice, cosmetics, drugs, and medical devices.
FDA Says FSMA’s Focus on Importer Responsibility Should Reduce Import Alerts
FDA states that “the verdict is out” on whether the FSMA will reduce the number of Import Alerts, but that is the goal. The new FSMA authorities include a requirement that importers verify that their foreign suppliers have preventive controls in place. In addition, if another country denies U.S. investigators access to a food-producing facility, FDA can keep the food from that producer from entering the U.S.
According to FDA, this means that more responsibility is being placed on the importers to verify that the products that they import are not contaminated and that their suppliers and customers have preventive controls in place.