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Import Alerts on Foods, Drugs, and Medical Devices That May be Detained

Tuesday, October 16, 2018
Sandler, Travis & Rosenberg Trade Report

Food and Drug Administration import alerts on the following have been modified in the past week

- processed human and animal foods

- raw agricultural products

- unapproved new drugs

- seafood products

- imported food products that appear to be misbranded

- active pharmaceutical ingredients that appear to be misbranded

[Click here for ST&R’s on-demand webinar on how to avoid costs and delays from FDA import alerts.] 

Importers of FDA-regulated goods are responsible for ensuring that such imports are in compliance with FDA laws and regulations. Before shipping into the U.S., importers should be aware of whether or not their product is listed on an import alert. 

Import alerts inform FDA field staff that the agency has enough evidence or other information to allow a product that appears to be in violation of FDA laws and regulations to be detained without physical examination at the time of entry. Import alerts may cover products from designated countries or areas (including from all foreign countries), manufacturers, or shippers. 

Firms and/or products on the “red list” of an import alert are subject to DWPE, while firms and/or products on the “green list” are not because they have met the criteria for exclusion. Some import alerts include a “yellow list” of firms, products, and/or countries subject to intensified surveillance because the nature of the violations may warrant further field examinations of individual entries and/or additional analyses. In addition, depending on the specific import alert, shipments of products subject to DWPE may still be imported into the U.S. if the importer has demonstrated that the shipment is in compliance.  

If a product is detained without physical examination the importer has the right to provide evidence to the FDA in an attempt to overcome the appearance of the violation. If no such evidence is submitted, or if the evidence provided is insufficient to overcome the appearance of the violation, the product will be subject to refusal of entry into the U.S.

Trade Agreement with Canada and Mexico to be Focus of ITC Investigation

The International Trade Commission has instituted an investigation to assess the likely impact of a trade agreement President Trump intends to enter into with Mexico and Canada to replace NAFTA.

For the U.S.-Mexico-Canada Trade Agreement to receive the expedited congressional consideration provided under the trade promotion authority law, the ITC must prepare a report that assesses the likely impact of the agreement on the U.S. economy as a whole, specific industry sectors, and the interests of U.S. consumers. This report, which will be made public, is due to the president and Congress no more than 105 days after the president signs the agreement, which he can do no earlier than Nov. 30.

The ITC will hold a public hearing in connection with this investigation Nov. 15 and requests to appear at the hearing are due by Oct. 29. Written submissions for the record are due by Dec. 20.

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