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FDA Seeks Input on Importer’s Entry Notice

Thursday, March 13, 2014
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration will accept comments through April 14 on the proposed extension of the Importer’s Entry Notice. This collection of information gathers data for FDA-regulated products being imported into the U.S. and is being used by the agency to review and prevent imported products from entering the U.S. if they do not meet the same requirements of the Federal Food, Drug, and Cosmetic Act as domestic products.

At each U.S. port of entry (seaport, landport and airport) where foreign-origin, FDA-regulated products are offered for import, FDA is notified through the Automated Commercial System by the importer or his/her agent of the arrival of each entry. Following such notification, FDA reviews relevant data to ensure the imported product meets the standards as required for domestic products, decides on the admissibility of the imported product, and informs the importer and CBP of its decision. FDA may authorize products listed on specific lines to enter the U.S. unimpeded, while other products listed in the same entry may be held pending further FDA review/action.

All entry data pass through a screening criteria program resident on a CBP computer, which makes the initial screening decision on every entry of foreign-origin, FDA-regulated products. Almost instantaneously after the entry is filed, the filer receives FDA’s admissibility decision for each entry, i.e., "MAY PROCEED" or "FDA REVIEW." In addition to the information collected by CBP, FDA requires four additional pieces of information that were not available from CBP’s system in order to make an admissibility decision for each entry. These data elements include the FDA product code, FDA country of production, manufacturer/shipper and ultimate consignee. The Office of Management and Budget has previously approved the automated collection of these four data elements for tobacco products that filers could provide to FDA along with other entry-related information. Providing this information to FDA results in importers receiving an admissibility decision more expeditiously.

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