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Food and Drug Administration Import Entry Filings


The FDA regulates a variety of products including food, medical products (such as drugs, devices, and biological products), radiation-emitting electronic products, animal feed, tobacco products, and cosmetics. Each FDA-regulated commodity is subject to specific regulations, which you should be aware of when importing products into the United States.  For more information visit the Regulated Products page.

All imported shipments of FDA-regulated products are reviewed by the FDA and must comply with the same standards as domestic products.  The FDA determines whether products are admissible into U.S. commerce and may refuse entry to any that violate or appear to violate any provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specific information must be provided to FDA when submitting an entry, which may include documentation. Failure to submit this information may delay the review of your entry.

Folgueras Customs Broker Corp. is very experienced with FDA regulations and can assist with the requirements of FDA-regulated products and their compliance during the entry/review process. Whether you are a first-time importer in need of assistance with registrations, listings, etc., or are an experienced importer that just needs facilitation and streamlining of the FDA entry process, we are here to ensure the clearance process is as straightforward and efficient as possible.

Please click here for some useful links to the FDA food facility registration site, FDA product code builder, etc.

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