Importing Food, Drugs, Medical Products, Cosmetics, and Tobacco Products

The US Food and Drug Administration (FDA) regulates the import of foods, drugs, medical products, cosmetics, and tobacco products.

The FDA covers a wide range of materials and each has their own unique import requirements.  At minimum, the importer is required to submit a Prior Notification to the FDA through an online reporting system for items subject to FDA import regulations.  These notifications must be submitted prior to a shipment arriving at the US port of entry.  Import paperwork should include a Prior Notice confirmation to notify CBP that this requirement was completed prior to entry.

For some FDA regulated items, such as those intended to be introduced into commerce in the United States, more stringent import requirements are involved.  The FDA Import Program provides details on which items are regulated and the specific requirements to import them into the US.

If your item is subject to FDA jurisdiction contact for assistance in determining the import requirements and completing the necessary steps to clear customs.