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Import Basics

All goods offered for entry into the U.S., including items for personal use, must be declared to U.S. Customs and Border Protection (CBP).  CBP refers all FDA-regulated products to FDA for review. CBP's regulations and requirements are at its website.

Most importers choose to hire licensed representatives when offering the goods for entry. These representatives are known as customs brokers or entry filers.  The entry filers can assist the importer by submitting necessary entry information and appropriate payments to CBP on behalf of the importer. CBP’s website has a clickable US map that will provide a list of specific ports, and under each port, you will find a list of brokers. 

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FDA Review

All imported shipments of FDA-regulated products are reviewed by FDA and must comply with the same standards as domestic products.  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 Food Drug and Cosmetic Act (FD&C Act).

FDA Entry Types

FDA receives many different types of entries (consumption, informal, warehouse, import for export, etc.). Most questions revolve around the difference between commercial and personal shipments.  

Regulated Products

Image for Import BasicsFDA 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.

Entry Review Process Specifics

During the entry review process, the imported products must be held and may not be distributed into U.S. commerce until FDA has determined their admissibility.

FDA-regulated products are refused entry if they appear to be or have been found to be:

  • adulterated, meaning the product is contaminated, is not safe, unapproved, or does not otherwise meet applicable standards,
  • misbranded, meaning the labels contain false or misleading information, or the product is not registered and listed, if required,
  • forbidden or restricted for sale.

Products that do not comply with U.S. requirements may be refused admission.  Refused products must be destroyed or exported from the United States within 90 days.

FDA's authority over certain imported products is granted by Congress through various laws and regulations. FDA's refusal authority is through sections 536 and 801 of the FD&C Act.

More Information

Additional information and resources related to Import Basics

Page Last Updated: 08/03/2018
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