Many products imported into the United States are regulated by the U.S. Food and Drug Administration (FDA) in addition to U.S. Customs and Border Protection (CBP). FDA-regulated goods can include food, dietary supplements, cosmetics, medical devices, human drugs, radiation-emitting electronic products, animal and veterinary products, tobacco products, and certain food-contact articles.


For logistics companies and shippers, FDA handling has three separate layers:

  1. Applicability: determine whether FDA regulates the product and which FDA program applies. 
  2. Compliance: confirm that the product, labeling, facility registrations, listings, approvals or other regulatory requirements are satisfied where applicable.
  3. Entry transmission: provide the FDA data required for the import entry through ACE/PGA.

Important: transmitting FDA data does not make a non-compliant product compliant. FDA may review the entry, request documents, examine or sample the goods, detain the shipment, or refuse admission if the product appears to violate applicable requirements.

FDA and CBP perform different roles

CBP manages the customs entry. FDA determines the admissibility of FDA-regulated goods under the laws it administers. A shipment may therefore have a valid customs entry while FDA is still reviewing the regulated lines.

Recommended workflow before shipping

  1. Identify whether the product is FDA regulated.
  2. Identify the FDA program and product code.
  3. Confirm the intended use and any program-specific data.
  4. Confirm applicable registrations, listings, prior notice, FSVP or other compliance requirements.
  5. Check labeling and product compliance before the goods leave origin.
  6. Check relevant FDA Import Alerts where risk exists.
  7. Transmit complete and accurate FDA information with the shipment.

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