Under provisions of the U.S. law contained in the U.S. Federal Food, Drug and Cosmetic Act, importers of food products intended for introduction into U.S. interstate commerce are responsible for ensuring that the products are safe, sanitary, and labeled according to U.S. requirements. (All imported food is considered to be interstate commerce.)
FDA is not authorized under the law to approve, certify, license, or otherwise sanction individual food importers, products, labels, or shipments. Importers can import foods into the United States without prior sanction by FDA, as long as the facilities that produce, store, or otherwise handle the products are registered with FDA, and prior notice of incoming shipments is provided to FDA.
Imported food products are subject to FDA inspection when offered for import at U.S. ports of entry. FDA may detain shipments of products offered for import if the shipments are found not to be in compliance with U.S. requirements. Both imported and domestically-produced foods must meet the same legal requirements in the United States.
May 16, 2022
The FDA is taking additional steps to increase infant formula supplies. The FDA issued a guidance to manufacturers of infant formula to announce the agency’s intention to temporarily exercise enforcement discretion, on a case-by-case basis, for certain requirements that apply to infant formula. This action is designed to increase infant formula supplies in the United States while protecting the health of infants, for whom infant formula is often the sole source of nutrition during a critical period of growth and development.
Procedures and Requirements for Importing Food Products
In addition to meeting the requirements of U.S. food regulations including food facility registration, importers must follow U.S. import procedures as well as the requirements of Prior Notice.
- Manual of Compliance Policy Guides Chapter 5 - Food, Colors, and Cosmetics
- Prior Notice of Imported Food
- Imported Seafood Safety Program
- Hazard Analysis Critical Control Point (HACCP)
- Accredited Third-party Certification Program
- Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals
- Voluntary Qualified Importer Program (VQIP)
- Import & Export Guidance Documents & Regulatory Information
Importing Food Gifts for Personal Use
- Sending Gifts to Your Friends and Family: Prior Notice Policy
- Importing Gift Packs and Prior Notice
- Sending Food through International Mail - Selected Excerpts from the Prior Notice Interim Final Rule, Guidance Documents, and Fact Sheets
Food Safety Modernization Act (FSMA) Resources
- FDA Strategy for the Safety of Imported Food
- International Cooperation on Food Safety
- FSMA Final Rule for Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals
- FSMA Final Rule on Accreditation of Third-Party Auditors
- Firm/Supplier Evaluation Resources for FSMA Rules