Blog: The Daily Intake
FDA Releases Draft Guidance on U.S. Origin Labeling for Seafood
- On October 27, 2026, FDA released a draft guidance document providing examples of U.S. origin statements that the Agency considers to be truthful and not misleading when used on seafood products.
- The draft guidance, titled “U.S.-Origin Statements on Seafood: Guidance for Industry,” explains that it may be difficult to establish where certain wild-caught fish originate due to, for example, open waters and fish migrations. The draft guidance is specific to U.S. origin statements and does not address more specific origin statements like states, territories, or localities.
- According to the draft guidance, the following statements are considered truthful and not misleading:
- “U.S-Caught” is appropriate for wild-caught seafood caught in the U.S. or by U.S. flagged vessels under U.S. jurisdiction.
- “U.S. Farm-Raised” is appropriate for seafood cultivated in aquaculture facilities in the U.S. and exported for processing.
- “Processed in the United States” is appropriate for seafood caught or raised outside of the U.S. and processed entirely in the U.S.
- “USA Seafood” is appropriate in the labeling of (a) “U.S.-Caught” seafood as described above that is harvested, processed in its entirety, and offered for sale in the U.S.; or (b) U.S. spawned and farm-raised seafood that is harvested, processed in its entirety, and offered for sale in the U.S.
- “Made with U.S. Seafood” is appropriate in the labeling of products, including multi-ingredient products, in which all seafood that otherwise meets the requirements for “USA Seafood” described above.
- The draft guidance further states that graphics, such as the American flag, may be used to convey a U.S. origin statement. These graphics should be accompanied by qualifying statements describing what product aspects are connected to the U.S. when appropriate.
- Finally, the draft guidance emphasizes that manufacturers and distributors must be able to substantiate all U.S. origin claims on seafood products. This could be in the form of standard recordkeeping showing that the claim is truthful and not misleading.
- Keller and Heckman will continue to update on new guidance from FDA.