Federal Register #2026-21838

FDA Draft Guidance on U.S.-Origin Statements for Seafood Labels

The FDA has announced draft guidance on U.S.-origin claims for seafood labels, not a request to buy products or services. - Government buyer: No buyer or procurement is identified. The Food and Drug Administration (FDA), within the Department of Health and Human Services, issued the guidance. - OEMs and vendors: None named; no products or services are being solicited. - Guidance scope: Examples of U.S.-origin statements FDA would consider truthful and not misleading for single-ingredient seafood and seafood components in multi-ingredient foods. - Notable considerations: The guidance is nonbinding. Businesses choosing to make U.S.-origin statements should be able to substantiate them. - Estimated labeling impact: FDA estimates voluntary relabeling could involve 1,150 firms revising five labels each, for 5,750 label revisions and $7,664,750 in capital costs; this is not a contract value.

Description

The FDA announces the availability of draft guidance entitled “U.S.-Origin Statements on Seafood.” When finalized, the guidance will provide examples of U.S.-origin statements in seafood product labeling that FDA would consider truthful and not misleading. The guidance covers single-ingredient seafood and seafood components of multi-ingredient foods; it is nonbinding and respondents choosing to use such statements should be able to substantiate them. Comments are due December 28, 2026.

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