FDA draft: U.S.-origin statements on seafood

FDA announced availability of a draft guidance for industry, "U.S.-Origin Statements on Seafood" (Docket No. FDA-2026-D-6729). 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 notice was filed for public inspection October 23, 2026 at 4:15 p.m., and is scheduled for publication October 27, 2026 (FR Doc. 2026-21838). Draft guidance is nonbinding (21 CFR 10.115).

Draft FDA guidance on voluntary U.S.-origin statements for seafood labeling. Comments by our count December 26, 2026. Substantiate any claim you make.

What the draft covers (and what it does not)

Coverage includes single-ingredient seafood and the seafood components of multi-ingredient foods. Statements are voluntary; firms that use U.S.-origin statements should be able to substantiate them. In general, FDA-regulated foods may bear truthful and not misleading statements, including U.S.-origin statements, in their labeling. This notice does not reprint the example statements from the draft guidance text, and this article does not invent them.

This is FDA labeling guidance. It does not change CBP country of origin marking under 19 U.S.C. 1304, and it does not rewrite USDA COOL rules. Keep FDA claim substantiation separate from CBP marking and AD/CVD country-of-origin determinations on imported seafood.

Comment window

Submit comments by 60 days after publication in the Federal Register to ensure FDA considers them before work on the final version. Counting from October 27, 2026, that is December 26, 2026, by our count. Confirm the date on the published notice or the regulations.gov docket. Comments may also be submitted at any time (21 CFR 10.115(g)(5)). Electronic comments: regulations.gov, docket FDA-2026-D-6729. Draft guidance: fda.gov/FoodGuidances. Contacts: Pedro Cruz (240-402-2371) and Deirdre Jurand (240-402-2378), Human Foods Program.

PRA burden estimate

FDA's Paperwork Reduction Act estimate (OMB control number 0910-0381, revision) assumes about 2,300 domestic seafood manufacturers, packers, and distributors; about half (1,150) would relabel to add or remove a U.S.-origin statement; 5 labels each; 1 hour per label (5,750 hours); and $1,333 per label, for an estimated one-time capital cost of $7,664,750. Substantiation-recordkeeping burden is treated as usual and customary business practice in the estimate.

Action items

• Audit "U.S." or "domestic" claims on seafood labels, especially multi-ingredient products that mix imported and domestic seafood.
• Keep substantiation records for any voluntary U.S.-origin statement you use or plan to use.
• Consider commenting by our count December 26, 2026 (confirm on the published notice or docket FDA-2026-D-6729).

This article is for general information and is not legal or tax advice. Drawback eligibility depends on your specific facts, and final refunds are determined by CBP at liquidation. Consult a licensed customs broker or attorney for your situation.