Federal · FDA draft guidance, FDA-2026-D-6729

"U.S.-Caught," "USA Seafood" and "Made with U.S. Seafood": FDA draft guidance on what made-in-America seafood labels should mean

Draft issued Oct. 23, 2026 · Comments due Dec. 28, 2026

Published October 25, 2026 · Last updated October 25, 2026

What it does

This is draft guidance, not a rule. FDA says U.S. law already bars food labeling that is false or misleading, and that food may carry truthful, not misleading U.S.-origin statements. The draft gives examples of U.S.-origin statements on seafood labels that FDA, depending on the label as a whole, would consider truthful and not misleading. (FDA draft guidance, sections I and III) Its examples:

• “U.S.-Caught” for wild-caught seafood caught in the United States (including the U.S. exclusive economic zone, which extends 200 nautical miles out from the baseline along the coast) or caught by U.S.-flagged vessels under U.S. jurisdiction outside that zone. (Draft guidance, sections II.A and III)
• “U.S. Farm-Raised” for seafood raised in U.S. aquaculture facilities and exported for processing. (Draft guidance, section III)
• “Processed in the United States” for seafood caught or farm-raised outside the United States and processed entirely in the United States. (Draft guidance, section III)
• “USA Seafood” for U.S.-caught, or U.S.-spawned and farm-raised, seafood that is harvested, processed in its entirety and offered for sale in the United States. (Draft guidance, section III)
• “Made with U.S. Seafood” for products, such as multi-ingredient foods, in which all of the seafood meets that same test. A qualified version, “Made with U.S.-Caught Seafood,” can be used when the seafood is wild-caught in the United States and exported for processing. (Draft guidance, section III)

Similar statements naming a specific seafood, such as “USA Salmon” or “Shrimp Processed in the United States,” would also be truthful and not misleading. If a label uses a graphic such as the American flag when only some steps are connected to the United States, FDA recommends adding a statement that says which steps (for example, catching or processing). Companies that use these claims should be able to back them up with records. (Draft guidance, section III and footnote 6)

Who it affects

• Seafood manufacturers, packers and distributors that choose to use U.S.-origin claims, for both single-ingredient seafood and the seafood in multi-ingredient foods (for example, the shrimp in frozen shrimp scampi). (Draft guidance, section II.B; FR notice, section II)
• Shoppers who read seafood labels.
• Not covered: catfish, which the U.S. Department of Agriculture regulates, and origin claims about states, territories or localities. (Draft guidance, footnote 2 and section II.B)
• Cost estimate. FDA estimates there are about 2,300 domestic seafood manufacturers, packers and distributors, and that about half (1,150) would change about 5 labels each to add or remove a U.S.-origin claim, at about $1,333 per label, or $7,664,750 in one-time costs. (FR notice, section II)

What it means for you

• Read the exact words. Under the draft, “Processed in the United States” can appear on seafood caught or farmed in another country, while “USA Seafood” means caught or farmed, processed and sold in the United States. (Draft guidance, section III)
• Required labels stay. The voluntary claims are not meant to take the place of mandatory country-of-origin labeling for fish and shellfish under USDA rules (7 CFR Part 60). (Draft guidance, footnote 3)
• Restaurants are a separate matter. South Carolina’s Act 254 requires restaurants that serve imported shrimp to post a disclaimer starting October 28, 2026. See our explainer on imported shrimp signs.
• Comment if you want to. Submit comments at regulations.gov in docket FDA-2026-D-6729, or on paper to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FDA lists a comment date of December 28, 2026, to make sure comments are considered before it works on the final version. (FDA guidance page; FR notice, Addresses)

Current status

FDA issued the draft guidance in October 2026 (its guidance page is dated October 23, 2026). The notice announcing it was filed for public inspection October 23, 2026, and is scheduled for publication in the Federal Register October 27, 2026 (FR Doc. 2026-21838). It is a draft, is not binding and is “not for implementation.” (FDA guidance page; draft guidance; FR notice)

What happens next

FDA will consider comments, including on costs or cost savings, before it works on a final version. When final, the guidance will represent FDA’s current thinking but will still not be binding. (FR notice, Dates and section I)

Sources

• FDA: Draft Guidance for Industry, “U.S.-Origin Statements on Seafood” (October 2026, docket FDA-2026-D-6729)
• Federal Register: “U.S.-Origin Statements on Seafood; Draft Guidance for Industry; Availability,” FDA notice, FR Doc. 2026-21838 (filed Oct. 23, 2026; publication Oct. 27, 2026)

Every statement above is drawn from the official source text linked here; section references are shown in grey. This is a plain-English summary, not legal advice. Spot an error? Tell us.