2026-21838NoticeWallet

FDA Wants Seafood Labels to Tell the Truth About America

Published Date: 10/27/2026

Notice

Summary

The FDA just dropped a draft guide to help seafood sellers make honest U.S.-origin claims on their labels. If you sell seafood, this guide shows how to say it’s from the U.S. without confusing customers. You’ve got until December 28, 2026, to share your thoughts before the FDA finalizes the rules—no extra costs yet, just clear labeling ahead!

Analyzed Economic Effects

5 provisions identified: 3 benefits, 2 costs, 0 mixed.

FDA estimates relabeling costs for seafood firms

FDA estimates about 1,150 firms would change labels (about 5 labels each) for a total of 5,750 relabeled products, with an estimated annual third-party disclosure burden of 5,750 hours and an annual capital cost of $7,664,750 (calculated as $1,333 per relabeled product assuming a three-year adoption period). FDA states this relabeling cost would be a one-time capital cost.

FDA gives examples of U.S.-origin seafood claims

The FDA released a draft guidance titled "U.S.-Origin Statements on Seafood" that, when finalized, will provide examples of U.S.-origin statements in seafood product labeling that the agency would consider truthful and not misleading. This guidance is intended for manufacturers, packers, and distributors of seafood and covers examples for labeling.

Using U.S.-origin statements is voluntary

FDA states that U.S.-origin statements on food labeling are voluntary and the draft guidance does not create binding rights; firms may use alternate approaches if they meet applicable statutes and regulations. FDA also notes it does not know how many firms will choose to add or remove U.S.-origin statements.

You must substantiate any U.S.-origin seafood claim

The draft guidance says respondents who choose to use U.S.-origin statements on their seafood products should be able to substantiate those statements to show they are truthful and not misleading. FDA frames this as an expectation for manufacturers, packers, and distributors of seafood.

Guidance covers single and multi-ingredient seafood

The draft guidance applies to both single-ingredient seafood and the seafood components of multi-ingredient foods, meaning examples and substantiation expectations cover both product types. Respondents are identified as manufacturers, packers, and distributors of seafood (private sector, for-profit businesses).

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Key Dates

Published Date
Comments Due
10/27/2026
12/28/2026

Department and Agencies

Department
Independent Agency
Agency
Health and Human Services Department
Food and Drug Administration
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