On October 27, 2026, the U.S. Food and Drug Administration (FDA) announced a draft guidance for industry entitled “U.S. Origin Statements on Seafood” (the draft guidance). The draft guidance provides examples of U.S.-origin statements that FDA would consider truthful and not misleading on seafood labeling. The draft guidance is nonbinding and, when finalized, will reflect FDA’s current thinking and how it is likely to evaluate U.S.-origin claims. This Legal Development provides background on the draft guidance, summarizes FDA recommendations, and identifies steps manufacturers, packers, and distributors may wish to consider.
FDA is accepting comments on the draft guidance until December 28, 2026.
Background
Pursuant to the Food, Drug, and Cosmetic Act (FD&C Act), food labeling must be truthful and not misleading. Among other things, food labeling may include voluntary claims about whether the food is a product of the USA. The U.S. Department of Agriculture (USDA) allows for the labeling of certain foods—including single-ingredient meat and poultry products—as “Made in the USA” when they use animals born, raised, slaughtered, and processed in the United States.
With this draft guidance, FDA recognizes that seafood products are often different than USDA-regulated products. For example, it could be difficult to establish where certain wild-caught fish were spawned, born, or lived.
FDA’s draft guidance therefore ties “U.S.-caught” claims to the federal fisheries management framework. Namely, this framework includes the U.S. exclusive economic zone (EEZ), whose outer boundary extends 200 nautical miles from the baseline used to measure U.S. territorial waters.
What does the draft guidance include?
The draft guidance covers U.S.-level origin statements on both single-ingredient seafood and the seafood components of multi-ingredient foods (e.g., the fish in breaded fish sticks or the shrimp in frozen shrimp scampi). It excludes state, territory, or local origin statements, and it does not cover catfish, which is regulated by USDA. FDA identifies the following examples of statements that, depending on the context of the labeling as a whole, the agency would consider truthful and not misleading:
- “U.S.-Caught”: Wild-caught seafood caught in the United States (including the U.S. EEZ) or caught by U.S.-flagged vessels under U.S. jurisdiction outside the EEZ, international fishery treaty implementing statutes, or other U.S. statutes.
- “U.S. Farm-Raised”: Seafood cultivated in aquaculture facilities within the United States and exported for processing.
- “Processed in the United States”: Seafood caught or farm-raised outside the United States and processed entirely in the United States.
- “USA Seafood”: Seafood that is harvested, processed in its entirety, and offered for sale in the United States that is either (1) “U.S.-Caught” seafood or (2) U.S.-spawned and farm-raised seafood.
- “Made with U.S. Seafood”: Products (such as multi-ingredient products) in which all seafood meets the “USA Seafood” criteria above. A qualified version, such as “Made with U.S.-Caught Seafood,” may be used when the seafood is wild-caught in the United States and exported for processing.
The draft guidance also applies to statements that name a specific type of seafood, such as “USA Salmon” or “Shrimp Processed in the United States,” which can be truthful and not misleading.
Images, such as an American flag, can also suggest that a product is of U.S. origin. The draft guidance provides two examples of graphics conveying U.S.-origin seafood claims.
If only certain aspects of the product are connected to the United States, FDA recommends adding a statement that explains that connection—for example, that the seafood was caught or processed in the United States. Companies that make U.S.-origin claims should be able to substantiate these claims, such as with records kept in the ordinary course of business.
Ashurst Perkins Coie’s food regulatory team is available to help clients comply with state and federal food regulations, including U.S.-origin and other labeling claims for seafood products.
