Seafood products may be placed under DWPE under an import alert by FDA due to the appearance of adulteration caused by pathogens, unlawful animal drugs, scombrotoxin (histamine), and/or decomposition. The recently issued guidance is intended to help foreign manufacturers and other processors of seafood products subject to DWPE collect representative samples for testing and submit evidence to FDA to support a request to have their products removed from DWPE. The draft guidance clarifies FDA’s thinking on when the appearance of adulteration may be removed while giving industry the tools it needs to help support importation, addressing industry concerns about challenges in supporting arguments for the safety of seafood products subject to DWPE.