Abstract
On November 19, 2015, the U.S. Food and Drug Administration (FDA) announced its long-awaited decision regarding AquaAdvantage Salmon, the first genetically engineered (GE) animal intended for food. The FDA has approved AquaBounty Technologies’ new animal drug application (NADA) for the Salmon, finding that it meets the statutory requirements under the Federal Food, Drug, and Cosmetic Act (FDCA). In particular, the FDA determined that the Salmon’s rDNA construct is safe for the fish itself, the fish reaches market size more quickly than non-GE farm-raised Atlantic salmon (as AquaBounty claimed), and food from the fish is safe to eat and as nutritious as food from non-GE salmon.
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