On November 19, 2015, FDA took actions regarding food from genetically engineered (GE) plants and animals. The agency gave its first approval for a GE animal intended for food, AquAdvantage Salmon. FDA also issued two guidance documents for manufacturers who wish to voluntarily label their products as containing ingredients from GE or non-GE sources - a draft guidance on labeling foods derived from Atlantic salmon and a final guidance on foods derived from GE plants.

The FDA approved the application for AquAdvantage Salmon, an Atlantic salmon that reaches market size more quickly than non-GE farm-raised salmon. The FDA regulates GE animals under the new animal drug provisions of the Federal Food, Drug, and Cosmetic Act, because the recombinant DNA (rDNA) construct introduced into the animal meets the definition of a drug. The rDNA introduces a trait that makes the AquAdvantage Salmon grow faster. FDA found the GE salmon met the regulatory requirements for approval, including that the fish is safe to eat. FDA also determined that the AquAdvantage Salmon is as nutritious as food from other non-GE Atlantic salmon and that there are no biologically relevant differences between AquAdvantage Salmon and other farm-raised Atlantic salmon.

The FDA imposed strict conditions to contain the fish and prevent their escape and establishment in the environment. The AquAdvantage Salmon may be raised only in land-based, contained hatchery tanks in two specific facilities in Canada and Panama. There must be physical barriers in the tanks and in the plumbing that carries water out of the facilities to prevent the escape of eggs and fish. The AquAdvantage Salmon are reproductively sterile so that even in the unlikely event of an escape, they would be unable to interbreed or establish populations in the wild. The approval does not allow AquAdvantage Salmon to be bred or raised in the United States.

FDA also published guidance documents on voluntary labeling of food from GE sources. These two documents include a draft guidance on voluntary labeling indicating whether food has or has not been derived from GE Atlantic salmon, and a final guidance on voluntary labeling indicating whether food has or has not been derived from GE plants. These guidance documents provide recommended actions for manufacturers who may wish to voluntarily label their products with information about whether the foods contain ingredients from GE sources.