On November 19, 2015, the Food and Drug Administration (FDA) approved as fit for human consumption a genetically engineered (GE) salmon. AquaBounty Technologies AquAdvantage Salmon has been modified to grow faster than non-engineered farmed salmon. This marks the first time the FDA has authorized the sale of a genetically engineered animal as food.

Because the FDA determined that there are “no biologically relevant differences in the nutritional profile of AquAdvantage Salmon compared to that of other farm-raised Atlantic salmon,” AquAdvantage will not need to label the fish as genetically modified. The FDA further found that approving the GE salmon would have no negative environmental impact.

Some consumer and environmental organizations oppose the FDA’s approval. Specifically, some consumer advocacy groups expressed concern because the FDA does not require labeling of genetically modified foods unless the GE product differs materially from its non-GE counterpart. Within hours of the FDA’s decision, the Center for Food Safety announced plans to file a lawsuit challenging the approval, and several major retailers issued statements indicating they will not sell the GE salmon.

Additional litigation could follow. Consumers have previously brought successful claims for false advertising and negligence against GMO food manufacturers. Some commentators have speculated that GE food manufacturers may face consumer lawsuits alleging a failure to warn, design defects, and manufacturing defects. The FDA’s approval leaves open whether consumers will have a cause of action for alleged harm caused by genetic modification under these or other legal theories.