Stopping Genetically Engineered Salmon
Center for Food Safety challenged FDA's approval of genetically engineered salmon, the first GE animal approved for food, arguing the agency failed to assess risks to wild salmon, fisheries, consumers, and the environment.
Case Overview
Center for Food Safety and allied fishing, consumer, environmental, and Tribal organizations challenged the U.S. Food and Drug Administration’s approval of AquaBounty’s genetically engineered AquAdvantage salmon, the first GE animal intended for consumption.
The salmon was engineered using genetic material from Atlantic salmon, Pacific king salmon, and Arctic ocean eelpout to grow more quickly than conventional salmon.
CFS argued FDA unlawfully approved the first genetically engineered animal for human consumption without fully assessing risks to wild salmon, fishing communities, marine ecosystems, and consumers.
Outcome and Significance
In 2015, FDA approved AquAdvantage® Salmon, the first GE animal intended for human consumption, produced by AquaBounty Technologies. In approving the AquaBounty transgenic salmon, FDA ignored millions of Americans and more than 40 members of Congress who have expressed vocal opposition. FDA also neglected the concerns of more than 300 environmental, consumer, health and animal welfare organizations, salmon and fishing groups and associations, food companies, chefs and restaurants.
In response, Center for Food Safety and a coalition of Tribes, fishing, consumer, and environmental groups sued FDA in 2016. We argued that FDA unlawfully regulated the fish as an “animal drug” under the 1938 Federal Food, Drug, and Cosmetic Act (a framework meant for veterinary drugs, not novel GE animals), failed to consult wildlife agencies as required under the Endangered Species Act despite threats to protected salmon populations, and approved the fish without adequately assessing the risk of escape and crossbreeding with wild salmon.
In 2020, Center for Food Safety and allies won a major legal victory when a federal court ruled FDA’s approval of genetically engineered salmon unlawful. The court found that FDA violated the National Environmental Policy Act by ignoring the environmental consequences of approving genetically engineered salmon, and separately violated the Endangered Species Act by incorrectly determining that the GE salmon could have no possible effect on endangered wild Atlantic salmon.
The Court also rejected FDA’s broader argument that it lacked authority to even consider adverse environmental impacts of GE animals, warning that such a position would lead to “absurd possibilities,” and ordered FDA to conduct a thorough new analysis of the environmental risks before the approval could stand.
In 2024, AquaBounty announced it was shutting down genetically engineered salmon production, marking a major victory after more than two decades of CFS legal action and campaigning.
Key Issues in the Case
We argued that the FDA failed to meaningfully analyze the environmental impacts of genetically engineered salmon, including the risks of escape, spread, and harm to wild salmon populations.
The lawsuit challenged FDA’s failure to consult expert wildlife agencies about potential impacts to endangered wild salmon and protected ecosystems, as required under the Endangered Species Act.
CFS raised concerns that FDA approved genetically engineered salmon without requiring clear labeling, leaving consumers without meaningful information about what they were buying.
The case set an important precedent when the court rejected FDA’s claim that it had no duty to protect the environment from genetically engineered animals approved for food.
