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FDA Appeals Order Rejecting GE Salmon Approval


FDA Appeals Order Rejecting GE Salmon Approval
Tuesday, April 20, 2021
The FDA is appealing a November 5, 2020 decision by the U.S. District Court for the Northern District of California which ordered the Agency to reconsider its 2015 approval of the genetically engineered (GE) AquAdvanage salmon.
In March 2016 a lawsuit was filed alleging that the FDA did not have jurisdiction to approve the GE salmon and, in the alternative, that the FDA unlawfully abused its authority by approving the GE salmon without appropriately considering its obligations under the National Environmental Policy Act (NEPA) and the Endangered Species Act (ESA). The jurisdictional claims were separately addressed in a December 19, 2019 opinion in which the Court held that the FDA could regulate the GE salmon as a drug because the Federal Food, Drug, and Cosmetic Act defines drugs in part as “articles (other than food) intended to affect the structure or any function of the body of ....

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