FDA sued over approval of genetically engineered salmon.

  • In November 2015, FDA issued its first approval for a genetically engineered (GE) animal intended for direct human consumption.  The AquAdvantage Salmon is an Atlantic salmon engineered to grow twice as fast as its natural counterpart.  Since the approval, the GE salmon has been mired in controversy.  A provision in the omnibus spending bill passed in December 2015 blocks the sale of GE salmon until FDA publishes labeling guidelines to inform consumers of the product’s GE content.
  • A number of environmental and consumer advocacy groups — including the Center for Food Safety, Food and Water Watch, and Friends of the Earth — have filed a lawsuit against FDA, asserting that the Agency overstepped its authority in approving the GE salmon in the first place.  In addition to challenging the substantive merits of FDA’s decision to approve the product, the complaint alleges that FDA’s lacks the statutory authority to regulate GE animals as “new animal drugs” under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
  • The current lawsuit is yet another development in the long-running debate over the safety of GE organisms in the food supply.  FDA does not comment on pending litigation as a matter of policy, but we anticipate that the Agency will continue to support the position it stated in its initial approval of the product, i.e., that the GE salmon are “as safe to eat and as nutritious as food from other non-GE Atlantic salmon and that there are no biologically relevant differences in the nutritional profile of AquAdvantage Salmon compared to that of other farm-raised Atlantic salmon.”