FDA Signs Off On Genetically Modified Salmon Without Labeling

While genetically modified agricultural products have been used in the U.S. for quite some time, the Food and Drug Administration had yet to approve the food use of any genetically engineered (GE) animals — until today. This morning, the agency announced the approval of an application for a salmon engineered to grow to market size faster than other farm-raised Atlantic salmon.

The FDA has declared AquAdvantage Salmon “safe to eat,” noting that testing of the fish “demonstrated that the inserted genes remained stable over several generations of fish, that food from the GE salmon is safe to eat by humans and animals, that the genetic engineering is safe for the fish, and the salmon meets the sponsor’s claim about faster growth.”

According to the FDA, the GE salmon shows “no biologically relevant differences” in its nutritional profile compared to other non-GE farm-raised Atlantic salmon.

The agency also considered the possibility that these GE salmon could end up mixing with other salmon and determined that the AquAdvanatage salmon farms in Panama and Canada “make it extremely unlikely that the fish could escape and establish themselves in the wild.”

There are multiple physical barriers to prevent AquAdvantage fish or their eggs from slipping out through these farms’ plumbing systems. If a fish were to escape or be otherwise introduced into other salmon population, the FDA says it would not matter because the AquAdvantage Salmon are reproductively sterile.

Today’s approval will not allow AquAdantage salmon to be raised in the U.S. Only the facilities explicitly included in the approval can provide these GE fish for sale in America.

Though the Federal Food, Drug, and Cosmetic Act (FD&C Act) gives the FDA the authority to require mandatory labeling of foods if there is a material difference between a GE product and its conventional counterpart, the agency says it is not requiring labeling of these GE fish “Because the data and information evaluated show that AquAdvantage Salmon is not materially different from other Atlantic salmon.”

Instead, the FDA says that it will be up to the sellers of these fish to voluntarily decide whether they choose to label their product as GE.

Genetically engineered animals fall under the FDA’s regulatory umbrella because the recombinant DNA (rDNA) introduced into the animals meets the legal definition of a drug.

In this case, the GE salmon use an rDNA construct composed of the growth hormone gene from Chinook salmon under the control of a promoter from another type of fish called an “ocean pout.” According to the FDA, this tweak to the DNA allows the salmon to grow to market size faster than non-GE farm-raised salmon.

Today’s news did not go over well with our colleagues at Consumers Union, especially because of the FDA’s decision to forgo labeling of the GE fish.

“We are deeply disappointed with the FDA’s decision to approve the AquaAdvantage salmon. And it’s even more concerning that the FDA chose not to require any form of labeling, making it extremely difficult for consumers to know if the salmon is GE or not,” says Michael Hansen PhD, Senior Scientist with Consumers Union. “Consumers deserve to know what type of food they’re buying – and an overwhelming majority has told us that they want genetically modified food labeled in poll after poll. The decision to not require a GE label for this product takes away the consumer’s ability to make a truly informed choice.”