Arizona Advanced Medicine Clinic

FDA Has Approved A New Animal Drug Application Concerning AquAdvantage Salmon

AquAdvantage Salmon

FDA has approved a new animal drug application concerning AquAdvantage Salmon, a genetically engineered Atlantic salmon. Documents related to this approval are available on the FDA website, last updated on 11-19-15.


salmonThe “new animal drug application” approval affirms the FDA’s position that the salmon, genetically engineered to grow faster and larger than the salmon we are familiar with, is just as safe to eat as any natural salmon. The approval letter states: “The approval is for a single copy of the α-form of the opAFP-GHc2 recombinant DNA (rDNA) construct at the α-locus in the EO-1α lineage of triploid hemizygous[1], all-female Atlantic salmon (Salmo salar) known as AquAdvantage Salmon (AAS) under the conditions of use specified in the application. This rDNA construct at this specific site in the genome is the new animal drug (“the article”) that is the subject of the new animal drug application (NADA) approval. For ease of reference, this Appendix will refer to “AAS,” or “the article,” or “the product” when referring to the drug.”

We all have the opportunity to become test cases for this “new animal drug product”. There have been no human studies, to my knowledge, on the results of eating this “new animal drug product”, no dosage calculations, no longitudinal human safety studies.

The new food product was developed using genetic engineering techniques developed in the 1980s to insert a gene which increases the production of an anti-freeze protein into the fish, so that it can continue to grow year round, instead of resting for a season and only reproducing in the spring, as naturally developed fish do. An additional gene from an ocean pout – a member of the eel family – was then introduced to enable the fish to continue to grow far larger than its natural cousins. The genetic alteration does appear to be stable in the offspring of these engineered fish for at least 6 generations, according to the published literature.

The Aquabounty company has assured us that their fish are all sterile. However, published literature shows that the fish can indeed breed with other fish and produce hybrid offspring. The trout-salmon hybrid suppressed both natural salmon and natural trout populations. “Transgenic hybrids appeared to express competitive dominance and suppressed the growth of transgenic and non-transgenic (wild-type) salmon by 82 and 54 per cent, respectively”.[2]

Since the new animal drug product can escape its confines in the farms where it is raised, and since it can potentially breed with wild salmon to produce hybrid progeny, there is no guarantee that any salmon will be free of the genetic modification introduced in this commercially bred new animal drug product.

I have decided that my only option is not to eat salmon and possibly also trout at all.

Each of us will have to make our own decision in this matter.

Key words: GMO fish, GMO salmon, food safety


[1] Hemizygous – having only a single copy of a gene. All genes on the male’s single X chromosome are hemizygous.

[2] Oke KB, Westley PAH et al. Hybridization between genetically modified Atlantic salmon and wild brown trout reveals novel ecological interactions. Proc R Soc B 280: 20131047. http://dx.doi.org/10.1098/rspb.2013.1047

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