Genetically Modified Organisms: Salmon, Labeling, and More 2016

FDA has approved a new animal drug application concerning AquAdvantage Salmon, a genetically engineered Atlantic salmon.

Freedom of Information Summary
FDA regulates genetically engineered (GE) animals under the new animal drug provisions of the Federal Food Drug and Cosmetic Act (FD&C Act), 21 U.S.C.§321,et seq.
Section 201(g) of theFD&C Act, 21 U.S.C.§321(g)(1)(C),defines drugsto include “articles (other than food) intended to affect the structure or any function of the body of man or other animals.” When, as is the case for AquAdvantage Salmon, the genetic material, or recombinant DNA (rDNA) construct, used to engineer the animal at issue is intended to affect the structure or function of that animal, the rDNA construct meets the definition of a drug in the FD&C Act.  As a short hand, the agency sometimes refers to regulating the article as regulating the GE animal.

About AquAdvantage Salmon aka AquaBounty Technologies, Inc.

AquaBounty is a small company with offices in Maynard, Massachusetts and Fortune, Prince Edward Island. Founded in 1991, AquaBounty’s driving force is the belief that modern genetics, married with land-based recirculating aquaculture systems (RAS), can spur a radically more responsible and sustainable way of growing Atlantic salmon. Breakthroughs in modern bioscience have revitalized aquaculture and AquaBounty is at the forefront of this Blue Revolution.

The AquaBounty story is driven by two scientific innovations. The first took place in 1989, when Garth Fletcher and his research team at Memorial University of Newfoundland, Canada discovered that they could use advanced molecular genetics to significantly increase the growth rate of an Atlantic salmon. The second was the development of land-based recirculating aquaculture systems, or RAS, that could eliminate salmon aquaculture’s impact on marine ecosystems.


Media Coverage on GMO Salmon (FDA Approved)

Genetically Engineered Salmon Approved for Consumption

Federal regulators on Thursday approved a genetically engineered salmon as fit for consumption, making it the first genetically altered animal to be cleared for American supermarkets and dinner tables.

The approval by the Food and Drug Administration caps a long struggle for AquaBounty Technologies, a small company that first approached the F.D.A. about approval in the 1990s. The agency made its initial determination that the fish would be safe to eat and for the environment more than five years ago.

The approval of the salmon has been fiercely opposed by some consumer and environmental groups, which have argued that the safety studies were inadequate and that wild salmon populations might be affected if the engineered fish were to escape into the oceans and rivers.


Further Information:

Vermont Senate passes GMO food-labeling law

The Vermont Senate passed a bill Wednesday that would make it the first state to enact mandatory labeling of foods made with genetically modified organisms, or GMOs.

Unlike bills passed last year in Maine and Connecticut, which require other states to pass GMO labeling laws before they can be enacted, Vermont’s contains no such trigger clause.

Vermont’s effort comes as the developers of genetically modified crops and the nation’s $360 billion packaged food industry push for passage of an opposing bill introduced in Congress last week that would nullify any law that would require labeling of foods made with genetically modified crops.

GMO labeling is just one front in an increasingly high-stakes food fight raging in the United States, where consumers increasingly are demanding to know where their food comes from and how it was produced.


Natural American Foods Receives Non-GMO Project Verification

Natural American Foods is one of the country’s largest processors of 100% pure all-natural honey. With operations in California and Michigan, the company serves some of the best-known manufacturers, distributors and retailers in the United States. Additionally, Natural American Foods is committed to retain the natural pollen in every batch of honey, which ensures a superior product and allows for third-party verification of geographical origin and floral source. Learn more at

“This latest achievement to source, distribute and market non-GMO honey and agave is reflective of the investments we’ve made in building a world-class global sourcing operation,” said Rolf Richter, CEO for Natural American Foods. “We’re pleased to be working with The Non-GMO Project in our efforts to meet consumer demands for transparency in the honey category. Honey and agave products that bear the Non-GMO Project Verified logo will be available for distribution starting in January 2016.”


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