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Written by Paul Melamud - Validation Manager, QPharma
INTRODUCTION
Sometimes, I don’t think FDA is given enough credit. Yeah, I know it’s always fun to armchair-quarterback their decisions and policies, or to scoff “how could they let that happen”s at some company’s shenanigans… But every once in awhile, they get something really cool to play with, and they give the science (and the company) a legitimate chance to justify themselves. And if you’re working for one of these groundbreaking, innovative sorts of companies, then you’ll agree it’s important to be able to figure out what kind of product your new “something” is, so you can start the laborious process of getting it approved the right way.
In that regard, I’m going to tell you a little story about salmon eggs, and the part I find most interesting is how FDA regulates this product. Do you think you can figure it out before I spill the answer? Let’s limit your choices – is this product regulated as a food, dietary supplement, human drug, animal drug, therapeutic biologic product, cosmetic, or medical device?
Let’s take a step away for a moment, though. As the world’s populations grow, fishing and hunting increase to meet rising demand (among other things, of course), and, as history shows, this can lead to depopulation, extinction of species, habitat destruction, and environmental activists sabotaging boats.
As you likely know, farming in general has been a dying art, subject to higher regulations and costs of doing business, and many are on the verge of collapse, unable to make a profit while trying to meet such high market needs. Consider the delicious world of aquaculture (AKA “fish farming”, AKA “the Blue Revolution”) for example, which is able to fulfill around 50% of the world’s piscine appetites and thereby circulates around $80B dollars.
In an effort to thwart these depressing factors, scientists have been teaming up with farmers to create new products that should help provide equal or more of the product at lower cost and impact. It is with one of these products that I start my story of roe.
ENTER THE FRANKENFISHAs recently as this past October, the government held three days of meetings about whether to approve AquaBounty’s AquAdvantage® salmon – a transgenic species whose eggs are genetically engineered (GE) to grow twice as fast – for human consumption. Some people have been referring to this product as the “Frankenfish”.
AquaBounty intends to market this product, making the following claim in its FDA application:
The website www.eatocracy.com has provided an excellent summary of what alterations make this salmon different from typical “wild type” Atlantic salmon:
So far, FDA has agreed with AquaBounty’s assessment that the salmon is as safe to eat as the wild variety, but they have not yet decided whether to approve the product. If approved, this will be the first GE food animal available in US supermarkets!
PROS AND CONS
As you can imagine, this controversy stems from a number of pros and cons that are very important considerations as GE technology continues to increase. Here is a quick summary, with a nod toward www.frankenfish.com for having compiled this information succinctly:
....... So, any guesses yet as to how this product gets approved and which part of FDA regulates it? Stay tuned for this author’s next blog entry on Monday June 6th, 2011, in which he will walk through the different product types and why or why not the FDA regulates the Frankenfish in that manner. In the meantime, share your guesses and your other thoughts about this product with us!
INTRODUCTION
Sometimes, I don’t think FDA is given enough credit. Yeah, I know it’s always fun to armchair-quarterback their decisions and policies, or to scoff “how could they let that happen”s at some company’s shenanigans… But every once in awhile, they get something really cool to play with, and they give the science (and the company) a legitimate chance to justify themselves. And if you’re working for one of these groundbreaking, innovative sorts of companies, then you’ll agree it’s important to be able to figure out what kind of product your new “something” is, so you can start the laborious process of getting it approved the right way.
In that regard, I’m going to tell you a little story about salmon eggs, and the part I find most interesting is how FDA regulates this product. Do you think you can figure it out before I spill the answer? Let’s limit your choices – is this product regulated as a food, dietary supplement, human drug, animal drug, therapeutic biologic product, cosmetic, or medical device?
Let’s take a step away for a moment, though. As the world’s populations grow, fishing and hunting increase to meet rising demand (among other things, of course), and, as history shows, this can lead to depopulation, extinction of species, habitat destruction, and environmental activists sabotaging boats.
As you likely know, farming in general has been a dying art, subject to higher regulations and costs of doing business, and many are on the verge of collapse, unable to make a profit while trying to meet such high market needs. Consider the delicious world of aquaculture (AKA “fish farming”, AKA “the Blue Revolution”) for example, which is able to fulfill around 50% of the world’s piscine appetites and thereby circulates around $80B dollars.
In an effort to thwart these depressing factors, scientists have been teaming up with farmers to create new products that should help provide equal or more of the product at lower cost and impact. It is with one of these products that I start my story of roe.
ENTER THE FRANKENFISHAs recently as this past October, the government held three days of meetings about whether to approve AquaBounty’s AquAdvantage® salmon – a transgenic species whose eggs are genetically engineered (GE) to grow twice as fast – for human consumption. Some people have been referring to this product as the “Frankenfish”.
AquaBounty intends to market this product, making the following claim in its FDA application:
“AquAdvantage® Salmon (AAS) reach market size twice as fast as traditional salmon. This advancement provides a compelling economic benefit to farmers (reduced growing cycle) as well as enhancing the economic viability of inland operations, thereby diminishing the need for ocean pens. AAS are also reproductively sterile [except for the small breeding stock maintained in land, which eliminates the threat of interbreeding amongst themselves or with native populations, a major recent concern in dealing with fish escaping from salmon farms. AAS grow faster and reach mature size earlier than standard salmon, but they do not grow to be larger. Mature AAS are indistinguishable from their conventional counterparts.”
The website www.eatocracy.com has provided an excellent summary of what alterations make this salmon different from typical “wild type” Atlantic salmon:
“The fish’s rapid growth will be boosted by the injection of a combination of a growth gene (GH-coding sequences) from the Pacific Chinook salmon and genetic material (the AFP gene) from the ocean pout – a large, eel-like fish – into the fertilized eggs of Atlantic salmon, making the recombined DNA present in cells throughout the body of the fish. The Chinook gene promotes the growth to market size, and the pout gene allows the fish to grow in the winter as well as the summer.”
Growth rate comparison of an AquAdvantage® Salmon
vs. a non-transgenic (wild-type) Atlantic salmon.
Size comparison of an AquAdvantage® Salmon (background) vs. a non-transgenic
Atlantic salmon sibling (foreground) of the same age.
PROS AND CONS
As you can imagine, this controversy stems from a number of pros and cons that are very important considerations as GE technology continues to increase. Here is a quick summary, with a nod toward www.frankenfish.com for having compiled this information succinctly:
....... So, any guesses yet as to how this product gets approved and which part of FDA regulates it? Stay tuned for this author’s next blog entry on Monday June 6th, 2011, in which he will walk through the different product types and why or why not the FDA regulates the Frankenfish in that manner. In the meantime, share your guesses and your other thoughts about this product with us!
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