Frankenfish Part 2

Written by Paul Melamud - Validation Manager, QPharma

Continued ...

 

ANSWERING THE QUESTION – HOW FDA REGULATES THIS PRODUCT

The question posed at the start of this article asked you to try to figure out as what kind of product FDA regulates this salmon.  Most people say “food”, because of course this fits the definition in 21 USC 321(f):

  

The term "food" means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.

While this salmon is most certainly a food, it is not regulated as such, because this product is much more than that (as we will see in a minute).  It is also worth noting that food producers (such as farms) and processed food manufacturers do not need to do anything other than register with FDA – there is no formal pre-marketing review/approval process. 

 

And I can hear now “but surely I am partially correct, this must be some sort of combination product!” – and to be honest, I agree with that in spirit.  Frustratingly, the definition in 21 CFR 3.2 for combination products (which stems from 21 USC 353(g)(1)) excludes food as a component of a combination product!  The likely explanation for this is that this concept was intended to reflect only therapeutic products with differing approval pathways.  Perhaps this definition will be updated if AquaBounty’s salmon is approved.  Anyway, no, you can’t win this argument with me on a technicality, either =).

 

So how is this product regulated?  Let’s look at the other types you were given to choose from:

 

This product cannot be a dietary supplement, which (summarized from 21 USC 321(ff)) is considered a type of food that contains a vitamin, mineral, herb or other botanical, amino acid, or some other type of ingredient to supplement the diet by increasing total dietary intake.

 

This product is also not a cosmetic, which is defined in 21 USC 321(i) as an article intended to be applied to the human body “for cleansing, beautifying, promoting attractiveness, or altering the appearance”, although this technically does not include soap (and our fishy friend is obviously not a soap, either!).

 

So – is this a drug, biologic, or medical device, and then, “human” or “animal”?  Have you figured it out yet? 

 

Let’s look at a boiled down version of the definitions:

1.  Drugs (human and animal) are ALL of the following (per 21 USC 321):

• Recognized in an official compendium (like the USP/NF)
• Intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease in man or   other animals, and/or a product that affects the structure or any function of the body of man or other animals

2.  Medical Devices (human or animal) are ALL of the following (per 21 USC 321):

• Recognized in an official compendium (like the USP/NF)
• Intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals
• A product that does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

3.  Biologic products are ALL of the following (per PHSA 21 USC 262, referenced to by FDA in 21 CFR 3.2):

• A virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein (except any chemically synthesized polypeptide)… (or any other trivalent organic arsenic compound)
• Applicable to the prevention, treatment, or cure of a disease or condition of human beings

The trick to answering this question lies in understanding that regardless of the final use of the product, the genetic change to the animal is also subject to FDA regulation because it fits one of the definitions.  Specifically, if you take a salmon egg, change its structure (by adding DNA) and function (salmon grows faster), and then later use that salmon for food, then of the three types above, only “drug” is defined by a chemical change that alters the structure and function of a body.  From there, as this is a change to an animal and not a human, “animal drug” is your correct answer – this product is regulated as a new animal drug.

 

The Center for Veterinary Medicine (CVM) is indeed responsible for the regulation of GE animals, whether they are intended for human consumption or not.  As of today, there are no CFRs for GE products, and only one guidance document (approved 01/2009):

  

CVM GFI #187 Regulation of Genetically Engineered Animals Containing Heritable Recombinant DNA Constructs (PDF - 128KB).

 

FINAL THOUGHTS

 

The three days of meetings provided plenty of criticism of the science used by the FDA to determine that the GE salmon is safe, as well as of the legal arguments that would not require special labeling of the salmon as “Genetically Engineered”.  Critics call this modified salmon a “Frankenfish” that could cause allergies in humans and the eventual decimation of the wild salmon population. 

 

Will the public have an appetite for this product?  GE is already widely used for crops, but the government until now has not considered allowing the consumption of modified animals.  Although the potential benefits – and profits – are huge, many people have qualms about manipulating the genetic code of other living creatures.

 

But what do the leaders at FDA, the Department of Health and Human Services, and even the White House, want? The approval of the GE salmon, as of now, could go either way. 

 

What do you think?  Would you eat a piece of salmon if you knew it was one of these genetically engineered variety?  If you would knowingly avoid it, would you care at all if you found out after the fact?  Do you think the benefits outweigh the risks?