FDA thinks DNA is a drug (or the FDA sucks reason #452)

[dead0man]

link-FDA

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If you were wondering, consuming DNA can't hurt you and nearly everything we eat contains DNA.

[publicunofficial]

damn this one story makes me want to abolish the FDA becuase that's how my caveman brain works

[dead0man]

look, we get that you're good at strawmans, you don't have to keep showing us.  We're all very proud.

[DrScholl]

It must be miserable to be easily outraged. What a sad existence.

[publicunofficial]

It must be miserable to easily outraged. What a sad existence.

Oh you have no idea how mad you just made him.

[dead0man]

the ironing is delicious

[Since I'm the mad scientist proclaimed by myself]

This pisses you off more then racial discrimination, doesn't it?

[Figueira]

It's about "altered DNA," not DNA in general.

Is there a reason why it shouldn't be considered a drug?

[Since I'm the mad scientist proclaimed by myself]

It's about "altered DNA," not DNA in general.

Is there a reason why it shouldn't be considered a drug?

The fact that there's no reason it should be considered a drug, due to not being biologically distinct from some random strand of "natural" DNA.

[JerryArkansas]

the ironing is delicious

The only thing that is great in this thread is your outrage at this.  You are acting so damn triggered by this it's amazing you can even type right now.

[dead0man]

I'm really not seeing the "triggered by this"....not everything everybody posts about is THE MOST IMPORTANT THING IN THE WORLD ^TM.  The FDA thinks DNA (altered or otherwise, it doesn't matter, DNA is harmless) is a "drug".  That is stupid.  I'm pointing it out.  I'm not about to go march, riot or sucker punch someone that is pro-FDA.  It's just a thread on a stupid message board.


...but if you want to picture me in tears banging on my keyboard, be my guest.  I suspect you're all projecting a bit, but whatever.

[Figueira]

It's about "altered DNA," not DNA in general.

Is there a reason why it shouldn't be considered a drug?

The fact that there's no reason it should be considered a drug, due to not being biologically distinct from some random strand of "natural" DNA.

There are a lot of drugs that can also be naturally occurring within the body. That doesn't mean they're not drugs.

[True Federalist (진정한 연방 주의자)]

First off, dead0, this isn't about consuming DNA, as should be clear to anyone giving even a cursory look at the draft. It also isn't about the FDA regulating all DNA.  It's specifically about the FDA regulating gene manipulation done for the purpose of treating a medical condition. For better or worse, the FDA acts as our nation's gatekeeper for new medical therapies.  Perhaps it would be better to call such manipulation a medical device.  I don't really care what the FDA chooses to call it.   By whatever term one wants to use, this clearly falls within the intended FDA remit, even if the language being used to justify doing so is clunky because gene manipulation wasn't a thing when the Federal Food, Drug, and Cosmetic Act was passed in 1938.

[🦀🎂🦀🎂]

the reason the fda regulates such things is DNA encodes for proteins, which could potentially be toxic or allergenic. Although one can make an argument that cisgenics are unfairly stigamtised that in a way that classically bred plants are though.

[emailking]

The FDA thinks DNA (altered or otherwise, it doesn't matter, DNA is harmless) is a "drug".  That is stupid.  I'm pointing it out. 

I mean, is it really not clear to you that they're saying it's effectively a drug in the sense that they have regulatory control over it, not that it literally is one?

[dead0man]

First off, dead0, this isn't about consuming DNA, as should be clear to anyone giving even a cursory look at the draft. It also isn't about the FDA regulating all DNA.  It's specifically about the FDA regulating gene manipulation done for the purpose of treating a medical condition. For better or worse, the FDA acts as our nation's gatekeeper for new medical therapies.  Perhaps it would be better to call such manipulation a medical device.  I don't really care what the FDA chooses to call it.   By whatever term one wants to use, this clearly falls within the intended FDA remit, even if the language being used to justify doing so is clunky because gene manipulation wasn't a thing when the Federal Food, Drug, and Cosmetic Act was passed in 1938.

What medical condition did the Enviropig fix?  It takes 20 years and a billion dollars to get something through the FDA process.  Maybe saving the environment isn't important to you, but what about unneeded pain and injuries to cows and farmers?  We should make them wait 20 years before we can have hornless dairy cattle?  How about the FDA only regulate things that are actually dangerous?  and of course their other important work of making sure something labeled "mayo" has eggs in it and nobody anywhere ever eats something labeled "cheese" that is really just "cheese product".  The horror.

A gizmodo article on the topic.

I'm guessing CRISPR scares the sh**t out of you guys, right?


-and thank you to the last few posters for actually discussing the topic unlike the first three clowns

[True Federalist (진정한 연방 주의자)]

I'll agree that the USDA approach of being more lenient with non-transgenic gene manipulation makes sense. I think the FDA will take note of that, assuming that Trump lets any new regulations go forth.  I think it'd be wonderful if the Gros Michel banana could get resistance to Panama disease spliced into it from another banana cultivar. That said, in the specific case of the Enviropig there are alternative ways of getting the desired benefits without splicing in genes from other species, such as adding phytase to their feed, so holding said pig to a high standard doesn't bother me.  By introducing a new enzyme into the pig, there easily could be unintended side effects, tho I'd think they'd be most likely to be harmful to the pig if they exist than consumers of the pig.

[dead0man]

I'll agree that the USDA approach of being more lenient with non-transgenic gene manipulation makes sense.

Aye

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Don't need NEW regulations, need to get rid of or fix the bad ones.

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k...but the fast growing salmon?the milk cows without horns? the many many other things that aren't even being looked at because the people that might look into it won't because they know it's not worth spending a billion dollars and waiting 20 years for?

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but they look for that sh**t.  These universities that come up with this stuff don't just edit the genes and hand them over to farmers.  They're doing science!

[dead0man]

link-CNBC
link-anitmedia
This O'Niell guy seems pretty cool....and pro-pot.  Potential pick to head the FDA.

[Antonio the Sixth]

It's a chemical product that has been made or altered by human activity. That makes it a drug.

[Since I'm the mad scientist proclaimed by myself]

It's a chemical product that has been made or altered by human activity. That makes it a drug.

To the human body, "modified" DNA is indistinguishable from "natural" (whatever that means) DNA. Making people pay millions of dollars and wait 20 years for approval of such a thing is stupid.

[Antonio the Sixth]

It's a chemical product that has been made or altered by human activity. That makes it a drug.

To the human body, "modified" DNA is indistinguishable from "natural" (whatever that means) DNA.

Pretty sure that's false as a blanket statement.

[dead0man]

It's a chemical product that has been made or altered by human activity. That makes it a drug.

Are you really saying any chemical product made or altered by human activity is a "drug" and should be regulated by the FDA?  Do you really want to say that?  'cause that seems to be what you're saying.

[Antonio the Sixth]

It's a chemical product that has been made or altered by human activity. That makes it a drug.

Are you really saying any chemical product made or altered by human activity is a "drug" and should be regulated by the FDA?  Do you really want to say that?  'cause that seems to be what you're saying.

If it's destined for human consumption, then yes? Is that really so controversial?

[🦀🎂🦀🎂]

It's a chemical product that has been made or altered by human activity. That makes it a drug.

To the human body, "modified" DNA is indistinguishable from "natural" (whatever that means) DNA.

Pretty sure that's false as a blanket statement.

nah, she's right. DNA is basically a long chain of four different repeating nucleotides (A G C and T). This is all DNA, including transgenically modified DNA (because all animals share the same structure of DNA). In the digestive tract, the DNA chains are immediately rippedup to their constituent ncleotides (which are further broken down). So the novel DNA combinations one can make from biotechnology become irrelevant.