FDA thinks DNA is a drug (or the FDA sucks reason #452) (user search)
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  FDA thinks DNA is a drug (or the FDA sucks reason #452) (search mode)
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Author Topic: FDA thinks DNA is a drug (or the FDA sucks reason #452)  (Read 1355 times)
True Federalist (진정한 연방 주의자)
Ernest
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« on: January 25, 2017, 11:51:38 PM »

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.
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True Federalist (진정한 연방 주의자)
Ernest
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« Reply #1 on: January 26, 2017, 11:30:00 PM »

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.
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True Federalist (진정한 연방 주의자)
Ernest
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« Reply #2 on: January 27, 2017, 09:07:03 PM »

Yes, except:
A.this is very very targeted manipulations we're talking about here.  It's not going to be poisonous because they aren't putting the genes for poison in.
2.even if by some unknown by science at this time mechanism somehow makes hornless milk cows highly toxic or whatever (which is totally impossible, but I'm humoring you here) they'd notice it in the testing
It's not only highly toxic effects that need to be checked out.  DES is a classic example of a drug that while not immediately poisonous had considerable side effects.  Studies are showing that it may even be affecting the grandchildren of the women who took it during pregnancy.  What all having phytase inside the body of a pig does to a pig is something that definitely needs investigation in my opinion
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