5 ms·

For a treatment to be granted 'FDA approval', the FDA needs to see evidence of two things: safety and efficacy. Even if a treatment is demonstrated to be safe,

For a treatment to be granted 'FDA approval', the FDA needs to see evidence of two things: safety and efficacy. Even if a treatment is demonstrated to be safe, if there's no evidence of therapeutic benefit, they won't approve it.

deleted 8y ago
[deleted]
BurningFrog 8y ago
Yeah, if you parse out the words, that is all they're actually saying. "There is no proven clinical benefit" and "there are risks associated with the use of any [...] product".
- ianhowson 8y ago
  They're also not saying "Ambrosia Medical must stop administering this treatment". They're just saying "we don't approve". So this thing on the Ambrosia website: > In compliance with the FDA announcement issued February 19, 2019, we have ceased patient treatments. doesn't quite make sense, because the FDA hasn't publicly asked Ambrosia to stop, and the FDA never did approve transfusions for the purpose of life extension or anti-aging. They're not complying with anything, because that announcement wasn't a 'cease treatments' notice. So we don't really know why Ambrosia has chosen to stop.
magduf 8y ago
So why is chiropractic and homeopathy allowed?
- ianhowson 8y ago
  I can't speak for chiropractic as that's out of scope for the FDA and I have no knowledge of the regulatory process there. Homeopathy and supplements are classified as food, not medicine. Therefore, they're not required to seek FDA approval. (They still have to meet food safety standards, of course.) If they could do anything meaningful, they'd be required to reclassify as medicine and undergo approval. So you get this fun situation where anything useful is locked up and can only make very specific claims about what it can cure. The things that can't cure anything can make weasel-worded claims about anything.
hopler 8y ago
Aging is the an FDA approved disease, but every symptom of aging is.

deleted 8y ago

[deleted]

BurningFrog 8y ago

Yeah, if you parse out the words, that is all they're actually saying. "There is no proven clinical benefit" and "there are risks associated with the use of any [...] product".

ianhowson 8y ago
They're also not saying "Ambrosia Medical must stop administering this treatment". They're just saying "we don't approve". So this thing on the Ambrosia website: > In compliance with the FDA announcement issued February 19, 2019, we have ceased patient treatments. doesn't quite make sense, because the FDA hasn't publicly asked Ambrosia to stop, and the FDA never did approve transfusions for the purpose of life extension or anti-aging. They're not complying with anything, because that announcement wasn't a 'cease treatments' notice. So we don't really know why Ambrosia has chosen to stop.

magduf 8y ago

So why is chiropractic and homeopathy allowed?

ianhowson 8y ago
I can't speak for chiropractic as that's out of scope for the FDA and I have no knowledge of the regulatory process there. Homeopathy and supplements are classified as food, not medicine. Therefore, they're not required to seek FDA approval. (They still have to meet food safety standards, of course.) If they could do anything meaningful, they'd be required to reclassify as medicine and undergo approval. So you get this fun situation where anything useful is locked up and can only make very specific claims about what it can cure. The things that can't cure anything can make weasel-worded claims about anything.

hopler 8y ago

Aging is the an FDA approved disease, but every symptom of aging is.