"We are not able to make any definitive claims that this compound is safe..."
Is this quote taken out of context? Because I thought the first step of any sort of human trial of a drug is to determine its safety. Intuitively I can't see how NR would be any different safety-wise than niacin (vitamin b3), but more clarification would be nice. Anyone who has read the paper willing to chime in?
It's fundamentally the responsibility of the FDA to regulate "definitive claims that a compound is safe", whereas the standard for approval for use in a clinical trial is a bit different.
And this is a general issue with prophylactic or anti-aging style 'drugs'. Demonstrating a compound is safe enough to not cause undue harm while helping to rid the body of an accute ailment is a very different kind of 'safe' than something one might be expected to take every day for years.
Tangentially related to the safety of niacin, for most people niacin/B3 is relatively inert and used by the body. In fact, if you don't get enough of it, you fall in danger of having pellagra [1].
If I eat it, I'm guaranteed to get an ocular (ophthalmic) migraine.
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"We are not able to make any definitive claims that this compound is safe..."
Is this quote taken out of context? Because I thought the first step of any sort of human trial of a drug is to determine its safety. Intuitively I can't see how NR would be any different safety-wise than niacin (vitamin b3), but more clarification would be nice. Anyone who has read the paper willing to chime in?
It's fundamentally the responsibility of the FDA to regulate "definitive claims that a compound is safe", whereas the standard for approval for use in a clinical trial is a bit different.
And this is a general issue with prophylactic or anti-aging style 'drugs'. Demonstrating a compound is safe enough to not cause undue harm while helping to rid the body of an accute ailment is a very different kind of 'safe' than something one might be expected to take every day for years.
Well, it is in cow milk: https://www.ncbi.nlm.nih.gov/pubmed/27052539
Tangentially related to the safety of niacin, for most people niacin/B3 is relatively inert and used by the body. In fact, if you don't get enough of it, you fall in danger of having pellagra [1].
If I eat it, I'm guaranteed to get an ocular (ophthalmic) migraine.
[1] https://en.wikipedia.org/wiki/Pellagra
What they mean is that they are not allowed by the FDA to make any such claims.