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by epmaybe 3004 days ago
"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?

4 comments

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.

[1] https://en.wikipedia.org/wiki/Pellagra

What they mean is that they are not allowed by the FDA to make any such claims.