> What about off-label medication?
Off-label means prescribed for a different purpose than originally indicated, at the prescriber's discretion. The medication must still have past safety testing and have shown efficacy for something.
> I also think it's unlikely enough to hurt people that FDA approval shouldn't be required. There's a lot of stuff in that category!
You can sell a lot of products as-is without FDA approval. However, making substantial claims about that product's medicinal properties is regulated in a different manner.
These people are trying to have the best of both worlds: Making extraordinary claims about preventing a medical condition, while also avoiding any participation in the FDA process or even funding standard trials.
I think the most obvious counter argument is that this could easily be a massively successful drug if it works as well as they claim. The TAM is everyone with teeth who wants to keep them, which is basically everyone. Yet instead they've chosen this weird path of embracing the rationalist community and supplement nuts, which is a much smaller market.