In some ways, I think the FDA is a victim of its own success. If I'm not mistaken, it was created in part because of the 100+ deaths around Elixir sulfanilamide. But since the FDA has helped prevent things like that from recurring, we underestimate the potential dangers of under-regulating.

Not that the FDA couldn't be more efficient (possibly considerably more so), but it's clear that most products that go into production work, and that can't be discounted.

https://en.wikipedia.org/wiki/Elixir_sulfanilamide