150 years ago, Bayer Inc. was mass producing Heroine. 130 years ago Merck and Parke-Davis were mass producing Cocaine(TM) -- all with zero oversight. It would be another 50 years before we even had an FDA and another 50 before the FDA was a reasonably well-oiled machine with a solid set of processes and requirements. Even then, it couldn't really (and can't really today either) prevent these non-US companies (both Heroine and Cocaine were German) from making and selling elsewhere.