The Food and Drug Administration frequently recalls dietary supplements that are found to contain banned substances. But a new study suggests that many of these products return to store shelves months later with the same dangerous ingredients.
With principles-based regulation, you look at companies to see if they have processes in place to ensure that they follow the right principles. Do the health-food stores have people in charge of checking the labels of what they put on shelves? Do the companies that manufacture drugs have people in charge of making sure that they do not put known dangerous chemicals into the drugs? Do the companies that import drugs from overseas have processes in place to ensure that they are not tainted? etc.
When you find processes that are flawed, you order fixes. When find an absence of processes, you impose heavy penalties, which might include prison for the executives.
That sounds like the FDA we currently have – at least as regards pharmaceuticals; maybe not supplements. They insist on seeing proof that you ran your factory the same way for this batch as you did for the last batch and the first batch. They don’t much care to see test results that the pills are the same unless those results are a double-blind study in humans.
Basically, they assume that we don’t know any chemistry at all, so pills are a black box. As a chemical engineer, I find that frustrating – no small improvements are welcome.