> Hard to argue with that logic, of course. But I don't see how this observation is relevant to the question I posed: why we should think that this hurdle, but

> Hard to argue with that logic, of course. But I don't see how this observation is relevant to the question I posed: why we should think that this hurdle, but not the many others that exist today, would stop people from selling melatonin, as nostromo suggested it would. (As opposed to merely making it marginally more difficult which, of course, is undeniable.) I guess I just don't see how this question isn't a tautology. No one is arguing that the other hurdles couldn't stop it either. But if the manufacturing costs are $1 million, and the FDA costs are $1 million, then I don't see how it isn't obvious that needing BOTH is $2 million and thus MUCH more difficult. I agree that if we could magically reduce manufacturing costs to zero it would be even better. But your argument literally seems to be "since this is already expensive and difficult, we can make it arbitrarily more expensive and difficult with no reduction in success rate". Which obviously isn't true. More to the point: we know that it can get through the manufacturing hurdles because it did. We thus know this company is capable of 1x costs. Had they ALSO had additional costs from the FDA then it would have been >1x costs and thus we don't know if they would have succeeded. Perhaps an analogy. Let's say someone proposed a new fee for graduating college of $50,000. I would say "well, that might make it so less people can graduate, since it'll cost more". Then you might respond "But what makes you think THIS cost will prevent them, and not the existing expensive tuition?". Well, both do, but they already pay one and we're in control of a theoretical second one. > Or, perhaps more to the point, why this particular hurdle is not worth the supposed consumer protection benefits of FDA regulation? This on the other hand is a completely reasonable question, but not more to the point, just a a compeletely different point than "the company already has costs, what is the problem with more costs?"