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As a species, we're horrible at statistical risk-based decision-making. My opinion is that we - as a society - should better educate and prepare children in statistical evaluation, and then as long as the behavior directly impacts only the individual, let people do what they want. The alternative is a morass of laws dictating personal behavior, with often unintended and arguably worse outcomes for society (c.f. The War on Drugs).
But in any case, FDA's job is to dictate the actions of companies, and prevent as well they can companies lying to and misleading consumers. Its mission is not to dictate individual behavior. And nor should it be.
FDA is there to stop cigarette companies from arguing or advertising to consumers that smoking is healthy, or that it makes you dick bigger, or whatever they think can make sales. FDA does not make rules preventing you from smoking.
What they're doing here is flexing control over a substance that has no giant, well-heeled organization pressuring them to allow companies to sell it.
I will note that I'm not an MDMA advocate; I've consumed a variety of chemicals, some in numerous quantities, but I've never knowingly taken MDMA. So my argument doesn't come from being butt-hurt about targeting my favorite drug; it's about the hypocrisy in the FDA wording of their warning.
Oh, I'll add: FDA doesn't make laws, but they're listened to by, and provide guidance for, lawmakers. And they do make decisions that decide whether a pharmaceutical or medical device company can bring a product to market, so they control legal supply. And this is only in the US, of course; the each country has their own version, and the EU has dozens from which corporations can pick and "give business to" to get approval to sell in that market.
There is this game where you get a million dollars with 99% probability and die a gruesome death with 1% probability if you press a certain button.
What would you do in that case?
IMO, statistics isn't everything, and one cannot only rely on statistics to make meaningful decisions. Lots of people I know wouldn't press that button.
Ah, but I disagree! The "gruesome" part is what changes it; it's an important detail in Pascal's Wager. If it were a sudden, painless death? I'd absolutely press it. If it meant death by being buried alive in a coffin? I wouldn't press it if the odds were 1,000:1, or 10,000:1. The "badness" vs "goodness" factor of each certainly factors into the decision process. The benefit would have to be enormous to outweigh the consequence of a long, terrifying, and/or painful death. Far more than money, for me.
But it if were even 50:1 odds, and the penalty is a sudden and painless death, vs the world being contacted and accepted into Iain Bank's The Culture? Heck yeah, gimme the button. I might take even worse odds.
And yet, I'm human, and humans are terrible at making decisions based on statistical odds; I'm maybe a little better than average for an American, but only because I have a formal process for making decisions like this. But I don't apply it intuitively to every risk, so I'm as bad as anyone else, in general.