It is not just about harm. FDA rules on medical products also in fitness of purpose. If you can show that your arsenic preparation is effective and safe, it will be allowed on the market. Likewise MDMA preparations and cannabis preparations for specific purposes. (They cannot because it is schedule I. )
DEA governs the drug schedule, not FDA. That should be don from almost strictly criminal point of view, with major politicization.
> It is not just about harm. FDA rules on medical products also in fitness of purpose.
This is because most drugs aren't really that good for you, however in the context of some illness, the disease may be worse than the unwanted effects of the drug.
A good example is methotrexate (MTX): wow, it really clears up its patients' arthritis, but it's so toxic that it's only administered to patients who are more at risk of dying of cancer than of the MTX.
I've appeared before the FDA (in pursuit of drug approval) and in my experience they're actually more than fair. The biggest problem is the assholes who try to game the system, which just gums up the works for everyone.
edit: I'm no longer in that biz so have nothing to gain by praising or condemning the FDA. The approval process is far from perfect but I honestly think it's pretty good overall.
Technically the DEA doesn't control the drug schedule either. Under the Controlled Substance Act the Attorney General controls the scheduling of drugs. Attorney General's have delegated this responsibility to the DEA but could reassign it to any part of the DoJ at anytime or choose to override any decision of the DEA.
People drink bleach to cure autism. Should we ban bleach?
First, there's a difference between allowing the sale and distribution of a substance at all and selling it with a claim. All I would say is that [almost?] no substance's sale should be banned. Maybe taxed or something.
Second, this is going to sound harsh to some, but I think at some point, if someone buys arsenic to cure baldness, it's their responsibility.
It's fairly common for people to seek expert advice on something not because it's legally mandated, but because there is a culture and individual understanding that something is outside of your ability/skill to do without severe negative consequences. I have someone else do my taxes because I don't want to screw something up. You can represent yourself in a court of law, but in most/many cases it's inadvisable. If I need to have certain things done on my house, I hire an expert because I don't want to cause damage and/or injury. I think a similar cultural norm needs to exist regarding substances and health care more broadly.
To me there's something fundamentally illogical about the current approach to drugs, because if taken to its logical conclusion, it involves banning people from purchasing any substance unless they have appropriate credentials. The government just allows exceptions to the logic (e.g, alcohol, household chemicals, etc.) because to enforce it would lead to a lot of uproar. That seems really legally unsound to me. The more sound approach would look totally different.
He's going to wait for a bunch of people to die, start a class action lawsuit, spend the next ten to fifteen years researching and litigating to determine whether or not arsenic does, in fact, cause cancer, and then, tens of millions of dollars and thousands of lives later, let a dozen people who were not smart enough to get out of jury duty make that determination.
Best case-for-the-public scenario, he's going to end up paying a fine to the government, that will be used to advertise the dangers of arsenic, and will be given retroactive immunity to any new class action lawsuits. The only way that he will be able to pay that fine, will be by continuing to selling arsenic to the public, killing thousands more.
If that seems too outlandish, may I direct you to tobacco trials? [1] Legal, until proven harmful turned out absolutely great there!
DEA governs the drug schedule, not FDA. That should be don from almost strictly criminal point of view, with major politicization.