Hopefully the FDA will learn something from this,
FDA is no longer able to make the kinds of demands for scientific information and validation of safety that they used to, on people who are selling food supplements.
If the FDA approves this drug, it is certain that it will have to be banned within a short time after marketing begins because of the high probability of further occurrence of the serious injuries it has already been found to cause.
It is an extremely dangerous drug, and it's just reckless for any company to be selling it, and it's reckless in the extreme for the FDA to allow this to stay on the market.