Yeah. Every drug has side effects; I’m saying that it’s a weak excuse for not approving it, considering all of the other crap FDA’s approved, with all of the other crap’s side effects. So label it, put a warning on it.
Cigarettes will most likely kill you if you smoke enough of them, and FDA still allows their sale even though they have no medical application. Same with alcohol; despite the alcohol industry’s efforts to link health benefits with alcohol consumption, there are as many studies showing there’s no verifiable link between any benefit and any amount of alcohol consumption. It’s a poison that dehydrates you and shrinks your brain a little every time you drink it. But it’s legal.
FDA is the only dyke preventing outright charlatanism by the pharma and medical device industries, but fuck them on this topic. They’re there to ensure companies don’t outright lie to consumers about benefits and risks; preventing access to risky behavior is not their job.