If the FDA views its role as evaluating for harms only and not efficacy, then this isn't itself necessarily a contradiction. That doesn't change the fact that

If the FDA views its role as evaluating for harms only and not efficacy, then this isn't itself necessarily a contradiction. That doesn't change the fact that this approval is deeply disheartening and tells us the FDA is cool with any random product claims so long as they don't actively hurt people. But, hey, for all those folks who glory in the good ol' days when men were men and radium was a cure-all, the good news is at this rate we'll be back to snake oil and patent medicine in no time!