> It's the job of a regulatory body to reduce risk.

Sure, and the parent comment's point was that there's a line where further risk reduction doesn't make sense anymore. The agency doesn't have the right incentives to stop at that line.

Plenty of very significant risks aren't regulated to the degree that Viagra and Cialis are. You don't need a note from a doctor or a govt-issued permit to buy kitchen knives or a table saw or a Bic lighter, for example.

Kitchen knives have multiple uses and discretion through education is expected as standard.

Viagra and Cialis have a singular use and contraindications aren't likely to be understood through cultural osmosis.