In many cases, it seems to come down to claims. For instance, a pill that fixes ED is a claim to fix a known health issue....ED. A pill that makes you "bigger, because she'll love it" is not a health claim as it doesn't claim to fix a medical condition. An undersized penis is not a medical condition....at least not in the eyes of the pharmaceutical companies. When their sales of boner pills slows, I'm sure they will create some named disorder like penile size syndrome (PSS) so they can classify it, diagnose it, and of course treat it with their FDA approved pills With that said, the FDA does have more control than just marketing claims, so undoubtedly they can ban *almost* at will. That is why it is important to get as much public support as quickly as possible. Public support from both smokers and non smokers goes a long way in shaping policy.