[ekianjo]

Completely false. Be it for the potential side effects of such a substance, it would be considered as a drug anyway since it would require proper medical monitoring. Even cosmetics are sometimes at the borderline of drugs based on the claims they make and the effects they have.

The reason why alcohol and cigarettes are not regulated as drugs is rather based on historical, political and economical factors. They have existed for a long time and people are considered responsible enough to know how not to abuse them, they have a well known risk factor, and they bring back lots of tax money to society when authorized.

But for any new substance, you bet FDA would be involved, no matter whether you call it a drug or not.