The logic of harm reduction couldn't be clearer: if smokers can get nicotine without smoke, millions of lives could be saved.

Sweden has already proven the point. Through widespread use of snus and nicotine pouches, the country has cut daily smoking to about 5 percent, the lowest rate in Europe. Lung-cancer deaths are less than half the continental average. This "Swedish Experience" shows that when adults are given safer options, they switch voluntarily—no prohibition required.

In the United States, however, the FDA's tobacco division has turned this logic on its head. Since Congress gave it sweeping authority in 2009, the agency has demanded that every new product undergo a Premarket Tobacco Product Application, or PMTA, proving it is "appropriate for the protection of public health." That sounds reasonable until you see how the process works.