This is the last in a three-part series on e-cigarettes. Part I is available here. Part II is available here.

E-cigarettes or vapor products aren’t specifically mentioned in the Tobacco Control Act. The FDA had no expressed mandate to do anything. But that isn’t stopping them from trying. If the FDA actions are not significantly changed by the administration, the Congress, and potentially the courts, FDA regulations will certainly do more to harm public health than benefit it. The nexus used by the FDA to sweep vapor products into its regulatory regime was that nicotine in the products was “tobacco derived.” Most, or all of it, is, just like the nicotine used in gums and patches. Frankly it’s cheaper to acquire nicotine from tobacco than it is to acquire it from other plants (it’s in tomatoes, eggplant, and other nightshades) or to create it in a lab. But, as regulatory agencies often do, the FDA has indicated that they will broadly exercise authority to regulate devices (that contain no nicotine and are not tobacco-derived) or zero nicotine liquids.

Most significantly, the FDA deeming rule related to these products creates an effective ban on tens (if not hundreds) of thousands of existing products. The Tobacco Control Act and subsequent FDA regulations allowed all cigarette products sold before 2007 to remain on the market so long as they complied with existing rules. Rather than allow existing vapor products to remain on the market upon publication of the deeming rule, the FDA immediately banned any new products from entering the market and will require all existing products to complete a prohibitively expensive and largely arbitrary application process, with no clear guidance from the FDA and little or no likelihood of approval.

This is the second in a three-part series on e-cigarettes. Part I is available here.

Vapor products contain no tobacco. They produce no smoke. Most contain nicotine and it’s the same nicotine used in FDA-approved gums and patches. While the devices look different, they all operate by heating a liquid solution (propylene glycol and/or vegetable glycerin, nicotine and flavor) to produce an aerosol. Importantly, the products allow users to replicate the act of smoking. Like smokers, vapers engage hands and mouths in a ritual similar to the one they practiced every day for many years as a smoker. Like a smoker, the vaper inhales and exhales and can both feel and see the vapor produced. But unlike cigarette smoke, the aerosol dissipates quickly. There’s no smoke, no tar, and no carbon monoxide – the things that cause half of all smokers to get sick and some to die. Nicotine doesn’t cause lung cancer or make smokers sick. As far as its heath impact, it’s comparable to caffeine. As long as you don’t consume caffeine or nicotine through smoking, most people can use it without incident for an entire adult lifetime. Nicotine also seems to bring health benefits for some.

There is little doubt that part of the consternation of tobacco control groups and regulators simply arose from the fact that products are called e-cigarettes and using them resembles smoking. That reaction is emotional, not rational. Perhaps we can appreciate that it motivates tobacco controllers to investigate further. Rather than investigate and try to understand, however, the FDA initially stepped in and attempted to shut the industry down by banning the importation of e-cigarettes as unapproved medical devices. And electronic cigarette company, NJOY (previously Sottera), was targeted by the FDA and had imported products seized at the US border. NJOY fought the federal government, ultimately winning in court.

Since the US Surgeon General’s report on smoking and health in 1964, governments (local, state, federal) and tobacco control groups have waged a comprehensive campaign to encourage smokers to quit and discourage non-smokers from starting. They have used every tool available with cost being of little concern.

They’ve educated about the harms associated with smoking. When that didn’t do the trick, they attempted to shock and scare smokers away from the habit with graphic images. They’re in a half-century cycle to fight for increased taxes. They’ve banned smoking anywhere people congregate. They’ve filed individual lawsuits, class action lawsuits, and lawsuits from state attorneys general (resulting in the tobacco master settlement agreement that forced tobacco companies to pay billions to the states, all costs passed on to consumers via increased prices).

They’ve restricted the ability of companies to sell and market products, restricted use of brand-name advertising and eventually they decided scaring children might discourage them from becoming smokers. They also thought sending terrified kids home to shame their smoking parents could only benefit their cause.