The FDA’s Insane Definition of ‘Tobacco Product’ Drives Vaping Innovation

Two companies try to dodge onerous rules with a system that delivers only synthetic nicotine.

By Jacob Sullum

(Reason)

The Food and Drug Administration’s onerous e-cigarette regulations, which are expected to put all but the largest producers of vaping equipment and e-liquids out of business, are based on the counterintuitive premise that tobacco products need not contain tobacco. If they contain nicotine derived from tobacco, as the fluid that e-cigarettes turn into an aerosol often does, that’s enough for the FDA to regulate them as tobacco products. But what about the many varieties of nicotine-free e-liquids, sold in disposable e-cigarettes, replaceable cartridges and bottles for refilling vaporizer tanks? Do those liquids and the systems in which they are used also qualify as tobacco products?

As I explain in a recent Forbes post, the FDA seems incapable of giving a straight answer to that question, which is crucial in determining which products are subject to regulatory requirements that will prove prohibitive for most of the companies that currently offer smokers a much safer alternative to conventional cigarettes. It sounds like nicotine-free fluid still counts as a tobacco product if it can be used in vaping equipment that also can be used with fluid that contains nicotine. If so, all e-liquids sold in bottles would be treated as tobacco products, even when they contain neither tobacco nor nicotine. But if that is the FDA’s (il)logic, a disposable nicotine-free e-cigarette or a closed vaping system that accepts only nicotine-free cartridges would not qualify as a tobacco product.

What about nicotine that is not derived from tobacco? Various other members of the nightshade family, including eggplant, tomatoes, and green peppers, contain nicotine, which also can be synthesized in a lab. Companies such as Amaranth Vapor advertise e-liquids containing “tobacco-free nicotine.” As the Manhattan Institute’s Jared Meyer notes at National Review, those liquids, like the nicotine-free versions, apparently are still covered by the FDA’s bizarrely broad definition of “tobacco product,” because they are used in devices that also can be used to deliver tobacco-derived nicotine.

But what if you had a vaporizer that worked only with “tobacco-free nicotine,” combined with liquids that worked only in that device? That is the convoluted idea behind a joint project announced today by the vaporizer company Vapeix and Next Generation Labs, which makes synthetic nicotine under the TFN brand. The press release says the two companies are “leveraging the world’s most advanced embedded firmware, software and hardware” to “develop both closed and open system vaping devices for Next Generation Labs’ e-liquid brand customers who use TFN Nicotine.”

Lack of flexibility is a key selling point. “Through the smart technology embedded in Vapeix Powered devices,” says Next Generation cofounder Ron Tully, “the vaporizers will only work with TFN brands—allowing us to create a vape market which is unequivocally disassociated from traditional vaping devices that are intended to be used with tobacco-derived nicotine.” Vapeix founder Kyle Newton notes “there’s currently a lot of fear in the market as vape businesses and analysts worry that regulation will stifle innovation in the industry.” He hopes the joint venture will create “a new product category that will enable future innovation in a narrowing industry.”

I suspect the FDA will try to regulate these high-tech contraptions as tobacco products too, although whether the agency’s reasoning will be upheld by the courts is another question.

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