Can the FDA regulate non nicotine electronic cigarettes? That’s the question put to the fore of the multi-faceted ecig debate recently. It’s also part of the lawsuit that eliquid maker Nicopure Labs brought against the FDA back in May. They’re suing the FDA over the now-implemented deeming rule that we’ve covered ever since it was suggested. This of course is the new set of regulations which is supposed to govern electronic cigarettes, and essentially put them in the bracket of tobacco products. But what about non nicotine electronic cigarettes?
It’s a tricky question. Certainly there has been a lot of confusion over the new regulations and what they mean. The FDA has made an effort to be available to answer questions, but this one is a much more nuanced question. It’s also an opening that Nicopure Labs sees as a way to try and strike down these new laws. After all, it’s going to hit eliquid makers the hardest, as they are the ones who will now need to submit every product of theirs for FDA testing. That means every flavor and every nicotine level variant of that flavor. With the costs of being put through regulation estimated between $500,000 and a cool million dollars, this stands to be a tough showdown.
Nicopure, which has stated in the past that the regulations “would subject electronic cigarettes and other vaping products to more onerous restrictions than combustible cigarettes under the Tobacco Control Act,” has no option but to fight them. They do make a good point, too. If the regulations place ecigs in the tobacco category because they use nicotine derived from tobacco, why would it extend to non nicotine electronic cigarettes? On the face of it, it seems they have a case here. Of course, the FDA also won’t take this lying down.
Non Nicotine Electronic Cigarettes Dilemma
No, the FDA very much disagrees with Nicopure on how they should view non nicotine electronic cigarettes. In a response they filed last week, the FDA wrote “Although the FDA recognized that completely switching to e-cigarettes may reduce the risk of tobacco-related disease for individuals currently smoking conventional cigarettes, it found that e-cigarettes still pose a number of significant health and safety risks.” This means both nicotine ecigs and non nicotine electronic cigarettes, according to the FDA at least. Whether it’s the fear that, attacked from this angle, their regulations regime will go crumbling, or if they are simply dead-set on encompassing all ecigs, they aren’t going to back down.
Of course this dilemma is a no-brainer for vaping activists. Gregory Conley, the American Vaping Association president, slammed into the FDA yet again. “At the same time that England and France are making great strides in distributing truthful information about vaping to the public, the FDA is ramping up the rhetoric and relying on easily debunked junk science,” said Conley. He also claims that Mitch Zeller is out to destroy the entire vapor industry. Zeller is currently head of the FDA’s center for Tobacco Products. But guess what? He was also a former pharmaceutical lobbyist. Thus, it’s not surprising that his policies are raising some eyebrows.
Conley wastes no time going after Zeller directly. Claiming that he “recognizes that unless you decimate nicotine-free e-liquids and open vapor system devices, there is no possible way for the agency to truly kill the industry.” Those looking for an electronic cigarette without nicotine might very well agree with Conley. It is, after all, a common pathway from making the switch to electronic cigarettes, first with nicotine and then later without. For a lot of people, this may be the last straw.
If all this sounds like a lot of mudslinging, you should prepare yourself for more. Remember, this is a billion dollar industry. Big Pharma, who would much prefer that smokers made the switch to one of their own nicotine replacement products, has not ignored that fact. It’s bound to lead to even more testy battles, in a judicial court as well as in the court of public opinion. Buckle up folks, we’re just getting started.