I frequently see vapers arguing that e-cigarettes are not a “tobacco product,” because they do not actually contain tobacco. They argue that nicotine e-cigarettes are not the same as tobacco or smoking cessation products and should have a classification all of their own.
However, nicotine isn’t regulated in the U.S. by what form it takes, but instead by “intended use.”
If the nicotine is contained in a product with an “intended use” as a smoking cessation or other treatment, it is then regulated as a “drug” and must go through clinical trials, studies, etc., and the product must meet strict manufacturing protocols before release to the public. If the nicotine is contained in a product with an intended use of “recreational” (ie. intended for human consumption but not as a treatment of any kind) it is regulated as a tobacco product. (A third classification is a pesticide, but that form of nicotine is not allowed for human consumption.)
It was this “intended use” criteria which kept the FDA from being able to deem non-therapeutic e-cigarettes as unapproved drugs. Judge Leon gave the opinion in Sottera, Inc vs. FDA that so long as the manufacturer/retailer made no treatment/health/therapeutic claims, they weren’t considered a drug. But that meant the only other option was “tobacco product.” The FDA defines a “tobacco product” as any product that not only contains tobacco leaf, but also any derivative (ie. “a compound derived or obtained from another and containing essential elements of the parent substance”) of tobacco. Nicotine is clearly a “derivative” of tobacco and while it is also a derivative of other plants, the nicotine in e-liquid is currently all derived from tobacco. However, since nicotine is classified by “intended use” and not the source, even nicotine from other plant material could be deemed a substantial equivalent and treated exactly the same as tobacco-derived nicotine, because of it’s intended use. It’s obvious to everyone that we use e-cigarettes with the same “intended use” as other tobacco products – mainly, the same way we used to use traditional cigarettes. It may be a far safer form of recreational nicotine use than regulators never foresaw, but it is still technically “recreational use” of nicotine derived from tobacco.
It’s important to note that the only “bad” things about being considered a tobacco product is 1) the public perception that all tobacco products are equally harmful and 2) the threat that the FDA will regulate them as if all tobacco is equally harmful. Educating the public and correcting this perception and convincing the FDA and politicians not to regulate low-risk tobacco products identically to high-risk products is the ultimate goal of many smoking alternative advocates. Changing perceptions and exposing the lie that there “is no safe tobacco product” will also go a long way towards gaining social acceptance. Something many vapers often overlook is that if the public still believes that all nicotine use should be discouraged because it’s equally dangerous or just socially unacceptable, then it won’t matter if e-liquid gets a separate category. They will just regulate that “e-cigarette category” as strictly as tobacco or possibly worse. We could end up with less hoops to jump through than drug products, but far more than if we are a tobacco product.
Consider the fact that a tobacco product such as snus already has reams of scientific data showing it is an extremely low-risk product. There is far more evidence of relative safety of snus than there is for e-cigarettes, yet the product is still banned in the EU and anti-tobacco zealots in the U.S. continue to attempt to regulate snus as if it was a deadly product. Yes, it is clearly a tobacco product (as it obviously contains actual tobacco leaf) but it just demonstrates the fact that actual public health risks and science is in no way dictating reasonable regulation. Regulation is obviously being pushed by an ideological opposition to recreational tobacco and nicotine use rather than science and reason. There is no reason to believe that separate e-cigarette regulation would be treated any differently by these people. In fact, a brand new category could prove to be a gift to the anti nicotine and tobacco zealots, as it could give them a blank slate for far more restrictive regulation than currently available to them for tobacco products. The point being, tobacco product or not, we would still be in the position of arguing that there is nothing wrong with recreational tobacco and nicotine use either way.
The chance that the FDA will treat a product that is derived from tobacco and used like tobacco as a whole separate category, with fewer rules and regulations than tobacco, is extremely slim. Especially if the public continues to believe that the ultimate goal in smoking cessation is eliminating the nicotine addiction instead of eliminating exposure to smoke.
Yes, e-cigarettes are going to be classified as a tobacco product, but the point being missed by many vapers is that there shouldn’t be anything wrong with that. What is wrong is how low-risk tobacco products are being irresponsibly regulated with prohibitionist ideology and lies instead of fact, science and reason. If we don’t change that, e-cigarettes won’t stand a chance no matter how they are categorized.
(Postscript: It has been brought to my attention that some folks may suspect this post was written in reaction to a recently broadcast, e-cigarette related internet show. The timing of this post is purely coincidental. This blog post was actually inspired by (and largely uses) my post on the ECF forum. )