Recently in the Federal Register, the FDA made an “interesting” conclusion about manufacturers of e-cigarettes, aka smokeless tobacco vaporizers. Their statement concludes that in order to market their products as a way to quit smoking cigarettes, e-cig manufacturers must go through an extensive and expensive process to redesignate e-cigs as pharmaceutical anti-smoking products.
They go on to say that e-cigs can no longer be marketed as a healthier alternative to smoking cigarettes. Thus the improvements that could have happened by smokers switching to the less hazardous e-cigs will not happen. The new rule should lead e-cig manufacturers to clarify more precisely when “a product made or derived from tobacco that is intended for human consumption will be subject to regulation as a drug, device, or a combination product”. In this way, they can divide what they allow as “medical” anti-smoking products such as Nicorette gum, patches, and what they consider non-medical tobacco products — which now include e-cigs.
From the FDA official report:
“Smoking cessation claims have also long been associated with intended uses of curing or treating nicotine addiction and its symptoms….Against this backdrop, smoking cessation claims on any product generally create a strong suggestion of intended therapeutic benefit to the user that generally will be difficult to overcome absent clear context indicating that the product is not intended for use to cure or treat nicotine addiction or its symptoms, or for another therapeutic purposes”.
There have been well documented cases of individuals who were able to utilize e-cigs, as well as other products to end their addiction to cigarettes. The variance is how the nicotine is delivered to people and through what medium.
Time will tell if the current restrictions imposed by this government agency are altered to be more consistent or if they remain unchanged. It is worth noting that this author neither condones or condemns the use of e-cigs or even cigarettes. The point here is to make sure the FDA and other government agencies stay consistent.
Let me know your thoughts about this issue.