- Thursday, 05 May 2016 21:04
By Dr Farsalinos
After a very long waiting period, the FDA released today its deeming regulation on e-cigarettes. The regulation is nothing unexpected and nothing new. The same regulations that apply to marketing a new tobacco (cigarette) product are used for e-cigarettes too.
Specifically, e-cigarette products need to follow one of the three options: premarket tobacco application (PMTA), substantial equivalent report or substantial equivalent exemption request. FDA is providing an extensive compliance period which differs depending on the application.
The cost for any of these routes is tremendous and prohibitive. The substantial equivalent report needs to refer to a predicate product, being marketed before February 2007. As we all know, only cigalikes were available at that time. Thus, it is virtually impossible for current new-generation products to follow this route. Moreover, it is questionable if e-cigarette components which are sold separately and not as kits (atomizers, e-liquid, batteries) will be able to use any of the three options. How can you define aerosol components and HPHCs when the e-liquid can be used with hundreds of different battery and atomizer combinations? How can an e-liquid manufacturer make any kind of application for a product? The same applies to atomizer and battery manufacturers. Moreover, with the current variability of e-liquid flavors and nicotine “strengths”, it is virtually impossible for anyone to have enough funds to submit so many applications. The only exceptions are the small number of companies who are selling kits, usually cigalikes or (at most) ego style batteries with prefilled tank atomizers and a limited range of flavors and nicotine strengths. We are well-aware that the new-generation devices are much more effective in substituting smoking because they are chosen based on self-preference and satisfaction, they provide the variability in flavors to avoid the sensory tolerance and saturation (which is not observed with tobacco cigarettes) and they are much better in delivering nicotine to the aerosol at high-enough levels and consistently (as we recently showed in one of our studies).
Many people will think that the FDA and its scientists are ignorant about how e-cigarettes are used, thus they created a totally inappropriate regulation. However, I think that FDA scientists are very clever and very well aware of the e-cigarette reality. Obviously I am not a lawyer but, in my opinion, the FDA officials were legally obliged to follow this path and create such a regulation. Even if they wanted to, there is no way to avoid the already-established regulation on tobacco products. This is the cost for classifying e-cigarettes as tobacco products, based on the fact that nicotine is derived from tobacco. I have published an article (co-authored with Gerry Stimson) supporting that this is not a science-based claim, but unfortunately this is the law in the US.
In Europe, the TPD regulation on e-cigarettes is much more appropriate and compliant for new-generation products, despite some unnecessary limitations and flaws. Since last year, when an FDA document with information about the regulation was leaked, I supported that Europeans should feel lucky for the TPD because it is much better than the disaster expected in the US. I was right. Unfortunately…