From: Alex Clark
To: FDA Center for Tobacco Products
RE: FDA, Docket No. FDA-2014-N-0189, Regulatory Information Number (RIN) 0910- AG38
August 8, 2014
I am writing to you as one of the primary stakeholders in this issue – as a consumer. The proposed FDA regulations (Deeming Tobacco Products To Be Subject to the Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products) should be designed to protect me and millions of other consumers. However, it is clear that the FDA is preoccupied with the impact on an unrealistically small portion of the industry. It is also apparent that the justifications for this proposed rule are supported, in large part, by politically motivated misinformation that is better suited for sensational headlines in the media. Allowing such a bias to work it’s way into policy is counter to the mission of the FDA to protect the public and ensure our access to quality products. Not only is this obviously damaging to consumer welfare, but it erodes any confidence we might have in federal regulatory agencies.
There are other aspects of this proposed rule that limit consumer awareness about these products. It is an apparent effort to limit information that would empower us to make better choices. For example, the inquiry into appropriate labeling requirements for tobacco products suggests that FDA would require all nicotine containing products (with the exception of approved cessation products) to display an addiction warning. This is, of course, offered without any investigation into the harm of “addiction”. Rather, the FDA seems to rely on the common notion that “addiction” is a disease for which there is no convenient pharmaceutical cure. Addiction is casually accepted as the root cause of the suffering and moral compromise experienced by addicts.
This is counter to a more enlightened view in which substance abuse is a symptom of a larger spiritual and emotional crisis. If federal regulatory agencies are to take the reins on combating or preventing future generations from becoming dependant on culturally deviant substances and/or activities as a means to alleviate the pains of modern life or personal trauma, it might be more productive to have a conversation about subjects including current population level attempts at social engineering and the effect such efforts have on our collective psyche. Or perhaps we need to re-evaluate our priorities as a society. Neither of which can be accomplished by restricting public access to valuable, honest information and the tools to understand it.
That having been said, it is obvious that such an “addiction warning” on low risk products like e-cigarettes is a thinly veiled attempt to mislead consumers into believing that these products are equally as harmful as combustible tobacco. Such disregard for consumers’ right to unbiased information is irresponsible, irrational, immoral, and downright patronizing. Furthermore, muddying the waters of the larger discussion on addiction can’t be ignored as having a net negative effect on the evolving clinical and common understanding of the issue which, in turn, negatively impacts public health.
I became a full-time smoker shortly after earning my driver’s license. Smoking was a quick and relatively effective means for coping with the anxiety of driving. From the age of 16, I was a two pack-a-day smoker for the better part of 21 years. The last 4 of which, I used nicotine gum at home and smoked one pack per day at work. In my 21 years as a smoker, I made 3 quit attempts. Once “cold turkey” and two other times with the aid of nicotine gum. Each attempt resulted in less than 24 hours of complete abstinence from smoking. Although during my last attempt I had been smoke free with the aid of nicotine gum for two days prior, once I was back at work the 4mg gum proved to be ineffective. I made it ⅔ of the way through my work day when I realized I felt inebriated from the withdrawal. I came to the conclusion that I would need to buy a pack of cigarettes and resume smoking if I was going to be physically able to drive home that night.
A couple of weeks after the disappointing experience of my last quit attempt I decided to try an e-cigarette on a whim. The $10 disposable devices I selected offered a proof of concept that I might be able to switch away from combustible tobacco. I spent the rest of that weekend researching and ordering devices. The only cigarettes I had after my first e-cigarette encounter were on Monday as I waited for my “starter kit” to arrive in the mail.
Since switching to electronic cigarettes a year and a half ago I have not smoked a single cigarette. I’ve noticed my senses of smell and taste have returned and I don’t get winded as easily (although, I suspect my sedentary work and leisure activities will be my next hurdle). I also don’t experience headaches as much as I used to. Admittedly, I am inconveniently reminded daily of my desire to smoke (similar to the experience I have with recovery from other substances). However, I have found e-cigarettes to be a useful and enjoyable tool in my daily struggle to remain smoke-free.
I discovered very quickly that the low power, mass produced “cig-a-like” products were not enough to fully replace my dependance on smoking. Although the placebo like “proof of concept” aspect helped to get me through my day, there was an obvious discrepancy in the amount of nicotine they delivered (after some cursory research, It is my understanding that there are other ingredients in combustible cigarettes that I had become dependant on). Using more capable devices seemed to fill the gap for me. This being the case, if “advanced devices”, “open systems”, and high nicotine concentration e-liquids (i.e. 24mg/ml +) are regulated off the market, I am concerned that I’ll be tempted to return to smoking. Although I would be able to substitute cigarettes with a smoke free option like snus (which I already use where laws prohibit vaping), there are significant elements of vaping/smoking that oral tobacco can not effectively replace.
On the other hand, over the past year and a half I’ve acquired enough knowledge of advanced devices that I’m confident I’ll be able to continue successfully using them. There is also an established “DIY” community with an evolving collection of online resources that I will be able to consult for information and instruction on making my own e-liquid at home. Similarly, there is an established community of “modders” who are able to produce and instruct others in making advanced devices. Sometimes the plans call for components that require machine skills and tools but, for the most part, advanced devices can be made from components readily available in hardware and electronics stores. I am also confident that fully assembled devices will still be available in private, online groups despite and likely in defiance of any regulation.
In addition to the threat of having advanced devices and open systems regulated off the market, it is being suggested that the FDA strictly regulate the wide variety of flavors, reducing them to traditional menthol and tobacco. This is a mistake as many of us have come to rely on the cornucopia of flavor options as a means to distance ourselves from the traditional combustible tobacco experience. Using myself as an example, I enjoy at least 3 different flavors throughout my day. Unlike the brand loyalty I experienced as a smoker, my inclination as a vaper is to explore. The variety of flavors and devices keeps me engaged with the product and less likely to seek other sources of nicotine.
Again, if this wide range of options were to eventually become narrowed to traditional tobacco flavors, I would have little problem accessing the knowledge to make my own flavored liquid at home. To be honest, I’m a little surprised I haven’t started doing this already. It’s also well within reason that the same groups I would turn to for information on producing my own liquid at home would be able to connect me with other “DIY” manufacturers that would be willing to sell me a completed product. Of course, I would be doing this with the full knowledge that I am risking exposure to potentially harmful contaminants that may have been missed in an unverifiable quality control process as black market manufacturers are understandably not very public with their manufacturing practices let alone their physical address and phone number.
Another dimension of these products that lacks consideration in the FDA’s calculations is the community that has developed around them. It is a fair assessment that the vaping community might be described best as an informal support network for recovering smokers. Although on the surface the community appears primarily concerned with proper and effective use of the products, there is an underlying encouragement among vapers to make positive health choices and remain smoke free.
In fact, prior to the proliferation of brick and mortar vapor stores, there are accounts of online vendors making special trips to help individual customers that had run out of supplies and were dangerously close to relapsing. I have witnessed the same camaraderie and support between individuals over great distances as well. Although the former example can be callously dismissed as motivated by profit, the latter is, undeniably, motivated by goodwill and speaks to the general atmosphere of the vaping community which includes participation from vendors. In areas where brick and mortar stores are common the accounts are less dramatic but, no less heroic. Retail locations have become popular gathering spots where vapers can help each other, both with product assistance and moral support. Although the community lacks the same guided soul searching and emotional work required in other, well known self help programs, the goal of supporting a person’s choice to move and stay away from harm is the same.
It would be fair to argue that the organic development of this informal support community is making measurable progress in reducing the overall smoking rate. Possibly more so than previous, funded tobacco control efforts. If the FDA is to allocate financial resources to study e-cigarettes and other novel nicotine products, the vaping community would be a good place to start. It should go without saying that this research should (and can) be performed in advance of any finalized regulation.
It is disappointing to see that one of the most significant decisions I’ve made in my adult life to improve my health has become part of a larger political tug of war (perhaps Chess is a more apt analogy as consumers are clearly pawns here). The weekly, almost daily, back and forth regarding the opinions of the scientific and public health community on the safety and efficacy of e-cigarettes is exhausting. It is, no doubt, reminiscent of the decades long debate over the health consequences of eggs.
That having been said, one of the obvious casualties in this debate will be the public’s trust in health groups, federal regulatory agencies, and legislators who blindly beat the drum for empty “feel good” laws. An even more disastrous, possibly unintended consequence of politicising the tobacco harm reduction debate is a growing mistrust of the scientific community. It is unfortunate to see highly educated and well qualified people who have become public figures in the anti-smoking movement presenting misinformation and hyperbole as fact.
As a matter of formality and in the spirit of redundancy I would also like to state that I support the Comments submitted by The Consumer Advocates for Smoke Free Alternatives (CASAA) in it’s entirety (Tracking number: 1jy-8do4-hbnw). I am currently serving as an unpaid, volunteer board member of this organization, which essentially means I am still an individual consumer.
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