“Once more unto the breach, dear friends, once more;
Or close the wall up with our English dead!
In peace there’s nothing so becomes a man
As modest stillness and humility:
But when the blast of war blows in our ears,
Then imitate the action of the tiger.”
-William Shakespeare, Henry V
In the first revelation I talked about my early experiences and gave some evidence of advocacy. I will be furthering this effort in this post as I will include my response to the FDA regarding their proposed deeming. Why do this? Because it might give some who follow this on Twitter and Facebook a chance to crib from my response and make one of their own.
Before I include that communique I want to share a few other revelations I’ve had since Part I.
The first is the realization that I’ve spent a lot of time doing the research, i.e. reading my backside off. For my friends and family that meant being uninterrupted and unavailable, up at all hours and with no real explanation other than: “The future availability of vaping as an alternative to smoking is at stake.” That’s hard for some to understand. It’s far easier to believe that other, better qualified and paid spokespeople should be doing the work. Unfortunately, while such people do exist they are few in number. The organizations who are attempting to regulate vaping out of existence are many, well funded and with much longer experience at manipulating public opinion. It is only when we the people add our voice that the message may begin to make a difference. So I am becoming one of those ‘better qualified’ albeit unpaid spokespeople because I can carry the message.
Second is the realization that the opposition doesn’t really have anything better in mind than their own self-importance and the preservation of their revenue stream. That and the idea fixed firmly in their rhetoric that the only good smoker is a dead smoker. I’ve either watched or read many transcripts from efforts around the country to deal with vaping in a reasonable way. Every time without exception I’ve seen the same players (the American Heart Association, the American Lung Association, the Center for Tobacco Free Kids to name a few of the most egregious) demonize vaping, ignore the preponderance of evidence, outright fabricating “facts” and lobbying against their own proposed legislation when they didn’t get what they wanted. Most telling was our recent efforts to ban the sale, use and possession of e-cigarettes by minors in Missouri. The legislation was clear, easy to understand and comprehensive. Amendments were attempted to define e-cigarettes as tobacco products. These amendments were defeated and the bill passed and was sent to Gov. Jay Nixon’s desk for signature. A bill that would ‘protect the children’ from the evils of vaping was passed and ready to be enacted into law with the stroke of the Governor’s pen. What happened? The very same above mentioned organizations who purport to be all ‘for the children’ lobbied the Governor’s office and he vetoed the legislation. Really! Governor Nixon vetoed legislation that would protect children by making the sale, use and possession of electronic cigarettes by a minor illegal, complete with provisions and penalties against the vendor who sold the youth the product! This is not an isolated incident either. In other states and counties legislation has been voted down, tabled, or withdrawn which would do exactly the same thing at the urging of these very same organizations because they couldn’t get the legislators to endorse their rhetoric when the science was clearly against them.
Third was the realization that our congress-critters have absolutely no clue what’s going on. Really it is the plethora of aides and staff members that habit the halls of government that determine what’s really going on. Congress members may come and go, but these dedicated government employees have been there forever. They are masters of Govspeak and can craft a form letter to constituents (if there isn’t one already in the files) that makes it look like your representative is on the ball, no matter which side of the issue you’re on. I’ve accumulated a nice collection of these missives of mediocrity. At least they all thank me for expressing my concerns. In talking directly with them they will listen once you can make it clear that the member’s stance will either gain or lose votes.
Finally I’ve realized that no matter how important something might be to someone, their ability to act on a threat is inversely proportional to the amount of time it takes away from the fun stuff in their lives. This may be the root of the problems in America today. A wise man once said: “Evil only succeeds when good men do nothing.” Indeed, we have acculturated entire generations to ‘do nothing’ because someone else will do it for them. Thus, even for something as seemingly important as freedom from smoking it is well near impossible to get most of the people who directly benefit to get motivated to act. Because of this I fear vaping will become extinct in two years. C’est la vie.
With all that having been said, one would think I’d give up myself. Well if it weren’t for the fact that I am a nurse and have acquired a deep affection for the health of my patients, many of whom smoke, I might have. But for them I’ll try to fight the good fight. For the person who hasn’t yet had the chance to experience freedom from tobacco having tried every other means to gain it is why I choose to do this. They truly don’t have a voice. The Anti-Nicotine and Tobacco Zealots (ANTZ) want them to die.
With all this in mind here’s the letter I sent to the FDA:
June 30, 2014
To: The Honorable Mitch Zeller, J.D.
Director, Center for Tobacco Products
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
From: Robert Bruce Nye, RN
1105 Hickory Hill Rd.
Papillion, NE 68046
Re: FDA, Docket No. FDA-2014-N-0189, Regulatory Information Number (RIN) 0910- AG38
Dear Mr. Zeller,
I am writing in regards to the Food and Drug Administration’s (“FDA”) Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the “Proposed Rule”) published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491.
I am both a Consumer and a Registered Nurse. I am very concerned that the proposed deeming regulation, while representing a sincere effort on the part of the FDA to bring order to tobacco harm reduction specifically in regards to electronic cigarettes (e-cigarettes), falls short of its goal. The proposed regulation will forever damage the current availability of all harm-reduction products and stifle innovation which produced these products.
I am further concerned that we are perceived at odds simply because the voice of the industry and its consumers was not present at the table to help craft regulations and support changes in the enabling legislation to enable the FDA to do a proper job of regulation. As a result I write this in opposition to the proposed deeming regulation with recommendations for more appropriate and meaningful legislation. Regulations that would more closely align the FDA with its goals of reducing the prevalence of tobacco use and promoting the public health both of current smokers and the non-smoking public.
I smoked since I was 12. I started when I found I wouldn’t get sick on the second-hand smoke from my parents cigarettes. After 42 years of smoking 1½ packs per day my lungs protested violently. On September 25, 2012 I was diagnosed with Stage II Chronic Obstructive Pulmonary Disease (COPD) subsequent to my smoking history and my fifth episode of bacterial pneumonia. My physician, Dr. Shalindra Saxena, MD urged me to do whatever it took to stop smoking as my health would likely rapidly deteriorate from this point forward. For the previous 22 years I tried every form of nicotine replacement therapy (NRT), pharmaceutical (bupropion and varenicline) and alternative therapies, none of them effective for more than 3 months (usually far less) and always ended up smoking again. Knowing I had to kick the burning leaf I researched e-cigarettes and, using advice from the E-Cigarette Forum and information provided by the Consumer Advocates for Smoke-free Alternatives Association (CASAA), made a committed purchase of equipment. It took a little while to learn to ‘vape'; once some skill is acquired it became natural. In short order I found the burning leaf intolerable, preferring my e-cigarettes instead.
After three months, I had a follow-up visit with my doctor. He immediately commented on how much better I looked, and after doing his assessment, how much better my chest sounded and how much my lung function had recovered. While I’ll always have stage I COPD due to the emphysema the chronic bronchitis flares very rarely now without the use of drug therapy. Concentrations of cigarette smoke and other lung irritants will set it off as will seasonal allergies.
It is now well over a year since my last tobacco cigarette on September 27, 2012. I’ve reduced the strength of nicotine from 24mg/ml to 6mg/ml and I am comfortable and much healthier. Before the switch to electronic cigarettes I was guaranteed to have two to three upper respiratory infections per year, to date I have had only one cold and it did not develop into pneumonia as was so typical when I smoked. Consider the economic and health impact for both me and my employer in reducing absence due to smoking related illness. Thanks to the free availability of an electronic vapor alternative I am tobacco free for the longest I have ever been. I don’t smell awful, I don’t hack constantly, I can taste and smell subtleties I’ve missed while smoking and I spend a fraction of what I paid for tobacco products or prescription NRT.
As a nurse with first-hand experience I have been called upon by colleagues to give information, including risks and benefits regarding my success. This has required diligence in keeping current with the state of research as it relates to e-cigarettes. As a result I am well aware of the weight of evidence that exists supporting the harm reduction and efficacy e-cigarettes represent. I am also well aware of the concerns and questions that are still in study or awaiting study. Indeed, my hospital began one of the larger longitudinal studies looking into the effectiveness and harm-reduction from the use of electronic cigarettes and the initial (unpublished) results are in line with other published studies in Europe that show the relative safety and effectiveness of this game-changing technology. There is a growing body of evidence which I cite only a few examples, that electronic cigarette use is an effective alternative to and radically less harmful than tobacco use (Brown, et al. 2014, Kotz, Brown and West 2013, Burstyn 2014). Studies which show the presence of harmful chemicals demonstrate both that they are far fewer in number and quantity (Goneiwicz, et al. 2014). The only study to achieve comparable levels of harmful chemicals to cigarettes (carbonyls) appears to have done so under conditions which are contrary to the actual use of the product and requires further study to validate this finding (Kosmider, et al. 2014).
Thus I am opposed to classifying electronic cigarettes as tobacco products for the purpose of regulation. Foremost among the reasons for my opposition is the association of electronic cigarettes with tobacco regulation creates a perception that electronic cigarette use is the same as smoking tobacco. This is at odds with the goal of harm reduction and smoking cessation. To create a false equivalence may damage the ability of citizens such as me to promote this safer alternative against the perception that it would be “just as bad as smoking the real thing”.
My second objection to regulation of electronic cigarettes as tobacco products stems from the treatment of other nicotine sources (e.g. Nicotine patches, gums, lozenges and inhalers) as exempt from tobacco regulation where their ingredients are basically the same as that found in electronic cigarettes: Those ingredients being a base, a variable amount of nicotine, and an optional flavor. To include electronic cigarettes as tobacco products will not likely survive legal challenge. The efforts to defend such challenges would be a drain on precious public revenues.
My third objection to regulation of electronic cigarettes as tobacco products stems from the problem of what constitutes the target of regulation. In the construction of an electronic cigarette there are three main parts: A battery, the vapor producing mechanism (often called an atomizer), and the liquid which is used to produce the vapor. As I mentioned previously, but worth repeating, the liquid consists of a base, a variable amount of nicotine, and optional flavor agents. In erecting a regulatory structure related to the notion of a tobacco product how would the FDA handle the fact that the nicotine content is entirely variable by user selection? Regulating a non-tobacco product without even a trace of nicotine simply because it used the same hardware (battery and atomizer) would open the regulation to litigation which would eventually overturn it. Basing the regulation on the nicotine content would complicate compliance to a point where the enforcement revenues required would be substantially increased by the likelihood of fraud, and the reporting, enforcement and prosecution required. That kind of legislative inefficiency is counterproductive to our society.
I get it. I do. I don’t want children to start smoking, I don’t want them to become addicted to nicotine, I don’t want them to suffer the harm that tobacco produces when ‘used as directed’. But I also don’t want children to suffer the loss of their parents and other family members from the harm produced by smoking. I am not alone in the sentiment, supported by a growing body of evidence, that the electronic cigarette products represent a huge step forward in reducing the harm from tobacco use. I support the idea of having a Federal law preventing the sale and marketing of any nicotine containing product, including all smoking alternatives to children. However I have yet to see evidence that the provisions in the Family Smoking Prevention and Tobacco Control Act (FSPTCA) has produced a meaningful difference in the smoking uptake of youth as promised when the legislation was enacted five years ago. I suggest that regulation of this kind is best encouraged locally and I have had success with our state in achieving this end. I am, however, dismayed that our neighboring state of Missouri has vetoed a similar provision based upon the advocacy of those who are at the forefront in opposition to electronic cigarettes leaving the matter of sales and marketing to youth an open issue. Federal guidelines and economic pressure would likely prevent this kind of shenanigans from happening and ensure universal and enforceable legislation amongst the several states.
I must now turn to the consequences of the deeming proposal for me and many of my fellows. After considered reading of the proposed regulation and the body of the FSPTCA, it becomes clear that the FSPTCA never anticipated such radically new technologies to come along in the fight against tobacco use. While the FDA is to be commended in attempting bring regulation to the industry to ensure consistent quality, prevent fraudulent and misleading products from entering the marketplace, and ensure the safety of the public health, the controlling law is insufficient to the task before the agency. The effect of the proposed deeming erects hurdles that will be insurmountable by the small businesses that are the bulk of the industry. While much focus has been on the larger suppliers of cigalike (Blu, NJOY, R.J.Reynolds, etc.) it is important to note that their market share is less than half of the total market. Most users surveyed by a number of sources use the cigalike products as a bridge to the second and third generation devices developed and marketed by small businesses. With the regulations in the FSPTCA requiring either Substantial Equivalence or New Product registration at enormous cost prior to being allowed to enter the market it is clear that most of the small businesses that are responsible for innovation will likely exit the marketplace, leaving only the larger suppliers with ties to the tobacco industry to fill the gap with inferior and ineffective products. This will effectively kill progress and availability of what a growing body of evidence shows is a significant technology in the fight against smoking and tobacco harm.
Should the proposed deeming be enacted without modification of the enabling legislation the consequences will throw those of us who use e-cigarettes into a vacuum of support for our efforts to remain tobacco free. I believe that within that vacuum will arise several probable and unintended consequences:
- First, those that are not yet committed to using e-cigarettes exclusively will return to smoking tobacco and any reduction in harm from reduced tobacco use will vanish.
- Second, a black market will likely emerge wherein equipment and liquid will be produced out of the public eye. The consequences of a shadow market would be diametrically opposed to the goal of the deeming regulations.
- Third, the products that will survive in the open marketplace will be produced by the same tobacco industry that the FSPTCA was designed to regulate out of existence. These products are the very ones which promote dual-use (the use of both tobacco products and electronic cigarettes). As the industries producing these products do not have a strong financial or social motivation to improve the harm reducing product they will most likely languish in the market becoming nothing more than a novelty.
- Other innovators who may be attempting to create new alternatives to the harmful tobacco use will abandon their efforts as the message will be clear, if it relates to smoking it is tobacco and it is unwelcome in the United States.
Again, I get it. I want the FDA to be able to enforce reasonable and sensible regulation of this emerging tobacco harm reduction technology. But the enabling legislation is inadequate to provide the FDA with the means to enact reasonable and sensible regulation. What is needed is a change in the FSPTCA or new legislation, to allow the FDA to regulate without killing the industry it is trying to regulate.
What would the type of legislation look like? What I would propose would have the following elements:
- Legislation at the Federal level that would make sale, possession and use of nicotine containing products illegal for minors, enforceable at the State level and funded from the Tobacco Master Settlement Agreement (MSA). This would be expansive and include both tobacco products, e-liquids containing nicotine and all other tobacco alternatives regardless of their status as drug or tobacco product.
- Requirement that any nicotine containing product, whether a drug, tobacco product, or tobacco alternative not be marketed in a way that demonstrably encourages use by youth.
- Require that all nicotine containing products whether they are drugs or not be sold in childproof containers with addiction warnings and tamper evident packaging.
- Tobacco alternatives and nicotine containing drugs must be sold only by face-to-face transaction or online with age verification at time of sale using data that is independently verifiable. [I would also propose that this same type of regulation be required for all sales of alcohol as that is also a product which is obtained too easily by youth and its abuse is far more immediately lethal.]
- Regarding the manufacture of liquids, waxes and other products containing nicotine which are intended to be vaporized and not sold as drugs under the F.D.&C. act, ingredients used must have traceability to an FDA approved source and be Generally Recognized As Safe by the FDA. The constituent products must list the ingredients, nicotine strength, and flavorings used. The manufacture of these products should conform to the guidelines set forth be the American Eliquid Manufacturing Standards Association (AEMSA) found at aemsa.org.
In short, there is much to be gained in having the FDA support tobacco harm reduction in whatever form it exists. This benefits public health and our economy. But the FDA needs to support legislation which has the flexibility to do the job of regulating the emerging products without tying them to the very product which has proven harmful to over 40 million Americans. We need coherent and cogent legislation to enable this result, and not what will result when putting the square peg of tobacco harm reducing products through the round hole of tobacco product regulations.
I will address the issue of characterizing flavors in regard to harm reduction products (e.g. SNUS, dissolvable films and e-cigarette liquids) simply. The FDA currently allows marketing of NRT’s in characterizing flavors as a result of studies done which showed a greater likelihood of use and compliance, particularly with polacrilex and troches when flavoring is added. Indeed there is a growing body of evidence which the FDA ought to be well aware of that flavors, particularly candies, mint and fruits are particularly helpful re-enforcing agents in any smoking cessation regimen regardless of the nicotine content.
Much has been made of the notion that flavored liquid in electronic cigarettes is designed to attract youth. Certainly we can understand that this is not the intent any more than it is the intent of alcohol distillers to market their flavored products to youth. We can also understand that, if a product is illegal to sell, possess or use by youth then the only way to obtain or use such a product would be an illegal act. Thus I strongly support universal regulation making and enforcing the sales, possession and use to an adult only population while I strongly oppose the restriction on characterizing flavors. It is simple and clear logic that flavors cannot attract youth to a product which is unobtainable by legal means.
In closing I want to thank the FDA for taking the time to consider regulation of the emerging tobacco harm reducing products. I applaud the effort of the number of people within the organization concerned for the public health leading to the proposed deeming. It is a truly difficult task at hand. However well-intentioned the effort has been, it will fall short in achieving the FSPTCA’s goal “to make tobacco-related death and disease part of America’s past, not America’s future, and, by doing so, ensure a healthier life for every American family.” This is through no fault of those whose efforts went into the work, but a result of enabling legislation that did not anticipate such game-changing new technologies would be developed outside of the traditional tobacco industry. As a result I must, in good conscious, oppose the current effort in the form of the deeming regulation, and offer the simpler and more effective alternative that will accomplish both the public goals to ensure the safety of our children as-well-as the availability and safety of tobacco harm reduction products. I look forward to working to support the FDA and the regulations that I have proposed. As I am a member of CASAA I feel confident that including them in your efforts will yield results that more closely fit our mutual goals.
Robert Bruce Nye, RN
Brown, Beard, Kotz, Michie, and West. “Real-world effectiveness of e-cigarettes when used to aid smoking cessation: a cross-sectional population study.” Addiction, 2014. doi: 10.1111/add.12623
Burstyn, Igor. “Peering through the mist: systematic review of what the chemistry of contaminants in electronic cigarettes tells us about health risks.” BMC Public Health, 2014. doi: 10.1186/1471-2458-14-18
Goneiwicz, Maciej L, et al. “Levels of selected carcinogens and toxicants in vapour from electronic cigarettes.” Tobacco Control, 2014. doi: 10.1136/tobaccocontrol-2012-050859
Kosmider, Leon, et al. “Carbonyl Compounds in Electronic Cigarette Vapors—Effects of Nicotine Solvent and Battery Output Voltage.” Nicotine & Tobacco Research, 2014. doi: 10.1093/ntr/ntu078
Kotz, Brown, and West. “Real-world effectiveness of smoking cessation treatments: a population study.” Addiction, 2013. doi: 10.1111/add.12429
An astute reader will notice that parts of this letter appeared in previous communications in Part I. This is by design. One of the most valuable resources an advocate can develop is a library of thoughts to copy and paste into a coherent response. Modern word processors are to advocates what programming libraries are to software engineers, a way to avoid re-inventing the wheel.
So if you vape, know someone who vapes, smoke or know someone who smokes borrow from my letters. Fold the text into something of your own and send it to the FDA. Please. This may be the last opportunity to turn the tide and get more reasonable regulation to come forth. There are those in the FDA, including Mitch Zeller himself who would like to say that a majority of the responses they received wanted something other than what was proposed and that something other was coherent, effective and better than what was proposed.
Here’s a few links to help:
The call to action with instructions on how to comment to the FDA is here:
A great summary of the FDA deeming regulation’s effect is here:
(But it is also important to note HOW these things specified will be accomplished, that involves a LOT of reading the legislation known as the Family Smoking Prevention and Tobacco Control act. The text of that act can be found here: http://www.gpo.gov/fdsys/pkg/PLAW-111publ31/pdf/PLAW-111publ31.pdf and a summary can be found here: http://www.fda.gov/tobaccoproducts/guidancecomplianceregulatoryinformation/ucm246129.htm)