At this stage in our policy development, it appears that most tobacco control authorities recognize that e-cigarettes and related vapor products are almost sure to be far less hazardous than cigarettes. Their remaining major objection to endorsing them for THR is based on the perception that they are or might be recruiting significant numbers of teen non-smokers to a lifetime of nicotine addiction. This perception, in turn, is based on deeply flawed published papers, disregard of contrary evidence, and disregard of the fact that the “epidemic” of e-cigarette use in federal surveys published to date has been almost entirely in teen smokers and has not increased the total number of teens using tobacco products.
The root of this problem, as I see it, continues to be traditional perceptions in the tobacco control community that rule out any consideration of THR as public policy. This is reflected in the goal of a “tobacco-free-society”. This orientation has distorted the process by which the findings of scientific studies and government-sponsored surveys are translated into policy. Rather than consider all options, and let the science drive policy, there seems, at least in the USA, a zeal to take bits of data out of context to justify pre-determined anti-tobacco policies while disregarding evidence to the contrary.
The main perception in question seems to be the view that all non-pharmaceutical nicotine delivery products are so addictive that none can be tolerated, and that once addicted, the user will then transition to cigarettes for a better and faster nicotine hit, negating any personal or public health benefit from the low risk product. A second perception is that the “tobacco industry” is monolithic, cannot be trusted, and is intent on addicting our children to deadly substances to assure future profits. These perceptions fail to recognize what we have learned about smokeless tobacco products and e-cigarettes in recent years, and fail to recognize the true structure, function and motives of a complex and highly competitive set of tobacco-related industries.
None of this is new. What is new, however, are current developments which deserve the attention of all concerned:
- Conflict between rhetoric and action: Within the FDA, Dr Gottlieb and Mr Zeller continue to talk about the need for innovation and the need to consider the role low-risk nicotine delivery products can play in reducing tobacco-related illness and death and do so in a manner that will not increase teen recruitment to nicotine addiction. Unfortunately, none of this rhetoric seems reflected in current FDA policy, especially their current attack on JUUL e-cigarettes and their continuing failure to propose a regulatory structure that will enhance the development and delivery of the low-risk products.
- Probably unjustified attack on e-cigarettes: The FDA’s all-out attack on JUUL and on e-cigarette flavours is being done without prior public release of the full set of national survey data pertinent to this issue. The data available from prior surveys and other sources leaves the impression that, while many kids experiment with these products, remarkably few continue their use, and that the vast majority of continuing vapers are smokers in the process of switching to these low-risk and easier-to-quit products. In other words, this image of an “epidemic” of non-smoking kids being recruited to nicotine addiction might be in error. Since the FDA declared the “epidemic,” the burden of proof lies with them. Their failure to date to release the full data set prior to announcing the “epidemic” is troublesome.
- Importance of industry sponsorship of THR-related research: We need to consider the possibility that investigators working with tobacco companies should not be considered any more conflicted or biased than investigators funded by federal agencies dedicated to the goal of a “tobacco-free-society”. We need to recognize that the THR “debate” is not between public health science and industry greed. Despite hype to the contrary, there is now overwhelming evidence from federal survey data and published literature (none of which was sponsored by tobacco companies) demonstrating major personal and public health benefits of e-cigarette products and snus as THR modalities. The problem here is not lack of scientific evidence. It is substantial bias on the public health side, apparently based on tradition within the public health community.
- Dysfunctional FDA Policy not enshrined in law: A “Spotlight on Tobacco” article in the current (October/November 2018) issue of the FDLI Member Journal highlights the absurdity of the current FDA approach to THR and low-risk nicotine delivery products. Based on the FDA presumption that all smoking is a disease, not a behaviour, the article recommends licensing e-cigarettes as over-the-counter drugs rather than tobacco-products, apparently recognizing that it is a physical impossibility for any single product to “prove” that, if approved, it will not recruit non-smokers to a lifetime of nicotine use. Since approval as a drug carries no such requirement, licensure as a drug would provide a regulatory pathway to FDA approval, without the FDA having to admit that their current smoking-cessation policy guideline makes no sense in the real world. Adjustment in FDA thinking to correct this policy error could be done without congressional action to amend the Tobacco Control Act. Such adjustment in thinking could also pave the way for FDA consideration of the possibility that the greatest public health benefit of e-cigarettes might be the diversion of teen smokers and would-be smokers away from a lifetime of nicotine addiction.
- Claims of brain damage to teens due to nicotine: Of late, much of the anti-e-cigarette rhetoric has included claims that nicotine causes permanent damage to the brains of teens. While all agree, for other reasons, that teens should not consume nicotine delivery products, the claims of brain damage should be either discontinued or be qualified by a statement that this only refers to the brains of mice and rats, since no such damage has ever been demonstrated in humans.
- Credibility of the public health establishment: As a public health physician, I have always been extremely careful to make sure that any declaration of a public health emergency or other policy pronouncement is fully justified by the best of available science. If our public health infrastructure is to effectively guide public health policy, we must do everything in our power to assure the public that our pronouncements are credible. As I see it, the widening gap between current anti-e-cigarette rhetoric and scientific fact is putting this credibility at risk.
The previous statement is my personal opinion and does not reflect the policy or opinion of any organization I might be affiliated with.
Dr. Nitzkin is a public health physician who has been involved in tobacco control since the mid 1970's. He has served as Senior Fellow for Tobacco Policy for the R Street Institute since 2012, and has been president of 2 national public health associations.