Bans, duty tax, and strict regulations on vaping have been used by many governments as a tool to limit smoking amongst youths and to curb smoke habit for adults. However, data demonstrate that restrictions on the access of nicotine products have unintended consequences such as illicit trade and limiting safer alternatives to combustible tobacco products. While associations and citizens challenge the decisions, what’s the reality behind a business of 24,5 billion yearly?
Patricia Kovacevic, the founder of RegulationStrategy.com, is a global legal and compliance FDA-regulated industry expert. Ms Kovacevic served on the board of directors of the Vapor Technology Association, on the advisory board of the Global Tobacco & Nicotine Forum, and is a member of the Society for Research on Nicotine and Tobacco (SRNT).
Ms Kovacevic, what is the best way to describe the Vaping Market today?
Depending on the country, the vaping market could be defined as a cautious success, an emerging – possibly growing – effort or legally unavailable. The single most important driver of harm reduction, as we know, is product regulation reflective of the risk profile of the product. Another important driver of consumer smoking deterrence is appropriate and candid communication of comparative product risk, preferably by governments. Only one country, the United Kingdom, have made important progress towards affirmatively integrating the vaping market into their government’s strategy towards tobacco harm reduction. Though not perfect, the United Kingdom’s government approach is a move in the right direction. At the other extreme are governments that have banned vaping, either recently or as early as 2009, and have not revisited their approach since, despite clear and conclusive evidence of the very different risk profile responsibly manufactured vaping products demonstrate compared with traditional, combustible cigarettes. Somewhere in between are countries that do not regulate vaping products, as well as countries like the United States, where a set of good intentions – consistent regulation of tobacco-derived nicotine products – yielded inconsistent results. There is only one reality – vaping products can be an important contributor towards overall tobacco harm reduction, and let us please not debate whether we should call it “reduction” or “minimization”, because that would mean we are side-stepping the issue, and that is – more needs to be done to explain how and why vaping is different than smoking.
Governments seems to demonise any products related to nicotine although many studies indicate Ecig as safer than traditional cigarettes.Do you agree?
Mitch Zeller, the U.S. Food and Drug Administration Director of the Center for Tobacco Products, stated that “ nicotine makes tobacco products addictive—but […] nicotine does not directly cause smokers’ cancer, lung disease, and heart disease. This renewed focus on nicotine is premised on the so-called “continuum of risk,” and the reality that the mechanism for the delivery of nicotine, rather than the drug itself, is the key to understanding potential harm at a population level.” Thus, there is awareness and understanding within one of the most prominent regulatory agencies in the world, the FDA, that nicotine in itself is not the problem – combustion of tobacco is. Furthermore, FDA has granted modified exposure product claims authorizations to several nicotine containing products under the pathways allowed by the Tobacco Control Act. And, last, but not least, virtually any country in the world has some form of medicinally approved nicotine containing replacement therapies, drugs that have been proven to be safe. Clearly smokers’ health and lives deserve a more reasoned and consistent regulatory approach to nicotine. Precenting smokers’ premature death and minimizing the disease burden remains an achievable, crucial public health goal that should not be forgotten even in the middle of a different type of health emergency. It still boggles the mind, and there is no reasonable justification, for the inability to integrate all types of products into a comprehensive regulatory society health improvement plan. Or perhaps the plan is missing, the vision, the big picture. A bold vision is imperative, articulated as ending smoking within a defined, measurable period of time. Just think of the millions of lives that could be saved if all stakeholders were pragmatic and not dogmatic.
Do you believe restrictions, bans, and duty tax by governments on e-cigarettes helps to restrain people smoking or it just limits the effectiveness of any Harm Reduction policy?
Time and again, it was proven – in various contexts – that product bans or unreasonable restrictions have severe unintended consequences, which more often than not outweigh any intended benefit. In brief, the criminal underworld rubs hands and starts counting the money every time a product is banned or overtaxed. And, sadly, many consumers eventually find their way to unregulated, irresponsibly manufactured illicit products, the countries’ budgets miss important tax revenues and the proceeds of illicit trade go on to fuel all sorts of terrible, violent crimes. Simplified, such is the vicious circle of righteousness. More specifically, in a recent research published in “Drugs and Alcohol Today”, my esteemed co-authors and I provided a case study on lives potentially saved based on the level of regulation and taxation. The potential to save millions of lives through carefully tailored and balanced product regulation and taxation is available to governments; lawmakers and regulators have the tools, the knowledge, the science to save those lives and reduce the overall burden of smoking on society. The question is: who should be held accountable if unreasonable regulation perpetuates premature loss of lives?