02.11.19

Reality check: Cigarettes are the only reason reduced risk tobacco products are even a thing

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First, a confession. I’m a total public health nerd. I’ve been absolutely captivated by the prevention of disease at a population level since I was introduced to the concept late in college. From the science that drives it to the programs, policies, and laws that either embrace or hinder it and everything in between and beyond, I’ve soaked up all things public health. That’s why sitting in a day-and-a-half meeting at the U.S. Food and Drug Administration (FDA) about modified risk tobacco product (MRTP) regulation is an exciting prospect for me and you get to hear about it!

Let me also provide some helpful context about this most recent FDA Tobacco Products Scientific Advisory Committee (TPSAC) meeting. It discussed two MRTP applications before the FDA that seek to legally market smokeless tobacco products in the U.S. using reduced risk claims (i.e. representing that the product is less harmful or has a lower risk of disease than other tobacco products). Perhaps the easiest way to think about this is to recall the “light,” “mild,” and “low tar” descriptors that were once used to market cigarettes. In this case, the makers of a snus product and a moist snuff product are seeking FDA authorization to use light-mild-low-tar-like claims when marketing a certain subset of snus and moist snuff products in the U.S. The FDA convened TPSAC, a body of scientific experts, to advise them on aspects of the applications. You can read FDA’s summaries of each specific request here and here.

What ensued at the TPSAC meeting was a thoughtful and interesting discussion about the relative risks of smokeless tobacco products compared to cigarettes, how challenging communicating those relative risks can be, and the potential implications to population health—both good and bad—of communicating (or not) those relative risks. As a public health nerd, I was intrigued by the nuanced discussion of:

  • The state of the science about the different risks for the various types of tobacco-nicotine products that span a continuum of risk, including current perceptions about those relative risks;
  • Who might benefit and/or be harmed from reduced risk product marketing and/or use and in what ways;
  • How to more narrowly target populations that could benefit most while also minimizing interest from those for whom using the product might be more detrimental to their health;
  • Methods and study designs to improve the collection of more precise and useful data; and
  • How reduced risk products fit into the larger tobacco-nicotine products regulatory framework.

I will also admit that the call from the tobacco industry, its allies, and others about the need to correct misperceptions about the differential harms of various tobacco-nicotine products is compelling. To date, my public health lens has steadfastly focused on preventing ALL tobacco product use and encouraging ALL tobacco product users to quit. While I’ve more precisely focused that lens at times (e.g. assessing the evidence base specific to cigars and whether they should be exempted from FDA tobacco product regulation altogether), I find myself coming to an admittedly difficult-to-swallow realization that perhaps my “no tobacco product is safe” drum banging—without much further qualification—is doing more harm than good. To be clear, while this all-or-nothing approach is factually true, it’s also not entirely the whole truth. This has been especially troubling for me given that the remaining combustible tobacco cigarette smokers are largely disadvantaged populations. The thought that I may be contributing to tobacco-related health inequities by withholding truthful information about the differential risks of tobacco products weighs heavy on me, and the TPSAC meeting discussion has provided a real wake-up call for me to consider what I can do to improve how I communicate about the harms of tobacco.

At the same time, what struck me as absolutely absurd about the proceedings of the TPSAC meeting was the degree to which some comments seemed to dismiss why we even need FDA authorization of reduced risk claims for tobacco products in the first place. Let’s not forget that a number of tobacco companies falsely marketed and promoted “light,” “mild,” and “low tar” cigarettes as less harmful to keep people smoking and sustain their revenues. Tobacco companies also lied under oath that nicotine is addictive.

These actions (and others, including continued efforts to undermine effective tobacco control policies) have led to combustible tobacco cigarettes remaining the number one cause of preventable death and disease worldwide. Many of the same companies seeking to market reduced risk tobacco products still manufacture, market, distribute, and profit off of the very product that created and sustains this devastating public health crisis: cigarettes. I raise this reality check not to relieve me of any of my own contributions to current misperceptions about tobacco product harms, but to ensure that we don’t lose sight of the path that got us here. Public health regulators must remain vigilant of the incentives and tactics of the industry they regulate so as not to repeat the mistakes of the past.

* Image courtesy of Searcy Law Video   

 

Posted in FDA, Food and Drug Law, Non-Communicable Diseases, Tobacco ; Tagged: , , , , .

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The views reflected in this blog are those of the individual authors and do not necessarily represent those of the O’Neill Institute for National and Global Health Law or Georgetown University. This blog is solely informational in nature, and not intended as a substitute for competent legal advice from a licensed and retained attorney in your state or country.

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