Tobacco-control advocates have enthusiastically embraced Food and Drug Administration Commissioner Scott Gottlieb’s proposal to focus on the potential for very low nicotine cigarettes, or VLNCs, to reduce the addictiveness of cigarettes.
But before embarking on a debate about whether regulators could force cigarette makers to switch, en masse, to low nicotine, perhaps a word or two is in in order about whether they should. It is bothersome that there has been essentially no discussion to date about whether such a shift would be ethical.
VLNCs contain nicotine at levels that do not produce physiological effects, rendering what residual nicotine they do contain ineffective. There is no other available consumer product that delivers only the harm and none of the perceived user benefit, especially one proposed by a health agency.
Using a public-health ethics framework, the proposal for VLNCs might not pass muster upon closer examination. There are several central questions proposed by Dr. Nancy Kass of Johns Hopkins University that would need to be considered before public health officials can decide whether VLNCs are in the best interests of society.
VLNCs do offer some promise to encourage cessation. A more detailed analysis indicates that people randomly assigned to VLNCs do, in fact, smoke fewer cigarettes per day and have lower nicotine biomarkers, as well as decreased cravings. In addition, there seem to be concentration-dependent effects where lower nicotine concentrations may offer assistance in quitting.
But with only a few clinical studies that examine the quit rates among people who use VLNCs, the assumption that these products make it easier to quit — especially for those who are not interested in quitting — remains open to question.
One study showed that, while nicotine levels in the bloodstreams of the VLNC group were indeed lower, the number of cigarettes smoked remained the same. Another showed that users compensate for lower nicotine levels either by using different puffing styles or by using other nicotine products, mainly e-cigarettes. In both studies, the toxins and carcinogens from combustion to which users are exposed remained the same, with the exception of those who substituted with noncombustible nicotine products.
In addition to determining the effectiveness of a given intervention, those in public health also must carefully balance coercive measures with personal liberties. Regulations that restrict access to products are the most intrusive approach to public health. According to Edmund Pellegrino and David Thomasma, these “must be undertaken with a clear perception of the dangers they pose to a democratic society,” including loss of personal choice and the imposition of cultural values.
This has been tested before. Admittedly, our history does show that prohibitions work, but they also produce significant negative consequences. Enactment of the Volstead Act of 1919 was followed by a temporary plummet in alcohol consumption across the nation. Unfortunately, with this loss of access came the proliferation of black-market products. The serious consequences of covert alcohol distribution included permanent damage from poorly distilled alcohol and flourishing organized crime. This rendered prohibition ineffective for a large number of people, while creating chaos that ultimately resulted in the repeal of prohibition just over a decade later.
If properly managed, these sorts of burdens can be minimized and balanced with benefits. The assumed benefit of VLNCs would be a reduction in smoking rates, followed by a reduction in diseases that kill 480,000 people every year. However, unless the implementation of VLNCs is carried out with extreme caution, the burdens will drastically outweigh the benefits. Points for policymakers to consider include whether to introduce price incentives to encourage users to switch to VLNCs without requiring a complete prohibition of normal-nicotine content cigarettes. Other approaches would include increased acceptance of and promotion by the FDA and other public health officials of less harmful alternatives, such as e-cigarettes.
Beyond whether VLNCs will be effective in preventing adolescents from starting smoking, or whether they will increase the quit rate among current smokers, we need to ask ourselves if we support a product that only delivers toxins and carcinogens. Comparisons can be made that this regulation would be akin to reducing the alcohol content in, say, single malt scotch, which would fundamentally change the product. However, reducing the alcohol content of scotch only makes scotch something that we all use everyday — a beverage. Reducing the nicotine content fundamentally changes cigarettes to literal “cancer sticks.”
Before those in both the tobacco control and tobacco harm reduction communities advocate for such a drastic shift in the tobacco landscape, it is imperative that we first consider the ethics of VLNCs.
Image by Jurgis Mankauskas