Should we just take the nicotine out of cigarettes?
In the United States, the ultimate goal of tobacco-control programming long has been a “tobacco-free society.” This goal is clearly articulated in the most recent Surgeon General Report, in the FDA Tobacco Law (formally, the Family Smoking Prevention And Tobacco Control Act of 2009) and in multiple pronouncements by the Centers for Disease Control and Prevention, the Food and Drug Administration, the Campaign for Tobacco-Free Kids and others.
All agree that smokers smoke for the nicotine, but die from the tar in the smoke. All of the commonly referenced 480,000 annual deaths from tobacco products in the United States are from a single tobacco product – the combustible cigarette. This being the case, pursuing a goal of a “smoke-free society” would seem more reasonable and more easily achievable than a goal that eliminates all tobacco products, regardless of their relative levels of risk.
For better and for worse, however, a “tobacco-free society” has been set as the goal, with the underlying problem framed as tobacco-company recruitment of teens to a lifetime of nicotine addiction, ultimately only satisfied by cigarettes, the most addictive and most hazardous nicotine-delivery products. This goal is pursued as a moral imperative – a crusade against the evil tobacco industry, as opposed to a more limited public-health initiative intended to reduce, if not eliminate, tobacco-related addiction, illness and death.
Thus, as seen by American tobacco-control leadership, there is no possibility that any non-pharmaceutical nicotine-delivery product, no matter what the risk, might have public-health benefits. High-risk products will kill people. Low risk products, as envisioned, will recruit teens to nicotine addiction, who will then switch to cigarettes for bigger and faster nicotine hits.
The British have wrestled with this same question. Looking at all the same research and survey data, they have reached a very different conclusion. They are endorsing e-cigarettes and related vapor products as low-risk alternatives to cigarettes, and doing so without fear of major additional recruitment of teens to nicotine addiction.
Ruling out any such endorsement, one of the more popular ideas in the American tobacco-control community has been removing nicotine from cigarettes. A provision was written into the FDA Tobacco Law that specifically authorizes the FDA to require nicotine in cigarettes be reduced to non-addictive levels.
Last fall, the New England Journal of Medicine published a paper and opinion piece exploring this issue. The basic message was that reduced-nicotine cigarettes could yield major reductions in smoking prevalence, but only if smokers could easily switch to satisfying lower-risk nicotine-delivery products.
Herein lies the rub. The only low-risk nicotine delivery products now recognized by the FDA are the pharmaceutical nicotine-replacement-therapy (NRT) products (gums, patches, etc.). These will not meet the need because they satisfy so few smokers.
The only families of low-risk nicotine-delivery products that appear capable of satisfying large numbers of smokers are the customizable nicotine vapor (i.e., e-cig) products assembled and sold by vape shops, or Swedish snus. Unfortunately, in its recently released deeming regulations, the FDA has proposed pre-market (PMTA) application requirements so costly that they will, if implemented as proposed, wipe out the entire vape-shop component of the e-cig industry by virtue of the cost to apply. Despite more than 30 years of high-quality epidemiologic data, the FDA has to date refused to allow the Swedish snus products to claim lower risk than cigarettes. Thus, at least for the time being, the FDA has slammed the door on tobacco harm reduction (THR) as a possible component of tobacco-control programming.
The FDA and others in the American tobacco-control community now face a difficult choice. Either they open themselves to the possibility of considering a THR initiative that uses non-pharmaceutical nicotine-delivery products, or they must give up their dream that eliminating most or all nicotine from cigarettes will do more good than harm.
If implemented, the THR initiative would be exceedingly low cost. It would simply consist of both public-health authorities and manufacturers of low-risk products advising smokers that they could reduce their risk of potentially fatal tobacco-attributable illness by 95 percent or more by switching from cigarettes to a low-risk product (e-cigs, snus or other smokeless tobacco).
As seen by this public-health physician, 90 percent or more of the desired public-health benefit could be secured by implementing a well-structured THR initiative. Once implemented, the FDA could then consider how much additional benefit could be secured by reducing the nicotine in cigarettes.
Reducing the nicotine in cigarettes to non-addictive levels in the absence of a pre-established THR initiative would likely do more harm than good. If the decrease is gradual, it could cause smokers to smoke more and inhale more deeply to secure the desired dose of nicotine, as appears to have been the case with the so-called “low-tar” cigarettes. Others, dissatisfied with this option, would likely turn to totally unregulated contraband cigarettes.
So, if the question is “should FDA just take the nicotine out of cigarettes?” the answer, at least for now, remains “not yet.”