Primary Care > Smoking & Tobacco
Friday Feedback: What's Next for Reduced-Nicotine Cigarettes
— Are they safer? Less addictive? And how do e-cigarettes fit in?
by Molly Walker, Contributing Writer October 2, 2015
A study in the New England Journal of Medicine suggested that reduced-nicotine cigarettes could cut overall cigarette consumption as well as nicotine intake, but the effects on smoking cessation and other hard clinical outcomes remain unclear.
We contacted tobacco and public health experts via email to ask:
Are these data adequate for the FDA to require lower nicotine content?
Should manufacturers be allowed to say these are safer than conventional cigarettes?
One commentator suggested that e-cigarettes (which deliver nicotine without the tar) might be a better approach -- do you agree or disagree?
The participants this week are:
Andrew Hyland, PhD, chair of the department of health behavior at Roswell Park Cancer Institute in Buffalo, N.Y.
Deborah Ossip, PhD, professor of public health sciences at the University of Rochester Medical Center in Rochester, N.Y.
Paul T. Harrell, PhD, assistant professor of the division of community health & research at Eastern Virginia Medical School in Norfolk
Suresh S. Ramalingam, MD, professor of hematology and medical oncology at Emory School of Medicine in Atlanta
Wael Al-Delaimy, MD, PhD, professor and division chief of family medicine and public health at University of California San Diego School of Medicine
David J. Drobes, PhD, senior member of health outcomes and behavior at Moffitt Cancer Center in Tampa, Fla. (Drobes disclosed that he was an investigator for the NEJM study.)
A Promising Start
Andrew Hyland, PhD: "This study addresses an important public health question. The data are a remarkable early step that could serve as part of the foundation for evidence the FDA would need to require greatly lowered nicotine content in cigarettes. This study of randomized smokers found smokers were not interested in quitting upon enrollment, but by the end of the study, those assigned to the lowest yield cigarettes smoked about 30% fewer cigarettes per day compared to those assigned to the highest yield cigarettes. This is a promising start that could lead to the FDA considering reducing nicotine levels in cigarettes."
Deborah Ossip, PhD: "These data are promising in that they provide evidence that, at least in the short term, smokers who used cigarettes made from tobacco with significantly reduced levels of nicotine smoked fewer cigarettes smoked/day, and had lower nicotine exposure, lower dependence scores, no significant increase in withdrawal symptoms, and more quit attempts compared to subjects who smoked their usual brands or cigarettes with typical nicotine levels. Whether these findings would be sustained over time and what the population health impact would be if such a measure were enacted are unknown; nevertheless, this study provides a timely scientific springboard for regulatory considerations regarding lowering nicotine content. "
Paul T. Harrell, PhD: "Reducing the nicotine content of cigarettes could reduce cigarette smoking in current smokers and, perhaps more importantly, help to prevent daily smoking among youth or others who try cigarettes for the first time. With this publication funded by the FDA and the National Institute on Drug Abuse, we now have a large multi-site clinical trial providing new support for this plan. The data are not without limitations, but they provide some replication to earlier, smaller studies. Specifically, compensatory smoking appears to be minimal. This is important because, conceptually, some might worry that reducing nicotine content would actually result in high levels of increased smoking and increased harm to smokers addicted to nicotine. We further see evidence from self-report measures of reductions in dependence and craving and increases in quit attempts."
Suresh S. Ramalingam, MD: "The study by Donny and colleagues clearly demonstrates the reduction in the number of cigarettes smoked by subjects that smoked low-nicotine cigarettes. It is noteworthy that the results were seen in a mere 6 weeks. This study strengthens the arguments from the medical community to the FDA to require a reduction in nicotine content of cigarettes."
More Data Needed
Wael Al-Delaimy, MD: " I think these findings are interesting and from a respected group of scientists, however, I caution against going through a potential slippery slope based on these results, that at best are preliminary. There is no safe level of tobacco and no nicotine level threshold that is not addictive. It has been shown that even minute amounts of nicotine in tobacco is enough to trigger the nicotine receptors in the brain. Compensation, or lack of it in this study, is not the ultimate measure of success of low nicotine cigarettes. The study had inconsistent findings for the different low levels of nicotine where some variables were significantly different from the high 15.8 mg of nicotine at 0.4 mg of nicotine while others at 5.2 mg or 2.4 mg and some of the more important and objective variables such as NNAL and carbon monoxide showed no difference regardless of the level of nicotine."
David J. Drobes, PhD: "Requiring reduced nicotine levels in cigarettes is a complex issue, and the FDA is in the best position to weigh various factors and make this decision in the interests of public health. However, these data do suggest that reducing nicotine content might reduce smoking, exposure to nicotine, and nicotine dependence."
Not a "Safer Cigarette"
Ramalingam: "It is well established that cigarette smoking is harmful to health and reduces the lifespan of the individual. It is hoped that a reduction in nicotine content of cigarettes will ultimately lower the number of smokers in the population. Claims that these are safer than conventional cigarettes might be made by devious interests, as has been done in related matters in the past. We have to make sure that any such claims are accompanied by the fundamental fact that cigarette smoking is detrimental to health."
Al-Delaimy: "We have been through this before many years ago when tobacco industry advertised the low nicotine "light" cigarettes while they knew they are still addictive and did not help smokers quit or cut down. This study was done in an experimental setting and participants were compensated relatively large sums of money, which encourages them to be compliant and use the low-nicotine cigarettes while still using their regular brands, and the difference was not dramatic nor consistent. There was no clear dose-response where the lower the nicotine the lower the number of cigarettes they smoke. The tobacco companies are on the losing end of their social status as evidence from lower and lower smoking prevalence in the countries that implemented effective tobacco control programs and would find such an approach as a much needed life line."
Potential Public Health Benefits
Harrell: "It is unclear if reducing nicotine content can lead to improved health or a 'safer cigarette.' However, creating a safer cigarette is only one potential benefit of this strategy. Although further research is needed, an arguably more important outcome is that these cigarettes may be less likely to lead to nicotine dependence in adolescents or others who have tried cigarettes, but not yet developed a daily habit. Additionally, this and other evidence suggests that the regulation would not be harmful to current cigarette smokers and may even lead to improved health by reducing the number of cigarettes smoked."
Hyland: "The current evidence does not definitively support that manufacturers of low nicotine yield cigarettes should be allowed to make safety claims. But if you imagine a time when FDA requires all cigarettes to have low nicotine yield then this issue becomes less relevant. A federal mandate that requires a reduced nicotine standard for all cigarettes has enormous public health potential because it would be an intervention. These early data show some promise that would be applied to the entire population of 40+ million U.S. smokers. Research would need to bear this out but such a policy may further reduce youth smoking initiation rates by limiting the dependence potential of cigarettes."
E-Cigarettes: The Jury is Still Out
Drobes: "Additional research is needed to determine the long-term health effects of e-cigarettes, and whether or not these products are effective for smoking cessation. Currently, the FDA does not regulate e-cigarettes, although they have proposed to do so. Ultimately, an effective strategy to reduce harms from tobacco may include multiple alternatives to conventional cigarettes, including both e-cigarettes and reduced nicotine cigarettes such as those studied here."
Ossip: "The potential for whether these devices can ultimately provide a significantly reduced risk source for nicotine delivery should not obscure the reality of what is currently available. There are over 400 companies producing e-cigarettes and over 7,000 different products available; none is yet regulated. A range of irritants and toxicants have been found in these products, some at levels lower than combustible cigarettes and others at levels equal to or greater than those found in cigarettes, there are some unique constituents not found in combustible cigarettes, and the lack of product standards and/or user modifications have resulted in injuries from ingestion of e-liquids and device explosions. Clean, FDA approved nicotine delivery alternatives with demonstrated safety profiles are available (e.g., nicotine patches, gum, lozenge, inhaler)."
Hyland: "We should focus on what we know for sure, which is that cigarette smoking is incredibly dangerous and getting smokers completely off cigarettes will yield tremendous public health benefits. I think we should start with what we know works while exploring ways we can do better. There are treatments that are proven effective, albeit modestly, in increasing the chances of quitting smoking. The Donny et al study shows the utility of reduced yield cigarettes in reducing consumption in the short-term and more studies are needed to see if this translates into more people stopping smoking altogether. How e-cigarettes are marketing is going to play a deciding role, in my opinion, to their utility to getting cigarette smokers completely off cigarettes."
Al-Delaimy: "I disagree based on the evidence from our studies and that of others that showed smokers who use e-cigarettes are less likely to quit in a naturalistic non-experimental setting. Similar to this study on low-nicotine, if study participants are volunteers, compensated financially and offered free products they will comply, but in a natural real life setting that is not the case."