Heavily-regulated industries are often at the mercy of their regulators. That became clear on Friday, July 28th when the US Food and Drug Administration (FDA) announced a sweeping new plan to regulate nicotine levels in tobacco cigarettes, a potential game-changer for cigarettes if there ever was one.
The bombshell announcement centered on the FDA’s plan to begin a public dialogue around lowering nicotine levels in ‘combustible cigarettes’ to non-addictive levels through ‘achievable product standards.’ This is a sea change in tobacco regulation; previous efforts have focused almost exclusively on encouraging consumers to quit smoking or never start in the first place. But why focus on nicotine? Scott Gottleib, commissioner of the FDA says: “Because nicotine lives at the core of both the problem, and, ultimately the solution to the question of addiction, and the harm caused by combustible forms of tobacco.”
The Family Smoking Prevention and Tobacco Control Act 2009
The adoption of the Family Smoking Prevention and Tobacco Control Act in the US in 2009 gave the FDA the authority to limit (but not eliminate) the amount of nicotine present in tobacco cigarettes – a regulatory tool that the agency has never acted on before. Could reducing nicotine levels send the wrong smoke signals to consumers? Sensing that this could be a possibility, the FDA has taken steps to differentiate between nicotine and other chemicals in tobacco smoke. Commissioner Gottleib notes: “It’s the other chemical compounds in tobacco, and in the smoke created by setting tobacco on fire, that directly or primarily cause the illness and death [associated with smoking], not the nicotine.”
This distinction between nicotine and the over 7,000 other chemicals in tobacco cigarette smoke signals a new regulatory approach that could be bad news for tobacco cigarettes and good news for other nicotine-delivery systems, including e-cigarettes. “We must acknowledge that there’s a continuum of risk for nicotine delivery” says Commissioner Gottleib. “That continuum ranges from combustible [tobacco] cigarettes at one end, to medicinal nicotine products at the other,” he added. Suggesting that e-cigarettes are closer to the latter, the FDA has concurrently announced plans to develop product standards to protect against known e-cigarette health risks like battery issues and children’s exposure to liquid nicotine.
Painting a picture of what could be the future for tobacco cigarettes, Commissioner Gottleib says: “We need to envision a world where cigarettes lose their addictive potential through reduced nicotine levels.” Toward this goal, Gottleib sees the FDA using its “clear authority under the product standard provisions in the Tobacco Control Act to regulate nicotine in combustible [tobacco] cigarettes and render them minimally or non-addictive.”
At this point, there is no consensus on how much nicotine would have to be removed from tobacco cigarettes to make them “minimally or non-addictive.” Some think a 95% reduction in nicotine would do the job. Others are not sure since nicotine delivery varies from smoker to smoker as does the speed with which nicotine is metabolised by the body. How does one remove nicotine from tobacco? Techniques include a process similar to that used to remove caffeine in coffee, or the use of tobacco genetically-engineered to be low in nicotine. The latter comes with its own special set of issues given consumer wariness toward anything genetically modified.
Ironically, the tobacco industry itself tried eliminating nicotine from cigarettes in the past. In the late 1980s, Philip Morris tested a ‘nicotine free’ cigarette under its Merit Free and Next brands in the US. Nicotine was removed from tobacco via a process similar to that used to decaffeinate coffee beans. Both products flopped in a market where so-called ‘ultra-low nicotine’ cigarette brands held a tiny market share of between 2% and 3%. At the time, Philip Morris even caught flak from the Coalition on Smoking or Health for daring to market nicotine-free cigarettes as a supposedly safer alternative.
Since the nicotine in cigarettes is what hooks smokers and keeps them smoking, its reduction figures to knock out a key driver for cigarette use. There are certainly social aspects to cigarette smoking which may still drive usage, but those aspects tend to dissipate with time and age. According to a GlobalData Q3 2016 survey, 10% of Americans age 18-24 say they only ever smoke when drinking alcohol with friends, a percentage that dwindles to nearly nothing by the age of 55.
The FDA’s announcement recognises that not all nicotine delivery systems are inherently harmful, a new stance that could green light a new level of e-cigarette innovation. Similar harm-reduction products like British American Tobacco’s new I-glo tobacco heating device also stand to gain. Shaped like a cigarette lighter, I-glo holds a single ‘Neostik’ (a tobacco stick shaped like a shorter-than-normal cigarette) that does not burn or produce ash. The device instead heats the stick to produce smoke. I-glo recently debuted in Canada and South Korea, joining a suddenly red hot market for similar products. Philip Morris is credited with creating the niche with the launch of a product called iQOS in Asia in 2014. Japan Tobacco is joining the fight this summer with a heat-not-burn product called Ploom launching in Japan which uses its own ‘tobacco capsules.’
Liquid-based e-cigarette products may also get a bump from the FDA’s changing views on nicotine delivery systems. Already, 58% of Americans say that the health aspect of e-cigarettes appeals to them most, according to a GlobalData Q4 2016 survey. That number could go up given the FDA’s near implicit approval or at least preference for e-cigarettes and other harm-reduction nicotine delivery systems, relative to conventional tobacco cigarettes.
But like tobacco cigarettes, e-cigarette adoption skews young, suggesting that newer technologies may fail to convince older smokers to switch. According to the FDA, 95% of adult smokers start smoking before the age of 21; only about 1% of cigarette smokers start at age 26 or later. Survey data from GlobalData shows that e-cigarettes have similar age-related characteristics. 80% of American consumers between the ages of 25-34 say they have at least tried e-cigarettes, according to GlobalData’s Q1 2017 survey. But just 29% of Americans age 45-54 say they have ever tried e-cigarettes. This bodes poorly for efforts – no matter how well intentioned by the FDA – to encourage older consumers to switch from tobacco cigarettes to less harmful products. Any change in e-cigarette adoption going forward is likely to come from younger smokers using the products in lieu of combustible cigarettes, not from older smokers switching to a ‘safer’ product.
An image issue?
E-cigarette makers also have some gender-related issues to overcome. Only about 10% of American men aged 25-34 say they have never tried e-cigarettes. For women of the same age, the figure is 36% which indicates that men are much more willing to experiment with e-cigarettes than women and that the whole concept of e-cigarettes may be off-putting to women. These facts indicate that e-cigarettes and other reduced-harm products have a rocky road to navigate, regardless of what happens with the nicotine levels of tobacco cigarettes.
Removing most of the nicotine from conventional tobacco cigarettes seems destined to produce a less appealing experience to smokers, but it may also end up having some unintended consequences. Nicotine has been demonized by anti-smoking groups for decades; nearly eliminating it from tobacco cigarettes may make them appear to be safer, giving smokers a green light to keep on smoking and making new smokers less apprehensive about picking up the habit. That is the fear that doomed earlier efforts to create a nicotine-free cigarette. It will be fascinating to see how the FDA plans on cutting nicotine levels without sending the wrong message to consumers.