In discussing proposed zoning, sales and flavor restrictions, witnesses and councilmembers provided insight into the mental gymnastics required to endorse prohibitions of products that are not only far less dangerous than those readily available, but can actually prevent early death and disease.

Those of us who advocate for sensible regulation of e-cigarettes—including controlled but reasonable access, and availability of flavors other than those that are already found in combustible cigarettes—are well aware of the challenges we face in public hearings. It’s always an odd feeling to watch some witnesses get a pass on the misinformation—and sometimes outright lies—about the roots of the vaping illnesses or the harms of e-cigarettes, while others have to justify their very existence.

At the DC hearing, claims abounded once again that the recent spate of vaping-associated illnesses were a consequence of e-cigarettes, or that e-cigarettes are uniquely dangerous for adolescents. 

But there is no evidence that e-cigarettes are uniquely dangerous for adolescents when compared to cigarettes. More importantly, vaping illnesses have not been linked to nicotine-containing e-liquids. And there is a reason for that: As a water-soluble chemical, there would be no reason to add an oil to nicotine. Doing so would make it difficult to keep nicotine in a solution that can be vaped.  

He referenced the National Academies of Sciences, Engineering and Medicine report—only to be criticized by the chair for “cherry-picking” evidence. 

Meanwhile harm reduction advocates get their academic and professional credentials called into question if, for example, they cite a report from the nation’s most respected collection of scientists and medical professionals. 

Providing testimony on January 2, Gregory Conley, president of the American Vaping Association*, referenced The Public Health Consequences of E-Cigarettes by the National Academies of Sciences, Engineering and Medicine—only to be criticized by Councilmember Charles Allen, the chair of the committee, for “cherry-picking” evidence. 

Chairman Allen went on to question Conley’s academic background, suggesting he is not qualified to make public health arguments because he holds a Juris Doctorate and not a master’s degree in public health. It is worth noting that Matt Meyers, president of the anti-vaping Campaign for Tobacco-Free Kids, provided testimony earlier in the day and was not questioned on his academic background, despite also not holding a public health degree.

The National Academies’ report states: “The net public health effect, harm or benefit, of e-cigarettes depends on three factors: their effect on youth initiation of combustible tobacco products, their effect on adult cessation of combustible tobacco products, and their intrinsic toxicity.” 

So how are we doing by those measures? 

Youth smoking rates have been consistently declining over the last decade (and are at their lowest yet). E-cigarettes have shown to be more successful as quit aids than their pharmaceutical counterparts. And vapes’ intrinsic toxicity is minimal compared to their combustible counterparts.

One can only conclude that e-cigarettes confer a net public health benefit by being available to replace cigarettes

The DC council members seemed to have missed that the FDA largely agrees with this report. Former FDA Commissioner Scott Gottlieb previously stated, “A key piece of the FDA’s approach is demonstrating a greater awareness that nicotine–while highly addictive–is delivered through products that represent a continuum of risk and is most harmful when delivered through smoke particles in combustible cigarettes.”

Furthermore, this continuum of risk is central to the FDA’s roadmap of the future of tobacco. Regarding the steps the FDA is taking to address youth use, the Commissioner stated that “While it’s the addiction to nicotine that keeps people smoking, it’s primarily the combustion, which releases thousands of harmful constituents into the body at dangerous levels, that kills people. This fact represents both the biggest challenge to curtailing cigarette addiction‒and also holds the seeds of an opportunity that’s a central construct for our actions. E-cigarettes may present an important opportunity for adult smokers to transition off combustible tobacco products.” 

However, the FDA has maintained that ensuring that adolescents are not uniquely driven to pick up nicotine when they otherwise wouldn’t is also a top priority. Even in 2018, the Commissioner stated that they seek to strike a balance between protecting underage and non-users from addiction to nicotine while keeping safer products available to adult smokers to enable them to transition away from combustible cigarettes.

This is exactly why one consideration for approving new nicotine products, including heat-not-burn, snus and even e-cigarettes, is the so-called “public health test” that takes into account the risks (increased tobacco or e-cigarette use) and benefits (decreased smoking to the population as a whole)—to both users and non-users of these products.

This ongoing process is why state and local governments should be wary of implementing prohibitions until the FDA has had the opportunity to review

What might not be obvious is what’s required to achieve approval through the FDA’s Premarket Tobacco Application, or PMTA, process. This approval process is necessary for any manufacturer looking to sell novel nicotine or tobacco products, including e-cigarettes, after May 2021. While there has been a lot of back-and-forth, the final deadline for manufacturers to submit applications is May 2020 and the FDA has until May 2021 to review the applications for final approval—failing which, they will be removed from the market. 

Manufacturers must specify every aspect of their product, including obvious things, like nicotine strength and flavors, but also things that aren’t as obvious—like data on population and individual health impacts of each individual product. All of these factors are taken into account to determine if the existence of the product would be an overall benefit to society. Clearly, the impact on adolescents and non-users will be a top consideration.

This ongoing process is why state and local governments should be wary of implementing prohibitions, including those on flavors, until the FDA has had the opportunity to review applications.

While it’s likely that the FDA will take an extreme approach to protecting adolescents— to the detriment of those who would benefit from e-cigarettes—it’s also likely that the products and flavors that they do approve will have large-scale benefits.

Across the US, too many bills to restrict or prohibit e-cigarettes and flavors have been filed to count. So it’s probably unrealistic to hope that lawmakers will table these proposals for another year. But we ought to expect more from our elected officials than behavior witnessed in past hearings.

Bullying of witnesses who don’t fit the perfect mold or refusing to acknowledge even the possibility that e-cigarettes might be a part of the solution to a much bigger problem isn’t going to help anyone. The simple truth is, a public health degree is not required to read academic reports that support the basis of a harm reduction approach to smoking; nor does having one give the recipient permission to ignore such evidence when creating policy.

* The R Street Institute, the author’s employer, previously provided a restricted grant to The Influence Foundation, which operates Filter, to support production of two reports on harm reduction topics.

* The nonprofit American Vaping Association has also previously provided grants to The Influence Foundation.

Photo by beasty on Unsplash.

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It’s no surprise that with this renewed focus on nicotine—and ensuing FDA-driven fear-mongering surrounding products that contain the substance, even if they don’t involve combustion of tobacco—people are more confused than ever about what nicotine is and what it does.

Does it cause cancer? Will smoking a cigarette or vaping instantly make you addicted? Does it cause brain worms?

Spoiler: No, no and unlikely.

Surely both the Food and Drug Administration and lawmakers should answer such questions accurately before going forward with policies that are likely to dissuade people from replacing combustible cigarettes with reduced-risk nicotine products?

What Nicotine Is and What it Does

Nicotine is naturally occurring chemical derived from plants of the nightshade family—which include tobacco, but also foods like tomatoes, potatoes and eggplant.

Though often thought of as a bad guy, nicotine itself is actually fairly safe. As with most substances, there is a lethal dose of nicotine, but the exact lethal dose is largely undetermined—in part because there are no realistic circumstances in which we would inadvertently encounter it.

Based on studies from a variety of species, the potential lethal dose for a human has generally been estimated at 60 milligrams or less, if taken all at once, although data indicate that 500mg of oral nicotine would be required to kill a human adult. Fatal nicotine poisonings are extremely rare. The average cigarette contains between 7-14mg of nicotine (much of that is not inhaled) and average consumption for smokers over the course of a day is 38mg (80mg at the highest end of the spectrum). There are reports of people surviving even extremely high doses of nicotine ingestion, including one of up to 4 grams of pure nicotine. This is likely due to nicotine causing vomiting quickly after ingestion, which prevents its uptake in the blood.

Nicotine works by binding to and activating nicotinic receptors in our bodies. We naturally produce a neurotransmitter called acetylcholine (ACH), which activates two distinct types of ACh receptors in our bodies: fast-acting nicotinic receptors (nACh), named because they are sensitive to nicotine; and slower-acting muscarinic receptors (mACh), named because they are sensitive to muscarine, another naturally occurring substance, found in mushrooms.

Both types of receptors play a role in our bodies’ nervous system. Untouched by outside chemicals, the nicotinic and muscarinic receptors work together to maintain balance, or homeostasis, between the body’s “fight or flight” response—primarily driven by the nicotinic receptor—and its “rest and digest” response, which is primarily driven by the muscarinic receptor.

When an outside chemical like nicotine is added, the scales are tipped, changing homeostasis. However, our bodies are amazingly adept at resetting homeostasis to maintain balance—in this case, the balance may be reset by decreasing or deactivating nicotinic receptors in response to a large influx or chronic exposure to the drug.

When it is taken orally, the effects are subtler—which is why people generally gravitate toward inhalation.

Changes in the way nicotine is consumed can lead to different results. Nicotine is most rapidly absorbed, and therefore has its most powerful effects in the brain, when it is inhaled. When it is taken orally, the effects are subtler—which is why people generally gravitate toward inhalation rather than consuming nicotine through other routes, such as chewing tobacco or nicotine gum.

Yet whether inhaled or chewed, when nicotine binds to the body’s nicotinic receptors, it affects dopamine release in the areas of the brain that process reward (more on that later).

But what about the consequences of long-term nicotine use?

Once upon a time, the FDA did not approve long-term use of nicotine replacement therapies, urging people to completely quit all forms of nicotine within a maximum of 12 weeks.

More recently, the agency has walked back those recommendations after realizing that long-term nicotine use is rather benign, and if nicotine replacement therapies can mitigate the risk for relapse to smoking, then continuing to use nicotine as a replacement therapy is better than an abstinence-only approach.

While the FDA has an eye to restrict vaping, a landmark study recently indicated that e-cigarettes are about twice as effective for smoking cessation as non-inhaled nicotine replacement therapies—a finding that chimes with the higher effectiveness of nicotine when it is inhaled.

Nicotine may exacerbate hypertension, but it is not responsible for the hardening of arteries, cancer or emphysema.

The health problems that are popularly associated with long-term nicotine use—including heart disease, various forms of cancer and stroke, to name a few—largely arise from smoking combustible cigarettes.

When not accompanied by tar, carbon monoxide and the myriad chemicals associated with combustible tobacco, nicotine may exacerbate hypertension, but it is not responsible for the hardening of arteries, cancer or emphysema.

So if nicotine does not cause cancer, heart disease or lung disease—but its use in isolation helps millions of people to avoid the combustible cigarettes that do cause these diseases, and indeed, as we’ll see, even has inherent benefits—then what’s the problem?

Why Public Health Agencies Are Worried About Nicotine Use

The FDA and other public health agencies concerned with nicotine use have taken to highlighting how it affects the brain—specifically the areas associated with reward and stress systems that mediate addiction. It is with these effects that nicotine’s use becomes both a practical and moral quandary.

Nicotine affects our brains—that cannot be denied. And the fact that nicotine increases dopamine transmission in the brain’s reward centers might cause longer-term—but not permanent—consequences, such as increasing reward thresholds (which leads to dissatisfaction or depression in the absence of nicotine) and altering our stress responses (resulting in anxiety and irritability during abstinence).

A typical smoker goes through several withdrawal cycles a day—followed by increases in stress hormones and heightened stress response. It is with this emerging adaptation that a state of addiction is believed to arise.

Nicotine also produces a common dependence syndrome: withdrawal.

While never an enjoyable experience, the dangers and discomforts of nicotine withdrawal rarely conform to the popular cultural portrayal of withdrawal symptoms. One interesting aspect of nicotine withdrawal is that the somatic, or bodily, withdrawal symptoms (including possible low blood pressure, an abnormally slow heart and intestinal distress) are quite weak compared to the psychological symptoms, which include irritability, anxiety, depressed mood, craving and malaise.

This is likely due to the fact that during nicotine withdrawal, the brain’s reward thresholds become elevated, meaning that more stimulus is required to produce the same reward during withdrawal than would otherwise be required. In other words, after abstaining from nicotine for a period of time, nicotine users experience a diminished sense of enjoyment from all rewarding stimuli. These effects far outlast the somatic withdrawal symptoms and encourage people to continue using nicotine products.

How does all of this happen? As with any rewarding stimuli, it is the “binge” and “withdrawal” cycles that are largely responsible for the emergence of the brain’s adaptations.

A typical smoker goes through several withdrawal cycles a day—usually during working and sleeping hours. These cycles are followed by increases in stress hormones and heightened stress response. It is with this emerging adaptation that a state of addiction is believed to arise, which may affect everything from attention to impulse control to mood. This may sound scary—and is probably a reason why people associate addiction, or the associated agents that bring about these changes, with brain damage. But brain changes aren’t brain diseases, and it’s rare that reinforcing drugs cause brain damage—it’s more common with toxic doses of amphetamine or amphetamine-like drugs that result in neuronal death.

Of course, we are not rats, and rats do not experience all the things humans do—poverty, wealth, isolation, social support or even variations in diet, to name a few.

Does nicotine always cause these effects? Probably not. When taken orally, nicotine does not affect the brain with the same intensity as it does when it is inhaled. Additionally, people have different experiences that may affect the way the brain reacts to rewarding stimuli—including transitioning from use to addiction. This transitioning phase, rightly or not, is a major concern for our public health agencies.

However, what we know about differential activation of brain reward and stress systems is primarily from animal studies. These are useful because, in a controlled environment, animal studies provide a common baseline for scientists to track and evaluate alterations in the brain.

But the consequences of these alterations are not as clear-cut as they may seem. And of course, we are not rats, and rats do not experience all the things humans do—poverty, wealth, isolation, social support or even variations in diet, to name a few. And with so many views of addiction, outside of a purely neurobiological model, it is difficult to discern what bearing any of this information has.

So Is Nicotine Addictive?

There is wide disagreement over whether nicotine per se is addictive. To begin, there are at least four separate, commonly referenced views of addiction:

The psychiatric view: Addiction has aspects of an impulse control disorder (taking something for pleasure) and a compulsive disorder (taking something to relieve stress).

Psychodynamic view: Addiction is the result of developmental difficulties, emotional disturbances, structural factors, personality organization and a dysfunctional view of “self.”

Social psychology view: Addiction is the result of poor self-regulation.

Dependence view of addiction: Addiction is the result of an abnormal state where administration of a drug is required to maintain physiological equilibrium.

As is often the case, some combination of these theories—along with others not mentioned here—is likely the most accurate way to define addiction right now. This is especially true when we consider the ever-changing social acceptability of certain drugs and behaviors, not to mention the legal, physiological and personal consequences that must be specifically considered for each.

One persuasive criterion for addiction—reflected, for example, in the American Psychiatric Association’s definition for substance use disorders—is that significant harms are associated with drug-seeking or taking.

Among researchers, physicians and harm reduction advocates, most agree that cigarettes are associated with addiction—whether because they define addiction by high relapse rates, increases in physiological dependence, the inclusion of psychoactive chemicals found in combustible tobacco, or the continuance of smoking despite clear health dangers.

But is taking nicotine that is not in the form of a cigarette a result of poor self-regulation? Or worse yet, brain damage? The answer largely depends on who you ask.

What Does This All Mean?

Initially, the FDA’s decision to reframe the public health interests from smoking to nicotine held some promise. Recognizing that the combustible cigarette, rather than nicotine, is the leading cause of preventable death in the United States could have blazed a trail for tobacco harm reduction and pushed tobacco companies that primarily sell products that kill to invest in products that do not.

Neither the benefits nor the  consequences of nicotine use need to be exaggerated for the good of public health.

Yet as unlikely as this new utopia may have seemed at the time, the FDA has since made achieving it downright impossible, with its constant attempts to force down the public’s throat the idea that nicotine is inherently damaging.

The reality is that nicotine isn’t scary—in fact, its benefits are well-documented: It increases attention span and concentration, can increase physical performance and prevent fatigue, and can elevate mood. Sure, it affects the brain in positive and negative ways, but that can truly be said of everything we do.

It’s easy to argue that poor regulatory policies are to blame for the upside-down world we live in, where more dangerous products are protected and far safer ones are facing extinction.

However, we cannot overlook the fact that the rhetoric and misinformation surrounding nicotine is scaring the pants off people who could benefit from safer forms of the drug— the forms that are more likely to result in successful quitting of cigarettes.

Neither the benefits nor the consequences of nicotine use need to be exaggerated for the good of public health. Perhaps the first step to understanding nicotine and, in turn, to ensuring that any necessary regulations do not exacerbate public health harms, is to simply have a normal, honest dialogue.

Photo via Vaping360.com

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During my first foray into this world, at the US E-Cig summit in 2017, I was surprised at the level of vitriol I witnessed, at the jeering and boos as different opinions, approaches and research were presented. Since then I have personally experienced such attacks, with the most recent coming at me on January 15.

My fellow panelists and I were invited by a state tax board to present on tobacco harm reduction and epidemiology, and traveled at our expense to do so. It turned out that we were walking into an ambush, complete with lies, attacks and humiliation.

At one point we were aggressively cornered into disclosing personal information—like who we associate with and the health status of our family members. We were even openly mocked when answering questions from the board members: Examples that we gave of other harm reduction approaches, like car safety and syringe access programs, were laughed at and dismissed as “not controversial and off topic.”

The result was that it was a waste of time and money. Rather than discussing the matters at hand, our personal lives and professional careers were called into question.

“I’ve been privy to reports of graduate students’ careers being threatened, and witnessed people’s livelihoods being questioned in private meetings.”

Those who advocate for, or produce and sell e-cigarettes or e-liquids, are also too often guilty of incivility. And we should acknowledge that, with trendy advertising and products seemingly appeal to children, there are definitely bad actors in this industry. Accounts of harm reduction advocates behaving badly are often shared, and there is vitriol on both sides—just look at any Twitter debate around the issue (and yes, I’m ashamed to admit that I’ve taken the bait a couple times myself). It’s easy for those of us on either side of the debate to imagine that the unprofessionalism is one-sided, but that is not the case.

Still, given my role as a tobacco harm reduction advocate, my experiences are skewed toward examples of bullying and harassment from those who are unwilling to concede that reduced-risk products have the potential to drastically reduce the death and destruction associated with cigarettes.

I’ve been privy to reports of graduate students’ careers being threatened, witnessed people’s livelihoods being questioned in private meetings, and seen and been a part of panels where equal time was promised, only for unwelcome voices to be filibustered offstage.

Opponents of tobacco harm reduction have legitimate concerns: Youth shouldn’t have access to these products, and there is an uptick in youth use. But while consensus on appropriate use, marketing, flavor options and packaging may never be achieved, one could hope that public health advocates—and that’s what we all are—avoid dividing into factions, hurling insults and claiming moral superiority.

The roots of anti-industry stances are understandable. Even for those of us not old enough to have seen the original testimony, watching old videos of the CEOs of the “big seven” tobacco companies saying with a straight face that nicotine isn’t addictive and that smoking isn’t bad for you is nauseating. As a result, acknowledging that industry could play a role in solving a problem of its own creation is a tough pill for many to swallow.

Anyone who works as a harm reduction advocate of any kind knows that a soft touch and evidence of positive outcomes are required to even get a foot in the door with policymakers. Being a jerk is a quick way to find the exit. This often means remaining civil in the face of personal attacks and rude behavior from the other side. In tobacco harm reduction advocacy, it’s difficult to name anyone who hasn’t had to take their licks when suggesting that industry, by developing and selling vaping products, could play a role in solving a health crisis—and to be clear, smoking, as the leading cause of preventable death, is a public health crisis.

To put an end to hostile work environments and promote civil discourse, the major charity Cancer Research UK (CRUK) recently adopted strict anti-bullying and harassment policies. (While this was not born out of a need to protect those who espouse tobacco harm reduction, it is noteworthy that CRUK does view e-cigarettes as potentially beneficial to public health.) CRUK has issued a notice to all grant recipients that abusive behavior will not be tolerated and will put research funding at risk. Interestingly, this extends past the grantee to include panel members and event speakers that are the guests of the grantee—putting the onus on funding recipients to ensure collaborative environments.

Anti-bullying and harassment policies should perhaps become much more widespread. After all, progress rarely happens without some degree of conflict, but I would argue that it never happens without a willingness to remain civil, to find common ground and compromises. The US surgeon general has correctly pointed this out, stating that personal attacks make future discussion or collaboration unlikely.

It’s high time we recognize that we harm reduction advocates, too, are complicit in a world where we often have to kowtow to those who feel they are on the side of virtue. Clearly, we in tobacco harm reduction underestimate the extreme and visceral feelings that nicotine and the tobacco industry elicit. Nevertheless, there is nothing to be gained from attacking each other personally instead of attacking the problem. The onus for maintaining civility lies with all of us, not just those with a controversial point of view. No matter who they come from, harassment and abuse are harassment and abuse.

Photo by Yosh Ginsu on Unsplash

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