(Editor’s note: though this article was released just prior to the FDA’s final ruling on e-cigarette regulations, it remains topical and contains much information necessary for understanding why the new legislation needs to be challenged.)
By Sarah Beller
With the release of new FDA rules regulating e-cigarettes expected to come any day now, our attitudes to these devices—and to tobacco harm reduction in general—matter more than ever. A debate over whether they should be viewed as a danger, as a lesser evil, or as a miracle, is splintering both the public and private realms, creating unexpected alliances and enemies. It is no exaggeration to say that millions of lives may hang in the balance.
The Disturbing Subplot
Since the surgeon general’s warning was mandated onto cigarette packs in 1966, the US smoking rate has been more than cut in half: In 1965, 50 percent of adults smoked; in 2014, 16.8 percent did. But according to the CDC, about 480,000 deaths annually are still attributable to smoked tobacco, which remains the leading cause of preventable death in the United States, responsible for about one in every five deaths.
Who still smokes cigarettes? The answer to that question is a “disturbing subplot” to the general decline in smoking rates. Cigarette smoking is highest among people living below the poverty level, about 26.3 percent of whom smoke, as opposed to 15 percent of people at or above the poverty line.
High-income families decreased their smoking by 62 percent from 1965 to 1999, versus only 9 percent for low-income families. Smoking is also disproportionately high among people with (other) problematic substance use, and psychiatric issues: 36 percent of people with mental illness smoke cigarettes, and a full 48 percent of people with mental illness living below the poverty level smoke—that’s nearly the same rate as that of the general population in 1965. Within specific populations, some of the numbers are even higher: In the US, 80 percent of people with schizophrenia smoke cigarettes.
Reducing harms associated with smoking cigarettes should obviously be of huge concern to anyone involved in public health. But it should also be a high priority for people who care about reducing inequalities.
The Future Is Here
Last week, Dr. Michael Siegel, a professor at Boston University School of Public Health, Skyped in to a conference in downtown Brooklyn to ask an audience what people would say if he told them he had a device that “looked and worked like a cigarette” but didn’t cause any of the harms.
He answered his own question: “People would say ‘wow, that sounds really intriguing.’ At which point I would tell them, the future is here. We have that: The electronic cigarette.”
“There’s certainly room for improvement,“ he admitted. “But we have it.”
His rapt audience of about 60 was gathered at the first ever Tobacco Harm Reduction conference in the US, held at the New York City College of Technology. Attendees included nursing students, health providers, members of the e-cigarette industry, policy leaders and “consumers”—i.e., “vapers.” The particular focus was on tobacco harm reduction among people with mental illness and substance use disorders.
Tobacco harm reduction is the replacement of tobacco with lower-risk products in order to reduce death and disease. There are currently seven FDA-approved products for smoking cessation; according to the FDA, they “supply you with nicotine in controlled amounts while sparing you from other chemicals found in tobacco products.” These include the patch, nicotine gum and lozenges, nicotine inhalers, and drugs like bupropion, an antidepressant which has been found to cut cravings.
Most who were at the conference believe that e-cigarettes should be added to the list—and indeed, should top the list for having the most potential to move people away from “combustibles.”
The alternatives are largely unpalatable or just not effective enough.
“Unfortunately, smoking is a very difficult addiction to break, even for those with a strong desire to quit,” writes Dr. Ricardo Poloso, director of the Institute for Internal and Emergency Medicine of the University of Catania in Italy, and a speaker at the conference. “It has been shown that approximately 80 percent of smokers who attempt to quit on their own relapse within the first month of abstinence, and only about 5 percent achieve long-term abstinence.”
It’s disheartening stuff. But there is hope in nicotine replacement, according to Polosa, because “nicotine per se does not cause much risk when separated from inhaling smoke.” (It may potentially be harmful during pregnancy, but less so than continued smoking). A study conducted by Public Health England concluded that “e-cigarette use is around 95% less harmful than smoking.”
Given this, why not embrace a method of nicotine delivery that can successfully encourage cigarette smokers to actually reduce their use, or even quit altogether?
Why E-Cigarettes Work
Conference attendees highlighted three interesting reasons why e-cigarettes may work better than other forms of nicotine delivery:
1. Drug Use as Ritual
Conference organizer and Influence contributor Helen Redmond works in supportive housing for people with a range of psychiatric diagnoses. “When it comes to drug use,” she said, “ritual is very important. For people who use drugs and particularly for people in some kind of psychological distress, the sensory aspects are really powerful.” Dr. Siegel talked about this sensory aspect as well: E-cigarettes are the first product, he said, “to mimic smoking” in terms of the “oral stimuli, throat-hit, vapor cloud and inhalation,” thereby maintaining smoking associations. Smoking cigarettes is also often “a social activity; vaping mimics this aspect as well, with things like “social support, vaping clubs, and vape fest.”
2. Vaping Is Fun
“Vape fest”? Sounds pretty fun, right? That’s another point for e-cigarettes. Dr. Christopher Russell, Ph.D., a researcher from Scotland, where the attitude toward e-cigarettes is much more receptive than in the US, highlighted this. He said: “People used to think of quitting smoking as a terrible time in your life you have to grit your teeth and get through.” But with vaping, it can be a “hobby.” There are different flavors, ways to experiment with mixing and matching e-cigarette parts and juices and “neat devices.” There’s also “skill formation.” He quoted a vaper who said: “I learned about the different bases and juices. There’s so much knowledge out there and I became a nerd. And it became a hobby.” Julie Woessner, executive director of CASAA (the Consumer Advocates for Smoke-free Alternatives Association), echoed these sentiments. She showed the audience different versions of e-cigarettes that she likes to carry with her: “I love those puppies when I’m traveling—they’re fun,” she said. “The fact that we’re enjoying what we’re doing doesn’t detract from the fact that we are enjoying significant health benefits.”
Smoking cigarettes can become an identity for some people, and with the patch or gum, Dr. Siegel explained, “you’re not really getting a substitute”—there’s not a vibrant community of people who identify as patch-users. Siegel quoted one vaper who illustrated how vaping, in contrast, fills the void: “You know, for years, I loved being able to carry around my pack of cigarettes and my Red Sox lighter. I miss carrying my Red Sox lighter. I still could but it’d be stupid. That’s how you feel about your [vape]; it’s your Red Sox lighter. It becomes who you are.”
The Devil We Know
But like the opioid-replacement treatments methadone and buprenorphine, e-cigarettes and other nicotine “replacement technologies” are still viewed with suspicion in some quarters. Many believe that nicotine users should be pressured to “taper off.”
For example, Dr. Shadi Chamany, Director of Science for the Division of Prevention and Primary Care at the New York City Department of Health and Mental Hygiene, stated at the conference that her department recommends that if people try to quit smoking combustibles by using e-cigarettes, they “set a quit date for e-cigarettes.”
For the most part, public health organizations in the US have promoted the idea that e-cigarettes are an unknown variable. They may be less harmful than combustibles, they may be more harmful, but we just don’t know yet.
Yet to tobacco harm reductionists, it seems like many mainstream public health organizations fan fears of e-cigarettes. For example, in a press release last year, the CDC director, Tom Frieden, MD, MPH said: “We want parents to know that nicotine is dangerous for kids at any age, whether it’s an e-cigarette, hookah, cigarette or cigar. Adolescence is a critical time for brain development. Nicotine exposure at a young age may cause lasting harm to brain development, promote addiction and lead to sustained tobacco use.”
Some health groups go even further. The American Lung Association states its concern about “the potential health consequences of e-cigarettes….Nicotine is not safe.”
Dr. Siegel presented slides of the distorted facts and outright lies against e-cigarettes that he believes many anti-smoking groups propagate. For example, he pointed out, Tobacco-Free UK (University of Kentucky) says: “It [vaping] causes cancer.” Dr. Siegel responded, with exasperation: “They don’t even say that it may cause cancer! There is absolutely no evidence for this.”
The FDA has said: “Studies evaluating whether e-cigarettes are less harmful than cigarettes are inconclusive.” Again, that is simply not true, said Dr. Siegel. They are conclusively less harmful.
True or not, public health campaigns against e-cigarettes have had an effect. One study showed that in 2010, 84.7 percent of smokers surveyed believed e-cigarettes were less harmful than traditional cigarettes, but by 2013, that number dropped to 65 percent.
Given the power of health organizations to shape public opinion, when Dr. Chamany of the NYC Health department, the only conference contributor representing a “mainstream” health organization, spoke, there was palpable tension. After all, her department was responsible for the very anti-smoking ads that organizer Helen Redmond had earlier criticized as ineffective and insensitive attempts to shame or scare people out of smoking cigarettes.
Dr. Chamany addressed this tension head-on: “When Helen told me about this conference,” she said. “I thought it was a good opportunity, not to peddle our wares, but to put the question out of how well is this working…from what I can tell, we’re getting a big F.” The audience agreed.
Yet she drew further disagreement when she said that, according to the health department, e-cigarettes, “while likely safer, are still unregulated.” Members of the audience spoke up: “It’s misleading to say that e-cigarettes are likely safer. They are safer.”
They Can’t Handle the Truth
Dr. Siegel can’t understand what’s going on. Why, he wonders, can’t health organizations “handle the truth” that e-cigarettes are much safer? After giving the matter years of thought—and having once worked at the CDC with the people he now finds himself railing against—he believes that e-cigarettes are a threat to “the status” of anti-smoking groups.
The ultimate reason for their opposition to these products, he believes, may be as simple as: They didn’t think of them first.
“I believe that if someone within tobacco control had invented the idea of the electronic cigarette, it would have been a completely different story,” he elaborated. Instead, “there’s a feeling that if this is something that the [tobacco] industry created and it ends up being a solution to the problem, we can’t accept that.”
Although e-cigarettes didn’t, in fact, come out of the tobacco industry, the industry is now involved in making and profiting from the product—and this is just not acceptable to many in public health.
“Essentially,” Dr. Siegel told me later, “It represents a threat to a lot of these groups because it violates their way of looking at the world. This is not supposed to happen…How could something that looks like smoking possibly be good?”
The CDC seems to prefer the fantasy of “the perfect” at the expense of “the good.” A CDC spokesperson told me that they want to wait until longitudinal studies can be carried out on the effects of e-cigarettes before commenting one way or another on their relative risks. And furthermore, he tells me, e-cigarette companies “have to play by the rules.”
So what are the “rules,” exactly?
FDA’s Rules Expected This Month
In 2014, the FDA’s Center for Tobacco Products first proposed a rule that would extend their authority to regulate e-cigarettes, based on the fact that they contain nicotine, a product which comes from tobacco. But it hasn’t yet been finalized.
In an email to The Influence, FDA spokesman Michael Felberbaum said: “Finalizing the rule to bring additional products under the agency’s tobacco authority is one of our highest priorities, and we look forward to a day in the near future when such products are properly regulated and responsibly marketed.” Industry and advocacy groups reportedly expect the decision this month.
Though e-cigarettes are seen by many to contribute to the FDA’s stated goal of ending smoking-related diseases and deaths, the framework proposed by the FDA would ironically wipe out most independent e-cigarette companies, and hand the remainder of the market over to Big Tobacco.
That’s because the rule would require any e-cigarette products that came on the market after February 15, 2007 (which is to say, almost all of them), to go through Pre-Market Tobacco Applications (PMTA), a process that the FDA itself estimates would take 5000 hours and cost $300,000. The only companies with that kind of capital are Big Tobacco, which presently control about 30% of the e-cigarette market.
Also, one of the provisions of the rule is that you cannot claim that your tobacco product is any safer than any other tobacco product. This provision was originally intended to stop tobacco companies that were advertising certain cigarettes as “light” or “mild.” However, says Siegel, “If [the FDA] applies these regulations, which it seems like they’re going to, it will mean that an e-cigarette company is not allowed to say they are less harmful than cigarettes. And that is counter-productive, because that is keeping from consumers the key piece of information that you need to know.”
If the rule is passed, Siegel says it would be “disastrous” for public health.
When I asked why e-cigarette companies aren’t trying to follow the path of the FDA approved smoking cessation tools (like the patch and gum), he explained that that process is even more time-consuming and expensive, but also suggested that “part of the key to the success of the [e-cigarette] market is that vaping is not viewed as a medicine or a drug.”
So tobacco harm reduction proponents believe that e-cigarettes require a “unique regulatory framework,” different to that for regular cigarettes and different from the one for medication like the patch.
The outlook for vapers may bleak, but they’re not going out without a fight. On April 19, the House Appropriations Committee passed an amendment which, among other things, would push back the date by which e-cigarette products had to enter the market in order to be exempt from the PMTA process. Instead of 2007, the entry date requirement would be any time before the date on which the FDA issues its final deeming regulations. If the amendment becomes law, it could “save 99 percent of e-cigarette products from prohibition.”
In the midst of this uncertainty, one thing is certain: Vulnerable populations will continue to inhale smoke and die preventable deaths unless anti-smoking groups reckon with the idea that something that looks just like smoking might possibly be a force for good.