Update: On April 24, 2014, the US Food and Drug Administration proposed new rules that would expand its regulatory authority to include electronic cigarettes. As reported in The New York Times, the regulations would ban the sale of e-cigarettes, cigars, and pipe tobacco to Americans under 18, and would require that people buying them show photo identification to prove their age. Below is a post that addresses the FDA’s concerns on the safety of e-cigarettes, featuring assistant director of Memorial Sloan Kettering’s Tobacco Treatment Program, Jack E. Burkhalter. Stay tuned to our blog for updates on Memorial Sloan Kettering’s latest research on e-cigarettes.
Many smokers around the world are choosing electronic cigarettes (also known as e-cigarettes) in the belief that they are less damaging to their health. Millions of Americans have joined the trend since the tobacco-free devices were introduced domestically in 2007, with sales estimated to reach $1 billion this year.
Although they differ in shape and size, e-cigarettes basically all function in the same way. The user inhales through a mouthpiece, triggering a sensor that turns on a battery-powered heater. This action vaporizes liquid nicotine and activates a light at the tip.
The heater also vaporizes substances such as propylene glycol and glycerol to produce theatrical smoke similar to the white puff produced when exhaling tobacco cigarettes. Flavorings such as mint, chocolate, and bubblegum are often added.
Among the new users are many young people. The number that have tried e-cigarettes doubled from 2011 to 2012, according to the Centers for Disease Control, which estimates that a total of 1.78 million middle and high school children have experimented with the devices.
As the assistant director of Memorial Sloan Kettering’s Tobacco Treatment Program, Jack E. Burkhalter hears questions and concerns about the safety of e-cigarettes every day.
We asked him to help us sort through the mixed safety messages.
Dr. Burkhalter says he often hears smokers claim e-cigarettes must be healthier than conventional cigarettes because they do not contain tobacco. But e-cigarettes do contain a liquid form of nicotine, a highly addictive tobacco component that may cause changes in the developing brains of young people. And the consequences of long-term nicotine use in adults have not even been fully studied, Dr. Burkhalter explains.
“Another problem is that we have no way of knowing what’s in a given product,” Dr. Burkhalter says, as manufacturers and types of e-cigarettes vary widely. “There is no one product — so it is impossible to determine whether any given e-cigarette is in fact safer than a conventional one, or safer than another brand of e-cigarette.”
Most electronic cigarettes sold in the United States are imported from China, which does not regulate or standardize the products. Domestic e-cigarettes are not government regulated, either. As a result, users are left in the dark regarding how much nicotine or other substances they are inhaling.
What those other substances might be is yet to be determined. While more research on the topic is needed, some studies indicate that e-cigarettes may contain a variety of chemicals, from suspected carcinogens to heavy metals and airway irritants.
Nor has much research been done to determine the health impact of inhaling e-cigarette vapors into the lungs.
“So while they may seem to be safer compared to tobacco cigarettes because they don’t contain tobacco and tobacco smoke, we can’t really quantify if that is the case,” Dr. Burkhalter says. “Overall, I hope for the best—but fear the worst.”
Questions of Safety to Others, and to Youth
“I hope for the best but fear the worst. The issue of whether e-cigarettes are safe and actually help smokers quit is a problem we will have to grapple with until we have more evidence.”
-Jack Burkhalter, Assistant Director, Tobacco Treatment Program
The health risks of secondhand exposure to tobacco smoke are well established. Still unclear, however, is the impact of secondhand vapor from e-cigarettes, Dr. Burkhalter says. “E-cigarette users may feel more at ease in smoking around others, including children — a decision based on their perception of reduced harm. Unfortunately, this perception isn’t supported with sound scientific data.”
He also finds the rising numbers of young people trying electronic cigarettes very concerning because the devices might serve as gateway products to tobacco use. According to the CDC report, of the nearly 1.8 million middle and high school children who have tried e-cigarettes, an estimated 160,000 of them have never used conventional cigarettes.
Any exposure to nicotine can have harmful effects on the development of the body and brain in a young person, Dr. Burkhalter notes.
Regulators and Options for People Trying to Quit
“E-cigarettes have an allure, and it’s difficult at times to convince people that instead of turning to products that we still don’t know a lot about, we have evidence-based ones that, unlike the e-cigarette, have been approved by the Food and Drug Administration and have proven track records for enabling many people to break their addition to nicotine,” Dr. Burkhalter explains.
In addition to nicotine replacement products such as chewing gum, lozenges, and skin patches designed to ease cravings, there is the nicotine inhalation system (such as the Nicotrol® Inhaler) — which he says is the closest in look and feel to the e-cigarette.
But what this prescription-only product doesn’t have is the benefit of styling in appealing shapes and colors, or the illusion, complete with visible vapor puffs, of smoking a cigarette. “Many of my patients won’t be seen with the Nicotrol Inhaler; marketing of the Food and Drug Administration–approved cessation products has not been as sophisticated and aggressive as those for e-cigarettes,” Dr. Burkhalter says.
What these FDA-approved nicotine replacement products do provide is definitive information about their ingredients, including how much nicotine they deliver. They represent tools to use along what is known as the “harm-reduction continuum,” with total abstinence on one end of the spectrum, the use of conventional tobacco cigarettes on the other, and products that offer less damaging alternatives at various points along the middle.
“If the FDA decides that it will start regulating the e-cigarette industry – a ruling on this is expected in the fall of 2013 – we will soon learn a lot more about what is contained in these devices and where they might fit along this harm-reduction continuum,” Dr. Burkhalter explains. Many countries with tobacco control policies are struggling to shape policies regarding safety and the appropriate use of e-cigarettes.
Meanwhile, research about e-cigarette use is under way at Memorial Sloan Kettering and elsewhere to take stock of how cancer patients use e-cigarettes, whether users are more likely to quit smoking tobacco cigarettes, what sorts of substances the products contain, and what the health risks of inhaling vaporized chemicals might be.