By Brandel France de Bravo, MPH; Sarah Miller, RN; and Jessica Becker
Updated JUNE 2014
Electronic cigarettes, or e-cigarettes, are being marketed as the “safe” new alternative to conventional cigarettes. They can be used indoors, allowing smokers to get their fix wherever and whenever they want. But are e-cigarettes safe? What does the FDA think about them? Are e-cigarettes going to reverse the decline in smoking—giving new life to an old habit—or can they help people quit smoking? Here is what you need to know before picking up an e-cigarette.
What are e-cigarettes?
E-cigarettes are battery-operated devices shaped like cigarettes that provide an alternative way to receive nicotine. Nicotine is an addictive drug (it stimulates and relaxes) that is naturally found in tobacco, but cigarette manufacturers have often added extra nicotine or engineered their cigarettes to maximize the amount of nicotine delivered to smokers in each puff. 1
E-cigarettes work by heating a liquid cartridge containing nicotine, flavors, and other chemicals into an inhalable vapor. Because e-cigarettes heat a liquid instead of tobacco, what is released is considered smokeless.2 However, studies show that exposure to the chemical used to create the vapor (propylene glycol mist) may cause respiratory inflammation and eye irritation.3 Propylene glycol is used in pet-friendly anti-freeze solutions (a safe alternative to ethylene glycol) and in smoke machines at dances or the theater.
Flavors, such as “gummy bear,” “cotton candy,” and “bubble gum” are not only encouraging teenagers to try e-cigarettes, they are resulting in accidental poisonings among children. Over half of the 2,405 calls to poison centers between September 2010 and February 2014 concerned children 5 and under who had come into contact with e-cigarettes. 4 E-cigarettes are far easier for young children to smoke as they require no matches. Worse still, the liquid in the cartridges is highly concentrated so absorbing it through the skin or swallowing it is far more likely to require an emergency room visit than eating or swallowing regular cigarettes.
Are e-cigarettes safer than conventional cigarettes?
The key difference between conventional and e-cigarettes is that e-cigarettes don’t contain tobacco. But, it isn’t just the tobacco in cigarettes that causes cancer. Conventional cigarettes contain a laundry list of chemicals that are proven harmful, and e-cigarettes have some of these same chemicals.
Nicotine is one of the chemicals found in both conventional and e-cigarettes. It is highly addictive and has been shown to reduce bone health.5
An analysis of e-cigarettes by the FDA in 2009 found that they “contained detectable levels of known carcinogens and toxic chemicals to which users could be exposed.”6 For example, in e-cigarette cartridges marketed as “tobacco-free,” the FDA detected diethylene glycol (a toxic compound found in antifreeze), tobacco-specific nitrosamines which are carcinogenic to humans, and other toxic tobacco-specific impurities. The body’s reaction to many of the chemicals in conventional cigarette smoke causes chronic inflammation, which in turn leads to chronic diseases like bronchitis, emphysema, and heart disease.7 Since e-cigarettes also contain many of the same toxic chemicals, there is no reason to believe that they will significantly reduce the risks for these diseases.
You may have also heard that free radicals produced by the smoke from cigarettes can damage veins and arteries and lead to heart disease. It is possible that the vapor from e-cigarettes may contain fewer free radicals because it is not smoke. This does not mean, however, that smoking e-cigarettes is safe for your heart.
There are no long-term studies to back up claims that the vapor from e-cigarettes is less harmful than conventional smoke. Cancer takes years to develop, and e-cigarettes were only very recently introduced to the United States. It is almost impossible to determine if a product increases a person’s risk of cancer or not until the product has been around for at least 15-20 years. Despite positive reviews from e-cigarette users who enjoy being able to smoke them where regular cigarettes are prohibited, very little is known about their safety and long-term health effects.
Can e-cigarettes be used to cut down or quit smoking regular cigarettes?
If a company makes a claim that its product can be used to treat a disease or addiction, like nicotine addiction, it must present studies to the FDA showing that its product is safe and effective for that use. On the basis of those studies, the FDA approves or doesn’t approve the product. So far, there are no large, high-quality studies looking at whether e-cigarettes can be used to cut down or quit smoking long-term. Most of the studies have been either very short term (6 months or less) or the participants were not randomly assigned to different smoking cessation methods, including e-cigarettes. Many of the studies are based on self-reported use of e-cigarettes. For instance, a study done in 4 countries found that e-cigarette users were no more likely to quit than regular smokers even though 85% of them said they were using them to quit. 8. Another year-long study, this one in the U.S., had similar findings.9 People may believe they are smoking e-cigarettes to help them quit but 6-12 months after being first interviewed, nearly all of them are still smoking regular cigarettes.
The FDA has not approved e-cigarettes for use in cessation, or quitting smoking.10
In September 2010, the FDA sent a warning letter to five distributors of e-cigarettes who were marketing their product this way: E-CigaretteDirect LLC, Ruyan America INC., Gamucci America (Smokey Bayou INC.), E-Cig Technology INC. and Johnson’s Creek Enterprises LLC. After this warning letter, four of the companies changed their position to say that their e-cigarettes are not intended to be used as a way to quit smoking. E-Cig Technology INC. hasn’t made any changes to their website in response to the warning letter.
Teenagers and e-cigarettes
The percentage of teenagers who have tried e-cigarettes has more than doubled in just a year, from 4.7% in 2011 to 10% in 2012. Over 1.78 million U.S. students in middle school and high school tried e-cigarettes in 2012, according to the National Youth Tobacco Survey. And this statistic greatly underestimates use because most teens don’t even know e-cigarettes as “e-cigarettes”; they call them “e-hookas” or “hookah pens” or “vape pipes.” Furthermore, 1 in 5 middle schoolers who said they had tried e-cigarettes also said they had never smoked conventional cigarettes. 11
Experimentation with e-cigarettes by young people is worrisome for a couple of reasons: 1) the younger people are when they begin smoking, the more likely it is they will develop the habit: nearly 9 out of 10 smokers started before they were 18;12 2) e-cigarettes may introduce many more young people to smoking who might otherwise never have tried it, and once they are addicted to nicotine, some may decide to get their “fix” from regular cigarettes. Whether e-cigarettes end up being a “gateway” to regular cigarettes or not, young people who use them risk becoming addicted to nicotine and exposing their lungs to harmful chemicals.
The sharp rise in young e-cigarette users highlights the need to stop manufacturers from targeting teenagers with candy-like flavors and advertising campaigns such as this one that appeal to young people’s natural desire to rebel.
How are e-cigarettes regulated?
On a national level
Originally, the FDA tried to block the sale of e-cigarettes on grounds that they were an untested drug-delivery device (nicotine is a drug), but in 2010 a federal appeals court ruled that the FDA could only regulate e-cigarettes as tobacco products.13 The FDA was given the authority to regulate the manufacturing, labeling, distribution and marketing of all tobacco products in 2009 when President Obama signed into law the Family Smoking Prevention and Tobacco Control Act. This Act also gave the FDA the authority to regulate “other tobacco products” (including products made from or derived from tobacco) by issuing a regulation “deeming” the additional products as subject to the same law.
In April 2014, the FDA issued its first proposal (a “deeming rule”) for regulating e-cigarettes. These proposed regulations are just that: a draft proposal, which the public, scientists, and e-cigarette companies have a chance to review and provide input on before it is finalized. The full text of the deeming rule can be found here but in short, the FDA is proposing:
- To prohibit the sale of e-cigarettes to children and teens (under 18)
- To prohibit vending machine sales of e-cigarettes
- People over 18 will be required to show photo i.d. to purchase e-cigarettes, including through the internet.
- The addition of a warning label to all packaging and advertisements stating “This product contains nicotine derived from tobacco. Nicotine is an addictive chemical”.
- All manufacturers of e-cigarettes will have to register with the FDA, which involves providing the agency with a detailed list of all the products’ ingredients, including how much nicotine they have, and information on their manufacturing process.
Despite these positive steps, the proposed rule is not nearly as tough as the regulations governing regular cigarettes. For instance, the FDA is still not proposing to limit the marketing of e-cigarettes to children and teens—only their sale. Also, it isn’t putting any restrictions on the media e-cigarettes can be advertised in, whereas regular cigarettes can’t advertise on television or radio. E-cigarette companies will continue to use celebrities to endorse their brands and market flavors such as “bubble gum” and “cookies and cream”.
When e-cigarette companies register their products with the FDA, they will have to apply for FDA approval of the products, but here’s the catch: they will have two years AFTER the deeming rule is finalized to apply for approval and will be able to keep selling their e-cigarettes during that time. While the FDA’s proposed rule leaves the door open for the agency to issue more regulations on the sale, advertisement and marketing of e-cigarettes down the road, issuing and finalizing additional regulations will take time. Moreover, companies have to be given time to comply. All of this means that omissions and loopholes can take years to fix. Lastly, the FDA rule proposal does not address the sale of liquid nicotine which is used to re-fill e-cigarettes and exists as an unregulated market. Presently, there is no requirement for childproof lids or restrictions on quantity on internet and retail outlet sales of liquid nicotine. If you would like to comment on the FDA’s proposal for regulating e-cigarettes, click here. The FDA has extended the deadline for comments until August 8, 2014.
On a state level
Individual states have taken action to govern the sale and use of e-cigarettes, including restricting their use in public areas and banning their sale to minors. For example, in May 2013, the California state senate proposed a law making all e-cigarettes subject to the same regulations and restrictions as traditional cigarettes and tobacco products.14
E-cigarettes have not been around long enough to determine if they are harmful to users in the long run. Unfortunately, many people, including teenagers, are under the impression that e-cigarettes are safe or that they are effective in helping people quit smoking regular cigarettes. Neither of these assumptions has yet been proven. Studies by the FDA show that e-cigarettes contain some of the same toxic chemicals as regular cigarettes even though they don’t have tobacco. The big three tobacco companies—Lorillard, Reynolds American, and Altria Group—all have their own e-cigarette brands so it’s not surprising that e-cigarettes are being marketed and advertised much the way regular cigarettes used to be. Here are the 7 Ways E-Cigarette Companies Are Copying Big Tobacco’s Playbook.
Unless you want to be a guinea pig, hold off on e-cigarettes until more safety information is available. And if you want to quit smoking or reduce the number of cigarettes you are smoking, check out these Quit Smoking Resources compiled by the Centers for Disease Control (CDC).
- Associated Press/USA Today Judge orders tobacco companies to say they lied. November 27, 2012. ▲
- Richard J. O’Connor Non-cigarette tobacco products: What have we learned and where are we headed? Tob Control. Author manuscript; available in PMC 2013 July 19. Published in final edited form as: Tob Control. 2012 March; 21(2): 181–190. doi: 10.1136/tobaccocontrol-2011-050281. ▲
- G Wieslander,D Norback, and T Lindgren. “Experimental exposure to propylene glycol mist in aviation emergency training: acute ocular and respiratory effects”. Occup Environ Med. 2001 October; 58(10): 649–655. < http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1740047/>. ▲
- Centers for Disease Control. Notes from the Field: Calls to Poison Centers for Exposures to Electronic Cigarettes — United States, September 2010–February 2014.April 4, 2014 / 63(13);292-293 ▲
- Tanaka, H.,Tanabe, N., Kawato, T., Nakai, K., Kariya, T., Matsumoto, S., & … Maeno, M. (2013). Nicotine Affects Bone Resorption and Suppresses the Expression of Cathepsin K, MMP-9 and Vacuolar-Type H+-ATPase d2 and Actin Organization in Osteoclasts. Plos ONE, 8(3), 1-12. doi:10.1371/journal.pone.0059402. ▲
- Summary of Results: Laboratory Analysis of Electronic Cigarettes Conducted By FDA. FDA News & Events. FDA, 22 July 2009. Web. 09 Aug. 2013. <http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm173146.htm>. ▲
- Stoller, JK & Juvelekian, G; Chronic Obstructive Pulmonary Disease; 2010 Cleveland Clinic Center for Continuing Education. Retrieved from www.clevelandclinic.meded.com/diseasemanagement/chronic-obstructive-pulmonary-disease on Sept. 2, 2010. ▲
- Adkison SE, O’Connor RJ, Bansal-Travers M, et al. Electronic nicotine delivery systems: international tobacco control four-country survey. Am J Prev Med. 2013;44(3):207-215 ▲
- Grana RA, Popova L, Ling PM. A Longitudinal Analysis of Electronic Cigarette Use and Smoking Cessation. JAMA Internal Medicine, published online March 24, 2014 ▲
- Electronic Cigarettes FDA News & Events. FDA, 25 July 2013. Accessed 14 Aug. 2013. <http://www.fda.gov/newsevents/publichealthfocus/ucm172906.htm>. ▲
- Centers for Disease Control and Prevention. E-cigarette use more than doubles among U.S. middle and high school students from 2011-2012. Accessed September 25, 2013. Available at: http://www.cdc.gov/media/releases/2013/p0905-ecigarette-use.html ▲
- Centers for Disease Control and Prevention. Fact sheets: Youth and tobacco use. Accessed September 25, 2013. Available at: http://www.cdc.gov/tobacco/data_statistics/fact_sheets/youth_data/tobacco_use/ ▲
- “Regulation of E-Cigarettes and Other Tobacco Products.” FDA News & Events. FDA, April 25, 2011. Accessed: Aug. 20, 2013. <http://www.fda.gov/newsevents/publichealthfocus/ucm252360.htm>. ▲
- Corbett, E.M. (2013) Electronic cigarettes: restriction of use and advertising. LEGISLATIVE COUNSEL’S DIGEST. February 22, 2013. Accessed: August 20, 2013. http://leginfo.ca.gov/pub/13-14/bill/sen/sb_0601-0650/sb_648_bill_20130222_introduced.html. ▲