On April 24, 2014, the U.S. Food and Drug Administration (FDA) publicly released a draft of its proposed rule – commonly called a “deeming document” – which seeks to regulate e-cigarettes and other tobacco products not currently regulated by the FDA. The Florida Department of Health appreciates the long overdue release by the FDA of its draft proposed rule regarding electronic cigarettes.
Bureau of Tobacco Free Florida’s Statement Regarding Electronic Cigarettes
The emergence of electronic cigarettes (also known as e-cigarettes, vapors, vaporizers, nicotine vaporizers or hookah pens) has triggered a flood of questions and considerable debate and discussion regarding their safety, ability to help smokers quit, and the risks they pose to children and teens. While the makers of e-cigarettes claim they are safe, there is uncertainty as to whether e-cigarettes are a safe alternative to smoking and Floridians should be very cautious. The Florida Department of Health’s Bureau of Tobacco Free Florida advises consumers to wait for reliable scientific evidence on their safety and effectiveness to become available before using e-cigarettes.
Preliminary analysis from the FDA e-cigarette samples contained detectable levels of known carcinogens and toxic chemicals to which users could potentially be exposed.1 There are more than 200 brands on the market and they have different chemicals that they use. Scientific testing shows that the products vary widely in the amount of nicotine and other chemicals they deliver. Therefore, currently there is no way for consumers to know what is actually delivered by the product they have purchased. Furthermore, these products have simply not been around long enough to determine their long-term health effects.
Tobacco Free Florida is concerned that, in addition to their possibly harmful effects, e-cigarettes may become a tool used to get youth and young adults hooked on nicotine, which is a highly addictive chemical.2,3,4 Many e-cigarette brands offer their products in fruit and candy flavors, like cotton candy and gummy bears, that are especially enticing to young people, and currently, they are easily available online, at mall kiosks or at local retailers. Furthermore, while tobacco products like cigarettes and dip have been banned from advertising on TV for decades, we have seen a notable increase in the marketing of e-cigarettes, including TV commercials. E-cigarette companies are using the same tactics of the tobacco industry to successfully market regular cigarettes to young people. In fact, according to the CDC, the number of middle school and high school students in the United States who used electronic cigarettes doubled in 2012 compared to just a year earlier.5
Furthermore, the number of calls to poison centers involving e-cigarette liquids containing nicotine rose from one per month in September 2010 to 215 per month in February 2014, according to a CDC study published April 3, 2014. The number of calls per month involving conventional cigarettes did not show a similar increase during the same time period. More than half of the calls to poison centers due to e-cigarettes involved young children under age 5.6
According to the FDA, e-cigarette makers cannot legally claim that an e-cigarette product “helps stop or reduce the cigarette urge,” “helps stop or reduce smoking,” or similar claims that it is a smoking deterrent drug product.7 Yet, many e-cigarette ads openly violate this restriction, causing concern that they are not interested in public safety. It is also worrisome that e-cigarette companies fought against treating e-cigarettes as drug-delivery devices, a standard that proven smoking cessation products like the patch and gum have met; products that have met the requirement to be drug-delivery devices have to submit clinical trials to the FDA to prove they are safe and effective and it appears e-cigarette companies want it both ways, to be able to make the claims without having to prove those claims are true.
There are additional important questions about e-cigarettes that remain unanswered. Some of these questions include:
Are they a youth gateway to nicotine addiction and the use of other tobacco products?
Does the alarming increase in e-cigarette use among youth and in their availability have the potential to normalize smoking again?
Do they encourage former smokers and current smokers who are trying to quit to reignite their nicotine addiction?
To what extent are current smokers using e-cigarettes and continuing to smoke traditional cigarettes thereby negating any potential health benefits, if any, of using e-cigarettes?
By using e-cigarettes inside places where they wouldn’t have normally smoked, current and former smokers may be increasing the amount of nicotine they’re consuming. Consequently, could e-cigarettes increase a person’s nicotine dependence?
Are current smokers using them to quit or to circumvent smoke-free indoor air laws?
How are they affecting people who have never smoked?
Without adequate scientific evidence from credible sources and without regulations from a national regulatory body, Tobacco Free Florida cannot endorse e-cigarettes.
For tobacco users looking for an effective way to quit, the best plan is to talk to your health care provider or seek help from an evidence-based resource, like Tobacco Free Florida. Additionally, there are nicotine replacement therapies (NRTs) and other quit aids that are approved by the FDA to help tobacco users quit and have been scientifically proven effective as part of a quit plan. These include: FDA-approved over-the-counter NRTs like the patch, gum and lozenges;8 FDA-approved prescription non-nicotine medications;8,9 and FDA-approved prescription NRTs such as the nicotine inhaler and nasal spray.8 FDA-approved means that these quit aids have gone through clinical trials to prove they are safe and effective.
Floridians who want to quit tobacco have access to the state’s free and proven-effective resources, which include free FDA-approved NRT like the patch or a combination of the patch and nicotine gum, when medically appropriate. This combined approach of counseling and NRT may double or triple a tobacco user’s chance of quitting. Tobacco Free Florida’s 3 Free & Easy Ways to Quit include:
CALL: Call the Florida Quitline at 1-877-U-CAN-NOW to speak with a Quit Coach who will help assess a user’s addiction and help create a personalized quit plan.
CLICK: Enroll in the Web Coach®, which will help to create a web-based quit plan unique to each individual user, visit www.quitnow.net/florida.
COME IN: Visit AHEC’s website, www.ahectobacco.com, to locate a local AHEC and sign up for group classes.
For more information about these resources, visit www.tobaccofreeflorida.com/how-to-quit/3-ways-quit/.
Tobacco Free Florida will update its recommendations as the body of scientific evidence strengthens and as regulations are made by a competent national regulatory body, such as the FDA.
What the Public Health Community Has Said About Electronic Cigarettes
“The increased use of e-cigarettes by teens is deeply troubling. Nicotine is a highly addictive drug. Many teens who start with e-cigarettes may be condemned to struggling with a lifelong addiction to nicotine and conventional cigarettes.” — Dr. Tom Frieden, Director of the Centers for Disease Control and Prevention (CDC)10
“This is an unproven device and we know very little about its long-term health effects. E-cigarettes are probably less harmful than combustible cigarettes, [but] we don’t have data to say that and can’t talk about long-term effect.” — Jennifer Pearson, PhD, MPH, Research Investigator at the Schroeder Institute for Tobacco Research and Policy Studies at Legacy11
“E-cigarettes may have the potential to make an important contribution to public health by helping some smokers stop. They are not likely to be a magic bullet any more than other quit smoking tools have been, at least to date. But their safety and effectiveness, their potential to keep some smokers from quitting, and possibly encourage young people to start smoking, require both investigation and thoughtful behavior and commentary by those on either side of this issue.” — Thomas J. Glynn, MA, MS, PhD, Director of Cancer Science and Trends and Director of International Cancer Control for the American Cancer Society12
“The electronic cigarette is not a proven nicotine replacement therapy. WHO has no scientific evidence to confirm the product’s safety and efficacy. Its marketers should immediately remove from their web sites and other informational materials any suggestion that WHO considers it to be a safe and effective smoking cessation aid.” — Dr. Ala Alwan, Assistant Director-General of WHO’s Noncommunicable Diseases and Mental Health Cluster13
Page Last Updated: April 24, 2014
1  U.S. Food and Drug Administration. Summary of Results: Laboratory Analysis of Electronic Cigarettes Conducted By FDA. Silver Spring, MD. U.S. Department of Health and Human Services. U.S. Food and Drug Administration. Page Last Updated 2014 Apr 23. [accessed 2014 Apr 24].
2  U.S. Department of Health and Human Services. The Health Consequences of Smoking—50 Years of Progress: A Report of the Surgeon General. Atlanta: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, 2014
3  U.S. Department of Health and Human Services. How Tobacco Smoke Causes Disease: The Biology and Behavioral Basis for Smoking-Attributable Disease: A Report of the Surgeon General. Atlanta: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, 2010
4  National Institute on Drug Abuse. Research Report Series: Tobacco Addiction. Bethesda (MD): National Institutes of Health, National Institute on Drug Abuse, 2009
5  U.S. Centers for Disease Control and Prevention (CDC). “Notes from the field: electronic cigarette use among middle and high school students – United States, 2011-2012.” Morbidity and Mortality Weekly Report (MMWR). 62 (35): 729–30. September 2013. [accessed 2014 Apr 24].
6  U.S. Centers for Disease Control and Prevention (CDC). Notes from the Field: Calls to Poison Centers for Exposures to Electronic Cigarettes — United States, September 2010–February 2014. MMWR 2014; 3(13);292-293. [accessed 2014 Apr 24].
7  U.S. Food and Drug Administration. E-Cigarette Direct, LLC 9/8/10. Warning Letter. Silver Spring, MD. U.S. Department of Health and Human Services. U.S. Food and Drug Administration. Page Last Updated 2010 Sept 9 [accessed 2014 Apr 24].
8  Fiore MC, Jaén CR, Baker TB, Bailey WC, Benowitz NL, Curry SJ, Dorfman SF, Froelicher ES, Goldstein MG, Froelicher ES, Healton CG, et al. Treating Tobacco Use and Dependence: 2008 Update—Clinical Practice Guidelines Rockville (MD): U.S. Department of Health and Human Services, Public Health Service, Agency for Healthcare Research and Quality, 2008
9  U.S. Food and Drug Administration The FDA Approves Novel Medication for Smoking Cessation. FDA Consumer, 2006. Page Last Update: 2013 Apr 8 [accessed 2014 Apr 24].
10  U.S. teen use of e-cigarettes doubled, CDC reports.” Reuters, 5 Sept. 2013. http://www.reuters.com/article/2013/09/05/us-usa-health-e-cigarettes-idUSBRE9840X820130905 [accessed 2014 Apr 24].
11  Mann, D. “Are E-Cigarettes Here to Stay?” WedMD. 2012 July 20. [accessed 2014 Apr 24].
12  Glynn, T. “Electronic Cigarettes – Boon, Bane, Blessing, or Boondoggle?” American Cancer Society. 2011 May 3. [accessed 2014 Apr 24].
13  O’Leary. “Marketers of electronic cigarettes should halt unproved therapy claims.” World Health Organization (WHO). 2008 Sept 19. [accessed 2014 Apr 24].