E-Cigarettes: Harm reduction or just harm?

Electronic cigarettes (or Electronic Nicotine Delivery Service—ENDS) are battery-powered devices that deliver heat to a liquid nicotine-containing solution, creating an inhalable aerosol or vapor. This simple description belies the fact they are currently one of the most controversial topics in public health.

Source: Michael Dorausch (Flcikr/CC)

Source: Michael Dorausch (Flcikr/CC)

ENDS were first introduced to the United States (US) market in 2006 after invention, research, and development in China and Hong Kong. ENDS manufacturers marketed them as a new and improved tool for harm reduction, due to lower or absent concentrations of toxins present in traditional cigarettes. However, ENDS manufacturers bypassed the traditional Food and Drug Administration (FDA) approval process necessary to make such claims, and have reaped a cash windfall, as 2013 US retail sales were approximately $1.7 billion (nearly 200% increase from 2012).

Early studies show that a preponderance of ENDS users are either current or former smokers. Evidence of whether or not ENDS usage decreases the mean daily number of cigarettes smoked is mixed, though some studies discovered over 90% of ENDS users surveyed used them indefinitely while decreasing the amount of traditional cigarettes consumed. Animal studies and non-randomized trials in healthy smokers indicate that the chemicals in ENDS vapor induce similar inflammation, immune impairment, and peripheral airway constriction as regular cigarettes. This is particularly concerning for those with chronic lung disease—the same people most likely to use ENDS. Further, the benefits of smoking cessation (decreased risk of cancer and heart and lung diseases) are only achieved with complete cessation.

Aggressive marketing tactics to low and middle income countries and children mirroring prior predatory behavior towards vulnerable populations have led to increased scrutiny of ENDS manufacturers. Critics fear that ENDS may be used to target nonsmokers, renormalize cigarette use in the general population, and cause unforeseen short- and long-term health concerns.

The 2009 Family Smoking Prevention and Tobacco Control Act equipped the FDA with power to regulate tobacco and nicotine-containing products. To the consternation of ENDS manufacturers, the FDA proposed rules in 2014 requiring all individual tobacco products on the market after February 2007 (99% of ENDS-related products) to retroactively apply for approval, a process with significant costs. Governing bodies, such as the American Heart Association and American Thoracic Society have released statements and policy recommendations on ENDS, many of which the FDA incorporated into draft regulations. In December 2015, Congress passed the $1.1 trillion fiscal 2016 spending bill, officially awarding the FDA with the power to regulate ENDS as tobacco products. Official regulations will be released in early 2016, and manufacturers will have 24 months to submit their applications with the opportunity to continue selling their products during the review process.

Are ENDS are a legitimate harm reduction tool (comparable to conventional smoking cessation methods) or a gateway drug? What are their short- and long-term effects? What are public attitudes and behaviors towards ENDS? These are just some of the questions requiring additional research. Some private companies along with city and state governments have opted for a conservative approach to regulate ENDS as traditional cigarettes. The FDA has now chosen to do the same.

Conversely, foreign public health bodies such as Public Health England have taking aggressive stances describing ENDS as, “95% safer than smoking.” In the absence of complete information, physicians must use their best judgment when counseling patients. Similarly, public health professionals must stress—particularly to adolescents—that abstinence is the best way to cure a nicotine addiction. Time and studies will show if ENDS are a tool for harm reduction or just the newest move in a decades-long chess match between the tobacco industry,  public health officials, and health care providers over public’s money and its lives.

This Policy Prescriptions® OP/note is written by Olubadewa Fatunde, MD, MPH