E-cigarettes and the ob/gyn: Key safety information for prenatal counseling

Dr. Phelan is Professor, Department of Obstetrics and Gynecology, University of New Mexico, Albuquerque. She is also a member of the Contemporary OB/GYN Editorial Board.

Ms. Mahoney is Director, the Providers Partnership Project, American College of Obstetricians and Gynecologists, Washington, DC.

Neither author has a conflict of interest to disclose with respect to the content of this article.

Until very recently, the discussion of tobacco use with patients, especially pregnant patients, was straightforward: No use was the best use.

Counseling and patient support, stronger tobacco control laws, and other measures have resulted in a slow but steady decline in prenatal cigarette use (from 18.4% in 1990 to 12.3% in 2010).¹ However, the emergence of novel nicotine delivery vehicles in the United States has complicated the tobacco control landscape. Table 1 outlines these novel products, which generally contain either tobacco-derived or synthetically produced nicotine and are not combusted.^2-5 

Among the products now available in retail outlets and online are electronic cigarettes (e-cigarettes), Snus, and the hookah. Dissolvable strips, sticks, and candies impregnated with ground tobacco are available in some markets. These products allow the addicted smoker to satisfy the craving for nicotine when and where cigarette smoking is not allowed.

Marketing campaigns on the web and by celebrities suggest that alternative nicotine delivery devices are safer for the user because, in most cases, the combustion inherent in tobacco products such as cigarettes-and the associated health impact of tars and chemicals in the smoke-is absent.

What information do pregnant patients need regarding these new nicotine products and their safety?

Obstetric providers should be prepared to emphasize 4 important messages:

--These products all contain nicotine, which by itself poses risk in pregnancy.

--These products have not been proven to be effective for smoking cessation, despite advertisements by the companies to the contrary.

--The content of e-cigarettes and dissolvables is currently not regulated by the FDA.

--These products all contain flavorings or other additives with unknown health effects.

What are the regulations and legislation regarding these alternative products?

The FDA currently regulates cigarettes and smokeless tobacco. The FDA does not currently regulate novel products such as e-cigarettes (including the additives and flavorings) but has requested such authority from Congress.

There are commonly no age limitations regarding who can purchase these products, although many individual states are enacting such legislation. Flavoring options and marketing are commonly directed toward teens and young adults. In the past year, the rate of e-cigarette use by teens has doubled, raising concerns that alternative products may act as gateways to nicotine addiction.⁶

Concerns also exist about attempts to circumvent clean air laws with use of methods that do not release smoke as the result of combustion (except the hookah). In addition, unlike cigarettes, which are subject to federal tax, alternative nicotine delivery systems are not taxed, making them potentially less expensive than regular cigarettes and enhancing the potential for addiction.

It is obvious that clean air regulations, age requirements, and the heavy tax burden imposed on cigarettes has decreased the number of smokers and, for those continuing to smoke, the number of cigarettes used.⁷

Without these barriers in place around alternative nicotine delivery systems, it is possible that nicotine users (ie, smokers) will be able to maintain or even increase their daily nicotine intake and that rates of nicotine addiction will begin to increase again.

Promoters of the alternative nicotine delivery systems say they help individuals to cut down or cease nicotine use. However, it is common that e-cigarette users continue to smoke. More studies are necessary to determine if industry claims are valid regarding smoking cessation.⁸

How do these products compare with nicotine replacement medications (eg, patch, gum, inhaler, lozenge) for prenatal smoking cessation?

Neither the American College of Obstetricians and Gynecologists (ACOG)⁹ nor the US Public Health Service Clinical Practice Guidelines (2008)⁷ promotes the use of nicotine replacement therapy (NRT) as a first-line treatment for smoking cessation during pregnancy. Most NRT products have an FDA pregnancy category D status (proven and known risk to the developing fetus). The few prenatal NRT clinical trials conducted have not demonstrated effectiveness for cessation. However, when counseling methods for smoking cessation have been unsuccessful, NRT is prescribed or recommended by many obstetric providers.^7,9 NRT provides a measured amount of nicotine to the user and does not contain carbon monoxide and other toxic chemicals commonly found in the combustible tobacco products. Unlike NRT, e-cigarettes use a nicotine solution, flavoring, and propellants. Although the flavorings and propellants (typically propylene glycol and glycerin) have been approved as food additives for ingestion, they have not been cleared for repeated inhalation. In fact, aerosolized propylene glycol is a lung irritant.¹⁰

It should be emphasized to patients that the use of any nicotine-containing products during pregnancy is potentially harmful for a developing fetus (Table 2). Abstinence from nicotine use is the safest action. If a patient does not choose abstinence, the next-safest choice is the use of a measured amount of nicotine without additional chemicals. That can be achieved with the NRT options.

The unknown and inconsistent content-and the difficulty in measuring the actual dosage of nicotine as women use these novel non-combusted nicotine delivery methods-is of concern to tobacco control experts. Moreover, it is unclear whether these products are safer than cigarette use during pregnancy. There is simply no evidence to support any level of safety. The avoidance of carbon monoxide may make e-cigarettes less dangerous but that does not mean that they are “safe.”

If nicotine supplementation or replacement is determined to be indicated, the “safest” method at this time is the use of an FDA-controlled NRT that has been formally studied.⁹ As a bonus, many insurance plans cover the cost of NRT use during pregnancy.   

References

1. Centers for Disease Control and Prevention. Trends in smoking before, during and after pregnancy – Pregnancy risk assessment monitoring system, United States, 40 Sites, 2000–2010. MMWR. 2013;62(6):1–19.

2. Martin JA, Hamilton BE, Sutton PD, et al. Births: final data for 2006. Natl Vital Stat Rep. 2009;57(7):1–104.

3. Pearson JL, Richardson A, Niaura RS, Vallone DM, Abrams DB. E-Cigarette awareness, use and harm perceptions in US adults. American Journal of Public Health. 2012;102(9):1758–1766.

4. Centers for Disease Control and Prevention. Calls to poison centers for exposures to electronic cigarettes - U.S. Sept. 2010–Feb 2014. MMWR. 2014:63(13);292–293.

5. Cobb CO, Sahmarani K, Eissenberg T, Shihadeh A. Acute toxicant exposure and cardiac autonomic dysfunction from smoking a single narghile waterpipe with tobacco and with a “healthy” tobacco-free alternative. Toxicology Letters. 2012;215:70–75.

6. Centers for Disease Control and Prevention. Notes from the field: Electronic cigarette use among middle and high school students - US 2011–2012. MMWR. 2013:62(35);729–730.

7. Fiore MC, Jaen CR, Baker TB, et al. Treating tobacco use and dependence: 2008 update. Clinical Practice Guideline. Rockville (MD): U.S. Department of Health and Human Services, Public Health Service; 2008. http://www.ahrq.gov/professionals/clinicians-providers/guidelines-recommendations/tobacco/clinicians/update/treating_tobacco_use08.pdf

8. Fairchild AL, Bayer R, Colgrove J. The renormalization of smoking? E-cigarettes and the tobacco “endgame.” N Engl J Med. 2014;370:293–295.

9. Smoking cessation during pregnancy. Committee Opinion No. 471. American College of Obstetricians and Gynecologists. Obstet Gynecol. 2010;116:1241–1244.

10. Reprotox Data Base. Propylene glycol Agent 1663 www.reprotox.org/Members/Printagentdetails.aspx?a=1663. Accessed Jan 2, 2014.