Electronic smoking devices to be regulated by the FDA effective August 8, 2016

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Electronic smoking devices to be regulated by the FDA effective August 8, 2016

There are an estimated 5.5 million e-cigarette users in the United States.  First introduced to the US in 2007, e-cigarettes are electronic devices that look like cigarettes but atomize liquid into a vapor rather than burning tobacco.  The liquid comes in a variety of flavors and typically contains nicotine.  Most users believe that e-cigarettes are a safer alternative to tobacco cigarettes; this belief is supported by manufacturer marketing.  The vapors produced by e-cigarettes might very well be safer than tobacco smoke, but the data to support this claim is lacking.

A 2015 analysis of 42 common brands of e-cigarette refill liquids was completed by Varlet et al.  This study found that every product contained some measurable amount of potentially harmful compound.  Most of the refill liquids contain nicotine, diethylene glycol, ethylene glycol, ethanol, formaldehyde, and acrolein.  All compounds were within FDA limits, but the long term effect of chronic exposure to these remains unknown.1

E-cigarettes are not allowed to be marketed for smoking cessation, but that hasn’t stopped people attempting to quit smoking by turning to e-cigarettes for help.  A small number of studies have shown smokers reduce the number of tobacco cigarettes while using e-cigarettes, but these studies are old and have several limitations, including insufficient statistical power, unequal losses of participants to follow up, and the use of now obsolete e-cigarette brands.

More recently, a 2015 study conducted by Primack et al. demonstrated, in a longitudinal cohort study of 694 participants between 16 and 26 who never smoked, that use of e-cigarettes at baseline was associated with eventual use of tobacco cigarettes.2  At the start of the study, 2.3% of participants reported e-cigarette use, by the end of the study 70% of e-cigarette users were smoking tobacco cigarettes, compared with 20% of participants that did not use e-cigarettes at the start of the study.

Drawing from data available from the National Poison Data System, Kamboj et al. conducted a retrospective study earlier this year and found that from January 2012 to April 2015 the number of calls related to e-cigarette exposure in children 6 or younger increased from 14 reports in January 2012 to 223 reports in April 2015.  Further analysis showed children exposed to e-cigarettes had greater risk of hospitalization (5.2 times) and greater risk of severe medical outcomes (2.6 times) than those exposed to tobacco cigarettes.3

Effective August 8, 2016, e-cigarettes will be covered under the FD&C Act, as amended by the Family Smoking Prevention and Tobacco Control Act.  The FDA will regulate e-cigarettes the same as it regulates all other tobacco products.  E-cigarettes will no longer be available to purchase for people under 18 and packaging will be required to display the same health warnings as other tobacco products.4

While e-cigarettes might appear to be a safe, convenient alternative to tobacco cigarettes, and other tobacco products, the data continues to suggest that for the majority of patients they are not safe.  Beyond the known possible hazards of potentially toxic compounds, inconsistent quality control and labeling may create additional health risks.  The use of e-cigarettes for smoking cessation should not be considered unless a patient has failed several other proven, effective methods.  If a patient decides to use e-cigarettes, the risks and benefit should be discussed in detail and it should be communicated that e-cigarettes are not necessarily a safer alternative to tobacco cigarettes.

 

 

  1. Varlet V, Farallinos K, Augsburger M, et al. Toxicity assessment of refill liquids for electronic cigarettes. Int J Environ Res Public Health 2015;12:4796-815.
  2. Primack BA, Soneji S, Stoolmiller M, et al. Progression to traditional cigarette smoking after electronic cigarette use among US adolescents and young adults. JAMA Pediatr 2015;169:1018-23.
  3. Kamboj A, Spiller HA, Casavant MJ, et al. Pediatric exposure to e-cigarettes, nicotine, and tobacco products in the United States. Pediatrics Published online ahead of print, May 9, 2016. Doi:10.1542/peds.2016-0041.
  4. Food and Drug Administration, HHS. Deeming tobacco products to be subject to the Federal Food, Drug, and Cosmetics Act, as amended by the Family Smoking Prevention and Tobacco Control Acts; Restrictions on the sale and distribution of tobacco products and required warning statements for tobacco products. Final rule.  Fed Regist 2016;18:28973-9106.