Science and Law
18th March 2015

FDA Mulling Over Potential E-Cig Health Effects

Last week, FDA hosted a 2nd workshop on e-cigarettes (e-cigs), this one focused on potential health effects of these products. The forum brought together hundreds of thought leaders, including regulators, industry scientists (big tobacco and small e-cig manufacturers), consumer advocacy groups, academics (medical and scientific), and attorneys.

FDA Mulling Over Potential E-Cig Health Effects

In a previous post, we talked about the importance of tracking the science related to electronic cigarettes (e-cigarettes or e-cigs). In this post, we turn to the regulatory framework and what issues we believe are likely to come under FDA scrutiny in the near future.

Last week, FDA hosted a 2nd workshop on e-cigarettes (e-cigs), this one focused on potential health effects of these products. The forum brought together hundreds of thought leaders, including regulators, industry scientists (big tobacco and small e-cig manufacturers), consumer advocacy groups, academics (medical and scientific), and attorneys.

Over two days, a wide range of topics were addressed in presentations, panel discussions, and a public comment session:

  • potential toxicity of heated flavors
  • potential toxicity of particulates, heated glycerin, and heated propylene glycol
  • abuse liability potential
  • e-cig topography
  • exposure biomarkers
  • e-cigs as cessation tools
  • potential health effects of nicotine
  • pharmacokinetics and pharmacodynamics of nicotine exposure

While some new data were presented, most of the science was previously published or presented at the recent Society for Research on Nicotine and Tobacco meeting held in February 2015.

At least three major take-away points emerged:

1)       Lack of data for long-term e-cig exposure in humans;

2)       E-cigs are likely less harmful than tobacco cigarettes, and thus may emerge as harm reduction tools;

3)       E-cig subsidiaries of “Big tobacco” appear to favor increased regulation with full characterization of products and ingredients. Smaller e-cig players believe increased regulation will stifle needed innovation, and may put them out of business.

Below are some highlights from portions of the workshop.

Evaluating Potential Toxicity of E-cig Ingredients

Presently, the long-term health effects of e-cigs are unknown. The first step in tackling potential e-cig toxicity, will be to gain an understanding of the constituents formed when e-cig “juice” is heated. Numerous presentations discussed in vitro and animal studies evaluating the by-products of heating glycerin, propylene glycol, flavorings, and a combination of these.

The concern is that the chemicals that may be formed upon heating could be more toxic and impact biological systems differently from the liquid (or juice) starting product. Some of the potential constituents of concern may be formaldehyde, aldehydes/acrolein, by-products of heating cinnamon flavorings, and particulate matter. This is an active area of research, and new studies will undoubtedly contribute to advancing our understanding of the potential health risks of e-cig ingredients.

E-Cigs as Nicotine Replacement Therapies (NRTs)

Older versions of e-cigs, such as cigalike, do a relatively poor job of delivering systemic doses of nicotine, and it has been suggested that cigalike users don’t effectively achieve the necessary doses of nicotine. However, newer e-cig products seem to do a better job at delivering nicotine, and in some cases, help to achieve blood nicotine levels similar to tobacco (combustible) cigarettes. One study demonstrated that 15 puffs from an e-cig product delivered nicotine at levels comparable to a traditional cigarette, with approximately 90% systemic nicotine retention.

Abuse Liability

Some believe that e-cigs show great promise as NRTs because they also satisfy some of the sensory attributes of a traditional cigarette (steam/smoke, hand-to-mouth behavior, etc.). However, the abuse liability potential (e.g. likability, satisfaction) of e-cigs was also discussed in great detail, although initial data suggest e-cigs may have a lower abuse potential than traditional cigarettes.

********************

Overall, preliminary data appear to support the view that e-cigs have the potential to deliver desired nicotine levels, while users that have switched (or are dual users) substantially decrease their exposure to toxicants.

FDA will likely follow this second workshop with an additional workshop to address the impact of e-cigs on the population. Topics may include product appeal (e.g. impact of advertising, marketing, flavorings, consumer perceptions), impact on non-users (second and third-hand exposures), and product labeling.

We will cover additional highlights in a subsequent post.

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