National Academies releases FDA-commissioned report on health effects of e-cigarettes

Today, the National Academies of Sciences, Engineering, and Medicine (NASEM) published an independent report, commissioned by FDA at the direction of Congress, to evaluate the available scientific evidence of the short- and long-term health effects related to the use of electronic nicotine delivery systems (ENDS), such as e-cigarettes, and to identify future federally-funded research needs. “We appreciate the National Academies’ review of the complex public health considerations around e-cigarettes. Their comprehensive report not only adds to our knowledge base, but also raises some important questions about the net effect of e-cigarettes. One finding that’s particularly troubling is that kids who experiment with e-cigarettes are more likely to try smoking. At the same time, the report finds that current smokers who completely switch to e-cigarettes may see improved short-term health outcomes,” said FDA Commissioner Scott Gottlieb, M.D. “Ultimately this report helps identify areas that need further study to better understand the net public health impact of e-cigarettes as we continue our work on policies to protect kids and significantly reduce tobacco-related disease and death. We need to put novel products like e-cigarettes through an appropriate series of regulatory gates to fully evaluate their risks and maximize their potential benefits.” Among other things, the NASEM report found conclusive evidence that completely switching from combustible cigarettes to e-cigarettes reduces an individual user’s exposure to numerous toxicants and carcinogens, and substantial evidence that switching also reduces some short-term health outcomes for complete switchers. The report also concluded that there is substantial evidence to suggest that youth and young adults who use e-cigarettes are more likely to try combustible cigarettes. The report calls for additional research on both the short- and long-term health effects of e-cigarettes. The report findings and research recommendations will help FDA further assess the net public health impact of e-cigarettes (e.g. are they leading to youth initiation of cigarettes, resulting in “dual use” with cigarettes among adults, or helping to accelerate the transition of current adult smokers away entirely from combustible cigarettes). The NASEM report also notes that the wide diversity within ENDS or e-cigarettes products poses a challenge for research on their risks and the public health impact, as well as safety concerns such as ENDS battery issues and children’s accidental exposure to liquid nicotine ‒ both of which FDA has announced its intention to address through product standards or other regulations. FDA continues to invest in research in many of the areas identified in the NASEM report to assess whether certain tobacco products are, in fact, less harmful and/or potential tools for helping smokers quit cigarettes, as well as understand the impact of ENDS – specifically who is using these products and how they are being used. This research will play a critical role as the agency moves forward with its comprehensive plan for tobacco and nicotine regulation, which focuses on addressing the role that nicotine plays in keeping smokers addicted to combustible cigarettes by proposing to lower the level of nicotine in cigarettes to minimally or non-addictive levels, and encouraging innovation to help smokers completely transition to potentially less harmful products, such as ENDS or e-cigarettes.

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