FDA needs to reconsider its promotion of the “continuum of risk” for e-cigarettes

As of February 22, 2024, the FDA was continuing to embrace the idea that there is a “continuum of risk” with combusted tobacco as the riskiest and e-cigarettes being substantially less risky. As a result, FDA promotes e-cigarettes as a way for smokers to reduce risk. This view is based on the fact that e-cigarettes deliver much lower levels of many toxic combustion products that cigarette do.

Here is what FDA said:

[The FDA Center for Tobacco Products] CTP prioritized research efforts throughout the past year to inform public education opportunities for adults who smoke, recognizing that adults also want and need help as they attempt to quit smoking. For example, CTP is conducting formative research among adults who smoke to assess their comprehension and perceptions of messaging that nicotine – while highly addictive – is delivered through products that represent a continuum of risk, and that combustible products such as cigarettes have the greatest risk. I [CTP Director Bian King] also authored an article published in the journal Addiction noting that opportunities exist to educate adults who smoke about the relative risks of tobacco products, including e-cigarettes. As was noted in the commentary, it’s important that these efforts be accompanied by efforts to prevent youth tobacco product use; encourage first-line use of FDA-approved cessation therapies; and for adults who both smoke and use e-cigarettes, reinforce the importance of completely transitioning to e-cigarettes. Because no tobacco product is safe, the eventual goal should be quitting all tobacco product use, including e-cigarettes. [emphasis added]

The more important and direct way to assess whether this is a sensible approach would be to consider disease outcomes rather than just exposure to some toxic compounds. That is exactly what we did in our new systematic review and meta-analysis, “Population-Based Disease Odds for E-Cigarettes and Dual Use versus Cigarettes.” We found for cardiovascular disease, stroke and metabolic disorder e-cigarette risks are similar to cigarettes and for respiratory and oral disease, while lower risk than cigarettes, the risks are still substantial.  Dual use (using e-cigarettes and cigarettes at the same time) is riskier than smoking alone for all outcomes.

What this means in terms of the “continuum of risk” is that, if it is present at all, it is much narrower than the FDA (and lots of others) have assumed. Moreover, many adults who don’t “switch completely” and end up dual users, which is riskier than continuing to just smoke. By promoting the idea — which is not supported by actual disease outcomes — FDA is likely misinforming the public about actual risks of e-cigarettes, including inadvertently promoting them to kids. FDA needs to stop promoting the “continuum of risk” while it reassess this strategy based on actual disease outcomes.

Published by Stanton Glantz

Stanton Glantz is a retired Professor of Medicine who served on the University of California San Francisco faculty for 45 years. He conducts research on tobacco and cannabis control and cardiovascular disease/

Leave a comment