I have written several times about the differences between e-cigarettes as a consumer product and as a cessation medicine. pointing out that population observational studies are relevant for e-cigarettes as a consumer product and randomized clinical trials (RCTs) are relevant for e-cigarettes as a smoking cessation therapy.
Now the US Preventive Services Task Force, a body appointed by the US Department of Health and Human Services Agency for Healthcare Research and Quality to assess evaluates scientific evidence on preventive services, including smoking cessation, has issued an updated assessment of the efficacy of various smoking cessation interventions. Because they are examining smoking cessation interventions in a medical context, they appropriately rely on RCTs.
While the Task Force continues to recommend use of counseling and FDA approved smoking cessation interventions for adults, they also continue to conclude that the evidence for e-cigarettes is “insufficient.” The formal definition of “insufficient” is:
… that the current evidence is insufficient to assess the balance of benefits and harms of the service. Evidence is lacking, of poor quality, or conflicting, and the balance of benefits and harms cannot be determined.
It is particularly important that they carefully look at “the balance of benefits and harms.” They find the evidence on e-cigarettes lacking on both dimensions. Sepcifically, they concluded:
The USPSTF concludes that the evidence on the use of e-cigarettes for tobacco smoking cessation in adults, including pregnant persons, is insufficient, and the balance of benefits and harms cannot be determined. The USPSTF has identified the lack of well-designed, randomized clinical trials on e-cigarettes that report smoking abstinence or adverse events as a critical gap in the evidence.
The Task Force also raised concerns about the substantial uptake of e-cigarettes among youth and, for adults, expresses concern that,
Given the high rate of continued e-cigarette use after smoking cessation, research on both the short- and long-term harms of e-cigarette use is needed, as well as the harms in dual users of e-cigarettes and conventional cigarettes. More research is needed on smoking relapse rates in adults who have used e-cigarettes for smoking cessation and how to help with cessation of e-cigarette use once smoking abstinence has been achieved.
All this reinforces the recommendation not to recommend e-cigarettes as a smoking cessation medicine, even in clinical environments.
Given these conclusions, together with a lack of cessation benefit in the population studies of e-cigarettes as consumer products for quitting, I don’t see how the FDA Center for Tobacco Products can authorize any e-cigarettes as “appropriate for the protection of public health.”
The full USPSTF recommendations and analysis are available at: US Preventive Services Task Force. Interventions for Tobacco Smoking Cessation in Adults, Including Pregnant Persons: US Preventive Services Task Force Recommendation Statement. JAMA. 2021;325(3):265–279. doi:10.1001/jama.2020.25019. It is available here.