Finally the US regulates e-cigarettes as tobaccoBMJ 2016; 353 doi: https://doi.org/10.1136/bmj.i2596 (Published 06 May 2016) Cite this as: BMJ 2016;353:i2596
All rapid responses
E-Cigarettes and "Quackery".
It is intriguing that at the same time that the FDA Regulations are published, new data reveals the current, relatively very narrow reach of the devices in helping smokers quit. Although proposed as a potential “greatest health advance since vaccinations” (1), a “Game Changer” (2), capable of “providing the end of tobacco use in the UK within five to 10 years if e-cigarettes are allowed to flourish” (3), the current situation has been summed up very succinctly by Robert West:
"If they were this game changer, if they were going to be – have this massive effect on everyone switching to e-cigarettes and stopping smoking we might have expected to see a bigger effect than we have seen so far which has actually been relatively small." (4)
New survey data published a week ago (5) in the U.S.A. casts significant doubt over the devices ability to, currently at least, be a “Disruptive Technology”, a further title and claim frequently proposed by e-cigarette advocates (e.g. 6). The new data concludes that:
“since most current smokers who have tried ENDS reject them as a satisfying alternative to regular cigarettes, the potential of ENDS becoming a disruptive technology replacing regular cigarettes remains uncertain.”
This adds to a recent review of the available data on efficacy of electronic cigarettes, and the inevitable conclusion that it is “weak” (7): one of the authors, indeed, being a contributor to the Cochrane Review of E-Cigarettes, which highlighted the “low” grade quality of the current evidence and uncertainty that surrounds the efficacy of ENDS (8). The recent Royal College of Physicians Report (9) on the devices and the subsequent sanction to readily recommend the devices to smokers appears, to many, “overly enthusiastic”, therefore.
Last year, in a wonderfully written American Thoracic Society opinion piece (10), the authors highlighted that:
“While treatment of tobacco dependence has been available for several decades, we continue to be frustrated by unacceptably high rates of tobacco use, especially in children and adolescents. From this perspective, it may appear warranted to advocate for the “supplement of quackery” in the desperate hope of saving lives that would otherwise be destined to be cut short by smoking.”
The authors here concluded by arguing that the FDA should predominantly regulate e-cigarettes to protect youth:
“It is time for the FDA to protect our children from becoming unwitting participants in a social science experiment”
The risks surrounding electronic cigarettes, adolescents and flavours was discussed in the “Quackery” opinion piece and in this current piece by Douglas Kamerow, with this risk being evidenced well in the U.K. (11) and the U.S.A. (12). The FDA have chosen not to immediately act on this – ongoing vigilance is required here certainly, but overall, even from organisations such as the Campaign for Tobacco-Free Kids (13), the response to the FDA regulations has been received positively by many. The “Independent” E-Cigarette industry have raised considerable protestations (e.g. 14), and a predictable legal challenge has already been raised (15). Cost of processing products appears to be a major concern, however, as others have previously argued:
“Given the paucity of information that is available regarding the effects, not only of E-Cigs, but also of many of the chemical constituents of e-liquids on the lungs, we propose that all commercially available E-Cig products be regulated in a similar fashion as any inhaled therapeutic agent, that is, thorough inhalation toxicology and safety-based clinical trials. Although this would be an undeniably expensive undertaking, the estimated value of the E-Cig market is in the billion dollar range, indicating that tobacco and E-Cig companies could likely foot this bill.” (16)
Indeed, given the current paucity of both efficacy and safety data, the suggestion of “Quackery” from some will likely remain for some time. Robert West, for example, has recently highlighted that it will likely be years before the results of currently running randomised controlled trials are known (17). In the meantime, the FDA Regulations should optimise safety of the devices and reduce exposure to children: all commendable objectives indeed. As for Big Tobacco involvement in e-cigarettes: they still maintain that selling tobacco will remain their “core business” (18). They have no genuine interest in reducing the harm their products cause, only genuine interest for maximising profits for their shareholders.
Competing interests: No competing interests