E-Cigarettes: The Case for Regulatory Restraint

Debate over FDA regulation of e-cigarettes often degenerates into bitter argument and ad hominem attack.  In contrast, a point/counterpoint presentation in the Journal of Policy Analysis and Management is calm, thoughtful and enlightening.

The case for stringent FDA regulation (citations here and here) is presented by Kurt Ribisl, a professor at the University of North Carolina, along with graduate students Andrew Seidenberg and Elizabeth Orlan (hereafter RSO).  Cornell University Professor Donald Kenkel makes the case for light regulation (here and here).

Describing the problem – “Smoking is estimated to result in 480,000 deaths per year in the United States” – Kenkel underscores a death toll that has not changed in 20 years, despite increasingly harsh anti-smoking policies.  Tobacco prohibitionists frequently cite this horrid data, but they rarely support vastly safer alternative products like e-cigarettes, referred to by Kenkel as “perhaps the most revolutionary product innovation in the market…”

Kenkel puts the risk differences in striking contrast.  He notes that if Britain’s health authorities are correct that vaping is no more than 5% as hazardous as smoking, then a world in which all smokers vape would suffer only 24,000 deaths attributable to e-cigarettes, compared to 480,000 actual deaths due to smoking.  This projection is similar to that in my 1994 publication (here), where I estimated 6,000 deaths among an imagined 46 million smokeless tobacco users – a mere 2% of the 419,000 actual deaths from smoking.

RSO acknowledge that vaping is less risky than smoking, but they reject the 5% estimate, arguing that it “lacks empirical basis, as it came from a multicriteria decision analysis model developed from one meeting of 12 people. This type of expert opinion is at the bottom rung of the evidence hierarchy…”  That is true, but the North Carolinians offer no counter-estimate.  Kenkel suggests that even if the e-cigarette risk was as high as 10% as that of smoking – which is highly implausible, the result “would still be a revolutionary public health gain.”

RSO “supports regulating e-cigarettes less stringently than combustible tobacco products,” however that position is not fully reflected in their policy recommendations.  As Kenkel notes, they still call for “restrictions on flavors, advertising and marketing restrictions, taxes, bans on indoor vaping, and mandatory product warnings.” 

Using “the conceptual framework of economics,” Kenkel brings a refreshing perspective to e-cigarette use: “the key question is whether vaping and smoking are substitutes or complements… if they are complements, a policy that encourages vaping will increase smoking… If they are substitutes, a policy that encourages vaping will cause consumers to substitute vaping products for combustible cigarettes and thus reduce smoking.”

Kenkel finds that “Accumulating evidence suggests that vaping is a substitute for smoking,” and he concludes: “Policies to encourage vaping could facilitate such a revolutionary change in the U.S. market for tobacco products.”

Government and insurance incentives are worth considering, says Kenkel: “the benefits of reducing smoking could also justify a more activist policy approach. Taxing cigarettes and subsidizing a substitute good are alternative approaches to correct market and individual failures in the cigarette market. Many private and public health insurance plans provide generous coverage for one class of substitute goods—nicotine replacement products approved as smoking cessation aids. The same rationale might support subsidies for vaping products.” (emphasis added)

Observing that vaping is “an existential threat to the market for combustible cigarettes, unless their spread is restricted by government regulation,” Kenkel seems to be in sync with new FDA Commissioner Scott Gottlieb, who has signaled a lighter approach toward e-cigarette regulation.