My AEI colleagues Sally Satel and Alan D. Viard have a sobering op-ed discussing the FDA’s proposed regulation of the e-cigarette industry.

On balance, e-cigarettes are so much safer [than traditional cigarettes] that doctors should advise smokers who are unwilling to stop using nicotine to take up “vaping,” as e-cigarette use is called. Smokers who have tried and failed to quite using nicotine gum, patches, medications such as varenicline, or behavioral techniques should also be encouraged to switch to e-cigarettes. Yet the FDA, which released its much-awaited proposed “deeming regulations” last spring, is advancing a prescription that will surely cripple the future of electronic cigarettes and, with it, the health of millions of smokers.


How will the FDA “cripple the future of” e-cigarettes, specifically? Administrative burdens.

The FDA estimates that conducting the necessary scientific investigations and preparing a premarket application would, on average, take more than 5,000 hours and cost more than $300,000. Only the large tobacco producers would be willing and able to incur these costs. As the FDA analysis states, the costs of submitting premarket applications for e-cigarettes “would be high enough to expect additional product exit, consolidation, and reduction in variety compared with the baseline.” The agency admits that nearly all e-cigarette products would be driven out of the market, simply by administrative burdens, not by any substantive health issues. The lack of product variety would thwart efforts to persuade smokers to switch to e-cigarettes, particularly because the surviving products are likely to be the “cigalikes” produced by the large tobacco companies, which are the least effective in luring smokers completely away from cigarettes.


The bold above is mine. You can read their entire op-ed here, and their response to the FDA’s call for public comments here.

In addition, they and my colleague Alex Brill have a great policy paper on whether e-cigarettes should be taxed, which you can find here.

— Michael R. Strain is a resident scholar at the American Enterprise Institute. You can write to him on Twitter at twitter.com/MichaelRStrain.