A Flawed E-Cigarette Regulation
Saturday, August 16, 2014
The FDA's proposed regulation should not go forward in its current form, or it will undermine efforts to persuade smokers to switch to e-cigarettes and will endanger public health.
Recently, the New York Times ran several high-profile essays justifying the liberalization of marijuana laws. Editorialists addressed the health effects, the need for product standards, and the importance of banning sales to minors. Another major recommendation was to keep marijuana production and marketing from becoming corporatized as "Big Pot."
Agree or disagree with marijuana legalization, it’s refreshing to see sober efforts to balance freedom to use marijuana, an intoxicant, against the harms that can result from expanded legal access to it. We only wish that such consideration was being extended to electronic cigarettes: a nicotine delivery device that has the potential to change the face of smoking and help alleviate one of the nation’s biggest public health problems. Instead, the FDA is considering a regulation that would block e-cigarettes from fulfilling that potential.
Electronic cigarettes and their relatives (called “vaping pens” or “mods”) are battery-powered devices that heat liquid nicotine and emit mostly water vapor. Because no tobacco is combusted, no carcinogenic tar is inhaled or released into the shared environment. That makes e-cigarettes far safer than traditional cigarettes.
Because we do not yet have data on the effects of long-term use of e-cigarettes, gathering such data should be a high priority.
This does not mean that e-cigarettes are completely safe. The risk, if any, of long-term inhalation of propylene glycol, the common substrate used for the nicotine solution in e-cigarettes, is not yet known because the devices have simply not been around long enough. However, the FDA regards limited exposure to propylene glycol, which is used in toothpaste, asthma inhalers, and many other foods and cosmetics, as generally safe. Also, some e-cigarette liquid contains glycerol, which can produce toxic acrolein when heated to higher temperatures. According to a recent study, acrolein was detected in the aerosol of some e-cigarette brands, but at levels much lower than in cigarette smoke. Some, but not all, e-cigarette liquids also contain traces of nitrosamines, which are known carcinogens, but only at levels comparable to those found in nicotine gum and patches and 500 to 1,400 times lower than those found in cigarettes.
E-cigarettes do provide nicotine, which can be addictive. Although non-experts often erroneously attribute the risk of smoking to nicotine rather than to combusted tobacco, the health effects of nicotine are generally benign. Smokers regularly switch to over-the-counter nicotine-replacement products such as patches, gum, nicotine lozenges, and snus and often use these products for months or years — a pattern of use approved last year by the FDA for gum and patches — with little or no risk to their health.
Because we do not yet have data on the effects of long-term use of e-cigarettes, gathering such data should be a high priority. Some risks may well be uncovered, but it is almost certain that the advantages to smokers who switch will exceed those risks.
On balance, e-cigarettes are so much safer 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.
The agency proposed to deem e-cigarettes to be covered by the Family Smoking Prevention and Tobacco Control Act. Although the proposed regulation would impose some sensible restrictions on e-cigarettes, particularly a prohibition on sales to minors and a required nicotine warning, other provisions would have a destructive effect, as we pointed out in our recent response to the FDA’s call for public comments.
One problem is that e-cigarette sellers would not be allowed to make appropriate health statements without agency approval that may be difficult to obtain. As the agency sensibly intends to require producers to warn that nicotine is addictive, it should allow them to inform consumers that e-cigarettes do not burn tobacco and are therefore safer for adult smokers than cigarettes.
Although non-experts often erroneously attribute the risk of smoking to nicotine rather than combusted tobacco, the health effects of nicotine are generally benign.
The proposed regulation’s fatal flaw, though, involves the requirement that “new” e-cigarette products file premarket applications with the agency. Because products introduced since February 2007 are considered to be new, the requirement would apply to virtually all of the products now on the market, as well as future products. The FDA’s own analysis makes clear that the administrative burdens of this requirement would have devastating effects on the e-cigarette market.
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.
Putting e-cigarettes into the framework of the Tobacco Control Act would be a mistake. Because the act requires premarket review for any products that it covers, it does not allow the FDA to fashion a sensible regulatory regime that would forbid sales to minors and require nicotine warnings without mindlessly destroying product variety. Congress and state and local governments should adopt bans on sales to minors (already in place in many states) and nicotine warning requirements. But the FDA’s proposed regulation should not go forward in its current form.
If the administrative burdens of the premarket review process are allowed to destroy the product variety available in today’s highly competitive e-cigarette market, it will undermine efforts to persuade smokers to switch to e-cigarettes and will endanger public health. That’s not the kind of regulation that smokers, vapers, or the country needs.
FURTHER READING: Sally Satel asks “Should Americans Buy E-Cigarettes?” Dr. Gilbert Ross contributes “Smoking Kills, and So Might E-Cigarette Regulation” and “The Deadly Crusade Against E-Cigarettes.” Alex Brill contributes “Don’t Tax E-Cigarettes.”
Image by Fred Wollenberg/Bergman Group