National Working Group for ACTTION

February 23, 2010

A federal appeals court will decide whether the Food and Drug Administration has the authority to regulate electronic cigarettes, known as e-cigarettes, as drug-delivery devices or should treat them as tobacco products, which have different regulatory standards.

The FDA has appealed a federal judge’s ruling that the agency does not have the authority to regulate e-cigarettes as drug-delivery devices. In early February the appeals court in Washington agreed to stay an order that prevented the agency from blocking electronic cigarettes from entering the country while the court reviews the merits of the appeal.

E-cigarettes are battery powered cigarette-shaped tubes that heat liquid nicotine into an inhalable vapor.  They do not contain tobacco.  They have been imported in the U.S. from China since 2004.

The FDA has confiscated imports of the devices since at least 2008. In court papers, the FDA said it considers the devices to be unapproved drug-delivery gadgets. It contends that e-cigarettes are not traditional tobacco products and that the products promise, among other things, to “alleviate nicotine withdrawal symptoms.” The FDA compares the devices to nicotine gum, which it already regulates as a cessation product.  When two distributors filed a legal challenge to the FDA’s confiscation, Judge Richard J. Leon of Federal District Court in Washington issued a preliminary injunction, blocking the FDA’s action.

Last July, before the court acted, the head of the FDA laid out the agency’s uncertainties about e-cigarettes.  She reported that a laboratory analysis of electronic cigarette samples had found that they contain carcinogens and toxic chemicals such as diethylene glycol, an ingredient used in antifreeze, and said that the agency “is concerned about the safety of these products and how they are marketed to the public.”

In addition to its concerns about easy availability of e-cigarettes, the FDA noted that these products do not contain any health warnings comparable to FDA-approved nicotine replacement products or conventional cigarettes. They are also available in different flavors, such as chocolate and mint, which may appeal to young people. FDA officials are also concerned that e-cigarettes could increase nicotine addiction and tobacco use by children.

Because e-cigarettes have not been submitted to the FDA for evaluation or approval,  the agency has no way of knowing, except for the limited testing it has performed, the levels of nicotine or the amounts or kinds of other chemicals that the various brands of these products deliver to the user.

The World Health Organization’s Study Group on Tobacco Product Regulation recently summarized its views on these devices.  It said, “There is insufficient evidence currently to assess whether electronic nicotine delivery systems may be used to aid cessation, create or sustain addiction, or deliver constituents other than nicotine to smokers.”

A study published in the February 2010 journal Tobacco Control found that relative to a tobacco cigarette, the e-cigarettes tested delivered little to no nicotine and suppressed craving less effectively.  The study tested volunteer smokers using e-cigarettes for the presence of nicotine in their bodies, their reported craving for conventional cigarettes, and certain physiological effects such as a change in heart rate.  The author, Thomas Eissenberg, a researcher at Virginia Commonwealth University Institute for Drug and Alcohol Studies, says the products tested “are as effective at nicotine delivery as puffing on an unlit cigarette.”  The study concluded that e-cigarettes need to be “evaluated, regulated, labeled and packaged in a manner consistent with cartridge content and product effect.”  However, this research project only studied 16 smokers.

Other critics have additional concerns.  Because of a lack of testing, their safety, as well as their efficacy, is unknown.  No standards exist for the potency of the nicotine they contain. Use of e-cigarettes may deter use of proven cessation methods.  They may appeal to underage population and lead to nicotine addiction in those previously not addicted, including children.

The very thing that makes e-cigarettes attractive to smokers—the simulation of smoking, holding a cigarette, inhaling—concerns some opponents who see them as undoing the efforts to denormalize smoking.

Supporters, on the other hand, argue that use of e-cigarettes is less hazardous than lighting tobacco and inhaling combusted material.  They see almost any alternative to a lighted cigarette as a reduction in risk to the user.  They argue that nicotine without the smoke provides a health advantage for cigarette smokers.

As the legal proceedings continue over the next few months, the debate over e-cigarettes as a harm reduction product will continue.