Electronic Cigarettes – Is FDA Regulation Imminent?

E-cigarettes are certainly getting a lot of attention. Concerns are rising with lack of data on long-term health effects. These devices simulate smoking with vapor that contains nicotine and flavoring agents, and are powered by batteries.

The Federal Drug Administration is currently proposing rules to gain the authority to regulate these devices. The rules were proposed in April and were available for public comment through August 8th. The ruling would prohibit distributing free samples and sales to minors. In addition, e-cigarettes would require a health warning label. New products could not be sold without FDA approval. The FDA must issue a final rule no later than April 25, 2015.

Electronic cigarettes contain nicotine. As tobacco remains the leading cause of death and disease in the United States, this is seen as an important consumer protection issue for many. The Centers for Disease control has raised concerns over e-cigarettes due to increased rates of exposure to poisoning because of accidental ingestion of the e-cigarette or its liquid. This is impacting children that may be attracted to them as they are often scented like fruit or candy.

Initially, e-cigarettes were marketed widely as smoking cessation devices. US News sites a London study that claims there is a place for e-cigarettes in smoking cessation. It claims they are a way to wean people off the regular cigarettes with a lower-dose product with the same hand-to-mouth motion to which smokers have become accustomed. On the contrary, however, the March 24, 2014 issue of JAMA Internal Medicine found that there is not a link with greater quit rates, or even reduced smoking, after one year.

Insurance carriers are not covering them. They do not seem to have the same replacement traction as gum or patches. The United States Air Force has included them in its regulations, prohibiting them in the workplace and medical treatment facilities.

The Affordable Care Act does not specify e-cigarettes as a cessation tool. The 50% tobacco surcharge can apply if insurers classify e-cigarettes as tobacco products. Since e-cigarettes are not currently FDA approved for quitting smoking, they are not covered as a free preventive benefit under the law.

The American Lung Association is concerned about safety, highlighting that without oversight, there is no way for consumers or the medical community to know what chemicals are contained within. There are 250 different types of e-cigarettes on the market containing a wide variation of chemicals. Second-hand smoke from e-cigarette admissions includes formaldehyde, benzene, and carcinogenic tobacco-specific nitrosamines.

Though they may help some smokers cut back their tobacco intake, doctors are unlikely to recommend e-cigarettes without more substantial research on the safety risks.

Sources:
The Nation’s Health, A Publication of the American Public Health Association, July 2014
The American Lung Association
US News and World Report May 21, 2014
Science AAAS, Brain & Behavior > E-cigarettes help smokers quit
Regulatetobacco.org
Kaiser Family Foundation

Update:

Expect the next legislative session in Washington state to see e-cigarettes contested in at least one bill.  The efforts will likely address “vaping”, e-cigarette use,  with the following components: applying the same regulations as for tobacco; banning on school property; increasing the age to purchase to 21 or 19; barring  internet sales; restricting flavors and advertisements that target children (e.g. Sugar-cereal flavor); and  prohibiting free samples and vending machine sales.

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