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E-Cigarettes Are Risky, Medical Center Professors Say

E-Cigarette E-cigarettes, which contain refined nicotine, should be regulated in a comprehensive way involving the FDA, Congress and the courts, according to Georgetown Medical Center experts.

September 22, 2011 – Devices marketed as “electronic cigarettes” are in reality crude drug delivery systems for refined nicotine, posing unknown risks with little new benefits to smokers, according to researchers at Georgetown University Medical Center (GUMC).

In an article recently published in the New England Journal of Medicine, GUMC assistant professor Dr. Nathan K. Cobb and David B. Abrams explore recent decisions about the device and implications for physicians, policymakers and e-cigarette users.

The U.S. Food and Drug Administration (FDA) announced April 25, 2011, that it would regulate e-cigarettes as “tobacco products” and not as “drug-delivery devices.”

Potentially Dangerous

The FDA’s action came after federal courts blocked the agency from regulating the products of the drug-delivering devices.  Cobb says the courts decision “has substantially delayed the FDA regulatory process that normally protects the public health.”

“It has the practical effect of allowing manufacturers to sell potentially dangerous refined nicotine products directly to consumers,” explains Cobb, a pulmonologist and research investigator at the Legacy’s Steven A. Schroeder National Institute for Tobacco Research and Policy Studies led by Abrams. “It is entirely possible that future modifications to the products will improve the efficiency of nicotine delivery and could dramatically increase the risks of addiction, abuse and serious overdose.”

E-cigarettes are constructed to mimic real cigarettes in size and appearance, but contain no tobacco and are not cigarettes at all. In reality, they are delivery devices for refined nicotine, but have more in common with inhalers used to treat asthma or other delivery devices than cigarettes. Though individual brands vary in construction, the products generally produce a propylene glycol mist containing nicotine along with flavorings and other chemicals.

The authors argue that a comprehensive approach to regulating products containing refined nicotine is needed to protect the public’s health and should involve Congress, the courts and the FDA.

Strict Regulation

While most devices and nicotine fluids are produced by small manufacturers, Cobb and Abrams note that the fact that leading cigarette manufacturers Philip Morris International and British American Tobacco recently purchased sophisticated nicotine inhaler technologies may be an indication that both companies are developing next generation nicotine delivery devices of their own.

“Any refined nicotine product, whether used for smoking cessation and tested and approved by the FDA … or a new product designed for ‘reduced or modified’ risk, can and must be tested and strictly regulated before being introduced to the market,” says Abrams.

Abrams is executive director of the Schroeder Institute, an adjunct professor at Georgetown’s Lombardi Comprehensive Cancer Center and a professor at Johns Hopkins Bloomberg School of Public Health.

In 2008, Legacy established the Schroeder Institute, which has formal academic ties with Johns Hopkins and Lombardi.

Safety Concern

Among other safety concerns noted in the New England Journal of Medicine article were:

• The devices do not reliably deliver nicotine, and have not been sufficiently evaluated in scientific studies the way the FDA requires of other drugs and devices used for smoking cessation. Smokers attempting to use e-cigarettes as quitting aids will most likely find them ineffective due to the fluctuating nicotine content and unpredictable delivery.

• Manufacturers sell cartridges for the devices with a range of up to 20 milligrams of nicotine. But refill kits allow consumers to fill used cartridges with replacement solutions at much higher doses.

• The safety of inhaling propylene glycol over an extended period of time has not been studied in humans.

For more information about Legacy’s e-cigarettes, please look at their fact sheet.

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