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In the latest salvo over marketing of electronic cigarettes, or e-cigarettes, as they are commonly called, researchers at Schroeder Institute warn that e-cigarettes are little more than crude drug delivery systems for refined nicotine. Furthermore, e-cigarettes pose unknown risks with few new benefits to smokers, according to the researchers.

The controversy over the current regulatory climate around electronic cigarettes is explored in a new "Perspective" published by the New England Journal of Medicine by researchers from the Legacy’s Steven A. Schroeder National Institute for Tobacco Research and Policy studies. The authors, David B. Abrams, Ph.D., executive director of the Schroeder Institute, and Nathan K. Cobb, M.D., a pulmonologist and assistant professor at Georgetown University Medical Center, also question future implications of e-cigarettes for physicians, policy makers and e-cigarette users.

E-cigarettes: What They Are

E-cigarettes are not cigarettes at all. They contain no tobacco. They are constructed to mimic real cigarettes in both size and appearance. But, in reality, they’re delivery devices for refined nicotine. In this, they have more in common with inhalers people use to treat asthma or other delivery devices for both approved and illicit drugs.

Individual e-cigarette brands vary in construction, but the products generally produce a propylene glycol mist that contains nicotine along with other chemicals and flavorings.

At the present time, three interrelated products are being sold:

• The delivery device itself
• Cartridges that can contain up to 20 milligrams of nicotine
• Refill kits that allow consumers to fill used cartridges with replacement nicotine solution

Some refill bottles, which are easily obtained over the Internet, contain enough nicotine to kill an adult if accidentally ingested.

How E-cigarettes Work

When a user inhales on the e-cigarette mouthpiece, a vaporizer is turned on and converts the liquid in the cartridge into a vapor. A rechargeable battery powers the vaporizer and has an indicator light to show when the device is "in use."

Cartridges generally contain nicotine, flavoring and other chemicals. The quality control of the ingredients varies and is of concern. Cartridges are sold containing various amounts of nicotine, from 0 milligrams (mg) to 18 mg of nicotine – or more. The FDA testing, however, has shown that advertised strengths can be very different than the actual amount of nicotine in the cartridges.

Some users refill their own cartridges. This can be dangerous because it involves dealing with levels of nicotine that are toxic. Some refill bottles, for example, contain over 1,000 mg of nicotine. The fatal dose for children is estimated at only 10 mg and for adults is estimated at 30 to 60 mg.

FDA Will Regulate E-Cigarettes as Tobacco Products

In an April 25, 2011 announcement, the U.S. Food and Drug Administration (FDA) said that it would regulate e-cigarettes as tobacco products, and not as drug-delivery devices. This action came after federal courts blocked the FDA from regulating the products as drug-delivery devices. The courts position was that, under the 2009 Family Smoking Prevention and Tobacco Control Act (FSPTCA), the FDA must regulate as tobacco products any product that contains nicotine from tobacco and that makes no claims to be therapeutic.

The Schroeder researchers note that these decisions together, "upend[ed] the status quo" by having the effect of allowing the sale of such unregulated refined nicotine directly to consumers – that is, unless and until the FDA takes further action.

Researchers Say Potential for Risks of Addiction Increases

In the Perspective, Cobb wrote that the court’s decision that e-cigarettes should be regulated as tobacco products and not as drug-delivery devices "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."

In addition, Cobb warned, "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."

Not only does the potential for addiction risk increase with the number of small manufacturers currently producing most devices and nicotine fluids, but the fact that two leading cigarette manufacturers – Philip Morris International and British American Tobacco – recently purchased "sophisticated" nicotine inhaler technologies may be an indication that both companies are at work developing next-generation nicotine delivery devices of their own.

Safety Concerns

Cobb and Abrams discuss a number of safety concerns in the Perspective. Among them:

• Testing of cartridges reveals poor quality control, variability in nicotine content among brands, and deviations between claims on the label and actual cartridge content.
• The devices not only do not deliver nicotine reliably, they have also not been sufficiently evaluated in scientific studies in the way that the FDA requires of other devices and drugs used for smoking cessation. Smokers attempting to quit using e-cigarettes will likely find them ineffective due to unpredictable delivery and fluctuating nicotine content.
• While manufacturers sell cartridges with a range of up to 20 milligrams of nicotine, refill kits allow consumers to fill used cartridges with replacement solutions containing much higher doses of nicotine. Cobb and Abrams warn that the devices aren’t limited to delivering nicotine. In the paper, they note that instructions for filling cartridges with marijuana has oil can be easily accessed via the Internet.
• The safety of inhaling propylene glycol over an extended period of time hasn’t been studied in humans.
• E-cigarettes may serve as a "bridge product" that smokers use at times and in places where traditional tobacco smoking is prohibited. This may tend to perpetuate their addiction and use of real cigarettes. Furthermore, e-cigarettes may be used by young people considering smoking as a "starter" product. This is especially concerning to the authors who note that the cartridges can be purchased over the Internet with youth-focused flavoring like grape and chocolate.

Countering Arguments by E-cigarette Advocates

Whenever there’s one position advocated, there’s always an opposite position. In the case of the Schroeder researchers’ position paper, authors Cobb and Abrams counter the argument made by e-cigarette advocates that taking the devices off the market could mean that current users would be forced back into using traditional tobacco products.

Instead, say the two researchers, consumers who want to quit can use the multiple pharmaceutical-grade nicotine products on the market that have been regulated, approved and considered safe and effective by the FDA.

Such products include patches, lozenges, gums, nasal sprays and an FDA-approved inhaler. Current users should also pursue research-proven effective smoking cessation tools, including telephone quit lines, Web-based cessation services, nicotine replacement products, and non-nicotine pharmacotherapies like Buproprion and varenicline.