Electronic cigarettes: In need of FDA regulation?

A federal judge is expected to rule soon on whether the FDA has the authority to regulate electronic cigarettes, or e-cigarettes, which contain nicotine but not tobacco.

They look like cigarettes, but they have names most people have never heard of: Gamucci, Cloud 9, and Njoy.

That's because they are electronic cigarettes, or e-cigarettes. These battery-powered devices do not create smoke but provide a mist of nicotine to the user's lungs.

These items are about to become better known because a federal judge is expected to decide shortly on whether the Food and Drug Administration has authority to regulate them. The devices, which do not contain tobacco, are already being sold around the country.

From the FDA's viewpoint, the e-smokes are "drug delivery" devices, the same as nicotine gum, which is regulated by the agency. The industry association for the product describes it as an "alternative to tobacco," and the association says it would like to work with the FDA. The public-health community is divided, with some wanting to see more research on the items and others seeing them as a way to help people quit tobacco use.

Already, e-cigarettes are entering the public arena.

One airline, Ryanair, which mainly operates in Europe, not only permits their use on flights, but also sells them to passengers. Some "no smoking" restaurants in the United States are permitting their use, say advocates for the product.

The devices are also available as e-cigars and e-pipes.

"Two years ago, no one had ever heard of these things," says Matt Salmon, president of the Electronic Cigarette Association (ECA) in Washington.

"Today, there is an estimate there are 300,000 users, but I think it's in excess of that," says Mr. Salmon, an antismoking advocate and former congressman.

In the e-cigarettes, most of which are made in China, there is no combustion of tobacco. Instead, the device contains a lithium battery. That heats up an atomizer, which turns the nicotine into a vapor.

When the user inhales the vapor, the device's tip glows with a red LED light to mimic the experience of smoking a cigarette.

On e-cigarette websites, former tobacco users offer testimonials about how the new product has saved their lives.

But John Banzhaf, a professor at George Washington University Law School who also heads up an organization called Action on Smoking and Health (ASH), wonders if there is a cardiovascular risk for e-smoke users. And, he adds, "We don't know to what extent kids get hooked."

Enter the FDA.

They have looked at those websites and more. "Some of the product information says you can use the e-cigarettes to help quit smoking," says Siobhan DeLancey, a spokeswoman for the FDA. The agency believes the products should be brought to it for premarket approval, and data should be presented showing the product is safe and effective for its intended use.

In July, the FDA did preliminary research, buying some of the products online and at shopping-center kiosks. The products were "inconsistent" in their levels of nicotine, Ms. DeLancey says.

However, some of the urban legends about the FDA wanting to ban the products are not true, DeLancey says. "What we are saying is for them to be sold, you should be able to evaluate how safe and effective they are – especially if they are a smoking replacement used over several years, perhaps a lifetime," she says.

In February, one manufacturer, Smoking Everywhere, which is not a member of the ECA, sued the FDA, claiming it did not have jurisdiction. Shortly, federal judge Richard Leon in Washington is expected to rule.

"It will be a seminal moment," says Mr. Banzhaf.


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