Last week, a federal appeals court ruled that electronic cigarettes should be regulated by the FDA as a tobacco product rather than drug-delivery devices, as the FDA had hoped. The latter are subject to far more rigorous regulatory control.
In reaching its decision, the 3-judge panel of the US Court of Appeals in Washington upheld a lower court ruling by Washington Federal District Judge Richard Leon. He had ruled against the FDA in a lawsuit brought by e-cigarette distributors. The successive judicial blows against the FDA means that for now, it cannot–as it would like–ban e-cigarettes until expensive, company-sponsored trials prove the products are safe and actually work as quit-smoking aids.
The FDA believes that e-cigarettes should be regulated in the same way as nicotine replacement products like chewing gum and patches. It also wants to curtail marketing campaigns for these products that are directed at children.
e-Cigarettes are battery-powered tubes that heat liquid nicotine into a vapor that is subsequently inhaled. They usually contain a small light on the tip which glows like a cigarette when the user inhales. The devices add ingredients that give the vapor a taste and smell that is reminiscent of cigarette smoke. They do not contain tobacco, and according to e-cigarette distributors, the inhaled vapors do not contain cancer-causing chemicals. More than 300 firms are believed to be involved in the production and distribution of e-cigarettes.
“We can now market our product the way we always should have been able to,” Matt Salmon, CEO of Sottera Inc., told the Associated Press. “This is plain and simple an alternative to smoking for committed, longtime smokers.” Sottera markets electronic cigarettes known as NJOY.
Sottera and other e-cigarette distributors claim their products are ideal quit-smoking agents because they address the behavioral aspects of smoking, like holding the cigarette, inhaling from it, observing smoke come out from it, and so forth.
But Matthew Myers, the president of the Campaign for Tobacco-Free Kids released a statement saying that the court’s decision will permit “any manufacturer to put any level of nicotine in any product and sell it to anybody, including children, with no government regulation or oversight at the present time.”
“This ruling invites the creation of a wild west of products containing highly addictive nicotine,” Myers added.
The FDA is reviewing the court’s ruling.
Most e-cigarettes are imported from overseas. They hit worldwide markets in 2002 and became available in the US 4 years later. Industry spokespeople claim that 20,000 to 30,000 people try the products each week.