Electronic Cigarettes: E-Cigarettes Should Fall Under FDA Regulation, Says Court
RICHMOND, Va. — A federal appeals court says electronic cigarettes should be regulated as tobacco products by the Food and Drug Administration rather than as drug-delivery devices, which have more stringent requirements.
The ruling means their makers won't have to conduct expensive clinical trials to prove to the FDA that the products are safe and effective as a stop-smoking aid.
The decision is a setback to the FDA and other public health organizations, which had argued e-cigarettes should be regulated like nicotine replacement gum or patches. They also have warned that e-cigarettes contain dangerous chemicals and are being marketed to children.
A three-judge panel of the U.S. Court of Appeals in Washington backed a lower court ruling that the devices should be considered under the agency's authority over tobacco, which means they would follow the same restrictions as traditional cigarettes and tobacco products.
Some sellers of e-cigarettes sued the FDA last year after the agency told customs officials to refuse entry of shipments into the U.S. A federal judge ruled in January that the FDA can't stop those shipments, saying the agency had overstepped its authority.
E-cigarettes are plastic and metal devices that heat a liquid nicotine solution in a disposable cartridge, creating vapor that the "smoker" inhales. A tiny light on the tip even glows like a real cigarette.
Nearly 46 million Americans smoke traditional cigarettes. About 40 percent try to quit cold turkey or with other nicotine replacements each year, according to the Centers for Disease Control and Prevention. But unlike patches or gums, e-smokes have operated in a legal gray area.
Users and distributors say e-cigarettes address both the nicotine addiction and the behavioral aspects of smoking – the holding of the cigarette, the puffing, seeing the smoke come out and the hand motion – without the more than 4,000 chemicals found in a traditional cigarette.
First marketed worldwide in 2002 as an alternative to regular cigarettes, e-cigarettes didn't become easily available in the U.S. until late 2006. Now, the industry has grown from the thousands in 2006 to several million worldwide, with estimated 20,000 to 30,000 new e-smokers every week, according to Jason Healy, the president of e-cigarette maker Blu Cigs.
The FDA said the agency is reviewing the opinion and considering its next steps.
"We can now market our product the way we always should have been able to," Matt Salmon, the newly tapped CEO of Sottera Inc., which markets NJOY-branded electronic cigarettes, said in an interview with The Associated Press. "This is plain and simple an alternative to smoking for committed, longtime smokers."
Matthew L. Myers, president of the Campaign for Tobacco-Free Kids said in a statement that the decision will allow "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 said, urging the FDA to appeal the decision to the Supreme Court.
American Heart Association CEO Nancy Brown also voiced concern over the ruling.
"There is no scientific evidence that e-cigarettes are effective smoking cessation devices and, until they undergo rigorous evaluation by the Food and Drug Administration, they should be pulled from the marketplace," she said in a statement.
In September, the FDA issued warning letters to several makers of electronic cigarettes or its components, saying the companies are violating the law with unsubstantiated health claims and poor manufacturing practices.
The FDA also has said that its tests found the liquid in some electronic cigarettes contained toxic substances – besides nicotine, which is itself toxic in large doses – as well as carcinogens that occur naturally in tobacco. Most e-cigarettes are imported from overseas.
However, some public health experts say the level of those carcinogens was comparable to those found in nicotine replacement therapy, because the nicotine in all of the products is extracted from tobacco.