FDA loses battle in war against e-cigarettes

Electronic cigarettes are nicotine-delivery devices that include a heating element that vaporizes chemicals in replaceable plastic cartridges. Researchers at the University of California, Riverside recently evaluated five e-cigarette brands and, finding design flaws, lack of adequate labeling, and several concerns about quality control and health issues, concluded that e-cigarettes are potentially harmful and urged regulators to consider removing e-cigarettes from the market until their safety is adequately evaluated.

This, however, did not deter a federal appeals court, which ruled on Tuesday that e-cigarettes are not drug-delivery devices but are more like mainstream tobacco products. Therefore, they do not need to go through rigid FDA trials, but can be regulated like regular cigarettes. Predictably, e-cigarette makers were happy about this ruling. But those who want to see potentially dangerous products heavily regulated or banned were not so happy.

"We're gravely concerned about the implications of today's ruling," the American Heart Association's chief executive, Nancy Brown, says in a statement. "The appeals court has cleared the way for the industry to peddle these products to consumers without any scrutiny as to their safety or efficacy. 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. With this ruling, e-cigarette manufacturers will continue to make misleading claims that their products can help smokers quit."

Matthew Myers, president of the Campaign for Tobacco-Free Kids, said it would take time for the FDA to assert its jurisdiction over e-cigarettes as tobacco products. "This 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," Myers says in a statement.
"We urge the government to appeal this ruling."

Bill Godshall, founder of Smokefree Pennsylvania, a nonprofit group supporting e-cigarettes, wrote in an e-mail message to The New York Times. "This is a huge victory for public health and civil justice. It's time for FDA officials to come to their senses by reclassifying (and promulgating reasonable regulations for) e-cigarettes as tobacco products."

Sounds like more showdowns await in higher courts.

- read about the ruling in The New York Times' Prescriptions blog
- and more coverage by Bloomberg
- and Reuters
- take a look at the UC Riverside study of e-cigarettes

Suggested Articles

The new digital Abilify is a breakthrough for Proteus Digital Health and its patient-tracking products, but not so much for Abilify's maker, Otsuka.

Adamis Pharmaceuticals' EpiPen contender Symjepi, which was rejected last year before the EpiPen havoc, won approval from the FDA.

Researchers in the U.K. have developed a technique to better predict results in liver cancer when drug-laden polymer beads are used to deliver medicines.