Lawyers for electronic cigarette distributors Smoking Everywhere and NJoy asked Judge Richard Leon at the U.S. District Court for the District of Columbia for a preliminary injunction that would lift the FDA’s embargo on their products.

Attorneys for Smoking Everywhere and NJoy told a federal judge on Monday that their clients do not market their products as a way to quit smoking, and that the Food and Drug Administration (FDA) was acting like “a dog chasing its own tail” as it tried to explain why it was barring shipments of the devices into the United States.
The companies sued the FDA in April, claiming the agency had erroneously classified e-cigarettes as unapproved drug devices, and banned imports of them into the states. At today’s hearing, Judge Leon asked the lawyers to explain how the recently passed Family Smoking Prevention and Tobacco Control Act, which brought cigarettes within FDA’s regulatory reach, might effect the case.
Thompson Hine partner Kip Schwartz, representing Smoking Everywhere, told the judge that the law made it clear that that the FDA was in the wrong. The act created a new regulatory category for tobacco-based products, he said. E-cigarettes couldn’t be regulated as drug devices, he said, because the companies did not claim their product improved users’ health, or effected the body any differently than smoking a normal cigarette. Schwartz was particularly insistent that e-cigarettes were not marketed as a way for users to get off nicotine.
Schwartz added that regulations for a drug device would be much more restrictive than for a tobacco-based product. He said the idea of regulating e-cigarettes differently from traditional tobacco products “didn’t pass the straight face test” given that they both do little but deliver nicotine. Justice Department attorney Drake Cutini, representing the FDA, contended that the e-cigarette companies were marketing their products using health claims, including customer testimonials that the devices helped them quit smoking. (pi)