Smoking Everywhere, Inc. announced that the U.S. District Court for the District of Columbia ruled in its favor Thursday, affirming that the company’s electronic cigarette product is legally considered a tobacco product and cannot be regulated by the U.S. Food and Drug Administration (FDA) as a drug.
Smoking Everywhere filed a lawsuit against the FDA in April 2009, claiming that inbound shipments of its products from overseas manufacturers had been denied entry into the United States, or had otherwise been detained, by order of the FDA on the ground that electronic cigarettes are an unapproved drug-device combination under the Food, Drug, and Cosmetic Act (FDCA). The court’s recent decision affirmed Smoking Everywhere’s assertion that its electronic cigarette is designed to compete with traditional burned tobacco products, rather than as a drug, as argued by the FDA.
“This is an important decision because it defines the scope of FDA authority under the Federal Food, Drug and Cosmetic Act, the newly enacted Family Smoking Prevention and Tobacco Control Act and properly frames the application of the laws regulating the use of tobacco products in the United States,” said Walt Linscott, Partner at Thompson Hine LLP, the law firm who argued the case.
Smoking Everywhere believes its electronic cigarette plays an important role in bringing an alternative to the use of smoked tobacco by providing the effect of a traditional cigarette without the more than 4,000 toxic and harmful compounds found in cigarette smoke.
“We’re hopeful that with the issuing of this ruling, the focus on the risk of our product can now properly turn to a comparison of our electronic cigarette product to the appropriate tobacco product benchmark, the smoke producing lit cigarette,” said Ray Story, Vice President of Sales and Operations, Smoking Everywhere, Inc.
Smoking Everywhere, Inc.