E-Cigs Win Court Ruling

Electronic cigarettes to be regulated by FDA as tobacco products, not drugs Dec. 10, 2010

WASHINGTON-- The Food & Drug Administration (FDA) can only regulate electronic cigarettes as tobacco products and not as drugs, and thus cannot block their import, a federal appeals court has ruled. According to a Reuters report, the ruling by three judges of the U.S. Court of Appeals for the D.C. Circuit will allow e-cigarette maker Sottera Inc. to start importing its NJOY products.

The court rejected the FDA's argument that NJOY e-cigarettes are drug delivery devices, the company said in a separate statement. Agreeing with Sottera's argument, the court ruled the company's [image-nocss] devices are tobacco products, which are subject to regulation, like traditional cigarettes, under the Family Smoking Prevention & Tobacco Control Act.

"Electronic cigarettes are battery-powered products that allow users to inhale nicotine vapor without fire, smoke, ash, or carbon monoxide," the court said in its ruling. "The liquid nicotine in each e-cigarette is derived from natural tobacco plants."

Congress gave the FDA authority to regulate tobacco products, but not to ban them, in 2009.

The ruling affirms a lower court decision from January. "The FDA's refusal to admit NJOY's products into the United States obviously destroyed the firm's ability in the United States to cover its costs for purchase or production of e-cigarettes," the appeals court said.

Scottsdale, Ariz.-based Sottera welcomed the ruling. "The ultimate impact of this court decision will be to lift the current import restrictions on NJOY electronic cigarettes and provide a regulatory framework for NJOY to make progress on its mission to be the most responsible electronic cigarette manufacturer on the market," the company said.

In September, the FDA sent warnings to five makers of electronic cigarettes, saying they were marketing them illegally as stop-smoking aids, and said it intended to regulate the products as drugs.

In October, e-cigarette maker Smoking Everywhere Inc. settled a civil suit brought by California by agreeing not to target sales and advertising to minors or to claim that its products are safe alternatives to tobacco. Sales of Smoking Everywhere products are banned outright to anyone under 18 years of age as part of the settlement.

The current case is Sottera Inc v. Food & Drug Administration, U.S. Court of Appeals, District of Columbia Circuit (Washington), No. 10-5032.

Click here to view the full text of the court document.

Members help make our journalism possible. Become a CSP member today and unlock exclusive benefits, including unlimited access to all of our content. Sign up here.