FDA Can’t Block E-Cigarettes, Court Says

A U.S. appeals court just ruled that the U.S. Food and Drug Administration (FDA) is only permitted to regulate electronic cigarettes—also known as <"http://www.yourlawyer.com/topics/overview/Electronic-Cigarettes">e-cigarettes—as tobacco products, not drugs, said Reuters. The ruling means that the FDA cannot block the devices’ import. In 2009, Congress allowed the FDA to regulate, but not ban, tobacco products, said Reuters.

The ruling by three judges of the U.S. Court of Appeals for the D.C. Circuit upset tobacco activist groups, said Reuters. “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,” it added, quoted Reuters.

The new ruling will also permit Sottera Inc. to begin importing its electronic cigarette NJOY products and also confirms a January decision made by a lower court, said Reuters. “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.

Naturally, Sottera Inc. is thrilled with 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,” said Sottera Inc. in a statement, quoted Reuters.

Consumer advocates are not pleased. Matthew Myers, president of the Campaign for Tobacco-Free Kids, said, “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,” quoted Reuters. “We urge the government to appeal this ruling,” added Myers.

In October Smoking Everywhere Inc., an e-cigarette maker settled a civil suit that was filed by the state of California by agreeing not to market to minors or claim its e-cigarettes provide a safer tobacco options, wrote Reuters. Also, as part of the settlement, sales of Smoking Everywhere products are illegal to people under 18 years of age, said Reuters.

The use of e-cigarettes, or electronic nicotine delivery systems, is on the rise globally, but with little information on related health effects. Electronic cigarettes burn and vaporize nicotine and other ingredients in its cartridge, via an aerosol created when heated. No information exists concerning the chemicals in the aerosolized vapors.

The batteries, atomizers, cartridges, cartridge wrappers, packs, and instruction manuals included with e-cigarette purchases do not contain critical information about ingredients, use, and important warnings. The cartridges can leak, releasing nicotine to children, adults, pets, and the environment. Nicotine, a key component in the manufacture of cigarettes, is an addictive and dangerous chemical and.

Because there are no way in which e-cigarette products and accessories, such as cartridges, are to be disposed, improper disposal could lead to nicotine contamination from discarded cartridges to water sources and soil. Manufacture, quality control, sales, and advertisement of the products is also not regulated.

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