E-cigarettes will get FDA oversight as tobacco products
The Food and Drug Administration announced Monday that it will act to ensure the government’s right to impose marketing, manufacturing and safety restrictions on “electronic cigarettes,” a nicotine delivery device widely billed as an alternative to cigarettes for those trying to quit and for smokers who can’t light up.
In a letter posted to the FDA’s website Monday, Dr. Lawrence R. Deyton, director of the FDA’s Center for Tobacco Products, said the agency will act to regulate e-cigarettes as tobacco products. To shore up its authority to do so, the agency will propose new regulatory language that would specifically define e-cigarettes as a tobacco product.
Electronic cigarettes do not burn tobacco directly, but allow a user to inhale heated nicotine derived from tobacco and suspended in a fluid canister. Instead of emitting tobacco smoke with a consumer’s use, electronic cigarettes and their users release only water vapor. While those who make and sell electronic cigarettes maintain the devices are far safer than smoking cigarettes, the FDA has begged to differ, noting that half of the 19 brands of e-cigarettes it sampled contained nitrosamines, a carcinogen found in real cigarettes, and many contained diethylene glycol, a poisonous ingredient in antifreeze.
The FDA’s move represents a fallback option for the agency, which had hoped to regulate electronic cigarettes as medical devices. The widespread marketing of e-cigarettes as an aid to quitting smoking, the FDA contended, made e-cigarettes a legitimate target for regulation as a medical device. But in a December 2010 court case, the U.S. Court of Appeals for the District of Columbia Circuit rejected the FDA’s claim, saying that while the agency arguably had a right to regulate e-cigarettes as tobacco products, they could not legitimately be considered medical devices because they are not primarily marketed as a smoking cessation device.
While the FDA has bowed to the court’s decision, the agency appears intent on taking the court at its word. If e-cigarettes cannot be construed as medical devices, then the FDA said it will consider “whether to issue a guidance and/or a regulation on ‘therapeutic’ claims.” If it takes such a step, the FDA could put a stop to any marketing of the enormously popular cigarette alternatives as an aid to help smokers kick the habit.
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