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.
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.