FDA Attempt to Regulate E-Cigarettes as "Drugs" Label Goes Up in Smoke

Sometimes a cigar is just a cigar. It seems the Food and Drug Administration agrees with Freud's alleged assertion, announcing today that it would regulate e-cigarettes as cigarette/tobacco products and not under more stringent drug-device guidelines. The news comes as a victory for e-cigarette manufacturers, who had been under FDA scrutiny since September 2010. At that time, the FDA sent a letter to five electronic cigarette distributors, claiming that their products were being marketed illegally, and were subject to FDA approval as drugs. Under the Food, Drug, and Cosmetic Act, a company cannot claim that its drug can treat or mitigate a disease, such as nicotine addiction, unless the drug's safety and effectiveness have been proven. E-cigarette distributor companies Smoking Everywhere and Sottera sued the FDA after the FDA denied their e-cigarette products entry into the United States. The US District Court in DC found the FDA overstepped its authority in stopping the imports. An appeals court agreed, leading to the FDA's announcement today. The court held that e-cigarettes and other products made or derived from tobacco can be regulated as “tobacco products” under the act and are not drugs/devices unless they are marketed for therapeutic purposes. For now, e-cigarettes remain in a regulatory limbo, as the exact rules for regulation will not be known for some time. It generally takes federal agencies upward of 18 months to arrive at new regulations, depending on the volatility of the issue. E-cigarettes are essentially cigarette substitutions for smokers. They provide nicotine and general flavor, but in a vaporized liquid form that eliminates smoke, odors, and, according to the companies who make them, many carcinogens and other side effects of smoking tobacco cigarettes.