FDA Cracks Down on E-Cigarettes

Aug. 13, 2010— -- The U.S. Food and Drug Administration on Thursday sent warning letters to five manufacturers of electronic cigarettes, noting that from now on the popular nicotine-packed devices will be subject to regulation as drugs.

The companies that received warning letters were E-CigaretteDirect LLC, Ruyan America Inc., Gamucci America (Smokey Bayou Inc.), E-Cig Technology Inc. and Johnson's Creek Enterprises LLC.

"Under the [Federal 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,"said Michael Levy, director of the Division of New Drugs and Labeling Compliance for the FDA's Center for Drug Evaluation and Research at a press conference Thursday. "Yet all five companies claim without FDA review of relevant evidence that the products help users quit smoking cigarettes.

"These products are not considered safe and effective yet."

In at least one case, the warning letter issued to a manufacturer addressed concerns other than just nicotine. According to the FDA, E-Cig Technology also markets refill cartridges for the devices that contain tadalafil, an erectile dysfunction drug, and rimonabant, a weight loss drug that has not been approved for use in the United States.

The FDA also issued a letter to the Electronic Cigarette Association in which they said the agency intends to regulate electronic cigarettes and related products in the interest of protecting the public health.

"FDA invites electronic cigarette firms to work in cooperation with the agency toward the goal of assuring that electronic cigarettes sold in the United States are lawfully marketed," the letter to the association reads.

E-cigarettes look like cigarettes, taste like cigarettes, and provide the same nicotine buzz. But proponents of the devices have claimed that the electronic cigarette is a far cry from traditional smokes in that the battery-powered gadgets are practically carcinogen-free.

Still, while users call this product a "miracle" and a "lifesaver," health authorities have been wary of e-cigarettes. The FDA action follows moves by several states, including New Jersey, New York, and New Hampshire, to ban them.

The e-cigarette uses an internal atomizer to vaporize nicotine, offering a smokeless, odorless, experience that manufacturers say eliminates the many health problems associated with lighting up.

Affordable and readily available online by adults and minors alike, some argue that this product, which comes in flavors like chocolate or apple, is just another way for teens to get hooked on nicotine.

Other public health organizations in addition to the FDA, including the National Cancer Society and the American Lung Association, have publically denounced the unregulated device as potentially unsafe, but that hasn't stopped thousands of smokers from going electronic.

Citing lack of research, health authorities have been quick to speak out against e-cigarettes.

The American Cancer Society, Cancer Action Network, American Lung Association and others said in a statement on the product that "absent scientific evidence, these claims…that they are safer than normal cigarettes ... are in blatant in violation of FDA rules."

And suspicions about these unregulated devices are not unfounded. The FDA survey of e-cigarettes found that one brand, Smoking Everywhere, contained diethylene glycol, a toxic chemical found in antifreeze.