Lautenberg Urges FDA To Remove Electronic Cigarettes From The Market Until Proven Safe

Main Category: Smoking / Quit Smoking
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 24 Mar 2009 - 5:00 PDT

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Sen. Frank R. Lautenberg (D-NJ) urged the Food and Drug Administration (FDA) to take electronic cigarettes, or "e-cigarettes," off the market until they are proven safe by the federal agency.

Electronic cigarettes, alternatives to cigarettes and other tobacco products, are battery-powered devices that use a vapor to deliver nicotine to smokers. When the smoker inhales through the device, air flow is detected by a sensor, which activates a heating element that vaporizes a nicotine solution stored in the mouthpiece.

Manufacturers and retailers of these products claim that electronic cigarettes are safe, and even that these products can help smokers quit traditional cigarettes. However, no clinical studies have proven these products are effective in helping smokers quit smoking, nor have any studies considered the safety of these products' long-term health effects. While the FDA has indicated it will evaluate electronic cigarettes on a case-by-case basis, it has not taken any enforcement action against these products, which are currently being sold in mall kiosks across the country and on the Internet.

Sen. Lautenberg is one of the Senate's leaders in protecting Americans from the dangers of smoking. Sen. Lautenberg wrote the law banning smoking on airplanes, which helped trigger a broader smoke-free revolution. Sen. Lautenberg is also the author of a law banning smoking in buildings that house federally-funded facilities that serve children.

Sen. Lautenberg also worked to prohibit tobacco companies from using a Federal Trade Commission (FTC) cigarette testing method to market their cigarettes as "light" or "low-tar." Sen. Lautenberg uncovered a lengthy history of false and deceptive cigarette ratings and marketing methods used by the tobacco industry based on this inaccurate testing method. After years of pressure from Sen. Lautenberg, the FTC announced last November that tobacco companies are no longer allowed to use the outdated "FTC Method" of testing tar and nicotine levels as the basis for marketing claims of "light" and "low-tar" cigarettes.

Sen. Lautenberg's letter to the FDA on electronic cigarettes is attached and pasted below:

March 23, 2009

The Honorable Frank M. Torti
Acting Commissioner
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20903

Dear Acting Commissioner Torti:

I am writing to request that the Food and Drug Administration (FDA) take immediate enforcement action against manufacturers of "electronic cigarettes" and take these products off the market until they are proven safe. In numerous media reports, the FDA has indicated that these products are considered drug-device combinations under the Food, Drug, and Cosmetic Act, and therefore require prior approval by the FDA before being sold in the United States. However, e-cigarettes are currently being sold in mall kiosks across the country and on the Internet.

Electronic cigarettes are being marketed as alternatives to cigarettes and other tobacco products. They are usually battery-powered devices that use a vapor to deliver nicotine to the smoker. When the smoker inhales through the device, air flow is detected by a sensor, which activates a heating element that vaporizes a nicotine solution stored in the mouthpiece. This vapor may also be flavored and provide a physical sensation similar to that of inhaling tobacco smoke.

Manufacturers and retailers of these products claim that e-cigarettes are safe, and even that these products can help smokers quit traditional cigarettes. However, there have been no clinical studies to prove these products are effective at helping smokers quit, nor have any studies verified the safety of these products or their long-term health effects. The World Health Organization (WHO), in a release dated September 19, 2008, stated that, "WHO has no scientific evidence to confirm the product's safety and efficacy."

For these reasons, I believe the FDA must take immediate action to take these products off the market. Thank you for your consideration of this request, and I look forward to hearing from you.

Sincerely,

Sen. Frank R. Lautenberg (D-NJ)

Source
Sen. Frank R. Lautenberg

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