Lautenberg Applauds FDA's Decision To Keep Up Fight To Regulate Electronic Cigarettes

Main Category: Smoking / Quit Smoking
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 04 Feb 2010 - 1:00 PDT

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Senator Frank R. Lautenberg (D-NJ), a longtime Senate leader in the fight against the tobacco industry, applauded the Food and Drug Administration's decision to continue their efforts to regulate electronic cigarettes. At Lautenberg's urging, the FDA is appealing a federal judge's ruling in the Smoking Everywhere case that the agency lacks the authority to regulate e-cigarettes as drug-device combinations.

"There have been no clinical studies to verify the safety of these products or the long-term health effects. To the contrary, FDA's own laboratory analyses of electronic cigarette samples found them to contain carcinogens and toxins such as antifreeze components," Lautenberg wrote in a letter to FDA Commissioner Margaret Hamburg. "I disagree with the decision in this case and support the FDA's position that electronic cigarettes are drug-device combinations."

In January, U.S. District Judge Richard J. Leon agreed with e-cigarette manufacturers Smoking Everywhere Inc. and NJoy that the FDA lacked the authority to regulate their products as drug-device combinations, a ruling that allowed their distribution to continue across the United States. FDA has the authority to ban unsafe drug-device combinations.

Sen. Lautenberg was the first to call on the FDA to protect the public from potential dangers of e-cigarettes. He wrote a letter to FDA Acting Commissioner Frank Torti in March 2009 urging that e-cigarettes be taken off the market until proven safe by the FDA.

Source
The Office of Senator Frank R. Lautenberg

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