FDA Issues Warnings To E-Cigarette Makers 9/16/2010
(RTTNews) - The FDA has given five e-cigarette makers 15 days to improve their manufacturing operations and cease marketing their products as "stop smoking aids."
"The companies must demonstrate to the agency that their products are safe and effective for their intended use," FDA reps said at a news teleconference. "Also they must take steps to ensure the quality and purity of the products."
The reps added the companies are guilty of "practices which violate various provisions of the Federal Food, Drug, and Cosmetic Act."
According to FDA labeling and compliance chief Michael Levy, the warning is not intended to wipe e-cigarettes off the map but rather to ensure that consumers are getting a safe and effective product.
"We have not made a decision to remove all e-cigarettes from the market," Levy said. "The action today only concerns the products outlined in the warning letters. We did indicate in the letter to the Electronic Cigarette Association that we are interested in having manufacturers who make these products seek FDA approval of them."
by RTT Staff Writer
(RTTNews) - The FDA has given five e-cigarette makers 15 days to improve their manufacturing operations and cease marketing their products as "stop smoking aids."
"The companies must demonstrate to the agency that their products are safe and effective for their intended use," FDA reps said at a news teleconference. "Also they must take steps to ensure the quality and purity of the products."
The reps added the companies are guilty of "practices which violate various provisions of the Federal Food, Drug, and Cosmetic Act."
According to FDA labeling and compliance chief Michael Levy, the warning is not intended to wipe e-cigarettes off the map but rather to ensure that consumers are getting a safe and effective product.
"We have not made a decision to remove all e-cigarettes from the market," Levy said. "The action today only concerns the products outlined in the warning letters. We did indicate in the letter to the Electronic Cigarette Association that we are interested in having manufacturers who make these products seek FDA approval of them."
by RTT Staff Writer
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