FDA Issues New Guidelines For E-Cigarette Manufacturers
by Robert Glisci, DDS, PC on 06/15/19
(CNN)The US Food and Drug Administration issued its final guidance for e-cigarette makers to submit premarket tobacco product applications, giving these companies a clearer path to seek official authorization to market their products, the agency announced Tuesday.
In doing so, companies must show that their products "would be appropriate for the protection of the public health," the agency says.
The announcement comes about a month after a federal judge ordered the agency to speed up its review of thousands of vaping products now on the market. That decision, part of an ongoing lawsuit filed by multiple health groups, said that the agency has acted illegally by allowing e-cigarettes to remain on the market until 2022 before requiring companies to apply for FDA authorization.
"There are no authorized e-cigarettes currently on the market," Acting FDA Commissioner Dr. Ned Sharpless said in a statement Tuesday, adding that the agency's oversight of such products "is critical to our public health mission and, especially, to protecting kids from the dangers of nicotine and tobacco-related disease and death."
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