FDA may consider over-the-counter regulation for e-cigarettes

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Kent C

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"A group of public health advocates and pediatricians sued the FDA on Tuesday for delaying regulation of e-cigarettes and some tobacco products.

"Gottlieb said the groups waited until he acted on the parts of his overhaul they liked, then sued for the parts they didn't.

"If you're in favor of getting adults to quit smoking you can't turn a blind eye to the people who want to get access to nicotine," he said.

"At the very time I am trying to take nicotine out of combustible tobacco, I don't want to be sweeping the market of products that provide an alternative to smokers who want to get access to nicotine," Gottlieb said."
 

Bill Godshall

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Ever since Mitch Zeller want back to FDA in 2013, he has been trying to encourage drug companies (that market NRT products) to begin marketing e-cigarettes (even though Zeller's former financier GlaxoSmithKline halted its multi million dollar exclusive contract with Zeller's former employer Pinney Associates around the same time Zeller left Pinney to go to the FDA).

It might be less expensive to submit a new drug application to FDA for a cigalike e-cig (than it costs to submit PMTA and MRTP applications to FDA to market the same cigalike e-cig as a tobacco product), but I don't know any vapor manufacturer that plans to (or has even seriously considered) submit a new drug application to FDA for their cigalike e-cig.
 
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