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US biotech company 22nd Century Group has insisted that it plans to resubmit a very-low-nicotine cigarette (VLNC) to the Food and Drug Administration (FDA) by the end of this year, while rebutting criticisms made on an influential investment website.
22nd Century originally filed modified risk tobacco product applications (MRTPs) and premarket tobacco applications (PMTAs) for its “Brand A” product at the end of 2015 but withdrew them a year later.
It said then it had received helpful advice from the FDA, and now it intends to put Brand A forward for approval again.
The product, which is a cigarette made from tobacco but containing “95% less” nicotine than typical combustibles currently on the market, would have to pass through the PMTA process in order to be sold in the US at all.
Successfully completing the MRTP process, which is regarded as much more difficult, would allow Brand A to be marketed overtly as a reduced-risk product....